The Vascular Architects aSpire® Covered Stent and 718™ Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms.

Device Description

The Vascular Architects aSpire® Covered Stent is a spiral stent made from Nickel Titanium covered with a thin layer of Silicone. Stainless Steel rings are located at the proximal and distal ends completely encapsulating the Nickel Titanium. The 718TM Delivery Catheter is designed to allow the user to expand the stent within the stricture and confirm positioning prior to release.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the Vascular Architects aSpire® Covered Stent and 718™ Delivery System, through a 510(k) premarket notification. It does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or the detailed aspects of a clinical study that would typically involve human subjects or complex performance metrics.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices. This means that the FDA determined the new device is as safe and effective as a legally marketed device that does not require premarket approval (PMA).

Here's an analysis based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in a quantitative or qualitative manner for specific performance metrics in relation to clinical outcomes. The "performance" assessment is based on demonstrating mechanical integrity and device performance through bench testing, which is considered "substantially equivalent" to the predicate device.

Acceptance Criteria Category	Specific Acceptance Criterion	Reported Device Performance
Substantial Equivalence	Device is as safe and effective as a legally marketed predicate.	"Results of the bench testing performed demonstrate the mechanical integrity and device performance of the subject device is substantially equivalent to that of the predicate device."
Mechanical Integrity	Implicitly, mechanical properties should be comparable to predicate.	Demonstrated via bench testing.
Device Performance	Implicitly, functional performance should be comparable to predicate.	Demonstrated via bench testing.
Intended Use	Must match the predicate device.	"The Vascular Architects aSpire® Covered Stent shares the same intended use as the predicate device..."
Mode of Action	Must match the predicate device.	"...and is identical in mode of action."
Materials	Must be similar to predicate device.	"The materials used in the subject device are similar to those used in the predicate device."
Stent Length	Acknowledged difference, but implicitly not affecting substantial equivalence.	"The only difference between the subject device and the predicate device is in the length of the stent."

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

Test Set Sample Size: Not applicable. The document describes "bench testing," not a clinical test set with human subjects. The sample size for the bench tests (e.g., number of stents tested for mechanical integrity) is not specified.
Data Provenance: The testing appears to be internal "bench testing" conducted by the manufacturer, Wallace Enterprises, Inc. DBA Vascular Architects. No information about country of origin of data or retrospective/prospective nature is provided, as it's not a clinical study.

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

Not applicable. For bench testing, ground truth is typically established by engineering specifications and industry standards, not expert clinical consensus.

4. Adjudication Method for the Test Set:

Not applicable. This concept applies to clinical studies where interpretation of results (e.g., imaging, clinical outcomes) requires expert review and potential tie-breaking, which is not described for bench testing.

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:

Not applicable. An MRMC study is relevant for AI-powered diagnostic devices involving human interpretation. This document is about a covered stent and delivery system, a physical medical device, not an AI product.

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

Not applicable, as this is not an AI algorithm.

7. The Type of Ground Truth Used:

For the bench testing, the "ground truth" would be established by:

Engineering Specifications: Designed parameters and expected performance characteristics of the device.
Predicate Device Performance: The established mechanical and functional performance of the legally marketed predicate devices serves as the benchmark against which the new device's performance is compared for substantial equivalence.
Standardized Test Methods: Adherence to recognized testing standards for medical devices (though specific standards aren't listed, they are implied).

8. The Sample Size for the Training Set:

Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" described is bench testing (simulated use and performance testing). The document states:
"Simulated use and performance testing was conducted on the Vascular Architects aSpire® Covered Stent and 718™ Delivery System. Results of the bench testing performed demonstrate the mechanical integrity and device performance of the subject device is substantially equivalent to that of the predicate device."

This bench testing aimed to demonstrate that the new device's mechanical integrity and overall performance were comparable to those of the predicate devices. The "acceptance criterion" was effectively substantial equivalence to the predicate device in terms of these performance aspects. The specific details of these bench tests (e.g., what parameters were measured, specific numerical results, the exact quantity of devices tested) are not provided in this 510(k) summary.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2006

The Wallace Enterprises, Inc. DBA Vascular Architects % Mr. Kevin F. MacDonald Regulatory Consultant 229 Marvilla Circle Pacifica, California 94044

Re: K031641

Trade/Device Name: Vascular Architects aSpire® Covered Stent and 718™ Delivery System

Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: May 27, 2003 Received: May 27, 2003

Dear Mr. MacDonald:

This letter corrects our substantially equivalent letter of August 1, 2003.

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.

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

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Page 2 - Mr. Kevin F. MacDonald

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) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Herbert Lemons

1 Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Vascular Architects aSpire® Covered Stent Amendment to K012544, K030567, K031641 July 28, 2006

Indications for Use

510(k) Number (if known):

Device Name:

K031641

718TM Delivery System

Indications for Use:

The Vascular Architects aSpire® Covered Stent and 718™ Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms.

Vascular Architects aSpire® Covered Stent and

Prescription Use X

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helmut Lehmann

(Per 21 CFR 801.109)

(Division ptional Format 1-2-96) Division of General, Restorative, and Neurological Devices

510(k) Number K031641

Page 8

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03/641 p. iota

Vascular Architects aSpire® Covered Stent Amendment to K012544, K030567, K031641 July 28, 2006

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in I his summary of 5 ro(it) sareems of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is K031641.

General Information

Date Amended:	July 28, 2006
Classification	Class II, Tracheal Prosthesis per 21 CFR § 878.3720
Product Code	JCT
Common Name:	Tracheal Stent
Trade Name	Vascular Architects aSpire® Covered Stent and 718TMDelivery System
Submitter	Wallace Enterprises, Inc. DBA Vascular Architects1650 Elm Hill PikeNashville, TN 37210
Contact	Kevin F. MacDonaldRegulatory ConsultantTel 415 600 0875

Intended Use

The Vascular Architects aSpire® Covered Stent and 718" Delivery System are indicated The Vascular Arenteets applies Connial strictures produced by malignant neoplasms.

Predicate Devices

K003173 Vascular Architects aSpire® Covered Stent and Delivery Catheter
K012544 Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System
K030567 Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System - 15cm stent length

Performance Standards

Performance Standards have not yet been established by the FDA under section 514 of the Federal Food, Drug and Cosmetic Act.

Device Description

The Vascular Architects aSpire® Covered Stent is a spiral stent made from Nickel The Vasculal Arentects aspires OOVE ou other of Steen Steen at the proximal and

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K03164/ p. 2 of 2

Vascular Architects aSpire® Covered Stent Amendment to K012544, K030567, K031641 July 28, 2006

distal ends completely encapsulating the Nickel Titanium. The 718TM Delivery Catheter is designed to allow the user to expand the stent within the stricture and confirm positioning prior to release.

Comparison To Predicate Device

The Vascular Architects aSpire® Covered Stent shares the same intended use as the predicate device and is identical in mode of action. The materials used in the subject device are similar to those used in the predicate device. The only difference between the subject device and the predicate device is in the length of the stent.

Testing Summary

Simulated use and performance testing was conducted on the Vascular Architects aSpire® Covered Stent and 718™ Delivery System. Results of the bench testing performed demonstrate the mechanical integrity and device performance of the subject device is substantially equivalent to that of the predicate device.

Statement of Substantial Equivalence

The Vascular Architects aSpire® Covered Stent and 718™ Delivery System is substantially equivalent to the legally marketed Vascular Architects aSpire™ Covered Stent size Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System.

Regulation Number and Section

§ 878.3720 Tracheal prosthesis.

(a)
Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”