(66 days)
Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the mechanical aspects of the stent and delivery system.
Yes
The device is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms, which is a therapeutic intervention.
No
The device is a stent and delivery system used for treatment, not for diagnosing a condition. Its function is to treat tracheobronchial strictures, not to identify or characterize them.
No
The device description clearly details physical components (stent made from Nickel Titanium and Silicone, Stainless Steel rings, delivery catheter) and performance testing related to mechanical integrity, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of tracheobronchial strictures produced by malignant neoplasms. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a stent and delivery system designed to be implanted within the tracheobronchial tree. This is a medical device used for treatment, not for analyzing samples from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for treatment.
N/A
Intended Use / Indications for Use
The Vascular Architects aSpire® Covered Stent and 718" Delivery System are indicated The Vascular Arenteets applies Connial strictures produced by malignant neoplasms.
Product codes (comma separated list FDA assigned to the subject device)
JCT
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tracheobronhial
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
Image /page/0/Picture/1 description: The image contains the words "Public Health Service" in bold black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or sign.
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected and form a single, abstract shape. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the image.
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
2
Vascular Architects aSpire® Covered Stent Amendment to K012544, K030567, K031641 July 28, 2006
Indications for Use
510(k) Number (if known):
Device Name:
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
OR
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
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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 718TM |
| Delivery System | |
| Submitter | Wallace Enterprises, Inc. DBA Vascular Architects |
| 1650 Elm Hill Pike | |
| Nashville, TN 37210 | |
| Contact | Kevin F. MacDonald |
| Regulatory Consultant | |
| Tel 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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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.