(335 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "For the treatment of chronic venous insufficiency, lymphedema, edema of venous origin, post amputation, lymphatic obstruction and contusions," indicating it is used for medical treatment.
No
Explanation: The Intended Use description focuses on the 'treatment' of various conditions (chronic venous insufficiency, lymphedema, etc.), which indicates a therapeutic rather than diagnostic purpose for the device. There is no mention of identifying, classifying, or predicting conditions.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of various conditions (chronic venous insufficiency, lymphedema, etc.). IVDs are used for the diagnosis or monitoring of diseases or conditions by examining specimens from the human body (like blood, urine, tissue).
- Lack of IVD Characteristics: The description doesn't mention anything about analyzing biological samples, using reagents, or providing diagnostic information.
Therefore, this device falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For the treatment of chronic venous insufficiency, lymphedema, edema of venous origin, post amputation, lymphatic obstruction and contusions.
Product codes
IRP
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
Not Found
Intended User / Care Setting
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which is a stylized depiction of a human figure embracing a bird. The emblem is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 22 1998
Mr. Walter L. Wasserman Agent for Grad-Line Corporation 762 South Federal Highway Deerfield Beach, Florida 33441
Re: K974395 Trade Name: ATLANT'S Regulatory Class: II Product Code: IRP Dated: July 28, 1998 Received: July 31, 1998
Dear Mr. Wasserman:
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 reqistration, listing of devices, qood 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 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 requlation (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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Walter L. Wasserman
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 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 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,
Sabine M. Whitaker, Ph.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
Enclosure
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510 (k) Number – K974395 Device Name - ATLANT'S
Indications For Use:
For the treatment of chronic venous insufficiency, lymphedema, edema of venous origin, post amputation, lymphatic obstruction and contusions.
(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K974395
20 THE MATERIALS CONTAINED WITHIN THIS SUBMISSION MARKED AS CONFIDENTIAL MAY NOT BE DISTRIBUTED OUTSIDE THE US GOVERNMENT WITHOUT THE WRITTEN CONSENT OF GRAD-LINE