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.

Device Description

The Peripheral ROTAPRO Rotational Atherectomy System consists of an Advancer pre-connected to a Catheter. The advancer functions as a guide for the sliding elements that control burr advancement and the catheter portion of the device guides the burr through the vasculature to the treatment site. The Peripheral ROTAPRO devices are provided sterile and non-pyrogenic unless the package has been opened or damaged. It is intended for one procedure use only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "ROTAPRO Rotational Atherectomy System," a medical device, and not an AI/ML software or a diagnostic device. Therefore, the acceptance criteria and study details requested in the prompt, such as those related to AI/ML performance, sample sizes for test/training sets, ground truth establishment, expert consensus, and MRMC studies, are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device (Rotablator™ Rotational Atherectomy System with Peripheral RotaLink Plus™) through bench testing and comparison of technological characteristics.

Instead, I can outline the performance data presented to support the substantial equivalence:

Device Performance Study Details (Non-AI/ML)

As this is a mechanical medical device, the "acceptance criteria" are related to functional performance tests and comparisons to a predicate device, rather than diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Bench Testing)	Reported Device Performance (Leveraged from predicate/reference device and new testing)
Functional Life	Demonstrated through testing
System Speed	Demonstrated through testing
Steady State Stall Torque	Demonstrated through testing
Dynamic Stall Torque	Demonstrated through testing
Transient Response	Demonstrated through testing
EMC Testing (EN 60601-1-2)	Demonstrated compliance
Material Compatibility (Patient contacting materials)	Identical to currently marketed IC ROTAPRO device (P900056/S166) and predicate Peripheral Rotablator Advancer (K133566) in formulation, processing, sterilization, and geometry. No additional chemicals.
Substantial Equivalence to Predicate Device (K133566)	Demonstrated based on indications for use, technological characteristics, safety, and performance testing.

2. Sample size used for the test set and the data provenance:

The document describes "bench testing" which implies engineering tests on device units, not a dataset of patient images or clinical cases. The "sample size" would refer to the number of devices or components tested. This specific number is not explicitly stated in the provided text.
Data Provenance: The tests are conducted by the manufacturer (Boston Scientific Corporation). The data comes from internal testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is mechanical. Ground truth would relate to physical measurements and engineering specifications, not expert interpretation of medical images or diagnoses.

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

Not applicable. Adjudication methods are relevant for subjective human interpretations, typically in diagnostic studies. Bench testing relies on objective, measurable performance characteristics.

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 a mechanical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a hardware device; there is no "algorithm only" performance to evaluate in this context.

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

The "ground truth" for this device's performance would be the established engineering specifications, material properties, and functional parameters that the device is designed to meet. This is determined by the manufacturer's design requirements and industry standards, verified through bench testing.

8. The sample size for the training set:

Not applicable. This is a mechanical device, not an AI/ML model where a "training set" of data is used.

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

Not applicable. As above, no training set for an AI/ML model.

Summary

{0}------------------------------------------------

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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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 Nameand Address	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311
Contact Name andInformation	Heather SchuchardSenior Regulatory Affairs SpecialistPhone: 763.494.1706Fax: 763.494.2981e-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 withPeripheral RotaLink Plus™
Reference Devices	P900056 ROTAPRO Rotational Atherectomy System
Device Description	The Peripheral ROTAPRO Rotational Atherectomy System consists ofan Advancer pre-connected to a Catheter. The advancer functions asa guide for the sliding elements that control burr advancement and thecatheter portion of the device guides the burr through the vasculatureto the treatment site. The Peripheral ROTAPRO devices are providedsterile and non-pyrogenic unless the package has been opened ordamaged. It is intended for one procedure use only.
Intended Use ofDevice	The Peripheral ROTAPRO is intended to ablate occlusive material andrestore luminal patency in the peripheral vasculature.
Indications for Use	The Peripheral ROTAPRO is intended for percutaneous use inperipheral vessels in patients with occlusive atherosclerotic diseasewho are acceptable candidates for endovascular procedures.
Comparison ofTechnologicalCharacteristics	The Peripheral ROTAPRO Rotational Atherectomy System issubstantially equivalent to the Rotablator Rotational AtherectomySystem (predicate device) and identical to the IC ROTAPRORotational Atherectomy System (reference device).

	Characteristic	PeripheralROTAPRO™RotationalAtherectomySystem(Subject)	Rotablator™RotationalAtherectomySystem withPeripheralRotaLink Plus™	InterventionalCardiologyROTAPRO(Reference Device)

	System(Subject)	PeripheralRotaLink Plus™(Predicate)
Product Code	MCW	MCW	N/A-InterventionalCardiologyROTAPRO productcode is forcardiovasculardevice
Class	II	II	III
Device Regulation	21 CFR Part870.4875 –Intraluminal ArteryStripper	21 CFR Part870.4875 –Intraluminal ArteryStripper	N/A-Deviceregulation notapplicable for ClassIII devices.

{4}------------------------------------------------

Indications for Use	The PeripheralROTAPRO isintended for	The RotablatorRotationalAtherectomy Systemis intended	Percutaneousrotational coronaryatherectomy with theROTAPRORotationalAtherectomySystem, as a soletherapy or withadjunctivepercutaneouscoronary intervention(PCI) is indicated in
	percutaneous use inperipheral vessels inpatients withocclusiveatheroscleroticdisease who areacceptablecandidates forendovascularprocedures.	for percutaneous usein the peripheralvessels in patientswith occlusiveatheroscleroticdisease who areacceptablecandidates forendovascularprocedures.	patients with calcificcoronary arterydisease who meetone of the followingselection criteria:•Singlevesselatheroscleroticcoronaryarterydiseasewithastenosisthatcanbepassedwith a guidewire;•Multiplevesselcoronaryarterydiseasethatinthephysician'sjudgmentdoesnotposeundue risk to thepatient;•Patients who havehad prior PCI, andwho have nativecoronary artery post-balloon angioplastyrestenosis; or,•Native vesselatheroscleroticcoronary arterydisease that is lessthan 25 mm inlength.
Mechanism ofOperation	The ROTAPROConsole deliverspneumatic output tothe Advancer gasturbine, enablingrotation of the burr.The Consoleprovides controls forand monitors therotational speed ofthe burr and displaysthe operator andproceduralinformation. Thediamond boated burrablates plaque andcalcium into fineparticles that aredisposed of by thebody'sreticuloendothelialsystem while leavinghealthy tissueunharmed.	Same	Same
Single UseCatheter/Burr	Yes	Yes	Yes
CatheterLength/CatheterSheath OD	Rotational Profile	135 cm/1.4mm	Brass/Diamonds	Same	Same	Same	Same

{5}------------------------------------------------

	Burr RotationMechanism	Rotation CuttingPneumaticallyactivated turbine	Same	Same
	Advancer/Catheter/Burr SterilizationMethod	EO	Same	Same
	Mode Selection andBurr Control	Advancer Button	Foot Petal	Advancer Button
	Console Control	Software Logic	Analog Circuit Logic	Software Logic
	Console Design	LED Display withSleek Housing	Display with MetalHousing	LED Display withSleek Housing
	AdvancerElectrical/Gas LineConnection	StreamlinedGas/ElectricalHarness	No ElectricalGas Line	StreamlinedGas/ElectricalHarness
	New Accessories	ROTAGO Cart andIV Stand	None	ROTAPRO Cart andIV Stand
Performance Data	To demonstrate substantial equivalence and adherence to applicablestandards and guidance the following bench testing was performed:● Anatomically Relevant Simulated Use (Functional Life,System Speed, Steady State Stall Torque, Dynamic StallTorque, and Transient Response)● EMC Testing: EN 60601-1-2All other testing was leveraged from the FDA approved referencedevice.The patient contacting (direct and indirect) materials of the proposedPeripheral ROTAPRO device are identical to the currently marketed ICROTAPRO device (P900056/S166) and predicate PeripheralRotablator Advancer (K133566) in formulation, processing,sterilization, and geometry. No other chemicals have been added(e.g., plasticizers, fillers, additives, cleaning agents, mold releaseagents).
Conclusion	Based on the indications for use, technological characteristics, safetyand performance testing, the Peripheral ROTAPRO RotationalAtherectomy System has shown to be appropriate for its intended useand is considered to be substantially equivalent to the RotablatorRotational Atherectomy System with Peripheral RotaLink Plus(K133566)

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).