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 Description

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. 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.

AI/ML Overview

Acceptance Criteria and Study for CapnoProbe A System

The provided 510(k) summary for the CapnoProbe A System does not explicitly state acceptance criteria in a quantitative table format as commonly seen in modern submissions. Instead, it focuses on demonstrating equivalence to predicate devices through various comparative studies. The underlying acceptance criterion for substantial equivalence is that the CapnoProbe A System performs "equally well" or is "as repeatable" as the predicate devices in relevant contexts.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the provided document, the "acceptance criteria" are inferred from the comparisons made to predicate devices.

Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (CapnoProbe A System)
Bench Performance: Perform equally well under laboratory conditions compared to predicate pCO2 measurement systems (e.g., Tonocap TC-200) with controlled levels of tonometered saline.	Performed "equally well" under laboratory conditions compared to Tonocap TC-200.
in vivo Performance (Animal Study): Demonstrate equivalence of pCO2 measurement compared to predicate systems (e.g., Tonocap TC-200) under varying physiological conditions (e.g., sublingual vs. stomach mucosal tissue).	"Both systems tracked pCO2 changes." The Pearson r Correlation Coefficient for two CapnoProbe A Systems was "higher than" that of two predicate Tonocap Systems.
Clinical Performance (Repeatability): Demonstrate repeatability comparable to published clinical data for predicate systems (e.g., Tonocap) in volunteer and stable subjects.	"CapnoProbe A System is as repeatable as the predicate TonoCap System."

2. Sample Size and Data Provenance for Test Set

Bench Data: No specific sample size is mentioned for the bench data. The data provenance is laboratory conditions using "controlled levels of tonometered saline."
Animal Study: No specific sample size (number of animals) is mentioned. The study involved "test animals" and compared "pCO2 measurement under the tongue, versus stomach mucosal tissue." No country of origin is specified, but it's implied to be a laboratory setting. This was a prospective study.
Clinical Data (Volunteer Study): No specific sample size (number of volunteers) is mentioned. The study involved "volunteer and stable subjects" to demonstrate repeatability. No country of origin is specified. This was a prospective study.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish a ground truth for the test sets in the typical sense for medical imaging or diagnostic device studies. The "ground truth" used for comparison appears to be the performance of the predicate device (Tonocap TC-200) or established physiological measurements, rather than a consensus of human experts interpreting data for the CapnoProbe A System itself.

4. Adjudication Method

The document does not describe any adjudication method for establishing ground truth, as the studies primarily focused on comparative performance against a predicate device or controlled laboratory conditions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or reported. The device is a direct physiological measurement device and not one that typically involves human interpretation of outputs requiring an MRMC study.

6. Standalone Performance

Standalone performance of the algorithm (or device in this context) was implicitly evaluated through the bench, animal, and clinical studies. The device itself, when used without human interpretation in the loop (beyond medical personnel observing the displayed CO2 value), is presented as providing the measurement. The comparison is made directly between the CapnoProbe A System and the predicate Tonocap System.

7. Type of Ground Truth Used

Bench Data: Controlled levels of pCO2 in tonometered saline served as the ground truth.
Animal Study: The comparison was made against the predicate Tonocap System's measurement of pCO2 in animal tissues (sublingual and stomach mucosal), implying the predicate's readings served as a comparative "ground truth" or reference for tracking changes.
Clinical Data: The "repeatability" of the CapnoProbe A System was compared against "published Tonocap clinical data," suggesting that established performance metrics of the predicate device derived from clinical studies served as the reference for repeatability.

8. Sample Size for Training Set

The document does not mention a "training set" in the context of machine learning or AI models, as the CapnoProbe A System is a physical measurement device. Therefore, no sample size for a training set is provided.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set, there is no information on how its ground truth would have been established. The device is described as measuring SL CO2 by a fiber optic sensor, implying its operation is based on known physical principles rather than learning from a training dataset.

Summary

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DEC 21 2000

K984579

Optical Sensors Incorporated

510(k) Summary

Company Name:	Optical Sensors Incorporated
Device Name:	CapnoProbe A System
Contact:	Paulita LaPlantePresident and CEOOptical Sensors Incorporated7615 Golden Triangle DriveEden 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 73CCKCarbon Dioxide Gas Analyzer
Predicate Devices:	SensiCath Blood Gas Sensor – 510(k) K 951094OpticalCAM Blood Gas Measurement System - 510(k) K963935Datex-Engstrom Tonocap - 510(k) K 962638

Description of Device 1.0

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

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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

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

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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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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

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

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Page ___of

510(k) Number (if known): -

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

(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

Regulation Number and Section

§ 868.1400 Carbon dioxide gas analyzer.

(a)
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.(b)
Classification. Class II (performance standards).