(237 days)
Not Found
Not Found
No
The summary describes a mechanical alternating pressure mattress system and does not mention any AI or ML components or functionalities.
Yes
The device is intended for medical purposes to prevent and treat decubitus ulcers, which is a therapeutic function.
No
Explanation: The device is an alternating pressure mattress system intended to prevent and treat decubitus ulcers, which is a therapeutic function, not a diagnostic one. It does not identify or detect a disease or condition.
No
The device description explicitly states it is an "alternating pressure air flotation mattress" with "multiple air cells" and "associated control units," indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, the RID-Decube II Alternating Pressure Mattress System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states the device is a mattress system used to prevent and treat decubitus ulcers (bedsores) by altering pressure distribution. This is a physical therapy/medical device applied externally to the patient's body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing.
Therefore, the RID-Decube II is a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RID-Decube II is intended to be used to prevent and treat decubitus ulcers.
The RID-Decube II Alternating Pressure Mattress System is intended for medical purposes to be used to prevent and treat decubitus ulcers.
Product codes
FNM
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Air Flow 5000 Manufactured by Atlantis Medical
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
ANDARAFES AN CARRE ין
510 (k) Summary
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: | (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 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 |
:
.
l
1
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
2
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
3
Extudit 20 - Skin Care Management - 210 (8) I remarket Notification - RD-Decube II : Marcations
Page_I
ol_
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)
Oતે
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)