(29 days)
Used to drain obstructed pancreatic ducts
The Modified Wilson-Cook Pancreatic Stent is a sterile, disposable device, used to drain obstructed pancreatic ducts.
The provided text is a 510(k) summary for a medical device modification (Wilson-Cook Pancreatic Wedge Stent). While it discusses safety, effectiveness, and design verification, it does not include a detailed study with specific acceptance criteria and reported device performance metrics in the format requested.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states: "All results obtained during our Design Verification met our predetermined acceptance criteria for this product line." However, it does not provide a table with specific, quantifiable acceptance criteria or the numerical results of the performance.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "dimensional and functional testing" during Design Verification but does not specify the sample size of devices used in these tests. The data provenance is not specified beyond being "internal procedures."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided. The testing appears to be internal engineering/design verification rather than a clinical study requiring expert ground truth assessment.
4. Adjudication Method for the Test Set:
Not applicable, as this was not a study involving expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not performed. This document focuses on a device modification's substantial equivalence to a predicate device, not on assessing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a medical device (stent), not an algorithm or AI system.
7. The Type of Ground Truth Used:
For the design verification, the "ground truth" would be established by engineering specifications, material standards, and functional requirements. For biocompatibility, it references an "extensive history of use in similar patient contacting medical devices and as applicable biocompatibility test results," implying adherence to established biocompatibility standards.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of What Can Be Extracted from the Document:
- Acceptance Criteria (Implied): The device underwent "dimensional and functional testing to ensure the performance and design integrity," and "All results obtained during our Design Verification met our predetermined acceptance criteria for this product line." The specific criteria are not detailed but relate to the device's physical and functional properties.
- Study That "Proves" Device Meets Criteria: The "Design Control/Risk Analysis/Design Verification" section describes the process. This involved:
- Design control activities in accordance with 21CFR § 820.30.
- Risk analysis identifying risks relative to performance requirements, including failure mode, effect of failure, severity, cause, rate of occurrence, and control elements.
- Design verification through "dimensional and functional testing."
- Ground Truth for Verification: Engineering specifications, material properties, and functional requirements. Biocompatibility relies on historical use and test results.
- Key Differences from Predicate Device: Changes in stent material (Polyethylene to Polycarbonate based Polyurethane), introducer components (Polyethylene to Polytetrafluoroethylene), stent configuration (Pigtail ends to Tapered ends), French sizes, and stent length.
Conclusion:
The provided 510(k) summary asserts that the modified device met its predetermined acceptance criteria through design verification activities. However, it does not present these criteria or the objective performance data in a detailed, quantifiable manner that would allow for a direct filling of the requested table. The document focuses on regulatory compliance and substantial equivalence rather than a detailed performance study with statistical results as might be expected for an AI/software device.
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2/12/99
990130
pg 1 of 2
- SPECIAL 510 (K) : DEVICE MODIFICATION FOR THE WILSON-COOK PANCREATIC RE: STENT
510(k) Summary of Safety & Effectiveness J.
Submitted By: Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem, NC 27105
Device Description: The Modified Wilson-Cook Pancreatic Stent is a sterile,
disposable device, used to drain obstructed pancreatic ducts.
Trade Name: Wilson-Cook Pancreatic Wedge Stent
Pancreatic Stent Common/Usual Name:
Classification Name/Code: Catheter, Biliary, GU/78 FGE
FDA has classified similar devices as Class II as per 21 CFR § Classification: 876.5010. This device falls within the purview of the theGastroenterology and Urology Devices Panel.
Establishment Registration Number: 1037905
- Validated EO cycle in accordance with AAMI Standard 11135 using an Sterility: SAL of 106.
- No performance standards applicable to Biliary Catheters Performance Standards: have been established by the Food and Drug Administration.
- Used to drain obstructed pancreatic ducts. Intended Use:
Predicate Devices:
| Predicate Device | Manufacturer | Document Control Number |
|---|---|---|
| Wilson-Cook PancreaticStent | Wilson-Cook Medical Inc. | K900923 |
Substantial Equivalence:
The Modified Wilson-Cook Pancreatic Stent is substantially equivalent to the referenced predicate devices in that it is similar with respect to technological characteristics and intended use.
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SPECIAL 510 (K) : DEVICE MODIFICATION FOR THE WILSON-COOK PANCREATIC RE: STENT
pg 2 of ..
510(k) Summary of Safety & Effectiveness (continued) J.
| Beadthene Wilson-CookPancreatic Stent(K911023) | Modified Wilson-CookPancreatic Stent (Subject of"Special" 510(k)) | |
|---|---|---|
| Intended Use | Drain obstructed pancreaticducts. | Drain obstructed pancreaticducts. |
| Stent | Polyethylene | Polycarbonate basedPolyurethane |
| IntroducerComponents | Polyethylene | Polytetrafluoroethylene |
| Sterility | Sterile, Disposable | Sterile, Disposable |
| Wire Guide | Accepts .035" wire guide | Accepts .035" wire guide |
| Stent Configuration | Pigtail ends for retention | Tapered ends for retention |
|---|---|---|
| Dimensions | Stent French Sizes: 5,7,9, 10Stent Length: 1-15 cm | Stent French Sizes: 6, 8, 10Stent Length: 4-24 cm |
| IntroducerComponents | Pushing CatheterWire Guide | Pushing CatheterGuiding CatheterWire Guide (Available separately) |
Biocompatibility: Reasonable assurance of biocompatibility for the patient contacting materials has been established through an extensive history of use in similar patient contacting medical devices and as applicable biocompatibility test results.
Design Control/Risk Analysis/Design Verification:
Design Control, risk analysis and design verification activities for the subject of this 510(k) have been conducted in accordance with all applicable internal procedures. The design control process employed is inclusive of the elements as stipulated by 21CFR § 820.30, as applicable to the project. The risk analysis performed identified the risks relative to the performance requirements, as specified by our internal procedure for Risk Analysis. The failure mode, effect of failure, severity, potential cause, rate of occurrence, design control element/production controls to eliminate, the potential to detect and our recommended actions were also documented. During Design Verification, dimensional and functional testing to ensure the performance and design integrity of this product line was conducted. All results obtained during our Design Verification met our predetermined acceptance criteria for this product line.
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Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure, with three lines representing the head, body, and legs. The figure is facing to the right and appears to be in motion.
FEB 1 2 1999
Ms. Paula Joyce QA/RA Manager Wilson Cook® Medical Inc. 4900 Bethania Station Road Winston-Salem, NC 27105 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K990130 Wilson-Cook® Pancreatic Wedge Stent Dated: January 13, 1999 Received: January 14, 1999 Regulatory Class: II 21 CFR 876.5010/Procode: 78 FGE
Dear Ms. Joyce:
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 redassified 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. 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 III (Special Controls) or dass III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 submission 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 requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
ﺮ ﺍ
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1_of_1_
510(k) Number (if known):__K990130 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Device Name:_Wilson-Cook Pancreatic Wedge Stent
Indications For Use:
Used to drain obstructed pancreatic ducts
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use V(Per 21 CFR 801.109) | OR Over-The-Counter Use__(Optional Format 1-2-96) |
|---|---|
| --------------------------------------------- | -------------------------------------------------------- |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K990130 |
|---|---|
| --------------- | --------- |
§ 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.