ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC

K082834 · Ellman Int'L, Inc. · GEI · May 7, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K082834
• Device Name: ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC
• Applicant: Ellman Int'L, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV The device is also indicated for: Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags and blepharoplasty. Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, and development of skin flaps. Hemostasis: control of bleeding, epilation, telangiectasia. Fulguration: basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, hemostasis. Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage.

Device Story

Surgitron is a compact high-power RF energy generator for radiosurgical procedures; operates via front panel selection of waveforms/power levels; provides feedback via push buttons/lights and digital display; output controlled by foot/hand switches. Uses monopolar and bipolar electrodes to deliver RF energy to tissue. Used in clinical settings by physicians for cutting, coagulation, hemostasis, and non-ablative wrinkle treatment. Device includes self-test/monitoring interlocks to prevent operation during failure. Benefits include precise tissue management and hemorrhage control.

Clinical Evidence

Bench testing only. Studies comparing subject device to predicate demonstrate safety and effectiveness for non-ablative treatment of mild to moderate facial wrinkles and rhytids.

Technological Characteristics

High-power RF energy generator; monopolar and bipolar electrode configurations; front panel digital display for power/status; foot/hand switch controls; self-test/monitoring interlocks. No specific materials or software architecture details provided.

Indications for Use

Indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids in skin phototypes I-IV; also indicated for various surgical cutting, coagulation, hemostasis, and fulguration procedures including snoring, palatal shrinkage, uvulopalatoplasty, myringotomy, epistaxis, turbinate shrinkage, skin incisions, biopsy, and removal of various skin lesions/tumors.

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 Surgitron IEC 120 / 4.0 DU (K013255)
• Thermage ThermaCool (K040135)

Submission Summary (Full Text)

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K 082834

### 510(k) Summary

#### Date Prepared [21 CFR 807.92(a)(1)]

. 8/11/08

MAY - 7 2009

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

Mr. Rick Epstein President & CEO Ellman International Inc. 3333 Royal Avenue Oceanside, NY 11572.

Telephone: [phone]

The establishment registration number for Ellman International is 2428235.

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

Trade Name

Surgitron

#### Device Common. Usual. or Classification Names

Electrosurgical Unit and Accessories, Electrosurgical Cutting and Coagulation and Accessories

#### Classification Panel

Classification of this device is at the discretion of the Center for Devices and Radiological Health (CDRH) and is presumed to be the Division of General, Restorative and Neurological Devices.

Class

Classification: Class II Product Code: GEI, 21 CFR 878.4400

# Description of the Device 121 CFR 807.92(a)(4){

The subject device is the same device that was authorized for use under 510(k) premarket notification K013255. The purpose of this submission is to add the indications for use of "non-ablative technique" used for the treatment of mild to moderate facial wrinkles and rhytids.

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K 0 8 2 8 3 4

The Ellman Surgitron is a compact source of high power RF energy to be employed for a variety of radiosurgical procedures. This action is achieved by front panel selection of waveforms and power levels. All selections are activated by push buttons with lights that give the operator feedback of operative status.

The power level for each mode is indicated by the front panel digital display, which also identifies the status of self-test and monitoring. This display is interlocked with the controls to prevent operation when fail is displayed. The final output power control is made through foot and/or hand switches. Both monopolar and bipolar electrodes are provided.

The subject device is packaged with the following items:

- o Ellman Surgitron IEC 120 / 4.0 DU Radiofrequency Generator
- o IEC Power Cord
- o Dual Footswitch & Cable
- o IEC Foot controlled Handpiece
- o Bipolar Cable
- o Disposable Neutral Plate
- o Instruction Manual
- o Three Button Fingerswitch Handpiece

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

The device has the following "Indications For Use":

- o Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV
The device is also indicated for:

- Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags and blepharoplasty.
- o Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage. skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, and development of skin flaps.
- · Hemostasis: control of bleeding, epilation, telangiectasia.
- o Fulguration: basal cell carcinoma, papilloma, cyst destruction, turnors, verrucae, hemostasis.

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- Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any field
(wet or dry), snoring, submucosal palatal shrinkage, traditional
uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage
control, epistaxis treatment and turbinate shrinkage.

082 934

### Technological Characteristics [21 CFR 807.92(a)(6)]

Ellman International believes that the subject device is substantially equivalent to the predicate devices.

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

Studies comparing the subject device to the predicate device demonstrate that the subject device is safe and effective for use in non-ablative procedures such as the treatment of mild to moderate facial wrinkles and rhytids.

### Predicate Device [21 CFR 807.92(a)(3)1

The predicate devices are as follows:

- o Ellman Surgitron IEC 120 / 4.0 DU K013255
- o Thermage ThermaCool K040135

The device is identical (materials, technology) to the Surgitron device in K013255. The only difference is the addition of the non-ablative indications for use.

The subject device is adding indications for use similar to the Thermage Thermacool device as found in K040135.

### Conclusion [21 CFR 807.92(b)(3)]

Based on the aforementioned information, the Ellman International Surgitron, with its expanded "Indication For Use" is safe and effective and substantially equivalent to the identified predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

Public Health Service

MAY - 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ellman International, Inc. % Mr. Rick Epstein President & CEO 3333 Royal Avenue Oceanside, New York 11572

Re: K082834

Trade/Device Name: Ellman International Non-Ablative Technique for Surgitron IEC Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 24, 2009 Received: April 29, 2009

Dear Mr. Epstein:

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 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 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.

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Page 2 - Mr. Rick Epstein

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Daniel Krone

Mark N. Melkerson 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

#### 510(k) Number (if known): K082834

Device Name: Ellman International Non-Ablative Technique for Surgitron IEC

Indications For Use:

- O Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV
The device is also indicated for:

- O Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, lumors, cosmetic repairs, development of skin flaps, skin tags and blepharoplasty.
- O Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids, verrucae, basal cell carcinoma, nevi, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, and development of skin flaps.
- O Hemostasis: control of bleeding, epilation, telangiectasia.
- O Fulguration: basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, hemostasis.
- O Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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)

Milke Syla formen

(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number. K082834

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