3160 MRI PATIENT MONITORING SYSTEM

K053462 · Invivo Corporation · MWI · Jan 18, 2006 · Cardiovascular

Device Facts

• Record ID: K053462
• Device Name: 3160 MRI PATIENT MONITORING SYSTEM
• Applicant: Invivo Corporation
• Product Code: MWI · Cardiovascular
• Decision Date: Jan 18, 2006
• Decision: SESE
• Submission Type: Special
• 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: physiological signals (CO2, invasive blood pressure, temperature, respiration). Operation: utilizes wireless communication, RF shielding, and digital signal processing (DSP) to function within high-field MRI environments (up to 3.0T). Output: real-time vital sign data and waveforms displayed for clinician review. Used in clinical MRI settings by healthcare professionals. Benefits: enables continuous, accurate patient monitoring and scanner synchronization without interference from or to the MRI magnetic field.

Clinical Evidence

Bench testing only. Validation performed in a 3.0T MRI environment using simulators and test equipment. Testing verified operation during TRUE-FISP and PLANAR-ECHO scans. Performance metrics for CO2 monitoring (accuracy ±2mmHg + 5% of reading), invasive pressure, temperature, and respiration monitoring met all specified ranges and accuracy requirements.

Technological Characteristics

Multiparameter monitor with wireless communication and RF shielding. CO2 sensor uses zinc selenium detector. Invasive BP, temperature, and respiration modules utilize established Invivo technology. Connectivity: wireless. Standards: UL60601, EN IEC 60601-1-2. Digital signal processing (DSP) architecture.

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

• 3160 MRI Patient Monitoring System (K050399)
• Magnitude 3150/3155 MRI Patient Monitoring System (K040915)
• Integrated Patient Monitoring System (K041918)
• Polaris 2004 Capnograph (K040011)

Submission Summary (Full Text)

{0}------------------------------------------------

-

・

510(K) NOTIFICATION 3160 MRI PATIENT MONITORING SYSTEM

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## SUBMITTER INFORMATION

| A. | Company Name: | Invivo Corporation |
|----|--------------------------------|----------------------------------------------------------------------------------------|
| B. | Company Address: | 12601 Research Parkway<br>Orlando, FL 32826 |
| C. | Company Phone:<br>Company Fax: | [phone]<br>[phone] |
| D. | Contact Person: | John Racette<br>Quality Assurance and Regulatory Affairs Manager<br>Invivo Corporation |
| E. | Date Summary Prepared: | December 2, 2005 |

## DEVICE IDENTIFICATION

| A. | Generic Device Name: | MRI compatible multiparameter patient monitor |
|----|-------------------------|-----------------------------------------------|
| B. | Trade/Proprietary Name: | 3160 MRI Patient Monitor |
| C. | Classification: | Class II |

D. Product Codes:

| Classification Names | | Code | CFR Ref |
|----------------------|---------------------------------------------------|------|----------|
| 1. | Monitor, Cardiac | DRT | 870.2300 |
| 2. | Monitor, Blood Pressure, Non-Invasive | DXN | 870.1130 |
| 3. | Oximeter | DQA | 870.2700 |
| 4. | Analyzer, Gas, Carbon Dioxide, Gaseous Phase | CCK | 868.1400 |
| 5. | Analyzer, Gas, Enflurane, Gaseous Phase | CBQ | 868.1500 |
| 6. | Analyzer, Gas, Halothane, Gaseous Phase | CBS | 868.1620 |
| 7. | Analyzer, Gas, Nitrous Oxide, Gaseous Phase | CBR | 868.1700 |
| 8. | Analyzer, Gas, Oxygen, Gaseous Phase | CCL | 868.1720 |
| 9. | Blood Pressure Computer (Invasive Blood Pressure) | DSK | 870.1110 |
| 10. | Thermometer, Electronic, Clinical | FLL | 880.2910 |
| 11. | Monitor, Breathing Frequency | BZQ | 868.2375 |
| 12. | Monitor, physiological, patient | MWI | 870.2300 |

## 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 MKI
the dynamic and evolving Massatio Recess in monitoring patient vital signs in the mi the dynamic and evolving Magnetic Resonance environmoning patis

Confidential

Page 5-1

{1}------------------------------------------------

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 MRI Patient Monitoring System provides accurate, continuous, and reliable performance during all phase of MRI applications.

#### SUBSTANTIAL EQUIVALENCE

The 3160 MRI Patient Monitoring System is of comparable type and is substantially equivalent to the following predicate devices:

| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|------------------------------------------------------|-----------------------|------------|--------------|
| 3160 MRI Patient<br>Monitoring System | Invivo Research, Inc. | K050399 | 08/26/05 |
| Magnitude 3150/3155 MRI<br>Patient Monitoring System | Invivo Research, Inc. | K040915 | 09/22/04 |
| Integrated Patient<br>Monitoring System | Invivo Research, Inc. | K041918 | 10/15/04 |
| Polaris 2004 Capnograph | Oridion Medical Ltd | K040011 | 05/13/04 |

#### 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 primary differences between this device and the predicate 3160 MRI Patient Monitoring System are as follows:

- The end-tidal CO2 monitoring option is the same as that incorporated into the . predicate 3160 MRI Patient Monitoring System (K050399), except that
- the sensor is smaller, which in turns allows for a smaller flow rate, .
- the detector material has been changed from a thermopile to zinc selenium, .
- one detector is used to read both the patient gas and the baseline reference. .

This same technology is used in the Oridion Medical Ltd Polaris 2004 Capnograph, which was cleared to market under 510(k) K040011.

- The invasive blood pressure monitoring option is exactly the same as that used in the . Magnitude™ MRI Monitoring System (K040915).
- The temperature monitoring option is exactly the same as that used in the . Magnitude™ MRI Monitoring System (K040915).
- The respiration monitoring option is exactly the same as that used in the Integrated . Patient Monitoring System, which was cleared to market under 510(k) K041918.

Confidential

{2}------------------------------------------------

### TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the 3160 MRI Patient Monitoring System and the predicate devices has been performed. The results of this comparison demonstrate that the 3160 MRI 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 UL60601 and EN IEC 60601-1-2 as well as other applicable particular standards and procedures. The 3160 MRI Patient Monitoring System passed all tests.

### PERFORMANCE DATA

The performance data included in this submission to compare equivalency of the Magnitude 3150/3155 MRI Patient Monitoring System and the Integrated Patient Monitoring System 510(k) cleared devices to the modified 3160 MRI 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 the modified device operates as designed and intended. A summary of this testing is as follows:

This device was validated using a 3.0T MRI System as a worst-case environment. These devices were validated by verifying proper operation of the device while being subjected to 3.0T magnetic fields using simulators and test equipment under actual use conditions. Two scans, TRUE-FISP and PLANAR-ECHO, were used in both magnetic fields to simulate normal and worst-case MRI conditions.

| End Tidal CO2 Monitoring (Capnometer) | | |
|---------------------------------------|------------------------------------------------------|-----------|
| Parameter | Specification | Pass/Fail |
| Measurement Range | 0-76 mmHg | Pass |
| Accuracy | ±2mmHg + 5% of reading | Pass |
| Flow Rate | 50 mL/min | Pass |
| Respiration Rate | 0 to 100 BPM | Pass |
| Zero Drift Rate | 0.5 mmHg/hr; 1.5 mmHg/24hr | Pass |
| Alarm Limits | Lower: Off, 5 to 60 mmHg<br>Upper: Off, 5 to 80 mmHg | Pass |
| Inspired CO2 | 25 mmHg | Pass |

{3}------------------------------------------------

#### INVIVO CORPORATION

1053-62

#### 510(K) NOTIFICATION 3160 MRI PATIENT MONITORING SYSTEM

| Invasive Pressure Monitoring | | |
|------------------------------|-------------------------------------------------------------------|-----------|
| Parameter | Specification | Pass/Fail |
| Channels | 1 or 2 simultaneous channels | Pass |
| Bandwidth (-3dB) | 0 to 12 Hz | Pass |
| Range | -10 to +248 mmHg | Pass |
| Sensitivity | 5 uV/V/mmHg | Pass |
| Gain Accuracy | $\pm$ 0.5 % | Pass |
| Auto Zero Feature | Zeroes with +/- 300 mmHg offset to 0+/- 5 mmHg within<br>1 second | Pass |
| Waveform Display Scales | 0 to 45, 0 to 75, 0 to 150, 0 to 200,<br>0 to 250 mmHg | Pass |
| High Pressure Alarm | 5 to 248 mmHg range; 1 mmHg resolution | Pass |
| Low Pressure Alarm | 5 to 248 mmHg range; 1 mmHg resolution | Pass |

| Temperature Monitoring | | |
|------------------------|--------------------------------|-----------|
| Parameter | Specification | Pass/Fail |
| Temperature Range | 25 to 44°C<br>(77° to 111.2°F) | Pass |
| Accuracy | ± 0.5°C (± 0.5°F) | Pass |
| Resolution | ± 0.1°C (± 0.18°F) | Pass |

| Respiration Monitoring | | |
|------------------------|-----------------------------------------------|-----------|
| Parameter | Specification | Pass/Fail |
| Range | 4 to 150 BPM | Pass |
| Resolution | 1 BPM | Pass |
| Accuracy | 2% to 60 BPM, 3.4% at 87 BPM, 5.6% at 142 BPM | Pass |

#### Conclusion:

The verification and validation activities for the 3160 MRI Patient Monitoring System confirm that all identified risks have been mitigated and that this device operates as designed and intended. The test results demonstrate the revised 3160 MRI Patient Monitoring System is substantially equivalent to the device cleared to market via 510(k) \ K050399 and the other predicate devices identified in this submittal.

Confidential

{4}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2006

Invivo Corporation c/o Mr. John Racette Quality Assurance and Regulatory Affairs Manager 12601 Research Parkway Orlando, FL 32826

Re: K053462

Trade Name: 3160 MRI Patient Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor Regulatory Class: Class II (two) Product Code: MWI Dated: December 6, 2005 Received: December 13, 2005

Dear Mr. Racette:

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.

{5}------------------------------------------------

Page 2 – Mr. John Racette

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 lease be advisou that 1 Dr o lation that your device complies with other requirements of the Act that I DA has made a acterimalations administered by other Federal agencies. You must of any I cueral statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the Not of Not of CFR Part 801); good manufacturing practice requirements as set CITY art 0077, idocinig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (2) = 1) = (2) = 1) = = 1 = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = This letter will anow you is ought tinding of substantial equivalence of your device to a legally prematics notineation: The President 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 dosire specific acripliance 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 informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duna R. Vachner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

## Indications for Use

510(k) Number (if known): Kos 346 Z

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.

> Prescription Use (Part 21 CFR 801 Subpart D)

... ... ... ... ... ... ... ... ... .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Valuer

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(Division Sign-Off) (Division Sign-Old)
Division of Cardiovascular Devices

510(K) Number_Les Les State

Page of of __