(155 days)
Not Found
No
The device is a coupling gel, which is a passive material used to facilitate ultrasound transmission. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
No.
This device is described as a coupling gel used to transmit sound waves for diagnostic ultrasound, not for therapeutic purposes.
No
The device is a coupling gel used in conjunction with ultrasound transducers, which are the diagnostic devices. The gel itself does not perform diagnosis; it facilitates the function of the diagnostic ultrasound equipment.
No
The device described is a physical substance (coupling gel) used in conjunction with ultrasound transducers, not a software program.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
- Device Function: Sono Image and Ultra Glide are coupling gels used on the body during ultrasound procedures. Their function is to facilitate the transmission of sound waves into the body for imaging purposes. They do not analyze or test any bodily fluids or tissues.
The provided information clearly describes a device used externally to aid in an imaging procedure, not a device used to analyze samples taken from the body.
N/A
Intended Use / Indications for Use
Sono Image and Ultra Glide are coupling gels and will be used in conjunction with ultrasound transducers during medical diagnostic ultrasound to couple sound waves into the patient's body. Sono Image is a high viscosity scanning gel suitable for echocardiography, vascular sonography and general ultrasound scanning procedures. Ultra Giide is a low viscosity scanning gel suitable for abdominal, OB/GYN and general ultrasound scanning procedures. Note: viscosity does not affect the safety or performance of a scanning gel. Scanning gels are selected by sonographers based on viscosity preference.
Product codes
90 ITX
Device Description
Sono Image and Ultra Glide are medical diagnostic ultrasound scanning gels that transmit sound waves into the body through the skin and whose formulas are identical except for the polymer (thickener) content. Sono Image and Ultra Glide do not contain silicon, mineral oil, surfactants or any chemicals which are considered harmful to ultrasound transducer material (see Sono Image and Ultra Glide product formulation).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
Not Found
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)
K883917/B, K931909, K931908/SI
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
SONO 774 Marine Drive Bellingham, WA 9822 Registration #2523891 510(k) Number K981028 Sono Image and Ultra Glide
AUG 21 1998
510(k) SUMMARY - #K981028
as required by 807.92(c)
SONOTECH, INC.
774 Marine Drive
Bellingham, WA 98225
Telephone: 360/671-9121
Fax: 360/671-9024
E-mail: sonotech@nas.com
Contact person: Margaret J. Larson
Date Prepared: August 3, 1998
1
SONOTECH, INC.
774 Marine Drive Bellingham, WA 98225 Registration #2523891 510(k) Number K981028 Sono Image and Ultra Glide
General Information
Reason for Premarket Notification: New device
Trade name of device: Sono Image and Ultra Glide
Common or usual name: Medical diagnostic ultrasound scanning gel
Regulatory Classification: II
Legally marketed devices to which we claim equivalence (see Comparison Table for further information): Natural Image Scanning Gel, K883917/B, reviewed and clearance received 3/31/89 Clear Image Sterile Scanning Gel, K931909, reviewed and clearance received 3/21/94 SonoMix Scanning Gel, K931908/SI, reviewed and clearance received 12/13/94
ﻤﺴﺎﻫﺎ Description: Sono Image and Ultra Glide are medical diagnostic ultrasound scanning gels that transmit sound waves into the body through the skin and whose formulas are identical except for the polymer (thickener) content. Sono Image and Ultra Glide do not contain silicon, mineral oil, surfactants or any chemicals which are considered harmful to ultrasound transducer material (see Sono Image and Ultra Glide product formulation).
Intended Use: Sono Image and Ultra Glide are coupling gels and will be used in conjunction with ultrasound transducers during medical diagnostic ultrasound to couple sound waves into the patient's body. Sono Image is a high viscosity scanning gel suitable for echocardiography, vascular sonography and general ultrasound scanning procedures. Ultra Giide is a low viscosity scanning gel suitable for abdominal, OB/GYN and general ultrasound scanning procedures.
Note: viscosity does not affect the safety or performance of a scanning gel. Scanning gels are selected by sonographers based on viscosity preference.
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is centered in the image and is the only element present.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 21 1998
Katie Monty Products and Sales Manager Sonotech, Inc. P.O. Box 2189 Bellingham, WA 98227-2189 Re:
K981028 Sono Image and Ultra Glide Dated: July 29, 1998 Received: August 6, 1998 Regulatory class: II 21 CFR 892.1570/Procode: 90 ITX
Dear Ms. Monty:
We have reviewed your Section 510%) 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 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 (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 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 510Ks) 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) 594-4613. 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/dsmaldsmamain.html".
Sincerely yours,
Kiliai Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K981028
Device Name: SONO IMAGE & ULTRA GLIDE
Indications For Use:
Sono Image and Ultra Glide are coupling gels and will be used in conjunction with Sono Image and offra Sirae are Coupaing genotic ultrasound to couple sound waves into the patient's body.
Sono Image is a high viscosity scanning gel suitable for echocardiography, bono finage is a high visuosaby and general ultrasound scanning procedures.
Ultra Glide is a low viscosity scanning gel suitable for abdominal, OB/GYN and general ultrasound scanning procedures.
viscosity does not affect the safety or performance of a scanning gel. Note: Scanning gels are selected by sonographers based on viscosity preference.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K981028 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------- | ---- | ---------------------- |
(Optional Formal 1-2-96)