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.

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.

AI/ML Overview

This K131905 submission describes the SOLID GEL PAD, an ultrasound gel pad designed for medical diagnostic ultrasound. The provided document focuses on demonstrating the device's substantial equivalence to existing predicate devices rather than presenting a study to prove meeting specific acceptance criteria for a novel performance claim.

Here's a breakdown based on the provided text, while acknowledging that many of the requested elements are not applicable or explicitly stated as this is a substantial equivalence submission for a relatively low-risk device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study/Test Reference
Biocompatibility	Absence of cytotoxicity	Device passed tests for in vitro cytotoxicity	ISO 10993-5:2009
	Absence of irritation and skin sensitization	Device passed tests for irritation and skin sensitization	ISO 10993-10:2010
Physical Properties	Density characteristics	Device's density was tested	ISO 12185:2003
	Kinematic viscosity and viscosity index	Device's kinematic viscosity and viscosity index were tested	KS M 2014:2004
Functionality	Ability to couple sound waves for diagnostic ultrasound	"All the test results supported that the subject device is substantially equivalent to the predicate device in safety and effectiveness."	Implicitly demonstrated through physical properties and comparison to predicates.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for any of the performance tests. The document refers to "tests" and "test results" but does not detail the number of units or samples tested for each criterion.
Data Provenance: Not explicitly stated. The document indicates the submitter is from the Republic of Korea, suggesting the testing might have occurred there, but this is not confirmed. The clinical nature (retrospective/prospective) is not applicable as this is not a clinical study, but rather a set of non-clinical, laboratory-based tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This submission focuses on non-clinical performance data (biocompatibility and physical properties) and substantial equivalence, not on establishing ground truth for diagnostic accuracy with expert consensus.

4. Adjudication Method

Not applicable. This is not a clinical study requiring adjudication of diagnostic outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is not mentioned as it is not relevant for demonstrating the safety and effectiveness of an ultrasound gel pad, which is a coupling agent and not a diagnostic algorithm.

6. Standalone (Algorithm Only) Performance Study

No. This is not an algorithm-based device. The device itself (the gel pad) is the product being evaluated.

7. Type of Ground Truth Used

Not applicable in the typical sense of diagnostic ground truth. For biocompatibility, the "ground truth" is adherence to standard biological responses (e.g., absence of cytotoxicity). For physical properties, the "ground truth" is the measured values against established physical standards.

8. Sample Size for the Training Set

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, no training set is involved.

Summary of the Study (Based on Provided Text):

The submission describes a series of non-clinical performance tests conducted on the SOLID GEL PAD. The "study" for this device is not a traditional clinical trial or an AI/ML performance study, but rather a set of laboratory tests designed to demonstrate that the device meets safety (biocompatibility) and basic functional (physical properties) standards, and is therefore substantially equivalent to legally marketed predicate devices.

The tests performed were:

Biocompatibility:
- Tests for In Vitro Cytotoxicity (based on ISO 10993-5:2009)
- Tests for Irritation and Skin Sensitization (based on ISO 10993-10:2010)
Physical Properties:
- Determination of density (based on ISO 12185:2003)
- Testing methods for kinematic viscosity and calculating method for viscosity index (based on KS M 2014:2004)

The results of these tests "supported that the subject device is substantially equivalent to the predicate device in safety and effectiveness." The conclusion drawn is that the SOLID GEL PAD is safe and effective and substantially equivalent to the identified predicate devices (Sheathes Ultrasound Gel and Thixo-Gel Ultrasound Spray). The primary acceptance criterion appears to be meeting the standards outlined in the referenced ISO and KS documents, thereby demonstrating equivalence to the predicates.

Summary

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K131905
Page 1 of 2

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:	BLUEMTECHOriental Medical Industry Development Center 301.Sangji Univ., Woosan-dong, Wonju-si, Gangwon-do,220-702 Republic of KoreaTel: +82-33-746-0110Fax: +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
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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:

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.

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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

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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

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Indications for Use

K131905 510(k) Number (if known):

Device Name: SOLID GEL PAD

Indications for Use:

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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Regulation Number and Section

§ 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.