The Model 300D Home Oxygen Liquefier is intended for use in liquefying oxygen supplied by a concentrator equipped with an oxygen sensing device. The concentrator used with the home oxygen liquefier should generate >90% oxygen purity nominally, and alert the user if this purity drops to unacceptable levels. This liquid oxygen is intended for use with the liquid portable products rated for 93% oxygen such as the Caire Spirit 300 HAS product. This system and the associated portable are intended for use with 93% (+3%) oxygen.

It may be used in the home or institution. It is intended to be used with both pediatric and adult patients. It is not intended to be a life sustaining or life supporting device. The device has no contraindications.

Device Description

The COPD Partners' model 300D is a home oxygen liquefaction device. The product is intended to connect to an oxygen concentrator that is equipped with an oxygen sensing device to assure adequate levels of oxygen purity. The model 300D then splits the gas source from the concentrator, giving the patient their desired level of gas flow and uses the remaining flow for the liquefaction portion of the unit. The liquefaction portion of the device consists of desiccants, a boost pump compressor, a high pressure compressor, a series of heat exchangers, a dual stage cascade refrigeration pre-cooler, a microcontroller based controller system, and a Dewar with a Joule Thompson (JT) valve. This device pressurizes the gas, cools it, and then expands the gas through the JT valve, where a portion of the gas will convert to liquid oxygen will be used to fill a liquid oxygen portable such as the COPD Partners' Model 300P. The device indicates the level of liquid in the Dewar and has a control system to display this information to the user. In addition, it automatically turns on to maintain a desired level of liquid in the Dewar.

AI/ML Overview

The provided 510(k) summary for the COPD Partners Model 300D Home Oxygen Liquefier details its performance and testing. However, it does not include all the specific information requested in your prompt regarding clinical studies, expert involvement, and detailed ground truth methodologies, as these are more typical for diagnostic AI/ML device submissions. This device is a home oxygen liquefier, which is a hardware device, not an AI/ML diagnostic tool. Therefore, the questions related to AI/ML specific aspects (like MRMC studies, training/test sets, expert ground truth establishment for algorithm performance) are not applicable to this submission.

Here's a breakdown of the available information based on your request, with an explanation for the missing AI/ML related details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Requirement)	Reported Device Performance
Liquefaction Rate	0.16 L Lox/Hr (after cool down)
Input Oxygen Purity Required	>85% (Device documentation indicates it expects concentrator to generate >90% nominally)
Meets UL 60601-1-1:2006	Met
Meets IEC 60601-1-2:2007	Met

2. Sample size used for the test set and the data provenance

Sample Size: The document mentions "Bench testing" and "Independent testing and evaluation" for verification and validation. However, it does not specify a sample size in terms of number of devices or number of test cases.
Data Provenance: The testing was "Bench testing" and "Independent testing and evaluation" implying laboratory-based assessments. No information on country of origin of data (though the submitter is based in PA, USA) or whether it was retrospective or prospective in a clinical setting is provided. Given the nature of the device (hardware), this likely refers to engineering and performance testing rather than clinical study data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the device is a hardware for liquefying oxygen, not a diagnostic device where expert ground truth for interpretation would be relevant. The "ground truth" here is objective physical measurements and adherence to safety standards.

4. Adjudication method for the test set

This question is not applicable for the same reasons as above. Adjudication methods are relevant for subjective interpretations, typically in diagnostic imaging or clinical assessments. Device performance was verified against pre-defined engineering and safety specifications.

5. 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

This question is not applicable as the device is a home oxygen liquefier and does not involve AI or human readers for interpretation.

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

This question is not applicable as the device is a hardware product, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on objective engineering specifications and recognized safety standards. This includes:
- Measured liquefaction rates.
- Measured oxygen purity levels.
- Compliance with UL 60601-1-1:2006 (Medical electrical equipment safety).
- Compliance with IEC 60601-1-2:2007 (Electromagnetic compatibility).
- Verification of safety mitigations identified in the risk assessment.

8. The sample size for the training set

This question is not applicable as the device is a hardware product and does not involve an AI/ML model requiring a training set.

9. How the ground truth for the training set was established

This question is not applicable as the device is a hardware product and does not involve an AI/ML model requiring a training set.

Summary of Study that Proves Device Meets Acceptance Criteria:

The 510(k) summary states that "Verification and Validation testing has been completed on the COPD Partners Model 300D Liquefier to assure that the device meets the safety and performance requirements described in the specifications." The testing included:

Bench testing: This verified that the liquefaction rates and oxygen purity levels met product specifications and that safety mitigations from the risk assessment were completed.
Independent testing and evaluation: This verified that the device met the requirements of UL 60601-1-1:2006 (Medical electrical equipment safety) and IEC 60601-1-2:2007 (Electromagnetic compatibility).

The document explicitly states: "All results of tests met the acceptance criteria."

It's important to reiterate that this is a submission for a physical medical device (oxygen liquefier), not a software or AI/ML-based diagnostic tool. Therefore, many of the questions asked, which are highly relevant for AI/ML device evaluations, do not apply to this specific 510(k) filing.

Summary

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KO7146

Non Confidential 510(k) Summary Page 1 of 3 COPD Partners Model 300 D Home Oxygen Liquefier

Date:	August 17, 2007	AUG 2 1 2007
Submitter:	Richard J. KocinskiVP of Product DevelopmentCOPD Partners, Inc.1061 Main Street - #24North Huntingdon, PA 15642Phone: 724-861-5510
Device Trade Name	Model 300 D Liquefier
Common Name	Accessory to Oxygen Concentrator and Liquid OxygenPortable
Classification	868.5440/868.5655
Product Codes	CAW/BJY
Predicate Device	In-X Corporation Home-Away System Model 1041 (K042944)Caire Spirit 300 HAS (K050153)

Device Description

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Non Confidential 510(k) Summary Page 2 of 3

Indications for Use

Environment of use

Home or institution.

Liquefaction rate	0.16L Lox/Hr (after cool down)
Input Voltage and Current	120 VAC (±10%) 60 HZ , 12 A
Average Power Consumption	950 Watts
Input Oxygen Purity Required	>85%
Input Oxygen Pressure	5 to 10 psig
Weight	180 Lbs $^{\pm}$ 5 Lbs
Storage and Transport Temperature	-20 to 50 oC
Operating Temperature	+ 5 to 40 oC
Operating Humidity	15 to 95% R. H., Non-Condensing

Device Attributes

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Non Confidential 510(k) Summary Page 3 of 3

Technological Characteristics as Compared to the Predicate

The COPD Partners Model 300D Home Oxygen liquefier is substantially equivalent to the In-X Home–Away System, Model 1041 cleared under K042944. Both systems are compatible with oxygen concentrators that deliver ≥ 5L/min USP Oxygen at a rated 93% USP O2 purity, and a minimum of 87% purity. Both systems are compatible with bottom fill type LOX portable units manufactured by their respective companies. Both have been tested to meet standards for medical device safety, EMC compatibility, liquid oxygen production rates, mechanical shock and vibration.

The primary difference between the COPD Partners Model 300 D Home Oxygen Liquefier and the In-X Model 1041 Home-Away system is the method of liquefaction of the oxygen. The COPD Partners Model 300 uses standard two stage refrigeration process with a separate refrigeration system and Joule-Thompson valve and a Joule Thompson valve integral to the Dewar assembly. The In-X System uses a Sterling Cycle liquefaction system with an integral cooler and Dewar Assembly.

This difference does not affect the safety or effectiveness of the COPD Partners Model 300D Home Oxygen Liquefier

Summary of Testing

Verification and Validation testing has been completed on the COPD Partners Model 300D Liquefier to assure that the device meets the safety and performance requirements described in the specifications. This testing includes:

Bench testing to verify that:

a. The liquefaction rates and Oxygen purity levels in the product specification are met.

b. Safety mitigations as identified in the Model 300D risk assessment have been completed.

Independent testing and evaluation to verify that the Model 300 D Liquefier meets the requirements of:

a. UL 60601-1-1:2006 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical system.

b. IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for safety - Section 2: Collateral standard: Electromagnetic compatibility - Requirements and tests.

All results of tests met the acceptance criteria.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

COPD Partners, Incorporated C/O Mr. Paul E. Dryden President Promedic, Incorporated 3460 Pointe Creek Court, Suite 102 Bonita Springs, Florida 34134-2015

AUG 2 1 2007

Re: K071461

Trade/Device Name: Model 300D Home Oxygen Liquefier Regulation Number: 868.5655 Regulation Name: Portable Liquid Oxygen Unit Regulatory Class: II Product Code: CAW, BYJ Dated: May 23, 2007 Received: May 25, 2007

Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Dryden

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Page 1 of 1

510(k) Number: .

K071461 (To be assigned)

Device Name:

Model 300D Home Oxygen Liquefier

Indications for Use:

Over-the-counter use Prescription Use XX (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

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Nision of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number Page 25

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).