(26 days)
Not Found
No
The description focuses on mechanical ablation and does not mention any AI/ML components or functions.
Yes
The device is described as ablating occlusive material to restore luminal patency, which directly treats a medical condition.
No
The device description states that the system ablates occlusive material and restores luminal patency, indicating a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines multiple hardware components including a burr, advancer, catheter, console, and foot pedal, indicating it is a physical medical device system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description details a mechanical system with a rotating burr used to ablate material within blood vessels. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The information provided does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The Rotablator system is a therapeutic medical device used to treat a condition within the body.
N/A
Intended Use / Indications for Use
The peripheral Rotablator system is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for bypass graft surgery or percutaneous transluminal angioplasty.
Product codes
MCW
Device Description
The Rotablator® Rotational Angioplasty system uses a high speed, rotating, diamondcoated burr to ablate occlusive material and restore luminal patency. The burr spins at 140.000-190.000 RPM and ablates material into very fine particles that are carried distally and removed via the reticuloendothelial system. The Rotablator System with Exchangeable Catheter comprises four main components: advancer, catheter with diamond-coated burr, console and foot pedal, and guide wire.
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
The proposed Rotablator system is considered to be substantially equivalent to the previously marketed Rotablator system based on a comparison of the intended uses and designs and results of the testing and evaluations performed.
Key Metrics
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).
0
Special 510(k): Device Modificatio Rotablator® Angioplasty System with RotaLink® Exchangeable Catheter for Peripheral Use
| 14 m . r . 1 . 1 . 1 . 1 . 1 | 11 - 1 - 1 - 1 - 1 - - - - f -- Darimbanal II -- |
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| Section III - 510(k) Summary | NOV 24 1999 |
|---|---|
| ------------------------------ | ------------- |
General Information
| Submitter | Boston Scientific Corporation Northwest Technology
Center, Inc.
17425 N.E. Union Hill Road
Redmond, WA 98052 |
|----------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Cyndy Adams
425-556-1570 (phone)
425-558-1400 (fax) |
| Classification Name | Catheter, Peripheral, Atherectomy
(per 21 CFR 870.4875) |
| Common or Usual Name | Rotational Angioplasty System
Rotablator® Rotational Angioplasty System with the
RotaLink® Exchangeable Catheter |
| Classification Panel | Cardiovascular |
Name of Predicate Device
Predicate Device 510(k) Reference No. K970296 Peripheral Rotablator® Rotational Angioplasty System with the RotaLink® Exchangeable Catheter
1
Device Description
The Rotablator® Rotational Angioplasty system uses a high speed, rotating, diamondcoated burr to ablate occlusive material and restore luminal patency. The burr spins at 140.000-190.000 RPM and ablates material into very fine particles that are carried distally and removed via the reticuloendothelial system. The Rotablator System with Exchangeable Catheter comprises four main components: advancer, catheter with diamond-coated burr, console and foot pedal, and guide wire.
Intended Use
The peripheral Rotablator system is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for bypass graft surgery or percutaneous transluminal angioplasty.
Summary of Technological Characteristics
The proposed Rotablator system is similar in construction and materials to the currently marketed Rotablator system.
Test Summary
The proposed Rotablator system is considered to be substantially equivalent to the previously marketed Rotablator system based on a comparison of the intended uses and designs and results of the testing and evaluations performed.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 1999
Ms. Cyndy Adams Sr. Regulatory Affairs Specialist Boston Scientific Corporation 17425 N.E. Union Hill Road Redmond, WA 98052-3376
Re: K993648
Peripheral Rotablator® Rotational Angioplasty System Trade Name: With the RotaLink™ Exchangeable Catheter Regulatory Class: II Product Code: MCW Dated: October 28, 1999 Received: October 29, 1999
Dear Ms. Adams:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements concerning action. your device in the Federal Register. Please note: this response to
3
Page 2 - Ms. Cyndy Adams
your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and advertising 594-4586. of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Ohto M. Mth for
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section I - Indications for Use
510(k) Number (if known)
| Device Name | Peripheral Rotablator® Rotational Angioplasty System with the RotaLink™ Exchangeable Catheter |
|---|---|
| Indications for Use | The peripheral Rotablator system is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for bypass graft surgery or percutaneous transluminal angioplasty. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) OR Over The Counter Use
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K993648
(Optional Format 1-2-96)