(90 days)
Not Found
Not Found
No
The device description and intended use clearly define it as an ultrasound coupling gel, with no mention of image processing, AI, or ML.
No
Explanation: The device is described as a coupling contact medium for diagnostic scanning procedures, not for treating any medical condition.
No
The device is described as a "coupling contact medium" for diagnostic scanning procedures, not the diagnostic device itself. Its purpose is to facilitate the use of an ultrasound device, which is the diagnostic tool.
No
The device description clearly states it is a gel used for coupling ultrasound devices, indicating it is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a "coupling contact medium for abdominal and OB/GYN diagnostic scanning procedures." This describes a physical medium used to facilitate the transmission of ultrasound waves, not a test performed on a biological sample in vitro (outside the body).
- Device Description: The description reinforces that it's a gel used for "coupling ultrasound devices to external surfaces such as skin." It doesn't mention any analysis of biological samples.
- Lack of IVD Characteristics: The description doesn't mention any reagents, assays, or analysis of biological fluids or tissues, which are hallmarks of IVD devices.
Therefore, Lubriscan® Ultra Scan Gel + is a medical device used in conjunction with an ultrasound system, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
Lubriscan® Ultra Scan Gel + is intended to be used on external, intact skin for short duration as a coupling contact medium for abdominal and OB/GYN diagnostic scanning procedures.
Product codes
90 ITX
Device Description
Lubriscan Ultra Scan Gel + is used for coupling ultrasound devices to external surfaces such as skin. The gel is not sterile. The raw materials comprising the gel have a long and established history as raw materials in cosmetics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
APR - 9 1998
510(k) Premarket Notification Lubriscan Ultrasound Gel
- 510(k) Summary
Submitted By:
Michael Caswell, Ph.D. Cosmaceutical Marketing, Inc. 10820 Alder Circle Dallas, TX 75238 (214) 340-1503 January 8, 1998
Device:
| Trade Name: | Lubriscan Ultra Scan Gel + |
|---|---|
| Common/Usual Name: | Ultrasound Gel |
| Proposed Classification: | 892.1560 Ultrasound pulsed echo imaging system |
| 892.1570 Diagnostic ultrasound transducer |
Predicate Devices:
Lubriscan Ultra Scan Gel + is similar in terms of intended use, materials of construction, and technological characteristics to predicate devices reviewed as coupling gels used to couple ultrasound devices to surfaces such as skin.
Device Description:
Lubriscan Ultra Scan Gel + is used for coupling ultrasound devices to external surfaces such as skin. The gel is not sterile. The raw materials comprising the gel have a long and established history as raw materials in cosmetics.
Substantial Equivalence:
The device will be manufactured and packaged according to specified process controls and a Quality Assurance Program similar to pharmaceuticals currently manufactured and marketed by Cosmaceutical Marketing, Inc. The device is similar with respect to indications for use, materials and physical characteristics to predicate devices in terms of section 510(k) substantial equivalency.
1
Image /page/1/Picture/0 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a stylized representation of an eagle or bird-like figure, with three curved lines forming the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Regille MD 20850
Michael Caswell, Ph.D. Cosmaceutical Marketing, Inc. 10820 Alder Circle Dallas, Texas 75238
Re:
K980091 Lubriscan® Ultra Scan Gel+ Dated: January 8, 1998 Received: January 9, 1998 Regulatory class: II 21 CFR 892.1570/Procode: 90 ITX
APR
Dear Dr. Caswell:
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 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 (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 requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the CMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 with disgnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/dsmadsmam.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D Director, Division of Reproductive Abdominal, Ear, Nose and Throst and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Premarket Notification Lubriscan Ultrasound Gel
8.6 Statement of Indication for Use
510(k) Number (if known): To Be Assigned
Lubriscan® Ultra Scan Gel + Device Name:
Indications for Use:
Lubriscan® Ultra Scan Gel + is intended to be used on external, intact skin for short duration as a coupling contact medium for abdominal and OB/GYN diagnostic scanning procedures.
(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__________________________________________________________________________________________________________________________________________________________