(158 days)
P900056
No
The summary describes a mechanical atherectomy system and does not mention any AI or ML components or functionalities.
Yes
Explanation: The device is intended for percutaneous use in peripheral vessels for patients with occlusive atherosclerotic disease, functioning as a rotational atherectomy system to remove plaque. This indicates a direct medical intervention to treat a disease, classifying it as a therapeutic device.
No
The device description indicates it is a treatment device (Rotational Atherectomy System) used for removing occlusive atherosclerotic disease, not for diagnosis.
No
The device description clearly states it consists of an Advancer and a Catheter, which are physical hardware components. The performance studies also focus on bench testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "percutaneous use in the peripheral vessels in patients with occlusive atherosclerotic disease." This describes a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The description details a mechanical system (Advancer, Catheter, burr) used to physically remove plaque from blood vessels. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. IVDs are used to perform tests on samples taken from the body.
Therefore, the Peripheral ROTAPRO is a therapeutic medical device, specifically an atherectomy system, and not an IVD.
N/A
Intended Use / Indications for Use
The Peripheral ROTAPRO is intended for percutaneous use in the peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for endovascular procedures.
Product codes
MCW
Device Description
The Peripheral ROTAPRO Rotational Atherectomy System 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 ROTAPRO devices are provided sterile and non-pyrogenic unless the package has been opened or damaged. It is intended for one procedure use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vessels, peripheral vasculature
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
To demonstrate substantial equivalence and adherence to applicable standards and guidance the following bench testing was performed:
- Anatomically Relevant Simulated Use (Functional Life, System Speed, Steady State Stall Torque, Dynamic Stall Torque, and Transient Response)
- EMC Testing: EN 60601-1-2
All other testing was leveraged from the FDA approved reference device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
P900056
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 6, 2022
Boston Scientific Corporation Heather Schuchard Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311
Re: K220962
Trade/Device Name: ROTAPRO Rotational Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: Class II Product Code: MCW Dated: March 31, 2022 Received: April 1, 2022
Dear Heather Schuchard:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220962
Device Name ROTAPRO Rotational Atherectomy System
Indications for Use (Describe)
The Peripheral ROTAPRO is intended for percutaneous use in the peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for endovascular procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 | Heather Schuchard
Senior Regulatory Affairs Specialist
Phone: 763.494.1706
Fax: 763.494.2981
e-mail: Heather.Schuchard@bsci.com | | | |
| Date Prepared | 31 March 2022 | | | |
| Proprietary Name | Peripheral ROTAPRO™ Rotational Atherectomy System | | | |
| Common Name | Rotational Atherectomy System | | | |
| Product Code | MCW – Catheter, Peripheral, Atherectomy | | | |
| Classification | Class II, 21 CFR Part 870.4875 – Intraluminal Artery Stripper | | | |
| Predicate Device | K133566 -- Rotablator™ Rotational Atherectomy System with
Peripheral RotaLink Plus™ | | | |
| Reference Devices | P900056 ROTAPRO Rotational Atherectomy System | | | |
| Device Description | The Peripheral ROTAPRO Rotational Atherectomy System 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 ROTAPRO devices are provided
sterile and non-pyrogenic unless the package has been opened or
damaged. It is intended for one procedure use only. | | | |
| Intended Use of
Device | The Peripheral ROTAPRO is intended to ablate occlusive material and
restore luminal patency in the peripheral vasculature. | | | |
| Indications for Use | The Peripheral ROTAPRO is intended for percutaneous use in
peripheral vessels in patients with occlusive atherosclerotic disease
who are acceptable candidates for endovascular procedures. | | | |
| Comparison of
Technological
Characteristics | The Peripheral ROTAPRO Rotational Atherectomy System is
substantially equivalent to the Rotablator Rotational Atherectomy
System (predicate device) and identical to the IC ROTAPRO
Rotational Atherectomy System (reference device). | | | |
| | | | | |
| | Characteristic | Peripheral
ROTAPRO™
Rotational
Atherectomy
System
(Subject) | Rotablator™
Rotational
Atherectomy
System with
Peripheral
RotaLink Plus™ | Interventional
Cardiology
ROTAPRO
(Reference Device) |
| | System
(Subject) | Peripheral
RotaLink Plus™
(Predicate) | |
|-------------------|--------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Product Code | MCW | MCW | N/A-Interventional
Cardiology
ROTAPRO product
code is for
cardiovascular
device |
| Class | II | II | III |
| Device Regulation | 21 CFR Part
870.4875 –
Intraluminal Artery
Stripper | 21 CFR Part
870.4875 –
Intraluminal Artery
Stripper | N/A-Device
regulation not
applicable for Class
III devices. |
4
| Indications for Use | The Peripheral
ROTAPRO is
intended for | The Rotablator
Rotational
Atherectomy System
is intended | Percutaneous
rotational coronary
atherectomy with the
ROTAPRO
Rotational
Atherectomy
System, as a sole
therapy or with
adjunctive
percutaneous
coronary intervention
(PCI) is indicated in | | | | |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|------|------|------|
| | percutaneous use in
peripheral vessels in
patients with
occlusive
atherosclerotic
disease who are
acceptable
candidates for
endovascular
procedures. | for percutaneous use
in the peripheral
vessels in patients
with occlusive
atherosclerotic
disease who are
acceptable
candidates for
endovascular
procedures. | patients with calcific
coronary artery
disease who meet
one of the following
selection criteria:
•Singlevesselatheros
cleroticcoronaryarter
ydiseasewithastenos
isthatcanbepassed
with a guidewire;
•Multiplevesselcoron
aryarterydiseasethati
nthephysician'sjudg
mentdoesnotpose
undue risk to the
patient;
•Patients who have
had prior PCI, and
who have native
coronary artery post-
balloon angioplasty
restenosis; or,
•Native vessel
atherosclerotic
coronary artery
disease that is less
than 25 mm in
length. | | | | |
| Mechanism of
Operation | The ROTAPRO
Console delivers
pneumatic output to
the Advancer gas
turbine, enabling
rotation of the burr.
The Console
provides controls for
and monitors the
rotational speed of
the burr and displays
the operator and
procedural
information. The
diamond boated burr
ablates plaque and
calcium into fine
particles that are
disposed of by the
body's
reticuloendothelial
system while leaving
healthy tissue
unharmed. | Same | Same | | | | |
| Single Use
Catheter/Burr | Yes | Yes | Yes | | | | |
| Catheter
Length/Catheter
Sheath OD | Rotational Profile | 135 cm/1.4mm | Brass/Diamonds | Same | Same | Same | Same |
5
| | Burr Rotation
Mechanism | Rotation Cutting
Pneumatically
activated turbine | Same | Same |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|-------------------------------|------------------------------------------|
| | Advancer/Catheter/
Burr Sterilization
Method | EO | Same | Same |
| | Mode Selection and
Burr Control | Advancer Button | Foot Petal | Advancer Button |
| | Console Control | Software Logic | Analog Circuit Logic | Software Logic |
| | Console Design | LED Display with
Sleek Housing | Display with Metal
Housing | LED Display with
Sleek Housing |
| | Advancer
Electrical/Gas Line
Connection | Streamlined
Gas/Electrical
Harness | No Electrical
Gas Line | Streamlined
Gas/Electrical
Harness |
| | New Accessories | ROTAGO Cart and
IV Stand | None | ROTAPRO Cart and
IV Stand |
| Performance Data | To demonstrate substantial equivalence and adherence to applicable
standards and guidance the following bench testing was performed:
● Anatomically Relevant Simulated Use (Functional Life,
System Speed, Steady State Stall Torque, Dynamic Stall
Torque, and Transient Response)
● EMC Testing: EN 60601-1-2
All other testing was leveraged from the FDA approved reference
device.
The patient contacting (direct and indirect) materials of the proposed
Peripheral ROTAPRO device are identical to the currently marketed IC
ROTAPRO device (P900056/S166) and predicate Peripheral
Rotablator Advancer (K133566) in formulation, processing,
sterilization, and geometry. No other chemicals have been added
(e.g., plasticizers, fillers, additives, cleaning agents, mold release
agents). | | | |
| Conclusion | Based on the indications for use, technological characteristics, safety
and performance testing, the Peripheral ROTAPRO Rotational
Atherectomy System has shown to be appropriate for its intended use
and is considered to be substantially equivalent to the Rotablator
Rotational Atherectomy System with Peripheral RotaLink Plus
(K133566) | | | |