(30 days)
Not Found
No
The summary describes a mechanical atherectomy system and its components. There is no mention of AI, ML, image processing, or any software-driven decision-making or analysis that would indicate the presence of AI/ML. The performance studies listed are focused on mechanical and biocompatibility aspects.
Yes
The device is intended to "ablate occlusive material and restore luminal patency," which directly treats a medical condition in the peripheral vasculature.
No
The device is intended to ablate occlusive material and restore luminal patency, which describes a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines a physical system consisting of an Advancer, Catheter, and burrs, which are hardware components used for a physical procedure (atherectomy). There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for ablating occlusive material and restoring luminal patency in the peripheral vasculature. This is a direct intervention on the patient's body.
- Device Description: The description details a mechanical system (Advancer, Catheter, Burr) designed to physically interact with and modify tissue within the blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, while this device is used to perform a procedure directly on the patient's body.
N/A
Intended Use / Indications for Use
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.
Product codes
MCW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following in-vitro performance tests were completed on the Peripheral RotaLink Plus:
Strain Relief
Operational Speeds
Stall Torque
Infusate Temperature Generation
Infusate Flow Rate
Catheter Advancement
Component Interface Compatibility
Burr Cutting Ability
Tensile Strength
Brake Engagement
Lumen Patency
Functional Life
The following biocompatibility and chemical characterization tests were completed on the Peripheral RotaLink Plus:
Natural Rubber Latex
Hemolysis Assay: Extract Method
Acute Systemic Injection Test
Hemolysis Assay: Direct Contact Method
Materials Mediated Rabbit Pyrogen Test
Complement Activation C3a and SC5b-9 Assay
USP Physicochemical Test for Plastics
Partial Thromboplastin Time (PTT)
In vitro Cytotoxicity Test: MEM Elution
In vitro Hemocompatibility Assay
FTIR Analysis
Guinea Pig Maximization Sensitization Test: Method for Biomaterial Extracts
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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K133566 510(k) Summary
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ن ته
DEC 2 0 2013
| Submitter's
Name and
Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311
Phone: 763-255-0877
Fax: 763-494-2222 | | | |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|------------------------------------------------|------------------|
| Contact Name
and
Information | Maylin Truesdell
Senior Regulatory Affairs Specialist
Phone: 763-255-0877
Fax: 763-494-2222
e-mail: maylin.truesdell@bsci.com | | | |
| Date Prepared | November 19, 2013 | | | |
| Proprietary
Name | Rotablator™ Rotational Atherectomy System with the Peripheral
RotaLink™ 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 | | | |
| Predicate
Devices | Rotablator® Rotational Angioplasty System
K901206, September 14, 1990 | | | |
| | Rotablator™ Rotational Atherectomy System with the Peripheral
RotaLink™ Plus | | | |
| | K121774, September 13, 2012 | | | |
| Device
Description | 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. | | | |
| Intended Use | The Rotablator Rotational Atherectomy System with the Peripheral
RotaLink Plus is intended to ablate occlusive material and restore luminal
patency in the peripheral vasculature. | | | |
| 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. | | | |
| | K133566 | | | Page 2 of 2 |
| Comparison of
Technological
Characteristics | The Rotablator Rotational Atherectomy System with the Peripheral
RotaLink Plus incorporates substantially equivalent device materials and
design, packaging materials and design, fundamental technology,
manufacturing processes, sterilization process and intended use as those
featured in the Boston Scientific predicate devices, Peripheral Rotablator
Rotational Angioplasty System with the RotaLink Exchangeable Catheter. | | | |
| Performance
Data | The following in-vitro performance tests were completed on the 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 | |
| | The following biocompatibility and chemical characterization tests were
completed on the Peripheral RotaLink Plus: | | | |
| | Natural Rubber Latex | | Intracutaneous Reactivity Test
(Irritation) | |
| | Hemolysis Assay: Extract
Method | | Acute Systemic Injection Test | |
| | Hemolysis Assay: Direct
Contact Method | | Materials Mediated Rabbit
Pyrogen Test | |
| | Complement Activation C3a
and SC5b-9 Assay | | USP Physicochemical Test for
Plastics | |
| | Partial Thromboplastin Time
(PTT) | | In vitro Cytotoxicity Test: MEM
Elution | |
| | In vitro Hemocompatibility
Assay | | FTIR Analysis | |
| | Guinea Pig Maximization
Sensitization Test: Method for
Biomaterial Extracts | | | |
| Conclusion | 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. | | | |
.
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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
3
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
4
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