(290 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and device name suggest a physical device for pressure ulcer management, not a software-based diagnostic or analytical tool.
Yes
The intended use explicitly states "prevention and treatment of pressure ulcers (bed sores)," which are therapeutic actions.
No
Explanation: The device is indicated for the "prevention and treatment" of pressure ulcers, which implies intervention rather than diagnosis. There is no mention of diagnostic functions such as detection, analysis, or identification of a disease state.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, the Apex Metal HydroTec™ is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "prevention and treatment of pressure ulcers (bed sores)". This describes a device that interacts with the patient's body externally or provides support, not a test performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Using reagents or assays
IVDs are devices used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Apex Metal HydroTec™'s intended use clearly falls outside of this definition.
N/A
Intended Use / Indications for Use
The Apex Metal HydroTec™ is indicated for the prevention and treatment of pressure ulcers (bed sores).
Product codes
IOQ
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
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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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5170 Powered flotation therapy bed.
(a)
Identification. A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.(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 § 890.9.
0
Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is a stylized design that resembles a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 17 1997
Ms. Jean Rozint Apex Metal, Inc. c/o Clinically Effective Outcomes, Inc. P.O. Box 1026 Mount Pleasant, South Carolina 29465-1026
K970363 Re: HydroTec™ Low Air Loss Therapy Bed Trade Name: K970364 AirTec2™ Low Air Loss Therapy Bed Trade Name: Requlatory Class: II Product Code: IOQ Dated: August 18, 1997 Received: August 19, 1997
Dear Ms. Rozint:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 chat have boon Food, Drug, and Cosmetic Act (Act). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, 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 devices in the Federal Register. Please note: this response to your premarket notification submission does
. .*
1
Page 2 - Ms. Jean Rozint
not affect any obligation you might have under sections 531 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 devices as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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) 594-4659. Additionally, for questions on the promotion and advertising of your devices, 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,
n Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
2
510(k) Number (if known): ____________________
Device Names: HydroTec™ Low Air Loss Therapy Bed ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Indications for Use:
ﺮ ﺍﻟﻤﺮﺍﺟﻊ
The Apex Metal HydroTec™ 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)
| (Division Sign-Off) | |
|---|---|
| Division of Genera | ces |
| 510(k) Number | K970363 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use X |
|---|---|---|
| ------------------------------------------ | ---- | ------------------------ |
(Optional Format 1-2-96)