EXHALE PROBE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the words "Kol 3111" in a bold, handwritten-like font. Below this, the words "Exhale™Probe" are printed in a clear, sans-serif font. The "TM" is a superscript, indicating a trademark. # OCT - 1 2001 # APPENDIX A. 510(k) SUMMARY This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. ## Name\Address: Broncus Technologies, Inc. 1400 N. Shoreline Boulevard, Building A, Suite 8 Mountain View, CA 94043 #### Telephone Number: (650) 428-1600 ### Fax Number: (650) 428-1542 ## Contact Person: Timothy R. Williams Director, Regulatory and Clinical Affairs Date Summary was Prepared: June 29, 2001 Trade Name: Exhale Probe Classification Number and Name: Class II, 21 CFR 892.1560, Ultrasound Pulsed Echo Imaging System Class II, 21 CFR 892.1570, Diagnostic Ultrasound Transducer Class II 21 CFR 874.4680, Bronchoscope & Accessories ## Device Description: The Exhale Probe is a multi-function catheter that provides: (1) Doppler audio output in the presence of pulmonary vessel blood-flow; and (2) radiofrequency (RF) energy to a target site within the upper airway or tracheobronchial tree. The probe is inserted into through the 2 mm working channel of a standard bronchoscope and connects to the Exhale Doppler Processing Unit and a standard, commercially available, electrocautery radiofrequency generator. {1}------------------------------------------------ ## Broncus Technologies. Inc. 6013111 Exhale™Probe #### Substantial Equivalence: The Exhale Probe is substantially equivalent to the Exhale Doppler Probe (K010649) and the Exhale RF Probe (K011267). with respect to intended use, method of introduction, method of operation, safety, and materials. #### Safety: The Exhale Probe consisting of a multi-function catheter contains a coagulation electrode and an ultrasonic transducer and is designed to comply with International Standard IEC 60601-1. The Exhale Probe will meet the requirements of the FDA's 510(k) Diagnostic Ultrasound Guidance for 1997 for a Track 1 device. #### Non-Clinical Test Results: #### Biocompatibility The materials used in the Exhale RF Probe have proven biocompatibility. # Summary of Substantial Equivalence: Based on the intended use and product performance information provided in this notification, the subject device has been shown to be substantially equivalent to the 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT = 1 2001 Broncus Technologies, Inc. C/O Mark Job TÜV Product Services 1775 Old Highway 8 New Brighton, MN 55412-1891 Re: K013111 Trade Name: Exhale Probe Regulation Number: 21 CFR 874.4680; 21 CFR 892.1570; 21 CFR 892.1560 Regulation Name: Bronchoscope and Accessory; Diagnostic Ultrasound Transducer; Ultrasound Pulsed Echo Imaging System Regulatory Class: Class II Product Code: EOQ; ITX; IYO Dated: September 17, 2001 Received: September 18, 2001 Dear Mr. Job: We have reviewed your Section 510(k) premarket 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 Amerodments, 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. This determination of substantial equivalence applies to the Model BT 1440 transducer intended for use with the Exhale Probe Catheter, as described in your premarket notification. 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 {3}------------------------------------------------ Page 2 - Mr. Mark Job 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 CI I rat 0077; mooning (21 CFR Part 820); and if applicable, the electronic form in the qualis (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050. This determination of substantial equivalence is granted on the condition that prior to shipping This device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers In Appendix O, (chelosod) of the Semies tic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded. The special report should reference the manufacturer's 510(k) number. It should be clearly and rne special report of the FILE" and should be submitted in duplicate to: > Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nontication. THE PDF Imaning of tastion for your device and thus permits your device to proceed to market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please If you desire specific at no issess at (301) 594-4591. Additionally, for questions on the comact the Office of Compilance at (301) 29 + + + > > = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = promotion and advertising or gulation entitled, "Misbranding by reference to premarket 4059. Also, please note the regations on ther general information on your responsibilities under the notification (21 CFR Par 80777). Only Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". {4}------------------------------------------------ Page 3 - Mr. Mark Job If you have any questions regarding the content of this letter, please contact Karen Baker MSN, RN at (301) 594-2080. Sincerely yours, David M. Whipple A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosures {5}------------------------------------------------ | Broncus Technologies, Inc. | | | | |----------------------------|--|--|--| |----------------------------|--|--|--| | 510(k) Number (if known): | K 013111 | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | The Exhale Probe | | Indications for Use: | The <i>Exhale Probe</i> is intended for blood-flow detection and electrosurgery procedures (i.e. coagulation/cauterization, hemostasis, etc.) in the upper airways and tracheobronchial tree through a bronchoscope. | # (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__________________________________________________________________________________________________________________________________________________________ Sonola (Division Sign-Off) Division of Ophthalmic Devices nor 3111 510(k) Number_ CONFIDENTIAL