COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115

{0}------------------------------------------------ # JAN 2 8 2000 # 510(k) Summary of Safety and Effectiveness This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is: K993700 # Applicant Information: Date Prepared: January 17, 2000 Name: Address: Broncus Technologies, Inc. 1400 N. Shoreline Boulevard Building A. Suite 8 Mountain View, CA 94043 Contact Person: Phone Number: Fax Number: John D'Angelo (650) 428-1600 ext. 312 (650) 428-1542 ## Device Information: | Classification | Class II | |----------------------|----------------------------------------------| | Trade Name: | Broncus™ Coagulation Electrode System | | Classification Name: | Bronchoscope and Accessories 21 CFR 874.4680 | # Equivalent Devices: The subject device is substantially equivalent in intended use and/or method of operation to the following predicate devices: | Broncus Technologies, Inc. | Broncus™ Bronchial Catheter System | |----------------------------|------------------------------------| | Olympus America Inc. | Coagulation Electrode | | Valleylab, Inc. | Force 2 Electrosurgical Generator | ## Description: The Broncus Coagulation Electrode System consists of a catheter, a RF generator, and a commercially available patient return electrode. The RF generator produces RF power in a monopolar mode. The catheter delivers RF energy to the desired target site and relays temperature and other feedback to the RF generator. The patient return electrode is used to complete the return path for the electrical current. ## Intended Use: The Broncus Coagulation Electrode System is intended for coagulation or hemostasis in the tracheobronchial tree. {1}------------------------------------------------ # 510(k) Summary of Safety and Effectiveness, continued ## Comparison to Predicate Devices: The Broncus Coagulation Electrode System is substantially equivalent in intended use and/or method of operation to the named predicate devices. #### Non-Clinical Test Results: #### Performance The Coagulation Electrode System has undergone and passed functional and electrical testing designed to assess the performance of the catheter and the RF generator. #### Biocompatibility The materials used in the Coagulation Electrode have proven biocompatibility. # Summary of Substantial Equivalence: Based on the intended use and the product performance information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three human profiles facing to the right. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 8 2000 Mr. John D'Angelo President and CEO Broncus Technologies, Inc. 1400 N. Shoreline Blvd. Building A, Suite 8 Mountain View, CA 94043 Re: K993900 Trade Name: Coagulation Electrode, Model 2000; Radiofrequency Generator Regulatory Class: Class II Product Code: 874.4680, 77EOQ and 878.4400, 79GEI Dated: November 15, 1999 Received: November 16, 1999 Dear Mr. D'Angelo: 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 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 (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 requirements, 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. {3}------------------------------------------------ Page 2 -- Mr. John D'Angelo · 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 questions on the promotion 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, A Roerl Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K493900 Device Name: Broncus™ Coagulation Electrode System Indications for Use: The Broncus™ Coagulation Electrode System is intended for coagulation or hemostasis in the tracheobronchial tree. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over- The Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Karen A. Bohr (Division Sign-Off) (Division Sign-Off) Division of Ophthalmic Devices 510(k) Number 2493470