SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM

K970081 · Cathay Consolidated, Inc. · FNM · Nov 7, 1997 · General Hospital

Device Facts

• Record ID: K970081
• Device Name: SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
• Applicant: Cathay Consolidated, Inc.
• Product Code: FNM · General Hospital
• Decision Date: Nov 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cathay Consolidated Super Air 9000 is indicated for the prevention and treatment of pressure ulcers ( bed sores).

Device Story

Super Air 9000 is an alternating air flotation mattress system; designed for pressure ulcer prevention and treatment. Device utilizes air-filled cells that cycle inflation/deflation to redistribute patient weight and reduce interface pressure on skin. Used in clinical or home settings; operated by healthcare providers or caregivers. System provides continuous pressure relief to aid healing and prevent tissue damage. Output is mechanical support via air pressure modulation.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Alternating air flotation mattress system; consists of air-filled cells and control unit for pressure modulation. Energy source: electrical power for air pump. Form factor: mattress overlay/system.

Indications for Use

Indicated for prevention and treatment of pressure ulcers (bed sores) in patients at risk of or suffering from pressure-related skin breakdown.

Regulatory Classification

Identification

An alternating pressure air flotation mattress is a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

NOV - 7 1997

Ms. Jean Rozint
Cathay Consolidated, Incorporated
C/O Clinically Effective Outcomes, Incorporated
P.O. Box 1026
Mt. Pleasant, South Carolina 29465-1026

Re: K970081
Trade Name: Super Air 9000 Alternating Air Flotation Mattress System
Regulatory Class: II
Product Code: ILA
Dated: August 7, 1997
Received: August 11, 1997

Dear Ms. Rozint:

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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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

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Page 2 - Ms. Rozint

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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/dsmamain.html".

Sincerely yours,

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

,Enclosure

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510(k) Number (if known): K970081

Device Name: Super Air 9000 Alternating Air Flotation Mattress System

Indications for Use:

The Cathay Consolidated Super Air 9000 is indicated for the prevention and treatment of pressure ulcers ( bed sores).

(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)

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