(7 days)
The RX ACCUNET™ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.25 mm and 7.0 mm.
The RX ACCUNET™ Embolic Protection System is a filtration type embolic protection system consisting of the RX ACCUNET™ Guide Wire, the RX ACCUNET™ Delivery System and the RX ACCUNET™ Recovery Catheter. The RX ACCUNET™ Embolic Protection System is delivery Sheath with a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once across the lesion, the Filter Basket is expanded in the arterial lumen by peeling the Delivery Sheath from the guide wire using the torque device and peel away adapter. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside the Recovery Catheter. Once collapsed, the entire system is removed as a single unit. The Recovery Catheter has a radiopaque tip to facilitate movement though tortuous anatomy
This document is a 510(k) summary for the RX ACCUNET™ Embolic Protection System. It does not contain information about a study with acceptance criteria and reported device performance in the context of an AI/ML device.
The provided text focuses on demonstrating substantial equivalence of the RX ACCUNET™ Embolic Protection System to a legally marketed predicate device (K042218). This is a regulatory filing for a medical device that appears to be a physical device (embolic protection system) and not an AI/ML-driven software device. Therefore, the questions related to AI/ML device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the information contained in this document.
The document discusses:
- Device Name: RX ACCUNET™ Embolic Protection System
- Intended Use: As a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) during angioplasty and stenting in carotid arteries, for artery diameters between 3.25 mm and 7.0 mm.
- Substantial Equivalence: The device is stated to be substantially equivalent to the RX ACCUNET™ Embolic Protection System (K042218) with minor design refinements to the filter basket end and additional in-process testing.
Without a study described in the provided text that evaluates the device against specific performance criteria (as would be typical for an AI/ML driven system), it is not possible to answer the questions about acceptance criteria, device performance, sample sizes, ground truth, or expert involvement.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Guidant Endovascular Solutions c/o Ms. Julia Anastas Advisor, Regulatory Affairs 3200 Lakeside Drive Santa Clara, CA 95054
Re: K052165
RX ACCUNET™ Embolic Protection System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: August 8, 2005 Received: August 9, 2005
Dear Ms. Anastas:
This letter corrects our substantially equivalent letter of August 16, 2005.
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 (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.
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.
NOV 2 8 2005
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Page 2 - Ms. Julia Anastas
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); 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.
This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address
http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
suma R. bi chines
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Guidant Corporation
Indications for Use Statement
510(k) Number
(if known)
Device Name RX ACCUNET™ Embolic Protection System
Indications for The RX ACCUNET™ Embolic Protection System is indicated for use as a Use guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.25 mm and 7.0 mm.
Prescription Use × (Pare 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
Concyrence of CDRH, Office of Device Evaluation (ODE) niminally (Division Sign-Off) Division of Cardlovascular Devices 510(k) Number_
Page 1 of 1
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GUIDANT
510(k) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| Submitter's Name: | Guidant Corporation |
|---|---|
| Submitter's Address: | 3200 Lakeside DriveSanta Clara, CA 95054 |
| Telephone: | 408 845 2201 |
| Fax: | 408 845 2304 |
| Contact Person: | Julia Anastas |
| Date Prepared: | August 8, 2005 |
| Device Trade Name: | RX ACCUNET Embolic Protection System |
| Device Common Name: | Embolic Protection System |
| Device Classification Name: | Embolic Protection System |
| Device Classification: | Class II |
Summary of Substantial Equivalence:
The RX ACCUNET™ Embolic Protection System is substantially equivalent to the RX ACCUNET™ Embolic Protection System (K042218).
Device Description:
The RX ACCUNET™ Embolic Protection System is a filtration type embolic protection The TX ACCHL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Delivery System and the RX ACCUNET™ Recovery Catheter. The RX ACCUNET™ Embolic Protection System is delivery Sheath with a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once across the lesion, the Filter Basket is expanded in the arterial lumen by peeling the Delivery Sheath from the guide wire using the torque device and peel away adapter. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside the Recovery Catheter. Once
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collapsed, the entire system is removed as a single unit. The Recovery Catheter has a radiopaque tip to facilitate movement though tortuous anatomy
Intended Use:
The RX ACCUNET™ Embolic Protection System is indicated for use as a guide wire and The NA / COONE Protection and remove embolic material (thrombus/debris) while onnoming angioplasty and stenting procedures in carotid arteries. The diameter of the porterning angroplasty blacement should be between 3.25 mm and 7.0 mm.
Technological Characteristics:
The modifications incorporated into the RX ACCUNET™ Embolic Protection System consist of a minor design refinement made to the end of the RX ACCUNET™ Filter Basket and the addition of specific in-process testing on the manufacturing line. No Basics and the addition of Spother™ Guide Wire, Delivery Sheath, or Recovery Catheter.
The RX ACCUNET™ Embolic Protection System is substantially equivalent to the RX ACCUNET™ Embolic Protection System (K024418) with regard to device design, principles of operation, materials, and indications for use. The following design attributes are the same or similar for both subject devices and the predicate device:
- Rapid exchange systems .
- Filter based technology .
- Polyurethane filter membrane .
- Nitinol filter/basket component .
- Compatibility with .014" guidewires .
- Compatibility with 6F guide catheters .
- Compatibility with the RX ACCUNET Recovery Catheter and the RX ACCUNET 2 . Recovery Catheter (K042908)
- Available in 190 and/or 300 cm lengths .
- Accommodates same vessel sizes .
- Radiopaque quidewire tips and/or delivery sheath tips .
- Radiopaque markers on filter .
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).