(161 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and deployment of a physical stent, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a stent used for palliation of malignant strictures in the biliary tree, which is a therapeutic purpose.
No
Explanation: The device is a stent system used for palliation of malignant strictures in the biliary tree, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly details physical components like a self-expanding stent made of nitinol, a catheter delivery system with a dilator and sheath, and a handle with a thumbwheel. This indicates a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "palliation of malignant strictures (neoplasms) in the biliary tree." This describes a therapeutic intervention performed within the body to treat a condition.
- Device Description: The device is a "self-expanding stent" that is "permanently implanted device used to maintain patency of a major bile duct." This is a physical implant designed to provide structural support and maintain an open passage.
- Mechanism of Action: The device works by physically expanding within the bile duct to counteract the stricture caused by a tumor.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide diagnostic information about a patient's condition. IVDs are used to diagnose diseases or conditions in vitro (outside the body).
This device is clearly a therapeutic medical device intended for implantation to treat a physical obstruction.
N/A
Intended Use / Indications for Use
The LifeStent / XL Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Product codes
FGE
Device Description
The LifeStent /XL Biliary Stent System consists of a self-expanding stent that is provided loaded into an over-the-wire catheter that acts as a delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor, The flexible, self-expanding stent is made by laser cutting an open lattice design into a nitinol tube. The subject device is supplied in lengths of 20-120 mm and diameter of 5 mm. A delivery system comprised of a dilator (inner shaft) and a sheath to enhance trackability, which are linked together by means of a handle. The dilator terminates distally in an atraumatic catheter tip and originates proximally in a luer hub designed to accept a 0.035" guidewire. The self-expanding stent is constrained within the space between the dilator and the sheath. Deployment is initiated by rotating the thumbwheel in the direction of the handle arrow while holding the handle in a fixed position until complete deployment of the stent is achieved.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary 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
To demonstrate substantial equivalence of the subject device to the predicate device, the technological characteristics and performance criteria were evaluated. Using the FDA guidance document, "Guidance for the content of premarket notifications for metal expandable Biliary Stents," dated February 5th, 1998, and internal risk assessment procedures, the following non-clinical tests were performed: Deployment Testing, Expansion Force Testing, Compression Force Testing, Dimensional Testing, Corrosion Testing. The results demonstrate that the technological characteristics and performance criteria of the 5mm LifeStent® / XL Biliary Stent System fulfill the same specifications as the predicate devices and therefore perform as safely and as effectively as the legally marketed predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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510(k) Summary 21 CFR 876.5010
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 information upon which substantial equivalence determination is based is as follows:
1. Submitter Information:
| Applicant: | Bard Peripheral Vascular, Inc.
1625 West 3rd Street
Tempe, Arizona 85281 | AUG 3 0 2013 |
|------------|---------------------------------------------------------------------------------|--------------|
| Phone: | 480-638-2925 | |
| Fax: | 480-449-2542 | |
| Contact: | Christoph Wagner von Hoff, Regulatory Affairs Specialist | |
| Date: | March 21st , 2013 | |
2. Subject Device:
| Device Trade Name: | LifeStent® / XL Biliary Stent System |
|---|---|
| Common or Usual Name: | Biliary Stent |
| Classification: | Class II |
| Classification Name: | Biliary, Catheter (FGE), Class II |
| Regulation Number: | 21 CFR 876.5010 |
3. Predicate Device:
LifeStent FlexStar Biliary Stent System (K053404; cleared December 21st, 2005) LifeStent FlexStar XL Biliary Stent System (K060487; cleared March 230, 2006) E-LUMINEXX® Biliary Stent (K063532; cleared May 30th, 2008)
4. Device Description:
The LifeStent /XL Biliary Stent System consists of a self-expanding stent that is provided loaded into an over-the-wire catheter that acts as a delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor, The flexible, self-expanding
Image /page/0/Picture/12 description: The image shows the word "BARD" in a bold, outlined font. The letters are all capitalized and evenly spaced. The overall impression is clean and simple.
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stent is made by laser cutting an open lattice design into a nitinol tube. The subject device is supplied in lengths of 20-120 mm and diameter of 5 mm. A delivery system comprised of a dilator (inner shaft) and a sheath to enhance trackability, which are linked together by means of a handle. The dilator terminates distally in an atraumatic catheter tip and originates proximally in a luer hub designed to accept a 0.035" guidewire. The self-expanding stent is constrained within the space between the dilator and the sheath. Deployment is initiated by rotating the thumbwheel in the direction of the handle arrow while holding the handle in a fixed position until complete deployment of the stent is achieved.
5. Indications for Use of Device:
The LifeStent® / XL Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
6. Technological Comparison to Predicate Devices:
The technological characteristics of the subject device are substantially equivalent to those of the predicate device, in terms of following:
- . Intended use
- Indications for use .
- Target population .
- Fundamental scientific technology .
- Operating principle .
- Implant design and materials .
- Packaging materials and configuration .
- . Sterility
The subject device is a modification of the predicate devices LifeStent FlexStar Biliary Stent System (K053404) and the LifeStent FlexStar XL Biliary Stent System (K060487). The subject device and the predicate devices are different in the following manner:
- The only change from the predicate devices is a 5 mm stent diameter for lengths . 20-120 mm to the same indications for use as the predicate device.
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7. Performance Testing Summary:
To demonstrate substantial equivalence of the subject device to the predicate device, the technological characteristics and performance criteria were evaluated. Using the FDA guidance document, "Guidance for the content of premarket notifications for metal expandable Biliary Stents," dated February 5th, 1998, and internal risk assessment procedures, the following non-clinical tests were performed:
- Deployment Testing .
- Expansion Force Testing .
- Compression Force Testing .
- Dimensional Testing .
- Corrosion Testing .
The results demonstrate that the technological characteristics and performance criteria of the 5mm LifeStent® / XL Biliary Stent System fulfill the same specifications as the predicate devices and therefore perform as safely and as effectively as the legally marketed predicate device.
8. Conclusion:
The LifeStent® / XL Biliary Stent System is substantially equivalent to the legally marketed predicate devices, the LifeStent FlexStar Biliary Stent System (K053404) and the LifeStent FlexStar XL Biliary Stent System (K060487).
2/30792
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 30, 2013
C.R. Bard, Inc. % Christoph Wagner von Hoff Regulatory Affairs Bard Peripheral Vascular 1415 West 366 Street Tempe, AZ 85281
K130792 Re:
Trade/Device Name: LifeStent® Biliary Stent System LifeStent® XL Biliary Stent System Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Class II Product Code: FGE Dated: August 1. 2013 Received: August 2, 2013
Dear Christoph Wagner von Hoff,
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
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Page 2 – Christoph Wagner von Hoff
The safety and effectiveness of this device for use in the vascular system have not been established.
Furthermore, the indication for biliary use must be prominently displayed in all labeling. including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
If your device is classified (see above) into cither 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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Page 3 – Christoph Wagner von Hoff
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Christy L. Foreman -S
Christy L. Foreman Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K130792 |
|---|---|
| Device Name: | LifeStent® / XL Biliary Stent System |
| Indications for Use: | The LifeStent / XL Biliary Stent System is indicated for |
| use in the palliation of malignant strictures (neoplasms) in | |
| the biliary tree. |
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner -S
Bard Peripheral Vascular, Inc.
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