VENTURE HOMEFILL II WITH OXYGEN CONSERVER

K021685 · Invacare Corp. · CAW · Jul 23, 2002 · Anesthesiology

Device Facts

• Record ID: K021685
• Device Name: VENTURE HOMEFILL II WITH OXYGEN CONSERVER
• Applicant: Invacare Corp.
• Product Code: CAW · Anesthesiology
• Decision Date: Jul 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended function and use of the Invacare Model Venture HomeFill II with oxygen conserver is to provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. It is not intended to sustain or support life.

Device Story

Electromechanical prescription device for home use; provides supplemental oxygen and fills portable gas cylinders. System comprises 5 LPM oxygen concentrator, compressor module, and portable oxygen cylinder with integrated oxygen conserver. Conserver delivers oxygen at start of each breath rather than continuous flow. Concentrator provides 87-96% oxygen concentration at 0-5 LPM; compressor fills cylinders to 90-96% concentration; cylinder regulator allows 0-6 LPM flow. Operated by patient in home setting. Healthcare provider prescribes device to manage supplemental oxygen needs; output affects patient ambulatory mobility and oxygen therapy compliance. Benefits include increased patient independence via portable oxygen supply.

Clinical Evidence

Bench testing only. Mechanical and electrical tests conducted to demonstrate intended performance.

Technological Characteristics

Electromechanical oxygen concentrator and compressor system. Concentrator flow: 0-5 LPM (87-96% O2); Cylinder fill concentration: 90-96% O2; Cylinder regulator flow: 0-6 LPM. Includes oxygen conserver for breath-actuated delivery. Non-sterile. Standalone home-use device.

Indications for Use

Indicated for patients in the home requiring supplemental oxygen. Not intended to sustain or support life.

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 Model HomeFill II Complete Home Oxygen System (K003939)

Submission Summary (Full Text)

{0}------------------------------------------------

K02)685

## 510(k) SUMMARY

#### Invacare Corporation's Model Venture HomeFill II With Oxygen Conserver

#### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: [phone] Facsimile: [phone]

#### Contact Person:

Edward A. Kroll Director, Regulatory Affairs

Date Prepared: May 21, 2002

#### Name of Device and Name/Address of Sponsor

Invacare Model Venture HomeFill II with Oxygen Conserver

Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: [phone] Facsimile: [phone]

#### Common or Usual Name

Oxygen Concentrator

# Classification Name

Portable Oxygen Generator

## Predicate Devices

Invacare Corporation Model HomeFill II Complete Home Oxygen System (K003939),

## Intended Use

The intended function and use of the Invacare Model Venture HomeFill II with oxygen conserver is to provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. It is not intended to sustain or support life.

{1}------------------------------------------------

#### Technological Characteristics and Substantial Equivalence

#### A. Device Description

The Invacare Venture Home Fill II with oxygen conserver is an electromechanical, prescription device designed for use in the home, by patients that require supplemental oxygen. It consists primarily of a 5 liter per minute (1pm) oxygen concentrator, a compressor module, and a portable oxygen cylinder with specially adapted cylinder fitting that includes an oxygen conserver. The oxygen conserver delivers oxygen to the user at the beginning of each breath instead of on a continuous basis.

The concentrator provides continuous flow of oxygen at concentrations of 87% to 96%, at flow rates of 0 to 51pm. The compressor fills the cylinder with oxygen concentrations of 90% to 96%. and the cylinder regulator allows flow rates of 0 to 6 lpm. The oxygen supplied by the oxygen concentrator is supplemental and is not considered to be life susporting or life sustaining. The system is not sold or labeled as sterile.

#### B. Substantial Equivalence

The Invacare Model Venture HomeFill II with oxygen conserver is substantially equivalent to the Invacare Model HomeFill II Complete home Oxygen System (K003939)

#### Performance Data

A number of mechanical and electrical tests were conducted on the Invacare Model HomeFill II with oxygen conserver and the oxygen conserver to demonstrate that the device performs as intended.

{2}------------------------------------------------

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three stylized profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 2 3 2002

Mr. Edward A. Kroll Director, Regulatory Affairs Invacare Corporation One Invacare Way Elyria, Ohio 44036-2125

Re: K021685

Trade/Device Name: Invacare Model Venture HomeFill II with Oxygen Conserver Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: May 21, 2002 Received: May 22, 2002

Dear Mr. Kroll:

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.

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.

{3}------------------------------------------------

Page 2 - Mr. Kroll

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone], Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours

Timothy A. Ulatowski

Timo A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

:510(k) Number (if known): fBB K021685

Device Name: Invacare Model Venture HomeFill II with Oxygen Conserver

#### Indications For Use:

The intended function and use of the Invacare Model Venture HomeFill II with oxygen conserver is to provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. It is not intended to sustain or support life.

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use** √
(Per 21 CFR 801.109)

OR

Over-The-Counter Use __

(Optional Format 1-2-96)

(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices 510(k) Number __

(Optional Format 1-2-96)