HYGEIA-5 OXYGEN CONCENTRATOR

K081267 · Kedl Internation Limited · CAW · Sep 23, 2008 · Anesthesiology

Device Facts

• Record ID: K081267
• Device Name: HYGEIA-5 OXYGEN CONCENTRATOR
• Applicant: Kedl Internation Limited
• Product Code: CAW · Anesthesiology
• Decision Date: Sep 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hygeia-5 Oxygen concentrators are indicated to provide supplemental oxygen for adults requiring supplemental oxygen and are intended to be used in the home or institutional environment. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Device Story

Prescription oxygen concentrator for home or institutional use; provides supplemental oxygen to adults. Operates via pressure swing adsorption (PSA) using molecular sieve material to extract oxygen from room air; delivers ~93% oxygen. Features 5 small sieve beds and a rotating valve for air distribution and cycle control (adsorption/regeneration). Includes oxygen reservoir for collection prior to patient delivery. Equipped with electronic alarms for power failure and pneumatic system pressure monitoring. Not life-supporting or life-sustaining.

Clinical Evidence

Bench testing only.

Technological Characteristics

Pressure swing adsorption (PSA) oxygen concentrator; 5-bed molecular sieve system with rotating valve; electronic alarms for power/pressure monitoring; delivers ~93% oxygen.

Indications for Use

Indicated for adults requiring supplemental oxygen in home or institutional settings. Not for life support; no patient monitoring capabilities.

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

• Devilbiss 5 Liter Oxygen concentrators (K991722)
• Sequal Integra Model 6323 concentrators (K942082)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS

## "510(k) SUMMARY" Prepared by: YC Lee Date Prepared: April 14, 2007

| 9.1 | Manufacturer: | KEDL International Limited<br>Unit C, Lot 1718-DD221,<br>Tan Cheung, Sai Kung,<br>New Territories, Hong Kong |
|-----|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| 9.2 | Submitted By: | Contact - P/L Biomedical<br>Lee Leichter<br>7690 Cameron Circle<br>Fort Myers, FL 33912<br>Tel -- 239-768-1118<br>Fax - 815-550-0162 |
| 9.3 | Trade/Proprietary Name: | Hygeia-5 Oxygen Concentrator |
| 9.4 | Common/Usual Name: | Oxygen Concentrator |
| 9.5 | Classification Name: | Portable Oxygen Generator<br>Panel: 73<br>Procode: CAW |

ે છે. ક Comparison to Currently Marketed Devices

The Hygeia-5 Oxygen concentrators are substantially equivalent to the Devilbiss 5 Liter Oxygen concentrators (K991722) and Sequal Integra Model 6323 concentrators (K942082).

#### 9.7 Device Description

The Hygeia-5 Oxygen Concentrators are prescription devices designed to provide an inexpensive supply of supplemental oxygen in a home or institution without a continuous source of purified oxygen. They are not life-supporting or life-sustaining devices. The device operates on the same pressure swing adsorption (PSA) principle as other oxygen concentrators. They use the same type of molecular sieve material that binds with the water and nitrogen in filtered room air to leave a gas that is approximately 93% oxygen when delivered to the patient. Most concentrators use two sieve beds, alternating between the beds using one bed to generate the oxygen while the other is flushed for regeneration. The Hygeia-5 differs in as much as it has 5 smaller beds instead of two large beds and uses a rotating valve to distribute the air to the sieve beds and control the cycle of the adsorption and regeneration. This concept/design is similar to the Sequal device. As with other concentrators, it has an Oxygen reservoir to collect the oxygen before

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distribution to the patient. The Oxygen concentrator is also equipped with electronic alarms to monitor for power failure and over or under pressure of the pneumatic system.

#### Indication/Intended Use 0.8

The Hygeia-5 Oxygen concentrators are indicated to provide supplemental oxygen for adults requiring supplemental oxygen and are intended to be used in the home or institutional environment. The device is not intended for life support nor does it provide any patient monitoring capabilities.

#### ರಿ. ಶಿ Technological Characteristics

The technological characteristics are the same as the predicate devices.

#### 9.10 Performance Data

Verification testing has confirmed the product meets its specifications.

#### 9.11 Conclusion

KEDL International concludes based on the information presented that the Hygeia-5 Concentrators are substantially equivalent to products currently legally marketed in the USA.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. U.S.A." in a circular arrangement.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 2008

KEDL International Limited C/O Mr. Lee Leichter P/L Biomedical 7690 Cameron Circle Fort Myers, FL 33912

Re: K081267

Trade/Device Name: Hygeia-5 Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Codc: CAW Dated: September 22, 2008 Received: September 22, 2008

Dear Mr. Leichter:

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. Leichter

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

Sincerely vours.

Thamuels Yermor

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 STATEMENT

510(k) File Number:

Device Name:

Indications For Use:

K081267

Hygeia-5 Oxygen Concentrator

The Hygeia-5 Oxygen concentrators are indicated to provide supplemental oxygen for adults requiring supplemental oxygen and are intended to be used in the home or institutional environment. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Prescription Use V

AND/OR

Over-The-Counter Use

(Per 21 CFR 801 Subpart D) Subpart C)

(21 CFR 801

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

> Concurrence of CDRH, Office of Device Eyaluation (ODE) That

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

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510(k) Number: _______________________________________________________________________________________________________________________________________________________________