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0(D1.K124061InvivoPageof 5invivoFEB222013SUBMITTER INFORMATIONEstablishment / Sponsor Name:Establishment / Sponsor Address:Invivo Corporation12151 Research ParkwayOrlando, FL 32826 USAManufacturer Name:Manufacturer Address:Philips Medical Systems3000 Minuteman RoadAndover, MA 0 18 10Company Phone:(407) 275-3220Company Fax:(407) 249-2022Person to contactregarding questions:EstablishmentRegistration Number:Date Summary Prepared:2.1Rusty KellySr. Quality & Regulatory Manager, Invivo Corporation(407) 455-6166Rusty.Kelly philips.com1051786 (Sponsor)1217116 (Manufacturer)August16 1h,2012MODIFIED DEVICE IDENTIFICATIONTrade / Proprietary Name:MRI Patient Monitoring System (Model 865214)Common name:MRM Patient Monitoring SystemClassification name:Cardiac monitor (including cardiotachometer and rate alarm)(21 CER 870.2300, Product Code MWI)Page 5-1

K124061Page 2 of 53.IDENTIFICATION OF LEGALLY MARKETED CLEARED DEVICEThe MRI Patient Monitoring System (Model 865214) is substantially equivalent to thefollowing cleared device:ICleared DeviceMRI Patient Monitoring System(Model 865214)4.IManufacturerInvivo CorporationI510(k) No.K09078511Clearance DateDec 15, 2009MODIFIED DEVICE DESCRIPTIONThe modified device, MRJ Patient Monitoring System (Model 865214), is substantiallyequivalent to the cleared device.Invivo has marketed the cleared device, MRI Patient Monitoring System (Model865214), since 2009. Invivo identified the opportunity to reduce healthcare costs byreplacing the current temperature option which is an Ethylene Oxide (EO) sterilizedsingle-use temperature sensor with a reusable temperature sensor that utilIizes single-usegamma irradiated sterilized jackets (sheath).The modified device, MRI Patient Monitoring System (Model 865214) and thepreviously cleared device, also identified as MRI Patient Monitoring System (Model865214) which received clearance to market under 5 10(k) K090785 on December, 152009, are identical with respect to indications for use, intended use, fundamentalscientific technology, software architecture and design. Both devices are multi-parameterpatient monitors intended for use by healthcare professionals to monitor vital signs forpatients undergoing Mid procedures and to provide signals for synchronization for theMR] scanner. Both devices provide patient monitoring data for EGG, SpO2, respiration,non-invasive blood pressure (NIBP), invasive blood pressure (IBP), temperature, oxygen(02), end-tidal carbon dioxide (EtCO2), and anesthetic agents.The modifications to the previously cleared device are only in regards to thetemperature parameter. The primary differences between the Mi Patient MonitoringSystem'(Model 865214) and the previously cleared device are listed below:* Body temperature measurement is completed with a reusable sensor that iscovered with a sterilized jacket (sheath)(rather than a single-use sterilizedsensor).* Sterilization method is Gamma Radiation (rather than Ethylene Oxide (EO))." The reusable sensor is not sterilized. Labeling of the sensor including theinstructions for use (IFU) identify the need to use a sterile jacket (sheath).* Product labeling and the IFU have been updated to reflect the modificationsaccordinglyThe differences between the modified device, MRI Patient Monitoring System (Model865214) and the previously cleared device are explained in greater detail in Section 12,the Substantial Equivalence Discussion, which includes a comparison table.Page 5-2

K124061Page 3 of 5INTENDED USE5.The intended use of the modified device, as described in its labeling, has not changedfrom that of the cleared device as a result of the modification.The MRI Patient Monitoring System (Model 865214) is intended to monitor vital signsfor patients undergoing MRI procedures and to provide signals for synchronization forthe MMI scanner. The MRI Patient Monitoring System (Model 865214) is intended foruse by healthcare professionals.FUNDAMENTAL SCIENTIFIC TECHNOLOGY SUMMARY6.The fundamental scientific technology employed in the operation of the MRI PatientMonitoring System (Model 865214) as modified, has not changed from that of thepreviously cleared device as a result of the modification. A detailed explanation of thefundamental scientific technology is provided in Section I1I of this submission.7.NON-CLINICAL PERFORMANCE DATA SUMMARYThe performance data referenced in this submission establishes substantial equivalence ofthe modified device, the MMI Patient Monitoring System (Model 865214), to thepreviously cleared device which received market clearance on December 15 th, 2009 in5 10(k) K090785. The modified device was evaluated to the following safety andperformance tests:1. Voluntary standards11.Verification and validation of performance specifications111.Verification and validation of MR conditions of useIn all testing, the device was verified using a worst-case environment.1.Voluntary StandardsThe MMI Patient Monitoring System (Model 865214) was evaluated to thefollowing voluntary standards where applicable to the modifications per FDAGuidance titled "Use of Standards in Substantial Equivalence DeterminationStandards are listed in Section 1 of the CDRI- Premarket Review SubmissionCover Sheet included in this submission. A declaration of conformity to therecognized consensus standards is included in Section 9 of this submission with aStandards Summary Report Table noting deviations and adaptions. Additionally,the Standards Data Reports for 510(k) for each voluntary standard (based on FormFDA 3654 (09/07)) is included in Section 21 of this submission.*IEC 60601-I1, Medical Electrical Equipment - Part 1: GeneralRequirements for Safety* IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: GeneralRequirements for Safety - Collateral Standard: ElectromagneticCompatibility -- Requirements and TestsPage 5-3

K124061Page 4 of 5*****"**"*JEC 60601-1-6, Medical' electrical equipment - Part 1-4: Generalrequirements for safety -- Collateral standard: UsabilitylEG 60601-2-49, Medical electrical equipment - Part 2-49: Particularrequirements for the basic safety and essential performance ofmultifunction patient monitoring equipmentASTM El 1112-00, Standard specification for electronic thermometerfor intermittent determination of patient temperature1S0 1497 1, Medical devices - Application of risk management tomedical devicesASTM F2503-08, Standard Practice for Marking Medical Devices andOther Items for Safety in the Magnetic Resonance EnvironmentASTM F2052-06, Standard Test Method for Measurement ofMagnetically Induced Displacement Force on Medical Devices in theMagnetic Resonance Environment.BS EN 12470-4, Clinical thermometers. Performance of electricalthermometers for continuous measurementISO 10993-1, Biological evaluation of medical devices Part]1:Evaluation and testing in the risk management processISO 10993-5, Biological evaluation of medical devices PartS5: Testsfor in vitro cytotoxicityISO 10993- 10, Biological evaluation of medical devices Part 10: Testsfor irritation and delayed-type hypersensitivityThe results of the testing performed in accordance with the VoluntaryStandards listed above demonstrated that the modified device is as safe andeffective as the previously cleared device. Evidence of this is documented inSection 18 of this submission.I. Verification and Validation of Performance SpecificationsTemperature measurement parameters of the MRI Patient Monitoring System(Model 865214) were verified according to the performance specificationsdefined by Invivo Corporation according to national standards, internationalstandards, market needs, risk management, and intended use. The Verificationand Validation Protocol for the specifications which are modified from thecleared device are provided in Section 18 of this submission.Results of the complete verification and validation indicate that the modifieddevice operates as intended within the performance specifications. The results donot raise issues regarding the safety and effectiveness of the device and clinicaldata was not required to substantiate claims of safety and effectiveness.Verification and validation of the other vital sign measuring parameters were notrequired because the modifications made to the cleared device were only inregards to the temperature parameter.Page 5-4

K124061Page 5 of 5111.Verification and Validation of MRI Conditions of UseThe MR conditions of use of the modified device are defined by InvivoCorporation according to national standards, international standards, intended use,risk management, and market needs. The modified device's reusable temperaturesensor was evaluated for magnetically induced displacement force, protonemissions, image artifact, and RF heating. Details are provided in Section I8.Test results demonstrate that the MRI Patient Monitoring System (Model 865214)meets the MR conditions of use as defined in the modified device labeling.CONCLUSION OF SUBSTANTIAL EQUIVALENCE8.The modified device, described in this submission is substantially equivalent to thepreviously cleared device. This conclusion is based on the guidance provided in the FDAGuidance Documents:aDeciding When to Submit a 5 10(k) for a Change to an Existing Device (IssuedJanuary 10, 1997),a Draft Guidance: 5 10(k) Device Modifications: Deciding When to Submit a 510(k)for a Change to an Existing Device (Issued July 27, 2011), and* 510(k) "Substantial Equivalence" Decision Making Process (last updated AprilI25,2009)*Guidance on the Content of Premarket Notification [5 10(K)] Submissions forClinical Electronic ThermometersThe modifications do not affect the indications for use. Clinical data was not necessaryto establish safety and effectiveness for the purpose of substantial equivalence of thepreviously cleared device, and design validation did not raise new questions regarding thesafety and effectiveness of the modified device. Design and labeling modifications donot raise new safety or effectiveness questions. Performance data is available throughoutSection 18 to support out claims of safety and effectiveness, and determination ofsubstantial equivalence.Page 5-5

DEPARTMENT OF HEALTH & HUMAN SERVICESPublic Health ServiceFood and Dnug Administration10903 New Hampshire AvenueDocument Control Center - W066-G609Silver Spring, MD 20993-0002February 22, 2013Invivo Corporationc/o Mr. Jeff D. RongeroUnderwriters Laboratories, Inc.12 Laboratory Dr.Research Triangle Park, NC 27709Re: K 124061Trade/Device Name: MRI Patient Monitoring System (Model 865214)Regulation Number: 21 CFR ยง870.2300Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm)Regulatory Class: Class 11 (two)Product Code: MWIDated: January 30, 2013Received: February 6, 2013Dear Mr. Jeff D. Rongero:We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstateprior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA) You may, therefore, market the device, subject to the general controls provisions of the Act.The general controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CDRH does not evaluate information related to contract liabilitywarranties. We remind you; however, that device labeling must be truthful and not misleading.-commerceIf your device is classified (see above) into either class 11 (Special Controls) or class III (PMA), itmay be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 2 1, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You must

Page 2 -Mr. Jeff D. Rongerocomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CER Part 801); medical device reporting (reporting of medicaldevice-related adverse events) (21 CER 803); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CER Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000- 1050.If you desire speci fic advice for your device on our labeling regulation (21 CER Part 801), pleasego to DRHOffices/ucm II 5809.htm forthe Center for Devices and Radiological Health's (CDRI-'s) Office of Compliance. Also, pleasenote the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (21CFR Part 803), please go aProblem/default.htm for the CDRH' s Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.You may obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-free number(800) 63 8-2041 or (301) 796-7100 or at its Internet esforYou/Industry/default.htm.Sincerely yours,Owel 4'.1JF ris -SforEnclosureBrain ZuckermanDirector of Division of Cardiovascular DevicesOffice of Device EvaluationCenter for Devices andRadiological Health

Indications for Use510(k) Number (if known): K124061Device Name: MRI Patient Monitoring System (Model 865214)Indications for Use: The MRI Patient Monitoring System (Model 865214) is intended tomonitor vital signs for patients undergoing MRI procedures and to provide signals forsynchronization for the Mid scanner.The Mid Patient Monitoring System (Model 865214) is intended for use by healthcareprofessionals.Prescriptioun Use:X(Part 21 CFR 801 Subpart D)AND/OR(PLEASE DO NOT WRITE BELOW THIS LINE-Over-the Counter Use:(21 CFR 807 Subpart CQCONTINUE ON ANOTHER PAGE IF NEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE)Page- of-Page 4-1