(22 days)
KI12827, K121311
K12827, K121311
No
The device is a physical ultrasound gel pad and the description focuses on its physical properties and intended use as a coupling agent. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
No
The 'Intended Use / Indications for Use' section explicitly states that the device is for "medical diagnostic ultrasound" and "non-invasive medical diagnostic ultrasound procedures," and the 'Device Description' refers to "ultrasound scanning for imaging diagnosis." While it mentions "ultrasound stimulator for treatment," the primary explicit stated uses are diagnostic, and the predicate devices are also diagnostic ultrasound gels.
No
Explanation: The device is an ultrasound couplant/gel pad, which is a medical accessory used to facilitate diagnostic ultrasound procedures by coupling sound waves. It does not perform the diagnostic function itself but assists a separate diagnostic device (the ultrasound imager).
No
The device description clearly states it is a "SOLID GEL PAD" which is a physical product (ultrasound gel) and not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "Non-sterile ultrasound couplant for use with medical diagnostic ultrasound." Its purpose is to facilitate the transmission of sound waves for imaging, not to perform tests on samples taken from the body (which is the core function of an IVD).
- Device Description: The description reinforces its role as a "solid-state" ultrasound gel pad used for "ultrasound scanning for imaging diagnosis or ultrasound stimulator for treatment." It's a physical coupling agent, not a reagent or instrument for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on the analysis of such samples.
Therefore, the device described is an accessory used in conjunction with diagnostic ultrasound equipment, not an IVD itself.
N/A
Intended Use / Indications for Use
Non-sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended to be used during non-invasive medical diagnostic ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gel is intended for use in all diagnostic ultrasound procedures which require ultrasound coupling gel or liquid or fluid.
Product codes
MUI
Device Description
The SOLID GEL PAD is ultrasound gel of the solid-state, generally used for ultrasound scanning for imaging diagnosis or ultrasound stimulator for treatment. The gel pad will be sold for single patient/procedure, disposable use. The SOLID GEL PAD is 9cm x 9cm aqueous, flexible. disposable ultrasound standoff for use in difficult to visualize and near field areas, or when gels alone won't do. Disposability eliminates the risk of cross contamination in diagnostic and therapeutic ultrasound procedures. It requires only gentle, even pressure.
The SOLID GEL PAD is especially very useful for using ultrasound over areas that are bony such as fingers, hands, wrists, elbows, and ankles. It also allows visualization of superficial structures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
fingers, hands, wrists, elbows, and ankles, superficial structures
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)
The following properties were tested based on the referenced standards. All the test results supported that the subject device is substantially equivalent to the predicate device in safety and effectiveness.
- · ISO 10993-5:2009. Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity (Biocompatibility)
- ISO 10993-10:2010. Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization (Biocompatibility)
- = ISO 12185 : 2003 Crude petroleum and petroleum products-Determination of density-Oscillating U-Tube method
- KS M 2014 : 2004 Testing methods for kinematic viscosity and calculating method for viscosity index of crude oil and petroleum products
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
KI12827, K121311
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.
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K131905
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This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
JUL 1 8 2013
Date:
510(k) Summary
1. Submitter:
| Name: | BLUEMTECH
Oriental Medical Industry Development Center 301.
Sangji Univ., Woosan-dong, Wonju-si, Gangwon-do,
220-702 Republic of Korea
Tel: +82-33-746-0110
Fax: +82-33-746-0210 |
|----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Heecheon Chae, CEO |
2. Submission Correspondent:
Priscilla Chung LK Consulting Group USA, Inc. 1515 E. Katella Ave. Unit 2115, Anaheim, CA 92805 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device:
| Proprietary Name: | SOLID GEL PAD |
|---|---|
| Common Name: | Ultra Sound Gel Pad |
| Classification Name: | Ultrasonic pulsed echo imaging system accessory |
| Classification: | Class II, 21 CFR 892.1570 |
| Classification Product Code: | MUI |
4. Predicate Device:
Sheathes Ultrasound Gel (KI12827) by Sheathing Technologies, Inc Thixo-Gel Ultrasound Spray (K121311) by Christina Bernstein BB Medical Surgical, Inc.
5. Device Description:
The SOLID GEL PAD is ultrasound gel of the solid-state, generally used for ultrasound scanning for imaging diagnosis or ultrasound stimulator for treatment. The gel pad will be
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K131905
Page 2 of 2
sold for single patient/procedure, disposable use. The SOLID GEL PAD is 9cm x 9cm aqueous, flexible. disposable ultrasound standoff for use in difficult to visualize and near field areas, or when gels alone won't do. Disposability eliminates the risk of cross contamination in diagnostic and therapeutic ultrasound procedures. It requires only gentle, even pressure.
The SOLID GEL PAD is especially very useful for using ultrasound over areas that are bony such as fingers, hands, wrists, elbows, and ankles. It also allows visualization of superficial structures.
6. Intended Use:
Non-sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended to be used during non-invasive medical diagnostic ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gel is intended for use in all diagnostic ultrasound procedures which require ultrasound coupling gel or liquid or fluid.
7. Performance Data(Non-Clinical):
The following properties were tested based on the referenced standards. All the test results supported that the subject device is substantially equivalent to the predicate device in safety and effectiveness.
- · ISO 10993-5:2009. Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity (Biocompatibility)
- ISO 10993-10:2010. Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization (Biocompatibility)
- = ISO 12185 : 2003 Crude petroleum and petroleum products-Determination of density-Oscillating U-Tube method
- KS M 2014 : 2004 Testing methods for kinematic viscosity and calculating method for viscosity index of crude oil and petroleum products
8. Substantial Equivalence
The SOLID GEL PAD is substantially equivalent to the Sheathes Ultrasound Gel (KI 12827) and Thixo-Gel Ultrasound Spray (K121311). They all are water based gel, but some compositions are different among the devices. The subject device is a gel pad type, whereas, the predicate devices are gel(K112827) and spray(K121311) type respectively. Despite these differences, we believe that the performance and biocompatibility testing results proves that the subject device is substantially equivalent to the predicate devices in safety and effectiveness.
9. Conclusion:
Based on the testing results, BLUEMTECH concludes that the SOLID GEL PAD is safe and effective also, substantially equivalent to predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
ﺔ ﺛﻴ
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2013
BLUEMTECH % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1515 E. Katella Avenue, Unit 2115 ANAHEIM CA 92805
Re: K131905
Trade/Device Name: SOLID GEL PAD Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: MUI Dated: June 17, 2013 Received: June 26, 2013
Dear Ms. Chung:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Chung
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Smh.7)
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
for
Enclosure
4
Indications for Use
K131905 510(k) Number (if known):
Device Name: SOLID GEL PAD
Indications for Use:
Non-sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended to be used during non-invasive medical diagnostic ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gel is intended for use in all diagnostic ultrasound procedures which require ultrasound coupling gel or liquid or fluid.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Sm(v.7)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K131905 510(k)
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