(231 days)
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No
The document describes an electroconductive gel and its performance testing, with no mention of AI or ML.
No
The device description states it is an electroconductive gel used with an external electrode to reduce impedance, not to treat a condition. It is an accessory to a device that may be therapeutic.
No
The description states that Endy Gel is an electroconductive gel media used with external electrodes to reduce impedance, enhancing electrical conductivity for radiofrequency signals. Its purpose is to facilitate the operation of other devices by improving conductivity, not to diagnose medical conditions or provide diagnostic information itself.
No
The device description explicitly states it is an "Electroconductive gel media," which is a physical substance, not software. The performance studies also focus on physical properties like biocompatibility and electrical performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that Endy Gel is an "Electroconductive gel media used with external electrode to reduce the impedance... of the contact between the electrode surface and the skin." This describes a topical product used to facilitate the delivery of electrical signals through the skin, not a product used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description reinforces this by explaining its function in enhancing electrical conductivity for radiofrequency signals.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVDs are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. Endy Gel is used in vivo (on the body) to improve the performance of another medical device (the external electrode).
N/A
Intended Use / 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.
Product codes
GYB
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
Impedance (at 1 MHz):
Proposed Device (EndyMed EndyGel): 527.68
Predicate device (Electro-Gel): 549.71
pH:
Proposed Device (EndyMed EndyGel): 7.15-7.33
Predicate device (Electro-Gel): 6.99
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 882.1275 Electroconductive media.
(a)
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.(b)
Classification. Class II (performance standards).
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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
1
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 (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" (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 (800) 638-2041 or (301) 796-7100 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
2
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 (972)4-638-8837; Fax (972)4-638-0510 Yoram@qsitemed.com
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/
Reference | Device Name | Manufacturer | 510k No. | Clearance
Date |
|-------------------------|-------------|-----------------------------------|----------|-------------------|
| Predicate | Electro-Gel | Electro-Cap International
Inc. | K111717 | Jan 05 2012 |
Comparison table with the predicate
| | EndyMed EndyGel
(proposed) | Predicate device:
Electro-Gel
(K111717) |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class | Class II | same |
| Classification
Panel | Neurology | same |
| Product Code | GYB | Same |
| Regulation
Description | Electroconductive media | Same |
| Regulation
number | 21 CFR 882.1275 | Same |
| | EndyMed EndyGel
(proposed) | Predicate device:
Electro-Gel
(K111717) |
| Indications for
Use (IFU)
statement | EndyMed's EndyGel TM 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. | The Electro-Gel device is
intended for use with
external electrodes as the
conductor between the scalp
and the electrodes. It also
reduces impedance
(resistance to alternating
current) between the
electrode surface and the
skin. |
| Principles of
Operation | EndyMed's EndyGel TM
functions as a conductor
between the skin and the
electrodes. EndyMed's
EndyGel TM is intended to
used prior to Handpiece's
electrodes placement to
reduce the impedance
(resistance to alternating
current) of the contact
between the electrode
surface and the skin. The
energy is then transferred via
the gel to the patient's tissue. | Same |
| Body contact | Intact Skin | Same |
| | EndyMed EndyGel
(proposed) | Predicate device:
Electro-Gel
(K111717) |
| Biocompatibility | Complies with requirements of ISO 10993-1, including:
Cytotoxicity (ISO 10993-5),
Irritation and Sensitization
(ISO 10993-10) | Same |
| Sterilization | Provided non-sterile | Same |
| Shelf life | 2 years | 3 years |
| Impedance (at 1
MHz) | 527.68 | 549.71 |
| Conductive
material | Water (Aqua) with
immersed Triethanolamine | Water (Aqua) with
immersed Sodium chloride |
| Composition | • Water (solvent)
• Carbomer (gel forming)
• Triethanolamine
(Buffering)
• Methylisothiazolinone and
Methylcloroisothiazolinone (preservative) | • Water (solvent)
• Sodium Chloride
(preservative)
• Aragum T-1998
(thickner)
• Potassium Bitartrate
(Stabilizer)
• Glycerin (lubricant)
• Methylparaben
(preservative)
• Propylparaben
(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.
-
- 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.