ROTAPRO Rotational Atherectomy System

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September 6, 2022 Boston Scientific Corporation Heather Schuchard Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311 ## Re: K220962 Trade/Device Name: ROTAPRO Rotational Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: Class II Product Code: MCW Dated: March 31, 2022 Received: April 1, 2022 ## Dear Heather Schuchard: 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 {1}------------------------------------------------ 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 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220962 Device Name ROTAPRO Rotational Atherectomy System Indications for Use (Describe) The Peripheral ROTAPRO is intended for percutaneous use in the peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for endovascular procedures. | 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary Per 21 CFR §807.92 | Submitter's Name<br>and Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 | | | | |---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------| | Contact Name and<br>Information | Heather Schuchard<br>Senior Regulatory Affairs Specialist<br>Phone: 763.494.1706<br>Fax: 763.494.2981<br>e-mail: Heather.Schuchard@bsci.com | | | | | Date Prepared | 31 March 2022 | | | | | Proprietary Name | Peripheral ROTAPRO™ Rotational Atherectomy System | | | | | Common Name | Rotational Atherectomy System | | | | | Product Code | MCW – Catheter, Peripheral, Atherectomy | | | | | Classification | Class II, 21 CFR Part 870.4875 – Intraluminal Artery Stripper | | | | | Predicate Device | K133566 -- Rotablator™ Rotational Atherectomy System with<br>Peripheral RotaLink Plus™ | | | | | Reference Devices | P900056 ROTAPRO Rotational Atherectomy System | | | | | Device Description | The Peripheral ROTAPRO Rotational Atherectomy System consists of<br>an Advancer pre-connected to a Catheter. The advancer functions as<br>a guide for the sliding elements that control burr advancement and the<br>catheter portion of the device guides the burr through the vasculature<br>to the treatment site. The Peripheral ROTAPRO devices are provided<br>sterile and non-pyrogenic unless the package has been opened or<br>damaged. It is intended for one procedure use only. | | | | | Intended Use of<br>Device | The Peripheral ROTAPRO is intended to ablate occlusive material and<br>restore luminal patency in the peripheral vasculature. | | | | | Indications for Use | The Peripheral ROTAPRO is intended for percutaneous use in<br>peripheral vessels in patients with occlusive atherosclerotic disease<br>who are acceptable candidates for endovascular procedures. | | | | | Comparison of<br>Technological<br>Characteristics | The Peripheral ROTAPRO Rotational Atherectomy System is<br>substantially equivalent to the Rotablator Rotational Atherectomy<br>System (predicate device) and identical to the IC ROTAPRO<br>Rotational Atherectomy System (reference device). | | | | | | | | | | | | Characteristic | Peripheral<br>ROTAPRO™<br>Rotational<br>Atherectomy<br>System<br>(Subject) | Rotablator™<br>Rotational<br>Atherectomy<br>System with<br>Peripheral<br>RotaLink Plus™ | Interventional<br>Cardiology<br>ROTAPRO<br>(Reference Device) | | | System<br>(Subject) | Peripheral<br>RotaLink Plus™<br>(Predicate) | | |-------------------|--------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------------------------------------------------------------| | Product Code | MCW | MCW | N/A-Interventional<br>Cardiology<br>ROTAPRO product<br>code is for<br>cardiovascular<br>device | | Class | II | II | III | | Device Regulation | 21 CFR Part<br>870.4875 –<br>Intraluminal Artery<br>Stripper | 21 CFR Part<br>870.4875 –<br>Intraluminal Artery<br>Stripper | N/A-Device<br>regulation not<br>applicable for Class<br>III devices. | {4}------------------------------------------------ | Indications for Use | The Peripheral<br>ROTAPRO is<br>intended for | The Rotablator<br>Rotational<br>Atherectomy System<br>is intended | Percutaneous<br>rotational coronary<br>atherectomy with the<br>ROTAPRO<br>Rotational<br>Atherectomy<br>System, as a sole<br>therapy or with<br>adjunctive<br>percutaneous<br>coronary intervention<br>(PCI) is indicated in | | | | | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|------|------|------| | | percutaneous use in<br>peripheral vessels in<br>patients with<br>occlusive<br>atherosclerotic<br>disease who are<br>acceptable<br>candidates for<br>endovascular<br>procedures. | for percutaneous use<br>in the peripheral<br>vessels in patients<br>with occlusive<br>atherosclerotic<br>disease who are<br>acceptable<br>candidates for<br>endovascular<br>procedures. | patients with calcific<br>coronary artery<br>disease who meet<br>one of the following<br>selection criteria:<br>•Singlevesselatheros<br>cleroticcoronaryarter<br>ydiseasewithastenos<br>isthatcanbepassed<br>with a guidewire;<br>•Multiplevesselcoron<br>aryarterydiseasethati<br>nthephysician'sjudg<br>mentdoesnotpose<br>undue risk to the<br>patient;<br>•Patients who have<br>had prior PCI, and<br>who have native<br>coronary artery post-<br>balloon angioplasty<br>restenosis; or,<br>•Native vessel<br>atherosclerotic<br>coronary artery<br>disease that is less<br>than 25 mm in<br>length. | | | | | | Mechanism of<br>Operation | The ROTAPRO<br>Console delivers<br>pneumatic output to<br>the Advancer gas<br>turbine, enabling<br>rotation of the burr.<br>The Console<br>provides controls for<br>and monitors the<br>rotational speed of<br>the burr and displays<br>the operator and<br>procedural<br>information. The<br>diamond boated burr<br>ablates plaque and<br>calcium into fine<br>particles that are<br>disposed of by the<br>body's<br>reticuloendothelial<br>system while leaving<br>healthy tissue<br>unharmed. | Same | Same | | | | | | Single Use<br>Catheter/Burr | Yes | Yes | Yes | | | | | | Catheter<br>Length/Catheter<br>Sheath OD | Rotational Profile | 135 cm/1.4mm | Brass/Diamonds | Same | Same | Same | Same | {5}------------------------------------------------ | | Burr Rotation<br>Mechanism | Rotation Cutting<br>Pneumatically<br>activated turbine | Same | Same | |------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|-------------------------------|------------------------------------------| | | Advancer/Catheter/<br>Burr Sterilization<br>Method | EO | Same | Same | | | Mode Selection and<br>Burr Control | Advancer Button | Foot Petal | Advancer Button | | | Console Control | Software Logic | Analog Circuit Logic | Software Logic | | | Console Design | LED Display with<br>Sleek Housing | Display with Metal<br>Housing | LED Display with<br>Sleek Housing | | | Advancer<br>Electrical/Gas Line<br>Connection | Streamlined<br>Gas/Electrical<br>Harness | No Electrical<br>Gas Line | Streamlined<br>Gas/Electrical<br>Harness | | | New Accessories | ROTAGO Cart and<br>IV Stand | None | ROTAPRO Cart and<br>IV Stand | | Performance Data | To demonstrate substantial equivalence and adherence to applicable<br>standards and guidance the following bench testing was performed:<br>● Anatomically Relevant Simulated Use (Functional Life,<br>System Speed, Steady State Stall Torque, Dynamic Stall<br>Torque, and Transient Response)<br>● EMC Testing: EN 60601-1-2<br>All other testing was leveraged from the FDA approved reference<br>device.<br>The patient contacting (direct and indirect) materials of the proposed<br>Peripheral ROTAPRO device are identical to the currently marketed IC<br>ROTAPRO device (P900056/S166) and predicate Peripheral<br>Rotablator Advancer (K133566) in formulation, processing,<br>sterilization, and geometry. No other chemicals have been added<br>(e.g., plasticizers, fillers, additives, cleaning agents, mold release<br>agents). | | | | | Conclusion | Based on the indications for use, technological characteristics, safety<br>and performance testing, the Peripheral ROTAPRO Rotational<br>Atherectomy System has shown to be appropriate for its intended use<br>and is considered to be substantially equivalent to the Rotablator<br>Rotational Atherectomy System with Peripheral RotaLink Plus<br>(K133566) | | | |