(87 days)
The Rotablator™ Rotational Atherectomy System with the Peripheral RotaLink™ Plus is intended to ablate occlusive material and restore luminal patency in the peripheral vasculature.
The Rotablator™ Rotational Atherectomy System is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for endovascular procedures.
The Rotablator Rotational Atherectomy System with the Peripheral RotaLink Plus is a catheter based angioplasty device that utilizes a high speed, rotating, diamond-coated burr to ablate occlusive material and restore luminal patency. The burr spins at up to 190,000 RPM and ablates material into very fine particles that are carried distally and removed via the reticuloendothelial system. There are three main components that comprise the Rotablator Rotational Atherectomy: 1) the Peripheral RotaLink Plus, 2) Peripheral RotaWire Guidewire with the wireClip Torquer, and 3) Rotablator Console with Dynaglide foot pedal. Rotaglide, a lubricant is also available as an accessory.
The provided document is a 510(k) submission for the Rotablator™ Rotational Atherectomy System. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through bench testing and biocompatibility testing, rather than clinical efficacy studies with specific performance metrics against acceptance criteria that are typically associated with AI/ML devices.
Therefore, many of the requested elements (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance, effect size of human improvement with AI) are not directly applicable or available in this type of submission.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define acceptance criteria in terms of quantitative performance metrics for a specific clinical outcome. Instead, it relies on demonstrating that the device's technological characteristics, safety, and performance are substantially equivalent to its predicate devices through a series of in-vitro and biocompatibility tests.
| Acceptance Criteria Category | Specific Tests Performed by Manufacturer | Reported Device Performance Summary |
|---|---|---|
| Material Biocompatibility | For Rotablator Rotational Atherectomy System; Peripheral RotaLink Plus: | Results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing. |
| - Natural Rubber Latex | ||
| - Hemolysis Assay: Extract Method | ||
| - Hemolysis Assay: Direct Contact Method | ||
| - Complement Activation C3a and SC5b-9 Assay | ||
| - Partial Thromboplastin Time (PTT) | ||
| - In vitro Hemocompatibility Assay | ||
| - Guinea Pig Maximization Sensitization Test: Method for Biomaterial Extracts | ||
| - Intracutaneous Reactivity Test (Irritation) | ||
| - Acute Systemic Injection Test | ||
| - Materials Mediated Rabbit Pyrogen Test | ||
| - USP Physicochemical Test for Plastics | ||
| - In vitro Cytotoxicity Test: MEM Elution | ||
| - FTIR Analysis | ||
| For Peripheral RotaWire Guidewire: | ||
| - Natural Rubber Latex | ||
| - Hemolysis Assay: Direct Contact Method | ||
| - Complement Activation C3a and SC5b-9 Assay | ||
| - Partial Thromboplastin Time (PTT) | ||
| - In vitro Hemocompatibility Assay | ||
| - Guinea Pig Maximization Sensitization Test: Method for Biomaterial Extracts | ||
| - Intracutaneous Reactivity Test (Irritation) | ||
| - In vitro Cytotoxicity Test: MEM Elution | ||
| - Materials Mediated Rabbit Pyrogen Test | ||
| - USP Physicochemical Test for Plastics | ||
| - Acute Systemic Injection Test | ||
| For Rotaglide: | ||
| - Hemolysis Assay: Direct Contact Method | ||
| - In vitro Cytotoxicity Test: MEM Elution | ||
| - Partial Thromboplastin Time (PTT) | ||
| - Materials Mediated Rabbit Pyrogen Test | ||
| Device Performance (In-vitro) | For Peripheral RotaLink Plus: | The results from these tests supported the conclusion of substantial equivalence. |
| - Strain Relief | ||
| - Operational Speeds | ||
| - Stall Torque | ||
| - Infusate Temperature Generation | ||
| - Catheter Advancement | ||
| - Component Interface Compatibility | ||
| - Burr Cutting Ability | ||
| - Tensile Strength | ||
| - Brake Engagement | ||
| - Infusate Flow Rate | ||
| - Lumen Patency | ||
| - Functional Life | ||
| For Peripheral RotaWire Guidewire and wireClip Torquer: | ||
| - Corrosion | ||
| - Radiodetectability | ||
| - Fracture | ||
| - Flexure | ||
| - Tensile Strength | ||
| - Tip Formability | ||
| - Torque Transmission | ||
| - Pushability | ||
| - Tip Deflection | ||
| - Stiffness | ||
| - Torque to Fail | ||
| - Functional Life |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The submission relies on bench testing and biocompatibility testing, not a clinical "test set" in the context of an AI/ML study. The sample sizes for each specific in-vitro or biocompatibility test would be contained within the full test reports, which are not detailed in this summary.
- Data Provenance: The data comes from internal bench testing and biocompatibility assessments conducted by Boston Scientific Corporation. This is not clinical data, so country of origin or retrospective/prospective classification isn't relevant to the summary provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. There is no "ground truth" derived from expert consensus on medical images or clinical outcomes, as this is not an AI/ML diagnostic device. The "ground truth" for the engineering and biocompatibility tests would be the established scientific and regulatory standards/protocols against which the device performance is measured (e.g., ISO standards for biocompatibility tests).
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no "test set" requiring adjudication in the context of this 510(k) summary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC study was not done. This device is a mechanical atherectomy system, not a diagnostic AI/ML tool that would involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a medical device, not an algorithm, so the concept of standalone performance isn't relevant. Its performance is demonstrated through its physical and material properties and how it functions as intended.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the biocompatibility and in-vitro performance tests, the "ground truth" is established by adherence to recognized standards (e.g., ISO standards for biocompatibility, internal engineering specifications for performance tests) and the comparison to previously cleared predicate devices. It is not clinical outcome data, pathology, or expert consensus in the diagnostic sense.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is a medical device submission, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable.
{0}------------------------------------------------
Traditional 510(k) Submission Rotablator™ Rotational Atherectomy System with the Peripheral RotaLink™ Plus SEP 1 3 2012
74
K12|7
510(k) Summary
per 21 CFR §807.92
| Submitter'sName andAddress | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311 | ||
|---|---|---|---|
| Contact NameandInformation | Beth TorokPrincipal Regulatory Affairs SpecialistPhone: 763-494-1273Fax: 763-494-2222e-mail: beth.torok@bsci.com | ||
| Date Prepared | 15 June 2012 | ||
| ProprietaryName | Rotablator™ Rotational Atherectomy System with the PeripheralRotaLink™ Plus | ||
| Common Name | Rotational Angioplasty System | ||
| Product Code | MCW - Catheter, Peripheral, Atherectomy | ||
| Classification | Class II, 21 CFR Part 870.4875 - Intraluminal Artery Stripper | ||
| PredicateDevice(s) | Peripheral Rotablator® RotationalAngioplasty System with theRotaLink™ Exchangeable Catheter | K993648 | 24 November 1999 |
| Peripheral Rotablator® RotationalAngioplasty System with theSupport and Rail RotaWire™Guidewires | K960379 | 25 April 1996 | |
| Peripheral Rotablator® RotationalAngioplasty System with Dynaglide | K933238 | 24 August 1993 | |
| Rotablator wireClip | K913450 | 06 September 1991 | |
| DeviceDescription | The Rotablator Rotational Atherectomy System with the PeripheralRotaLink Plus is a catheter based angioplasty device that utilizes a highspeed, rotating, diamond-coated burr to ablate occlusive material andrestore luminal patency. The burr spins at up to 190,000 RPM and ablatesmaterial into very fine particles that are carried distally and removed via thereticuloendothelial system. There are three main components thatcomprise the Rotablator Rotational Atherectomy: 1) the PeripheralRotaLink Plus, 2) Peripheral RotaWire Guidewire with the wireClip Torquer,and 3) Rotablator Console with Dynaglide foot pedal. Rotaglide, a lubricantis also available as an accessory. | ||
| Intended Useof Device | The Rotablator Rotational Atherectomy System with the PeripheralRotaLink Plus is intended to ablate occlusive material and restore luminalpatency in the peripheral vasculature. | ||
| Indications forUse | The Rotablator Rotational Atherectomy System is intended forpercutaneous use in peripheral vessels in patients with occlusiveatherosclerotic disease who are acceptable candidates for endovascularprocedures. |
·
{1}------------------------------------------------
Traditional 510(k) Submission
·
.
Rotablator™ Rotational Atherectorny System with the Peripheral RotaLink™ Plus
| Comparison ofTechnologicalCharacteristics | The Rotablator Rotational Atherectomy System with the PeripheralRotaLink Plus incorporates substantially equivalent device materials anddesign, packaging materials and design, fundamental technology,manufacturing processes, sterilization process and intended use as thosefeatured in the Boston Scientific predicate devices. | |
|---|---|---|
| PerformanceData | Currently no FDA mandated or voluntary performance standards exist forthis atherectomy catheter. Bench testing and biocompatibility testing wereperformed to support a determination of substantial equivalence. Theresults of these tests provide reasonable assurance that the proposeddevice has been designed and tested to assure conformance to therequirements for its intended use. No new safety or performance issueswere raised during the testing and, therefore, these devices may beconsidered substantially equivalent to the predicate devices.The following biocompatibility and chemical characterization tests werecompleted on the Rotablator Rotational Atherectomy System;Peripheral RotaLink Plus: | |
| Natural Rubber Latex | Intracutaneous Reactivity Test(Irritation) | |
| Hemolysis Assay: Extract Method | Acute Systemic Injection Test | |
| Hemolysis Assay: Direct ContactMethod | Materials Mediated RabbitPyrogen Test | |
| Complement Activation C3a and SC5b-9 Assay | USP Physicochemical Test forPlastics | |
| Partial Thromboplastin Time(PTT) | In vitro Cytotoxicity Test: MEMElution | |
| In vitro Hemocompatibility Assay | FTIR Analysis | |
| Guinea Pig MaximizationSensitization Test: Method forBiomaterial Extracts |
.
·
・
·
:
:
・ ·
{2}------------------------------------------------
Traditional 510(k) Submission
Rotablator™ Rotational Atherectomy System with the Peripheral RotaLink™ Plus
| Peripheral RotaWire Guidewire: | |
|---|---|
| Natural Rubber Latex | Intracutaneous Reactivity Test(Irritation) |
| Hemolysis Assay: Direct ContactMethod | In vitro Cytotoxicity Test: MEMElution |
| Complement Activation C3a andSC5b-9 Assay | Materials Mediated RabbitPyrogen Test |
| Partial Thromboplastin Time(PTT) | USP Physicochemical Test forPlastics |
| In vitro Hemocompatibility Assay | Acute Systemic Injection Test |
| Guinea Pig MaximizationSensitization Test: Method forBiomaterial Extracts | |
| Rotaglide: | |
| Hemolysis Assay: Direct ContactMethod | In vitro Cytotoxicity Test: MEMElution |
| Partial Thromboplastin Time(PTT) | Materials Mediated RabbitPyrogen Test |
| The following in-vitro performance tests were completed on the RotablatoRotational Atherectomy System: | |
| Peripheral RotaLink Plus: | |
| Strain Relief | Burr Cutting Ability |
| Operational Speeds | Tensile Strength |
| Stall Torque | Brake Engagement |
| Infusate Temperature Generation | Infusate Flow Rate |
| Catheter Advancement | Lumen Patency |
| Component Interface Compatibility | Functional Life |
Peripheral RotaWire Guidewire and wireClip Torquer:
| Corrosion | Torque Transmission |
|---|---|
| Radiodetectability | Pushability |
| Fracture | Tip Deflection |
| Flexure | Stiffness |
| Tensile Strength | Torque to Fail |
| Tip Formability | Functional Life |
Conclusion
Based on the indications for use, technological characteristics, safety and performance testing, the Rotablator Rotational Atherectomy System with the Peripheral RotaLink Plus has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Rotablator Rotational Angioplasty System as submitted in K993548, K960379, K933238, and K913450.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 13 2012
Boston Scientific Corp. % Ms. Beth Torok One Scimed Place Maple Grove, MN 55311
Re: K121774
Trade/Device Name: Rotablator Rotational Atherectomy System with the Peripheral RotaLink Plus Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: Class II Product Code: MCW Dated: June 15, 2012 Received: June 18, 2012
Dear Ms. Torok:
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. 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.
{4}------------------------------------------------
Page 2 - Beth Torok
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): K121774
Device Name:
Rotablator™ Rotational Atherectomy System with the Peripheral RotaLink™ Plus
Indications for Use:
The Rotablator™ Rotational Atherectomy System is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for endovascular procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sian-Off) Division of Cardiovascuk 510(k) Number
Page 1 of 1
§ 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).