(79 days)
Not Found
Not Found
No
The summary describes a physical medical device (stent graft and delivery system) and its materials, intended use, and performance studies comparing it to predicate devices. There is no mention of software, algorithms, image processing, or terms related to AI/ML.
Yes.
The device is used to treat tracheobronchial strictures, which is a therapeutic intervention.
No
This device is a therapeutic device (stent graft) used to treat tracheobronchial strictures by maintaining patency, not to diagnose a condition.
No
The device description clearly states it is a physical stent graft made of Nitinol and ePTFE, pre-loaded on a delivery system, and includes radiopaque markers. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Description: The FLUENCY® Tracheobronchial Stent Graft is a physical device (a stent graft) that is implanted inside the body to treat strictures in the tracheobronchial tree.
- Intended Use: The intended use is to treat tracheobronchial strictures, which is a therapeutic intervention performed within the body.
The device is an implantable medical device, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The FLUENCY™ Tracheobronchial Stent Graft is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms or in benign strictures after all alternative therapies have been exhausted.
The FLUENCY® Tracheobronchial Stent Graft is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
Product codes (comma separated list FDA assigned to the subject device)
JCT
Device Description
The FLUENCY™ Tracheobronchial Stent Graft includes a self-expanding Nitinol Stent encapsulated with ePTFE pre-loaded on a flexible "pull-back" delivery system. It is a single use prosthetic device designed to maintain the patency of the tracheobronchial tree in patients with tracheobronchial strictures produced by malignant neoplasms or in benign strictures after all alternatives have been exhausted. Highly radiopaque Tantalum markers on the stent graft ends facilitate stent graft placement. The FLUENCY™ Tracheobronchial Stent Graft is available in various lengths and diameters. It is preloaded into various size delivery catheters, depending on the size of the stent graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tracheobronchial tree
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)
Not Found
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.
Not Found
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
JUN 19 2003
Kø3/ø41 (P. 1 of 2)
510(k) Summary of Safety and Effectiveness Information VI.
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based follows:
- Submitter Information: A.
| Applicant: | Bard Peripheral Vascular, a division of C.R. Bard, Inc.
1625 West 3rd Street
Tempe, Arizona 85280 |
|------------|---------------------------------------------------------------------------------------------------------|
| Phone: | 480-303-2752 |
| Fax: | 480-449-2546 |
| Contact: | Aymee R. Berry, Associate Manager, Regulatory Affairs |
- B. Device Name:
| Trade Name: | FLUENCY™ Tracheobronchial Stent Graft |
|---|---|
| Common or | |
| Usual Name: | Tracheal Prosthesis |
| Classification | |
| Name: | Prosthesis, tracheal |
- C. Predicate Device Name(s): WALLGRAFT™® Tracheobronchial Endoprosthesis
Boston Scientific
Bard LUMINEXX™ 7F Biliary Stent C.R. Bard. Inc.
Bard memotherm® Covered Esophageal Stent C.R. Bard, Inc.
VIABAHN™ Endoprosthesis W.L. Gore & Associates, Inc.
- D. Device Description:
The FLUENCY™ Tracheobronchial Stent Graft includes a self-expanding Nitinol Stent encapsulated with ePTFE pre-loaded on a flexible "pull-back" delivery system. It is a single use prosthetic device designed to maintain the patency of the tracheobronchial tree in patients with tracheobronchial strictures produced by malignant neoplasms or in benign strictures after all alternatives have been exhausted. Highly radiopaque Tantalum markers on the stent graft ends facilitate stent graft placement. The FLUENCY™ Tracheobronchial Stent Graft is available in various lengths and
1
\$\phi3/1041 (P.2 of 2)
diameters. It is preloaded into various size delivery catheters, depending on the size of the stent graft.
-
E. Statement of Intended Use:
The FLUENCY™ Tracheobronchial Stent Graft is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms or in benign strictures after all alternative therapies have been exhausted. -
ட் Substantial Equivalence:
A variety of tests, assessments, and comparisons demonstrate that the FLUENCY™ Tracheobronchial Stent Graft is substantially equivalent to the following predicates in terms of composition, design, intended use, and performance attributes as noted below: -
The FLUENCY™ Stent Graft is substantially equivalent to the . WALLGRAFT™ Endoprosthesis in indication for use, method of deployment, and in-vitro testing.
-
The FLUENCY™ Stent Graft is substantially equivalent to the ● VIABAHN™ in both stent graft materials and indication for use.
In addition, safety and effectiveness of the FLUENCY™ Stent Graft is further supported by comparability to other legally marketed devices as follows:
- The FLUENCY™ Stent Graft and delivery system is comparable to the . LUMINEXX™ 7F Biliary Stent Graft (Nitinol stent) and delivery system as previously demonstrated.
- The FLUENCY™ Stent Graft is comparable to the memotherm® . Esophageal in covering and stent material.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
JAN 1 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bard Peripheral Vascular, Inc. % Mr. Joshua Smale Regulatory Affairs Specialist 1625 West 3rd Street P.O. Box 1740 Tempe, Arizona 85280
Re: K031041
Trade/Device Name: FLUENCY™ Tracheobronchial Stent Graft Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: March 31, 2003 Received: April 7, 2003
Dear Mr. Smale:
This letter corrects our substantially equivalent letter of June 19, 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
3
Page 2 - Mr. Joshua Smale
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,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known): K031041
Device Name: FLUENCY® Tracheobronchial Stent Graft
Indications for Use:
The FLUENCY® Tracheobronchial Stent Graft is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
Prescription Use X (Part21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) storative. officies Listices and Of General, free Jrative,
Image /page/4/Picture/14 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and modern appearance. The font style is consistent throughout the word, creating a unified and recognizable logo or brand name.