Purpose: The purpose of the Ceramatec family of galvanic oxygen sensors is to be the oxygensensing component in a finished medical device that monitors oxygen concentration.

Function: The Ceramatec galvanic oxygen sensors are used in finished medical device products such as oxygen monitors, oxygen analyzers, ventilators and humidifiers.

Target Patient Population: The target patient population consists of those patients who require the oxygen concentration in their breathing environment to be monitored.

Environment of Use: The Ceramatec family of galvanic oxygen sensors is used in finished medical devices (i.e., oxygen monitors, oxygen analyzers, ventilators, etc.) in patient environments whose temperatures range from 5 ℃ - 40 ℃ and from 5% - 95% relative humidity (non-condensing).

Device Claims: The Ceramatec family of galvanic oxygen sensors consists of oxygen sensing components in finished medical devices that have the indication or claim of monitoring oxygen concentration in the patients' breathing environment.

Device Description

Ceramatec galvanic oxygen sensors are lead-oxygen batteries consisting of a lead anode and an oxygen cathode. The oxygen cathode is to be made up of gold and an aqueous electrolyte solution.

The gold electrode is in close proximity to a non-porous fluoropolymer membrane. Oxygen permeating through the membrane is reduced electrochemically at the gold electrode. An electronic network, consisting of one or more resistors and/or thermistors for temperature compensation, is connected between the cathode and anode which allows the lead-oxygen battery to continually discharge in the presence of oxygen. The said network may reside either within the sensor or be incorporated in an attached analyzer.

The current that flows through the device is proportional to the partial pressure of oxygen of the gas in contact with the fluoropolymer membrane. An attached analyzer detects the oxygen concentration by measuring the voltage between the ends of the resistor network.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Ceramatec MAXCELL and CAG Galvanic Oxygen Sensors, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria were established by comparison to a predicate device (Seatronics Company, Inc. family of galvanic oxygen sensors). The "reported device performance" reflects that the Ceramatec devices meet or exceed the predicate device's specifications. The summary explicitly states "SAME" for most categories, indicating equivalence. For "Operating Life" and "Temperature Range", the Ceramatec device performance is slightly different but deemed equivalent or better.

Criteria/Specification	Acceptance Criteria (from Predicate Device)	Reported Device Performance (Ceramatec MAXCELL/CAG)
RANGE	0-100%	SAME (0-100%)
ACCURACY	$\pm2%$ @ constant T, P	SAME ($\pm2%$ @ constant T, P)
90% RESPONSE TIME	<20 s	SAME (<20 s)
HUMIDITY	5-95% non-condensing	SAME (5-95% non-condensing)
INTERFERENCE	$\pm2%$	SAME ($\pm2%$)
LINEARITY	$\pm2%$	SAME ($\pm2%$)
OPERATING LIFE	12 MONTHS	>12 MONTHS
TEMPERATURE RANGE	0 °C-40 °C	5 °C-40 °C
STORAGE TEMPERATURE	Not explicitly stated for predicate	-15 - 50 °C

Note on Temperature Range: The document clarifies that the operating temperature range of 5°C-40°C for the Ceramatec devices is considered equivalent to the predicate's 0°C-40°C range because "the patient breathing environment is a temperature-controlled setting, the galvanic oxygen sensors are not typically used at 0℃ to 5℃."

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not specify a sample size for a test set in the traditional sense of a clinical trial or performance study on a specific cohort of devices. Instead, the performance is stated as product specifications that apply to all devices in the family.

The data provenance is implied to be internal testing by Ceramatec, Inc., to confirm that their devices meet the listed specifications. There is no mention of country of origin for specific test data, nor whether it was retrospective or prospective, as this is a device design and engineering specification comparison rather than a human-subject study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and therefore not provided in the 510(k) summary. The "ground truth" for these technical specifications would be established by validated measurement equipment and engineering standards, not by expert consensus in a medical diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert reviewers evaluate cases. For technical device specifications, performance is typically measured against established benchmarks using instruments and protocols, not subjective adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI diagnostic tool on human reader performance for tasks like image interpretation. The Ceramatec oxygen sensors are hardware components for measuring oxygen concentration, not diagnostic AI software.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Yes, a form of standalone performance evaluation was done. The entire 510(k) submission describes the standalone performance of the Ceramatec galvanic oxygen sensors against specific technical specifications (accuracy, response time, linearity, etc.). These devices operate as described in their "Method of Operation" to produce a current proportional to oxygen partial pressure, without human intervention in the core sensing mechanism. The "reported device performance" in the table above stands as the standalone performance of the devices.

7. The Type of Ground Truth Used

The "ground truth" for the device specifications (e.g., accuracy, linearity, response time) would be established by validated measurement standards and reference gases/conditions. For instance, accuracy would be verified against certified oxygen gas mixtures, and temperature performance against calibrated thermostatic chambers. It is not expert consensus, pathology, or outcomes data in the medical diagnostic sense.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The Ceramatec galvanic oxygen sensors are not AI algorithms that require a "training set" of data for machine learning. They are physical devices that operate based on electrochemical principles.

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

This information is not applicable and therefore not provided, as the device does not use a training set in the context of machine learning.

Summary

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K972992

SECTION 21 510 (k) SMDA SUMMARY

1.0 Date: August 5, 1997
MAR 30 1998
2.0 Submitter: Ceramatec, Inc. 2425 South 900 West Salt Lake City, Utah 84119

3.0 Contact Person:

Gordon Roth Quality System Manager

4.0 Telephone:

Phone Direct:	(801) 978-2117
Phone Business:	(801) 972-2455
FAX	(801) 972-1925

Proprietary Device Name: 5.0

MAXCELL-1 Oxygen Sensor MAXCELL-11 Oxygen Sensor CAG-2 Oxygen Sensor CAG-8 Oxygen Sensor CAG-9 Oxygen Sensor CAG-10 Oxygen Sensor CAG-12 Oxygen Sensor CAG-13 Oxygen Sensor CAG-15 Oxygen Sensor CAG-17 Oxygen Sensor CAG-18 Oxygen Sensor CAG-19 Oxygen Sensor CAG-250 Oxygen Sensor

6.0 Classification Name: Oxygen Gas Analyzer

7.0 Common Name: Galvanic Oxygen Sensor

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8.0 Predicate Device:

Seatronics Company, Inc. family of galvanic oxygen sensors.

9.0 Device Function:

Monitor oxygen concentration in the patient environment.

10.0 Method of Operation:

Ceramatec galvanic oxygen sensors are lead-oxygen batteries consisting of a lead anode and an oxygen cathode. The oxygen cathode is to be made up of gold and an aqueous electrolyte solution.

The following electrochemical reaction occurs in Ceramatec galvanic oxygen sensors:

Cathode:	$O_2 + 4e^- \rightarrow 2O^{2-}$
Anode:	$2Pb \rightarrow 2Pb^{2+} + 4e^-$

Although a sensor is sealed against electrolyte leakage, it is open to ambient atmosphere so it can detect oxygen. The membrane is chosen to govern gas flow into the sensor to give a good compromise between sensor response and environmental tolerance. A more open membrane may give faster response, but allows ingress of other atmospheric species such as acid vapor and water vapor.

In summary, Ceramatec galvanic oxygen sensors are designed to provide a current output that, at constant temperature and pressure, is linearly proportional to the oxygen partial pressure.

Both the Ceramatec family of galvanic oxygen sensors and the predicate device family operate in the manner described above.

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SECTION 21 510 (k) SMDA SUMMARY

11.0 Device Materials of Construction:

Housing:	Corrosion-resistant plastic
Anode:	Lead
Cathode:	Gold
Membrane:	Fluoropolymer
Sealing:	Elastomeric polymer
Separator	Porous Polymeric Sheet

12.0 Device Specifications:

Product Specifications

	PRODUCT	MAXCELL-1	CAG-2	CAG-9	CAG-12	CAG-250
RANGE	0-100%	SAME	SAME	SAME	SAME	SAME
ACCURACY	$\pm2% @$constant T, P	SAME	SAME	SAME	SAME	SAME
90% RESPONSE TIME	<20 s.	SAME	SAME	SAME	SAME	SAME
TEMPERATURE RANGE	5 - 40 °C	SAME	SAME	SAME	SAME	SAME
HUMIDITY	5-95% non-condensing	SAME	SAME	SAME	SAME	SAME
INTERFERENCE	$\pm2%$	SAME	SAME	SAME	SAME	SAME
LINEARITY	$\pm2%$	SAME	SAME	SAME	SAME	SAME
OPERATING LIFE	>12 MONTHS	SAME	SAME	SAME	SAME	SAME
STORAGE TEMPERATURE	-15 - 50 °C	SAME	SAME	SAME	SAME	SAME

13.0 Intended Use:

Monitoring of oxygen concentration.

14.0 Patient Population:

Those patients who require the oxygen concentration in their breathing environment to be monitored.

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SECTION 21

510 (k) SMDA SUMMARY

15.0 Comparison of Technological Characteristics:

Comparitive Results *

PRODUCT	SEATRONICS	MAXCELL-1	CAG-2	CAG-9	CAG-12	CAG-250
RANGE	0-100%	SAME	SAME	SAME	SAME	SAME
ACCURACY	$\u00b12%$ @constant T, P	SAME	SAME	SAME	SAME	SAME
90% RESPONSE TIME	<20 s	SAME	SAME	SAME	SAME	SAME
TEMPERATURE RANGE	0 °C-40 °C	5 ° -40 °C+	SAME	SAME	SAME	SAME
HUMIDITY	5-95%	SAME	SAME	SAME	SAME	SAME
INTERFERENCE	$\u00b12%$	SAME	SAME	SAME	SAME	SAME
LINEARITY	$\u00b12%$	SAME	SAME	SAME	SAME	SAME
OPERATING LIFE	12 MONTH	>12 MONTHS	SAME	SAME	SAME	SAME

16.0 Conclusion:

In summary, based on the information provided, it has been determined that the Ceramatec, Inc., family of galvanic oxygen sensors is substantially equivalent to the Seatronics Company family of galvanic oxygen sensors and are safe and effective for their intended use.

* MAXCELL 11 is the dual-cathode version of the MAXCELL-1. Otherwise, they are identical and will be treated as one.

CAG-2, CAG-8, and CAG-10 differ only in body shape and electronic connection and are otherwise identical. Therefore, the CAG-2, CAG-8 and the CAG-10 will be treated as one.

CAG-9, CAG-15, CAG-18, and CAG-19 differ only in body shape and electronic connection and are otherwise identical. Therefore they will be treated as one.

CAG 12, CAG 13, and CAG-17 differ only in electronic connection and will therefore be treated as one. " Since the patient breathing environment is a temperature-controlled setting, the galvanic oxygen sensors are not typically used at 0 ℃ to 5 ℃. Therefore, the operating temperature ranges of the Ceramatec family of galvanic oxygen sensors and the Seatronics family of galvanic oxygen sensors are equivalent.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 1998

Mr. Gordon Roth Ceramatec, Inc. 2425 South 900 West Salt Lake City, UT 84119

Re: K972992 Ceramatec Maxcell and Cag Galvanic Oxygen Sensors Requlatory Class: II (two) Product Code: 73 CCL January 8, 1998 Dated: Received: January 9, 1998

Dear Mr. Roth:

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 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 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 A substantially equivalent determination assumes compliance to 895. 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 Failure to comply with the GMP regulation may result in assumptions. 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 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. Gordon Roth

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 requlation (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/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

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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Kanza 92

510K Number (if known) :

Device Name: Ceramatec MAXCELL and CAG Galvanic Oxygen Sensors

Indication for Use:

Purpose: The purpose of the Ceramatec family of galvanic oxygen sensors is to be the oxygensensing component in a finished medical device that monitors oxygen concentration.

Function: The Ceramatec galvanic oxygen sensors are used in finished medical device products such as oxygen monitors, oxygen analyzers, ventilators and humidifiers.

Target Patient Population: The target patient population consists of those patients who require the oxygen concentration in their breathing environment to be monitored.

Legally Marketed Predicate Device: The legally marketed predicate device is Seatronics Company's family of galvanic oxygen sensors. The predicate device was assigned 510(k) number K953351 and was declared substantially equivalent by FDA.

Safety and Effectiveness: No differences in intended use or application of the Ceramated family of galvanic oxygen sensors or the predicate device family have been identified that could affect safety or effectiveness.

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

Concurrence of CDRH, Office of Device Evaluation (ODE

My Dering Ya. W. Sapirsteen

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

510(k) Number _

ber __

CEW ? Ret

Over-The-Counter Use __

Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 868.1720 Oxygen gas analyzer.

(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).