SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF

K013255 · Ellman Intl., Inc. · GEI · Nov 7, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K013255
• Device Name: SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF
• Applicant: Ellman Intl., Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 7, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cutting Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Blepharoplasty, Blended Cutting and Coagulation Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, 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 120 IEC is a compact high-power RF electrosurgery generator; provides energy for radiosurgery procedures. Inputs: user-selected waveforms/power levels via front panel push buttons. Operation: generates 4.0 MHz sine-wave (CW, fully/partially rectified) or 1.7 MHz spark-gap output. Output: delivered via monopolar or bipolar electrodes; controlled by foot/hand switches. Used in clinical settings by physicians. Features digital displays for power levels, self-test, and monitoring status; interlocked controls prevent operation during failure. Benefits: precise cutting/coagulation with hemorrhage control; enables diverse surgical applications including ENT, dermatology, and cosmetic procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics, design specifications, and compliance with international safety standards (UL/IEC).

Technological Characteristics

RF electrosurgery generator; 120W output; 4.0 MHz sine-wave and 1.7 MHz spark-gap waveforms. Monopolar and bipolar delivery. Complies with UL2601, IEC 601-1, IEC 601-2-2, and BS15724:2.2. Features digital display, self-test, and monitoring interlocks. Biocompatible electrodes.

Indications for Use

Indicated for patients requiring electrosurgical cutting, coagulation, hemostasis, or fulguration for procedures including snoring, palatal shrinkage, uvulopalatoplasty, myringotomy, epistaxis, turbinate shrinkage, skin incisions, biopsy, cyst/abscess/tumor removal, cosmetic repairs, skin flaps, skin tags, blepharoplasty, papilloma, keloids, keratosis, verrucae, basal cell carcinoma, nevi, fistulas, epithelioma, epilation, and telangiectasia.

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

• Surgitron IEC II (K001253)
• Surgitron IEC II (K933157)
• ERBOTOM ICC 200 (K933157)

Submission Summary (Full Text)

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NOV 0 7 2001

# @llman Surgitron 120 IEC 510 (k) Summary 013255

### 1. Submitter name and address:

Frank Lin, Ph.D. Director of R&D engineering මංගික්ක international 1135 Railroad Avenue Hewlett, New York 11557

### 2. Device name and classification:

| 2.1 Device Name: | Surgitron 120 IEC (Also known as Surgitron 4.0 Dual RF) |
|---------------------|---------------------------------------------------------|
| 2.2 Classification: | Class 2 device, 21 CFR 878.4400 |

## 3. Description of the device:

The @Wman Surgitron 120 IEC enhanced capability Electrosurgery Generator described herein is a compact source of high power RF energy to be employed for a variety of radiosurgery procedures. This action is achieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays which also show 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. It is designed to comply with international safety standards.

### 4. The intended use/indication for use of the device:

### 4.1 Cutting

Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Blepharoplasty,

### 4.2 Blended Cutting and Coagulation

Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps,

4.3 Hemostasis Control of Bleeding, Epilation, Telangiectasia

Page 1 of 2

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## 4.4 Fulguration

.4 Fulguration
Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Verrucae, Hemostasis.

### 4.5 Bipolar

.5 Bipolar
Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry), Snoring, Pinpoint, Flecise Coagulation, Finpoint Firmiopalatoplasty (RAUP), myringotomy Submucosal palatal sinmkage, traditional availopmants (
with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.

# 5. Identification to predicate devices

5.1.Sugitron IEC II with general use indication K001253 5.1.Sugitron IEC If with general use indication K933157
5.2 ERBOTOM ICC 200 with general use indication K933157

# 6. Summary of the technological characteristics of the new device in comparison to the predicate devices.

| FEATURE | ollman<br>SURGITRON 120 IEC<br>(New Application Device) | ollman<br>SURGITRON IEC II<br>WITH GENERAL USE<br>INDICATION K001253<br>PREDICATE | ERBOTOM<br>ICC200 WITH<br>INDICATION<br>K933157 PREDICATE |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------|
| Indications For Use | Snoring, submucosal<br>palatal shrinkage,<br>traditional<br>uvulopalatoplasty (RAUP),<br>myringotomy with<br>effective hemorrhage<br>control, epistaxis treat, and<br>turbinate shrinkage. Also,<br>see page 5 for detail. | Same As New Device | Same As New Device |
| Design Specification | UL544 and IEC601-2-2 | Same As New Device | Same As New Device |
| Output Energy | 120 Watt | 100 Watt | 200 Watt |
| Output Waveform (s) | 4.0 MHz Sin-wave CW,<br>Fully Rectified, Partially<br>Rectified, and 1.7 MHz for<br>Fulgurating Spark-Gap | Same As New Device | 350KHz Sine-Shaped and<br>1 MHz Pulse-modulated |
| Standards Met | UL2601 and IEC<br>601-1 601-2-2,<br>BS15724:2.2 | UL2601 and IEC<br>601-1 601-2-2,<br>BS15724:2.2 | IEC 601-1 |
| Delivery system and<br>configuration | Monopolar and Bipolar | Monopolar and Bipolar | Same As New Device |
| Biocompatibility Test | Electrodes identical to<br>predicate device | Same As New Device | Same As New Device |
| Sterilization Method(s) | Refer to page 6, Note I | Same As New Device | Not Indicated |

# Substantial equivalence In Technological Characteristics comparison

Page 2 of 2

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Image /page/2/Picture/1 description: The image shows a black and white seal of the Department of Health & Human Services. The seal is circular and contains an emblem of a stylized bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle. The emblem is centrally located within the circle.

Public Health Service

**DEC 2 2007**

Food and Drug Administration 00 Corporate Boulevard Rockville MD 20850

Mr. Frank Lin Director of Engineering Research and Development Department Ellman International, Inc. 1135 Railroad Avenue Hewlett, New York 11557-2316

Re: K013255

Trade/Device Name: Surgitron 120 IEC Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 27, 2001 Received: September 28, 2001

Dear Mr. Lin:

This letter corrects our substantially equivalent letter of November 7, 2001 regarding the file number.

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). 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.

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); 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. Frank Lin

This letter will allow you to continue marketing your device as described in your section 510(k) I his letter will anow you to continue manoling your at economialence of your device to a legally premarket notification. THE PDA midning of backanded of a classification for your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, al [phone]. Additionally, 10. quest 301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, responstonities under the Act may of country of country toll free number [phone] or at (301) International and Consumer I Belodition://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

NOV 0 7 2001

510K Notification
Surgitron - General & Plastic Surgery Use

page S

@llman international

| 510(k) Number (if known): | K013255 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | SURGITRON 120 IEC |
| | Indication For Use: is idendical to the Surgitron as a preammendment device such as: |
| | * Cutting |
| | Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP),<br>myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate<br>shrinkage, Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs,<br>Development of Skin Flaps, SkinTags, Blepharoplasty, |
| | * Blended Cutting and Coagulation |
| | Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP),<br>myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate<br>shrinkage, Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma,<br>Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, 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,<br>Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy<br>with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE<br>IF NEEDED) |
| | Concurrence of CDRH, Office of Device Evaluation (ODE) |

| Prescription Use | <div style="text-align:left;"><span style="vertical-align:top;">/</span></div> |
|----------------------|--------------------------------------------------------------------------------|
| (Per 21 CFR 801.109) | |

Susan Walk-

(Division Sign-Off)

Division of General, Restorative-The- Counter Use __________

and Neurological Devices (Optional Format 1-2-96)

| 510(k) Number | K013255 |
|---------------|---------|
|---------------|---------|