The A&J-POCA01 Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc. The A&J-POCA01 is available by prescription only under the supervision of a physician, and is not intended to support or sustain life.

Device Description

The A&J-POCA01 is an AC power electrically operated. The unit separates oxygen from room air (ambient air) which allows high-purity supplemental oxygen to be delivered through the oxygen outlet, although the concentrator filters the oxygen in a room, it will not affect the normal amount of oxygen in your room. Air is drawn into the device with a compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components until they are released when the pressure is vented to the atmosphere. This cycle is controlled by a motorized value and protected from over pressurization by the compressor's pressure relief value.

Oxygen provided by the A&J-POCA01 Oxygen Concentrator is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula or mask. A standard bubble humidifier may be used, if physician has prescribed an oxygen humidifier as part of therapy.

The front panel of the A&J-POCA01 contains the controls and indicators. These include the status lights (included power light, normal oxygen light, low oxygen light and service required light), standard power switch, flow meter and the flow meter knob, a circuit breaker which could reset the device after electrical overload shutdown, a oxygen outlet which oxygen is dispersed through, a monitor display which indicates the condition of system status (included pressure status, oxygen purity status and electric hour meter, etc). The user could operated the device conveniently according the instructions.

AI/ML Overview

The provided 510(k) summary for the A&J-POCA01 Oxygen Concentrator describes a medical device seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring a detailed clinical study with acceptance criteria and ground truth validation as would be typical for novel or higher-risk devices.

Therefore, the document does not contain information on:

Acceptance criteria in the manner of performance metrics (e.g., sensitivity, specificity) for diagnosing or detecting a condition.
A "study that proves the device meets the acceptance criteria" in a clinical sense with a test set, ground truth, and expert evaluation.
Sample sizes for test sets or training sets for an AI/algorithm.
Number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance studies.
Type of ground truth used (e.g., pathology, outcomes data).

Instead, the submission focuses on bench performance testing to demonstrate functional equivalence and safety.

Here's a summary of the information available, framed in response to your request, but highlighting the type of study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission for an oxygen concentrator, the "acceptance criteria" are not based on diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they are related to engineering specifications and functional safety. The document does not provide a table with specific numerical targets and measured performance for each criterion. However, it states:

Acceptance Criteria Category (Implied)	Reported Device Performance
Design Specifications	Met all design specifications.
Substantial Equivalence	Demonstrated substantial equivalence to the predicate device (Mark 5 Nuvo Oxygen Concentrator).
Environmental Testing	Compliant with FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document.
Industry Standards Compliance	Compliant with ASTM F1464, ISO 8359, IEC60601-1, IEC60601-1-2, IEC60601-1-4, and ISO14971.
Safety & Effectiveness	Technologies "bring forth no new questions of safety and effectiveness." Differences from predicate (dimensions, weight, storage, power consumption, oxygen percentage) do not affect safety and efficiencies, with some characteristics being "better than the predicate."
Hazard Analysis	Performed, and testing conducted to validate system's overall operation.

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

Sample Size: Not applicable in the context of a clinical test set for diagnostic performance. The testing involved laboratory and bench testing of the device itself.
Data Provenance: Not applicable for clinical data. The testing was conducted in a laboratory setting by the manufacturer, Zhongshan A & J Medical Equipment CO., LTD in China, to evaluate the device against specified engineering and regulatory standards. The testing was described as "Laboratory testing."

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

This is not applicable as the study did not involve a clinical test set requiring expert-established ground truth for diagnostic purposes. The "ground truth" for this device would be its adherence to engineering specifications and performance standards as measured by laboratory equipment.

4. Adjudication Method for the Test Set

Not applicable as there was no clinical test set requiring expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. The device is an oxygen concentrator, not an imaging or diagnostic AI tool that would typically involve human readers.

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

Not applicable. The device is a physical medical device (an oxygen concentrator), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this medical device submission is its functional performance measured against established engineering specifications, safety standards, and regulatory requirements. This includes:
- Compliance with various international and national standards (e.g., ASTM F1464, ISO 8359, IEC60601-1).
- Verification against the predicate device's performance characteristics where relevant.
- Results from hazard analysis.
- Meeting internal design specifications.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI that would require a "training set."

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

Not applicable.

Summary

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K071608

Chapter 04 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

Submitter:

Zhongshan A & J Medical Equipment CO., LTD

Address: No.3 Shenghui South Road Nantou Town, Zhongshan, City, Guangdong CHINA P.R.C.

Contact Person: ●
Polo Chen R&D Manager Email: polochen888@hotmail.com Tel: 0086-760-3133726 Fax: 0086-760-3133724

Applicant: Zhongshan A & J Medical Equipment CO., LTD

Address: No.3 Shenghui South Road Nantou Town, Zhongshan, City, Guangdong CHINA P.R.C

Date Prepared: ●
January 15, 2007

Name of the device:

Trade/Proprietary Name: The A&J-POCA01 Oxygen Concentrator .
Common Name: Oxygen Concentrator
Classification

Portable Oxygen Generator 21 CFR 868.5440

Class II

Legally Marketed Predicate Device:

K032509 Mark 5 Nuvo Oxygen Concentrator

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Description:

Statement of intended Use:

The A&J-POCA01 Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc. The POCA01 is available by prescription only under the supervision of a physician, and is not intended to support or sustain life.

Technological Characteristics:

Technologies utilized by the A&J-POCA01 Oxygen Concentrator bring forth no new questions of safety and effectiveness. These technologies are also currently being used in the identified predicate device.

Bench performance testing has demonstrated that the A&J POCA01 Oxygen

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510 (k) Summary

Concentrator is substantially equivalent to the predicate device.

The main different between the A&J-POCA01 Oxygen Concentrator and the Mark 5 Nuvo Oxygen Concentrator are the physical characteristics, such as the dimensions, the weight, the storage conditions, these different would not affect the safety and efficiencies of the A&J-POCA01, also, the power consumption and the oxygen percentage of the A&J-POCA01 are different to the predicate, but these characteristics are better than the predicate. The A&J-POCA01 Oxygen Concentrator is substantially equivalent to the predicate device.

Testing:

Laboratory testing was conducted to validate and verify that the A&J-POCA01 Oxygen Concentrator met all design specifications and was substantially equivalent to the predicate device. This testing consisted of all environmental testing identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document. Additional testing was performed to demonstrate compliance with the standards of ASTM F1464 and ISO 8359. Finally, a hazard analysis of the system and its software was performed and testing was conducted to validate the systems overall operation. The A&J POCA01 Oxygen Concentrator has also been tested to assure compliance to the requirements of various published standards, including IEC60601-1, IEC60601-1-2, IEC60601-1-4, and ISO14971.

Conclusion:

The conclusions drawn from the testing of the A&J-POCA01 Oxygen Concentrator demonstrates that the device is substantially equivalent to the predicate device.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

JAN 1 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zhongshan A&J Medical Equipment Company, Limited C/O Ms. Michelle S. Lee Responsible Third Party Official Underwriters Laboratories, Incorporated Laboratory and Testing 2600 NW Lake Road Camas, Washington 98607-9526

Re: K071608

Trade/Device Name: A&J-POCA01 Oxygen Concentrator Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: December 20, 2007 Received: December 28, 2007

Dear Ms. Lee:

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 - Ms. Lec

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) 276-0120. 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,

Suyle 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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Chapter 03

Page __ 1___ of ___ of ___ 1_

510(k) Number (if known):

Device Name: A&J-POCA01 Oxygen Concentrator

Indications For Use:

Prescription Use _ x (Per 21 CFR 801 Subpart D)

Over-The Counter Use OR (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

un Thinh

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

1107 1608 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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).