(66 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
Yes
The device is used to prevent and treat pressure ulcers, which are medical conditions, thus qualifying it as a therapeutic device.
No
The "Intended Use / Indications for Use" states the device is used to "help prevent and treat pressure ulcers," which indicates a therapeutic or preventative function, not a diagnostic one.
Unknown
The provided text is a 510(k) summary template with no information filled in the "Device Description" section, which is crucial for determining if the device is software-only.
Based on the provided information, the Mighty*Air device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to help prevent and treat pressure ulcers." This describes a device used directly on or with a patient's body for a therapeutic or preventative purpose.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on in vitro analysis.
- Using reagents or other substances to perform tests outside the body.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Mighty*Air's function of preventing and treating pressure ulcers falls outside this definition.
N/A
Intended Use / Indications for Use
The Mighty*Air is used to help prevent and treat pressure ulcers.
Product codes
FNM
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lee Frickey President Wheelchairs of Kansas P.O. Box 320 204 W. 2nd Street Ellis, Kansas 67637
JAN 22 1998
K974319 Re : Mighty Air Trade Name: Requlatory Class: II Product Code: FNM Dated: November 10, 1997 Received: November 17, 1997
Dear Mr. Frickey:
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, Drug, 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. 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 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
1
Page 2 - Mr. Frickey
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 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 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.fla.gov/cdrh/dsmamain.html".
Sincerely yours
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
Page of
510 (k) NUMBER (IF KNOWN) : __________________________________________________________________________________________________________________________________________________
DEVICE NAME: Mighty *Air
INDICATIONS FOR USE:
. "
The Mighty*Air is used to help prevent and treat pressure ulcers.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Adrance Cuesenti
(Division Sign Off)
(Division Sign-Off) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Division of Dental, Infection Contrel; and General Hospital Device 74517 Over-The-Counter-Use Eretchamberon Use OR (Optional Format 1-2-96) (Per 21 CFR 801.109)