AUTOGEL PAD

• K Number: K031018
• Device Name: AUTOGEL PAD
• Manufacturer: RICH-MAR CORP.
• Date Cleared: 2003-12-08 ( 252 days)
• Product Code: MUI
• Regulation Number: 892.1570
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Conductive medium for transmission of therapeutic ultrasound to tissue.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "AutoGel Pad." This document pertains to the regulatory clearance of a device based on substantial equivalence to a predicate device, rather than a de novo approval that would detail extensive performance studies against acceptance criteria.

Therefore, the input document does not contain the information requested in the prompt regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How training set ground truth was established.

This document merely states that the FDA found the "AutoGel Pad" to be substantially equivalent to a legally marketed predicate device, indicating it can be marketed for its stated "Indications For Use: Conductive medium for transmission of therapeutic ultrasound to tissue." The FDA's determination of substantial equivalence often relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device, but it does not typically involve the detailed performance study reporting requested in the prompt.

Summary

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Image /page/0/Picture/0 description: The image is a seal for the Department of Health & Human Services (HHS) in the USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 8 2003

Mr. David Richards Vice President and Director of Regulatory Affairs Rich-Mar Corporation P.O. Box 879 INOLA OK 74036-0879

Re: K031018

Trade/Device Name: AutoGel Pad Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer

Regulatory Class: II Product Code: 90 MUI Dated: November 18, 2003 Received: November 18,2003

Dear Mr. Richards:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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 device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510(k) Number (if known): K031018

Device Name:

AutoGel Pad

Indications For Use:

Conductive medium for transmission of therapeutic ultrasound to tissue.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

David R. Lynn

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number .

Prescription Use

し

Regulation Number and Section

N/A