MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES

K091541 · Sequal Technologies Co., Ltd. · CAW · Dec 31, 2009 · Anesthesiology

Device Facts

• Record ID: K091541
• Device Name: MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES
• Applicant: Sequal Technologies Co., Ltd.
• Product Code: CAW · Anesthesiology
• Decision Date: Dec 31, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SeQual Model 2-6000 Series, MESA Oxygen Concentrator, is intended for the administration of supplemental oxygen up to 5 LPM. The device is not intended for life support nor does it provide any patient monitoring capabilities. The device has no contraindications.

Device Story

MESA Oxygen Concentrator (Model 2-6000 Series) is a portable oxygen generator using pressure swing adsorption (PSA) technology. Device inputs include ambient air; internal components include inlet filtration, air compressors, heat exchanger, and synthetic zeolite molecular sieve beds with a rotary valve. System produces continuous flow oxygen (0.5 to 5.0 LPM). Device includes outlet filtration and electronic flow control with audible/visual alarms. Intended for clinical or home use to provide supplemental oxygen; not for life support or patient monitoring. Healthcare providers or patients use the device to deliver oxygen therapy; output affects oxygen saturation levels in patients requiring supplemental oxygen.

Clinical Evidence

Bench testing only. Oxygen concentration testing performed in accordance with ISO 8359 and ASTM 1464 standards confirmed the device meets performance specifications.

Technological Characteristics

Pressure swing adsorption (PSA) oxygen generator. Components: inlet/outlet filtration, air compressors, heat exchanger, synthetic zeolite molecular sieve beds, rotary valve. Electronic flow control. Audible/visual alarms. Standards: ISO 8359, ASTM 1464.

Indications for Use

Indicated for patients requiring supplemental oxygen up to 5 LPM. Not for life support or patient monitoring. 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

• Integra Oxygen Concentrators Model 6400-OM (K003472)
• DEVILBISS 5 Liter Compact Oxygen Concentrator (K071397)

Submission Summary (Full Text)

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109154

## 510(k) Summary

### Submitter Information:

| Submitter: | SeQual Technologies Co., Ltd<br>6F-7, No.136, Sec.3, Ren-ai Rd.<br>10657, Taipei, Taiwan (R.O.C.) |
|---------------------------|---------------------------------------------------------------------------------------------------|
| Contact: | Cearo Huang, Director, Engineering & Research Division |
| Phone: | 886-2-2700-2737 |
| Fax: | 886-2-2707-9253 |
| Date of Summary: | January 5, 2009 |
| Device Name: | |
| Proprietary Name: | MESA Oxygen Concentrator, Model 2-6000 Series |
| Common Name: | Oxygen Concentrator |
| Classification of Device: | Generator, Oxygen, Portable as per 21 CFR 868.5440 |

#### Predicate Device Equivalence:

SeQual Technologies Co., Ltd is claiming substantial equivalence to the following legally marketed predicate devices: K003472 - Integra Oxygen Concentrators Model 6400-OM K071397 – DEVILBISS 5 Liter Compact Oxygen Concentrator

#### Description of Device:

The SeQual Model 2-6000 Series, MESA Oxygen Concentrator, is a 0.5 to 5.0 Liter per minute (LPM) continuous flow pressure swing adsorption (PSA) type system that produces oxygen.

The SeQual Model 2-6000 Series, MESA Oxygen Concentrator, consists of pneumatic and electrical components. The system has inlet filtration, air compressors, heat exchanger, and

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Synthetic Zeolite molecular sieve beds with a rotary valve, outlet filtration, electronic flow control and audible / visual alarms.

#### Intended Use:

The SeQual Model 2-6000 Series, MESA Oxygen Concentrator, is intended for the administration of supplemental oxygen up to 5 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 2-6000 Series, MESA 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.

#### 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 2-6000 Series, MESA Oxygen Concentrator is substantially equivalent to the currently marketed devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol of three stylized human profiles facing right. The profiles are stacked vertically, with the top profile being the largest and the bottom profile being the smallest. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Mr. Cearo Huang Director, Engineering & Research SeQual Technologies Company, Limited 6F-7, No. 136, Sec.3, Ren-ai Rd. Taipei CHINA (TAIWAN) 10657

DEC 3 1 2009

Re: K091541

Trade/Device Name: MESA Oxygen Concentrator, Model 2-6000 Series Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: December 17, 2009 Received: December 23, 2009

Dear Mr. Huang:

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 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. Register. Begister

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#### Page 2 - Mr. Huang

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours, i

h for

Anthony D. Watson, B.S., M.S., M.B.A. 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

# Indications for Use

510(k) Number (if known): Device Name: MESA Oxygen Concentrator Indications For Use:

The MESA Oxygen Concentrator (Model No .: 2-6000 Series) is intended to provide supplemental oxygen. It is not intended for life supporting, or life sustaining applications nor does it provide any patient monitoring capabilities.

Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)

Signature

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

510(k) Number: k091541

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