(36 days)
Not Found
Not Found
No
The device is a coupling gel, a passive material used in ultrasound procedures, and the description contains no mention of AI or ML.
No
The device is described as an ultrasound coupling gel, which facilitates the transmission of ultrasound waves for diagnostic or monitoring purposes, it does not provide therapeutic treatment.
No
Explanation: The device is a coupling gel for ultrasound procedures, facilitating the imaging process rather than performing a diagnosis itself. It is explicitly stated as "coupling medium for Ultrasound procedures."
No
The device description clearly states it is a "viscous, clear blue, water-soluble gel" and is packaged in "plastic bottles and plastic containers," indicating it is a physical substance, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: Uni-Patch Ultrasound Coupling Gel is a substance applied to the external skin to facilitate the transmission of ultrasound waves during imaging procedures. It does not analyze or test any biological samples.
- Intended Use: The intended use clearly states it's for "use as the coupling medium for Ultrasound procedures on external, intact skin." This is a physical function, not a diagnostic test performed on a sample.
Therefore, based on the provided information, Uni-Patch Ultrasound Coupling Gel is a medical device used in conjunction with an imaging modality (ultrasound), but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Uni-Patch Ultrasound Coupling Gel is intended for use as the coupling medium for Ultrasound procedures on external, intact skin
Uni-Patch Ultrasound Coupling Gel is intended to be used as an ultrasound coupling medium on external, intact skin for short duration.
Product codes
90 MUI
Device Description
Uni-Patch Ultrasound Coupling Gel is a viscous, clear blue, water-soluble gel. Typical packaging configuration for the Uni-Patch Ultrasound Coupling Gel is 250 ml plastic bottles and 5 liter plastic containers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
external, intact skin
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)
FDA has not established special controls or performance standards for this device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Aquasonic 100 Ultrasound Transmission Gel
Reference Device(s)
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
§ 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
tyco/Healthcare/Ludlow
MAY 1 5 2002
The Ludiow Company L.P Two Ludlow Park Drive Chicopee, MA 01022
510(k) Summary
Date Prepared: April 3, 2002
- The Ludlow Company LP Manufacturer Two Ludlow Park Drive Chicopee, MA 01022 Registration Number: 1219103
Uni-Patch Manufacturing Location 1313 West Grant Blvd. Wabasha, MN 55891 Registration Number: 2183164
M. Beth Rice Contact Person Regulatory Affairs Manager Phone: (413)-593-8266
Uni-Patch Ultrasound Coupling Gel Device Trade Name
Ultrasound gel Common Name
Classification Name Transmission medium for acoustical coupling
Fax: (413) 593-7266
Regulatory Reference MUI
Predicate Device Aquasonic 100 Ultrasound Transmission Gel
Uni-Patch Ultrasound Coupling Gel is a viscous, clear blue, water-soluble gel. Description: Typical packaging configuration for the Uni-Patch Ultrasound Coupling Gel is 250 ml plastic bottles and 5 liter plastic containers.
Intended Use Uni-Patch Ultrasound Coupling Gel is intended for use as the coupling medium for Ultrasound procedures on external, intact skin
Physical and Technical Comparison:
Uni-Patch Ultrasound Coupling Gel is similar in terms of intended use and technological characteristics to predicate devices reviewed as coupling gels used to couple ultrasound device is similar with respect to indications for use and physical characteristics to predicate devices in terms of section 510(k) substantial equivalency.
Performance FDA has not established special controls or performance standards for this Summary device
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of three human profiles facing right, stacked on top of each other. The profiles are stylized with flowing lines, giving the impression of movement or wind.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 5 2002
Re: K021132
Ms. M. Beth Rice Regulatory Affairs Manager The Ludlow Company, LP Two Ludlow Park Drive CHICOPEE MA 01022
Trade/Device Name: Uni-Patch Ultrasound Coupling Gel Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 MUI Dated: April 3, 2002 Received: April 9, 2002
Dear Ms. Rice:
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 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.
2
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 nredicate 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 this 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" (21 CFR Part 807.97). 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
3
510(k) Number (if known): K021132
Device Name: Uni-Patch Ultrasound Coupling Gel
Indications for Use:
Uni-Patch Ultrasound Coupling Gel is intended to be used as an ultrasound coupling medium on external, intact skin for short duration.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
David A. Seymour
Division of Reproductive, Abdominal, iological Dev