(252 days)
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No
The summary describes a conductive medium for ultrasound, which is a passive material and does not involve AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
Yes
The intended use explicitly states "transmission of therapeutic ultrasound to tissue," indicating its role in a therapeutic process.
No
Explanation: The intended use states it is a "Conductive medium for transmission of therapeutic ultrasound to tissue," which implies it is for treatment delivery, not for diagnosing conditions.
No
The intended use describes a "conductive medium for transmission of therapeutic ultrasound to tissue," which strongly suggests a physical substance or material, not software. The lack of a device description further prevents confirmation of a software-only nature.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Conductive medium for transmission of therapeutic ultrasound to tissue." This describes a device used on the body for a therapeutic purpose (transmitting ultrasound), not a device used to examine specimens from the body to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
This device appears to be a medical device used for a therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Conductive medium for transmission of therapeutic ultrasound to tissue.
Product codes
90 MUI
Device Description
AutoGel Pad
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
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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
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Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
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.
1
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (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 (800) 638-2041 or (301) 443-6597 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
2
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