CAPNO PROBE A

K984579 · Optical Sensors, Inc. · CCK · Dec 21, 2000 · Anesthesiology

Device Facts

• Record ID: K984579
• Device Name: CAPNO PROBE A
• Applicant: Optical Sensors, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Dec 21, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2

Intended Use

The CapnoProbe Sublingual Tonometer System is indicated for monitoring sublingual PCO2. It is indicated for use in hospital patients. This device is indicated for use by qualified medical personnel only.

Device Story

CapnoProbe A System measures sublingual pCO2 and temperature; utilizes disposable sensor containing fiber optic pCO2 and temperature sensors; sensor placed under tongue. System includes disposable sensor, instrument, fiber optic interconnect cable, and tonometered saline calibration fluid. Instrument is software-modified ABG module/Optical CAM; processes optical signals to calculate and display pCO2. Used in hospital settings by qualified medical personnel. Provides real-time sublingual pCO2 monitoring to assist clinical assessment. Calibration performed prior to use using provided saline.

Clinical Evidence

Bench testing compared CapnoProbe A to Tonocap TC-200 using tonometered saline, showing equal performance. Animal study demonstrated equivalence of sublingual vs. stomach mucosal pCO2 measurement; both systems tracked pCO2 changes. Volunteer clinical study demonstrated repeatability comparable to Tonocap system.

Technological Characteristics

Fiber optic pCO2 sensor; temperature sensor; fiber optic interconnect cable; software-modified ABG module/Optical CAM instrument. Calibration via tonometered saline. Standalone monitor/module configuration.

Indications for Use

Indicated for monitoring sublingual PCO2 in hospital patients. For use by qualified medical personnel only.

Regulatory Classification

Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

Predicate Devices

• SensiCath Blood Gas Sensor (K951094)
• OpticalCAM Blood Gas Measurement System (K963935)
• Datex-Engstrom Tonocap (K962638)

Reference Devices

• Tonocap TC-200

Submission Summary (Full Text)

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

DEC 21 2000

K984579

# Optical Sensors Incorporated

## 510(k) Summary

| Company Name: | Optical Sensors Incorporated |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | CapnoProbe A System |
| Contact: | Paulita LaPlante<br>President and CEO<br>Optical Sensors Incorporated<br>7615 Golden Triangle Drive<br>Eden Prairie, MN 55344 |
| Phone: | 612-947-9595 |
| Fax: | 612-944-6022 |
| Summary Date: | December 13, 2000 |
| Trade Name: | CapnoProbe A System |
| Common Name: | Carbon Dioxide Gas Analyzer |
| Classification Name: | CFR 868-1400 73CCK<br>Carbon Dioxide Gas Analyzer |
| Predicate Devices: | SensiCath Blood Gas Sensor – 510(k) K 951094<br>OpticalCAM Blood Gas Measurement System - 510(k) K963935<br>Datex-Engstrom Tonocap - 510(k) K 962638 |

#### Description of Device 1.0

The CapnoProbe A System provides a measurement of Sublingual pCO2 (SL CO2). The CapnoProbe A consists of a Disposable Sensor, Instrument, Fiber Optic Interconnect Cable and Calibration Fluid. The Disposable Sensor contains a fiber optic pCO- sensor and temperature sensor. The Disposable Sensor is placed under the tongue for a measurement of pCO2 and temperature.

The Disposable Sensor connects to the fiber optic interconnect cable. The fiber optic interconnect cable connects to a software modified ABG Module.

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

The instrument is a software modified Optical CAM and ABO Module. The softwaremodified instruments measures SL CO2 and temperature, displaying SL CO2. The instrument is dedicated to the function as programmed by the software. The instruments are referred to as a CapnoProbe A Monitor and a CapnoProbe A Module. Prior to use the CapnoProbe A System with disposable pCO2 sensor is calibrated with provided tonometered saline. The saline calibration fluid is the same as the predicate SensiCath System initialization fluid.

#### 2.0 Intended use of Device

The CapnoProbe Sublingual Tonometer System is indicated for monitoring sublingual PCO2. It is indicated for use in hospital patients. This device is indicated for use by qualified medical personnel only.

#### 3,0 Technological Characteristics

The technical characteristics of the CapnoProbe A System are measurement of pCO2 by a fiber optic sensor. The fiber optic pCO2 technical features of the CapnoProbe A System are equivalent to the predicate SensiCath Blood Gas Sensor and OpticalCAM Blood Gas Measurement System.

#### 4.0 Data Summary

Laboratory and animal data are presented to establish and compare performance of the CapnoProbe A System to a predicate pCO2 measurement system, the Tonocap TC-200. The bench data establishes performance of the CapnoProbe A System and Tonocap to controlled levels of tonometered saline. Both systems perform equally well under laboratory conditions.

The animal study demonstrates equivalence of pCO2 measurement under the tongue, versus stomach mucosal tissue of test animals. Both systems tracked pCO2 changes. The Pearson r Correlation Coefficient of the two CapnoProbe A Systems is higher than the Pearson r Correlation Coefficient of the two predicate Tonocap Systems.

A comparison of clinical data for the CapnoProbe A System and published Tonocap clinical data on volunteer and stable subjects indicates the CapnoProbe A System is as

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

repeatable as the predicate TonoCap System. A volunteer clinical study demonstrates repeatability of the CapnoProbe A System.

#### Conclusions 5.0

The data and information presented supports the conclusion the technology of the CapnoProbe A System is substantially equivalent to the noted prodicate devices.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image contains the words "Public Health Service" in bold black font. The words are stacked on top of each other. The words are centered in the image.

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design resembling three abstract shapes, possibly representing human figures or wings, stacked on top of each other.

DEC 21 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Paulita LaPlante President & CEO Optical Sensors Incorporated 7615 Golden Triangle Drive Technology Park Five Minneapolis, MN 55344

Re: K984579 Trade Name: CapnoProbe-A SL Regulatory Class: II (two) Product Code: 73 CCK, 73 CBR, 78 KNT Dated: July 18, 2000 Received: July 20, 2000

Dear Ms. LaPlante:

We have reviewed your Section 510(k) notification of intent to market we nave referenced above and we have determined the device is ent dovelally 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 Incorpours of and of 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 ene golors 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 (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 periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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

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

### Page 2 - Ms. Paulita LaPlante

obligation you might have under sections 531 through 542 of the Act obrigation you might welectronic Product Radiation Control provisions, or other Federal laws or regulations.

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 Also, please note the regulation entitled, [phone]. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its be obtainou more [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices . Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Page ___of

510(k) Number (if known): -

Sublingual Tonometer CO2 Measurement System Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use:

The CapnoProbe Sublingual Tonometer System is indicated for monitoring sublingual PCO2. It is indicated for use in hospital patients. This device is indicated for use by qualified medical personnel only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

pöölle
K984579