INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10

K042262 · Sequal Technologies, Inc. · CAW · Sep 10, 2004 · Anesthesiology

Device Facts

• Record ID: K042262
• Device Name: INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10
• Applicant: Sequal Technologies, Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: Sep 10, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, is intended for the administration of supplemental oxygen up to 10 LPM. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Device Story

SeQual Model 6323A-OM-10 is a continuous flow oxygen concentrator; utilizes pressure swing adsorption (PSA) technology to extract oxygen from ambient air. System components include inlet filtration, air compressors, heat exchanger, synthetic zeolite molecular sieve beds, rotary valve, outlet filtration, and electronic flow control. Produces oxygen at flow rates from 0.5 to 10.0 LPM. Device includes audible and visual alarms for operational status. Intended for clinical or home use; operated by patients or caregivers. Output is supplemental oxygen for patient inhalation; does not provide life support or patient monitoring. Benefits include providing a continuous source of supplemental oxygen without the need for high-pressure oxygen cylinders.

Clinical Evidence

Bench testing only. Oxygen concentration performance verified against ISO 8359 and ASTM 1464 standards.

Technological Characteristics

Continuous flow PSA oxygen concentrator; 0.5-10.0 LPM output. Components: inlet/outlet filters, air compressors, heat exchanger, synthetic zeolite molecular sieve beds, rotary valve. Electronic flow control with audible/visual alarms. Tested to ISO 8359 and ASTM 1464.

Indications for Use

Indicated for patients requiring supplemental oxygen therapy up to 10 LPM. Not for life support. No contraindications.

Regulatory Classification

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).

Predicate Devices

• SeQual Technologies Model 6323-OM Oxygen Concentrator (K942082)
• Integra Oxygen Concentrators Model 6400-OM (K003472)
• OMNI Oxygen System, Model 1000 (K013931)

Submission Summary (Full Text)

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K042262

# Special 510(k) Summary

#### Submitter Information:

SEP 1 0 2004

| Submitter: | SeQual Technologies, Inc.<br>11436 Sorrento Valley Road<br>San Diego, CA 92121 |
|---------------------------|--------------------------------------------------------------------------------|
| Contact: | Brian Jarrell, Director of Quality and Regulatory |
| Phone: | [phone] |
| FAX: | [phone] |
| Date of Summary: | August 11, 2004 |
| Device Name: | |
| Proprietary Name: | Integra Oxygen Concentrator, Model 6323A-OM-10 |
| Common Name: | Oxygen Concentrator |
| Classification of Device: | Generator, Oxygen, Portable as per 21 CFR 868.5440 |

#### Predicate Device Equivalence:

SeQual Technologies is claiming substantial equivalence to the following legally marketed predicate devices:

K942082 - SeQual Technologies Model 6323-OM Oxygen Concentrator K003472 - Integra Oxygen Concentrators Model 6400-OM K013931 - OMNI Oxygen System, Model 1000

#### Description of Device:

The SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, is a 0.5 to 10.0 Liter per minute (LPM) continuous flow pressure swing adsorption (PSA) type system that produces oxygen.

The SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, consists of pneumatic and electrical components. The system has inlet filtration, air compressors, heat exchanger, and Synthetic Zeolite molecular sieve beds with a rotary valve, outlet filtration, electronic flow control and audible / visual alarms.

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### Intended Use:

The SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, is intended for the administration of supplemental oxygen up to 10 LPM. The device is not intended for life support nor does it provide any patient monitoring capabilities.

The device has no contraindications.

#### Technological Characteristics:

The SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, operates comparably to the listed predicate devices. The technology employed to generate the oxygen is well established, and therefore, raise no new questions of safety and effectiveness.

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#### Performance Data:

Results of the oxygen concentration testing to ISO 8359 and ASTM 1464 standards confirm the device meets specifications and is substantially equivalent to the predicate devices.

#### Conclusion:

Based on the design, performance specifications, tests and intended use, the SeQual Model 6323A-OM-10, Integra Oxygen Concentrator is substantially equivalent to the currently marketed devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### SEP 1 0 2004

Mr. Brian Jarrell Director, Quality and Regulatory Affairs Sequal Technologies, Incorporated 11436 Sorrento Valley Road San Diego, California 92121-1306

Re: K042262

Trade/Device Name: SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: August 17, 2004 Received: August 23, 2004

Dear Mr. Jarrell:

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 Eederal Register.

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Page 2 - Mr. Jarrell

Please be advised that FDA's issuance of a substantial equivalence determination does not I teast 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. or the Act of ally I out's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and instille (2 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - requirence as between is 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) This reter wifi ano in J The FDA finding of substantial equivalence of your device to a promainer results in a classification for your device and thus, pour 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), 11 you deems the Office of Compliance at [phone]. 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 maj count Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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### SeQual Technologies Inc. 11436 Sorrento Valley Road, San Diego CA 92121 USA

## Indications for Use Statement

Verl 3 - 4/24/96

Applicant: SeQual Technologies Inc.

510(k) Number (if known):

Device Name: SeQual Model 6323A-OM-10, Integra Oxygen Concentrator,

Indications For Use:

The SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, is intended for the administration of supplemental oxygen up to 10 LPM. The device is not intended for life support nor does it provide any patient monitoring capabilities.

| Prescription Use | X | AND/OR | Over-The-Counter Use |
|-----------------------------|-----------------------------------------------------------------------------------------------------|------------------------|----------------------|
| (Part 21 CFR 801 Subpart D) | (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | (21 CFR 807 Subpart C) | |
| 510(k) Number: | | | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

| Int510k/induse | (Division Sign-Off) Division of Anesthesiology, General Hospital, |
|----------------|-------------------------------------------------------------------|
|----------------|-------------------------------------------------------------------|

Infection Control, Dental Devices

510(k) Number:_