Pollogen's Applicator 3 Fractional (A3F) is a treatment handpiece to be attached to the FDA cleared Pollogen's apollo™ system (K111026). The A3F tip emits bipolar RF energy that flows between electrodes to create micro-ablation points on the skin, forming superficial ablation with a volumetric non ablative heating effect in the dermis.

AI/ML Overview

Here's an analysis of the provided text regarding the Pollogen Applicator 3 Fractional (A3F) device, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not explicitly state quantitative acceptance criteria or a direct comparison of the device's performance against such criteria. The "Summary of Pre-Clinical performance data" only states a general conclusion about safety and efficacy without numerical benchmarks.

Acceptance Criteria (Not Explicitly Stated/Implied)	Reported Device Performance
Safety: Device is safe for use.	Histological evaluation study on porcine skin showed the device to be "safe."
Efficacy: Device is effective for intended use.	Histological evaluation study on porcine skin showed the device to be "effective" for skin resurfacing.
Intended Use Fulfillment: Ablation and resurfacing of the skin.	"The results of this study clearly indicate that the Applicator 3 Fractional (A3F) offers an effective, safe device for skin resurfacing."

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

Sample Size: Not explicitly stated. The study was a "histological evaluation study on porcine skin," implying a limited number of animal subjects.
Data Provenance: Porcine (animal) skin, retrospective (historical data is not mentioned to be used).

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. It's implied that experts in histology and skin biology would have assessed the porcine samples.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study Done: No. The provided document describes a pre-clinical histological study on porcine skin, not a comparative effectiveness study involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance Done: N/A. The A3F is a physical medical device (applicator/handpiece) that emits RF energy, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not applicable here.

7. The Type of Ground Truth Used

Type of Ground Truth: Histological evaluation. This means tissue samples were examined under a microscope by experts to determine the effects of the device (ablation, heating, resurfacing).

8. The Sample Size for the Training Set

Sample Size for Training Set: N/A. As stated in point 6, this is a physical medical device, not an AI/ML algorithm that requires a training set. The "study" mentioned is a pre-clinical performance evaluation, not an algorithm training process.

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

Ground Truth for Training Set: N/A. Not applicable for this type of device.

Summary

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Pollogen™

510(K) SUMMARY

. Page 1 of (2)

Applicator 3 Fractional (A3F) 510(k) Number K122200

APR 1 8 2013

Pollogen Ltd. Applicant's Name: 6 Kaufman St. Gibor House, P.O.B. 50320 Tel Aviv ISRAEL 68012 Tel. (972)3-510-4110 Fax (972)3-510-4112

Contact Person: Yoram Levy, Qsite 31 Haavoda Street Binyamina, Israel 30500 Tel (972)4-638-8837; Fax (972)4-638-0510 Yoram@gsitemed.com

Trade Name: Applicator 3 Fractional (A3F)

Summary Preparation Date: July 18, 2012

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

Device Description:

Pollogen's Applicator 3 Fractional (A3F) is a treatment handpiece to be attached to the FDA cleared Pollogen's apollo™ system (K111026).

The A3F tip emits bipolar RF energy that flows between electrodes to create micro-ablation points on the skin, forming superficial ablation with a volumetric non ablative heating effect in the dermis.

Applicator 3 Fractional (A3F) - 510k Submission

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Pollogen™

Page 2 of 2

Intended Use Statement:

The Applicator 3 Fractional (A3F) is intended for dermatological procedures requiring ablation and resurfacing of the skin

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

Device Name	510k No	Date of Clearance
Syneron Matrix RFApplicator	K073572	Sep 17, 2008

Performance Standards:

Applicator 3 Fractional (A3F) complies with

IEC 60601-1 Medical Electrical Equipment-Part 1: General . · Requirements for Safety. Collateral Standard: Safety Requirements
for Medical Electrical Systems.
IEC 60601-1-2 Medical Electrical Equipment Part 1-2: . Collateral Standard: Electromagnetic Compatibility -Requirements and Tests.
IEC 60601-2-2 Medical Electrical Equipment-Part 2: . Particular requirements for the safety of high frequency surgical equipment.

A detailed description appears in Section 14.

Summary of Pre-Clinical performance data:

safety and efficacy of the Applicator 3 Fractional The (A3F) was supported by performing histological evaluation study on porcine skin.

The results of this study clearly indicate that the Applicator 3 Fractional (A3F) offers an effective, safe device for skin resurfacing.

Applicator 3 Fractional (A3F) - 510k Submission

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

April 18, 2013

Pollogen, Ltd. % QSite Mr. Yoram Levy 31 Haavoda Street Binyamina 30500 Israel

Re: K122200

Trade/Device Name: Applicator 3 Fractional (A3F) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: February 20, 2013 Received: February 26, 2013

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

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Page 2 - Mr. Yoram Levy

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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. FOR

Peter DRumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Pollogen"

INDICATIONS FOR USE STATEMENT

K122200 510(k) Number (if known):

Device Name:

Applicator 3 Fractional (A3F)

Indications for Use:

The Applicator 3 Fractional (A3F) is intended for dermatological procedures requiring ablation and resurfacing of the skin

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joshua C. Nipper
FDA-S

For

(Division Sign-off) Division of General, Restorative and Neurological Devices 510(k) Number: K122200

Applicator 3 Fractional (A3F) - 510k Submission

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.