(100 days)
Not Found
No
The summary describes a mechanical stent and delivery system and does not mention any software, image processing, or AI/ML terms.
Yes
The device is used for the treatment of tracheobronchial strictures, which is a therapeutic intervention.
No
The device is indicated for treatment of tracheobronchial strictures, not for diagnosis.
No
The device description explicitly mentions a "Covered Stent and Controlled Expansion® Delivery System," which are physical medical devices, not software. The performance studies also focus on the mechanical integrity and performance of this physical system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use clearly state that this device is a stent and delivery system used to treat tracheobronchial strictures within the body. It is an implantable device used for a therapeutic purpose, not for testing samples outside the body.
The information provided describes a medical device used for direct intervention and treatment within a patient's airway, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms.
Product codes
JCT
Device Description
The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery I he vasound firemted the luminal diameter within tracheobronhial strictures produced by malignant neoplasms.
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 Controlled Expansion® Delivery System. Results of the bench testing performed demonstrate the mechanical integrity and device performance of the subject device are substantially equivalent to that of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K003173 - Vascular Architects aSpire® Covered Stent and Delivery Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 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 an eagle with its wings spread, with three human profiles incorporated into the design of the eagle's body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2006
The Wallace Enterprises, Inc. DBAVascular Architects % Mr. Kevin F. MacDonald Regulatory Consultant 229 Marvilla Circle Pacifica, California 94044
Re: K012544
K012544
Trade/Device Name: Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: October 26, 2001 Received: October 31, 2001
Dear Mr. MacDonald:
This letter corrects our substantially equivalent letter of November 15, 2001.
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because as (t) personal ally equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments or to conninered proc to May 20, 1978, the encordance with the provisions of the Federal Food. Drug, de vices that have been recuire approval of a premarket approval (PMA). You may, allo Cosment Act (Tech mat do not required to the general controls provisions of the Act. The general therefore, mander the act include requirements for annual registration, listing of devices, Controls provisions of are ce, 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 If your device is exassified (000 ac) Existing major regulations affecting your device can be may be subject to additions, 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 I lease oc advised that I Dr o issuants over device complies with other requirements of the Act that I Dri has made a actuations administered by other Federal agencies. You must or any I odetar batales and registments, including, but not limited to: registration and listing (21 Compry with an the 110 - 21 CFR Part 801); good manufacturing practice requirements as set
1
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,
Holbert Lemming
- 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
K012544 510(k) Number (if known): Vascular Architects aSpire® Covered Stent and Device Name: Controlled Expansion® Delivery System The Vascular Architects aSpire® Covered Stent and Indications for Use: Controlled Expansion® Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms.
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)
Herbert Leun
(Per 21 CFR 801.109)
Optional Format 1-2-96) Division of General, Restorative, and Neurological Devices
510(k) Number K012544
Page 6
3
012544 p. lot 2
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 accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is K012544.
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 |
| Controlled Expansion® Delivery System | |
| Submitter | Wallace Enterprises, Inc. DBA Vascular Architects |
| 1650 Elm Hill Pike | |
| Nashville, TN 37210 | |
| Contact | Kevin F. MacDonald |
| Regulatory Consultant | |
| Tel 415-600-9875 |
Intended Use
The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms.
Predicate Devices
K003173 - Vascular Architects aSpire® Covered Stent and Delivery Catheter
Device Description
The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery I he vasound firemted the luminal diameter within tracheobronhial strictures produced by malignant neoplasms.
Comparison To Predicate Device
The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System has a similar intended use and shares the same technological characteristics as the predicate device.
4
012544 p. 2 of 2
Vascular Architects aSpire® Covered Stent Amendment to K012544, K030567, K031641 July 28, 2006
The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System are well-characterized materials and are suitable for this use. The materials are similar to those used to manufacture the predicate device.
The available lengths and diameters of the Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System are similar to the lengths and diameters available for the predicate device.
Testing Summary
Simulated use and performance testing was conducted on the Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System. Results of the bench testing performed demonstrate the mechanical integrity and device performance of the subject device are substantially equivalent to that of the predicate device.