RID-DECUBE II

K965207 · Skin Care Management, Inc. · FNM · Aug 21, 1997 · General Hospital

Device Facts

• Record ID: K965207
• Device Name: RID-DECUBE II
• Applicant: Skin Care Management, Inc.
• Product Code: FNM · General Hospital
• Decision Date: Aug 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RID-Decube II Alternating Pressure Mattress System is intended for medical purposes to be used to prevent and treat decubitus ulcers.

Device Story

RID-Decube II is an alternating pressure air flotation mattress system. Device consists of multiple air cells and an associated control unit. Control unit fills and empties air cells in an alternating pattern to provide regular, frequent, and automatic changes in body pressure distribution. Used in medical settings to prevent and treat decubitus ulcers by reducing sustained pressure on patient skin.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and functional similarity to the predicate device.

Technological Characteristics

Alternating pressure air flotation mattress; multiple air cells; external control unit for automated inflation/deflation cycles. Class II device (21 CFR 880.5550).

Indications for Use

Indicated for the prevention and treatment of decubitus ulcers in patients requiring pressure relief.

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.

Predicate Devices

• Air Flow 5000 (Manufacturer: Atlantis Medical)

Submission Summary (Full Text)

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510 (k) Summary

K 965207

# RID-Decube II

# 510(k) SUMMARY

1. Submitter's Name: Skin Care Management, Inc.
AUG 21 1997
Address: 202 East Maple Street
Jeffersonville, Indiana 47130
Telephone Number: [phone]
Contact Person: John Keesaer
Date Prepared: December 18, 1996

2. Trade Name: RID-Decube II
Common Name: Alternating Pressure Air Flotation Mattress
Classification Name: Alternating Pressure Air Flotation Mattress
Class II CFR 21 880.5550

3. Predicate Device: Air Flow 5000 Manufactured by Atlantis Medical

4. Description: The RID-decube II is an alternating pressure air flotation mattress intended for medical purposes with multiple air cells that can be filled and emptied in an alternating pattern by associated control units to provide regular, frequent and automatic changes in the distribution of body pressure.

5. Indications for Use: The RID-decube II is intended to be used to prevent and treat decubitus ulcers.

6. Substantial Equivalence: The product is similar in function and intended use as labeled to the Air Flow 5000 Manufactured by Atlantis Medical.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Skin Care Management
Eric Flam, Ph.D
President
NTL Associates, Incorporated
29 Ainsworth Avenue
East Brunswick, New Jersey 08816

Re: K965207
Trade Name: Rid-Decube II
Regulatory Class: II
Product Code: FNM
Dated: May 22, 1997
Received: May 23, 1997

Dear Dr. Flam:

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 requirements, 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

AUG 21 1997

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Page 2 - Dr. Flam

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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Exhibit 20 - Skin Care Management - 510(k) Premarket Notification - RID-Decube II: Indications for Use Statement

Page 1 of 1

510(k) Number (if known): _________________________

Device Name: **RID-Decube II Alternating Pressure Mattress System**

Indications For Use: _________________________

The RID-Decube II Alternating Pressure Mattress System is intended for medical purposes to be used to prevent and treat decubitus ulcers.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number **K965207**

Prescription Use ☐
(Per 21 CFR 801.109)

Or

Over-The-Counter Use ☑
(Optional Format 1-2-96)