(32 days)
The Guidant MEGALINK™ Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree.
The Guidant MEGALINK™ Biliary Stent is a balloon-expandable stent designed to be placed percutaneously into the common bile duct and intended to treat malignant strictures in the biliary tree. The stent is for single use only and is a permanent implant. The Guidant MEGALINKTM Biliary Stent is fabricated from a single piece of 316L medical grade stainless steel tubing which conforms to ASTM Standard F-138-92 Grade 2. The stent is comprised of a scries of multiple rings with multiple links aligned along a common longitudinal axis. Each ring is approximately 2 mm long. The number of rings per stent is dependent upon the length of the stent, i.e., 8 rings for 18 mm, 13 rings for 28 mm and 17 rings for 38mm. The nominal strut thickness is .0060" and the nominal strut width is .00575". The stent is balloon-expandable with an expansion range from 6 - 10 mm in diameter for the 58 mm length stents. The stent is designed to be hand crimped onto a percutaneous transluminal angioplasty (PTA) balloon catheter for stent delivery and deployment in the biliary tree. The stent may be post dilated with a PTA balloon catheter to ensure good stent deployment. The maximum post dilatation diameter for the 58 mm stent length is 11 mm.
The Guidant MEGALINK™ Biliary Stent is a medical device designed for the palliation of malignant strictures in the biliary tree. The provided document, K991032, primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a comprehensive study for novel device performance. However, based on the available information, we can infer some aspects.
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "In vitro bench testing was performed to demonstrate that the Guidant MEGALINK Biliary stent met the acceptance criteria and performed similar to the predicated evices. The functional tests met product specifications."
This indicates that specific "product specifications" served as acceptance criteria. Unfortunately, the document does not enumerate these criteria or provide quantitative performance results. It only broadly states that the device "met the acceptance criteria" and "performed similar to the predicated devices."
| Acceptance Criteria (Inferred from "Product Specifications") | Reported Device Performance |
|---|---|
| Material Composition: Conformance to ASTM Standard F-138-92 Grade 2 (316L medical grade stainless steel tubing) | Met |
| Physical Dimensions: (e.g., nominal strut thickness, nominal strut width, stent length based on number of rings) | Met |
| Balloon-Expandability: Expansion range from 6 - 10 mm in diameter (for 58 mm length stents). Maximum post dilatation diameter of 11 mm (for 58 mm stent length). | Met (Functional tests met product specifications) |
| Functional Properties: (Includes implied properties like structural integrity, radial force, fatigue resistance, deliverability, etc. as per typical stent testing) | Met (Functional tests met product specifications) |
| Biocompatibility: (Inferred from "Technological Characteristics" being identical or substantially equivalent to predicate device) | Met (Similar to predicate devices) |
| Sterilization: (Inferred from "Technological Characteristics" being identical or substantially equivalent to predicate device) | Met (Similar to predicate devices) |
| Packaging: (Inferred from "Technological Characteristics" being identical or substantially equivalent to predicate device) | Met (Similar to predicate devices) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only mentions "In vitro bench testing."
- Data Provenance: Not specified. It's likely that the testing was conducted by Guidant Corporation (manufacturer) in a laboratory setting, but the country of origin is not explicitly stated. The testing was retrospective in the sense that the device had already been manufactured for testing, but it wasn't a retrospective analysis of clinical patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no information about experts establishing ground truth for the in vitro bench testing. Bench testing typically relies on predefined engineering specifications and measurement techniques, not expert consensus on qualitative observations like in clinical imaging studies.
4. Adjudication Method for the Test Set
Not applicable for in vitro bench testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of data (e.g., medical images) by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states the study was "In vitro bench testing." This is not a clinical study involving human readers or comparative effectiveness with or without AI assistance. This device predates widespread AI in medical devices by decades.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a physical medical implant, not a software algorithm.
7. The Type of Ground Truth Used
For the in vitro bench testing, the "ground truth" was established based on:
- Engineering Specifications: Predefined design parameters, material standards (e.g., ASTM F-138-92 Grade 2), and functional requirements for stent performance (e.g., expansion diameter, strut dimensions).
- Predicate Device Performance: The device's performance was evaluated against that of the predicate devices (Guidant MEGALINK™ Biliary Stent K983075), implying that the predicate's known performance served as a benchmark for equivalence.
8. The Sample Size for the Training Set
Not applicable. The device is a physical stent, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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4/30/99
K991032
page 1/2
510(k) Summary
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| 1. | Submitter's Name: | Guidant CorporationAdvanced Cardiovascular Systems, Inc. |
|---|---|---|
| 2. | Submitter'sAddress: | 3200 Lakeside DriveSanta Clara, CA 95054 |
| 3. | Telephone: | 408-235-4174 |
| 4. | Fax: | 408-235-3743 |
| 5. | Contact Person: | Kobby Dankwah |
| 6. | Date Prepared: | March 22, 1999 |
| 7. | Device TradeName: | Guidant MEGALINK™ Biliary Stent |
| 8. | Device CommonName: | Biliary Stents |
| 9. | DeviceClassificationName: | Biliary Catheter (78 FGE) |
-
Predicate Device:
-
Device Description:
The Guidant MEGALINK™ Biliary Stent is a balloon-expandable stent designed to be placed percutaneously into the common bile duct and intended to treat malignant strictures in the biliary tree. The stent is for single use only and is a permanent implant. The Guidant MEGALINKTM Biliary Stent is fabricated from a single piece of 316L medical grade stainless steel tubing which conforms to ASTM Standard F-138-92 Grade 2.
Guidant MEGALINKTM Biliary Stent (K983075)
The stent is comprised of a scries of multiple rings with multiple links aligned along a common longitudinal axis. Each ring is approximately 2 mm long. The number of rings per stent is dependent upon the length of the stent, i.e., 8 rings for 18 mm, 13 rings for 28 mm and 17 rings for 38mm. The nominal strut thickness is .0060" and
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the nominal strut width is .00575". The stent is balloon-expandable with an expansion range from 6 - 10 mm in diameter for the 58 mm length stents. The stent is designed to be hand crimped onto a percutaneous transluminal angioplasty (PTA) balloon catheter for stent delivery and deployment in the biliary tree. The stent may be post dilated with a PTA balloon catheter to ensure good stent deployment. The maximum post dilatation diameter for the 58 mm stent length is 11 mm.
-
- Intended I Ise:
The Guidant MEAGALINK™ Biliary stent is indicated for the palliation of malignant strictures in the biliary tree.
- Intended I Ise:
-
- Technological Characteristics:
Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization, and packaging are identical or substantially equivalent to the currently marketed predicate devices. The design modifications of the new guide wires compared to that of the predicate wire are the lengths of the stents.
- Technological Characteristics:
14. Performance Data:
In vitro bench testing was performed to demonstrate that the Guidant MEGALINK Biliary stent met the acceptance criteria and performed similar to the predicated evices. The functional tests met product specifications.
15. Conclusions
Since the new stent length have the same intended use, technological characteristics, performance properties, identical sterilization and packaging, process and no new safety or effectiveness issucs, the Guidant MEGALINKTM Biliary Stent ( 58 mm stent length) may be considered substantially equivalent to the predicate Guidant MEGALLNKTM Biliary Stent (18 mm, 28 mm, and 38 mm stent length),
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 1999
Mr. Kobby Dankwah Manager, Regulatory Affairs Guidant Corporation P.O. Box 58167 Santa Clara, California 95052
Re: K991032 Guidant MEGALINK™ Biliary Stent, 58 mm Length Dated: March 26, 1999 Received: March 29, 1999 Regulatory Class: II
21 CFR 876.5010 Product Code: 78 FGE
Dear Mr. Dankwah:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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.
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:
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.
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Page 2 - Mr. Kobby Dankwah
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 femarks) Appto tal), it the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good A substantiany equivalences, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (I'DA) will verify such assumptions. Failure to mspections, in 1 ou and Dation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device The I Dri mianing of business of backers and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.
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.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrlv/dsma/dsmamain.html".
Sincerely yours.
Ph.D., M.D Susan Alr 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): K991032
Device Name: Guidant MEGALINK™ Biliary Stent, 58 mm Length
FDA's Statement of the Indications for Use for device:
The Guidant MEGALINK™ Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree.
David A. Sezman
bdominal. E
Prescription Use
(Per 21 CFR 801.109) OR
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.