DR. OPPEL ST-501

{0}------------------------------------------------ ## 510(k) Summary 051956 0009 This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: JUNE 7, 2005 l. Submitter: | | Company | |---------|---------------------------------------------------------------------------------| | Name | SOMETECH INCORPORATED | | Address | Byucksan Digital Valley III 212-13<br>Guro-dong Guro-gu<br>Seoul, 152-050 Korea | | Phone | +82 2 547-3422 | | Contact | Young-Soo Seol | #### 2. Device: Proprietary Name - Dr. OPPEL ST-501 Common Name - Electrosurgical unit and accessories Classification Name - Electrosurgical cutting and coagulation device and Accessories #### 3. Predicate Device: Aaron 900 High Frequency Desiccator/Handpiece, Aaron Medical Industries, K000961 Aaron Reusable Electrosurgical Electrode, Aaron Medical Industries, K014201 Surgitron 120 IEC, Ellman International, Inc., K013255 ## 4. Classifications & Citations: 21CFR 878.4400, GEI Class 2 510(k) Guidance Document for General Surgical Electrosurgical Devices #### 5. Description: Dr. OPPEL ST-501 is a electrosurgical unit using high frequency current to cut and/or coagulate tissue. It consists of Electrosurgical Unit generator, Handpiece, Electrodes, a cable for disposable patient plate and foot switch. It is a compact source of high power RF energy to be employed for a variety of radiosurgery procedures. This action is action is achieved by front panel selection of power level and time. All selection is effected through push buttons and lamps that give the operator feedback of status. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are provided. Monopolar electrodes have needle, ball, loop and blade types. Electrodes are supplied non-sterile and reusable. - 6. Indication for use: Dr. OPPEL ST-501 is intended for the removal and destruction of skin legions and the coagulation of tissue. Non-sterile and reusable electrodes are used in conjunction with an electrosurgical handpiece and generator. . ﻳ SOMETECH INCORPORATED 好: {1}------------------------------------------------ 510(k) Submission -- Dr. OPPEL ST-501 # 7. Technological characteristics | Feature | Dr. OPPEL ST-501 | Aaron 900 High Frequency Desiccator/ Handpiece | Aaron Reusable Electrosurgical Electrode | Surgitron 120 IEC | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications<br>for use | Dr. OPPEL ST-501 is intended for the removal and destruction of skin legions and the coagulation of tissue. Non-sterile and reusable electrodes are used in conjunction with an electrosurgical handpiece and generator. | The Aaron 900 High Frequency Desiccator and Handpiece are intended for the removal and destruction of skin legions and the coagulation of tissue. | Aaron Reusable Electrosurgical Electrodes are non-sterile, the reusable electrosurgical electrodes, used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during surgery. | 1. Cutting - Snoring, Submucosal palatal shrinkage, etc.<br>2. Blended Cutting and Coagulation - Snoring, Submucosal palatal shrinkage, etc.<br>3. Hemostasis - Control of Bleeding, Epilation, etc.<br>4. Fulguration - Basa Cell Carcinoma, Papilloma, etc.<br>5. Bipolar - Pinpoint, Precise Coagulation, etc. | | Design<br>specification | IEC601-2-2<br>ANSI/AAMI HF-18 | IEC601-2-2<br>UL2601-1 | N/A | IEC601-2-2<br>UL544 | | Output<br>energy | 100 Watt at 200Ω | 30 Watt | N/A | 120 Watt | | Output<br>waveform | 4.0 MHz Partially rectified | 550 kHz Partially rectified | N/A | 4.0 MHz Continuous, Fully rectified, Partially rectified, 1.7MHz fulguration | | Delivery<br>system | Monopolar and Bipolar | Monopolar and Bipolar | N/A | Monopolar and Bipolar | | Tip<br>configuration | Needle<br>Blade<br>Ball<br>Loop<br>Bipolar Forceps | N/A | Needle<br>Blade<br>Ball<br>Loop<br>Bipolar Forceps | Needle<br>Blade<br>Ball<br>Loop<br>Bipolar Forceps | | Sterilization<br>method | Non-sterile | N/A | Non-sterile | Non-sterile | | Standard | IEC601-1<br>IEC601-1-2<br>IEC601-2-2<br>ANSI/AAMI HF18 | UL2601-1<br>EN60601-1-2<br>IEC601-2-2 | N/A | UL2601<br>IEC601-1<br>IEC601-2-2 | SOMETECH INCORPORATED ": い {2}------------------------------------------------ 051956 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ - 8. Similarities to, and differences from, the above predicate devices: 、 : 4 : Dr. OPPEL ST-501 is similar to the above predicate devices based on the intended use, Dr. OPPEL ST-501 1s Sinitial to the "alord" processor "processor of the mance characteristics. technology used, the claims, the material composition employed and personal wou technology used, the claims, the material composition employ and output waveform. #### 9. Conclusions : In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, FDA's In accordance with the Techar 1000, Brug and Sectrosurgical Devices" and based on the "STU(K) Guldance Document for General Surgical Slouveaught - Previous Chat Dr. information provided in this premarket notification Sometech Incorporated concludes desiress as information provided in this premarket notheation weeks. Interprises of the predicate devices as described herein. END {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA". The eagle is positioned in the center of the circle, with its head facing to the right. SEP - 8 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Sometech Incorporation c/o Mr. Marc M. Mouser Office Coordinator Underwriters Laboratories, Inc. Laboratory and Testing 2600 N.W. Lake Road Camas, Washington 98607-8542 Re: K051956 Trade/Device Name: Dr. OPPEL ST-501 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 22, 2005 Received: August 25, 2005 Dear Mr. Mouser: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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. {4}------------------------------------------------ ### Page 2- Mr. Marc M. Mouser This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely vours. Neil R. Ogden Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ 510(k) Number K _051956 Dr. OPPEL ST-501 Device Name: ::: Indication for use: Dr. OPPEL ST-501 is intended for the removal and destruction of skin legions and the coagulation of tissue. Non-sterile and reusable electrodes are used in conjunction with an electrosurgical handpiece and generator. Prescription Use AND/OR (Part 21CFR801 Subpart D) Over-The-Counter Use (21CFR801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) NilRedglen (Division Sign-Off) Sw.m.416 Division of General, Restorative. and Neurological Devices 510(k) Number K051956 .. • . ﻳﺘﻢ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ Indication for use Page # 1 of 1