K Number

Device Name

COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE

Manufacturer

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES

Date Cleared

1998-11-05

(251 days)

Product Code

LKD

Regulation Number

868.2480

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 Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K900333, K954852

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard physiological monitoring device and makes no mention of AI or ML.

Therapeutic

No
The device is used for monitoring physiological parameters (oxygen and carbon dioxide levels) rather than directly treating a disease or condition. While monitoring is crucial for patient care, it does not fit the typical definition of a therapeutic device which actively intervenes to mitigate, prevent, or treat a disease.

Diagnostic

Yes
The device is used for non-invasive continuous monitoring of oxygen and/or carbon dioxide levels, which provides crucial information to assess a patient's physiological state. This monitoring helps in detecting and identifying potential medical conditions or changes in a patient's health, fitting the definition of a diagnostic device.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "Module" and requires connection to other hardware (Marquette Medical Systems' Solar Monitor Series and the Tram-Rac 4A interface) to function, indicating it is not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Corometrics TCpO2/CO2 Module is described as a device for non-invasive continuous monitoring of oxygen and carbon dioxide. It measures these parameters through the skin (transcutaneous).
Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. The monitoring is done externally and continuously.

Therefore, since the device does not perform tests on samples taken from the body, it does not fit the definition of an In Vitro Diagnostic device. It is a patient monitoring device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Corometrics TcpO2/CO2 Module provides 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.

Product codes (comma separated list FDA assigned to the subject device)

73 LKD

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

neonates

Intended User / Care Setting

hospital/clinical environment.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K900333, K954852

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 868.2480 Cutaneous carbon dioxide (PcCO2) monitor.

(a)
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.(b)
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.

Summary

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: 203-949-2538 Fax: 203-284-9465

[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
Cutaneous, Carbon
Dioxide Sensor	Radiometer America
Westlake, Ohio	K900333	II
Solar Series of
Monitors	Marquette Medical
Systems Milwaukee,
WI	K954852	II

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

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
Monitoring

Capability	Yes	No	Yes
TCpO2
Monitoring
Capability	Yes	No	Yes
TcpCO2 User
Interface and
Display Capability	Yes	Yes	No
TCpO2 User
Interface and
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.

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The text is in all caps and is evenly spaced around the circle. The eagle is facing to the right.

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.

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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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

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

Device Name: Corometrics TCpO2/CO2 Module

Indications for Use:

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)
--------------------------------------------------------

	11-3-98
--------------------------------------------	---------

Prescription Use
(Per 21 CFR 801.19)

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

Optional Format 1-2-96
------------------------

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
K980050

510(k) Number

K940751