510 (K) Summary: Submitter Information

DEC 312009
510(k) Summary
Submitter Information:
Submitter: SeQual Technologies Co., Ltd

6F7-7, No. 136, Sec.3, Ren-ai Rd.
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 Coneentrator, 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.
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.
Technolog~ical 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.
-2-
4
DEPARTMENT OF HEALTH & HUMAN SERVICESPulcHatSeve
~~~~~~~~~~~~~~~~~~~~~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 DC320
6F-7, No. 136, Sec.3, Ren-ai Rd. DC3120
Taipei
CHINA (TAIWAN) 10657
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 5 10(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 2 1, Parts 800 to 898. In
addition, FDA may publish further announcements concerning your device in the Federal
Register.
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 53 1-542 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/ucmI 15809.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/nidr/ 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 (800) 638-2041 or (240) 276-3150 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html.*
Sincerely yours,
hi {~~~~~~6C
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
CITATUNOrSQIA
Indications for Use
51 0(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 D3) (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)
Infection Control, Dental Devices

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DEC 312009

Submitter: SeQual Technologies Co., Ltd

Contact: Cearo Huang, Director, Engineering & Research Division

Date of Summary: January 5, 2009

Proprietary Name: MESA Oxygen Concentrator, Model 2-6000 Series

Predicate Device Equivalence:

The device has no contraindications.

Mr. Cearo, Huang

Dear Mr. Huang:

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

Indications for Use

51 0(k) Number (if known):

Device Name: MESA Oxygen Concentrator

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 D3) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

Concurrence of CDRH, Office of Device Evaluation (ODE)

Infection Control, Dental Devices

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