The COPD Partners Model 300P Liquid Oxygen Portable will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing medical grade liquid oxygen, and then dispensing it to the patient via an integral electronic conserving device. The Model 300P Liquid Oxygen Portable is neither a life-sustaining nor life-supporting device.

Device Description

The COPD Partners' Model 300P is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum-insulated cryogenic Dewar, an economizer regulator, electronic printed circuit board (PCB), an oxygen conserving system, and a protective case.

The Dewar has a capacity and capability to store 0.33 liters of liquid oxygen. Dependant on the flow selection setting, the control system either delivers the oxygen to the conserving device or delivers a 2 LPM continuous flow directly to the oxygen outlet. The continuous flow setting is labeled CF on the flow method selector. The conserving device has an equivalent setting for 1, 2, 3, 4, and 5 LPM prescriptions. At the various conserving device settings, the outlet oxygen gas is delivered in quick pulses beginning at the start of inhalation.

The device also has a provision to track the patient's breath rate and in the event of an increase in breath rate, will deliver an increased volume of oxygen. There are two levels of increased volume, one at 4 breath per minute (BPM) over normal breath rate and another at 8 BPM over normal breath rate. The device delivers an extra 16 cc at each of these two thresholds. The COPD Partners Model 300P is transfilled from a commercially available medical grade liquid oxygen source.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device, the COPD Partners Model 300P Liquid Oxygen Portable. This document primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing and compliance with electrical safety standards. It does not contain information about studies involving human readers, ground truth established by experts, or the specific details typically found in studies for AI/algorithm-driven diagnostic or prognostic devices.

Therefore, many of the requested categories cannot be filled from the provided text.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Bench Testing	Oxygen Purity Levels: Product specifications for oxygen purity are met.	Not explicitly stated in quantitative terms but "All results of tests met the acceptance criteria" implies compliance.
	Safety Mitigations: All safety mitigations identified in the Model 300P risk assessment have been completed.	Not explicitly stated in quantitative terms but "All results of tests met the acceptance criteria" implies compliance. No new patient safety issues identified due to the lack of a 1.5 LPM setting or the new algorithm.
	Oxygen Delivery Rate Settings: Oxygen delivery rate settings as defined in the product specification are met. (Specifically for the conserving device: 1, 2, 3, 4, and 5 LPM prescriptions, and an extra 16 cc at +4 BPM and +8 BPM over normal breath rate)	The device's method of delivering oxygen has been optimized to deliver an "extra 16 cc at each of these two thresholds" (+4 BPM and +8 BPM breath rate increase). The device "delivers an additional 16 cc of oxygen per breath, the equivalent to turning the knob up one setting" when a rise of > 4 BPM is noticed, and "yet another 16 cc of O2 per breath" if > 8 BPM. Also, the new conserver algorithm is indicated to be "capable of covering this flow rate" (1.5 LPM).
Independent Testing	Electrical Safety Standard (UL 60601-1-1:2005): Requirements for medical electrical equipment safety are met.	"All results of tests met the acceptance criteria."
	Electromagnetic Compatibility (IEC 60601-1-2:2001 and A1-2004): Requirements for electromagnetic compatibility are met.	"All results of tests met the acceptance criteria."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable. The testing described is bench testing of the device's physical and electronic performance, not testing on a patient data set.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth as typically understood for diagnostic/AI devices (e.g., expert consensus on medical images or pathology reports) is not relevant for this type of device and testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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

No MRMC comparative effectiveness study was done. This device is a portable oxygen unit, not an AI-assisted diagnostic or prognostic tool.

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

Stand-alone performance was assessed for the device's oxygen delivery mechanism and safety features through bench testing. The "algorithm" for adjusting oxygen delivery based on breath rate was tested as part of the device's overall function. No specific "algorithm-only" performance metrics are provided in isolation from the integrated device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on engineering specifications and regulatory standards. For example, oxygen purity levels are compared against an acceptable standard, and delivery rates are compared against the intended programmed output (e.g., 16cc per breath increase).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

Not applicable.

Summary

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Section 5 - 510(k) Summary

OCT 1 8 2007

K072050

510(k) Summary COPD Partners Model 300P Liquid Oxygen Portable

Submitter	Richard J. KocinskiCOPD Partners, Inc.1061 Main Street - #24North Huntingdon, PA 15642Phone: 724-861-5510FAX: 724-861-5530e-mail rkocinski@copdpartners.net
Date Prepared	7-19-2007
Device Trade Name	Model 300 P Liquid Oxygen Portable
Common Name	Portable Liquid Oxygen Unit
Classification	868.5655
Product Codes	BYJ
Predicate Device	Spirit 300510(k) Number: K013251Manufacturer:Caire Inc.,1800 Sandy Plains Industrial ParkwayMarietta, GA 30066

Intended use

Device Description

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Section 5 - 510(k) Summary

device has an equivalent setting for 1, 2, 3, 4, and 5 LPM prescriptions. At the various conserving device settings, the outlet oxygen gas is delivered in quick pulses beginning at the start of inhalation.

Technological Characteristics as Compared to the Predicate

The COPD Partners 300P Liquid Oxygen portable is mechanically the same as the Caire Spirit 300 portable oxygen system. As such, the user interface and physical attributes are the same.

There are three primary differences:

The method of delivering oxygen in the COPD Partners 300P Liquid Oxygen Portable has been optimized to deliver the required volume of 16 cc per L seting at a variable flow rate using two control valves to deliver the best flow rate based upon the patient's current breath rate and prescription setting. The Caire Spirit 300 uses a single control valve (flow) which delivers a fixed volume of 15 cc per L of prescription flow setting.

Additonally, the COPD Partners' Model 300P uses a relatively quick rise in breath rate as an indicator of need. When a rise of > 4 breaths per minute (BPM) in rate is noticed, the unit delivers an additional 16 cc of oxygen per breath, the equivalent to turning the knob up one setting. If the patient's BPM rises > 8 BPM, the conserver adds yet another 16 cc of O2 per breath. When the user drops below the 4 BPM threshold and returns to normal breathing, the volume is lowered to the normal setting volume. In this way, the device does not stay at a higher O2 delivery mode. which can happen when patients are adjusting their own settings. In effect, the COPD Partners' conserver attempts to automate an adjustment that is currently being done by the user in a manual process.

The Caire Spirit 300 does not have this capability.

The 300P Liquid Oxygen System uses 4 AA batteries for an estimated 300 hours of battery life. The Caire Spirit 300 uses 2 C batteries for and estimated 500 hours of battery life. Since both systems have a low battery warning indicator and allow the patient to switch to a manual 2 LPM continuous flow setting if batteries are depleted, there is no change in safety of effectiveness of the COPD Partners 300P Liquid Oxygen Portable vs.

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Section 5 - 510(k) Summary

the Caire Spirit 300 Portable.

The COPD Partners model 300P does not have a 1.5 LPM flow rate setting. The bench testing for the revised conserver algorithm indicate the new algorithm is capable of covering this flow rate. No new patient safety issues have been identified

Summarv of Testing

Verification and Validation testing has been completed using the COPD Partners Model 300P Liquid Oxygen Portable to assure that the device meets the safety and performance requirements described in the specifications. This testing includes:

1. Bench testing to verify that:
- a. Oxygen purity levels in the product specification are met.
- b. Safety mitigations as identified in the Model 300P risk assessment have been completed
- c. Oxygen delivery rate settings as defined in the product specification are met
1. Independent testing and evaluation to verify that the Model 300P Liquid Oxygen Portable meets the requirements of:
- a. UL 60601-1-1:2005 Medical electrical equipment Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical system
- b. IEC 60601-1-2:2001 and A1-2004 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. Testing demonstrates that the COPD Partners Model 300P Liquid Oxygen Portable performs at least as well and is as safe and as effective as the predicate Caire 300.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an abstract image of a human figure with three arms or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2007

COPD Partners, Incorporated Mr. Paul Dryden Consultant ProMedic, Incorporated 3460 Pointe Creek Court, # 102 Bonita Springs, Florida 34134-2015

Re: K072011

Trade/Device Name: Model 300P Liquid Oxygen Portable Regulation Number: 21 CFR 868.5655 Regulation Name: Portable Liquid Oxygen Unit Regulatory Class: II Product Code: BYJ Dated: July 19, 2007 Received: July 23, 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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Image /page/4/Picture/2 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that create the impression of feathers.

Page 2 - Mr. Dryden

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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 (QS) 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) 276-0115. 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,

Synette Y. Michael Davis

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

510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Prescription Use XX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mill Holland

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K072011

Regulation Number and Section

§ 868.5655 Portable liquid oxygen unit.

(a)
Identification. A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.(b)
Classification. Class II (performance standards).