Pounce™ Sheath

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line. September 7, 2023 Surmodics, Inc. Peter Bather Sr. Regulatory Affairs Associate 7905 Golden Triangle Dr. Ste. 190 Eden Prairie, Minnesota 55344 # Re: K231828 Trade/Device Name: Pounce™ Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: June 21, 2023 Received: June 22, 2023 # Dear Peter Bather: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Misti E. Malone -S Misti Malone, PhD 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 Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231828 Device Name Pounce Sheath Indications for Use (Describe) The Pounce sheath is intended to introduce therapeutic devices into the vasculature. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### 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." {3}------------------------------------------------ # 510(K) Summary Date Prepared: June 21, 2023 Submitters Name / Contact Person | General Information | | |----------------------------|----------------------------------------------------------------------------------| | Trade Name: | Pounce™ Sheath | | Common / Usual Name: | Catheter Introducer | | Regulatory Classification: | Class II | | Product Code: | DYB | | Device Panel: | Cardiovascular | | Predicate Device: | Cook Performer Introducer K171999 | | Reference Device: | Inari ClotTriever Sheath (device in ClotTriever Thrombectomy<br>System) K210689. | #### Device Description The Pounce™ Sheath is a single-use, sterile introducer sheath intended for the introduction of therapeutic or diagnostic devices within the vasculature. The Pounce™ Sheath includes the following features: - . Braided nitinol, self-expanding funnel at the sheath's distal end - Handle assembly with slider button to actuate the funnel's deployment - Hub and hemostasis valve assembly to allow for device introduction and removal . - Aspiration assembly to include tubing, a stopcock, and connection for a 60 cc syringe . Additional components provided within the packaging include: - . 0.035" guidewire compatible dilator designed for atraumatic introduction of the sheath {4}------------------------------------------------ - . 60 cc locking syringe, compatible with the sheath's aspiration assembly A radiopaque marker band is located at the distal tip of the sheath during introduction and removal, when the funnel is sheathed. When the funnel is unsheathed, the radiopaque marker band is located proximally to the funnel is sheathed and unsheathed with the actuation of a slider button located on the handle assembly. The hemostasis valve can be actively defeated (opened), prior to device introduction or removal, by pressing down on the base of the surrounding hub. This action is designed to minimize device contact across the hemostatic valve during the introduction or removal of devices. The aspiration assembly also aids in the delivery of contrast or saline. #### Intended Use The Pounce™ Sheath is intended to introduce therapeutic devices into the vasculature. ### Comparison of Technological Characteristics The Pounce Sheath is similar to the legally marketed predicate device (Cook Performer Introducer, K171999) in design, indications for use, principles of use, materials, and sterility. The Pounce sheath and the predicate device are intended to introduce therapeutic or diagnostic devices into the vasculature. Differences in the principles of use and technological characteristics from the predicate device are limited to the use of the distal wire funnel feature, which is the same as the reference device (Inari ClotTriever Sheath, K210689). ### Substantial Equivalence and Summary of Studies The Pounce Sheath is substantially equivalent to the predicate device based on the indications for use, technological characteristics, and principles of use. Results of successful design verification testing demonstrate the safety and effectiveness of the Pounce Sheath and that the technological differences identified do not raise new questions of safety or effectiveness compared to the predicate device. All test results met documented acceptance criteria. The subject device has been evaluated through the following categories of testing. - Performance Bench Testing ● - Biocompatibility - Sterilization # Performance Bench Testing The Pounce Sheath has been evaluated through the following tests: - Dimensional (Working Length, ID, OD, Funnel Length) - Funnel Radial Force ● - Funnel Column Strength ● - Insertion Force - Dilator Withdrawal Force - Shaft Flexibility (Sheath and Dilator) ● - Simulated Use ● - Funnel Deployment/Retraction Force . - Funnel Sheath Lock Action/Force ● - Hemostasis Valve Leakage ● {5}------------------------------------------------ - Hemostasis Valve Defeater Action/Force ● - Aspiration Pathway ● - Kink Radius - Torque Strength ● - Tensile Strength - Syringe Connection and Connector Strength ● - Liquid Leakage ● - Air Leakage ● - Atraumatic Surfaces/Tips ● - Radiopacity - Stopcock Luer Defeatable Valve Compatibility ● - Dilator Hub Compatibility ● - Stopcock Open Force - Dilator Locking Force - Device Markings - Clean Surface ● - Corrosion Resistance ● # Biocompatibility Biocompatibility of the Pounce Sheath has been evaluated in accordance with ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and FDA Guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, Guidance for Industry and Food and Drug Administration Staff'. Per the requirements of ISO 10993-1 the Pounce Sheath is classified as an externally communicating device in contact with circulating blood for limited exposure duration. Biocompatibility tests appropriate for the device classification were selected, and testing was completed in accordance with FDA Good Laboratory Practice (GLP) regulations (21 CFR, Part 58). The following biocompatibility tests were performed in accordance with ISO 10993-1: - Cytotoxicity ● - Irritation / Intracutaneous Reactivity ● - Sensitization ● - Acute Systemic Toxicity ● - Material Mediated Pyrogenicity - Hemocompatibility ● - o ASTM Hemolysis Assay - SC5b Complement Activation Assay O - Partial Thromboplastin Time (PTT) O - Heparinized Platelet and Leukocyte Count Assay O - o In Vivo Thrombogenicity All test results met documented acceptance criteria. {6}------------------------------------------------ #### Sterilization The results of the sterilization product testing have demonstrated that the Ethylene Oxide (EtO) sterilization method for the Pounce Sheath meets the requirements of ISO 11135. ### Animal Testing No animal testing data was required for the Pounce Sheath. #### Clinical Data No clinical data was required for the Pounce Sheath. #### Conclusions Based upon the device description, intended use, technological characteristics & performance data it can be concluded that the Pounce Sheath is substantially equivalent to the predicate device.