TRELLIS-8 PERIPHERAL INFUSION SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration." November 22, 2021 Bacchus Vascular, Inc. Maureen Bensing Manager, RA & QA 3110 Coronado Dr. Santa Clara, California 95054 Re: K050147 Trade/Device Name: Trellis-8 Peripheral Infusion System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA Dear Maureen Bensing: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 3. 2005. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell(@FDA.HHS.gov. Sincerely, Gregory W Digitally signed by Gregory W. O'connell -S O'connell -S Pate: 2021.11.22 Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB - 3 2005 Ms. Maureen Bensing Manager, Regulatory Affairs and Quality Assurance Bacchus Vascular, Inc. 3110 Coronado Drive Santa Clara, CA 95054 K050147 Re: Trade/Device Name: Trellis-8 Peripheral Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: January 21, 2005 Received: January 24, 2005 Dear Ms. Bensing: 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 I ou mayy arons 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 (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 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 {2}------------------------------------------------ Page 2 - Ms. Maureen Bensing forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFF 1000-1050. product radiation control provisions (Sections 531-542 of the Actil; ad in rever Section S product radiation control provisions (Decisions on device as described in your Section 510(k) I his letter will anow you to begin manxoning your antial equivalence of your device to a legally premarket notification. The PDA miding of basification 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), please If you desire specific advice for your act 101) 594-4648. Also, please note the regulation entitled, contact the Office of Compulation at (501) 597 - 10 - (21CFR Part 807.97). You may obtain "Misbranding by reference to premation inclinear notifical viring the Act from the Division of Small other general Information on your responsible and its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistance at its toll-free number (800) 67 Manufacturers, International and Octobern 11/2018 11:52 PM www.fda.gov/cdrh/dsmamain.html Sincerely yours, Duina P. Vichener (A Bram D. Zuckerman, M.D. Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: Indications for Use: This application Ko50i47 Trellis-8 Peripheral Infusion System The Trellis™-8 Peripheral Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. Prescription Use X (Per 21 CFR 801.109) Over-The-Counter Use_ (Optional Format 1-2-96) ### PLEASE DO NOT WRITE BELOW THIS LINE -(CONTINUE ON ANOTHER PAGE IF NEEDED) ## Concurrence of CDRH, Office of Device Evaluation (ODE) Diana R. Victurner OR Division Sign-Off) Civision of Cardiovascular Devices 510(k) Number K050147 Confidential {4}------------------------------------------------ # 510(k) Summary FEB - 3 2005 Date Prepared January 21, 2005 General Information | Class | Class II | |------------|-----------------------------------------------------------------------------------------------------------------| | Trade Name | TrellisTM-8 Peripheral Infusion System | | Submitter | Bacchus Vascular, Inc<br>3110 Coronado Drive<br>Santa Clara, CA 95054<br>Tel: 408-980-8300<br>Fax: 408-980-8383 | | Contact | Maureen Bensing<br>Manager, Regulatory Affairs and Quality Assurance | #### Intended Use The Trellis™-8 Peripheral Infusion System is intended for controlled and selective infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature. #### Predicate Device Trellis Reserve Infusion System K032261 - -Bacchus Vascular, Inc #### Device Description The Trellis-8 Peripheral Infusion System enables the physician to isolate a treatment region, infuse a physician-specified fluid, and disperse the fluid by means of oscillation of a Dispersion Wire. The Isolation/Infusion component is a multi-lumen catheter with two compliant balloons at the distal end and infusion holes located between these balloons. The device also has a central through-lumen that is compatible with a 0.035" guidewire. The Dispersion Wire provides oscillation when activated. The Dispersion Wire is connected to an integral Oscillation Drive Unit that oscillates the Dispersion Wire within the isolated region to further disperse the infused fluid. If desired by the physician, post procedure aspiration of the isolated area between the occluding balloons may be accomplished through the catheter by using the guidewire lumen. #### Materials All materials used in the manufacture of the Trellis-8 Peripheral Infusion System are suitable for this use and have been used in numerous previously cleared products. #### Testing Summary The Trellis-8 Peripheral Infusion System was tested in the same manner as the Trellis Reserve. All components, subassemblies, and/or full devices met the required specifications for the completed tests. The Trellis-8 Peripheral Infusion System was designed under Bacchus Vascular Quality System which is in compliance with 21CFR. #### Summary of Substantial Equivalence The Trellis-8 Peripheral Infusion System is equivalent to the predicate product, the Trellis Reserve Infusion System. The indications for use, function, methods of manufacturing, and materials used are substantially equivalent. Bacchus Vascular, Inc believes the Trellis-8 Peripheral Infusion System is substantially equivalent to existing legally marketed devices.