Vado Steerable Sheath

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 7, 2017 Kalila Medical, Inc. Carrie Neuberger Regulatory Affairs 745 Camden Ave., Suite A Campbell CA, 95008 Re: K160721 Trade/Device Name: Vado Steerable Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: January 29, 2017 Received: January 31, 2017 Dear Carrie Neuberger: 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 mav 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 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 device-related 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. {1}------------------------------------------------ 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" (21CFR 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, Fernando Aguel Fernando Aguel -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Change Control Table, Change History ## Change Control Table | Version | Document Author | Document Approver | Date Approved | |---------|---------------------|---------------------|---------------| | 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY | Complete Change Control Table (all versions) retained in SWIFT Docs. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for Kalila Medical. The logo consists of an orange and gray abstract shape resembling two intertwined letter 'S' shapes, followed by the text "Kalila Medical" in a combination of orange and gray colors. The word "Kalila" is in orange, while "Medical" is in gray. ## Indications for Use DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page 510(k) Number (if known) K160721 Device Name Vado Steerable Sheath Indications for Use (Describe) The Vado Steerable Sheath is indicated for introducing various catheters into the vasculature and into the chambers of the heart including the left side of the heart through the interatrial septum. Type of Use (Select one or both, as applicable) Z Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The word "Kalila" is in orange, while the word "Medical" is in gray. | Section 5 | | 510(k) Summary | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------| | 510(k) Number | K160721 | | | Submitter Name and Address | | | | Name: | Kalila Medical, Inc. | | | Address: | 745 Camden Avenue, Suite A | | | | Campbell, CA 95008 | | | Telephone: | 408-637-2150 | | | Fax: | 408-370-6325 | | | Contact: | Carrie Neuberger | | | Date Prepared: | June 13, 2016 | | | General Device Information | | | | Device Name: | Vado Steerable Sheath | | | Common Name: | Catheter introducer | | | Classification: | 21 CFR 870.1340<br>A catheter introducer is a sheath used to<br>facilitate placing a catheter through the skin<br>into a vein or artery. | | | Device Class: | Class II | | | Product Code: | DYB | | | Predicate Device | | | | Manufacturer | Device Name | 510(k) Number | | Kalila Medical | Vado Steerable Sheath | K140420 | | Device Description | | | | The Vado Steerable Sheath consists of an 8.8F (ID) sheath and dilator, which is<br>designed to provide flexible catheter positioning in the cardiac anatomy. The<br>steerable introducer includes a hemostasis valve to minimize blood loss during<br>catheter exchange. A sideport with three-way stopcock is provided for aspiration,<br>fluid infusion, blood sampling and pressure monitoring. A handle equipped with a<br>deflection knob, deflects the sheath tip. The steerable introducer features distal vent<br>holes for aspiration and radiopaque markers to facilitate visualization under<br>fluoroscopy. | | | | Intended Use (Indications) | | | | The Vado Steerable Sheath is indicated for introducing various cardiovascular<br>catheters into the vasculature and into the chambers of the heart including the<br>left side of the heart through the interatrial septum. | | | | Comparison to the Predicate Device | | | | The Vado Steerable Sheath has the same intended use and fundamental<br>scientific technology as the predicate device, including biocompatibility,<br>packaging, sterilization, and labeling. Where dimensional differences exist<br>between the subject device and the predicate device, performance testing<br>demonstrates that these differences do not adversely affect safety and | | | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for Kalila Medical. The logo consists of an orange and black abstract shape resembling a stylized "S" or a winding path, followed by the words "Kalila" in orange and "Medical" in dark gray. The text is positioned to the right of the abstract shape. effectiveness. This submission supports the position the modified Vado Steerable Sheath, FG1_007, is substantially equivalent to the Vado Steerable Sheath, FG1_005 (K140420). Summary of Non-Clinical and Clinical Testing The 510(k) notice contains summaries of bench performance tests, packaging performance tests, and biocompatibility studies to evaluate the performance characteristics of the modified Vado Steerable Sheath, FG1_007. The data presented demonstrate that the modified Vado Steerable Sheath meets its functional and performance characteristics in accordance with applicable industry standards and is equivalent to the predicate device. To verify that the modified Vado Steerable Sheath met its functional and performance requirements, representative sterilized samples of the device underwent sterilization, biocompatibility, bench testing, packaging integrity, and shelf life testing. GLP Biocompatibility Tests: - 1. Cytotoxicity (MEM Elution) - 2. Sensitization (Guinea Pig Maximization Sensitization) - 3. Irritation (Intracutaneous Reactivity Irritation in Rabbits) - 4. Acute Systemic Toxicity - 5. Pyrogen (Materials Mediated in Rabbits) - 6. Hemolysis (Direct Contact) - 7. Hemolysis (Indirect Contact) Bench Performance Tests: - 1. Steerable Sheath and Dilator Visual Inspection - 2. Steerable Sheath Dimension Inspection - 3. Steerable Sheath Marker Band Location - 4. Dilator Dimensional Inspection - 5. Valve Leakage Resistance at 40kPa - 6. Leakage Resistance at 300kPa - 7. Device Preparation - 8. Dilator Snap Disengagement - 9. Dilator Insertion and Retraction - 10. Shaft Deflection - 11. Curvature Dimensions - 12. Aspiration - 13. Catheter Insertion Cycling and Flexion Cycling - 14. Bend Radius to Kink - 15. Corrosion Resistance - 16. Junction Strengths - 17. Torque and Turns to Failure {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Kalila Medical. The logo consists of an orange square with a stylized "S" shape inside, with the text "Kalila Medical" to the right of the square. The word "Kalila" is in orange, while the word "Medical" is in gray. 18. Radiopacity Packaging Integrity Tests: - 1. Pouch Seal Strength - 2. Gross Leak Detection Pre-Clinical testing is not provided in this submission. Clinical testing is not provided in this submission. The fundamental scientific technology and technological characteristics of the modified Vado Steerable Sheath are the same as the Vado Steerable Sheath (K140420) predicate device including mechanism of action, packaging, biocompatibility, sterilization, and labeling. Through bench performance testing it was demonstrated that the modified Vado Steerable Sheath is as safe, and is as effective as the predicate device, and does not raise any new questions of safety and effectiveness. Statement of Equivalence The Vado Steerable Sheath has the same indications for use and technological characteristics as the predicate device. Based on this and the data provided in this pre-market notification, the subject device and the predicate device have been shown to be substantially equivalent.