The Pounce™ Thrombus Retrieval 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 5Fr Basket Delivery Catheter, a Basket Wire Assembly and a Trumpet Assembly. The system also includes a Basket Loading Tool accessory for loading the Basket Wire Assembly into the Basket Delivery Catheter. The system contains the necessary radiopaque components to conduct the procedure and the system should be introduced through a minimum 7Fr guide sheath.

AI/ML Overview

This document describes the Surmodics Pounce™ Thrombus Retrieval System, a medical device intended for the non-surgical removal of thrombi and emboli from the arterial peripheral vasculature. The information provided is from a 510(k) summary submitted to the FDA. The following aims to extract details regarding acceptance criteria and the study proving the device meets them, based solely on the provided text.

Based on the provided FDA 510(k) summary, the Pounce™ Thrombus Retrieval System underwent various performance bench tests, packaging tests, biocompatibility tests, and an animal study to demonstrate substantial equivalence to its predicate devices. The document explicitly states that "All test results met documented acceptance criteria and/or included justification of values."

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

The document does not explicitly present a table of specific numerical acceptance criteria alongside corresponding numerical reported device performance for each test. Instead, it states that "All test results met documented acceptance criteria and/or included justification of values," indicating qualitative compliance. The tests performed are listed, implying that the device successfully met the undisclosed acceptance criteria for each.

Test Category	Specific Tests Performed	Reported Device Performance (as stated in document)
Performance Bench Testing	Liquid leak, Air leak, Visual Inspection, Simulated Use, Corrosion, Trackability, Tip pull, Burst, Tensile, Hemostasis valve lock, Particulate (Radiopacity, Visual, Dimensional), Kink, Radial force, Tip Flexibility, Flushability, Component compatibility, Hemostasis valve leak, Luer connection, Torque	"All test results met documented acceptance criteria and/or included justification of values."
Packaging Testing	Visual inspection, Seal Strength, Bubble leak, Environmental monitoring, Distribution simulation	"Packaging testing was successfully performed in accordance with ISO 11607-1" and implied acceptance criteria were met.
Biocompatibility Tests	Cytotoxicity, Sensitization, Irritation, Systemic toxicity (acute), Hemocompatibility, Pyrogenicity, Chemical characterization	"Biocompatibility tests were performed in accordance with ISO 10993-1" and implied acceptance criteria were met.
Sterilization Evaluation	Ethylene Oxide (EtO) sterilization method	"demonstrated that the Ethylene Oxide (EtO) sterilization method for the Thrombus Retrieval System meets the requirements of ISO 11135 and sterility of the system will be maintained over the entirety of the shelf life."

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

The document does not specify the sample sizes used for each of the bench tests, packaging tests, or biocompatibility tests. It also does not provide details on the data provenance for these tests, such as country of origin or whether they were retrospective or prospective.

For the animal study, it states: "The Thrombus Retrieval System device was subjected to an acute animal GLP study to evaluate and confirm the substantially equivalent performance and safety of the Pounce Thrombus Retrieval System device use within an arterial vasculature system." However, the number of animals or specific details of the study design (e.g., prospective) are not mentioned.

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)

The document makes no mention of experts being used to establish ground truth for any of the tests, nor does it specify their qualifications. The tests conducted (bench, packaging, biocompatibility) are typically objective engineering and scientific evaluations that do not rely on expert consensus for "ground truth" in the same way clinical image interpretation might. The animal study would involve veterinary professionals, but their specific roles in establishing "ground truth" are not detailed.

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

The document does not describe any adjudication methods used for the test set. This is consistent with the nature of the tests performed, which are primarily objective and do not typically involve human interpretation needing adjudication.

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 multi-reader, multi-case (MRMC) comparative effectiveness study was done. The document explicitly states: "No Clinical data is being submitted for the Thrombus Retrieval System." This device is a mechanical thrombus retrieval system, not an AI-assisted diagnostic or interpretative tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.

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

This question is not applicable as the Pounce™ Thrombus Retrieval System is a physical medical device for mechanical thrombus removal, not an algorithm or AI system. Therefore, standalone algorithm performance without human-in-the-loop is not relevant.

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

The types of "ground truth" used for the various tests are inherent to the nature of those tests:

Performance Bench Testing: Engineering specifications, material properties, and functional design requirements serve as the ground truth. For example, a "burst" test would have an acceptance criterion for the pressure it withstands, which is its engineered breaking point.
Packaging Testing: Compliance with ISO 11607-1 standards and internal design specifications for package integrity.
Biocompatibility Tests: Compliance with ISO 10993-1 series standards for biological safety, with established limits for various toxicological endpoints.
Sterilization Evaluation: Compliance with ISO 11135 standards for ethylene oxide sterilization.
Animal Testing: Physiological and histological assessments in an animal model to evaluate device performance and safety in a living system. The "ground truth" here would be the biological response and observable effects.

8. The sample size for the training set

This question is not applicable. This device is a physical medical device, not a software algorithm that requires a training set.

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

This question is not applicable as there is no training set for a physical medical device.

Summary

{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 21, 2020

Surmodics, Inc. Amy Yanta Regulatory Affairs 9924 West 74th Street Eden Prairie, Minnesota 55344

Re: K192814

Trade/Device Name: Pounce™ Thrombus Retrieval System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: August 14, 2020 Received: August 17, 2020

Dear Amy Yanta:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

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.

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K192814

Device Name Pounce™ Thrombus Retrieval System

Indications for Use (Describe)

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

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)

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

510(k) Summary - K192814

Image /page/3/Picture/4 description: The image shows the word "SURMODICS" in a sans-serif font. The letters are all capitalized and in a dark gray color. To the left of the word is a blue and green geometric shape that resembles a stylized ribbon or folded paper.

Date Prepared: September 18, 2020

Submitters Name / Contact Person

510k Submitter Address

Surmodics, Inc. 9924 W 74th St Eden Prairie MN 55344 Phone - (952) 500-7562 Fax - (952) 500-7001

Contact for Official/Routine Correspondence

Amy Yanta, Regulatory Affairs 9924 W 74th St Eden Prairie, MN 55344 Phone – (952) 500 – 7562 Fax – (952) 500-7001

General Information
Trade Name:	Pounce™ Thrombus Retrieval System
Common name:	Thrombectomy catheter
Classification name:	Embolectomy catheter
Regulation Number:	21 CFR 870.5150
Classification:	Class II
Product Code:	QEW
Review Panel:	Cardiovascular
Predicate Devices:	1. Predicate Device: NexGen Peripheral Mechanical Retrieval Device (K110315)2. Reference device: NexGen Peripheral Expandable Catheter (K102925)

Device Description

The Basket Delivery Catheter is a flexible 5Fr (distal 30 cm) catheter designed to deliver the Basket Wire Assembly to the location of the thrombus. Incorporated in the catheter is a radiopaque marker band located approximately 3 mm from the distal tip.

{4}------------------------------------------------

The Basket Wire Assembly is comprised of two distal nitinol self-expanding baskets mounted in series on a 0.026" diameter nitinol core wire for capturing thrombus. Unconstrained, both baskets are 6 mm in diameter. The core-wire is tapered on the distal end with a safety coil for atraumatic delivery. The distal capture baskets have integral radiopaque markers mounted on the basket. The Basket Wire Assembly also comes with a Basket Loading Tool for easy loading into the Basket Delivery Catheter.

The Trumpet Assembly is used for thrombus collection and retrieval. The Trumpet Assembly is made of an inner trumpet catheter and an outer trumpet delivery catheter. The two catheters work together to allow deployment and retraction of the trumpet feature. The trumpet feature is made of soft, self-expanding nitinol that has integrated radiopaque wires for enhanced visualization. Unconstrained, the nitinol trumpet is 7 mm in diameter. The two-catheter device is manipulated at the proximal end using dual Tuohy-Borst adapters.

Indications for Use/Intended Use

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

Comparison of Technological Characteristics

The Pounce™ Thrombus Retrieval System is equivalent to the legally marketed predicate and reference devices in principles of use, design, and materials. The Thrombus Retrieval System and the predicate and reference devices are both intended for non-surgical removal of thrombi and emboli from the peripheral arterial vasculature and share the same device classification.

	Pounce™ Thrombus Retrieval System	Predicate Device	Reference Device
		The NexGenMechanical RetrievalDevice (MRD)(K110315)	NexGen PeripheralExpandable Catheter(K102925)
DeviceComponent	Basket WireAssembly	TrumpetAssembly	Coil (wire assembly)	Expandable Catheter
DeploymentMechanism	Inserted into 5FCatheter	Loaded ontoproximal end ofBasket Wire	Inserted into 4F GuideCatheter	Inserted overguidewire into 8Fguide catheter
			Operator Controlled –linear actuation	Operator Controlled– linear actuation
	OperatorControlled – linearactuation	OperatorControlled –linear actuation
Material	Nitinol,Platinum/Iridium,Platinum/TungstenGuide/DeliveryCatheter: HDPE,Platinum/Iridium	Pebax, HDPE andNitinol	Stainless Steel,Polymer, Nitinol, andPlatinum Alloy	Pebax, HDPE andNitinol
	Pounce™ Thrombus Retrieval System		Predicate Device	Reference Device
			The NexGen	NexGen Peripheral
			Mechanical Retrieval	Expandable Catheter
			Device (MRD)	(K102925)
			(K110315)
GuidewireCompatibility	Guide/DeliveryCatheter: 0.035"	Uses the BasketWire fordeployment(0.26")	.035"	.035"
DeployedDiameter	Baskets: 6mm	Trumpet: 7mm	Loop Coil: 12 mm	Funnel: 5mm, 7mm,9mm, 11mm
WorkingLengths	140cm	120cm	125 cm	43cm and 116cm
Principals ofUse	Guide/DeliveryCatheter andbasket wire aredeployed distal tothe occlusion.Guide/DeliveryCatheter iswithdrawn as thebasket wire Basketsare released distalto occlusion andcapturing theembolic materialfor removal asbaskets areretracted back.	Trumpetassembly isproximally loadedonto basket wireand into guidesheath untilbeyond the tip ofguide sheath.While holding theproximal Tuohy-borst (TB) valve,the distal TB valveis retracted backto unsheathe thetrumpet.	Guide Catheter and Coilwire are deployed distalto the occlusion. Guidecatheter is withdrawnas the MRD coils arereleased distal toocclusion andenmeshing the embolicmaterial for removal ascoils are retracted back.	Expandable catheteris inserted overguidewire into theguide catheter untilflush with the guidecatheter tip.Retraction of theguide catheterdeploys theexpandable nitinolencapsulatory.
Intended Use/ Indications	The Thrombus Retrieval System isintended for the non-surgical removal ofthrombi and emboli from the arterialperipheral vasculature.		The NexGenMechanical RetrievalDevice (MRD) isindicated for theremoval ofembolic/thromboticmaterial, includingthrombus and debris,from peripheral arteriesand veins, peripheralbypass grafts, and theremoval of thrombusfrom clotted syntheticdialysis grafts andarterio-venous fistulas.	The NexGenPeripheralExpandable Catheteris indicated for thepercutaneous accessto the peripheralvascular system andis designed to assistin the placement andremoval of devices.This device is notintended for use inthe coronary orcerebral vasculature.

Surmodics Thrombus Retrieval System and Predicate(s) Comparison:

{5}------------------------------------------------

Assessment of Differences

Technological differences between the Surmodics Thrombus Retrieval System and the predicate

{6}------------------------------------------------

devices are listed below.

Device Materials: The Surmodics basket material is Nitinol while the NexGen (K110315) coil material is Stainless-Steel. The superelastic Nitinol material used for the baskets allows them to be collapsed and deployed multiple times while retaining their shape.
. Thrombi/emboli capture device Dimensions: The Surmodics basket deployment diameter is 6mm while the NexGen (K110315) loop coils have a deployed diameter of 12mm. Surmodics specifically defines the vessel size the Thrombus Retrieval System is compatible for use with.
. Configuration: The Surmodics Thrombus Retrieval System linear actuation utilizes Tuohy-Borst (TB) Valves as the user interface for the push/pull of the device components by the user. The NexGen Retrieval Device (MRD) (K110315) linear actuation utilizes a retractor handle to retract the nitinol pull wire, which actuates the coil. The TB valves enable the user to perform flushing through side ports, sealing of the components, and locking of the system components as needed during the procedure.
. Intended use/Indications: The Thrombus Retreival System and Predicate device (K11035) have similar intended use for the use of removal of emboli and thrombi in the arterial peripheral vasculature. The predicate adds additional use in viens, grafts, and fistulas.

Potential risks posed by the Thrombus Retrieval System were evaluated in a risk analysis process compliant with ISO 14971 Medical Devices – Application of Risk Management to Medical Devices. The potential hazards identified in the risk analysis, their causes, and the mitigation measures and related verification are identified in the risk documentation. The dimensional differences of the thrombi/emboli capture devices of the Thrombus Retrieval System and the NexGen predicate (K110315) are insignificant due to the different vessel sizes each has claimed compatibility with and does not change the similar functions of each. Additionally, design and packaging verification testing was completed and demonstrates the Thrombus Retrieval System meets the design requirements.

Results of the risk analysis demonstrated that following risk mitigation, the identified potential hazards are considered acceptable (low risk) in all instances.

Substantial Equivalence and Summary of Studies

The Thrombus Retrieval System is substantially equivalent to the predicate and reference devices based on intended use/indications for use, technological characteristics and principles of use. Based on the results of successful design verification testing, the Pounce Thrombus Retrieval System was shown to be substantially equivalent to the predicate device and any technological differences between the Pounce Thrombus Retrieval System and the predicate and reference devices did not raise new questions of safety or effectiveness. All test results met documented acceptance criteria and/or included justification of values. The subject device has been evaluated through the following performance bench testing:

Liquid leak
Air leak
. Visual
- Inspection
Simulated Use
Corrosion
Trackability
Tip pull ●
Burst ● Tensile
Hemostasis valve
lock ● Particulate
- Radiopacity
- Visual
- Dimensional
Kink ●
Radial force
Tip Flexibility ●
Flushability
Component compatibility ●
Hemostasis valve leak ●
Luer connection
Torque ●

{7}------------------------------------------------

Packaging testing was successfully performed in accordance with ISO 11607-1 and included:

Visual inspection
. Seal Strength
. Bubble leak
Environmental monitoring ●
Distribution simulation

Biocompatibility tests were performed in accordance with ISO 10993-1 and included:

. Cytotoxicity
Sensitization
Irritation
Systemic toxicity (acute)
Hemocompatibility
Pyrogenicity
Chemical characterization

Sterilization evaluation demonstrated that the Ethylene Oxide (EtO) sterilization method for the Thrombus Retrieval System meets the requirements of ISO 11135 and sterility of the system will be maintained over the entirety of the shelf life.

Animal Testing:

The Thrombus Retrieval System device was subjected to an acute animal GLP study to evaluate and confirm the substantially equivalent performance and safety of the Pounce Thrombus Retrieval System device use within an arterial vasculature system.

Clinical Data:

No Clinical data is being submitted for the Thrombus Retrieval System.

Conclusions:

Based upon the device indications for use, technological characteristics and performance data it can be concluded that the Thrombus Retrieval system is substantially equivalent to the predicate and reference devices and is appropriate for the indications for 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).