NON-ABLATIVE WRINKLE TREATMENT HANDPIECE

K102368 · Ellman Int'L, Inc. · GEI · Sep 7, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K102368
• Device Name: NON-ABLATIVE WRINKLE TREATMENT HANDPIECE
• Applicant: Ellman Int'L, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 7, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Non-ablative treatment of mild to moderate facial wrinkles for skin phototypes I-IV

Device Story

The Non-Ablative Wrinkle Treatment Handpiece is an electrosurgical accessory used for the non-ablative treatment of mild to moderate facial wrinkles. The device is identical to the predicate (K101967) in design, technology, and intended use, with the only modification being the cleaning and disinfection protocol. The device is intended for prescription use. The updated cleaning method involves wiping the handpiece and cable with a 70% isopropyl alcohol solution, ensuring the surface remains wet for at least 5 minutes. This modification was validated through testing to demonstrate adequate log reduction of challenge organisms.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing (SGS Protocol #09A1006547 and SGS Report #09A1006548) to validate the efficacy of the modified cleaning and disinfection method.

Technological Characteristics

Electrosurgical handpiece for cutting and coagulation. Identical to predicate (K101967) in all technological aspects. Cleaning/disinfection method: 70% isopropyl alcohol wipe with 5-minute wet contact time.

Indications for Use

Indicated for non-ablative treatment of mild to moderate facial wrinkles in patients with skin phototypes I-IV.

Regulatory Classification

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.

Predicate Devices

• Ellman Non-Ablative Wrinkle Treatment Handpiece (K101967)

Submission Summary (Full Text)

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510(K) Summary

102368

Page 1, 2

#### Date Prepared [21CFR 807.92(a)(1)] 8/19/2010

# Submitter's Information [21CFR 807.92(a)(1)]

Mr. Jonathan Achenbach Sr. Dir. R&D, Clinical & Regulatory Affairs Ellman International Inc. 333 Royal Ave. Oceanside, NY. 11572 Telephone: [phone]

SEP. 0'7 2010

The establishment registration number for Ellman International is 2428235

## Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade Name

Non-Ablative Wrinkle Treatment Handpiece

#### Device common, usual or Classification Names

Device: Electrosurgical, cutting & coagulation & accessories

Regulation Description: Electro surgical cutting and coagulation device and accessories

#### Class

Classification: Class II Product Code: GEI

# Device Description [21 CFR 807.92(a)(4)]

The purpose of this submission is to modify the Cleaning / Disinfection methods of the Non-Ablative Wrinkle Treatment Handpiece cleared as Ellman Non-Ablative Wrinkle Treatment Handpiece under K101967. The device is identical to the device cleared under K101967 Ellman International Non-Ablative Wrinkle Treatment Handpiece except for the modified Cleaning/Disinfection method.

The proposed method is:

#### Method:

Disinfect Handpiece and Cable prior to and after each procedure by wiping exterior surfaces with a lint free cloth soaked in liquid solution containing 70% Isopropyl Alcohol. Ensure surface

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remains wet for at least 5 minutes. An additional application of 70% Isopropyl Alcohol should be applied if the surface appears dry during the 5 minute period.

Ellman International has presented a successfully executed test protocol as part of this submission to demonstrate that the methods described above achieve an adequate log reduction of inoculated challenge organisms on the test devices.

Further to this, Ellman International has presented substantial evidence to support the claims made in method above to provide an effective alternate cleaning and disinfection to the existing instructions for use.

## Intended Use [21 CFR 807.92(a)(5)}

:

ﺮ ﺍ

The device has the following "Indications For Use"

- Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin . phototypes I-IV
#### Technological Characteristics [21 CFR 807.92(a)(6)}

Ellman International maintains that the subject device is identical to the predicate device except for the modified cleaning and disinfection method.

## Labels, Labeling [21 CFR XXXX]

Per section "Product Labels"

#### Performance Data [21 CFR 807.92(b)(1)]

# As defined in SGS Protocol # 09A1006547 and demonstrated in SGS Report# 09A1006548

## Predicate Devices [21 CFR 807.92(a)(3)(1)|

The device is substantially equivalent to the Non-Ablative Wrinkle Treatment Handpiece cleared as Ellman Non-Ablative Wrinkle Treatment Handpiece under K101967.

# Consideration for Special 510(k) Status

In accordance with the FDA guidance document: The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance Attachment 2, Ellman Internal maintains that this change in the cleaning and disinfection method is a "Device Modification" and therefore requests that the FDA considers it as such.

As there are no technological, structural, design or intended use changes for the subject device, Ellman International believes that no further data or clinical study is required to support the position that the device is safe and effective to use with the changes delineated in the instructions for use.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans.

#### Public Health Service

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

Ellman International, Inc. % Mr. Jonathan Achenbach Sr. Director R & D. Clinical And Regulatory Affairs 3333 Royal Avenue Oceanside, New York 11572

SEP 0 7 2010

Re: K102368

Trade/Device Name: Non-Ablative Wrinkle Treatment Handpiece Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 19, 2010 Received: August 20, 2010

Dear Mr. Achenbach:

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

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Page 2 - Mr. Jonathan Achenbach

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 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health .

Enclosure

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# "INDICATIONS FOR USE" Statement

KI 02368 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

SEP 0 7 2010

Device Name: _________ Non-Ablative Wrinkle Treatment Handpiece

The Device has the following "Indications for Use":

Non-ablative treatment of mild to moderate facial wrinkles for skin phototypes I-IV

Prescription Use X (per 21 CFR 801.109)

ない

OR

Over-The Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 1-2-96)

Division Sign-(ft)

(Division Sign Division of Surgeal. Orthopedic, and Restorative را vices

**510(k) Number** K102368