VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM

K983627 · Invacare Corp. · CAW · Oct 22, 1999 · Anesthesiology

Device Facts

• Record ID: K983627
• Device Name: VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM
• Applicant: Invacare Corp.
• Product Code: CAW · Anesthesiology
• Decision Date: Oct 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is indicated for supplemental Medical Oxygen for treatment of Respiratory Diseases.

Device Story

Invacare Venture Home Fill Complete Oxygen System provides supplemental oxygen to patients with respiratory diseases. System functions as home-based oxygen source; fills portable oxygen cylinders from stationary oxygen concentrator. Operated by patient or caregiver in home setting. Device transforms ambient air into concentrated oxygen; compresses oxygen into portable cylinders for patient mobility. Enables patient to receive continuous oxygen therapy outside of stationary concentrator range. Benefits include increased patient independence and mobility while maintaining prescribed oxygen therapy.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Home oxygen system consisting of a stationary oxygen concentrator and portable oxygen cylinder filling mechanism. Operates by concentrating ambient air and compressing it into portable vessels. Designed for home use.

Indications for Use

Indicated for patients requiring supplemental medical oxygen for the treatment of respiratory diseases.

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).

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 22 1999

Mr. Edward A. Kroll Invacare Corporation One Invacare Way P.O. Box 4028 44036-2125 Elyria, OH

K983627 Re: Model IHO 100 Home Fill Complete Home Oxygen System Requlatory Class: II (two) 73 CAW Product Code: Dated: July 23, 1999 Received: July 26, 1999

Dear Mr. Kroll:

.

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Edward A. Kroll

This letter will allow you to begin marketing your device as described in your 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 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

focanne A. Webster

Wolf Sapirstein, M.D. is, Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known): TBD

Device Name: Invacare Venture Home Fill Complete Oxygen System

Indications For Use: This device is indicated for supplemental Medical Oxygen for treatment of Respiratory Diseases.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Lo AWetters
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K983627

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

(Optional Format 1-2-96)