The Surmodics Pounce™ Thrombectomy System is a percutaneous catheter system designed to facilitate mechanical thrombus removal in the peripheral arterial vasculature. The system is comprised of three separate components: a Delivery Catheter, a Basket Wire, the Funnel Catheter, and cleaning tool accessories. The system contains radiopaque components to conduct the procedure and is intended to be introduced through appropriately sized guide sheath.

The Delivery Catheter is flexible and designed to deliver the Basket Wire to the location of the thrombus. Incorporated in the catheter is a radiopaque marker band located at the distal tip.

The Basket Wire is comprised of two distal self-expanding baskets mounted a core wire for capturing thrombus. The distal capture baskets have integral radiopaque markers mounted on the struts of the basket for basket visibility under fluoroscopy.

The Funnel Catheter is used for thrombus collection and retrieval in conjunction with the Basket Wire. The Funnel Catheter is comprised of an inner funnel catheter and an outer delivery catheter. The two catheters work together to allow unsheathing of the funnel using the slider button on the integrated handle.

AI/ML Overview

The provided document describes the Pounce™ Thrombectomy System, specifically the Pounce LP Thrombectomy System, for which Surmodics Inc. sought 510(k) clearance (K231022). This submission is for modifications to an existing predicate device (Pounce™ Thrombectomy System, K220501) to extend its use to smaller vessels.

The document explicitly states: "No clinical studies were required for the Pounce Thrombectomy System."

Therefore, the following information regarding acceptance criteria, device performance, and study details is not available in the provided text, as the clearance was based on bench testing and a determination of substantial equivalence to a predicate device, rather than a clinical study demonstrating performance against specific acceptance criteria.

However, based on the provided information, we can infer some aspects relevant to a hypothetical acceptance criteria and the type of study conducted (bench testing) to support the device's substantial equivalence.

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

Since no clinical study was performed and the clearance was based on substantial equivalence to a predicate, there isn't a table of clinical acceptance criteria and device performance in the traditional sense for this submission. The "acceptance criteria" here would be the successful completion of various bench tests demonstrating that the modified device performs similarly to the predicate and meets engineering specifications.

Acceptance Criteria (Implied from bench tests)	Reported Device Performance (Summary)
Dimensional specifications met	Testing demonstrated conformity to design specifications.
Adequate Radial Force	Testing demonstrated sufficient radial force.
Sufficient Tensile Strength	Testing demonstrated sufficient tensile strength.
Resistance to Kink	Testing demonstrated resistance to kinking.
Air and Liquid Leak integrity	Testing demonstrated no air or liquid leaks.
Basket Wire Fatigue resistance	Testing demonstrated adequate fatigue resistance for the basket wire.
Atrumatic Surfaces maintained	Testing confirmed smooth, atraumatic surfaces.
Simulated Use functionality	Testing showed proper function during simulated use.
Adequate Removal Force	Testing demonstrated appropriate removal force.
Sufficient Radiopacity	Testing confirmed clear visibility under fluoroscopy.
Luer Compatibility	Testing confirmed compatibility with Luer fittings.
Ancillary Device Compatibility	Testing confirmed compatibility with ancillary devices.
Adequate Torque Strength	Testing demonstrated sufficient torque strength.
Rated Burst Pressure resistance	Testing demonstrated resistance to rated burst pressure.
Coating Integrity maintained	Testing confirmed integrity of device coating.
Sterile Packaging/Distribution integrity	Testing confirmed packaging and distribution effectiveness in maintaining sterility.
Biocompatibility	Biocompatibility testing confirmed material safety and compatibility.

Study that proves the device meets the acceptance criteria:

The study that "proves the device meets the acceptance criteria" in this context is the Performance Bench Testing listed on page 5 of the document. These tests evaluated mechanical properties, device functionality, material integrity, and compatibility with the intended use environment.

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: The document does not specify the sample sizes used for each of the bench tests.
Data Provenance: Not applicable. These were bench tests, not clinical data from patients. They would have been conducted within Surmodics Inc. (an American company) or contracted labs.
Retrospective or Prospective: Not applicable, as these were non-clinical, controlled bench tests.

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. For bench testing, "ground truth" is typically established by engineering specifications, validated test methods, and industry standards, rather than expert clinical consensus.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical trial endpoints or image interpretation where human judgment is involved. Bench tests rely on objective measurements and established pass/fail criteria.

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

Not applicable. No clinical studies were required or performed for this submission. The device is a mechanical thrombectomy system, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI improvement.

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

Not applicable. The device is a mechanical thrombectomy system, not an algorithm.

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

Not applicable for the bench testing. The "ground truth" for each bench test was defined by the specified engineering requirements and performance parameters that the device was designed to meet, often in accordance with ISO or ASTM standards.

8. The sample size for the training set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.

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

Not applicable. See point 8.

Summary

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June 12, 2023

Surmodics Inc. Holly Ramirez Senior Staff Regulatory Affairs Specialist 7905 Golden Triangle Drive Suite 190 Eden Prairie, Minnesota 55344

Re: K231022

Trade/Device Name: Pounce™ Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: April 10, 2023 Received: April 10, 2023

Dear Holly Ramirez:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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,

Ariel G. Ash- Digitally signed by
shakoor -S Ariel G. Ash-shakoor -S
Date: 2023.06.12
17:03:14 -04'00'

For

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

Enclosure

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Indications for Use

510(k) Number (if known) K231022

Device Name Pounce™ Thrombectomy System

Indications for Use (Describe)

The Pounce Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.

The Pounce LP Thrombectomy System is indicated for use in vessels ranging from 2 mm in diameter.

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)

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Image /page/3/Picture/0 description: The image contains the word "SURMODICS" in a bold, sans-serif font. To the left of the word is a stylized logo. The logo is a geometric shape with two overlapping sections, one in a darker blue and the other in a lighter teal color.

510(k) Summary

Date Prepared: 10 April 2023

Submitters Name/Contact Person

510K Submitter and Contact for Routine Correspondence

Holly Ramirez Senior Staff Regulatory Affairs Specialist 7905 Golden Triangle Dr. Ste. 190 Eden Prairie, MN 88344 Phone (952)-500-7545 Email: hramirez@surmodics.com

510k Submitter Establishment Registration Number

3014687026

General Information
Trade Name:	Pounce™ LP Thrombectomy System
Common / Usual Name:	Thrombectomy Catheter
Classification Name	Embolectomy Catheter
Regulation/Product Code	21 CFR 870.5150
Device Panel	Cardiovascular
Regulatory Classification:	Class II
Product Code:	QEW
Predicate Device:	Pounce™ Thrombectomy System (K220501)

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Image /page/4/Picture/0 description: The image shows the logo for Surmodics. The logo consists of a stylized blue and green icon to the left of the company name, "SURMODICS," which is written in a simple, sans-serif font. The icon appears to be an abstract representation of folded or layered shapes, with the blue color dominating and a touch of green at the bottom. The overall design is clean and modern.

Device Description

The Delivery Catheter is flexible and designed to deliver the Basket Wire to the location of the thrombus. Incorporated in the catheter is a radiopaque marker band located at the distal tip.

Indication for Use

The Pounce™ Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.

The Pounce LP Thrombectomy System is indicated for use in vessels ranging from 2 mm to 4 mm in diameter.

Comparison of Technological Characteristics

The Pounce LP Thrombectomy System is substantially equivalent to the previous Pounce Thrombectomy System (K220501) in design, intended use, principles of use, biocompatibility, sterility, and labeling. Changes to the predicate device that have led to the submission of this new 510(k) are to extend the product line to include the use in vessels ranging from 2 mm. The smaller basket wire and catheter size has been verified through performance bench and biocompatibility testing and determined to be substantially equivalent.

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Image /page/5/Picture/0 description: The image shows the logo for Surmodics. The logo consists of a blue and green abstract shape on the left, followed by the word "SURMODICS" in a dark gray sans-serif font. The abstract shape appears to be a stylized ribbon or folded paper design, with the blue portion on top and the green portion underneath.

Performance Bench Testing

Results of design verification and biocompatibility testing demonstrates that the technological and material differences identified do not raise new questions of safety or effectiveness compared to the predicate device. The Pounce LP Thrombectomy System has been evaluated through the following tests:

-Dimensional
Radial Force -
-Tensile Strength
-Kink
-Air and Liquid Leak
Basket Wire Fatigue -
-Atraumatic Surfaces
-Simulated Use
Removal Force -
-Radiopacity
-Luer Compatibility
Ancillary Device Compatibility -
Torque Strength -
-Rated Burst Pressure
-Coating Integrity
Packaging/Distribution -
-Biocompatibility

Clinical Studies and Testing

No clinical studies were required for the Pounce Thrombectomy System.

Conclusion

Based on the device description, materials, technological characteristics, and accompanying performance and biocompatibility data it can be concluded that the device modifications made to the Pounce LP Thrombectomy System are substantially equivalent to the predicate device and the device will continue to function per its intended use.

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).