(139 days)
Atherectomy of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries in patients with occlusive atherosclerotic disease.
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, 200cm, and 60cm lengths with burr diameters of 1.33mm, 1.66mm, 2.00mm, and 2.33mm.
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)
The provided document is a 510(k) summary for the Revolution™ Peripheral Atherectomy System. It describes the device, its intended use, and compares it to a predicate device (K191419). However, it does not contain any information regarding clinical studies, AI/algorithm performance, or human reader effectiveness with or without AI assistance.
The document details non-clinical performance data and testing methods used to demonstrate substantial equivalence, focusing on the physical and functional aspects of the device in simulated environments. It does not provide the kind of information requested in points 1-9, which are typically associated with AI/ML device approval studies.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance related to an AI/ML algorithm.
- Sample sizes used for a test set, or data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results or effect sizes for human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
This document pertains to the clearance of a mechanical medical device (Atherectomy System), not an AI-powered diagnostic or assistive tool.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
December 15, 2021
Rex Medical, L.P. Colin Valentis Project Leader and Senior Developement Engineer 555 East North Lane, Suite 5035 Conshohocken, Pennsylvania 19428
Re: K212351
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: November 23, 2021 Received: November 24, 2021
Dear Colin 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.
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
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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 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
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Indications for Use
510(k) Number (if known) K212351
Device Name Revolution Peripheral Atherectomy System
Indications for Use (Describe)
Atherectory of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries in patients 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/0 description: The image shows the logo for Rex Medical. The logo features the company name in bold, black lettering. A blue swoosh design wraps around the left side of the word "REX".
| Submitter: | Rex Medical, L.P.555 East North Lane, Suite 5035Conshohocken, PA 19428 |
|---|---|
| ContactPerson: | Colin ValentisProject Leader and Senior Development EngineerTel: (610) 940-6051Fax: (610) 940-1590E-mail: cvalentis@rexmedical.com |
| Date Prepared: | July 30th, 2021 |
| Trade Name: | Revolution™ Peripheral Atherectomy System |
| CommonName: | Peripheral Atherectomy Catheter |
| ClassificationName: | Intraluminal Artery Stripper (21 CFR 870.4875) |
| Product Code: | MCW |
| RegulatoryClass: | Class II |
| PredicateDevice: | K191419Revolution™ Peripheral Atherectomy SystemRex Medical, L.P. |
| DeviceDescription: | The Revolution Peripheral Atherectomy System is sterile, single-use device designedfor atherectomy of the peripheral vasculature and to break apart and remove thrombusfrom the peripheral arteries in patients with occlusive atherosclerotic disease.The Revolution device incorporates a flexible drive shaft designed to track over theRevolution guidewire. Attached to the distal end of the drive shaft is a diamond coatedspheroid shaped burr which rotates at high speed to ablate occlusive material andrestore luminal patency. Power is derived from a mains source and converted using thereusable power supply. During treatment, the rotating burr ablates material into fineparticles. This particulate is conveyed proximally by a mechanical means through thecatheter and handle into a collection receptacle that resides outside the patient. Thedevice is available in 145cm, 200cm, and 60cm lengths with burr diameters of 1.33mm,1.66mm, 2.00mm, and 2.33mm.The Revolution Peripheral Atherectomy System consists of the following components: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) |
| Indication forUse: | The Revolution Peripheral Atherectomy System is intended for atherectomy of theperipheral vasculature and to break apart and remove thrombus from the peripheralarteries in patients with occlusive atherosclerotic disease. |
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Image /page/4/Picture/0 description: The image shows the logo for Rex Medical. The logo features the text "REX MEDICAL" in a bold, sans-serif font. The word "REX" is slightly larger than "MEDICAL". A blue swoosh design wraps around the left side of the word "REX", adding a dynamic element to the logo. The overall design is clean and professional, conveying a sense of reliability and innovation.
510(k) Summa Per 21 CFR 807.
Technological The proposed Revolution Peripheral Atherectomy System is substantially equivalent to Characteristics the currently marketed Revolution Peripheral Atherectomy System (K191419). The Comparison: 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 differences between the subject and predicate device include the addition of several product codes and modifications to the construction and materials of certain components.
Changes in catheter material and drive wire construction were implemented in order to reduce the total stiffness of the system to improve performance in highly tortuous anatomy.
The additional product code offerings include a 2.33mm bit, a 200cm length, and lowprofile sheath options for the 1.66mm and 2.00mm bits which reduces the sheath compatibility to 6F.
| Description | Revolution PeripheralAtherectomy System(Predicate) | Revolution PeripheralAtherectomy System(Subject) |
|---|---|---|
| 510(k) Number | K191419 | K212351 |
| Indications for Use | Atherectomy of the peripheralvasculature and to break apartand remove thrombus fromthe peripheral arteries inpatients with occlusiveatherosclerotic disease. | Unchanged |
| Cutting Mechanism | Spheroid diamond coated burr | Unchanged |
| Device Type | Rotational | Unchanged |
| Burr Advancement | Direct-Push Type | Unchanged |
| Debris Collection | Continuous collection andremoval of excised debris viamechanical conveyance | Unchanged |
| Max. Rotational Speed | 140,000 RPM | Unchanged |
| Guidewire Exchange | Over-the-Wire | Unchanged |
| Guidewire Compatibility | 0.014" x 335cm | 0.014" x 335cm0.014" x 445cm |
| Sheath Compatibility | 4F - 7F | Unchanged |
| Catheter Working Length | 60cm145cm | 60cm145cm200cm |
| Crossing Profile | 1.33mm1.66mm2.00mm | 1.33mm1.66mm2.00mm2.33mm |
| Capital Equipment | No | Unchanged |
| Rotation Profile | Axial, Rotational | Unchanged |
| Infusion | Yes, Saline | Unchanged |
| Sterilization | Ethylene Oxide | Unchanged |
| Single-Use | Yes | Unchanged |
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Image /page/5/Picture/0 description: The image shows the logo for Rex Medical. The logo features the text "REX MEDICAL" in a bold, sans-serif font. A blue crescent shape is above and to the left of the text, adding a visual element to the logo. The overall design is clean and professional.
510(k) Summary
(Per 21 CFR 807.92)
1 CFR 807.92)
K212351
| Non-ClinicalPerformanceData: | To demonstrate the substantial equivalence of the Revolution™ Peripheral AtherectomySystem to the selected predicate device, the performance and technologicalcharacteristics will be evaluated in an anatomically correct model and under simulatedbiological conditions, when necessary, in the following tests:Dimensional Verification Testing Testing in Simulated Lesion Plaque Removal Efficiency and Embolization Analysis Fatigue Testing Tensile & Torsional Testing Stall Testing |
|---|---|
| -------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
- Heat Generation Testing
- Kink Bend Radius Testing
- Corrosion Resistance Testing .
- Flow Rate Testing ●
- Coating Integrity Testing
- Comparative Surface Assessment ●
- . Guidewire Testing
- Corrosion, Tensile, Flex, Fracture, and Fatigue O
- . Sterilization Validation
- Shelf Life
- Simulated Distribution ●
- Electrical and EMC Testing ●
- EN 60601-1 O
- o EN 60601-1-2
- Biocompatibility Testing ●
- Cytotoxicity Study Using the ISO Elution Method o
- O ASTM Hemolysis 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 Thromboresistance Study O
- Partial Thromboplastin Time O
- Heparinized Blood Platelet and Leukocyte Count o
- Conclusion: Rex Medical, L.P. considers the proposed Revolution Peripheral Atherectomy System to be substantially equivalent to the currently marketed Revolution Peripheral Atherectomy System (K191419) based on the intended use, technological characteristics, and performance testing included in this submission.
§ 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).