ROCKET ELECTRODE

{0}------------------------------------------------ 1173 K974138 # 510(k) Summary As Required by 21 section 807.92 ( c ) A & A Medical, Inc. 1-Submitter Name: 4100 Nine McFarland Drive, suite B 2-Address: Alpharetta, GA 30004 3-Phone: (770) 343- 8400 (770) 343- 8985 4-Fax: 5-Contact Person: Jihad Mansour 6-Date summary prepared: October 31tt, 1997 7-Device Trade or Proprietary Name: Rocket Electrode 8-Device Common or usual name: Electrode (Blade, Ball, Needle, Square and Loop) Gynecologic electrocautery and accessories 9-Device Classification Name: 10-Substantial Equivalency is claimed against the following devices: *Electrodes (Blade, Ball, Needle, Square and Loop) from AARON MEDICAL INDUSTRIES #### 11-Description of the Device: This group of electrodes consists basically of a metal shaft partly insulated with two extensions connected by means of a metal wire (square and loop types). Or in case of the other types, it may be connected by blade, ball or needle. All the electrodes are supplied with different sizes ### 12-Intended use of the device: (ALSO PRINTED SEPARATELY ON FDA FORM) Each Rocket Electrode is to be used as a gynecologic electrocautery device for tissue excision. It is designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. This is to excise cervical lesions, perform biopsies, or treat chronic cervitiis under direct visual observation {1}------------------------------------------------ ## 11974138 ### 13-Safety and Effectiveness of the device: PLU) Rocket Electrode is as safe and effective as the other predicate devices cited above. This is better expressed in the tabulated comparison ( Paragraph 14 below ) ### 14-Summary comparing technological characteristics with other predicate devices: Please find below a tabulated comparison supporting that Rocket Electrode is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached P.S. Abbreviations used below: E=Equivalent, S=Similar, D=Different, N/A= Not Applicable, DES=Description available, N/I=No Information available, 510(k)Sum=510(k)Summary available, 510(k)=510(k) available, web=fda web printout enclosed | | TECHNOLOGICAL CHARACTERISTICS | | | | | | | | | | | | | | | | | | | | | |----------------------------------------------------------------------------------|-------------------------------|---------------------------------|---------------------|-------------------|--------|-----------|-------------|-----------|------------------|-------------------|-----------------|------------------|---------------|------------------------------|----------------------------------------------|------------|---------------|-------------------|----------------|------------------|--| | | FDA file reference number | Attachments inside Notification | Indications for use | Target population | Design | Materials | Performance | Sterility | Biocompatibility | Mechanical Safety | Chemical Safety | Anatomical sites | Human Factors | Energy used and/or delivered | Compatibility w/ environment & other devices | Where used | Standards met | Electrical Safety | Thermal Safety | Radiation Safety | | | Electrodes (Blade, Ball, Needle, Square<br>& Loop) from Aaron Medical Industries | k942986 | web 510k | m | m | m | m | m | m | m | m | N/A | m | m | m | m | m | m | m | m | N/A | | {2}------------------------------------------------ Image /page/2/Figure/2 description: This image is a flowchart titled "510(k) \"Substantial Equivalence\" Decision-Making Process (Overview)". The flowchart outlines the steps involved in determining whether a new device is substantially equivalent to a marketed device. The process begins with comparing the new device to a marketed device and proceeds through a series of questions about intended use, technological characteristics, and performance information. The flowchart indicates that if the new device is not substantially equivalent, additional information may be required. A more Detailed version is also available in ndf version or found directly below. {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES - USA Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 3 0 1998 Jihad Mansour A & A Medical, Inc. 4100 Nine McFarland Drive Suite B Alpharetta, GA 30004 Re: K974138 Rocket Electrode (Gynecological Electrocautery and accessories) Dated: October 31, 1997 Received: November 3, 1997 Regulatory Class: II 21 CFR 884.4120/Procode: 85 HGI Dear Mr. Mansour: 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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drog-and Eosmetic Act (Act): You may, therefore, 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, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (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 (OS) 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 Radiation Control provisions, or other Federal laws or regulations. 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 (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, h.T.Liau Yi Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ | Page | __________ of __________ | |------|--------------------------| |------|--------------------------| K914158 510(k) Number (if known): Rocket Electrode Device Name: Indications For Use: - Rocket Electrode is to be used as a gynecologic electrocautery device for tissue excision. It is designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. This is to excise cervical lesions, perform biopsies, or treat chronic cervititis under direct visual observation (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | | <div align="center"> <p>Peter R Satling</p> <p>(Division Sign-Off)</p> </div> | | |--|-------------------------------------------------------------------------------|--| |--|-------------------------------------------------------------------------------|--| Division of Reproductive, Abdominal, ENT, and Radiological Devices | 510(k) Number | K974138 | |---------------|---------| |---------------|---------| | Prescription Use | <div align="left">✓</div> | OR | Over-The-Counter Use ______ | |----------------------|---------------------------|----|-----------------------------| | (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |