EndyGel

K161715 · Endymed Medical, Ltd. · GYB · Feb 7, 2017 · Neurology

Device Facts

• Record ID: K161715
• Device Name: EndyGel
• Applicant: Endymed Medical, Ltd.
• Product Code: GYB · Neurology
• Decision Date: Feb 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1275
• Device Class: Class 2

Indications for Use

EndyGel is an Electroconductive gel media used with external electrode to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.

Device Story

EndyGel is an electroconductive gel applied to intact skin prior to electrode placement. It functions as a conductive interface to reduce impedance (resistance to alternating current) between the electrode surface and the patient's skin, facilitating the transfer of radiofrequency energy to tissue. The device is used in a clinical setting by healthcare professionals. It benefits the patient by ensuring efficient energy delivery during procedures requiring external electrodes.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing (ISO 10993-5 cytotoxicity, ISO 10993-10 irritation and sensitization), electrical performance testing (impedance measurement), and stability testing. No clinical data presented.

Technological Characteristics

Electroconductive gel composed of water, carbomer, triethanolamine, and preservatives. Non-sterile. Shelf life 2 years. Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 14971, and ISO 13485.

Indications for Use

Indicated for use as an electroconductive gel media with external electrodes to reduce impedance between the electrode surface and intact skin.

Regulatory Classification

Identification

Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.

Predicate Devices

• Electro-Gel (K111717)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol of three stylized human profiles facing right, with flowing lines beneath them. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the circular seal.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 7, 2017

EndyMed Medical Ltd. % Yoram Levy Osite General Manager Qsite 31 Haavoda St. Binyamina, 30500 Israel

Re: K161715

Trade/Device Name: EndyGel Regulation Number: 21 CFR 882.1275 Regulation Name: Electroconductive Media Regulatory Class: Class II Product Code: GYB Dated: December 29, 2016 Received: January 4, 2017

Dear Yoram Levy:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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" (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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Michaelリ. Hoffmann -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K161715

Device Name EndyGel

Indications for Use (Describe)

Endy Gel is an Electroconductive gel media used with external electrode to reduce the impedance to alternating current) of the contact between the electrode surface and the skin.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Endymed 3DEEP Skin Science. The logo is purple and features the word "ENDYMED" in large, bold letters. Below the word "ENDYMED" is the phrase "3DEEP SKIN SCIENCE" in smaller letters. The letters are all capitalized.

# 510(K) SUMMARY

# EndyMed's EndyGel™ 510(k) Number K161715

| Applicant's Name: | EndyMed Medical Ltd. |
|-------------------|--------------------------|
| | 12 Leshem Street |
| | North Industrial Park |
| | Caesarea, 3088900 Israel |
| Tel: | (972)4-630-9100 |
| Fax: | (972)4-630-9101 |

- Contact Person: Yoram Levy, Qsite 31 Haavoda Street Binyamina, 30500 Israel Tel [phone]; Fax [phone] [e-mail]
EndyGel™ Trade Name:

510(k) Summary Preparation Date: February 2, 2017

- Classification: Name: Electroconductive media Product Code: GYB Regulation No: 21 CFR 882.1275 Class: II Panel: Neurology
Indications for Use (IFU) Statement:

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Image /page/4/Picture/0 description: The image contains the logo for Endymed 3DEEP Skin Science. The word "ENDYMED" is in large, bold, purple letters. Below that, in smaller purple letters, are the words "3DEEP SKIN SCIENCE".

EndyGel™ is an Electroconductive gel media used with external electrode to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.

## Device Description:

EndyMed's EndyGel™ is an Electroconductive gel media used with external electrode to enhance electrical conductivity by reducing the impedance (resistance to alternating current) of the radiofrequency signals path from the electrode surface between the electrode surface and the skin.

#### Predicate Devices:

Substantial equivalence to the following predicate device is claimed:

| Predicate/<br>Reference | Device Name | Manufacturer | 510k No. | Clearance<br>Date |
|-------------------------|-------------|-----------------------------------|----------|-------------------|
| Predicate | Electro-Gel | Electro-Cap International<br>Inc. | K111717 | Jan 05 2012 |

## Comparison table with the predicate

| | EndyMed EndyGel<br>(proposed) | Predicate device:<br>Electro-Gel<br>(K111717) |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class | Class II | same |
| Classification<br>Panel | Neurology | same |
| Product Code | GYB | Same |
| Regulation<br>Description | Electroconductive media | Same |
| Regulation<br>number | 21 CFR 882.1275 | Same |
| | EndyMed EndyGel<br>(proposed) | Predicate device:<br>Electro-Gel<br>(K111717) |
| Indications for<br>Use (IFU)<br>statement | EndyMed's <i>EndyGel</i> TM is an<br>Electroconductive gel media<br>used with external electrode<br>to reduce the impedance<br>(resistance to alternating<br>current) of the contact<br>between the electrode<br>surface and the skin. | The <b>Electro-Gel</b> device is<br>intended for use with<br>external electrodes as the<br>conductor between the scalp<br>and the electrodes. It also<br>reduces impedance<br>(resistance to alternating<br>current) between the<br>electrode surface and the<br>skin. |
| Principles of<br>Operation | EndyMed's <i>EndyGel</i> TM<br>functions as a conductor<br>between the skin and the<br>electrodes. EndyMed's<br><i>EndyGel</i> TM is intended to<br>used prior to Handpiece's<br>electrodes placement to<br>reduce the impedance<br>(resistance to alternating<br>current) of the contact<br>between the electrode<br>surface and the skin. The<br>energy is then transferred via<br>the gel to the patient's tissue. | Same |
| Body contact | Intact Skin | Same |
| | EndyMed EndyGel<br>(proposed) | Predicate device:<br>Electro-Gel<br>(K111717) |
| Biocompatibility | Complies with requirements of ISO 10993-1, including:<br>Cytotoxicity (ISO 10993-5),<br>Irritation and Sensitization<br>(ISO 10993-10) | Same |
| Sterilization | Provided non-sterile | Same |
| Shelf life | 2 years | 3 years |
| Impedance (at 1<br>MHz) | 527.68 | 549.71 |
| Conductive<br>material | Water (Aqua) with<br>immersed Triethanolamine | Water (Aqua) with<br>immersed Sodium chloride |
| Composition | • Water (solvent)<br>• Carbomer (gel forming)<br>• Triethanolamine<br>(Buffering)<br>• Methylisothiazolinone and<br>Methylcloroisothiazolinone (preservative) | • Water (solvent)<br>• Sodium Chloride<br>(preservative)<br>• Aragum T-1998<br>(thickner)<br>• Potassium Bitartrate<br>(Stabilizer)<br>• Glycerin (lubricant)<br>• Methylparaben<br>(preservative)<br>• Propylparaben<br>(preservative) |
| pH | 7.15-7.33 | 6.99 |

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Image /page/5/Picture/0 description: The image contains the brand name ENDYMED in large purple font. Below the brand name is the text 3DEEP SKIN SCIENCE, also in purple font, but smaller than the brand name. The text is centered and the brand name has a trademark symbol on the upper right.

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Image /page/6/Picture/0 description: The image shows the logo for EndyMed. The logo is purple and consists of the word "ENDYMED" in large, bold letters, with the letters slightly overlapping. Below the main logo, in smaller font, are the words "3DEEP SKIN SCIENCE".

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Image /page/7/Picture/0 description: The image shows the logo for ENDYMED. The logo is purple and consists of the word "ENDYMED" in large, bold letters. Below the word "ENDYMED" is the phrase "3DEEP SKIN SCIENCE" in smaller letters. There is a trademark symbol in the upper right corner of the logo.

#### Substantial Equivalent Discussion

The EndyGel, like its predicate device, is indicated for use as an Electroconductive gel media used with external electrode to reduce the impedance (resistance to alternating current) of the contract between the electrode surface and the skin.

The EndyGel and the predicate device have similar technological Electroconductive gel media.

The impedance of the EndyGel is within 4% and the pH within 2.2% compared to the predicate device. The difference in total impedance and in pH between the two gels is negligible and do not impact the safety and effectiveness of the EndyGel.

### Performance

The safety and efficacy of the EndyGel™ were established by a series of performance tests, including biocompatibility testing, electrical performance and stability.

The design of EndyGel™ was done in accordance with EndyMed Medical Ltd. quality management system and design controls per 21CFR820 and ISO 13485. V&V and compliance testing, including: Biocompatibility testing, Electrical Performance testing and Stability testing, were successfully conducted and did not raise any new safety questions or identify any new risks.

### Standards:

The EndyGel™ complies with the following standards

- ISO 14971-1:2009 Risk management for medical devices 1.
- 2. ISO13485:2003 Medical devices -- Quality management systems -- Requirements for 0regulatory purposes.
- ISO 10993-1:2009 Biological Evaluation of Medical Devices -- Part 1: Evaluation and 3. testing within a risk management process.
- ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for in vitro 4. cytotoxicity

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Image /page/8/Picture/0 description: The image shows the logo for ENDYMED, a company specializing in 3DEEP skin science. The word "ENDYMED" is displayed in large, bold, purple letters, with a small trademark symbol in the upper right corner. Below the company name, the words "3DEEP SKIN SCIENCE" are written in a smaller, sans-serif font, also in purple. The logo is clean and modern, reflecting the company's focus on advanced skin technology.

- ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation న్. and skin sensitization
- EN ISO 15223-1 Medical devices -- Symbols to be used with medical device labels, 6. labelling and information to be supplied -- Part 1: General requirements

# Conclusion:

The EndyGel™, like its predicate devices, is indicated for use as an Electroconductive gel media used with external electrode to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.

The EndyGel™, the predicate device and reference device have similar technological features of an Electroconductive gel media.

Results of tests, performed with the proposed EndyGel™ demonstrate that it is as safe and effective as its predicate device, without raising any new safety and/or effectiveness concerns.

Therefore the EndyGel™ is substantially equivalent to its predicate device.