ATLANT'S by GRAD-LINE CORP. | FDA 510(k) Summary

This document is a 510(k) clearance letter from the FDA for a device named "ATLANT'S." This type of document primarily confirms that a new medical device is "substantially equivalent" to a legally marketed predicate device, allowing it to be marketed. It does not typically contain detailed study data, acceptance criteria, or performance metrics in the way a clinical study report or a premarket approval (PMA) application would.

Therefore, most of the information requested in your prompt cannot be extracted from this document. The letter focuses on regulatory approval rather than a detailed technical performance evaluation.

Here's what can be extracted based on the provided text, and where gaps exist:

A table of acceptance criteria and the reported device performance
- Not available in this document. This letter does not specify acceptance criteria for device performance nor does it report detailed performance metrics from a study. It only states that the device is "substantially equivalent" to a predicate device for its stated indications for use.
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in this document. No information on sample sizes, data provenance, or study design (retrospective/prospective) is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not available in this document. No details about experts, ground truth establishment, or their qualifications are included.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in this document. No information on adjudication methods is present.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not available in this document. This is a 510(k) for a device, not explicitly an AI-driven one (though the document is from 1998, well before the widespread use of AI in medical devices). No MRMC study details are provided.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not available in this document. Not applicable as this is not an AI algorithm approval, and no standalone performance data is mentioned.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not available in this document. The ground truth for any potential studies is not mentioned.
The sample size for the training set
- Not available in this document. No information on a training set or its size is provided.
How the ground truth for the training set was established
- Not available in this document. No information on a training set or how its ground truth was established is provided.

In summary, this 510(k) clearance letter serves as regulatory approval based on "substantial equivalence" to a predicate device, rather than a detailed report of clinical study data or performance metrics. Therefore, the specific details regarding acceptance criteria, study design, expert involvement, and ground truth establishment are not present in this document.

Summary

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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)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

(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

Regulation Number and Section

§ 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).