SURGITRON RADIOLASE

K992382 · Ellman Intl., Inc. · GEI · Oct 14, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992382
• Device Name: SURGITRON RADIOLASE
• Applicant: Ellman Intl., Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cutting Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures. Blended Cutting and Coagulation Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures. Hemostasis Control of Bleeding, Epilation, Telangiectasia

Device Story

Surgitron Radiolase is a high-frequency, medium-power electrosurgical device; provides precision cutting, coagulation, and hemostasis. Operates at 4 MHz frequency; maximum 50-watt output. Input: electrical current; Output: high-frequency energy delivered via monopolar electrodes. Used in clinical settings by physicians for procedures including skin incisions, biopsies, and oculoplastic surgery. Healthcare providers use the device to manage tissue during surgery; benefits include precise tissue handling and effective bleeding control. Device is a simple, energy-efficient electrosurgical unit.

Clinical Evidence

No clinical data. Substantial equivalence is based on technological characteristics and compliance with international safety standards (IEC 601-1, 601-2-2, UL2601).

Technological Characteristics

High-frequency electrosurgical unit; 4.0MHz sine-shaped, fully rectified, and partially rectified waveforms. Monopolar operation. Max 50W output. Complies with IEC 601-1, 601-2-2, BSI5724, and UL2601. No software component.

Indications for Use

Indicated for patients requiring electrosurgical cutting, blended cutting/coagulation, or hemostasis for dermatological, oculoplastic, and arthroscopic procedures, including skin incisions, biopsies, tumor removal, and bleeding control.

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 (K980177)
• ERBOTOM ICC 200 (K933157)

Submission Summary (Full Text)

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# OCT 1 4 1999

## Surgitron Radiolase 510(k) Summary

992382

## 1. Submitter Name and Address:

Frank Lin, Ph.D. Director of R&D Engineering Ellman International 1135 Railroad Ave. Hewlett, NY 11557

### 2. Device Name and Classification

2.1 Device Name: Surgitron Radiolase 2.2 Classification: Class 2 Device, 21 CFR 878.4400

## 3. Description of The Device

@liman Surgitron Radiolase is a high frequency, medium power output electrosurgical device. The design is unique, simple, energy efficiency, safe, and user friendly. Furthermore, it equips the essential operational modes that are most often used in electrosurgical application. The unit has a maximum 50 watt output power and provides the capability of precision cutting, coagulating, and hemostasis in four megacycle frequency electrical current. It is designed to comply with international safety standards.

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

- 4.1. Cutting
Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures.

### 4.2. Blended Cutting and Coagulation

Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures.

### 4.3. Hemostasis

Control of Bleeding, Epilation, Telangiectasia

## 5. Identification to predicate devices

- 5.1. Surgitron IEC with general use indication K980177
- 5.2. ERBOTOM ICC 200 with indication K933157

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

| In Technological Characteristics Comparison | | | |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| FEATURE | SURGITRON<br>RADIOLASE<br>(NEW)* | SURGITRON IEC<br>WITH GENERAL<br>USE INDICATION<br>K980177<br>PREDICATE | ERBOTOM<br>ICC 200<br>WITH<br>INDICATION<br>K933157<br>PREDICATE |
| Indications For Use | Refer to Note 1 | Same As New Device | Same As New Device |
| Design Specification | IEC 601-1 and 601-2-2<br>The CE Aspects of<br>Council Directive<br>93/42/EEC The<br>Medical Device<br>Directive | IEC 601-1 and 601-2-2<br>The CE Aspects of<br>Council Directive<br>93/42/EEC The<br>Medical Device<br>Directive | UL544 |
| Output Energy | 50 Watts | 100 Watts | 200 Watts |
| Output Waveform (s) | 4.0MHz Sine-shaped,<br>Fully Rectified,<br>Partially Rectified. | 1.7MHz, Sine-shaped<br>Fully Rectified,<br>Partially Rectified,<br>Fulgurating-Spark-Gap | 350kHz Sine-shaped<br>1MHz<br>Pulse-modulated |
| Monopolar/Bipolar | Monopolar | Monopolar and Bipolar | Monopolar and Bipolar |
| Standards Met | IEC 601-1, 601-2-2,<br>BSI5724:Section 2.2,<br>and UL2601 | IEC 601-1, 601-2-2,<br>BSI5724:Section 2.2,<br>and UL2601 | IEC 601-1 |
| Biocompatibility Tests | Monopolar Electrodes<br>identical to predicate<br>device | Same As New Device | Same As New Device |
| Sterilization Method(s) | Refer to Note II | Same As New Device | Not Indicated |

# Substantial Equivalence In Technological Characteristics Comparison

* There is no software component in this new device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or progress.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 1999

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

K992382 Re:

> Trade Name: Surgitron Radiolase Regulatory Class: II Product Code: GEI Dated: July 14, 1999 Received: July 16, 1999

Dear Mr. Lin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Frank Lin

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510K Notification Surgitron Radiolase - General Use page 5

ellman international

510(k) Number (if known): k992 382

Device Name: SURGITRON RADIOLASE

Indication For Use: is idendical to the Surgitron as a preammendment device such as:

- * Cutting
Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures.

- * Blended Cutting and Coagulation
Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures.

- * Hemostasis Control of Bleeding, Epilation, Telangiectasia
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K992382 |

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align: center;">X</div> | OR | Over-The-Counter Use |
|------------------------------------------|------------------------------------------|----|----------------------|
|------------------------------------------|------------------------------------------|----|----------------------|

(Optional Format 1-2-96)