The Canogen Portable Oxygen Generator, Model 615 provides an average of 6.5 liters a minute for a minimum of 15 minutes, through a chemical reaction. The Canogen Portable Oxygen Generator, Model 615 consists of three parts. The first part is a reaction vessel in which the chemical reaction takes place. The reaction vessel may be reused. The second part is the cartridge containing the chemicals required to generate the oxygen produced by this device. The third part of the generator consists of the plastic tubing and gas mask which are attached to the outlet of the generator.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Canogen Portable Oxygen Generator, Model 615:

The provided text is a 510(k) summary for a medical device and is primarily focused on demonstrating substantial equivalence to a predicate device. It details product specifications and some basic bench testing. It does not describe a complex study involving human readers, AI, or extensive ground truth establishment as might be found in a clinical trial or AI/ML device submission.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Produce humidified oxygen at >99% purity	Determined to produce humidified oxygen at a purity of greater than 99%
Produce oxygen for a minimum of 15 minutes	Determined to produce oxygen for a minimum of fifteen (15) minutes
Produce oxygen at an average flow rate of 6.5 L/minute	Determined to produce oxygen at an average flow rate of six and a half (6.5) liters per minute (The Device Description also states "provides an average of 6.5 liters a minute for a minimum of 15 minutes").

Study Details

The provided document describes a bench test rather than a full clinical study or comparative effectiveness study.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of devices or test runs. The text states "Bench test runs were conducted," implying multiple runs, but no specific count is given.
- Data Provenance: The tests were conducted internally by Canogen International, Ltd. and are "bench tests." There is no indication of country of origin for data or whether it's retrospective or prospective beyond the internal testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here is based on physical measurements from calibrated instruments (flow gauges, temperature sensors, pressure gauges). There are no human experts establishing a subjective ground truth for the performance of this type of device in the context of this summary.
Adjudication method for the test set:
- Not applicable. This was a bench test involving objective measurements, not a test set requiring expert adjudication for subjective interpretation.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC comparative effectiveness study was not performed. This device is an oxygen generator, not an imaging or diagnostic AI device that would involve human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable directly as an AI algorithm. However, the performance assessment described is a standalone performance evaluation of the physical device itself (without human intervention in its oxygen generation function). The device operates independently once activated.
The type of ground truth used:
- Instrumental Measurements/Physical Standards. The "ground truth" for purity, flow rate, and duration was established by measurements from "flow gauges, temperature sensors, data logger and pressure gauges." These instruments provide objective, quantitative data against which the device's performance was compared to established physical parameters and its own design specifications.
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI algorithms, and therefore, there is no "training set."
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI algorithm, this requirement does not apply.

Summary of Device and Study Type:

This K982143 submission describes a portable oxygen generator. The "study" referenced is a series of internal bench tests designed to verify the physical operating specifications of the device (oxygen purity, flow rate, and duration) against its pre-defined performance goals. This is a common and appropriate type of testing for a device of this nature to demonstrate its fundamental functionality. The submission is not for a computational or AI-driven device, hence many of the requested categories related to AI/ML studies are not applicable.

Summary

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K982143

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA

I. General Information

A.	Submitted By:	Canogen International, Ltd.P.O. Box 766Syosset, New York 11791Tel: (516) 228-6600Fax: (516) 228-6664
	Contact Person:	Steven R. Broder at address above
B.	Device Trade Name:Common Name:Classification Name:	Canogen Portable Oxygen Generator, Model 615Portable Oxygen GeneratorPortable Oxygen Generator
C.	Predicate Device:	Jet Research Center, Model 415 Oxygen Canisterand Dispenser Model 3445-c, 510(k) #K780020

D. Device Description:

E. Indications for Use:
!

The Canogen Portable Oxygen Generator. Model 615 is intended to produce oxygen for emergency use.

F. Technological Comparison:
The Canogen Portable Oxygen Generator, Model 615 and the Model 415 Oxygen Canister are designed to generate oxygen. Both devices are provided in

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kit form with the necessary containers. chemicals and accessories to provide oxygen for emergency use (with the exception of tap water for the Portable Oxygen Generator). As with the Jet Research Model 415, the chemicals used in the Canogen Portable Oxygen Generator are packaged in cartridges which are inserted into the reaction vessel to contain the reaction and port the gas to the face mask tubing.

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II. Testing

Bench test runs were conducted while using flow gauges, temperature sensors, data logger and pressure gauges to monitor performance characteristics during each run. The cartridge was inserted into the reaction vessel. The gas generated by the reaction was ported through plastic tubing to the flow sensor and manual flow gauges. For each test run the data acquisition system was used to log the flow rate, and temperatures.

The Canogen Portable Oxygen Generator. Model 615 was determined to produce humidified oxygen at a purity of greater than 99% for a minimum of fifteen (15) minutes at an average flow rate of six and a half (6.5) liters per minute.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the United States. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 1998

Ms. Melissa Mahall Canogen International Ltd. c/o Bio-Reg Associates, Inc. 14900 Sweitzer Lane, Suite 200 Laurel, MD 20707

Re: K982243 Canogen Portable Oxygen Generator, Model 615 Requlatory Class: II (two) Product Code: 73 CAW Dated: October 7, 1998 Received: October 13, 1998

Dear Ms. Mahall:

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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, and 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

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Page 2 -- Ms. Melissa Mahall

forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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.

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 the 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. Cella

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

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Canogen Portable Oxygen Generator, Model 615 Device Name:

Canogen International Ltd. Sponsor Name:

Indications for Use

The Canogen Portable Oxygen Generator, Model 615 is intended to produce oxygen for emergency use.

Do Not Write Below This Line - Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark kramer

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

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Regulation Number and Section

§ 868.5440 Portable oxygen generator.

(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).