PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC by ELLMAN INTERNATIONAL, INC.

The device is a hand-held, non-ablative wrinkle treatment handpiece available with various size electrode end effectors and a detachable cable. The device is activated using a hand or footswitch based on user preference and is used with the Ellman radiofrequency generators labeled for the treatment of wrinkles and rhytides. The radiofrequency generator operates 4 mHz and is used in the CUT or PELLEVE mode for non-ablative wrinkle treatments.

AI/ML Overview

This set of documents describes a 510(k) submission for the Pellevé Non-Ablative Wrinkle Treatment System, seeking to amend its indications for use. It is a modification of an already cleared device, not a new device, and therefore the application does not contain a study to prove acceptance criteria. Instead, it argues for substantial equivalence based on the technological characteristics and intended use.

Here's a breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission does not provide specific acceptance criteria or performance metrics for a new study. The rationale is based on the system's inherent properties (RF energy interaction with tissue) and equivalence to the predicate device.

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

Not applicable. No new test set data was submitted as part of this 510(k) modification.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No new test set data or ground truth establishment was conducted for this submission.

4. Adjudication Method

Not applicable. No new test set data requiring adjudication was submitted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This submission is for an amendment to indications for use based on existing technology, not for a comparative effectiveness study involving human readers and AI.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is an electrosurgical system, not an AI algorithm.

7. Type of Ground Truth Used

Not applicable. No new ground truth was established for this submission. The rationale relies on the scientific understanding of radiofrequency energy's interaction with tissue as the basis for expanding the indications for use.

8. Sample Size for the Training Set

Not applicable. This is not an AI/algorithm device that requires a training set.

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

Not applicable. This is not an AI/algorithm device that requires a training set.

Summary of the Submission and Rationale:

The Pellevé Non-Ablative Wrinkle Treatment System was previously cleared for "Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV." This 510(k) submission (K132665) seeks to amend the indication to: "Non-ablative treatment of mild to moderate facial wrinkles and rhytids."

The key change is the removal of the specific mention of "skin phototypes I-IV." The rationale provided is that the system utilizes radiofrequency (RF) energy, and RF interaction with tissue is based on impedance rather than melanin. Therefore, skin phototype does not affect RF treatments.

The applicant asserts that the device has the same technological characteristics as the predicate device and that the modifications for use raise no new issues of safety or effectiveness. Based on this, the FDA determined the device to be substantially equivalent to its predicate.

In essence, no new studies or performance data were submitted because the change was based on a well-established understanding of how RF energy interacts with skin, making the previous limitation on skin phototypes I-IV unnecessary and scientifically unfounded for this type of technology.

Summary

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K132665

510(K) Summary

This 510(K) Summary of safety and effectiveness for the Pellevé Non-Ablative Wrinkle Treatment System is submitted in accordance with the requirements of the SMDA 1990 and FDA guidance concerning the organization and content of a 510(K) summary.

Applicant:	Ellman International
Address:	Ellman International400 Karin LaneHicksville, NY 11801
Contact Person:	Alison Sathe
Telephone:	513-658-8960asathe@ellman.com
Preparation Date:	August 21, 2013
Device Trade Name:	Pellevé Non-Ablative Wrinkle Treatment System
Common Name:	Electrosurgical, cutting & coagulation & accessories
Classification Name:	Electrosurgical, cutting & coagulation & accessoriesGEI, 878.4400
Legally Marketed PredicateDevice(s):	Pellevé Non-Ablative Wrinkle Treatment System

Device Description:

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Intended Use:

The device has been cleared pursuant to K102698 for the following Indications For Use: Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV.

Rationale presented herein is provided to amend the indication for use to: Non-ablative treatment of mild to moderate facial wrinkles and rhytids

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The basis for this rationale is the system utilization of radiofrequency (RF) energy. RF interaction with tissue is based on impedance rather than melanin therefore skin phototype does not affect RF treatments.

Technological Characteristics:

The Pellevé Non-Ablative Wrinkle Treatment System has the same technological characteristics as the predicate device.

Performance Data: None submitted

Substantial Equivalence:

The Pellevé Non-Ablative Wrinkle Treatment System has the same principles of operation and technological characteristics as the predicate. The modifications for use raises no new issues of safety or effectiveness. Thus, Pellevé Non-Ablative Wrinkle Treatment System is substantially equivalent to the predicate.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

September 25, 2013

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

Ellman International, Incorporated Ms. Alison Sathe Director of Regulatory and Clinical Affairs 400 Karin Lane Hicksville, New York 11801

Re: K132665

Trade/Device Name: Pellevé Non-Ablative Wrinkle Treatment System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagniation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 23, 2013 Received: September 3, 2013

Dear Ms. Sathe:

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 - Ms. Alison Sathe

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Neil R Ogden===
2013.10.16 12:37:17 -04'00'

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

Enclosure

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Indications for Use

510(k) Number (if known):__ K132665

Pellevé Non-Ablative Wrinkle Treatment System Device Name:

Indications for Use:

The Pellevé Non-Ablative Wrinkle Treatment System is indicated for the non-ablative treatment of mild to moderate facial wrinkles and rhytids.

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

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

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For MXM (Division Sign-off) Division of Surgical Devices 510(k) Number K132665

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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.