COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE

K980756 · Ge Medical Systems Information Technologies · LKD · Nov 5, 1998 · Anesthesiology

Device Facts

• Record ID: K980756
• Device Name: COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE
• Applicant: Ge Medical Systems Information Technologies
• Product Code: LKD · Anesthesiology
• Decision Date: Nov 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2480
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Corometrics TCpO2/CO2 Module is used for non-invasive continuous monitoring of oxygen and/or carbon dioxide when used with the Marquette Medical System's Solar Monitor Series and TRAM-RAC 4A. It is indicated for use as a monitor of oxygen and/or carbon dioxide in neonates not under anesthesia.

Device Story

The Corometrics TcpO2/CO2 Module provides continuous, non-invasive monitoring of transcutaneous oxygen (pO2) and carbon dioxide (pCO2) levels. The device functions as a module integrated with Marquette Medical Systems' Solar Monitor Series and Tram-Rac 4A interface, which provide the display and control functions. It is intended for use in hospital or clinical settings on neonates not under anesthesia. Healthcare providers use the displayed output to monitor patient respiratory status and inform clinical decision-making regarding oxygenation and ventilation. The device benefits patients by providing real-time physiological data without invasive sampling.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Transcutaneous pO2/pCO2 sensing module. Designed for integration with Marquette Solar Monitor Series and TRAM-RAC 4A interface. Class II device (21 CFR 868.2480, 868.2500(a)).

Indications for Use

Indicated for non-invasive continuous monitoring of oxygen and/or carbon dioxide in neonates not under anesthesia in hospital/clinical environments.

Regulatory Classification

Identification

A cutaneous carbon dioxide (PcCO2) monitor is a noninvasive heated sensor and a pH-sensitive glass electrode placed on a patient's skin, which is intended to monitor relative changes in a hemodynamically stable patient's cutaneous carbon dioxide tension as an adjunct to arterial carbon dioxide tension measurement.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document.

Predicate Devices

• Cutaneous, Carbon Dioxide Sensor (K900333)
• Solar Series of Monitors (K954852)

Submission Summary (Full Text)

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NOV - 5 355 Corometrics Medical Systems, Inc.

K980756

Corometrics TcpO2/CO2 Module

510(k)

#### 9.0 510(k) SUMMARY: Corometrics TcpO2/CO2 Module

Prepared: 26 February 1998

#### [807.92(a)1] Contact Information

Richard J. Cebovsky Regulatory Affairs Manager

Address: Corometrics Medical Systems, Inc. 61 Barnes Park Road North Wallingford, CT 06492

Phone: [phone] Fax: [phone]

## [807.92(a)2] Device Name and Classification

The proprietary name of the device to be introduced into interstate commerce is the Corometrics TcpO2/CO2 Module. Common name includes: TC Module and Solar TC Module.

Current classifications that apply to this device are: 21 CFR 868,2480, Cutaneous carbon dioxide monitor, Class II and 21 CFR 868.2500(a), Cutaneous oxygen monitor, Class II.

# [807.92(a)3] Identification of Legally Marketed Equivalent Devices (Predicate Systems).

| Predicate System | Manufacturer | K Number | Class |
|-------------------------------------|-----------------------------------------------|----------|-------|
| Cutaneous, Carbon<br>Dioxide Sensor | Radiometer America<br>Westlake, Ohio | K900333 | II |
| Solar Series of<br>Monitors | Marquette Medical<br>Systems Milwaukee,<br>WI | K954852 | II |

### [807.92(a)4 & 807.92(a)5] Device Description & Intended Use

The Corometrics TcpO2/CO2 Module provided continuous monitoring of transcutaneous pO2 and pCO2 when used in conjunction with the Marquette Medical Systems' solar Monitor Series and the Tram-Rac 4A interface. The Solar monitor provides the display and control function for the TC Module.

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Corometrics TcpO2/CO2 Module

## 510(k) SUMMARY (Continued): Corometrics TCpO2/CO2 Module

The Corometrics TcpO2/CO2 Module is intended for non-invasive monitoring of oxygen and/or carbon dioxide in neonates not under anesthesia. The device is intended for use in a hospital/clinical environment.

# [807.92(a)6] Predicate Device Comparison of Technological Characteristics

| TcpCO2<br>Monitoring<br>Capability | Yes | No | Yes |
|----------------------------------------------------|-----|-----|-----|
| TCpO2<br>Monitoring<br>Capability | Yes | No | Yes |
| TcpCO2 User<br>Interface and<br>Display Capability | Yes | Yes | No |
| TCpO2 User<br>Interface and<br>Display Capability | Yes | Yes | No |

## [807.92(b)1, 807.92(b)2 & 807.92(b)3] Performance Standards per the Food, Drug Cosmetic Act

To date, the Food and Drug Administration have promulgated no performance standards relating to devices of this type.

## [807.92(d)] Additional Information

The Corometrics TCpO2/CO2 Module has been extensively tested to meet its requirements and design.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 1998

Mr. Richard J. Cehovsky Corometrics Medical Systems, Inc. 61 Barnes Park Road North P.O. Box 333 Wallingford, CT 06492-0333

Re: K980756 Corometrics Transcutaneous TCpO2/pCO2 Module Requlatory Class: II (two) Product Code: 73 LKD Dated: August 6, 1998 Received: August 7, 1998

Dear Mr. Cehovsky:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, listing of devices, qood 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through perfodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 ~ Mr. Richard J. Cehovsky

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K980756 *

Device Name: Corometrics TCpO2/CO2 Module

Indications for Use:

The Corometrics TCpO2/CO2 Module is used for non-invasive continuous monitoring of oxygen and/or carbon dioxide when used with the Marquette Medical System's Solar Monitor Series and TRAM-RAC 4A. It is indicated for use as a monitor of oxygen and/or carbon dioxide in neonates not under anesthesia.

* To be assigned by FDA upon receipt of 510(k) submission.

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

| Concurrence if CDRH, Office of Device Evaluation (ODE) |
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|--------------------------------------------------------|

| <img alt="Signature" src="signature.png"/> | 11-3-98 |
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| Prescription Use | <img alt="Check Mark" src="check_mark.png"/> |
|---------------------|----------------------------------------------|
| (Per 21 CFR 801.19) | |

OR

| Over the Counter Use | __________ |
|----------------------|------------|
|----------------------|------------|

| Optional Format 1-2-96 |
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| (Division Sign-Off) |
|------------------------------------------|
| Division of Cardiovascular, Respiratory, |
| and Neurological Devices |
| K980050 |

510(k) Number

K940751