EndyMed's Intensif Applicator is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (K08346) (EndyMed Pro). The Intensif Applicator has a custom grid array of micro electrodes that is used to deliver the energy into the tissue. The Intensif Applicator tip emits bipolar RF energy that flows between electrodes to create thermal heating of the tissue for hemostasis and coagulation. The Intensif Applicator consists of: . Disposable treatment element (tip) . RF electrodes on a disposable tip . Operation trigger.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Intensif Applicator, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance	Description / Reported Performance
Safety	Compliance with IEC 60601-1:2005 / EN 60601-1:2006 (Medical electrical equipment - General requirements for basic safety and essential performance, 3rd edition for basic safety and essential performance). Compliance with IEC/EN 60601-1-2 (Electromagnetic compatibility (EMC)). Lab performance tests, design validation, software verification and validation. Ex Vivo studies (laboratory and animal) showed similar thermal and biological effects to previously FDA cleared fractional skin hemostasis and coagulation devices.
Efficacy	Lab performance tests, design validation, software verification and validation. Ex Vivo studies (laboratory and animal) showed similar thermal and biological effects to previously FDA cleared fractional skin hemostasis and coagulation devices. Device performs according to its specifications.
Operational Performance	Intensif Applicator's power control and accuracy. Intensif Applicator's safety features functionality. Intensif Applicator needle depth validation.
Intended Use	For use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis. The results of preclinical testing indicate it offers a "minimally invasive, effective, safe device for skin hemostasis and coagulation."
Substantial Equivalence	The device has the same intended use and similar indications as predicate devices (Primaeva Medical System K080145, EndyMed FSR K101510, EndyMed Imagine TC Skin Treatment System K083461). Technology is similar. Power and frequency envelopes covered by predicate devices. Minor differences in human interface/accessories do not raise new safety/effectiveness issues, as verified by performance and ex vivo testing.

Study Information

This device did not involve a clinical study with human subjects. The supporting studies are entirely preclinical and ex vivo.

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

Test Set Sample Size: Not specified. The document mentions "a few Ex Vivo laboratory studies and Ex Vivo animal studies tests" but does not quantify the number of samples or animals used.
Data Provenance: The studies were "Ex Vivo laboratory studies and Ex Vivo animal studies tests." The location where these studies were performed is not explicitly stated, but the company is based in Israel. This is a preclinical type of data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the studies were preclinical (ex vivo laboratory and animal) and did not involve human interpretation or expert evaluation to establish ground truth in the context of clinical outcomes. The "ground truth" was based on measurable physical and biological effects in the lab.

4. Adjudication Method for the Test Set

Not applicable. There was no human expert adjudication of a test set as the studies were preclinical.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. This device is not an AI-assisted diagnostic tool; it's an electrosurgical applicator.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

While the device itself operates without human intervention post-activation, this question is typically relevant for diagnostic algorithms or AI. For this medical device, the "standalone" performance refers to its ability to achieve its intended physical effect (electrocoagulation and hemostasis) as demonstrated in the ex vivo studies. It is not an "algorithm only" type of device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance was established through measurable physical and biological effects in ex vivo laboratory settings and animal tissues. This included:
- Evaluating thermal and biological effects.
- Measuring power control and accuracy.
- Testing safety features functionality.
- Validating needle depth.

8. The Sample Size for the Training Set

Not applicable. This device is a medical device for electrocoagulation and hemostasis, not an AI/machine learning algorithm requiring a "training set" of data in the conventional sense. Its design and performance are based on engineering principles and physical testing.

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

Not applicable, as there was no "training set" in the context of AI/machine learning for this device.

Summary

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MAR 1 3 2014

K130501

Page 1 of 3

510(K) SUMMARY

Intensif Applicator

510(k) Number K130501

Applicant's Name:	EndyMed Medical Ltd.7 Bareket Street,North Industrial Park,Caesarea, 30889 IsraelTel: (972)4-630-9100Fax: (972)4-630-9101
Contact Person:	Yoram Levy, Qsite31 Haavoda StreetBinyamina, Israel 30500

Binyamina, Israel 30500 Tel (972)4-638-8837; Fax (972)4-638-0510 Yoram@gsitemed.com

Trade Name: Intensif Applicator (Ilooda Secret) Common Name: Electrosurgical RF applicator
Preparation Date: February 7, 2013

Name: Electrosurgical, cutting & coagulation device Classification: & accessories Product Code: OUH, GEI Regulation No: 21 CFR 878.4400 Class: II Panel: General and Plastic Surgery

Device Description:

The Intensif Applicator consists of:

. Disposable treatment element (tip)
. RF electrodes on a disposable tip

2-1 EndyMed Intensif Applicator 510k Notification

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Operation trigger .

Intended Use Statement:

The Intensif Applicator is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

Substantial equivalence to the following predicate devices is Predicate Devices: claimed:

Device Name	510(k) No	Date of Clearance
Primaeva Medical System	K080145	Feb 28, 2008
EndyMed FSR	K101510	Feb 17, 2011
EndyMed Imagine TC SkinTreatment System	K083461	Jul 24, 2009

Performance Standards:

Intensif Applicator complies with the following standards:

· IEC 60601-1:2005 / EN 60601-1:2006 Medical electrical equipment - part 1 General requirements for basic safety and essential performance, 3td edition
· IEC/EN 60601-1-2 Electromagnetic compatibility (EMC)

Summary of Technologies

The Intensif Applicator uses microneedles and implies IMHz RF energy to achieve their intended use.

Performance Bench Testing Data

The safety and efficacy of the Intensif Applicator were established by a series of performance tests. Lab performance tests, design validation and software verification and validation. Verification and testing have shown that the Intensif Applicator device performs according to its specifications.

The following tests were conducted:

. Intensif Applicator 's power control and accuracy
. Intensif Applicator's safety features functionality
. Intensif Applicator needle depth validation. 2-2

EndyMed Intensif Applicator 510k Notification

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Summary of Preclinical Data

of the Intensif In order to evaluate efficacy and safety safety Applicator, a few Ex Vivo laboratory studies and Ex Vivo animal studies tests were conducted, while the Intensif Applicator was connected to the EndyMed PRO (K083461) treatment console.

The results of these studies clearly indicate that the treatment with Intensif Applicator connected to the EndyMed PRO system produces thermal and biological effects similar to previously FDA cleared fractional skin hemostasis and coagulation devices

Summary of Clinical performance data:

The safety and efficacy of the Intensif Applicator was evaluated in a performance and preclinical testing.

The results of this testing clearly indicate that the Intensif Applicator offers a minimally invasive, effective, safe device for skin hemostasis and coagulation.

No clinical studies were conducted.

Substantial Equivalence

Intensif Applicator device has the same intended use and similar indications as its predicate devices. The technology of the predicate devices is also the same.

The envelope of power and frequency of the submitted Intensif Applicator is covered by the envelopes of its predicate devices. Any minor differences in the human interface and accessories design do not raise any new types of safety and effectiveness issues, as verified by performance and ex vivo testing. Therefore the Intensif Applicator nonclinical and ex vivo testing submitted demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device and thus is substantially equivalent to its predicate devices.

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Public Health Service

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

March 13, 2014

EndyMed Ltd. % Mr. Yoram Levy Qsite 31 Haavoda Street Binyamina, Israel 30500

Re: K130501

Trade/Device Name: Intensif Applicator Regulation Number: 21 CFR 878.4800 Regulation Name: Electrosurgical, Cutting, Coagulation, & Accessories Regulatory Class: Class II Product Code: OUH, GEI Dated: January 21, 2014 Received: January 27, 2014

Dear Mr. 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 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 - Mr. Yoram Levy

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/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Felipe Aguel

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for EndyMed, a company that specializes in 3DEEP technology. The logo features the company name in a bold, sans-serif font, with the tagline "THE 3DEEP COMPANY" underneath. The logo is simple and modern, and the use of black and white gives it a clean and professional look.

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

KI30201

Device Name:

Intensif Applicator

Indications for Use:

The Intensif Applicator is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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Lona e: 2014.03.11 12:24:08 -04 DO for BSA

(Division Sign-off) Division of Surgical Devices 510(k) Number: K130501

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.