RID-DECUBE II by SKIN CARE MANAGEMENT, INC.

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.

AI/ML Overview

The provided text is a 510(k) summary for the RID-Decube II, an alternating pressure air flotation mattress. This type of document is for premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Based on the information provided, the document does not contain acceptance criteria for device performance or any study details that would prove the device meets such criteria.

Here's why and what information is available:

Purpose of a 510(k) Summary: A 510(k) is primarily to demonstrate that a new device is "substantially equivalent" to a predicate device already on the market. This often means showing similar design, materials, intended use, and performance characteristics, but typically doesn't involve presenting detailed clinical study results with acceptance criteria in the summary document unless specific performance claims are being made that exceed the predicate's established use.
Missing Information: The provided text is essentially a cover letter and a brief description of the device and its intended use. It does not include:
- Specific performance metrics (e.g., pressure redistribution efficacy, durability, patient comfort levels)
- Acceptance criteria for any performance metrics
- Details of any study (clinical or non-clinical) conducted to evaluate the device's performance
- Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
- Any information regarding MRMC studies or standalone algorithm performance, as this device is a physical medical mattress, not an AI/software device.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
N/A	N/A

(No acceptance criteria or device performance data is provided in the document.)

Other Information based on the provided text:

Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable, as no study or ground truth establishment details are provided.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no study or adjudication details are provided.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The RID-Decube II is an alternating pressure air flotation mattress, not an AI/software device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The RID-Decube II is an alternating pressure air flotation mattress, not an AI/software device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no study or ground truth establishment details are provided.
The sample size for the training set: Not applicable, as no training set (relevant for AI/ML) or study details are provided.
How the ground truth for the training set was established: Not applicable, as no training set or ground truth establishment details are provided.

Summary from the provided documents:

The RID-Decube II is an alternating pressure air flotation mattress intended for medical purposes to prevent and treat decubitus ulcers. It was found substantially equivalent to the Air Flow 5000 Manufactured by Atlantis Medical. The 510(k) process focuses on demonstrating equivalence to an already approved device rather than presenting detailed performance studies with acceptance criteria in the summary itself.

Summary

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ANDARAFES AN CARRE ין

510 (k) Summary

RID-Decube II

K965207

510(k) SUMMARY

1.	Submitter's Name	Skin Care Management, Inc.
	Address	202 East Maple StreetJeffersonville, Indiana 47130
	Telephone Number:	(800) 682-7163
	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 MattressClass 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 flotationmattress intended for medical purposes with multiple aircells that can be filled and emptied in an alternatingpattern by associated control units to provide regular,frequent and automatic changes in the distribution ofbody pressure.
5.	Indications for Use	The RID-decube II is intended to be used to prevent andtreat decubitus ulcers.
6.	Substantial Equivalence	The product is similar in function and intended use aslabeled to the Air Flow 5000 Manufactured by AtlantisMedical

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

AUG 2 1 1997

K965207 Re : Trade Name: Rid-Decube II Requlatory Class: II Product Code: FNM May 22, 1997 Dated: 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ್ 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 In addition, FDA may publish further announcements action. 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 - Dr. Flam

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

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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Extudit 20 - Skin Care Management - 210 (8) I remarket Notification - RD-Decube II : Marcations

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for Use Statement

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)

Patricia Caceres

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

510(k) Number K965207

Prescription Lise (Per 21 CFR 801.109)

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 880.5550 Alternating pressure air flotation mattress.

(a)
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).(b)
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.