(87 days)
Not Found
No
The description focuses on mechanical ablation and does not mention any AI/ML components or functions.
Yes
The device is used to ablate occlusive material and restore luminal patency in peripheral vessels, thus treating a medical condition.
No
This device is designed to ablate occlusive material and restore luminal patency in peripheral vessels, which describes a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including a catheter, burr, guidewire, console, and foot pedal. It is a physical medical device with software likely controlling some functions, but it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "ablate occlusive material and restore luminal patency in the peripheral vasculature." This describes a therapeutic procedure performed directly on a patient's body.
- Device Description: The device is a "catheter based angioplasty device that utilizes a high speed, rotating, diamond-coated burr to ablate occlusive material." This is a surgical/interventional tool.
- Anatomical Site: The anatomical site is "peripheral vessels," which are part of the living body.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health. This device operates within the body to treat a condition.
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 Atherectomy 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 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.
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)
Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The 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 and, therefore, these devices may be considered substantially equivalent to the predicate devices.
The following biocompatibility and chemical characterization tests were completed on the Rotablator Rotational Atherectomy System; Peripheral RotaLink Plus:
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.
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.
Rotaglide:
Hemolysis Assay: Direct Contact Method, In vitro Cytotoxicity Test: MEM Elution, Partial Thromboplastin Time (PTT), Materials Mediated Rabbit Pyrogen Test.
The following in-vitro performance tests were completed on the Rotablato Rotational Atherectomy System:
Peripheral RotaLink Plus:
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K993648, K960379, K933238, K913450
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).
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's
Name and
Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 | | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------------|
| Contact Name
and
Information | Beth Torok
Principal Regulatory Affairs Specialist
Phone: 763-494-1273
Fax: 763-494-2222
e-mail: beth.torok@bsci.com | | |
| Date Prepared | 15 June 2012 | | |
| Proprietary
Name | Rotablator™ Rotational Atherectomy System with the Peripheral
RotaLink™ Plus | | |
| Common Name | Rotational Angioplasty System | | |
| Product Code | MCW - Catheter, Peripheral, Atherectomy | | |
| Classification | Class II, 21 CFR Part 870.4875 - Intraluminal Artery Stripper | | |
| Predicate
Device(s) | Peripheral Rotablator® Rotational
Angioplasty System with the
RotaLink™ Exchangeable Catheter | K993648 | 24 November 1999 |
| | Peripheral Rotablator® Rotational
Angioplasty System with the
Support and Rail RotaWire™
Guidewires | K960379 | 25 April 1996 |
| | Peripheral Rotablator® Rotational
Angioplasty System with Dynaglide | K933238 | 24 August 1993 |
| | Rotablator wireClip | K913450 | 06 September 1991 |
| Device
Description | 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. | | |
| Intended Use
of Device | 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. | | |
·
1
Traditional 510(k) Submission
·
.
Rotablator™ Rotational Atherectorny System with the Peripheral RotaLink™ Plus
| 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. | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Performance
Data | Currently no FDA mandated or voluntary performance standards exist for
this atherectomy catheter. Bench testing and biocompatibility testing were
performed to support a determination of substantial equivalence. The
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 and, therefore, these devices may be
considered substantially equivalent to the predicate devices.
The following biocompatibility and chemical characterization tests were
completed 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 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 | |
.
·
・
·
:
:
・ ·
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 Contact | |
| Method | In vitro Cytotoxicity Test: MEM |
| Elution | |
| Complement Activation C3a and | |
| SC5b-9 Assay | Materials Mediated Rabbit |
| Pyrogen Test | |
| Partial Thromboplastin Time | |
| (PTT) | USP Physicochemical Test for |
| Plastics | |
| In vitro Hemocompatibility Assay | Acute Systemic Injection Test |
| Guinea Pig Maximization | |
| Sensitization Test: Method for | |
| Biomaterial Extracts | |
| Rotaglide: | |
| Hemolysis Assay: Direct Contact | |
| Method | In vitro Cytotoxicity Test: MEM |
| Elution | |
| Partial Thromboplastin Time | |
| (PTT) | Materials Mediated Rabbit |
| Pyrogen Test | |
| The following in-vitro performance tests were completed on the Rotablato | |
| Rotational 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