Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire

K191419 · Rex Medical, L.P. · MCW · Sep 12, 2019 · Cardiovascular

Device Facts

• Record ID: K191419
• Device Name: Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire
• Applicant: Rex Medical, L.P.
• Product Code: MCW · Cardiovascular
• Decision Date: Sep 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Indications 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 with occlusive atherosclerotic disease.

Device Story

System consists of sterile, single-use catheter with diamond-coated spheroid burr at distal end of flexible drive shaft; reusable power supply; infusion assembly; collection receptacle. Operated by physician in clinical setting. Device tracks over .014" guidewire; burr rotates at high speed to ablate occlusive material/thrombus into fine particles. Particulate conveyed proximally via mechanical means through catheter/handle into external collection receptacle. Restores luminal patency. Output is visual angiographic confirmation of vessel patency. Benefits include removal of obstructive material, restoration of blood flow, and reduction of stenosis in peripheral arteries.

Clinical Evidence

REVEAL study: prospective, multi-center, non-randomized, single-arm study (n=121). Evaluated safety/effectiveness in infrainguinal peripheral arterial occlusive disease. Primary safety endpoint: 30-day freedom from Major Adverse Events (MAE) was 97.3% (110/113). Primary effectiveness endpoint: technical success (≤50% residual stenosis) was 90.2% (111/123). Secondary outcomes: 98.2% freedom from distal embolization, 99.1% freedom from arterial perforation. Procedural success (<30% stenosis) was 93.7% (PP) and 92.8% (ITT).

Technological Characteristics

Diamond-coated spheroid burr; flexible drive shaft. Available in 145cm/60cm lengths; 1.33mm, 1.66mm, 2.00mm diameters. Mains-powered reusable supply. Mechanical debris conveyance. Sterilization: sterile single-use components. Electrical safety: EN 60601-1, EN 60601-1-2. Biocompatibility: ISO 10993 standards (cytotoxicity, hemolysis, systemic toxicity, intracutaneous, sensitization, complement activation, thrombogenicity).

Indications for Use

Indicated for atherectomy of peripheral vasculature and removal of thrombus from peripheral arteries in patients with occlusive atherosclerotic disease.

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• Rotablator Rotational Atherectomy System (K901206)

Reference Devices

• Pathway Medical Jetstream System (K082664)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X 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/1 description: The image shows the logo for Rex Medical. The logo features the text "REX MEDICAL" in a bold, sans-serif font. A blue, curved graphic element is placed to the left of the text, partially encircling the "R" in "REX."

510(k) Summary

(Per 21 CFR 807.92)

| Submitter: | Rex Medical, L.P.<br>555 East North Lane, Suite 5035<br>Conshohocken, PA 19428 | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Colin Valentis<br>Project Leader and Senior Development Engineer<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | |
| 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: | K901206<br>Rotablator Rotational Atherectomy System<br>Heart Technologies (Acquired by Boston Scientific) | |
| Reference Device: | K082664<br>Pathway Medical Jetstream System<br>Pathway Medical Technologies (Acquired by Boston Scientific) | |
| Device Description: | The Revolution Peripheral Atherectomy System is sterile, single-use device<br>designed for atherectomy of the peripheral vasculature and to break apart and<br>remove thrombus from the peripheral arteries in patients with occlusive<br>atherosclerotic disease. | |
| | The Revolution device incorporates a flexible drive shaft designed to track over<br>the Revolution guidewire. Attached to the distal end of the drive shaft is a<br>diamond coated spheroid shaped burr which rotates at high speed to ablate<br>occlusive material and restore luminal patency. Power is derived from a mains<br>source and converted using the reusable power supply. During treatment, the<br>rotating burr ablates material into fine particles. This particulate is conveyed<br>proximally by a mechanical means through the catheter and handle into a<br>collection receptacle that resides outside the patient. The device is available in<br>145cm and 60cm lengths with burr diameters of 1.33mm, 1.66mm, and<br>2.00mm. | |
| | The Revolution Peripheral Atherectomy System consists of the following<br>components:<br>1. Single-use Revolution Device (provided sterile)<br>2. Single-use Revolution .014" Guidewire (provided sterile)<br>3. Single-use infusion assembly (provided sterile)<br>4. Single-use collection receptacle (provided sterile)<br>5. Single-use guidewire clip (provided sterile)<br>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.