(88 days)
The Wilson-Cook Biliary Dilation Balloon is intended to dilate strictures in the biliary tree. This device is supplied sterile and intended for single use.
The proposed Wilson-Cook Biliary Dilation Balloon is a triple lumen catheter with a balloon mounted on the distal tip. The three lumens allow one lumen for wire guide access and two lumens for inflation/deflation of the balloon when placed through the accessory channel of an endoscope. The balloon is inflatable with water to nominal pressures to exert force on biliary strictures resulting in stricture dilation. It is offered in a variety of diameters to accommodate a range of biliary strictures
The provided text describes a 510(k) premarket notification for a medical device called the "Wilson-Cook Biliary Dilation Balloon." It outlines the device's intended use, description, and comparison to predicate devices, focusing on the substantial equivalence argument for regulatory approval. However, it does not contain any information regarding specific acceptance criteria, study details, or performance metrics beyond a general statement about "Non-Clinical Testing."
Therefore, I cannot provide the requested table or detailed answers to questions 2 through 9.
Here's an explanation of what can be extracted and why the other information is missing:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | The document states "Non-Clinical Testing was performed on characteristics of the balloon with respect to The FDA Guidance for Urological Balloons and additional tests as needed to verify safety and performance." However, no specific performance data or numerical results are provided. |
Explanation for missing data:
The 510(k) summary provided is a high-level overview for regulatory submission. It focuses on demonstrating substantial equivalence to existing predicate devices. While it mentions that "Non-Clinical Testing" was performed to verify safety and performance, it does not include the detailed results of engineering tests, bench tests, or clinical studies that would contain specific acceptance criteria and performance data (e.g., burst pressure, inflation/deflation times, material strength, fatigue testing, etc.). These details are typically found in the full 510(k) submission, which is much more extensive than this summary.
As a result, I cannot answer questions 2 through 9 because the provided text does not contain the necessary information. This includes:
- Sample size used for the test set and the data provenance: Not mentioned. The testing was non-clinical, so there wouldn't be a "test set" in the sense of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this was non-clinical testing.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned, and highly unlikely for a device of this nature in a 510(k) submission, especially a non-clinical one.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
- The type of ground truth used: Not explicitly stated beyond "safety and performance" verified through non-clinical testing.
- The sample size for the training set: Not applicable, as this is a physical device, not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory approval document for a physical medical device, not an AI/software device that would typically involve the detailed study characteristics you've requested. The "Performance Data" section briefly notes that non-clinical testing was done, but does not elaborate on the specific criteria or results.
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JUN 2 5 2004
Page 1 of 1
ATTACHMENT E: 510(k) Summary
| SPONSOR: | Wilson-Cook Medical4900 Bethania Station RoadWinston-Salem, NC 27105 |
|---|---|
| CONTACT/SUBMITTER: | Marge Walls-WalkerRequlatory Affairs Specialist[336] -744-0157 Ex.290 |
| DATE OF SUBMISSION: | March 25, 2004 |
| DEVICE: | Biliary Dilation Balloon |
| Trade Name:Common Name:Classification: | Wilson-Cook Biliary Dilation BalloonBiliary Dilation BalloonDilator, Esophageal, Class II 78 KNQ21 CFR § 876.5365 |
| PREDICATE DEViCES: | Wilson-Cook Quantum T.T.C.Dilation Balloon(K935094)Microvasive RX Biliary Balloon Dilation Catheter(K001338) |
| INTENDED USE: | Wilson-Cook's Biliary Dilation Balloon isintended to dilate strictures in the biliary tree.This device is supplied sterile and intended forsingle use |
| DEVICE DESCRIPTION: | The proposed Wilson-Cook Biliary DilationBalloon is a triple lumen catheter with a balloonmounted on the distal tip. The three lumensallow one lumen for wire guide access and twolumens for inflation/deflation of the balloon whenplaced through the accessory channel of anendoscope. The balloon is inflatable with waterto nominal pressures to exert force on biliarystrictures resulting in stricture dilation. It isoffered in a variety of diameters toaccommodate a range of biliary strictures |
| COMPARISON OF CHARACTERISITICS: | We believe the proposed device to besubstantially equivalent to the named predicatesin terms of Intended Use, Indications for Use,performance characteristics tested, balloondiameter and length available andbiocompatibility. |
| PERFORMANCE DATA: | Non-Clinical Testing was performed oncharacteristics of the balloon with respect to TheFDA Guidance for Urological Balloons andadditional tests as needed to verify safety andperformance. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 2004
Ms. Marge Walls-Walker Regulatory Affairs Specialist Wilson-Cook Medical, Inc. GI Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105
Re: K040800
Trade/Device Name: Wilson-Cook Biliary Dilation Balloon Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: March 25, 2004 Received: March 29, 2004
Dear Ms. Walls-Walker:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your becasin 3 re(s) press.
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 for use stated in the endobure) to regard comment date of the Medical Device Amendments, or to commerce prior to may 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices mat have occh rochasined in avee approval of a premarket approval application (PMA). and Cosmetic Act (10t) that do not request to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the fiest labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is classified (500 a0070) in Friday major regulations affecting your device can be it may of Subject to adultional controlians, 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 ITTCase oc actived that I Dr Srissantes or our device complies with other requirements of the Act mat IDA has made a determination administered by other Federal agencies. You must of any Federal statures and roganders including, but not limited to: registration and listing Comply with an the Act 5 requirement Part 801); good manufacturing practice requirements as set (21 CFR Part 607), lubonus (21 CFR Part 820); and if applicable, the electronic forth in the quanty by stolins (QB) rog (sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k)
The are and and and and finding of substantial equivalence of vour device to a This letter will allow you to begin matkenes your active of your device of your device to a legally
premarket notification. The FDA includification for vour device and thus, premarket notification. The FDA inding of substantial ogardents of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (2) CFR Part 801), please
r and the may of the following for fith of the following numbers, based on If you desire spective advice for your device on our lasting of your and on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advice, please contact the Additionally, for questions on the promotion and the regulation entitled, "Missionaling
Office of Compliance at (301) 594-4639. Association may obtain . Other general Office of Compliance at (301) 394-4057. Assistence of Commary obtain. Other general by reference to premarket notificans under the Act may be obtained from the Division of Small
information on your responsibilities under the Act may be rits toll fire number information on your responsibilités mire Assistance at its tall-free murber (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free managemana Manufacturers, International and Collistation and Collist.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Numbêr (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Wilson-Cook Biliary Dilation Balloon
indications for Use:
The Wilson-Cook Biliary Dilation Balloon is intended to dilate strictures of the biliary tree. This The Wilson Ocon Sterile and intended for single use only.
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE-IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Only
(Per 21 CFR § 801.109)
OR
David A. Legnon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
Over-the-Counter______________________________________________________________________________________________________________________________________________________________
§ 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.