(80 days)
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Not Found
No
The summary provides no information suggesting the use of AI or ML. It describes a pressure-relieving mattress.
Yes
The device is indicated for the prevention and management of decubitus ulcers, which is a therapeutic purpose. It provides alternating pressure support to achieve this.
No
The device is described as providing alternating pressure support for the prevention and management of decubitus ulcers, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states "REST Mattress," which is a physical hardware device. There is no mention of software as the primary or sole component.
No, this device 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.
- REST Mattress Function: The REST Mattress is a physical device designed to provide alternating pressure support to the body's surface. It does not analyze biological samples.
- Intended Use: The intended use is for the prevention and management of decubitus ulcers (bedsores) by providing physical support and pressure relief. This is a mechanical/physical intervention, not a diagnostic test.
The information provided clearly describes a medical device that interacts with the patient's body externally, not a test performed on a sample taken from the body.
N/A
Intended Use / Indications for Use
The REST Mattress is indicated for all patients highly susceptible to decubitus ulcers. The REST Mattress provides alternating pressure support for the prevention and management of these sores.
Product codes
FNM
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Yoav Gershoni Rest Mattress 19636 Club House Road, Suite 120 -Gaithersburg, Maryland 20879 T
JUL 18 1997
K971568 Re : REST Mattress Trade Name: Requlatory Class: II Product Code: FNM Dated: April 29,1 997 April 29, 1997 Received:
Dear Mr. Gershoni:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Paqe 2 - Mr. Gershoni
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) 594-4618. 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 qeneral 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.qov/cdrh/dsmamain.html".
Sincerely yours,
L. Whitmarsh
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K97/568
XII. Statement of Indications For Use
The REST Mattress is indicated for all patients highly susceptible to decubitus ulcers. The REST Mattress provides alternating pressure support for the prevention and management of these sores.
Your D.
Signature
Signature
Your Gerstein
Name
6/18/97
Date
(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 Divisioneral Hospital Devic 1 - 1 Number _ 1 9 2 /
Preseription Use (Pcr 21 CFR 801.109)
ાર
Over-The-Counter Use Or (Optional Format 1-2-96
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