(30 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 Atherectory 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 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 RotaLink Plus devices are provided sterile and non-pyrogenic. It is intended for one procedure use only. The Rotablator Rotational Atherectomy System with the Peripheral RotaLink Plus currently offers burr sizes 1.5, 1.75, 2.00, 2.15, 2.25, 2.38 and 2.5mm, with 1.25mm being introduced in this submission.
The provided text is a 510(k) summary for the Rotablator™ Rotational Atherectomy System with the Peripheral RotaLink™ Plus. It describes the device, its intended use, and the performance data submitted to support its substantial equivalence to predicate devices. However, this document does not contain acceptance criteria or detailed results of a study designed to prove the device meets specific acceptance criteria in the way one would expect for a deep learning algorithm or diagnostic AI tool.
Instead, the submission focuses on demonstrating substantial equivalence of a modified medical device to previously cleared predicate devices through a series of in-vitro performance tests and biocompatibility/chemical characterization tests. These tests ensure the new device iteration (with a new burr size) performs safely and effectively in a manner consistent with its predecessors.
Therefore, many of the requested elements (like "reported device performance" against acceptance criteria for a diagnostic measure, sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable to the type of device and submission described.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance tests but does not provide specific numerical acceptance criteria or detailed performance results in the format of a typical diagnostic study. The "reported device performance" is essentially that the device passed these tests, affirming its safety and function consistent with predicate devices.
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| In-Vitro Performance Tests | Strain Relief | Consistent with predicate device performance/safety | Passed (Implied by conclusion of substantial equivalence) |
| Operational Speeds | Within specified ranges for safe and effective operation | Passed (Implied by conclusion of substantial equivalence) | |
| Stall Torque | Consistent with predicate device performance/safety | Passed (Implied by conclusion of substantial equivalence) | |
| Infusate Temperature Generation | Below thresholds for tissue damage | Passed (Implied by conclusion of substantial equivalence) | |
| Catheter Advancement | Smooth, controlled advancement | Passed (Implied by conclusion of substantial equivalence) | |
| Component Interface Compatibility | Proper fitting and function of all components | Passed (Implied by conclusion of substantial equivalence) | |
| Burr Cutting Ability | Effective ablation of occlusive material | Passed (Implied by conclusion of substantial equivalence) | |
| Tensile Strength | Sufficient strength to withstand operational forces | Passed (Implied by conclusion of substantial equivalence) | |
| Brake Engagement | Proper and reliable brake function | Passed (Implied by conclusion of substantial equivalence) | |
| Infusate Flow Rate | Within specified ranges for effective flushing/cooling | Passed (Implied by conclusion of substantial equivalence) | |
| Lumen Patency | Maintenance of lumen patency during use | Passed (Implied by conclusion of substantial equivalence) | |
| Functional Life | Meets single-procedure use requirement | Passed (Implied by conclusion of substantial equivalence) | |
| Biocompatibility & Chemical | Natural Rubber Latex | Absence of natural rubber latex | Absence confirmed (Implied by conclusion of substantial equivalence and standard safety testing) |
| Hemolysis Assay: Extract Method | Non-hemolytic | Passed (Implied by conclusion of substantial equivalence) | |
| Hemolysis Assay: Direct Contact Method | Non-hemolytic | Passed (Implied by conclusion of substantial equivalence) | |
| Complement Activation C3a and SC5b-9 | Non-activating of complement system | Passed (Implied by conclusion of substantial equivalence) | |
| Partial Thromboplastin Time (PTT) | No adverse effect on blood clotting | Passed (Implied by conclusion of substantial equivalence) | |
| In vitro Hemocompatibility Assay | Biocompatible with blood | Passed (Implied by conclusion of substantial equivalence) | |
| Guinea Pig Maximization Sensitization | Non-sensitizing | Passed (Implied by conclusion of substantial equivalence) | |
| Intracutaneous Reactivity Test | Non-irritating | Passed (Implied by conclusion of substantial equivalence) | |
| Acute Systemic Injection Test | No systemic toxicity | Passed (Implied by conclusion of substantial equivalence) | |
| Materials Mediated Rabbit Pyrogen Test | Non-pyrogenic | Passed (Implied by conclusion of substantial equivalence) | |
| USP Physicochemical Test for Plastics | Meets USP standards for plastics | Passed (Implied by conclusion of substantial equivalence) | |
| In vitro Cytotoxicity Test: MEM Elution | Non-cytotoxic | Passed (Implied by conclusion of substantial equivalence) | |
| FTIR Analysis | Material composition consistent with predicate/expected | Passed (Implied by conclusion of substantial equivalence) |
2. Sample size used for the test set and the data provenance:
* Sample Size: Not specified in the summary. Performance tests for medical devices typically involve testing a statistically representative sample of units.
* Data Provenance: Not applicable in the context of diagnostic data. These are engineering and biological tests conducted on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. The ground truth for these performance and biocompatibility studies would be established by validated test methods and industry standards, not expert consensus on diagnostic images.
4. Adjudication method for the test set:
* Not applicable. No image review or diagnostic adjudication is mentioned.
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 not an AI/diagnostic software device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is not an AI/diagnostic software device.
7. The type of ground truth used:
* For performance tests: Engineering specifications, validated test methodologies, and established industry standards for mechanical, electrical, and functional properties.
* For biocompatibility tests: International standards (e.g., ISO 10993 series) and recognized test methods for assessing biological responses to medical devices.
8. The sample size for the training set:
* Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
* Not applicable.
Summary of the Study:
The "study" described in the 510(k) summary is a comprehensive set of in-vitro performance tests and biocompatibility/chemical characterization tests. These tests were conducted to demonstrate that the modified Rotablator Rotational Atherectomy System with the Peripheral RotaLink Plus (specifically, the introduction of a new 1.25mm burr size) is substantially equivalent to its predicate devices (K901206 and K121774) in terms of safety and effectiveness.
The conclusion states that "Based on the indications for use, technological characteristics, and safety and performance testing, the Peripheral Rotablator 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 Peripheral Rotablator Rotational Angioplasty System as submitted in K901206 and K121774." This implies that the device passed all listed tests and met the internal acceptance criteria for each test, which would be consistent with the performance of the predicate device and established engineering/biological safety standards.
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K133566 510(k) Summary
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ن ته
DEC 2 0 2013
| Submitter'sName andAddress | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311Phone: 763-255-0877Fax: 763-494-2222 | |||
|---|---|---|---|---|
| Contact NameandInformation | Maylin TruesdellSenior Regulatory Affairs SpecialistPhone: 763-255-0877Fax: 763-494-2222e-mail: maylin.truesdell@bsci.com | |||
| Date Prepared | November 19, 2013 | |||
| ProprietaryName | Rotablator™ Rotational Atherectomy System with the PeripheralRotaLink™ Plus | |||
| Common Name | Rotational Angioplasty System or Rotational Atherectomy System | |||
| Product Code | MCW - Catheter, Peripheral, Atherectomy | |||
| Classification | Class II, 21 CFR Part 870.4875 - Intraluminal Artery Stripper | |||
| PredicateDevices | Rotablator® Rotational Angioplasty SystemK901206, September 14, 1990 | |||
| Rotablator™ Rotational Atherectomy System with the PeripheralRotaLink™ Plus | ||||
| K121774, September 13, 2012 | ||||
| DeviceDescription | The Rotablator Rotational Atherectomy System with the PeripheralRotaLink Plus consists of an Advancer pre-connected to a Catheter. Theadvancer functions as a guide for the sliding elements that control burradvancement and the catheter portion of the device guides the burrthrough the vasculature to the treatment site. The Peripheral RotaLinkPlus devices are provided sterile and non-pyrogenic. It is intended for oneprocedure use only. The Rotablator Rotational Atherectomy System withthe Peripheral RotaLink Plus currently offers burr sizes 1.5, 1.75, 2.00,2.15, 2.25, 2.38 and 2.5mm, with 1.25mm being introduced in thissubmission. | |||
| Intended Use | 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. | |||
| K133566 | Page 2 of 2 | |||
| 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, Peripheral RotablatorRotational Angioplasty System with the RotaLink Exchangeable Catheter. | |||
| PerformanceData | The following in-vitro performance tests were completed on the PeripheralRotaLink 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 | |||
| The following biocompatibility and chemical characterization tests werecompleted on the Peripheral RotaLink Plus: | ||||
| Natural Rubber Latex | Intracutaneous Reactivity Test(Irritation) | |||
| Hemolysis Assay: ExtractMethod | Acute Systemic Injection Test | |||
| Hemolysis Assay: DirectContact Method | Materials Mediated RabbitPyrogen Test | |||
| Complement Activation C3aand SC5b-9 Assay | USP Physicochemical Test forPlastics | |||
| Partial Thromboplastin Time(PTT) | In vitro Cytotoxicity Test: MEMElution | |||
| In vitro HemocompatibilityAssay | FTIR Analysis | |||
| Guinea Pig MaximizationSensitization Test: Method forBiomaterial Extracts | ||||
| Conclusion | Based on the indications for use, technological characteristics, and safetyand performance testing, the Peripheral Rotablator Atherectomy Systemwith the Peripheral RotaLink Plus has been shown to be appropriate for itsintended use and is considered to be substantially equivalent to thePeripheral Rotablator Rotational Angioplasty System as submitted inK901206 and K121774. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2013
Boston Scientific Corporation Ms. Maylin Truesdell Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566
Re: K133566
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: November 19, 2013 Received: November 20, 2013
Dear Ms. Truesdell:
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. However, we remind you 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
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Page 2 - Ms. Maylin Truesdell
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K133566 510(k) Number (if known):
Device Name: Rotablator™ Rotational Atherectorny System with the Peripheral RotaLink™ Plus
Indications for Use:
The Rotablator Rotational Atherectory System is intended for perculaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for endovascular procedures.
Prescription Use _ × (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)
K
§ 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).