WIRION by Cardiovascular Systems, Inc

The WIRION™ is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing atherectomy in calcified lesions of the lower extremities. The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION™ may be used with commercially available 0.014" guide wires.

Device Description

WIRION™ is a temporary Embolic Protection System (EPS), filtering distal to the intervention site. The system is a rapid exchange, pre-crimped filter that can be used with any commercially available 0.014" guide wires.

AI/ML Overview

This document is for an embolic protection system (WIRION™), a medical device, and not an AI/ML powered device. Therefore, many of the requested criteria (e.g., acceptance criteria for an AI algorithm, expert ground truth establishment, MRMC study, training/test set sample sizes, data provenance) are not applicable to this 510(k) submission.

The core of this 510(k) submission is that the WIRION™ device is identical to a previously cleared predicate device (K180023). This means the manufacturer is asserting substantial equivalence based on the device being literally the same as one already on the market, rather than needing to prove performance through new clinical or algorithm-specific studies.

Here's how to address the request based on the provided document:

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

Since this is a substantial equivalence claim based on identity to a predicate device, there are no specific performance acceptance criteria or reported performance data for this specific submission. The acceptance is predicated on the prior clearance of the identical device.

Acceptance Criteria (Not explicitly stated for new testing, but implied by identity to predicate)	Reported Device Performance (Implied by identity to predicate)
Device is identical to K180023 WIRION™	Device is identical to K180023 WIRION™ and thus is expected to perform as previously demonstrated by the predicate.
Meets Indications for Use: "contain and remove embolic material (thrombus/debris) while performing atherectomy in calcified lesions of the lower extremities... vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION™ may be used with commercially available 0.014" guide wires."	Expected to contain and remove embolic material in calcified lower extremity lesions with specified vessel and guidewire parameters, as demonstrated by the predicate device.

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

Not Applicable. No new test set or data provenance details are provided because the device is stated to be identical to a previously cleared predicate.

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. No ground truth establishment by experts for a test set was required for this submission.

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

Not Applicable. No adjudication method for a test set was required for this submission.

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. This is not an AI/ML device, and no MRMC comparative effectiveness study was performed or required.

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

Not Applicable. This is not an algorithm, so no standalone performance evaluation was done.

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

Not Applicable. No new ground truth types were used or established for this submission, as it relies on the predicate device's prior clearance. The previous clearance would have relied on data and performance demonstrations appropriate for a mechanical medical device, likely including preclinical testing and/or clinical data that established safety and effectiveness.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device, so there is no "training set."

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

Not Applicable. No ground truth for a "training set" was established.

Summary

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March 18, 2020

Cardiovascular Systems, Inc. Erika Huffman Regulatory Affairs Manager 1225 Old Hwy 8 NW Saint Paul, Minnesota 55112

Re: K200198

Trade/Device Name: WIRION™M Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: January 24, 2020 Received: January 27, 2020

Dear Erika Huffman:

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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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,

Finn Donaldson 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) K200198

Device Name WIRIONTM

Indications for Use (Describe)

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

Submitter:	Cardiovascular Systems, Inc.1225 Old Highway 8 NWSaint Paul, MN 55112
Contact Person:	Erika Huffman, MS, RACRegulatory Affairs ManagerCardiovascular Systems, Inc.1225 Old Highway 8 NWSt. Paul, MN 55112Ph: 651-259-1608ehuffman@csi360.com
Date Prepared:	January 24, 2020
Trade Name:	WIRIONTM
Common Name:	Embolic Protection System
Regulation Number:	870.1250, Percutaneous Catheter
Classification:	Class II
Product Code:	NTE
Predicate Device(s):	K180023 - WIRION™ (Gardia Medical Ltd.)
Device Description:	WIRION™ is a temporary Embolic Protection System (EPS),filtering distal to the intervention site. The system is a rapidexchange, pre-crimped filter that can be used with anycommercially available 0.014" guide wires.
Indications for Use:	The WIRION™ is indicated for use as an embolic protectionsystem to contain and remove embolic material(thrombus/debris) while performing atherectomy in calcifiedlesions of the lower extremities. The diameter of the vessel atthe site of filter basket placement should be between 3.5mm to6.0mm. WIRION™ may be used with commercially available0.014" guide wires.
Comparison toPredicate Device:	The proposed device is identical to the predicate device.
Functional andSafety Testing:	No new functional or safety testing was conducted or deemednecessary since the device is identical to the predicate device.
Conclusion:	No new questions of safety or effectiveness were identifiedcompared to the predicate device and the device should performas intended under the specified use conditions.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).