The MRI Patient Monitor (Model 865353) is intended to monitor vital signs for patients undergoing MRI procedures. The MRI Patient Monitor (Model 865353) is intended for use by healthcare professionals.

Device Description

The MRI Patient Monitor (Model 865353) is substantially equivalent to the cleared device. Invivo has marketed a stand-alone pulse oximeter for the last 20 years as cleared to market in K864730 (Invivo Pulse Oximeter, Model 4500). This technology is over 20 years old and has not changed in design or fundamental technology since cleared to market. Invivo has identified the need to market an improved standalone pulse oximeter as a replacement for this device. The modified device is predicated from the MRI Patient Monitoring System (Model 865214) which received clearance to market under 510(k) K090785 on December 15, 2009. The cleared device consists of a processing unit, display, and wireless SpO2 module which is directly connected to the patient by a fiber optic sensor, clip, and grip. All oximetry data collection and processing is completed by the wireless SpO2 module and fiber optic sensor. The module transmits the patient data to the processing unit using telemetry, and the processing unit transmits the data to the display using telemetry. The modified device incorporates the same wireless SpO2 module and fiber optic sensor that is currently used with the cleared device. In the modified device, the module transmits the data directly to the display using telemetry. The following modifications have been incorporated to create the modified device: The display was reduced in size and weight. The operator interface is a touch screen (instead of a rotary knob and keypad). SpO2, pulse rate (derived from SpO2), and perfusion index parameters only are measured and displayed. The following parameters are no longer measured and displayed: ECG, non-invasive blood pressure, invasive blood pressure, respiration, temperature, end-tidal CO2, and anesthetic agents concentrations. The device does not provide signals for synchronization for the MRI scanner ("gating"). "Gating", or lack thereof, has no effect on patient monitoring ability or quality. The display is battery-operated only. The display does not offer connections to AC mains. The radio printed circuit board layout was reduced in size to accommodate the smaller display size. The display radio antenna was reduced in size to accommodate the smaller display size and the antenna was concealed in the device handle. The module used with the device also communicates with the existing cleared MRI Patient Monitoring Systems, Models 865214 and 3160. The operating platform was modified to the MicroBlaze soft-core microprocessor running on the Spartan 6LX45 FPGA. The operational system was modified to the uC ("micro C") from company Micrium. The display was modified to provide unlatched alarms only. Latched alarms are no longer provided. The intelligent battery charger is located in the battery (instead of in the device). The modified device has the same performance specifications (SpO2 operating range and accuracy) and uses the same patient applied parts (wireless SpO2 module, fiber optic sensor, clips, and grips) as the cleared device. The MRI Patient Monitor consists of the following primary components: Display ("Vital Signs Viewer"), Wireless SpO2 Module, SpO2 Sensor, SpO2 Grips and Clips. The display and SpO2 module enclose the transceiver and antennas that support bi-directional 2.4 GHz wireless communication. The modified device's operator interface consists of a color 5.7-inch LCD display and touch screen. The modified device's display provides the same vital sign information regarding SpO2, generates the same types of alarms (audible, lights, and text), and controls the same functions (alarm limits, patient type, display setup, and network selection) as the cleared device.

AI/ML Overview

This document is a 510(k) summary for the Invivo Essential MRI Patient Monitor (Model 865353). It describes the device, its intended use, and its substantial equivalence to a previously cleared device (Invivo MRI Patient Monitoring System, Model 865214, K090785). The submission primarily focuses on demonstrating that modifications made to the predicate device do not raise new questions of safety or effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, not on proving general safety and effectiveness through de novo clinical trials. The document explicitly states: "The results do not raise issues regarding the safety and effectiveness of the device and clinical data was not required to substantiate claims of safety and effectiveness." Therefore, many of the typical clinical study components (like expert consensus for ground truth, MRMC studies, standalone performance studies with large patient datasets) are not applicable or not explicitly detailed in this type of submission. The focus is on demonstrating that the modified device's performance aligns with the predicate, especially in critical areas like SpO2 accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal "acceptance criteria" table in the sense of a clinical trial endpoint. Instead, it refers to compliance with standards and equivalence to the predicate device's established performance. The key performance specifications for SpO2 are considered unchanged from the predicate device.

Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (Modified Device)
Pulse Oximetry (SpO2) Saturation Range: 1-100%	IDENTICAL TO CLEARED DEVICE (1-100%)
Pulse Oximetry (SpO2) Saturation Accuracy: ±3% at 70-100%	IDENTICAL TO CLEARED DEVICE (±3% at 70-100%)
Pulse Rate Range: 30-250 BPM	IDENTICAL TO CLEARED DEVICE (30-250 BPM)
Pulse Rate Accuracy: ±2% or 1 BPM, whichever is greater	IDENTICAL TO CLEARED DEVICE (±2% or 1 BPM, whichever is greater)
MR Conditional: According to ASTM F2503	Device is MR Conditional according to ASTM F2503
Wireless Communication Functionality, Technology, Operating Performance: (Specifics on RF Output Power, Frequency Range, FCC Approvals for SpO2 Module)	IDENTICAL TO CLEARED DEVICE (wireless SpO2 module including its radio)
General Safety: Compliant to IEC 60601-1, -1-2, -1-4, -1-6, -1-8	Complies to the requirements in these standards.
Alarm System: Compliant to IEC 60601-1-8	Compliant to IEC 60601-1-8 (unlatched alarms only)
Biocompatibility: ISO 10993-1	Demonstrated through risk management analysis and evaluation of modified device against history of cleared devices.
Risk Management: ISO 14971	Demonstrated by risk management summary.

Explanation: The fundamental premise of this 510(k) is that the core SpO2 measurement technology (module, technology, patient-applied parts, algorithm, and software) is identical to the cleared predicate device. Therefore, its performance in these aspects is assumed to be the same and does not require re-validation. The validation efforts for the modified device focused on ensuring that the changes (smaller display, touch screen, reduced parameters, battery-operated display, modified radio layout, etc.) did not negatively impact safety or the existing performance specifications.

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

Given this is a 510(k) for a modified device and "clinical data was not required," specific sample sizes for a traditional test set (e.g., patient data for algorithm evaluation) are not provided.

The "test set" in this context refers to various engineering and functional tests:

Verification and validation of performance specifications: Protocols were established for modified specifications.
Verification and validation of MR conditions of use: This involved testing using "3.0T and 1.5T magnetic fields, simulators, and test equipment under the most extreme use conditions." No human subject sample size is mentioned for these MR compatibility tests.
Environmental testing: Conducted to confirm conformity over device use life.
Evaluation of wireless technology: FCC Part 15 testing and integrity validation of wireless communication.

Data Provenance: The data provenance is from in-house engineering testing (Invivo Corporation) and third-party laboratory testing for standards compliance (e.g., IEC 60601 series). It is entirely prospective in the sense that the new device was built and then specifically tested against established standards and internal specifications. There is no mention of external data or patient data from a specific country of origin in the context of device performance evaluation.

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

This information is not applicable and not provided in the document. For 510(k) submissions focusing on substantial equivalence of a modified device, especially one where "clinical data was not required," the ground truth is established by:

Engineering specifications and national/international standards (e.g., ISO 9919 for pulse oximeters, IEC standards for electrical safety).
The performance of the legally marketed predicate device.

No medical experts are mentioned as establishing ground truth for performance testing of this device.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or patient outcomes, often with multiple human readers. The tests described are engineering and compliance tests (e.g., electrical safety, MR compatibility, wireless function), where results are objective and measured against predefined limits or standards, not subject to subjective expert interpretation requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

An MRMC comparative effectiveness study was not done. This type of study is relevant for AI/CADe devices that assist human interpretation of medical images. The Invivo MRI Patient Monitor is a vital signs monitor, not an imaging analysis device with an AI component designed to assist human readers, and it explicitly states that "clinical data was not required."

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

A standalone performance evaluation of the SpO2 algorithm was not done for the modified device, per se. The document states: "Verification and validation of SpO2 accuracy in the modified device is not required because the SpO2 module, technology, patient-applied parts, algorithm, and software is the same as the cleared device." This implies that the standalone performance of the SpO2 algorithm was established during the clearance of the predicate device (K090785) and is considered identical in the modified device.

The "standalone" performance that was evaluated for the modified device focused on its new components and functionalities separate from core SpO2 algorithm, such as:

The display (size, resolution).
The operator interface (touch screen).
The new radio layout and antenna.
The operating platform and system.
MR compatibility.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the core physiological measurements (SpO2, pulse rate) relies on the established accuracy and performance of the predicate device's SpO2 module, technology, algorithm, and software, which are stated to be identical. This performance would have originally been validated against a reference standard for pulse oximetry, likely involving subjects in a controlled hypoxia study, as per ISO 9919. However, this specific validation against a "ground truth" was not repeated for the modified device.

For the other aspects, the ground truth was based on:

National and international standards: e.g., IEC 60601 series for safety, ISO 9919 for pulse oximeters, ASTM F2503 for MR compatibility.
Internal performance specifications: Defined by Invivo Corporation based on market needs and risk management.
FCC regulations: For wireless technology evaluation.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is not an AI/ML device that requires a "training set" in the conventional sense. The "algorithm" for SpO2 measurement is a mature, established technology from the predicate device.

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

This information is not applicable and not provided as there is no "training set" for an AI/ML algorithm. The core SpO2 algorithm's performance would have been validated against a "ground truth" during its initial development and clearance, likely through controlled studies comparing measured SpO2 values to arterial blood gas measurements, as per relevant standards for pulse oximeters. This process is not described for the modified device as its algorithm is considered identical to the predicate.

Summary

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K103700

MAR 1 5 2011

510(K) SUMMARY

2.1 SUBMITTER INFORMATION

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Establishment / Sponsor Name:Establishment / Sponsor Address:	Invivo Corporation12151 Research ParkwayOrlando, FL 32826 USA
Manufacturer Name:	Sanmina- SCI Systems SingaporePTE.LTD.
Manufacturer Address:	2 Chai Chee DrSingapore, SG-NOTA 469044, Singapore
Company Phone:	(407) 275-3220
Company Fax:	(407) 249-2022
Person to contactregarding questions:	Rusty KellyQuality & Regulatory Manager, Invivo Corporation(407) 455-6166Rusty.Kelly@philips.com
EstablishmentRegistration Number:	1051786 (Sponsor)3006606827 (Manufacturer)
Date Summary Prepared:	December 17, 2010

2.2 DEVICE IDENTIFICATION

Trade name:	Essential MRI Patient Monitor (Model 865353)
Common name:	MRI patient monitor
Classification name:	Oximeter (21 CFR 870.2700, Product Code DQA)

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2.3 IDENTIFICATION OF LEGALLY MARKETED CLEARED DEVICE

The MRI Patient Monitor (Model 865353) is substantially equivalent to the following cleared device:

Cleared Device	Manufacturer	510(k) No.	Clearance Date
MRI Patient Monitoring System(Model 865214)	Invivo Corporation	K090785	Dec 15, 2009

2.4 MODIFIED DEVICE DESCRIPTION

The MRI Patient Monitor (Model 865353) is substantially equivalent to the cleared device.

Invivo has marketed a stand-alone pulse oximeter for the last 20 years as cleared to market in K864730 (Invivo Pulse Oximeter, Model 4500). This technology is over 20 years old and has not changed in design or fundamental technology since cleared to market. Invivo has identified the need to market an improved standalone pulse oximeter as a replacement for this device.

The modified device is predicated from the MRI Patient Monitoring System (Model 865214) which received clearance to market under 510(k) K090785 on December 15, 2009. The cleared device consists of a processing unit, display, and wireless SpO2 module which is directly connected to the patient by a fiber optic sensor, clip, and grip. All oximetry data collection and processing is completed by the wireless SpO2 module and fiber optic sensor. The module transmits the patient data to the processing unit using telemetry, and the processing unit transmits the data to the display using telemetry. The modified device incorporates the same wireless SpO2 module and fiber optic sensor that is currently used with the cleared device. In the modified device, the module transmits the data directly to the display using telemetry.

The following modifications have been incorporated to create the modified device:

. The display was reduced in size and weight.
The operator interface is a touch screen (instead of a rotary knob and � keypad).
. SpO2, pulse rate (derived from SpO2), and perfusion index parameters only are measured and displayed. The following parameters are no longer measured and displayed: ECG, non-invasive blood pressure, invasive blood pressure, respiration, temperature, end-tidal CO2, and anesthetic agents concentrations.

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. The device does not provide signals for synchronization for the MRI scanner ("gating"). "Gating", or lack thereof, has no effect on patient monitoring ability or quality.
. The display is battery-operated only. The display does not offer connections to AC mains.
The radio printed circuit board layout was reduced in size to accommodate . the smaller display size.
The display radio antenna was reduced in size to accommodate the smaller . display size and the antenna was concealed in the device handle.
The module used with the device also communicates with the existing . cleared MRI Patient Monitoring Systems, Models 865214 and 3160.
. The operating platform was modified to the MicroBlaze soft-core microprocessor running on the Spartan 6LX45 FPGA. The operational system was modified to the uC ("micro C") from company Micrium.
. The display was modified to provide unlatched alarms only. Latched alarms are no longer provided.
The intelligent battery charger is located in the battery (instead of in the . device).

The modified device has the same performance specifications (SpO2 operating range and accuracy) and uses the same patient applied parts (wireless SpO2 module, fiber optic sensor, clips, and grips) as the cleared device.

The MRI Patient Monitor consists of the following primary components:

Display ("Vital Signs Viewer") .
Wireless SpO2 Module .
SpO2 Sensor .
SpO2 Grips and Clips .

The display and SpO2 module enclose the transceiver and antennas that support bi-directional 2.4 GHz wireless communication. The modified device's operator interface consists of a color 5.7-inch LCD display and touch screen. The modified device's display provides the same vital sign information regarding SpO2, generates the same types of alarms (audible, lights, and text), and controls the same functions (alarm limits, patient type, display setup, and network selection) as the cleared device.

2.5 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.

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2.6 SUBSTANTIAL EQUIVALENCE COMPARISON

The modified device, the MRI Patient Monitor (Model 865353), and the cleared device, the MRI Patient Monitoring System (Model 865214) which received clearance to market under 510(k) K090785 on December 15, 2009, are identical with respect to indications for use, intended use, and fundamental scientific technology. Both devices are multi-parameter patient monitors intended to monitor vital signs for patients undergoing MRI procedures. Details of all modifications are listed in the following table:

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Table 2-1: Substantial Equivalence Comparison
510(k) Number	Cleared DeviceMRI Patient Monitoring System(Model 865214)	Modified DeviceMRI Patient Monitor(Model 865353)
510(k) Number	K090785, Cleared on December 15, 2009	Pending
General Safety	Compliant to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-6, and IEC 60601-1-8Defibrillator protection up to 5kV	IDENTICAL TO CLEARED DEVICE
PowerRequirements	Battery Type: Lithium-ionBattery Operation Time: At least 8 hoursAlso uses AC mains to AC-DC power converter	Battery Type: IDENTICAL TO CLEARED DEVICEBattery Operation Time: IDENTICAL TO CLEARED DEVICENo AC power available
Environmental	Operating Temperature: 10-44°CRelative Humidity: 0-80% non-condensingStorage Temperature: -40 – 75°C	IDENTICAL TO CLEARED DEVICE
Display	Type: Color LCD with 800 x 600 resolutionSize: 12.25-inch diameterWeight: 17 lbs (7.7 Kg)Dimensions:Height: 11.5 inches (29.2 cm)Width: 15.4 inches (39.1 cm)Depth: 5.5 inches (14.0 cm)	Type: Color LCD with 640 x 480 resolutionSize: 5.7-inch diameterWeight: 3.3 lbs (1.5 Kg)Dimensions:Height: 6.1 inches (15.5 cm)Width: 6.9 inches (17.5 cm)Depth: 3.7 inches (9.4 cm)
OperatorInterface	Rotary knob and keypad	Touch screenThe layout of menus and patient data is IDENTICAL TOCLEARED DEVICE
MountingConfigurations	Traditional roll around cartMounting options able to be mounted permanently tovarious surfaces	IDENTICAL TO CLEARED DEVICE
	Cleared DeviceMRI Patient Monitoring System(Model 865214)	Modified DeviceMRI Patient Monitor(Model 865353)
	RF Output Power: +20 dBmFrequency Range: 2.4GHz band	The functionality, technology, and operating performance of thewireless communication is IDENTICAL TO CLEARED DEVICE.
		The wireless SpO2 module including its radio is IDENTICAL TOCLEARED DEVICE.
WirelessCommunication	Radios have FCC approval under the followingidentification numbers:SpO2 Module: S6W2GMOD Processing Unit: S6WDR3160BAS Display: HSW-2410NF	The cleared device radio in the Processing Unit was modified tocreate the radio in the display. The only modifications are asfollows:The radio printed circuit board layout was reduced in size toaccommodate the smaller device size. The radio antenna was reduced in size to accommodate thesmaller device size and is concealed in the device handle. For these reasons, a new FCC evaluation was required for the radioin the display.
Vital SignsMonitored	SpO2, ECG, NIBP, pulse rate (derived from SpO2, ECG,or NIBP), perfusion index, IBP, ETCO2, respiration,agents, and temperature	Radios have FCC approval under the following identificationnumbers:SpO2 Module: IDENTICAL TO CLEARED DEVICE Display: S6WESSENTIAL SpO2, pulse rate (derived from SpO2), and perfusion index
Pulse Oximetry(SpO2)	Saturation Range: 1-100%Saturation Accuracy: ±3% at 70-100%Pulse Rate Range: 30-250 BPMPulse Rate Accuracy: ±2% or 1 BPM, whichever is greater	IDENTICAL TO CLEARED DEVICE
Patient AppliedParts	SpO2 Fiber optic sensor, SpO2 fiber optic grips and clips	IDENTICAL TO CLEARED DEVICE
	Cleared DeviceMRI Patient Monitoring System(Model 865214)	Modified DeviceMRI Patient Monitor(Model 865353)
	Device is MR Conditional according to ASTM F2503	Device is MR Conditional according to ASTM F2503
Labeling		Labeling was modified as follows:Added photographs and specifications showing dimensional modifications to display Cited use of the touch screen display Removed references to ECG, non-invasive blood pressure, invasive blood pressure, temperature, respiration, end-tidal CO2, and anesthetic agents monitoring, and gating which were present on the cleared device Cited that device is battery operated only Added instructions for battery charging Added description of communication between the modified device and existing cleared devices, MRI Patient Monitoring System Models 865214 and 3160
BatteryCharger	Integral to patient monitor and separate charger	Integral to battery
OperatingPlatform	STPC 486 Processor	MicroBlaze soft-core microprocessor running on the Spartan 6LX45 FPGA
OperatingSystem	Multitask	uC ("micro C")
Alarms	Provides latched and unlatched alarms.Alarm system compliant to IEC 60601-1-8.	Provides unlatched alarms only.Alarm system compliant to IEC 60601-1-8.

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2.7 SUMMARY OF NON-CLINICAL PERFORMANCE DATA

The performance data included in this notification establishes substantial equivalence of the modified device, the MRI Patient Monitor (Model 865353), to the cleared device which received market clearance in 510(k) K090785 on December 15, 2009. The modified device was evaluated to the following safety and performance tests:

FDA Guidance Documents .
. Voluntary standards
Verification and validation of performance specifications .
. Verification and validation of MR conditions of use
. Environmental testing
. Evaluation of wireless technology

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

Verification and validation of SpO2 accuracy in the modified device is not required because the SpO2 module, technology, patient-applied parts, algorithm, and software is the same as the cleared device.

FDA Guidance Documents

The modified device, MRI Patient Monitor (Model 865353), was designed and evaluated in accordance with the following FDA Guidance Documents:

· Use of Standards in Substantial Equivalence Determination (Issued March 12, 2000)
Pulse Oximeters Premarket Notification Submission (Issued July 19, . 2007)
· Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Issued May 11, 2005)
· Radio-Frequency Wireless Technology in Medical Devices (Issued January 3, 2007)

Voluntary Standards

Standards Data Reports (Form FDA 3654 (09/07)) are provided in Section 3 of this notification. The MRI Patient Monitor (Model 865353) was evaluated to the following voluntary standards where applicable:

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 60601-1-4. Medical electrical equipment Part 1-4: General . requirements for safety -- Collateral standard: Programmable electrical medical systems
. IEC 60601-1-6, Medical electrical equipment - Part 1-4: General requirements for safety -- Collateral standard: Usability

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IEC 60601-1-8, Medical electrical equipment Part 1-8: General . requirements for safety - Collateral Standard: Alarm Systems -Requirements, tests and guidance - General requirements and guidelines for alarm systems in medical equipment
IEC 60601-2-33, Medical electrical equipment Part 2-33: Particular ● requirements for the safety of magnetic resonance equipment for medical diagnosis
ISO 9919, Medical electrical equipment Particular requirements for . the basic safety and essential performance of pulse oximeter equipment for medical use
ISO 10993-1, Biological evaluation of medical devices -- Part 1: . Evaluation and testing within a risk management process
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

The modified device, MRI Patient Monitor (Model 865353), was evaluated by a third party laboratory to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-1-8, and ISO 9919 and complies to the requirements in these standards.

Compliance of the modified device to ISO 14971 is demonstrated by risk management summary provided in Section 6.3.

Compliance of the modified device to ISO 10993-1 is demonstrated through risk management analysis and evaluation of the modified device against a history of cleared devices provided in Section 6.12.

Compliance of the modified device to IEC 60601-2-33, ASTM F2503-08, and ASTM F2052-06 was demonstrated through validation testing performed by Invivo Corporation in the MR environment. The modified device complies to the applicable requirements of these standards.
A Standards Summary Report Table noting deviations, adaptations, or options used in demonstrating compliance of the modified device to the standards is provided in Section 6.10.

Verification and Validation of Performance Specifications

All performance specifications of the modified device, MRI Patient Monitor (Model 865353), were defined by Invivo Corporation according to national standards, international standards, market needs, risk management, and intended

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use. The verification and validation protocol for the specifications which are modified from the cleared device are provided in Section 6.4.

Results of the complete verification and validation indicate that the device operates as intended within the performance specifications. The results do not raise issues regarding the safety and effectiveness of the device and clinical data was not required to substantiate claims of safety and effectiveness.

Verification and Validation of MR Conditions of Use

The MR conditions of use of the modified device, MRI Patient Monitor (Model 865353), were defined by Invivo Corporation according to national standards, international standards, intended use, risk management, and market needs. The modified device was evaluated for proton emissions, image artifact, magnetically induced displacement force, RF heating, Specific Absorption Rate, and Peripheral Nerve Stimulation (PNS) using 3.0T and 1.5T magnetic fields, simulators, and test equipment under the most extreme use conditions within the intended use. Details are provided in Sections 6.6, 6.7, and 6.8.

Test results demonstrate that the MRI Patient Monitor (Model 865353) met the MR conditions of use as defined in the modified device labeling. Test results are provided in Sections 6.6, 6.7, and 6.8.

Environmental Testing

Environmental specifications for the modified device, MRI Patient Monitor (Model 865353) were defined by Invivo Corporation according to international standards, intended use, risk management, and market needs. Test results demonstrate conformity to customer requirement specifications over the device use life and ensure longevity of the modified device within the use model. Test data was not provided in this submission but is contained within the modified device's Design History File.

Evaluation of Wireless Technology

The modified device display was evaluated to FCC Part 15 for Low Power Communication Device Transmitters. Test results are provided in Section 6.9.

The modified device incorporates the same wireless SpO2 module including radio that is currently used with the cleared device. Additional evaluation of the wireless SpO2 module was not required.

Integrity of the wireless communication between the modified device display and cleared wireless SpO2 module was validated to operate as intended. Results are provided in Section 6.9.

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Conclusion

The conclusion of all testing confirms that all identified risks have been mitigated, the device operates as designed and intended within the performance specifications, and the device meets the labeling claims.

The results do not raise issues regarding the safety and effectiveness of the device and clinical data was not required to substantiate claims of safety and effectiveness.

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Image /page/11/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

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

Mr. Rusty Kelly Quality & Regulatory Manager Invivo Corporation 12150 Research Parkway Orlando, Florida 32826

MAR 1 5 2011

Re: K103700

Trade/Device Name: MRI Patient Monitor (Model 865353) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: February 11, 2011 Received: February 14, 2011

Dear Mr. 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.

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Page 2- Mr. Kelly

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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,

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental 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 Monitor (Model 865353)

Indications For Use: The MRI Patient Monitor (Model 865353) is intended to monitor vital signs for patients undergoing MRI procedures. The MRI Patient Monitor (Model 865353) is intended for use by healthcare professionals.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schuberth

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).