(121 days)
802146
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of an ultrasound gel, with no mention of AI or ML.
Yes
The "Intended Use / Indications for Use" section states it is used for "diagnostic and therapeutic procedures".
Yes
The intended use explicitly states "used as an ultrasound coupling medium for diagnostic and therapeutic procedures".
No
The device description clearly states it is a "colorless, thisotropic gel contained in a dispenser," indicating a physical substance and container, 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 an ultrasound coupling medium for diagnostic and therapeutic procedures on external, intact skin. This is a topical application to facilitate the transmission of ultrasound waves, not a test performed on a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description confirms it's a gel applied to the skin.
- Lack of IVD Characteristics: There is no mention of analyzing a biological sample, detecting a substance, or providing information about a patient's health status based on a sample analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely physical – to improve ultrasound transmission.
N/A
Intended Use / Indications for Use
Thixo-Gel Ultrasound Spray® is used as an ultrasound coupling medium for diagnostic and therapeutic procedures on external, intact skin for a short duration.
Product codes (comma separated list FDA assigned to the subject device)
MUI
Device Description
Thixo-Gel Ultrasound Spray® is a colorless, thisotropic gel contained in a dispenser that allows it to be dispersed as a thin layer on external, intact skin.
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)
Bench Top Testing:
Tests for biocompatibility were performed in accordance with ISO-10993.
Bacterial contamination retests were also performed on the subject device for shelf life.
Physical property comparison tests were performed on the submitted device and predicate.
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.
802146
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
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510(k) Summary
This summary of 510(k) safety and effectiveness information is furnished in accordance with requirements detailed in 21 CFR 807.92.
The assigned 510(k) number is K-121311
Submitter's Identification: Cloverline International Pharma Services GmbH Teinacher Strasse 49 Ludwigsburg, Germany D-71634 Correspondence:
Christina Bernstein BB Medical Surgical, inc. 2670 Leavenworth Street San Francisco, CA 94133. Tel: 415-450-0515 Email tina@bbmedicalsurgical.com
Date of submission 25 April 2012 Date of revised summary 31 July 2012, second revision 15 August 2012.
Device name:
Proprietary name: Thixo-Gel Ultrasound Spray®
A.Regulation Section: 21 CFR 892-1570 Diagnostic Ultrasound Transducer Accessory
B.Classification: Class II
C.Product Code: MUI
D.Panel: Radiology
Intended Use:
য
Thixo-Gel Ultrasound Spray® is used as an ultrasound coupling medium for diagnostic and therapeutic procedures on external, intact skin for a short duration.
Device Description:
Thixo-Gel Ultrasound Spray® is a colorless, thisotropic gel contained in a dispenser that allows it to be dispersed as a thin layer on external, intact skin.
Summary 15 August Thixo-gel page 1
1
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Substantial Equivalence Information:
- A. Predicate device name: Aquasonic 100®
- B. Predicate device K number: 802146
- C. Comparison with predicate:
| SUBSTANTIAL
EQUIVALENCE TABLE | THIXO-GEL
ULTRASOUND SPRAY ® | AQUASONIC 100 ® |
|----------------------------------|-----------------------------------------------|-------------------------------------------|
| K-Number | 121311 | 802146 |
| Device Description | Ultrasound
Couplant | Ultrasound
Couplant |
| Acoustic Impedance | 0.166 gm/cm2 | 0.163 gm/cm2 |
| Density | 1056 km/m3 | 1012 km/m3 |
| Attenuation @ 10 MHz | 1-2 dB/mm | 1-2 dB/mm |
| Sound Velocity | 1566 m/sec | 1588 m/sec |
| Dispenser | 250 ml nozzle
spray bottle
(single use) | 250 ml squeeze.
bottle
(refillable) |
6.
Test Principle, Performance Characteristics:
FDA has not established special controls or performance standards for this device.
Bench Top Testing:
Tests for biocompatibility were performed in accordance with ISO-10993. ^
- Bacterial contamination retests were also performed on the subject device for shelf life
1 201 2007 :
.
- Physical property comparison tests were performed on the submitted device and predicate. Comparison
1 ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
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onclusions:
Thixo-Gel Ultrasound Spray® is similar in intended use and technological characteristics to predicate devices reviewed used to couple ultrasound devices to skin. The device is similar with respect to indications for use and physical characteristics to predicate devices in terms of section 510(k) substantial equivalency.
Contraindications: Thixo-Gel Ultrasound Spray® is not:for use with defibrillators. Warnings and Precautions: The precautions are provided in the device labeling for Thixo-Gel Ultrasound Spray®. There is no warning associated with this lavine.
9.
| Description | Comparison with Predicate Device |
|---|---|
| Biocompatibility | Safe as Predicate Device |
| Performance Characteristics | Substantially equivalent |
| Intended Use | Substantially equivalent |
| Performance Tests | Not Required |
The device Thixo-Gel Ultrasound Spray®, based on the information submitted in this device 4 QUAACONIC 1980 TI 2015 Cranetially equivalent to the predicate device AQUASONIC 100® (K-802146), manufactured by Parker Laboratories Inc.
Summary 15 August Thixo-gel par
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AUG 3 0 2012
Cloverline International Pharma Services GmbH % Ms. Christina Bernstein US Agent BB Medical Surgical, Inc. 2670 Leavenworth Street SAN FRANCISCO CA 94133
Re: K121311
Trade/Device Name: Thixo-Gel Ultrasound Spray® Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: MUI Dated: August 7, 2012 Received: August 7, 2012
Dear Ms. Bernstein:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your occurity in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to regally manetee profite Medical Device Amendments, or to commerce prior to May 20, 1977, the encordance with the provisions of the Federal Food, DNAA devices that have been recialsmod in acce approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, dicretore, market the act include requirements for annual registration, listing of general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is Classificu (sec above) into enas ff (one device can be found in Title 21, additional controls. Existing major regulations and to 895. In addition, FDA may publish further Ood of I cannouncements your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation on a succession make a mains of the Act
that FDA has made a determination that your device complies . You must that FDA has made a determination and regulations administered by other Federal agencies. You must of any Federal statutes and regulations administered of on registration and listing (21).
comply with all the Act's requirements, including, but not limited to: registing of comply with all the Act 3 requirements, including, or medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
STO (K) APPLIC TION THING GEL UTITASQUAD SPRAY®
Indications for Use Form
510(k) Number (if known): K-121311
Device Name: Thixo-Gel Ultrasound Spray®
Indications for Use:
Thixo-Gel Ultrasound Spray® is used as an ultrasound coupling medium for diagnostic and therapeutic procedures on external, intact skin for a short duration.
Over-The-Counter Use Prescription Use _ Yes AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Kla1311
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