The Revolution Peripheral Atherectomy System is intended for atherectomy of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries with occlusive atherosclerotic disease.

Device Description

The Revolution Peripheral Atherectomy System is sterile, single-use device designed for atherectomy of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries in patients with occlusive atherosclerotic disease.

The Revolution device incorporates a flexible drive shaft designed to track over the Revolution guidewire. Attached to the distal end of the drive shaft is a diamond coated spheroid shaped burr which rotates at high speed to ablate occlusive material and restore luminal patency. Power is derived from a mains source and converted using the reusable power supply. During treatment, the rotating burr ablates material into fine particles. This particulate is conveyed proximally by a mechanical means through the catheter and handle into a collection receptacle that resides outside the patient. The device is available in 145cm and 60cm lengths with burr diameters of 1.33mm, 1.66mm, and 2.00mm.

The Revolution Peripheral Atherectomy System consists of the following components:

Single-use Revolution Device (provided sterile)
Single-use Revolution .014" Guidewire (provided sterile)
Single-use infusion assembly (provided sterile)
Single-use collection receptacle (provided sterile)
Single-use guidewire clip (provided sterile)
Reusable power supply (provided non-sterile)

AI/ML Overview

This document describes the Revolution™ Peripheral Atherectomy System, a medical device. The information provided outlines the acceptance criteria and the study conducted to prove the device meets these criteria.

Here's the breakdown as requested, based on the provided text:

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

The document provides primary safety and effectiveness endpoints with predefined success criteria, which can be interpreted as acceptance criteria.

Acceptance Criteria (Primary Endpoints)	Reported Device Performance
Safety: Freedom from 30-day Major Adverse Events (MAE)	97.3% (110/113) freedom from MAE
(MAE defined as composite of all-cause mortality, clinically-driven TLR, major target limb amputation, target vessel perforation requiring endovascular or surgical repair, and clinically significant distal embolization in the target limb)
Effectiveness: Technical success (≤50% diameter residual stenosis after atherectomy, prior to adjunctive therapy)	90.2% (111/123) technical success

Comment: The document explicitly states, "Both primary endpoints met the predefined IDE study success criteria."

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:
- Total Patients Enrolled: 121
- Evaluated for 30-day Primary Safety Endpoint (ITT population): 113 patients
- Evaluated for Primary Effectiveness Endpoint (PP population): 123 lesions (from 121 enrolled subjects)
Data Provenance:
- Country of Origin: U.S. (17 U.S. centers)
- Study Design: Prospective, multi-center, non-randomized, single-arm study (REVEAL clinical study).

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 mentions two independent groups involved in establishing ground truth for the clinical study:

Independent Clinical Events Committee (CEC): Adjudicated the primary safety endpoint (MAE). The number of experts is not specified, nor are their exact qualifications, but they are identified as an "independent" committee.
Independent Angiographic Core Laboratory: Evaluated residual stenosis for the primary effectiveness endpoint. The number of experts is not specified, nor are their exact qualifications, but they are identified as an "independent" core lab.

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

Safety Endpoint: "adjudicated by the independent Clinical Events Committee (CEC)." The specific voting mechanism (e.g., 2+1) is not provided.
Effectiveness Endpoint: "evaluated by an independent Angiographic Core Laboratory." This implies a systematic evaluation, but the specific adjudication method (e.g., multiple readers, consensus) is not detailed.

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

There is no indication that an MRMC comparative effectiveness study involving human readers with and without AI assistance was conducted or reported in this document. This study is for a medical device (atherectomy system), not an AI algorithm for diagnostic reading.

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

This question is not applicable. The device is a physical atherectomy system used in a procedure, not a diagnostic algorithm. Therefore, "standalone" performance in the context of an algorithm does not apply. The performance evaluated is the device's ability to achieve clinical outcomes (safety and effectiveness) when used by a human operator.

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

The ground truth for the clinical study was established through a combination of:

Adjudicated Clinical Outcomes Data: For the safety endpoint (MAE), adjudicated by an independent Clinical Events Committee.
Core Lab Measurements/Expert Interpretation of Imaging: For the effectiveness endpoint (residual stenosis), evaluated by an independent Angiographic Core Laboratory based on angiographic measurements.

8. The sample size for the training set

The document describes a clinical study to evaluate safety and effectiveness. It does not mention a training set in the context of machine learning or AI. This is a clinical trial for a physical medical device.

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

As there is no mention of a training set or AI model in the provided text, this question is not applicable.

Summary

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September 12, 2019

Rex Medical, L.P. Mr. Colin Valentis Project Leader and Senior Development Engineer 555 East North Lane, Suite 5035 Conshohocken, Pennsylvania 19428

Re: K191419

Trade/Device Name: Revolution Peripheral Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: August 8. 2019 Received: August 12, 2019

Dear Mr. Valentis:

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.

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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 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 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) K191419

Device Name

Revolution Peripheral Atherectomy System

Indications for Use (Describe)

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

(Per 21 CFR 807.92)

Submitter:	Rex Medical, L.P.555 East North Lane, Suite 5035Conshohocken, PA 19428
Contact Person:	Colin ValentisProject Leader and Senior Development EngineerTel: (610) 940-6051Fax: (610) 940-1590E-mail: cvalentis@rexmedical.com
Date Prepared:	May 24th, 2019
Trade Name:	Revolution™ Peripheral Atherectomy System
Common Name:	Peripheral Atherectomy Catheter
Classification Name:	Intraluminal Artery Stripper (21 CFR 870.4875)
Product Code:	MCW
Regulatory Class:	Class II
Predicate Device:	K901206Rotablator Rotational Atherectomy SystemHeart Technologies (Acquired by Boston Scientific)
Reference Device:	K082664Pathway Medical Jetstream SystemPathway Medical Technologies (Acquired by Boston Scientific)
Device Description:	The Revolution Peripheral Atherectomy System is sterile, single-use devicedesigned for atherectomy of the peripheral vasculature and to break apart andremove thrombus from the peripheral arteries in patients with occlusiveatherosclerotic disease.
	The Revolution device incorporates a flexible drive shaft designed to track overthe Revolution guidewire. Attached to the distal end of the drive shaft is adiamond coated spheroid shaped burr which rotates at high speed to ablateocclusive material and restore luminal patency. Power is derived from a mainssource and converted using the reusable power supply. During treatment, therotating burr ablates material into fine particles. This particulate is conveyedproximally by a mechanical means through the catheter and handle into acollection receptacle that resides outside the patient. The device is available in145cm and 60cm lengths with burr diameters of 1.33mm, 1.66mm, and2.00mm.
	The Revolution Peripheral Atherectomy System consists of the followingcomponents:1. Single-use Revolution Device (provided sterile)2. Single-use Revolution .014" Guidewire (provided sterile)3. Single-use infusion assembly (provided sterile)4. Single-use collection receptacle (provided sterile)5. Single-use guidewire clip (provided sterile)6. Reusable power supply (provided non-sterile)

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Indication for Use: The Revolution Peripheral Atherectomy System is intended for atherectomy of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries in patients with occlusive atherosclerotic disease.
Non-Clinical To demonstrate the substantial equivalence of the Revolution™ Peripheral Performance Data: Atherectomy System to the selected predicate devices, the performance and technological characteristics will be evaluated in an anatomically correct model and under simulated biological conditions when necessary in the following tests:
Dimensional Verification Testing ●
. Comparative Predicate Testing in Simulated Lesion
Comparative Predicate Testing in Thrombus ●
Debris Removal and Collection Testing ●
Tensile & Torsional Testing ●
Stall Torque Testing ●
Luminal Gain Testing ●
Heat Generation Testing ●
Infusion and Aspiration Assembly Leak Testing
Kink Resistance and Maximum Kink Radius
Fatigue Testing ●
o Sheath Compatibility Testing
Sheath Flow Rate Testing ●
o Motor Controller Software Testing
Catheter Trackability in Below-the-Knee Anatomy
Motor Control Board Testing ●
Rotational Speed Testing ●
Bit Coating Integrity Testing ●
Tip Robustness Testing ●
Guidewire Testing ●
- Corrosion, Tensile, Flex, Fracture, Fatigue, and Coating Integrity O
o Sterilization Validation
Packaging and Shelf Life ●
o Electrical and EMC Testing
- EN 60601-1 O
- EN 60601-1-2 o
Biocompatibility Testing ●
- Cytotoxicity Study Using the ISO Elution Method o
- o ASTM Hemolvsis Study
- USP Rabbit Pyrogen Study, Material Mediated O
- ISO Systemic Toxicity Study in Mice o
- ISO Intracutaneous Study in Rabbits o
- ISO Maximization Sensitization Study Extract O
- C3a Complement Activation Assay o
- SC5b-9 Complement Activation Assay O
- In vivo thrombogenicity Study O
- Non-Clinical Testing

●

Ovine study with acute and chronic (30-day) in-vivo comparison o to the predicate Rotablator Rotational Atherectomy System using comparable sizes

Clinical Summary: The REVEAL clinical study was a prospective, multi-center, non-randomized, single-arm study to evaluate the safety and effectiveness of the Revolution™ Peripheral Atherectomy System in the treatment of infrainguinal lower extremity peripheral arterial occlusive disease.

A total of 121 patients were enrolled in the REVEAL study across 17 U.S. centers. The treated population consisted of subjects with symptomatic PAD with target lesions present in the superficial femoral, popliteal and tibial arteries who met all eligibility criteria. The primary disease had to be located in

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reference vessel diameters of ≥2.0mm - ≤4.0 mm, not exceed 15cm in length, and have a ≥70% stenosis as measured by site-reported angiography.

The primary safety endpoint was evaluated in the Intent-to-Treat (ITT) population by assessing freedom from 30-day Major Adverse Events (MAE), defined as the composite of all-cause mortality, clinically-driven target lesion revascularization (TLR), major target limb amputation, target vessel perforation requiring endovascular or surqical repair, and clinically significant distal embolization in the target limb; as adjudicated by the independent Clinical Events Committee (CEC).

The primary effectiveness endpoint was assessed by technical success in the Per-Protocol (PP) population, defined as ≤50% diameter residual stenosis after atherectomy with the Revolution Peripheral Atherectomy System, prior to adjunctive therapy as evaluated by an independent Angiographic Core Laboratory.

Among the 121 enrolled subjects, the 30-day primary safety endpoint was evaluable in 113. The 30-day freedom from MAE rate was 97.3% (110/113) and technical success was achieved in 90.2% (111/123) of the lesions treated in the PP group with evaluable core laboratory measurements. Both primary endpoints met the predefined IDE study success criteria.

Secondary outcome measures were also favorable. Through 30 days, freedom from significant distal embolization was 98.2% (111/113), freedom from arterial perforation was 99.1% (112/113), and there were no deaths, CD-TLRs, or major amputations. The two distal embolizations were CEC-adjudicated as being procedure related, not device related.

Procedural success (<30% stenosis) at the conclusion of atherectomy and adjunctive therapy was achieved in 119/127 or 93.7% of PP lesions and 129/139 or 92.8% of ITT lesions with evaluable core laboratory post-adjunctive procedure angiographic measurements.

The proposed Revolution Peripheral Atherectomy System is substantially Technological equivalent to the currently marketed Rotablator Rotational Atherectornv Characteristics: System (K901206) and Pathway Medical Jetstream System (K082664). The subject and predicate devices share the following technological characteristics:

. Intended Use
Fundamental Cutting Mechanism
Fundamental Scientific Technology ●
Principles of Operation ●
. Conditions of Use
Sterilization Method

The Revolution Peripheral Atherectomy System uses a mechanical means of convevance to remove residual debris from the patient whereas the Jetstream systems uses an electronic pump. The Rotablator does not aspirate. Other differences include: working length, distal burr diameter, rotational speed, power source (pneumatic vs. electronic), sheath compatibility, and minimum vessel size for device use.

Conclusion: Rex Medical, L.P. considers the proposed Revolution Peripheral Atherectorny System to be substantially equivalent to the currently marketed Rotablator Rotational Atherectomy System (K901206) and Pathway Medical Jetstream System (K082664) based on the intended use, technological characteristics, safety and performance testing included in this submission.

Regulation Number and Section

§ 870.4875 Intraluminal artery stripper.

(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).