The ACCUNET™ Embolic Protection System and the RX ACCUNET™ Embolic Protection System are 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.

Device Description

The ACCUNET™ Embolic Protection System is an over-the-wire, filtration-type, embolic protection device, filtering distal to the interventional site. The ACCUNET™ System is delivered via a Delivery System, utilizing a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once the Guide Wire is across the lesion, the Filter Basket is expanded in the artery lumen by removing the Delivery Sheath. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside the Recovery System, retaining any potential embolic collected during the procedure. The system and any captured embolic particles are then removed through the guiding catheter or sheath.

Like the ACCUNET™ Embolic Protection System, the RX ACCUNET™ Embolic Protection System is a filtration type embolic protection device, filtering distal to the interventional site. The RX ACCUNET™ System is delivered in 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 advancing the Filter Basket from the Delivery Sheath from the Guide Wire using the torque device. 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.

AI/ML Overview

The provided text describes the ACCUNET™ Embolic Protection System and the RX ACCUNET™ Embolic Protection System. It outlines the indications for use and mentions several studies conducted to demonstrate its safety and effectiveness. However, it does not explicitly provide a table of acceptance criteria with reported device performance or detail the specific acceptance criteria for each test. Instead, it generally states that the device was considered "substantially equivalent" to a predicate device and that studies demonstrated acceptable functional performance.

Here's an attempt to structure the available information regarding acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a direct table of acceptance criteria with corresponding performance metrics. It rather indicates a general claim of "substantially equivalent."

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred/General)	Reported Device Performance (Inferred/General)
Predicate Equivalence	Substantially equivalent to Boston Scientific FilterWire EX™ Embolic Protection System (K023691) regarding device design, principles of operation, materials, and indications for use.	The ACCUNET™ and RX ACCUNET™ Embolic Protection Systems were determined to be substantially equivalent to the predicate device.
In Vitro Safety & Effectiveness	Consistent with "Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: Intravascular Stents US FDA May 1995" and applicable ASTM Standards.	Relevant tests outlined in the guidance were conducted and demonstrated in vitro safety and effectiveness. (Specific acceptance values are not provided).
In Vivo Functional Performance	Acceptable functional performance in an in vivo setting; no untoward hemodynamic vascular or other biological (e.g. thrombotic events, etc.) responses in non-atherosclerotic swine model.	Animal studies demonstrated acceptable functional performance and no untoward responses. (Specific metrics for "acceptable" are not provided).
Clinical Equivalence (ARCHeR Trials)	Non-inferiority to historical control (standard of care) for primary endpoint rates. Non-inferiority of rapid exchange RX ACCULINK™ and RX ACCUNET™ to ACCULINK™ and ACCUNET™ based on 30-day results.	ARCHeR 1 & ARCHeR 2: Upper confidence limits for primary endpoint rates were 8.28% and 8.63%, respectively. This was compared to a historical control of 14.9%. ARCHeR 3: Upper confidence limits for primary endpoint rates in ARCHeR 3 and ARCHeR 2 were 6.20% and 6.00%, respectively. The upper bound of the 95% confidence interval of the difference was determined to be equivalent to that of ARCHeR 2.
Safety & Efficacy (New Issues)	Resolution of any new issues of safety or efficacy through extensive clinical and pre-clinical evaluation.	New issues of safety or efficacy were addressed through extensive testing.

2. Sample Sizes and Data Provenance:

Clinical Trials (ARCHeR 1, ARCHeR 2, ARCHeR 3):
- Sample Size (Total): 657 patients.
- Data Provenance: United States (45 clinical sites) and five sites outside of the United States.
- Retrospective/Prospective: Prospective, non-randomized, multi-center, single-arm clinical trials.
Animal Studies:
- Sample Size: Not explicitly stated, but performed in non-atherosclerotic swine.
In Vitro Testing:
- Sample Size: Not explicitly stated, but included biocompatibility, sterilization, packaging and shelf-life, and product performance testing.

3. Number of Experts and Qualifications for Ground Truth - Test Set:

The document does not mention the use of experts to establish ground truth for a test set in the context of device performance, as it is a medical device for embolic protection rather than an AI/diagnostic software. The clinical trials aimed to demonstrate the device's safety and effectiveness in patients, with outcomes being the primary measure.

4. Adjudication Method for the Test Set:

Not applicable in the context of this medical device approval, as there is no "test set" in the sense of a dataset requiring expert adjudication for ground truth. Clinical outcomes from the ARCHeR trials were used.

5. MRMC Comparative Effectiveness Study:

Not applicable. This is a medical device, not an AI or imaging diagnostic software that would involve human readers.

6. Standalone Performance Study:

The clinical trials (ARCHeR) evaluated the performance of the ACCUNET™ and RX ACCUNET™ Embolic Protection Systems in conjunction with the ACCULINK™ and RX ACCULINK™ Carotid Stent Systems. Therefore, it's not strictly a "standalone" or "algorithm-only" performance in isolation, but rather its performance as part of a therapeutic system. The animal and in-vitro studies also assessed the device's performance directly.

7. Type of Ground Truth Used:

Clinical Trials (ARCHeR): The "ground truth" was based on clinical outcomes in patients (e.g., primary endpoint rates which would likely include stroke, MI, death), as defined by the study protocols.
Animal Studies: In vivo functional performance and biological responses.
In Vitro Testing: Adherence to established performance standards and guidance documents.

8. Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI algorithm that requires a training set. The term "training set" is typically used in machine learning. The clinical trials served as the pivotal studies for demonstrating device effectiveness and safety.

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

Not applicable, as there is no "training set" in this context.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with flowing lines connecting them.

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: K042218

RX ACCUNET™ Embolic Protection System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: August 3, 2004 Received: August 5, 2004

Dear Ms. Anastas:

This letter corrects our substantially equivalent letter of August 31, 2004.

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 (OS) 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Duna R. Vidmer

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

510(k) Number (if known): ΚΟΥΣΟΥ

Device Name:

ACCUNET™ Embolic Protection System RX ACCUNET™ Embolic Protection System

Indications For Use:

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)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K092215

Page 1 of

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K042218 p1/3

Amendment to PMA P040012

510(k) SUMMARY

The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92

Submitter's Name:	Guidant CorporationEndovascular Solutions
Submitter's Address:	3200 Lakeside DriveSanta Clara, CA 95052
Telephone:Fax:	(408) 845-3000(408) 845-2304
Contact Person:	Laraine Pangelina, Principal Regulatory Affairs Associate
Date Prepared:	August 3, 2004
Device Trade Name:	ACCUNET™ Embolic Protection SystemRX ACCUNET™ Embolic Protection System
Device Common Name:	Embolic Protection Device
Device Class:	Class II
CFR Classification/Name:	21 CFR 870.1250, Percutaneous Catheter

Identification of Predicate Device:

The ACCUNET™ and RX ACCUNET™ Embolic Protection Systems are substantially equivalent to the Boston Scientific FilterWire EXTM Embolic Protection System (K023691).

Device Description:

The ACCUNET™ Embolic Protection System is an over-the-wire, filtration-type, embolic protection The NOONE . - Embello vinterventional site. The ACCUNET™ System is delivered via a Delivery System, likening distantes movement of the Sheath through tortuous anatomy. Once Sheath wire is across the lesinated in the Filter Basket is expanded in the artery lumen by removing the the Guide Wille is across the fisce is recovery System, retaining any potential embolic collected during the procedure. The system and any captured embolic particles are then removed through the guiding catheter or sheath.

Like the ACCUNET™ Embolic Protection System, the RX ACCUNET™ Embolic Protection System's a Elke the NOONE . - Entection device, filtering distal to the interventional site. The RX ACCUNET™ millation type cinioule protocion a news in 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 movement of the onount mough the Delivery Sheath from the Guide Wire using the torque expanded in the arenal lanter by Position of the interventional procedure, the Filter Basket is collapsed inside the Recovery Catheter _ Once collapsed, the entire system is removed as a single unit.

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Indication for Use:

Technological Characteristics:

The ACCUNET™ and RX ACCUNET™ Embolic Protection Systems are substantially equivaient to the Boston Scientific FilterWire EX™ Embolic Protection System (K023691) 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:

Over the wire and/or rapid exchange systems �
Filter based technology 4
Polyurethane filter membrane ●
. Nitinol filter/basket component
Compatibility with .014" guidewires .
Compatibility with 6F quide catheters .
Available in 190 and/or 300 cm lengths .
Accommodates similar vessel sizes .
Radiopaque guidewire tips and/or delivery sheath tips .
Radiopaque markers on filter .

Any new issues of safety or efficacy were addressed through extensive clinical testing and pre-clinical evaluation including functional, animal, biocompatibility, packaging and shelf-life testing.

Performance Data:

In vitro testing of the ACCUNET™ and RX ACCUNET™ Embolic Protection Systems included biocompatibility, sterilization, packaging and shelf-life, and product performance testing. In vitro bench testing was developed based on the device risk assessment and is consistent with Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: Intravascular Stents US FDA May 1995, and the applicable ASTM Standards. The relevant tests outlined in the guidance were conducted to demonstrate the in vitro safety and effectiveness of these devices.

The ACCUNET™ and RX ACCUNET™ Embolic Protection Systems were subjected to a series of acute and chronic animal studies in conjunction with the ACCULINK™ and RX ACCULINK™ Carotid Stent Systems. The intent of the studies was to demonstrate acceptable functional performance of the subject devices in an in vivo setting and to ensure that the devices do not cause untoward hemodynamic vascular or other biological (e.g. thrombotic events, etc.) responses. All studies were performed in the nonatherosclerotic swine model in accordance with the FDA Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices dated May 1994. All studies were conducted in accordance with Good Laboratory Practices (GLP) per 21 CFR § 58.

The ACCULINK™ for Revascularization of Carotids in High Risk Patients (ARCHeR) Clinical Trials were a series of prospective, non-randomized, multi-center, single-arm clinical trials. These trials were performed Sches of prospocires, non fanabiliable of the ACCULINK™ and RX ACCULINK™ Carotid Stent Systems and ACCUNET™ and RX ACCUNET™ Embolic Protection Systems when used to treat high-risk surgical and non-surgical symptomatic (≥50% stenosis) and asymptomatic (≥80% stenosis) subjects with disease

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in the internal carotid artery. A total of 657 patients were enrolled at 45 clinical sites in the United States and five sites outside of the United States.

The ARCHeR 1 and ARCHeR 2 trials were designed to show equivalence (non-inferiority) between carotid The ARCHEN T and ARTOFICH Entrol, based on the standard of care. The historical control was established Stemlig and an illioncal control, basou on the statistic and medical therapy and is defined based on a leview of the Gurrent licrutare on Jurous and one year has been calculated for both as the weighted filstonour online (1971) HeR 3 trial was designed to demonstrate equivalence (non-ARCHEN T and 2 to be 14.9%. The AROTTOTTE the rapid exchange RX ACCULINK™ and RX ACCUNET™ to infendity) of the Salety and portuniance SPN.O TEP ACCULINK™ and ACCUNET™ based on 30-day results.

With respect to ARCHeR 1 and ARCHeR 2, the upper confidence limits for primary endpoint rates were Will respect to ARCHEN T and AROHER 2, the apper connecendont rates in ARCHeR 3 and ARCHeR 2 were 8.28% and 8.63%, respectively. The upper bound of the 95% confidence interval of the difference is were 6.20 % and 6.00%, responvary. The appendent and included in the stare delermined to be equivalent to that of ARCHeR 2.

The differences observed in primary endpoint event rates between the three trials is not statistically The ultrerences observed in phinary chaponk of the ACCULINK™ carotid stent used with or without the ACCUNET™ embolic protection device.

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).