The RX ACCUNET™ 2 Embolic Protection System is indicated for use as a guidewire 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 portery at the site of filter basket placement should be between 3.25 mm and 7.0 mm.

Device Description

The RX ACCUNET™ 2 Embolic Protection System is a filtration type embolic protection device, filtering distal to the interventional site. The System consists of the RX ACCUNET™ Delivery System and a second-generation RX ACCUNET™ 2 Recovery Catheter. The RX ACCUNET™ 2 Embolic Protection System is delivered via a 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

AI/ML Overview

This document is a 510(k) summary for the RX ACCUNET™ 2 Embolic Protection System. It outlines the device's substantial equivalence to a predicate device and provides an overview of its intended use and technological characteristics.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the format of a numerical target for specific performance metrics. Instead, it relies on the concept of substantial equivalence to a predicate device (RX ACCUNET™ Embolic Protection System, K024418).

The "performance" is implicitly deemed acceptable if the new device demonstrates similar safety and effectiveness to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Safety and effectiveness comparable to predicate device	"The results of the in vitro bench tests and in vivo studies demonstrated the safety and effectiveness of the RX ACCUNET™ 2 Embolic Protection System."
Design, principles of operation, materials, and indications for use substantially equivalent to predicate device	Stated: "The RX ACCUNET™ 2 Embolic Protection System is substantially equivalent to the RX ACCUNET™ Embolic Protection Systems (K024418) with regard to device design, principals of operation, materials, and indications for use."
No new issues of safety or efficacy	"Any new issues of safety or efficacy were addressed through pre-clinical evaluation including functional, in vivo and in vitro testing."
Technological characteristics (materials, biocompatibility, performance properties, sterilization, packaging) equivalent to predicate device	"Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization and packaging are substantially equivalent to the currently marketed predicate devices."

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: The document does not specify a numerical sample size for the "in vivo studies." It simply states "in vivo studies." It's common in 510(k) submissions for device modifications to refer to previous studies or a cumulative understanding rather than detailing new, large-scale clinical trials for minor changes.
Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. It only mentions "in vitro bench tests and in vivo studies." Given the context of a 510(k) submission, these would typically be internal company studies or studies conducted under contract for the company.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the given text. The document refers to "in vivo studies" but does not detail the methodology for establishing ground truth, such as expert review, for these studies.

4. Adjudication Method for the Test Set:

This information is not provided in the given text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable to this document. The RX ACCUNET™ 2 Embolic Protection System is a medical device (filtration type embolic protection device), not an Artificial Intelligence (AI) or software as a medical device (SaMD) product. Therefore, MRMC studies and AI-assisted improvements for human readers are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable for the same reasons as point 5. It's a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The document does not explicitly state the type of ground truth used for the "in vivo studies." For an embolic protection system, "safety and effectiveness" in vivo would likely involve:

Outcomes data: Such as rates of stroke, TIA, or other neurological events post-procedure, as well as the amount and type of embolic material captured by the filter.
Imaging: Assessment of vessel patency and absence of new lesions.
Histopathology: Analysis of captured embolic material (if possible and relevant to the study design).

However, the specific methods are not detailed. The phrase "demonstrated the safety and effectiveness" is a general conclusion.

8. The Sample Size for the Training Set:

This is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for such devices typically involves design iterations, bench testing, and potentially animal studies.

9. How the Ground Truth for the Training Set was Established:

This is not applicable for the same reasons as point 8.

Summary

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KO42908 p/2

NOV 1 2 2004

RX ACCUNET™ 2 Embolic Protection System Special 510(k)

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 95052
Telephone:Fax:	408-845-2233408-845-2304
Contact Person:	Virginia Singer
Date Prepared:	October 20, 2004
Device Trade Name:	RX ACCUNET™ 2 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™ 2 Embolic Protection System is substantially equivalent to the RX ACCUNET™ Embolic Protection System.

Device Description:

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Guidant Corporation

RX ACCUNET™ 2 Embolic Protection System Special 510(k)

Intended Use:

Technological Characteristics:

The design modifications incorporated into the RX ACCUNET™ 2 Embolic Protection System include minor material, dimensional and design configuration changes made to the Oyclommeraus Minor mucery System. No changes were made to the RX ACCUNET™ Delivery System.

The RX ACCUNET™ 2 Embolic Protection System is substantially equivalent to the RX ACCUNET™ Embolic Protection Systems (K024418) with regard to device design, principals 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 .
Available in 190 and/or 300 cm lengths .
Accommodates same vessel sizes .
Radiopaque guidewire tips and/or delivery sheath tips .
Radiopaque markers on filter .

Any new issues of safety or efficacy were addressed through pre-clinical evaluation including functional, in vivo and in vitro testing.

Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization and packaging are substantially equivalent to the currently marketed predicate devices.

Performance Data:

The results of the in vitro bench tests and in vivo studies demonstrated the safety and effectiveness of the RX ACCUNET™ 2 Embolic Protection System.

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Public Health Service

Image /page/2/Picture/2 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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wing segments.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 12 2004

Ms. Virginia Singer Manager Regulatory Affairs Guidant Corporation Mailstop S216 3200 Lakeside Drive Santa Clara, CA 95054

Re: K042908

RX ACCUNET™ 2 Embolic Protection System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NFA Dated: October 20, 2004 Received: October 21, 2004

Dear Ms. Singer:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your been wind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to ecommerce prior to Has) 2011-11-11 in accordance with the provisions of the Federal Food, Drug, devices that hat to been 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 r ou mayy aron's 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 such additional controls. Existing major regulations affecting your device can may or our 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.

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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 begin 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 (301) 594-_. 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Diana P. Buchner

( / 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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Indications for Use Statement

510(k) Number:

Device Name:

The RX ACCUNET™ Embolic Protection System is Indications For Use: indicated for use as a guidewire 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 × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Diana R. Vachner

(Division Sign-Off) (Division Olgh of Cardiovascular Devices

510(k) Number_k 042968

Regulation Number and Section

§ 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).