YIELD MINI DOPPLER SYSTEM

{0}------------------------------------------------ K090743 Page 1 of 2 # Appendix A: 510(k) SUMMARY 1. Date of Summary March 2, 2009 APR - 3 2009 ## 2. 510(k) Applicant Broncus Technologies, Inc. 1400 N. Shoreline Blvd., Bldg. A, Suite 8 Mountain View, California 94043 Phone: (650) 428-1600 FAX: (650) 428-1542 | Contact Person: | Nancy Isaac | |-----------------|-------------------------| | Phone: | (650) 428-1600 ext. 305 | | Fax: | (650) 428-1542 | | e-mail: | nisaac@broncus.com | #### 3. Device Overview | Trade Name: | Yield™ Mini Doppler System | |----------------------|---------------------------------------------------------| | Common Name: | Doppler Probe and Processing Unit | | Classification Name: | Radiology Device<br>21 CFR 892.1550<br>Product Code IYN | #### 4. Predicate Device The predicate devices identified for the Yield Mini Doppler Probe are as follows: | Trade Name | 510(k) Submitter | 510(k) Number | |--------------------------------------------------------------------------------------------------|---------------------------------|---------------------------------------------------| | Exhale Doppler System | Broncus<br>Technologies, Inc | K010649, cleared to market<br>on March 20, 2001 | | P.D. Access Percutaneous<br>Doppler Vascular Device<br>and P.D. Access Dual<br>Frequency Monitor | Cardiovascular<br>Dynamics, Inc | K973713, cleared to market<br>on January 23, 1998 | # 5. Device Description This premarket notification covers Broncus' Yield Mini Doppler System, which comprises the Yield Mini Doppler Probe and Broncus Monitor. The Mini Doppler System will enable {1}------------------------------------------------ the bronchoscopist to identify vessel-free areas prior to performing transbronchial procedures such as needle aspiration or biopsy. #### 6. Intended Use The Yield Tissue Mini Doppler Probe with Broncus Monitor is intended for use through a bronchoscope to detect blood flow behind the airway wall in the tracheobronchial tree. ## 7. Comparison to Predicate Device The Yield Mini Doppler System is substantially equivalent to the predicates. The Mini Doppler System has the same intended use, methods of introduction, method of operation and design features. Furthermore, all materials were tested for biocompatibility per ISO10993, Biological Evaluation of Medical Devices. ## 8. Performance Data Performance testing of the Yield Mini Doppler System included mechanical, thermal and electrical safety testing. These tests demonstrate that all items tested were within specification tolerances. There were no failures during the testing. ## 9. Safety and Effectiveness The Yield Mini Doppler Probe and Broncus Monitor labeling contain instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device. The biocompatibility assessment was performed in accordance with ISO10993, Biological Evaluation of Medical Devices. In addition, the device will be sterilized using e-beam sterilization. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present. The image is simple and straightforward. 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, with flowing lines beneath them. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Broncus Technologies, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313 Re: K090743 Trade/Device Name: Yield™ Mini Doppler System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN and ITX Dated: March 19, 2009 Received: March 20, 2009 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 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. APR - 3 2009 This determination of substantial equivalence applies to the following transducers intended for use with the Yield™ Mini Doppler System, as described in your premarket notification: Transducer Model Number Yield Mini Doppler Probe 11781 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. {3}------------------------------------------------ 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. 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 predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html If vou have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666. Sincerely yours, Jules Reiner Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health #### Enclosure(s) ()() {4}------------------------------------------------ # Indications for Use Statement K 090743 510(k) Number: Device Name: Yield™ Mini Doppler System Indications for Use: The Yield Mini Doppler Probe with Broncus® Monitor is intended for use through a bronchoscope to detect blood flow behind airway walls in the tracheobronchial tree. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-CounterUse (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) [signature] (Division Sign Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _ Page of {5}------------------------------------------------ K090743 | | Ultrasound Indications for Use Form | | | | | | | | |--------------------------------|------------------------------------------------------------------------------------|---|---|-------------------|-----|------------------|-----------------------|---------------------| | System: | Yield Mini Doppler System | | | | | | | | | Transducer: | Yield Mini Doppler Probe 11781 | | | | | | | | | Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | Clinical Application | | | | Mode of Operation | | | | | | General<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal<br>Imaging<br>&<br>Other | Fetal | | | | | | | | | | Abdominal | | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (Specify) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal<br>(Conventional) | | | | | | | | | | Musculo-skeletal<br>(Superficial) | | | | | | | | | | Intravascular | | | | | | | | | | Other (Specify) | | | | Nº | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | | Other (Specify) | | | | | | | | N4: Intraluminal ultrasound for the tracheobronchial tree. N = new Indication; P = previously cleared by FDA; E = added under this appendix D "Examples of other modes of operation may include, Andritude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Moton Doppler, and Color Velocity Imaging Dopplar, and Color Velocity Imaging (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Prescription Use) (per 21 CFR 801.109) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number K090743 Page . of