SURGITRON RADIOLASE II

{0}------------------------------------------------ APR 7 2005 Image /page/0/Figure/1 description: The image shows the logo for Ellman International, Inc. The word "ellman" is in a large, outlined font. To the right of "ellman" is the phrase "international, inc." in a smaller, solid font. established 1959 # ellman Surgitron Radiolase II #### 510(k) Summar 04211 1. Submitter name and address: Dr. Jon. C. Garito President @lliman international 3333 Royal Avenue Oceanside, New York 11572-3625 Page 1 9 ② #### 2. Device name and classification: Surgitron Radiolase II 2.1 Device Name: Class II device, 21 CFR 878.4400 2.2 Classification: ### 3. Description of the device: The @llman Surgitron Radiolase II is a high frequency, medium power output electrosurgical medical device. The design is similar to currently marketed ​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​ electrosurgical generators and provides the essential operational modes that are most often used in medium power electrosurgical applications. The unit consists of both a nominal 50 Watt maximum output power in monopolar mode and a nominal 55 Watt maximum output power in bipolar mode, providing the capability of precision cutting, coagulation, and hemostasis in a four megacycle frequency electrical current. The unit is designed to comply with the 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 Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures, ENT procedures - 4.3 Hemostasis Control of Bleeding, Epilation, Telangiectasia - 4.4 Bipolar Pinpoint, Precise Cutting and Coagulation, Pinpoint Hemostasis in any field (Wet or Dry) Page 1 of 2 Image /page/0/Picture/23 description: The image shows a logo with the text "CERTIFIED COMPANY" arranged in a circular fashion around the letters "ISO". The logo has a jagged, starburst-like outline. The letters "ISO" are in a bold, sans-serif font and are stacked vertically in the center of the logo. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the text "ellman international, inc.". The word "ellman" is written in a large, outlined font. The words "international, inc." are written in a smaller, solid font to the right of "ellman". established 1959 # 5. Identification to predicate devices 5.1.Sugitron Radiolase with general use indication K992382 5.2 Surgitron 4.0 Dual RF/120 IEC with general use indication K013225 Page 2 of 2 ### 6. Summary of the technological characteristics of the new device in comparison to the predicate devices. | FEATURE | ellman<br>SURGITRON<br>RADIOLASE II<br>(New Application Device ) | ellman<br>SURGITRON<br>RADIOLASE<br>K992382 PREDICATE | ellman<br>SURGITRON<br>4.0 Dual RF/120 IEC<br>K013225 PREDICATE | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications For Use | Monopolar and /or Bipolar<br>Electrosurgical Cutting,<br>Blended Cutting and<br>Coagulation, and<br>Hemostasis<br>Refer to Page 5 for more<br>specific indications for use | Monopolar- covers all<br>indications for use as the<br>Surgitron Radiolase II<br>device.<br>Refer to Exhibit D | Monopolar-covers many<br>indications for use listed<br>for Surgitron Radiolase II<br>device.<br>Bipolar- covers all<br>indications of use listed<br>for Surgitron Radiolase II<br>device.<br>Refer to Exhibit D | | Design Specification | IEC 60601-1 and<br>60601-2-2<br>Requirementrs of the<br>Medical Device Directive<br>93/42/EEC | Same As New Device | UL544 and<br>IEC 601-2-2 | | Enclosure Size<br>(inches) | 10.3" wide x 4.5" high<br>x 10.5" deep | 7.0" wide x 4.3" high<br>x 9.0" deep | 9.3" wide x 5.0" high<br>x 13.5" deep | | Output Energy | Monopolar - 50 Watts<br>Bipolar - 55 Watts | Monopolar- 50 Watts | Monopolar - 120 Watts<br>Bipolar - 120 Watts | | Output Waveform (s) | Monopolar and Bipolar-<br>4.0 MHz Sine-wave<br>shaped, Fully Rectified,<br>Partially Rectified. | Monopolar- 4.0 MHz<br>Sine-wave shaped, Fully<br>Rectified, Partially<br>Rectified. | Monopolar- 4.0 MHz<br>Sine-wave shaped, Fully<br>Rectified, Partially<br>Rectified<br>Bipolar- 1.7 MHz with<br>modulated waveform. | | Software | Device does not contain<br>software | Device does not contain<br>software | Device contains<br>operational software | | Standards Met | IEC 60601-1, 60601-2-2<br>BS 5724-1 | IEC 60601-1, 60601-2-2<br>BS 5724: Section 2.2<br>UL2601 | IEC 601-1, 601-2-2<br>BS 5724: Section 2.2<br>UL2601 | | Delivery system and<br>configuration | Monopolar and Bipolar | Monopolar | Monopolar and Bipolar | | Biocompatibility Test | Not applicable | Not applicable | Not applicable | | Sterilization Method(s) | Not applicable | Not applicable | Not applicable | Substantial equivalence ﺎﺀ - - ﺍ 1 01 . . Page 2 of 2 Image /page/1/Picture/10 description: The image shows a black and white logo for a certified ISO company. The logo is circular with a jagged edge, resembling a seal. The letters "ISO" are prominently displayed in the center of the logo in a bold, sans-serif font. The words "CERTIFIED" and "COMPANY" are arranged around the top and bottom of the circle, respectively, in a smaller font size. {2}------------------------------------------------ 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" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services. APR 7 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Jon Garito Ellman International, Inc. 3333 Royal Avenue Oceanside, New York 11572-3625 Re: K042710 Trade/Device Name: Surgitron Radiolase II Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 10, 2005 Received: February 11, 2005 Dear Mr. Garito: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your become 310(t) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the enorosary to regary to regars and the Medical Device Amendments, or to commerce prof to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). allu Cosmete 71ct (11ct) that do not requesabject to the general controls provisions of the Act. The 1 ou may, therefore, thanker the act include requirements for annual registration, listing of general controls provisions of tactice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (36€ doove) inrols. Existing major regulations affecting your device FDA It inay be subject to ston additional Communisms, Title 21, Parts 800 to 898. In addition, FDA can be found in the Code of Featur regular regularing your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease be advised that I DTC 3 issuantes or our device complies with other requirements of the Act that IDA has made a determination administered by other Federal agencies. You must of ally Federal Statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set and CrK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic a forth in the quality systems (QD) regations (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - Mr. Jon Garito This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter witi anow you to oogin mains of substantial equivalence of your device to a legally premarket notification: "The PDF interlight 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), please If you desire specific advice 10. Jour acon 2011 276-0120 . Also, please note the regulation entitled, Contact the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnation on Journer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet and odress http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, signature \$\pi\$ Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ | international, inc.<br>established 1959 | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | 510(k) Premarket Notification | | | @Wiman international<br>page 5<br>Surgitron Radiolase II - General Surgery Use | | | | | | 510(k) Number K042710 | | | SURGITRON RADIOLASE II<br>Device Name: | | | Indication For Use: is idendical to the Surgitron as a preamendment device such as: | | | * Cutting | | | Skin and Mucosal Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, | | | Development of Skin Flaps, Skin Tags, Nevi, Keratosis, Oculoplastic Procedures,<br>Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures | | | | | | * Blended Cutting and Coagulation | | | Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, | | | Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps,<br>Oculoplastic Procedures, Arthroscopic Procedures, ENT procedures | | | | | | * Hemostasis | | | Control of Bleeding, Epilation, Telangicctasia | | | * Bipolar | | | Pinpoint, Precise Cutting and Coagulation, Pinpoint Hemostasis in any field (Wet or | | | Dry) | | | | | | | | | Prescription Use<br>Over-The- Counter Use<br>OR | | | (Per 21 CFR 801.109)<br>(Optional Format 1-2-96) | | | | | | | | | | | | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE<br>IF NEEDED) | | | | | | Concurrence of CDRH, Office of Device Evaluation (ODE) | | | | | | | | | | | | | | | storative<br>100%<br>. | | | | | ﺍﻷﻓﺮﻳﻘﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ 3333 Royal Avenue Oceanside, NY 11572-3625 U.S.A. Tel: (800) 835-5355 • (516) 594-333 www.ellman.co! 710