The MRI Patient Monitoring System (Model 865214) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. The MRI Patient Monitoring System (Model 865214) is intended for use by healthcare professionals.

Device Description

The modified device, MRI Patient Monitoring System (Model 865214), is substantially equivalent to the cleared device. Both devices are multi-parameter patient monitors intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. Both devices provide patient monitoring data for ECG. SpO2, respiration, non-invasive blood pressure (NIBP), invasive blood pressure (IBP), temperature, oxygen (O2), end-tidal carbon dioxide (EtCO2), and anesthetic agents. The modifications to the cleared device are only in regards to the temperature parameter, specifically the reusable temperature sensor.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Invivo MRI Patient Monitoring System (Model 865214), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Cleared Device)	Modified Device Performance (Acceptance Criteria)
Temperature Accuracy (outside MR bore)	±0.5℃ (±0.9ºF)	±0.5℃ (±0.9ºF)
Temperature Accuracy (inside MR system magnet bore)	±0.5℃ (±0.9ºF) (Implied, as this was the previous spec for the single-use sensor)	Up to a -0.5℃ shift (-1.0℃ to 0.0°C, -1.8°F to 0.0°F)

Note: The document explicitly states that the modifications only pertain to the temperature parameter, specifically the reusable temperature sensor. Therefore, the acceptance criteria and performance for other vital signs (ECG, SpO2, NIBP, IBP, end-tidal CO2 (ETCO2), oxygen (O2), and anesthetic agents) are presumed to remain unchanged from the cleared device and are not detailed in this submission as they were not re-evaluated.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the "sample size" in terms of number of patients or individual measurements for the performance verification tests. It refers generally to "results of the complete verification and validation" for performance specifications and "the modified device's reusable temperature sensor was evaluated" for MRI conditions of use.

Data Provenance: The studies were conducted by Invivo Corporation as part of their verification and validation process for the modified device. The studies were likely internal, prospective tests, rather than retrospective analysis of patient data. The country of origin for the data is not specified, but the manufacturer is based in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable. The ground truth for this device modification (temperature sensor accuracy) was established against calibrated reference standards and physical measurements, not through expert consensus on medical images or clinical observations.

4. Adjudication Method for the Test Set

Not Applicable. As the ground truth was established through physical measurements and calibrated equipment, an adjudication method for human reviewers is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This was not an MRMC study. The device is a physiological monitor, not a diagnostic imaging device requiring human interpretation for its primary function. Its performance was assessed against technical specifications and standards.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes. The performance evaluation was a standalone assessment of the device's measurement capabilities. There is no "human-in-the-loop" performance being evaluated in this context. The device directly measures physiological parameters.

7. The Type of Ground Truth Used

Calibration Standards and Physical Measurements: For temperature accuracy, the ground truth would have been established using highly accurate, calibrated temperature reference devices and control environments (e.g., water baths, environmental chambers). For MRI conditions of use, physical measurements and established protocols (e.g., using a thermocouple for RF heating, measuring displacement force in a magnetic field) would have constituted the ground truth.

8. The Sample Size for the Training Set

Not Applicable. This is a hardware device modification and its performance was evaluated through engineering verification and validation, not through machine learning or AI models that require training data.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. (See point 8).

Summary

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K132359

Section 5

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510(k) Summary

SUBMITTER INFORMATION 1.

Establishment / Sponsor Name:	Invivo Corporation
Establishment / Sponsor Address:	12151 Research ParkwayOrlando, FL 32826 USA
Manufacturer Name:	Philips Medical Systems
Manufacturer Address:	3000 Minuteman RoadAndover, MA 01810 USA
Company Phone:	(407) 455-6166	AUG 30 2013
Company Fax:	(407) 249-2022
Person to contactregarding questions:	Rusty KellySr. Quality & Regulatory Manager, Invivo Corporation(407) 455-6166Rusty.Kelly@philips.com
EstablishmentRegistration Number:	1051786 (Sponsor)1218950 (Manufacturer)
Date Summary Prepared:	July 15, 2013

2. MODIFIED DEVICE IDENTIFICATION

Trade / Proprietary Name:	Expression MRI Patient Monitoring System (Model 865214)
Common name:	MRI Patient Monitoring System
Classification name:	Cardiac monitor (including cardiotachometer and rate alarm)(21 CFR 870.2300, Product Code MWI)

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3. IDENTIFICATION OF LEGALLY MARKETED CLEARED DEVICE

The MRI Patient Monitoring System (Model 865214) is substantially equivalent to the following cleared device:

Cleared Device	Manufacturer	510(k) No.	Clearance Date
MRI Patient Monitoring System(Model 865214)	Invivo Corporation	K124061	Feb 22, 2013

4. MODIFIED DEVICE DESCRIPTION

The modified device. MRI Patient Monitoring System (Model 865214), is substantially equivalent to the cleared device. Invivo began marketing the cleared device, MRI Patient Monitoring System (Model 865214) in 2009. In 2012 Invivo identified the opportunity to reduce healthcare costs by replacing the temperature option which was an Ethylene Oxide (EO) sterilized. single-use temperature sensor with a reusable temperature sensor that utilizes single-use, gamma irradiated sterilized jackets (sheath) and submitted a special 510(k) which received clearance to market on Feb 22, 2013.

Since February 22, 2013 we have determined that the production process used to manufacture the temperature sensor is not able to meet the necessary production vield. Therefore, the production process has been modified to improve yield. The modifications to the production process have indirectly affected the measurement accuracy of the reusable temperature sensor within the MRI environment as described below.

The modified device, MRI Patient Monitoring System (Model 865214) and the cleared device, also identified as MRI Patient Monitoring System (Model 865214) which received clearance to market under 510(k) K124061 on February, 22 2013, are identical with respect to indications for use, intended use, fundamental scientific technology, software architecture, and design. Both devices are multi-parameter patient monitors intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. Both devices provide patient monitoring data for ECG. SpO2, respiration, non-invasive blood pressure (NIBP), invasive blood pressure (IBP), temperature, oxygen (O2), end-tidal carbon dioxide (EtCO2), and anesthetic agents.

The modifications to the cleared device are only in regards to the temperature parameter, specifically the reusable temperature sensor. The primary differences between the MRI Patient Monitoring System (Model 865214) and the cleared device are listed below:

The accuracy of the cleared device is ±0.5℃ (±0.9ºF). whereas the accuracy . of the modified device is ±0.5°C (±0.9°F) except inside the MR system magnet bore where the magnetic field creates up to a -0.5℃ shift (-1.0℃ to 0.0°C. -1.8°F to 0.0°F)
. Device labeling has been updated to reflect the modified measurement accuracy accordingly.

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The differences between the modified device, MRI Patient Monitoring System (Model 865214), and the cleared device are explained in greater detail in Section 12, the Substantial Equivalence Discussion, which includes a comparison table. No modifications have been made to the software or design of the patient monitor itself or the single-use jacket (sheath) used with the temperature sensor including its sterilization method.

ട്. INTENDED USE

The intended use of the modified device, as described in its labeling, has not changed from that of the cleared device as a result of the modification.

FUNDAMENTAL SCIENTIFIC TECHNOLOGY SUMMARY 6.

The fundamental scientific technology employed in the operation of the MRI Patient Monitoring System (Model 865214) as modified, has not changed from that of the cleared device as a result of the modification. A detailed explanation of the fundamental scientific technology is provided in Section 11 of this submission.

NON-CLINICAL PERFORMANCE DATA SUMMARY 7.

The performance data referenced in this submission establishes substantial equivalence of the modified device, the MRI Patient Monitoring System (Model 865214), to the cleared device which received market clearance on February 22nd, 2013 under 510(k) K124061. The modified device was evaluated to the following safety and performance tests:

I. Voluntary consensus standards
II. Verification and validation of performance specifications
III. Verification and validation of MR conditions of use

In all testing, the device was verified using a worst-case environment.

【. Voluntary Consensus Standards
- The MRI Patient Monitoring System (Model 865214) was evaluated to the following voluntary standards. where applicable to the modifications, per FDA Guidance titled "Use of Standards in Substantial Equivalence Determination". Standards are listed in Section 1 of the CDRH Premarket Review Submission Cover Sheet included in this submission. A declaration of conformity to the recognized consensus standards is included in Section 9 of this submission with a Standards Summary Report Table noting deviations and adaptions. Additionally, the Standards Data Reports for 510(k) for each voluntary standard (based on Form FDA 3654 (09/07)) is included in Section 21 of this submission.

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. IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety
IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General . Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests
. IEC 60601-1-6, Medical electrical equipment - Part 1-4: General requirements for safety -- Collateral standard: Usability
. IEC 60601-2-49, Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
. ASTM E1112-00. Standard specification for electronic thermometer for intermittent determination of patient temperature
ISO 14971. Medical devices Application of risk management to . medical devices
. ASTM F2503-08, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
ASTM F2052-06, Standard Test Method for Measurement of . Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
. BS EN 12470-4, Clinical thermometers. Performance of electrical thermometers for continuous measurement
ISO 10993-1, Biological evaluation of medical devices Part 1: . Evaluation and testing in the risk management process
ISO 10993-5, Biological evaluation of medical devices Part 5: Tests . for in vitro cytotoxicity
. ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity

The results of the testing performed in accordance with the Voluntary Consensus Standards listed above demonstrate that the modified device is as safe and effective as and substantially equivalent to the cleared device. Evidence of this is documented in Section 18 of this submission.

II. Verification and Validation of Performance Specifications Temperature measurement parameters of the MRI Patient Monitoring System (Model 865214) were verified according to the performance specifications defined by Invivo Corporation according to national standards, international standards, market needs, risk management, and intended use.

Results of the complete verification and validation indicate that the modified device operates as intended within the performance specifications. Clinical data was not required to substantiate claims of safety and effectiveness. Performance data is available throughout Section 18 and the risk assessment is available in Section 22 to support our claims of safety and effectiveness and determination of substantial equivalence. Based upon the design validation and risk assessment,

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specifications and labeling modifications do not raise new concerns regarding safety or effectiveness of the modified device.

Verification and validation of the other vital sign parameters-ECG, SpO2, NIBP, IBP, end-tidal CO2 (ETCO2), oxygen (O2), and anesthetic agents- are not required because the device modifications pertain only to the temperature parameter, specifically the reusable temperature sensor.

】【】【】】】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】 Verification and Validation of MRI Conditions of Use

The MRI conditions of use of the modified device are defined by Invivo Corporation according to national standards, international standards, intended use, risk management, and market needs. The modified device's reusable temperature sensor was evaluated for magnetically induced displacement force, proton emissions, image artifact, and RF heating. Details are provided in Section 18.

Test results demonstrate that the MRI Patient Monitoring System (Model 865214) meets the MRI conditions of use as defined in the modified device labeling.

CONCLUSION OF SUBSTANTIAL EQUIVALENCE 8.

The modified device, described in this submission is substantially equivalent to the cleared device. This conclusion is based on the guidance provided in the FDA Guidance Documents:

Deciding When to Submit a 510(k) for a Change to an Existing Device (Issued . January 10, 1997)
. 510(k) "Substantial Equivalence" Decision Making Process (last updated April 25, 2009)
. Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers (issued March 1993)

The modifications do not affect the indications for use. Clinical data was not necessary to establish safety and effectiveness for the purpose of substantial equivalence of the cleared device, and design validation did not raise new questions regarding the safety and effectiveness of the modified device. Specifications and labeling modifications do not raise new concerns regarding safety or effectiveness. Performance data is available throughout Section 18 and the risk assessment is available in Section 22 to support our claims of safety and effectiveness and determination of substantial equivalence.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Image /page/5/Picture/3 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services.

August 30, 2013

Invivo Corporation Rusty Kelly 12151 Research Pkwy Orlando, FL 32826 US

K132359 Re: Trade/Device Name: MRI Patient Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Monitor, Physiological, Patient ( Without Arrhythmia Detection or Alarms) Regulatory Class: II Product Code: MWI Dated: July 15, 2013 Received: August 2, 2013

Dear Rusty Kelly:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices 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 of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Rusty Kelly

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Owen-Paris-S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: MRI Patient Monitoring System (Model 865214)

Indications for Use: The MRI Patient Monitoring System (Model 865214) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.

The MRI Patient Monitoring System (Model 865214) is intended for use by healthcare professionals.

Prescription Use: AND/OR Over-the Counter Use: X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by
Owen Faris -S
Date: 2013.08.30
14:53:29-04'00'

Page of

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).