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
. 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.

AI/ML Overview

The provided text is a 510(k) summary for the Pounce™ Sheath, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study proving a device meets specific acceptance criteria in the context of an AI/ML algorithm or a complex diagnostic device.

Therefore, the information required to answer questions 1-9 is largely not present in this document. The 510(k) process for a device like the Pounce™ Sheath (a catheter introducer) relies heavily on bench testing (performance, biocompatibility, sterilization) to show that a new device is as safe and effective as a legally marketed predicate device. It does not involve the types of studies typically conducted for AI/ML algorithms, such as MRMC studies, expert ground truthing, or large-scale clinical trials (unless specifically mandated for a higher risk classification or novel technology).

Here's a breakdown based on the provided text, and where the requested information is absent:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document generically states, "All test results met documented acceptance criteria." It does not provide the specific numerical acceptance criteria for each bench test (e.g., minimum tensile strength, maximum insertion force).
Reported Device Performance: Similarly, it states, "The subject device has been evaluated through the following categories of testing... All test results met documented acceptance criteria." However, the actual performance values are not reported. For example, it lists "Funnel Radial Force" as a test but doesn't provide the measured radial force.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for any of the bench tests.
Data Provenance: Not applicable in the context of bench testing for a physical device. Data is generated in a lab setting, not from patient populations.
Retrospective/Prospective: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is not an AI/ML algorithm or a diagnostic tool that requires expert interpretation for ground truth establishment. Bench testing relies on engineering specifications and physical measurements, not expert human assessment of images or clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No human interpretation or adjudication is involved in the bench testing described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is a physical medical device (catheter introducer), not an AI algorithm for diagnostic imaging. Therefore, no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an algorithm. Bench tests evaluate the physical performance of the device itself.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Engineering Specifications/Physical Standards: For bench tests, the "ground truth" or reference is typically defined by engineering design specifications, industry standards (e.g., ISO for biocompatibility and sterilization), and regulatory requirements. It is a measurement against a predefined acceptable range, not a "diagnosis."

8. The sample size for the training set

Not applicable. This device does not use a training set as it's not an AI/ML algorithm or a data-driven model.

9. How the ground truth for the training set was established

Not applicable. As above, no training set is used.

Summary regarding the device and its studies:

The document states:

"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 studies performed were:

Performance Bench Testing: A long list of physical and mechanical tests (e.g., Dimensional, Funnel Radial Force, Insertion Force, Hemostasis Valve Leakage, Radiopacity, Torque Strength).
Biocompatibility: Tests performed according to ISO 10993-1, including Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility (ASTM Hemolysis Assay, SC5b Complement Activation Assay, Partial Thromboplastin Time (PTT), Heparinized Platelet and Leukocyte Count Assay, In Vivo Thrombogenicity).
Sterilization: Demonstrated compliance with ISO 11135.

Crucially, the document explicitly states:

"No animal testing data was required for the Pounce Sheath."
"No clinical data was required for the Pounce Sheath."

This indicates that the FDA deemed the bench testing sufficient to establish substantial equivalence given the nature of the device and its predicate.

Summary

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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

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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

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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)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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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 ThrombectomySystem) K210689.

Device Description

. 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

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. 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 ●

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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.

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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.

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).