(97 days)
Not Found
No
The summary describes a physical medical device (stent graft) and its delivery system, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a stent graft used to maintain patency in the tracheobronchial tree. While it alleviates symptoms of strictures, it is a prosthetic device for mechanical support rather than directly treating or curing a disease.
No
The device is a stent graft used for the treatment of tracheobronchial strictures, not for diagnosing conditions.
No
The device description clearly states it is a physical stent graft made of Nitinol and ePTFE, pre-loaded on a delivery system. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat tracheobronchial strictures by maintaining the patency of the airway. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a physical stent graft designed to be implanted in the tracheobronchial tree.
- 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 compatibility testing.
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 FLUENCY® Plus 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.
Product codes
JCT
Device Description
The FLUENCY® Plus Tracheobronchial Stent Graft includes a self-expanding Nitinol stent encapsulated with carbon-impregnated 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. Highly radiopaque tantalum markers on the stent graft ends facilitate stent graft placement. The FLUENCY® Plus 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 and is available in various delivery system lengths.
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
Non-Clinical Performance Data: Design verification and validation of the modified device was done with conformance to or evaluated based on the following FDA guidance: Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses. April 28, 1998. All test results confirm the modified device to be substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
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.”
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K050832 pg. lot 3
JUL - 7 2005
ecial 510(k) LUENCY® Plus Tracheobronchial Stent Graft
Page 78
FLUENCY® Plus Tracheobronchial Stent Graft 510(k) Summary of Safety and Effectiveness 21 CFR 807.92(a).
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 as follows:
General Information:
| Submitter Name:
Address: | Bard Peripheral Vascular, Inc.
1625 W. Third Street
P.O. BOX 1740
Tempe, AZ 85280-1740 |
|----------------------------------|-------------------------------------------------------------------------------------------------|
| Telephone Number:
Fax Number: | (480) 894-9515
(480) 449-2546 |
| Contact Person: | Dennis Salzmann, Ph.D.
Regulatory Affairs Technical Manager |
Device Information:
| Device Trade Name: | FLUENCY® Plus Tracheobronchial Stent Graft |
|---|---|
| Common/Usual Name: | Tracheal Prosthesis |
| Classification: | Class II with Special Controls |
The special controls for this device are compliant with FDA Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses. April 28, 1998.
Classification Panel: General & Plastic Surgery
Predicate Device:
FLUENCY® Tracheobronchial Stent Graft (K031041, cleared June 19, 2003)
Summary of Change:
The design modifications to the FLUENCY® Tracheobronchial Stent Graft are modification of the inner catheter tip, and modification to the outer catheter material and configuration. These changes result in a subject device that has a reduced deployment force, reduced risk of tip entanglement during withdrawal of the delivery system, allows
Bard Peripheral Vascular, Inc
TRADE SECRET/CONFIDENTIAL INFORMATIC Notify CR Bard Before Releasing this Docume
Image /page/0/Picture/18 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and clear appearance. The overall design is simple and straightforward, focusing on the legibility of the word.
1
K050832 pg 2 of 3
for more precise stent graft placement during deployment, and provides more delivery system length options for physicians. All other aspects of the subject device remain the same as the predicate device.
Device Description:
The FLUENCY® Plus Tracheobronchial Stent Graft includes a self-expanding Nitinol stent encapsulated with carbon-impregnated 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. Highly radiopaque tantalum markers on the stent graft ends facilitate stent graft placement. The FLUENCY® Plus 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 and is available in various delivery system lengths.
Intended Use of Device:
The FLUENCY® Plus 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.
Technological Comparison to Predicate Device:
The technological characteristics of FLUENCY® Plus Tracheobronchial Stent Graft are substantially equivalent to those of the predicate FLUENCY® Tracheobronchial Stent Graft in terms of intended use, application, user population, basic design, performance, labeling, packaging, and sterilization method.
Non-Clinical Performance Data:
Design verification and validation of the modified device was done with conformance to or evaluated based on the following FDA guidance:
Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses. April 28, 1998.
Image /page/1/Picture/15 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct appearance. The overall design is simple and clear, making the word easily readable.
2
K050832 pg 3 of 3
All test results confirm the modified device to be substantially equivalent to the predicate device.
Conclusions:
The FLUENCY® Plus Tracheobronchial Stent Graft met all the predetermined performance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The FLUENCY® Plus Tracheobronchial Stent Graft is substantially equivalent to the legally marketed predicate device, the FLUENCY® Trachobronchial Stent Graft.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the caduceus symbol.
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: K050832
Trade/Device Name: FLUENCY® Plus Tracheobronchial Stent Graft Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: June 6, 2005 Received: June 7, 2005
Dear Mr. Smale:
This letter corrects our substantially equivalent letter of July 7, 2005.
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
4
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) I mis letter will and in your he FDA finding of substantial equivalence of your device to a legally promatics noticate 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 If you a 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,
Kio
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if known): K050832
Device Name: FLUENCY® Plus Tracheobronchial Stent Graft
Indications for Use:
The FLUENCY® Plus 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 CORH, Office of Device Evaluation (ODE)
Signature
100-01 Division of General, Restorative, and Neurological Devices
310(k) Number /