The CAPERE® Thrombectomy System is indicated for:
-Non-surgical removal of soft emboli and thrombi from blood vessels.
-Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel.
The CAPERE® Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.

Device Description

The CAPERE® Thrombectomy System primarily consists of an 9Fr Delivery Catheter and 12Fr Guide Catheter. The CAPERE® Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE® System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the CAPERE® Thrombectomy System, based on the provided FDA 510(k) summary:

This device is not an AI/ML device, so some of the requested information (like MRMC studies, training set details, and expert qualifications for ground truth) is not applicable or not provided in this regulatory document. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Study Type
Functional Bench Testing:		Non-Clinical Performance Testing
- Compliance with ISO 10555-1 (Sterile, single-use intravascular catheters)	Demonstrated compliance	Functional Bench Testing
- Compliance with ISO 594-2 (Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment)	Demonstrated compliance	Functional Bench Testing
- Compression resistance maintained similar to predicate	Maintained predicate characteristics	Functional Bench Testing
- Bond joints integrity maintained similar to predicate	Maintained predicate characteristics	Functional Bench Testing
- Force to retract basket into funnel catheter meets requirements (same as predicate)	Determined to meet the same retraction force requirements as the predicate	Functional Bench Testing (Simulated-use test method)
- Ability to capture and remove clot completely (same as predicate)	Determined to completely capture and remove the simulated clot and therefore maintains the characteristics of the predicate	Functional Bench Testing (Simulated-use test method)
Biocompatibility:	Unchanged from the predicate; predicate characteristics maintained	Based on predicate device's characteristics
Sterilization:	Unchanged from the predicate; predicate characteristics maintained	Based on predicate device's characteristics
Packaging:	Unchanged from the predicate; predicate characteristics maintained	Based on predicate device's characteristics
Overall Performance:	Functioned as intended under previously established test methods	Non-Clinical Performance Testing

Study Details

Sample size used for the test set and the data provenance:
- The document does not specify a "sample size" in terms of number of devices or number of tests for each specific functional bench test. It mentions "functional bench testing was conducted" and describes the types of tests.
- Data Provenance: The studies are non-clinical, in-vitro bench tests conducted to evaluate device performance against established standards and predicate device characteristics. No information on geographical origin is typically relevant or provided for this type of testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as this is a non-clinical, physical device. "Ground truth" in the context of expert review for diagnostic AI/ML is not relevant here. The acceptance criteria are based on engineering standards (ISO) and performance equivalence to a legally marketed predicate device.
Adjudication method for the test set:
- Not applicable. The tests are objective measurements against defined standards and predicate performance, rather than subjective interpretations requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This is a physical medical device (thrombectomy system), not a diagnostic AI/ML system that would involve human readers interpreting cases.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical medical device, not a software algorithm.
The type of ground truth used:
- The "ground truth" for the performance evaluation is based on engineering standards (ISO 10555-1, ISO 594-2) and the established performance characteristics of the predicate device. For clot capture, the "ground truth" is complete capture and removal of a simulated clot.
The sample size for the training set:
- Not applicable. This device does not use machine learning, so there is no training set in the sense of data used to train an algorithm.
How the ground truth for the training set was established:
- Not applicable, as there is no training set.

Summary

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July 8, 2020

Vascular Medcure, Inc. % Ms. Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, PA 19103

Re: K201216

Trade/Device Name: CAPERE® Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: June 12, 2020 Received: June 12, 2020

Dear Ms. Hogan:

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

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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 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 medical devices and radiation-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,

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) K201216

Device Name CAPERE® Thrombectomy System

Indications for Use ( Describe )
-----------------------------------------

The CAPERE® Thrombectomy System is indicated for:

-Non-surgical removal of soft emboli and thrombi from blood vessels.

-Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel.

The CAPERE® Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.

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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510(k) SUMMARY

Vascular Medcure, Inc.'s CAPERE® Thrombectomy System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Jeffrey P. DuMontelle Vascular Medcure, Inc. 1500 S. Sunkist Street, Suite H Anaheim, CA 92806 Office: 657-549-5175 714-915-0886 Cell: Date Prepared: May 28, 2020

Name of Device

CAPERE® Thrombectomy System

Common or Usual Name

Embolectomy Catheter

Classification

21 CFR 870.5150, Class II, product code QEW, KRA

Predicate Devices

CAPERE® Thrombectomy System (K192935)

Intended Use / Indications for Use

The CAPERE® Thrombectomy System is indicated for:

Non-surgical removal of soft emboli and thrombi from blood vessels. o
Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel. O

The CAPERE® Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.

Device Description

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Technological Characteristics

The CAPERE® Thrombectomy System has the same technological characteristics as its predicate device CAPERE Thrombectomy Catheter (K192935). Both CAPERE® Thrombectomy Systems have either the same components or substantially equivalent components (addition of suture support for the basket assembly). Each device system includes a guide catheter, delivery catheter, and a mechanism for capturing/removing the soft emboli or thrombi. The CAPERE® Thrombectomy System uses a 9Fr delivery catheter while the predicate uses a 6Fr delivery catheter. The CAPERE® Thrombectomy System utilizes and the predicate utilizes an 8Fr quide catheter. In addition, the CAPERE® Thrombectomy System and the predicate both use a 0.014" guidewire during the procedure.

The CAPERE® System includes a Guide Catheter and a Delivery Catheter. In the same manner as the previously cleared device, the Guide Catheter and Delivery Catheter are advanced to the therapy site. The funnel of the Guide Catheter is unsheathed, and the Delivery Catheter is then advanced passed the obstruction. A nitinol basket connected to the Delivery Catheter is deployed by retracting the outer sheath of the catheter.

To capture the soft emboli or thrombi ("clot"), the deployed basket is retracted while simultaneously being extended to surround and capture the length of the clot. The Delivery Catheter and clot-load is then retracted into the funnel of the Guide Catheter where the clot is captured and can be removed.

The basket design in the CAPERE® Thrombectomy Systems is the same (nitinol,11.4cm length) as the basket design in the predicate. The only difference between the baskets of the two systems is the addition of the suture support to the basket to aid in maintaining basket perpendicularity during basket retraction.

Therefore, the subject CAPERE® Thrombectomy System has the same technological characteristics as its predicate.

Performance Data

The following nonclinical performance testing has been conducted, using the established test methods used in the cleared predicate device, to support the substantial equivalence of the CAPERE® Thrombectomy System to its predicate device. In all instances, the CAPERE® Thrombectorny System functioned as intended under the previously established test methods.

. Functional bench testing was conducted (including demonstrated compliance with relevant standards such as ISO 10555-1 and ISO 594-2) on the compression resistance and bond joints affected by the change in diameter of the CAPERE® Thrombectomy System with respect to the predicate and demonstrated that the CAPERE® Thrombectomy System maintained the predicate characteristics. Specifically,
- The force to retract the basket into the funnel catheter was evaluated in о accordance with the same simulated-use test method used to clear the predicate and the CAPERE® was determined to meet the same retraction force requirements as the predicate.
- The ability of the CAPERE® to capture and remove clot was evaluated in the o accordance with the same simulated-use test method used to clear the predicate and the CAPERE® was determined to completely capture and

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remove the simulated clot and therefore maintains the characteristics of the predicate.

. The materials and packaging are unchanged from the predicate therefore the biocompatibility, sterilization, and packaging characteristics of the predicate were maintained.

Substantial Equivalence

The CAPERE® Thrombectomy System has the same intended use and indications for use, technological characteristics, and principles of operation as its predicate devices. Nonclinical testing, including functional testing and simulated use testing demonstrated that the minor differences between the device and predicate (i.e. addition of suture support) do not raise new types of safety or effectiveness questions. Thus, the CAPERE® Thrombectomy System is substantially equivalent to the predicate devices.

Conclusion

Vascular Medcure's CAPERE® is an Embolectomy Catheter, Class II device that has been evaluated in nonclinical testing in accordance with FDA's recognized standards and preestablished acceptance criteria. Testing demonstrated that the device performs as intended. The CAPERE® is substantially equivalent to its predicate device.

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).