The Precision Medical Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining. The concentrator is intended for use in the home or hospital institutional environment.

Device Description

Precision Medical, Inc. Concentrator is a medical device that produces concentrated oxygen from room air. The concentrator uses a molecular sieve and a pressure differential absorption process to concentrate oxygen from air.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study conducted to prove the device meets those criteria:

Acceptance Criteria and Device Performance

Specifications	Acceptance Criteria	Reported Device Performance	ISO 8359:1996 Clause	Meets The Requirement
Oxygen %	93% ±3%	93% ±3%	8.1, 50.4, 50.5	Meets requirements
Liter flow	0.5 to 5.0 liters per minute	0.5 to 5.0 liters per minute	8.1, 50.6, 50.5	Meets requirements
Flow accuracy	10% or ±200ml (comparison to predicate shows this is the acceptance spec)	10% or ±200ml	8.1, 50.3	Meets requirements
Operating temperature	55 to 90 °F	55 to 90 °F	7-42.3	Meets requirements
Storage temperature	-30 to 140 °F (based on reported performance of Precision Medical)	-30 to 140 °F	60601-1 Section 10.1	Meets requirements
Humidity	Up to 95% noncondensing	Up to 95% noncondensing	60601-1 Section 10.1	Meets requirements
Power requirements (Voltage)	120 vac ±10%	120 vac ±10%		Meets requirements
Power requirements (Wattage)	450w	450w		Meets requirements
Power requirements (Frequency)	60 HZ	60 HZ		Meets requirements
Power alarm	LED and audible	LED and audible		Meets requirements
O2 concentration Alarm	LED and audible	LED and audible		Meets requirements
Warm up time	≤ 10 minutes	≤ 10 minutes	8.1, 50.4	Meets requirements
Dimensions	29 inches x 15 inches x 10 inches	29 inches x 15 inches x 10 inches		na
Weight	≤ 36 lbs. (based on reported performance of Precision Medical)	≤ 36 lbs.		na
Sound level	53.3 dBA (based on reported performance of Precision Medical)	53.3 dBA	4.6, 26.1	Meets requirements
Outlet pressure	5.0 psi (based on reported performance of Precision Medical)	5.0 psi	8.1, 50.8	Meets requirements
Back pressure	1.0 psi (based on reported performance of Precision Medical)	1.0 psi	8.1, 50.7	Meets requirements
Outlet gas temp	Max above ambient 0.5 °F or 0.3 °C	Max above ambient 0.5 °F or 0.3 °C	7, 42.3	Meets requirements

Note: For "Flow accuracy," "Storage temperature," "Weight," "Sound level," "Outlet pressure," and "Back pressure," the acceptance criteria were inferred from the reported performance of the Precision Medical device, as the table presents them as if the Precision Medical performance is the criteria for meeting the requirement within its own column.

Study Information

Based on the provided text, the study focuses on technical performance testing rather than a clinical study involving human subjects or expert assessment of data.

Sample size used for the test set and the data provenance:
- The document does not specify a "sample size" in terms of cases or patients for a test set. The tests described are for the device itself (e.g., mechanical, climatic, life test, alarm testing).
- Data Provenance: Not applicable in the context of clinical data provenance. The data comes from internal testing of the Precision Medical, Inc. Oxygen Concentrator. It is a prospective study in the sense that the tests were specifically conducted on the manufactured device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for this device is based on objective measurements against engineering specifications and regulatory standards (like ISO 8359:1996 and 60601-1). No human "experts" are establishing a subjective "ground truth" for interpretation of data in the way radiologists establish ground truth for medical images. The measurements themselves are the ground truth.
Adjudication method for the test set:
- Not applicable. This is not a study involving human interpretation or subjective assessments that would require an adjudication method. The device's performance is objectively measured.
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 document describes the technical performance testing of a medical device (oxygen concentrator), not an AI-powered diagnostic or assistive tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The entire performance evaluation reported is a "standalone" evaluation of the device itself (the oxygen concentrator). There is no "algorithm" in the sense of AI being evaluated here, but the device's functional performance criteria are tested without human intervention impacting its core operation.
The type of ground truth used:
- The ground truth is based on engineering specifications, objective measurements, and compliance with recognized standards (e.g., ISO 8359:1996, 60601-1 Section 10.1). For example, oxygen percentage is measured and compared to the 93% ±3% specification.
The sample size for the training set:
- Not applicable. This is a medical device (oxygen concentrator) whose performance is evaluated against physical and functional specifications. It does not involve machine learning or a "training set" for an algorithm.
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied for this device's evaluation.

Summary

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OCT 2 7 2008

510(k) Summary Precision Medical, Inc. Oxygen concentrator

Submitter Information

Submitter

Contact

Tel: Fax: Preparation Date:
Precision Medical, Inc. 300 Held Drive Northampton, Pa. 18067 James Parker Quality Assurance Manager (610)-262-6090 Extensions 228 (610)-262-6080 August 17, 2007

Device Name

Proprietary Name: Common Name: Classification Name: Classification Product Code: Regulation number:

Precision Oxygen Concentrator Oxygen concentrator Concentrator, oxygen CAW 868.5440

Predicate Device Equivalence

Precision Medical, Inc. is claiming substantial equivalence to the Respironics Oxygen concentrator ,L4 Manufactured by: Respironics Inc. 1001 Murry Ridge Lane. Murrysville, Pa 15668 510 K number: K061261

Device Description

Intended Use

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Specifications	Respironics	Precision Medical	Precision medical test number	ISO 8359 :1996 Clause	Meets The requirement
Oxygen %	93% ±3%	93% ±3%	731-1,22,23	8.1,50.4,50.5	Meets requirements
Liter flow	0.5 to 5.0 liters per minute	0.5 to 5.0 liters per minute	731-24	8.1,50.6,50.5	Meets requirements
Flow accuracy		10%or ±200ml	731-14	8.1,50.3	Meets requirements
Operating temperature	55 to 90 °F	55 to 90 °F	731-4A	7-42.3	Meets requirements
Storage temperature	-30 to 160°F	-30 to 140°F	731-5	60601-1 Section 10.1	Meets requirements
Humidity	Up to 95% noncondensing	Up to 95% noncondensing	731-5	60601-1 Section 10.1	Meets requirements
Power requirements	120 vac ±10%360w 60 HZ	120 vac ±10%450w 60 HZ	731-15		Meets requirements
Power alarm	LED and audible	LED and audible	731-10		Meets requirements
O2 concentration Alarm	LED and audible	LED and audible	731-10		Meets requirements
Warm up time	≤ 10 minutes	≤ 10 minutes	731-1	8.1,50.4	Meets requirements
Dimensions	29inches x 15 inches x 10 inches	29inches x 15 inches x 10 inches	731-2		na
Weight	≤31lbs.	≤36lbs.	731-2		na
Sound level	45 dBA	53.3dBA	731-9	4.6,26.1	Meets requirements
Out let pressure	5.5psi	5.0psi	731-19	8.1,50.8	Meets requirements
Back pressure	Unknown	1.0psi	731-20	8.1, 50.7	Meets requirements
Out let gas temp	unknown	Max above abient 0.5°F or 0.3°C	731-18	7,42.3	Meets requirements

Table of Comparisons to Predicate Device

Summary of Performance Testing

The Precision Medical, Inc. Oxygen Concentrator will successfully pass tests in the following areas;

Mechanical / Climatic Device Performance Life test Alarm testing

Conclusions

In Summary, Precision Medical, Inc. has demonstrated that the Precision Medical, Inc. oxygen Concentrator is safe and effective. The combined testing and analysis of results provides assurance that the device meets the specifications and is safe and effective for the intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James Parker Quality Manager Precision Medical, Incorporated 300 Held Drive Northampton, Pennsylvania 18067

OCT 2 7 2008

Re: K072348

Trade/Device Name: Precision Medical Inc. Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: October 17, 2008 Received: October 20, 2008

Dear Mr. Parker:

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. Parker

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

CHSkomell-Rukins for U

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: K072348

Device Name: Precision Medical Inc. Concentrator

Indications For Use:

Prescription Use × (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)

A. m, D

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

Page 1 of 1

510(k) Number: K072344

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).