MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160

K050399 · Invivo Research, Inc. · MWI · Aug 26, 2005 · Cardiovascular

Device Facts

• Record ID: K050399
• Device Name: MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160
• Applicant: Invivo Research, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Aug 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. The 3160 MRI Patient Monitoring System is intended for use by health care professionals.

Device Story

3160 MRI Patient Monitoring System monitors vital signs during MRI procedures; provides synchronization signals for MRI scanners. Inputs: ECG, pulse oximetry, non-invasive blood pressure, respiration, anesthetic agents, CO2, N2O. System utilizes wireless communication for ECG/SpO2 leads, RF shielding, digital signal processing (DSP), and adaptable mounting. Powered by lithium-ion battery. Operated by healthcare professionals in MRI environment. Output: continuous vital sign data displayed to clinician; assists in clinical decision-making during MRI. Benefits: enables safe, accurate patient monitoring within dynamic, high-field MRI environment; maintains signal integrity via RF shielding and wireless transmission.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed device operation per design specifications. Performance metrics for heart rate, NIBP, pulse oximetry, respiration, and anesthetic agents met established accuracy and precision requirements. Electromagnetic compatibility and electrical safety verified per EN 60601-1 and EN 60601-1-2.

Technological Characteristics

Non-magnetic materials for MRI compatibility. Wireless ECG/SpO2 transmission. Lithium-ion battery (>8 hours). Operating voltage 90-264 VAC. Digital signal processing. RF shielding. Standards: UL-2601-1, IEC 60601-1-2, EN 60601-1.

Indications for Use

Indicated for patients undergoing MRI procedures requiring vital sign monitoring and scanner synchronization. Intended for use by healthcare professionals.

Regulatory Classification

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.

Predicate Devices

• Magnitude 3150/3155 MRI Patient Monitoring System (K040915)
• Integrated Patient Monitoring System (K041918)

Submission Summary (Full Text)

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# K050399 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

#### SUBMITTER INFORMATION

| A. | Company Name: | Invivo Research, Inc. |
|-----------------------|--------------------------------|-----------------------------------------------------------------------------------|
| B. | Company Address: | 12601 Research Parkway<br>Orlando, FL 32826 |
| C. | Company Phone:<br>Company Fax: | [phone]<br>[phone] |
| D. | Contact Person: | Neil Battiste<br>Director of Regulatory Affairs (acting)<br>Invivo Research, Inc. |
| E. | Date Summary Prepared: | February 10, 2004 |
| DEVICE IDENTIFICATION | | |
| A. | Generic Device Name: | 3160 MRI Patient Monitor |
| B. | Trade/Proprietary Name: | 3160 Series MRI Compatible Patient<br>Monitoring System |

- Class II C. Classification: DRT, DXN, DQA, CCK, CBQ, CBS, Product Codes: D. CBR, CCL, MWI
### DEVICE DESCRIPTION

The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. It is designed to assist clinicians in monitoring patient vital signs in the midst of the dynamic and evolving Magnetic Resonance environment. A combination of wireless communication, radio frequency (RF) shielding, digital signal processing (DSP), and adaptable mounting technologies address the challenges associated with patient monitoring in the MRI area. Built on Invivo's strong heritage in MRI patient vital signs monitoring, the 3160 orovides accurate, continuous, and reliable performance during all phase of MRI applications.

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K050399

### SUMMARY OF SAFETY AND EFFECTIVENESS Page 2/4

### SUBSTANTIAL EQUIVALENCE

The Invivo Research System is of comparable type and is substantially

equivalent to the following predicate devices:

| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|-----------------------------------------------------------|-----------------------|------------|--------------|
| Magnitude ™<br>3150/3155 MRI Patient<br>Monitoring System | Invivo Research, Inc. | K040915 | 09/22/04 |
| Integrated Patient<br>Monitoring System | Invivo Research, Inc. | K041918 | 10/15/04 |

#### INTENDED USE

The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.

The 3160 MRI Patient Monitoring System is intended for use by health care professionals.

### COMPARISON TO PREDICATE DEVICE:

The MRI Compatible Patient Monitoring System and the predicate devices (Magnitude 3150/3155 and the Integrated Patient Monitoring System) are all portable monitors which are used to transmit vital sign information to a patient monitor during MRI procedures.

The systems differ in that the MRI Compatible Patient Monitor has been enhanced by providing wireless technology for the ECG leads and the pulse oximeter function, and by moving to a lithium battery for longer battery life.

Confidential

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#### KO50394

### SUMMARY OF SAFETY AND EFFECTIVENESS Page 3/4

### TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the 3160 MRI Compatible Patient Monitoring System and the predicate devices has been performed. The results of this comparison demonstrate that the 3160 MRI Compatible Patient Monitoring System is equivalent to the marketed predicate devices in technological characteristics.

## ENVIRONMENTAL AND NON-CLINICAL TESTING:

Applicable environmental and non-clinical testing was performed per UL-2601-1 and IEC 60601-1-2 as well as other applicable standards and procedures. The 3160 MRI Compatible Monitoring System passed all tests.

#### PERFORMANCE DATA

The performance data included in this submission to compare equivalency of the Magnitude 3150/3155 and the Integrated Patient Monitor System 510(k) cleared devices to the modified 3160 MRI Compatible Patient Monitoring System met the performance requirements for accuracy and precision and indicates substantial equivalence to the predicate devices. Equivalent performance in meeting user requirements was also determined.

### Summary of Performance Testing:

Validation and Verification Testing confirmed that this device operates as designed and intended:

| Parameter | Specification |
|-------------------------------------------|------------------------------------------------------------------------|
| ELECTRICAL AND MECHANICAL CHARACTERISTICS | |
| Operating Voltage | 90 to 264 VAC |
| Power Consumption | 30 Volt-Amperes with Charged batteries (48 VA maximum during charging) |
| Battery | Lithium Ion, Capacity > 8 hours |
| Electrical Safety | Per EN 60601-1 |
| Electromagnetic Compatibility | Per EN 60601-1-2 |

Confidential

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Page 4/4

K050399

| PERFORMANCE REQUIREMENTS | | |
|----------------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Heart Rate Monitor | | |
| Range/Resolution | Adult: 30 to 249 BPM Neonate: 30 to 300 BPM / 1 BPM | |
| Rate Accuracy | $\pm$ 1% from 30 to 200 BPM | |
| | $\pm$ 1.5% from 201 to 250 BPM | |
| | $\pm$ 2% from 251 to 300 BPM (Neonate only) | |
| Defibrillator Protection | Accepts and recovers from a defibrillator discharge up to 5 KV | |
| Non-Invasive Blood Pressure Monitoring | | |
| Auto Mode Set Intervals | OFF, 1, 2, 2.5, 3, 5, 10, 15, 20, 30, 45 Min, or 1, 2 and 4 Hrs | |
| Pop-Off Pressure Level | 285 +/- 14 mmHg | |
| Cuff Inflation Time | 3 to 20 seconds | |
| Pulse Oximetry | | |
| Range | 0 to 100% saturation | |
| Accuracy | < 3.0% (60% to 100%) | |
| Averaging Period | 3, 6, or 12 seconds | |
| Respiration Monitoring | | |
| Range | 4 to 150 RPM | |
| Resolution | 1 RPM | |
| Accuracy | +/- 5% or 2rpm (whichever is greater) | |
| Anesthetic Agents | | |
| Halothane | Range: 0.15 to 6.0 Vol.% | Accuracy: $\pm$ 0.15 Vol.% +15% relative |
| Enflurane | Range: 0.15 to 8.0 Vol % | Accuracy: (0.15-7 %) $\pm$ 0.15 Vol% + 15% relative |
| Isoflurane | Range: 0.15 to 6.0 Vol % | Accuracy: $\pm$ 0.15 Vol.% +15% relative |
| Sevoflurane | Range: 0.15 to 9.0 Vol% | Accuracy: (0.15-8%) $\pm$ 0.15 Vol% + 15% relative |
| Desflurane | Range: 0.15 to 20 Vol% | Accuracy: $\pm$ 0.15 Vol.% +15% relative |
| Carbon Dioxide | Range: 0 to 10 Vol% | Accuracy: (measured with agent option) $\pm$ 4mmHG or 12%, whichever is greater |
| Nitrous Oxide | Range: 0 to 99 Vol % | Accuracy: (measured with agent option) $\pm$ 2% Vol + 8% relative |
| MRI COMPATIBILITY | | |
| Maximum RF Emissions | Maximum -150dB RF noise at MRI Larmor Frequencies | |
| MRI In-Bore Materials Used | All materials are non- magnetic, and do not produce proton-signal emissions during MRI | |

### CONCLUSION

The test results demonstrate the 3160 MRI Compatible Patient Monitoring System is substantially equivalent to the Magnitude 3150/3155 Series Patient Monitoring System and the Integrated Patient Monitoring System devices.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

AUG 2 6 2005

Food and Drug Administration

Public Health Service

9200 Corporate Boulevard Rockville MD 20850

Invivo Resarch, Inc. c/o Eduardo Rey Regulatory Compliance Engineer 12601 Research Parkway Orlando FL 32826

Re: K050399

Trade/Device Name: Patient Monitor System, Model 3160 Regulation Number: 21 CFR 870. Regulation Name: Regulatory Class: Class II Product Code: MWI Dated: August 22, 2005 Received: August 23, 2005

Dear Mr. Rey:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 -- Mr. Eduardo Rey

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality Bystellin (Sections 531-542 of the Act); 21 CFR 1000-1050. product faction of to begin marketing your device as described in your Section 510(k) I mis lotter will and w yourse of substantial equivalence of your device to a legally premance hother hother results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please if you active of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Vitimotov

Brand 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): _K050399

Device Name: 3160 MRI Patient Monitoring System

Indications for Use:

The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.

The 3160 MRI Patient Monitoring System is intended for use by health care professionals.

V Prescription Use (Part 21 CFR 801 Subpart D)

Canada Canada Canada Callery Comments Comments Comments of Commendential Andress

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Bremmer

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