PulmoVia Working Channel

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 11, 2015 Sanovas, Inc. c/o Cynthia Nolte, Ph.D., RAC Senior Director of Regulatory Affairs ICON Clinical Research LLC 62 Forest Street, Suite 300 Marlborough, MA 01752 Re: K150280 Trade/Device Name: PulmoVia Working Channel Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) Regulatory Class: Class II Product Code: EOO Dated: April 22, 2015 Received: April 22, 2015 Dear Dr. Nolte: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {1}------------------------------------------------ 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K150280 Device Name PulmoVia Working Channel ## Indications for Use (Describe) The Pulmo Via Working Channel is intended to be used as an access channel through which a bronchoscope and other endoscopic tools may be introduced to treat targeted tissue of the airways. The Pulmo Via Working Chamel can also provide means for bronchoalveolar lavage. The PulmoVia Working Channel is indicated for adult patients. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301)-443-6740 B {3}------------------------------------------------ #### ട്. 510(K) SUMMARY # Sanovas, Inc. PulmoVia Working Channel (per 21CFR 807.92 and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm) #### 1. SUBMITTER/510(K) HOLDER | Sanovas, Inc. | |-----------------------------------------------------| | 2597 Kerner Blvd | | San Rafael, CA 94901 | | Phone: 415-729-9391 | | Contact: Roy Morgan, VP of Research and Development | | Contact's Phone: 415-729-9391 | | Contact's Email: regulatory@sanovas.com | | Date Prepared: June 10, 2015 | #### 2. DEVICE NAME | Trade Name: | PulmoVia Working Channel | |----------------------------|--------------------------------------------------| | Classification Name: | Bronchoscope (flexible or rigid) and accessories | | Classification Panel: | Ear, Nose, and Throat Devices Panel | | Classification Regulation: | 21 CFR 874.4680 | | Device Classification: | Class II | | Product Code: | EOQ | #### 3. PREDICATE DEVICES - LungPoint™ Tools (LungPoint Sheath and LungPoint Dilation Balloon), K131234 ● - KimVent BAL Cath Bronchial Aspirate Sampling Catheter, K112562 ● - Olympus Guide Sheath, K060243 ● #### DEVICE DESCRIPTION 4. The PulmoVia Working Channel is a single-use disposable, terminally-sterilized device for transtracheal access to bronchi of the lungs, and consists of a hollow tube with an angled flexible tip to assist in anatomical navigation. A radiopaque marker is located 4 mm from the distal tip to aid in localization under fluoroscopy/CT. Printed markings are positioned at 370 mm from the distal tip, and every 50 mm proximally from that point. The distal tip of the device has a pliable leading edge. The device also contains a disposable Tuohy-Borst adaptor to allow use of third-party devices such as ultrathin bronchoscopes. The full assembly will be packaged in a polyethylene and Tyvek pouch, sterilized via ethylene oxide (EO). {4}------------------------------------------------ #### 5. INDICATION FOR USE/INTENDED USE The PulmoVia Working Channel is intended to be used as an access channel through which a bronchoscope and other endoscopic tools may be introduced to treat targeted tissue of the airways. The PulmoVia Working Channel can also provide means for bronchoalyeolar lavage. The PulmoVia Working Channel is indicated for adult patients. ### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE 6. DEVICES Both the proposed PulmoVia Working Channel and the predicate Lung Point Sheath are catheters designed for use with a bronchoscope to reach a targeted area of the bronchial tree. The working length of the PulmoVia Working Channel (485 mm) is less than that of the predicate Lung Point Sheath and reference devices. The inner diameter of the catheter (5.25 mm) is greater than that of the Lung Point and Olympus Guide Sheath. The inner diameter was established in order to be compatible with bronchoscopes with an OD of 4.0 mm. The predicate Lung Point Sheath is supplied with a stylet. Neither the proposed PulmoVia Working Channel nor the reference device Olympus Guide Sheath are supplied with a stylet. The proposed PulmoVia Working Channel has an angled, flexible tip to aid in navigation of the PulmoVia Working Channel within the lung. The BAL Cath tip is also designed with a flexible tip. The materials used for the proposed device are provided in the side-by-side comparison table. Like the predicate devices, the PulmoVia Working Channel sheath and connector are composed of polymers. As will be discussed in Section 7, the PulmoVia Working Channel meets the biocompatibility requirements of ISO 10993-1:2009 for the nature and duration of contact. ### SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL 7. EQUIVALENCE Non-clinical performance testing consisted of sterility, shelf-life, packaging validation, transport, biocompatibility and mechanical bench testing which demonstrated that the device met all mechanical design and safety requirements. The biocompatibility testing included: - . Cytotoxicity (ISO 10993-5:2009, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity) {5}------------------------------------------------ - Irritation/ Intracutaneous (ISO 10993-10:2010, Biological Evaluation Of Medical ● Devices - Part 10: Tests For Irritation And Skin Sensitization) - Sensitization (ISO 10993-10:2010, Biological Evaluation Of Medical Devices Part . 10: Tests For Irritation And Skin Sensitization) - Acute systemic toxicity (ISO 10993-11:2006, Biological Evaluation Of Medical . Devices - Part 11: Tests For Systemic Toxicity) - . Pyrogenicity (ISO 10993-11:2006 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity) The mechanical testing included: (Side by side testing indicated by an asterisk *) - . Pull test* - Torque test* - Kink test* ● - . Bend test* - . Leak test* - Vacuum test* - Operating temperature/humidity test* ● - Radiopaque test ● - Gravity fed hydrostatic flow test* ● #### SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE 8. No clinical studies were performed using the PulmoVia Working Channel. Usability assessments were conducted in a simulated use environment to optimize the safety of the device design and validate the usability of the device. The results demonstrated that users can operate the PulmoVia Working Channel safely and effectively. #### SUMMARY OF OTHER INFORMATION 9. No other information is available. ## 10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS Non-clinical testing confirms that the PulmoVia Working Channel is sterile, has a packaging system adequate to maintain sterility and transportation hazards, and a validated shelf life. The PulmoVia Working Channel is biocompatible and side by side testing confirms that the proposed device has equivalent physical and mechanical characteristics to the identified predicates. Human factors testing confirms that users can operate the PulmoVia Working Channel safely and effectively. {6}------------------------------------------------ The similarities in intended use, operational characteristics, functional technological characteristics and conclusions drawn from nonclinical testing between the proposed PulmoVia Working Channel and the predicate LungPoint Sheath and KimVent BAL Cath lead to a conclusion of substantial equivalence between the proposed and predicate devices. A side-by-side comparison of the predicate devices and the proposed device is provided in the table at the end of this section. | | PulmoVia™ | LungPoint™ Tools | Olympus Guide<br>Sheath | BAL Cath* | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Working Channel<br>(Proposed) | K131234<br>(Predicate) | K060243<br>(Reference) | K112562<br>(Reference) | | Indication for Use | The PulmoVia<br>Working Channel is<br>intended to be used<br>as an access channel<br>through which a<br>bronchoscope and<br>other endoscopic<br>tools may be<br>introduced to treat<br>targeted tissue of<br>the airways. The<br>PulmoVia Working<br>Channel can also<br>provide means for<br>bronchoalveolar<br>lavage. The<br>PulmoVia Working<br>Channel is indicated<br>for adult patients. | The LungPoint<br>Sheath is intended<br>to be used as a<br>working channel<br>through which<br>endoscopic tools<br>may be introduced<br>to targeted tissue.<br>Not for pediatric<br>use. | The instrument has<br>been designed to be<br>used with Olympus<br>bronchoscopes,<br>endo-therapy<br>accessories or<br>ultrasound probe to<br>the targeted area<br>within the<br>respiratory organs. | The BAL Cath is<br>used in the<br>diagnosis of diffuse<br>lung disease by<br>allowing collection<br>of bronchoalveolar<br>lavage (BAL)<br>specimens from<br>deep within the<br>lung. The use of a<br>bronchoscope is not<br>necessary. This<br>catheter is used in<br>adult intubated<br>patients. | | Single Use | Single use | Single use | Single use | Single use | | Sterile | Yes (Ethylene<br>oxide) | Yes (E-beam) | Yes | Yes | | Catheter Working<br>Length | 485 mm | 900 mm | 1050 mm | Not known | | Catheter Internal<br>Diameter (ID) | 5.25 mm | 2.0 mm | 2.1 mm | 4 mm | | Maximum Catheter<br>Outer Diameter<br>(OD) | 6.0 mm | 2.65 mm | 2.7 mm | 5.2 mm | | Bronchoscope<br>Compatibility | Max OD: 4.0 mm<br>Min Working<br>Length: 600 mm | Not known | Not known | Not used with a<br>bronchoscope | | Catheter Length | 495 mm | 975 mm | 900 mm | Not known | | Tuohy-Borst<br>Adaptor | Yes | No | Not known | Not known | | Stylet | No | Yes | No | No | | Distal Tip | Angled, flexible | Not known | Not pliable | Flexible, directional | | Radiopaque | Yes | Yes | Yes | Yes | | Feature<br>Markers | PulmoViaTM<br>Working Channel<br>(Proposed) | LungPointTM Tools<br>K131234<br>(Predicate) | Olympus Guide<br>Sheath<br>K060243<br>(Reference) | BAL Cath*<br>K112562<br>(Reference) | | Materials | Extrusion:<br>Tecothane and<br>Pebax<br>Marker Band:<br>Platinum-Iridium<br>Hub: Polycarbonate<br>Tuohy Borst<br>Connector:<br>Polycarbonate with<br>silicone gasket | Extrusion: Not<br>known^<br>Marker band: Not<br>known^ | Extrusion:<br>Polymer^<br>Marker band:<br>Radio-opaque metal<br>Accessory Port:<br>Polymer^<br>Tri-Channel<br>Connector:<br>Polymer^ | Extrusion:<br>Polymer^<br>Marker band: Not<br>known^<br>Collar: Polymer^ | ## Side-by-Side Comparison of the PulmoVia™ Working Channel with the LungPoint™ Tools and Reference Devices {7}------------------------------------------------ *BAL Cath: Kimberly-Clark KimVent BAL Cath Bronchial Aspirate Sampling Catheter ^Material composition is not known