LONGFEI LFY-I-5 OXYGEN CONCENTRATOR

K033405 · Zhejiang Longfei Industrial Co., Ltd. · CAW · Oct 18, 2005 · Anesthesiology

Device Facts

• Record ID: K033405
• Device Name: LONGFEI LFY-I-5 OXYGEN CONCENTRATOR
• Applicant: Zhejiang Longfei Industrial Co., Ltd.
• Product Code: CAW · Anesthesiology
• Decision Date: Oct 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended function and use is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.

Device Story

The Longfei LFY-I-5 is a 5-liter per minute pressure swing adsorption (PSA) oxygen concentrator for home use. It separates nitrogen from room air using synthetic Zeolite molecular sieve beds. Input is ambient air; output is concentrated oxygen delivered via standard tubing and nasal cannula. The device features an air compressor, heat exchanger, distribution valve, and outlet filtration. It is operated by the patient or caregiver. Monitoring circuits track oxygen concentration and trigger a visual alarm/shutdown during malfunction. The device provides supplemental oxygen to improve patient respiratory status; it does not sustain life.

Clinical Evidence

Bench testing only. The device complies with ASTM Standard Specifications for Oxygen Concentrators for Domiciliary Use and ISO 8359:1996 Oxygen Concentrators for Medical Use.

Technological Characteristics

Pressure swing adsorption (PSA) oxygen concentrator. Components: inlet/outlet filtration, air compressor, heat exchanger, synthetic Zeolite molecular sieve beds, distribution valve, flow meter. Electrical: AC power, double insulated. Monitoring: oxygen concentration monitoring circuit with visual alarm and auto-shutdown. Standards: ASTM, ISO 8359:1996.

Indications for Use

Indicated for the administration of supplemental oxygen to patients with respiratory disorders. Not for life support; provides no patient monitoring capabilities. Prescription use.

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

• Invacare Platinum 5 Oxygen concentrator (K020386)

Submission Summary (Full Text)

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K033405

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OCT 1 8 2005

ng Longfei Industrial Co., L

338 Ningkang West Road, Yueqing, Zhejiang, P.R. China

II. 510(K) Summary

| Submitted by: | Zhejiang Longfei Industrial Co., Ltd. |
|----------------------|--------------------------------------------------------------|
| | No.338, Ningkang West Road, |
| | Yueqing 325600, Zhejiang, |
| | P.R.China |
| | Tel: [phone] |
| | Fax: [phone] |
| Contact Person: | Ms. Coco Wang |
| Date Prepared: | 2003-10-08 |
| Proprietary Name: | Longfei LFY-I-5 Oxygen concentrator |
| Common Name: | Oxygen concentrator |
| Classification Name: | Portable Oxygen Generator (21 CFR 868.5440) |
| Predicate Device: | Invacare Platinum 5 Oxygen concentrator<br>510(k) #K[020386] |

# Description of the Device:

The Longfei Model LFY-I-5 Oxygen concentrator is an electromechanical, prescription device designed for use in the home, by patients that require supplemental oxygen. Its intended function and use is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.

Oxygen is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula, which are not supplied with the device. A standard humidifier bottle may be used, if desired.

The front panel of the device contains the controls and indicators. These include a standard barb fitting for attaching the oxygen tubing, the adjustable flow meter, a power light indicator, an elapsed time meter, and a standard on/off rocker type power switch.

# Intended Use of the Device:

The LFY-I-5 Oxygen concentrator is a 5-liter per minute oxygen concentrator that is of the pressure swing adsorption (PSA) type. The pneumatic system consists of 5 major components: inlet filtration, air compressor and heat exchanger, synthetic Zeolite molecular sieve beds and

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Zhejiang Longfei Industrial Co., Ltd.

No. 338 Ningkang West Road, Yueqing, Zhejiang, P.R. China

distribution value module, outlet filtration, and flow meter.

The electrical system consists of AC power distribution to the air compressor and a motor with gear reduction used to drive the distribution valve; the unit is double insulated and uses a two-conductor power cable. Device monitoring circuit are included that monitor oxygen concentration. In the event of a malfunction, the unit will shut down and activate visual.

The intended function and use is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.

### Technological Characteristics:

The Longfei LFY-I-5 Oxygen concentrator complies with the ASTM Standard Specifications for Oxygen concentrators for Domiciliary Use (Anesthesia) and the ISO standard 8359: 1996, Oxygen concentrators for Medical Use (Anesthesia). Conformance or variance with these standards is described on the following pages.

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#### Public Health Service

OCT 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Coco Wang General Manager Zhejiang Longfei Industrial Company Limited Room 1202, No. 28 Building 2288 Caoyang Road Shanghai, CHINA 200333

Rc: K033405

Trade/Device Name: Model LFY-1-5 Oxygen Concentrators Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: August 1, 2005 Reccived: August 1, 2005

Dear Ms. Wang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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. Wang

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 [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 responsibilitics 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,

Swa Runsey
Chiu Lin, Ph.D.

Director Division of Anesthesiology, Gencral 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: K033405

Device Name: Model LFY-I-5 Oxygen Concentrators

# Indications For Use:

The LFY-I-5 Oxygen Concentrators are indicated fro the administration of supplemental The LT-T-F o Oxygon Contractors for life support nor does it provide any patient monitoring capabilities.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (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)

Melvin McDonald

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

510(k) Number K033405