(231 days)
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.
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.
This document is a 510(k) Pre-Market Notification for EndyGel™, an electroconductive gel media. The purpose is to demonstrate substantial equivalence to a predicate device, Electro-Gel (K111717).
Here's the analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from Predicate Device) | Reported Device Performance (EndyGel™) |
|---|---|
| Device Class: Class II | Class II |
| Classification Panel: Neurology | Neurology |
| Product Code: GYB | GYB |
| Regulation Description: Electroconductive media | Electroconductive media |
| Regulation number: 21 CFR 882.1275 | 21 CFR 882.1275 |
| Indications for Use: 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. | EndyMed's 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. |
| Principles of Operation: Functions as a conductor between the skin and the electrodes. Intended to be 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 as predicate. |
| Body contact: Intact Skin | Intact Skin |
| Biocompatibility: Complies with requirements of ISO 10993-1, including: Cytotoxicity (ISO 10993-5), Irritation and Sensitization (ISO 10993-10) | Complies with requirements of ISO 10993-1, including: Cytotoxicity (ISO 10993-5), Irritation and Sensitization (ISO 10993-10) |
| Sterilization: Provided non-sterile | Provided non-sterile |
| Shelf life: 3 years | 2 years |
| Impedance (at 1 MHz): 549.71 | 527.68 |
| Conductive material: Water (Aqua) with immersed Sodium chloride | Water (Aqua) with immersed Triethanolamine |
| Composition: Water (solvent), Sodium Chloride (preservative), Aragum T-1998 (thickener), Potassium Bitartrate (Stabilizer), Glycerin (lubricant), Methylparaben (preservative), Propylparaben (preservative) | Water (solvent), Carbomer (gel forming), Triethanolamine (Buffering), Methylisothiazolinone and Methylcloroisothiazolinone (preservative) |
| pH: 6.99 | 7.15-7.33 |
Study proving device meets acceptance criteria:
The safety and efficacy of the EndyGel™ were established by a series of performance tests, including biocompatibility testing, electrical performance, and stability.
- Biocompatibility testing:
- Complies with ISO 10993-1, ISO 10993-5 (Cytotoxicity), and ISO 10993-10 (Irritation and Sensitization).
- Electrical Performance testing:
- The impedance of EndyGel™ (527.68 at 1 MHz) is within 4% of the predicate device (549.71).
- Stability testing:
- The EndyGel™ has a shelf life of 2 years (compared to 3 years for the predicate).
- pH:
- The pH of EndyGel™ (7.15-7.33) is within 2.2% of the predicate device (6.99).
The document states that "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." Also, "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."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for the test set or the data provenance for the performance tests (biocompatibility, electrical performance, stability). It broadly refers to "performance tests" that were successfully conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is an electroconductive gel, and the "ground truth" for its performance is based on quantifiable physical and chemical properties and standard biological safety tests, not human expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/software device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-based device. Performance is based on intrinsic physical, chemical, and biological properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the acceptance criteria for this device are established by:
- Industry standards (ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 13485, ISO 14971-1).
- Quantifiable physical properties (impedance, pH, shelf life).
- Chemical composition analysis.
- Comparison to an existing legally marketed predicate device with a history of safe and effective use.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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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 (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
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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 (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. | ClearanceDate |
|---|---|---|---|---|
| Predicate | Electro-Gel | Electro-Cap InternationalInc. | K111717 | Jan 05 2012 |
Comparison table with the predicate
| EndyMed EndyGel(proposed) | Predicate device:Electro-Gel(K111717) | |
|---|---|---|
| Device Class | Class II | same |
| ClassificationPanel | Neurology | same |
| Product Code | GYB | Same |
| RegulationDescription | Electroconductive media | Same |
| Regulationnumber | 21 CFR 882.1275 | Same |
| EndyMed EndyGel(proposed) | Predicate device:Electro-Gel(K111717) | |
| Indications forUse (IFU)statement | EndyMed's EndyGel TM is anElectroconductive gel mediaused with external electrodeto reduce the impedance(resistance to alternatingcurrent) of the contactbetween the electrodesurface and the skin. | The Electro-Gel device isintended for use withexternal electrodes as theconductor between the scalpand the electrodes. It alsoreduces impedance(resistance to alternatingcurrent) between theelectrode surface and theskin. |
| Principles ofOperation | EndyMed's EndyGel TMfunctions as a conductorbetween the skin and theelectrodes. EndyMed'sEndyGel TM is intended toused prior to Handpiece'selectrodes placement toreduce the impedance(resistance to alternatingcurrent) of the contactbetween the electrodesurface and the skin. Theenergy is then transferred viathe 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 1MHz) | 527.68 | 549.71 |
| Conductivematerial | Water (Aqua) withimmersed Triethanolamine | Water (Aqua) withimmersed Sodium chloride |
| Composition | • Water (solvent)• Carbomer (gel forming)• Triethanolamine(Buffering)• Methylisothiazolinone andMethylcloroisothiazolinone (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.
§ 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).