(290 days)
Not Found
No
The summary describes a low air loss therapy bed and does not mention any AI or ML capabilities.
Yes
The device is indicated for pressure relief and pain management for patients with various medical conditions, including pressure sores, burns, amputations, arthritis, AIDS, and cancer. These indications fall under therapeutic uses.
No
The device is listed for therapy and pressure relief, not for diagnosing medical conditions.
No
The device description clearly identifies it as a "Low Air Loss Therapy Bed," which is a physical piece of medical equipment, not software.
Based on the provided information, the Apex Metal AirTec2 Low Air Loss Therapy Bed 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 and intended use clearly indicate that the AirTec2 is a therapy bed designed for pressure relief and pain management for patients with various conditions. It is a physical device used externally on the patient, not a test performed on a biological sample.
- Lack of IVD Characteristics: The provided information does not mention any analysis of biological samples, laboratory procedures, or diagnostic testing.
Therefore, the AirTec2 Low Air Loss Therapy Bed falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Apex Metal AirTec2 Low Air Loss Therapy Bed is indicated for pressure relief for patients with pressure sores, burns, amputations, shin flap or graft surgery, that may be in Neurology, Dermatology, Rehabilitation or Orthopedics. For pain management and pressure relief consider the AirTec2 for patients with arthritis, AIDS or cancer.
Product codes
IOQ
Device Description
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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 logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 1997
Ms. Jean Rozint Apex Metal, Inc. c/o Clinically Effective Outcomes, Inc. P.O. Box 1026 29465-1026 Mount Pleasant, South Carolina
K970363 Re: HydroTec™ Low Air Loss Therapy Bed Trade Name: K970364 AirTec2™ Low Air Loss Therapy Bed Tame Name : Regulatory 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 of the Federal 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, labelinq, 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 Regulations, 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 requlation may result in requlatory In addition, FDA may publish further announcements action. 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 regulation (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,
G. Colin M. Witton Ph.D. M.D.
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
Page 1 of 1
510(k) Number (if known): K970364
Device Name: AirTec2 Low Air Loss Therapy Bed
Indications for Use:
September 1998 - 1997 - 1992 - 1992 - 1992 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 199
:
,「
The Apex Metal AirTec2 Low Air Loss Therapy Bed is indicated for pressure relief for patients with pressure sores, burns, amputations, shin flap or graft surgery, that may be in Neurology, Dermatology, Rehabilitation or Orthopedics. For pain management and pressure relief consider the AirTec2 for patients with arthritis, AIDS or cancer.
(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 General Restorative Devices | |
| 510(k) Number | K970364 |
Prescription Use _____
(Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)