(29 days)
No
The summary describes a physical stent used for drainage and does not mention any software, image processing, or AI/ML terms.
Yes
The device is used to drain obstructed pancreatic ducts, which is a therapeutic intervention aimed at treating a medical condition.
No
Explanation: The device is used to drain obstructed pancreatic ducts, which is a therapeutic intervention, not a diagnostic one. It is a stent, a device used to maintain an open lumen in a bodily duct.
No
The device description explicitly states it is a "sterile, disposable device" and a "stent," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "drain obstructed pancreatic ducts." This is a therapeutic procedure performed in vivo (within the living body) to treat a medical condition.
- Device Description: The description confirms it's a device used for drainage, which is a physical intervention.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with patient specimens outside the body.
Therefore, the Modified Wilson-Cook Pancreatic Stent is a medical device used for a therapeutic purpose, not an IVD.
N/A
Intended Use / Indications for Use
Used to drain obstructed pancreatic ducts
Product codes (comma separated list FDA assigned to the subject device)
78 FGE
Device Description
The Modified Wilson-Cook Pancreatic Stent is a sterile, disposable device, used to drain obstructed pancreatic ducts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pancreatic ducts
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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 Pancreatic | ||
| Stent | 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.
1
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-Cook
Pancreatic Stent
(K911023) | Modified Wilson-Cook
Pancreatic Stent (Subject of
"Special" 510(k)) |
|--------------------------|--------------------------------------------------------|---------------------------------------------------------------------------|
| Intended Use | Drain obstructed pancreatic
ducts. | Drain obstructed pancreatic
ducts. |
| Stent | Polyethylene | Polycarbonate based
Polyurethane |
| Introducer
Components | 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, 10 | |
| Stent Length: 1-15 cm | Stent French Sizes: 6, 8, 10 | |
| Stent Length: 4-24 cm | ||
| Introducer | ||
| Components | Pushing Catheter | |
| Wire Guide | Pushing Catheter | |
| Guiding Catheter | ||
| Wire 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.
2
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
3
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 |
|---|---|
| --------------- | --------- |