(30 days)
The DYNALINK™ .035 Biliary Self-Expanding Stent System is indicated for palliation of malignant strictures in the biliary tree.
The DYNALINK™ .035 Biliary Self-Expanding Stent System is a catheter designed to deploy a self-expanding nickel titanium (Nitinol) stent into the biliary tree. The catheter body is constructed from two coaxial members. The inner member (IM) is compatible with a 0.035" guide wire in an over-the-wire configuration. The outer member (OM) is composed of a distal sheath that constrains the unexpanded stent, an outer shaft over most of the catheter length, and a proximal handle used to retract the assembly. The distal end of the delivery system includes the DYNALINK™ Biliary Self-Expanding Stent in its constrained state within the restraining sheath, a soft, low profile tip, and two radi-opaque markers to indicate the proximal and distal ends of the stent. At the proximal end of the delivery system is a pull-back handle that is free to slide axially, and a luer fitting that is rigidly fixed to the shaped housing. The DYNALINK™ Biliary Self-Expanding Stent is fabricated from superelastic nickel titanium (Nitinol). The stent is comprised of a series of rings that are aligned along a common longitudinal axis. The stent is laser cut from a tube of superelastic nitinol. All of the stent diameters are cut with a similar stent pattern. The stent is expanded and heat-treated to be stable at the body temperature. The stents are electropolished to obtain a smooth finish with a thin layer of titanium oxide on the surface. The DYNALINK™ Biliary Self-Expanding Stent is available in diameters of 5-10 mm and in lengths of 28, 38, and 56 mm.
Here's an analysis of the provided text regarding the acceptance criteria and study for the DYNALINK™ .035 Biliary Self-Expanding Stent System:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria and corresponding performance metrics from a study are not explicitly stated. The document primarily focuses on establishing substantial equivalence to a predicate device and broadly mentions performance data without quantitative details.
| Acceptance Criteria Category | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|---|
| Effectiveness (Palliation of Malignant Strictures) | Reduction/elimination of biliary stricture, improved bile flow, relief of symptoms, stent patency rate, etc. | (Not provided in the summary, likely from clinical trial data not included). |
| Safety | Low complication rates (e.g., migration, occlusion, perforation, infection, adverse tissue reaction) | (Not provided in the summary, likely from clinical trial data not included). |
| Mechanical Performance (In Vitro) | Stent expansion force, radial strength, fatigue resistance, chronic outward force, recoil, deliverability, deployment accuracy, integrity during deployment. | "demonstrated through data collected from in vitro bench tests and analyses." (Specific metrics not disclosed). |
| Biocompatibility | No adverse biological reactions. | "substantially equivalent to the currently marketed predicate devices." (Implied by equivalence to predicate). |
| Sterilization | Sterility assurance level. | "substantially equivalent to the currently marketed predicate devices." (Implied by equivalence to predicate). |
| Packaging | Maintenance of sterility and device integrity. | "substantially equivalent to the currently marketed predicate devices." (Implied by equivalence to predicate). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a sample size for any "test set." The performance data mentioned is from "in vitro bench tests and analyses."
- Data Provenance: The data provenance is "in vitro bench tests and analyses." There is no mention of human clinical data, animal studies, or specific geographic origins (ee.g., country of origin).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts used to establish ground truth for a test set, as the performance evaluation cited is limited to "in vitro bench tests and analyses." This type of testing typically relies on engineering specifications and laboratory measurements rather than expert clinical consensus.
4. Adjudication Method for the Test Set
As no "test set" relying on human interpretation or ground truth requiring adjudication is mentioned, there is no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not mentioned in this 510(k) summary. The provided text details in vitro bench testing for substantial equivalence, not a comparative clinical effectiveness study involving human readers or AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not Applicable. This device is a physical medical device (stent system), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
For the "in vitro bench tests and analyses," the "ground truth" would be the engineering specifications, material properties, and physical measurements obtained through standardized laboratory testing. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this particular submission.
8. The Sample Size for the Training Set
Not Applicable. As this is a physical medical device and not an AI algorithm, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no AI algorithm or training set, this question is not relevant.
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JUL 1 8 2001
Koll 881
510(k) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| Submitter's Name: | Guidant CorporationAdvanced Cardiovascular Systems, Inc. |
|---|---|
| Submitter's Address: | 3200 Lakeside DriveSanta Clara, CA 95052 |
| Telephone:Fax: | 408/845-1067408/845-3743 |
| Contact Person: | Saba Modjarrad |
| Date Prepared: | June 15, 2001 |
| Device Trade Name: | DYNALINK™ .035 Biliary Self-Expanding Stent System |
| Device Common Name: | Biliary Stent |
| Device Classification Name: | Biliary Catheter |
Class II Device Classification:
Summary of Substantial Equivalence:
The design, materials, method of delivery and intended use features of DYNALINK™ .035 Biliary Self-Expanding Stent System with stents in diameters of 5-10 mm and lengths of 28, 38, and 56 mm are substantially equivalent with regard to these features in the predicate device, the DYNALINK™ Biliary Self-Expanding Stent System (K002143, October 12, 2000).
Device Description:
The DYNALINK™ .035 Biliary Self-Expanding Stent System is a catheter designed to deploy a self-expanding nickel titanium (Nitinol) stent into the biliary tree.
The catheter body is constructed from two coaxial members. The inner member (IM) is compatible with a 0.035" guide wire in an over-the-wire configuration. The outer member (OM) is composed of a distal sheath that constrains the unexpanded stent, an outer shaft over most of the catheter length, and a proximal handle used to retract the assembly.
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Koll881 41
The distal end of the delivery system includes the DYNALINK™ Biliary Self-Expanding The distal end of the defreery by steath restraining sheath, a soft, low profile tip, Stellt neid in hs constramod state of the stories and distal ends of the stent. At the and two fault-opaque markers to muleate and present is composed of a pull-back handle proximal end of the dell rery byseeils) it thandle to slide axially, and a luer fitting that is rigidly fixed to the shaped housing.
The DYNALINK™ Biliary Self-Expanding Stent is fabricated from superelastic nickelthe DITATIER - Dimary - Biliary Self-Expanding Stent is comprised of a thamulif (intinor). Things that are aligned along a common longitudinal axis.
The stent is laser cut from a tube of superelastic nitinol. All of the stent diameters are cut rife sicil is its its from a table e stent is expanded and heat-treated to be stable at the with simmal stents patter. The stents are electropolished to obtain a smooth finish with a thin layer of titanium oxide on the surface.
The DYNALINK™ Biliary Self-Expanding Stent is available in diameters of 5-10 mm and in lengths of 28, 38, and 56 mm.
Intended Use:
The DYNALINK™ .035 Biliary Self-Expanding Stent System is indicated for palliation of malignant strictures in the biliary tree.
Technological Characteristics:
Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization and packaging are substantially equivalent to the currently marketed predicate devices. The design modification of the new biliary stent system compared to that of the predicate biliary stent system is the length of the stent.
Performance Data:
The safety and effectiveness of the DYNALINK™ .035 Biliary Self-Expanding Stent System has been demonstrated through data collected from in vitro bench tests and analyses.
Page 2|2
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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with three heads. The eagle is facing to the right and has its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2001
Ms. Saba Modjarrad Regulatory Affairs Coordinator Guidant Corporation Vascular Intervention Group 3200 Lakeside Drive Santa Clara, California 95054
Re: K011881
DYNALINK™ .035 Biliary Self-Expanding Stent System Regulatory Class: II 21 CFR §876.5010 Product Code: 78 FGE Dated: June 15, 2001 Received: June 18, 2001
Dear Ms. Modjarrad:
We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section - rots) notifications in the indications for use above and we nave delemined the uevices marketed in interstate comments on to devices th stated in the enclosure) to legally marked precised in one of the Amendments, or to devices that prox to May 26, 1970, the chaolinen date of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions Cosmetic Act (Act). You may, defectors, marited below. The general cools provisions of the provisions of the Act and the minutures stoons of devices, good manufacturing practice,
Act include requirements for annual registration, list in Act merade requireritions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this I he Office of Device Evaluation has detectified in the proposed labeling and that such use device will be used for an michded as the racitiation 513(i)(1)(E) of the Act, the following Could Cause nami." Ear in the Warnings section of the device's labeling:
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. Furthermore, the Indication for othary ase mast of promotional materials, in
including pouch, box, and carton labels, instructions for use, and other promotional materials, i meluding pouch, oox, and carvere, of a similar point size, and in bold print.
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Page 2 – Ms. Saba Modjarrad
If your device is classified (see above) into either class II (Special Controls) or class III
ng major reass If your device is classified (see above) into cities in controls. Existing major regulations
(Premarket Approval), it may be subject to such additions (Designal Rights Repro (Premarket Approval), it may be subject to such as a such the 21, Parts 800 to 895.
affecting your device can be found in the Code of Federal Regulations, Current Good affecting your device can be found intinues compliance with the Current Good A substantially equivalent decemmants, as set forth in the Quality System Regulation (OS) for Manufacturing Practice requirences, as our 820) and that, through periodic QS
Medical Devices: General regulation (21 CFR Part 820) and that, the accumptions Medical Devices: General regulation (21 CFR Far 020) will verify auch and on mptions. Failure to inspections, the Food and Drug Auministration in addition, FDA may publish .
comply with the GMP regulation may result in regulation. Recess note: this comply with the GMP regulation may result in the Federal Register. Please note: this further announcements concenting your arrants inn does not affect any obligation you might
response to your premarket notification submission the Flectronic Product response to your premarket nonmoution bac.Act for devices under the Electronic Product
have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Radiation Control provisions, of other Federal laws of regard to the market . This The FDA finding of substantial equivalence or your device to proceed to the market. This results in a classification for your device as described in your 510(k) premarket
letter will allow you to begin marketing your device as described letter will anow you to begin marketing your above is added to your labeling, as described.
Please note that the above labeling limitations are required by Section 513(i)(1)(2) of the Act. Please note that the above labeling innitations are required by and the modified in any way or removed from the device's labeling.
If you desire specific information about the application of other labeling requirements to your If you desire specific information about the upplied to the vitro diagnostic devices on the promotion and device (21 CFR Part 801 and additionally 807.10 for questions on the promotion and the Office of Compliance at (301) 394-4010. I Idalaof Compliance at (301) 594-4639. Also,
advertising of your device, please contact the Office of Compliance at (301) 594-46 advertising of your device, prease contier and on by reference to premarket notification's please note the regulation entition, "Albertainments" on the Act may be (21 CFK 9007.97). Other general Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K011881
Device Name: DYNALINK™ .035 Biliary Self-Expanding Stent System
FDA's Statement of the Indications For Use for device:
The DYNALINK™ .035 Biliary Self-Expanding Stent System is indicated for the palliation of malignant strictures in the biliary tree.
Brom
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
kol1881
Prescription Use V OR (Per 21 CFR 801.109)
Over-The-Counter Use_
§ 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.