(88 days)
Not Found
No
The description focuses on the mechanical function of a balloon catheter for dilation and does not mention any computational or learning capabilities.
Yes
The device is intended to dilate strictures in the biliary tree, which is a therapeutic intervention.
No
The device is intended to dilate strictures in the biliary tree, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical catheter with a balloon, which is a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "dilate strictures in the biliary tree." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a physical catheter with a balloon designed for mechanical dilation within the biliary tree.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (in glass, or outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (in the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
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.
Product codes
78 KNQ, 78 FGE
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tree
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUN 2 5 2004
Page 1 of 1
ATTACHMENT E: 510(k) Summary
| SPONSOR: | Wilson-Cook Medical
4900 Bethania Station Road
Winston-Salem, NC 27105 |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Marge Walls-Walker
Requlatory 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 Balloon
Biliary Dilation Balloon
Dilator, Esophageal, Class II 78 KNQ
21 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 is
intended to dilate strictures in the biliary tree.
This device is supplied sterile and intended for
single use |
| DEVICE DESCRIPTION: | 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 |
| COMPARISON OF CHARACTERISITICS: | We believe the proposed device to be
substantially equivalent to the named predicates
in terms of Intended Use, Indications for Use,
performance characteristics tested, balloon
diameter and length available and
biocompatibility. |
| PERFORMANCE DATA: | 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. |
1
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.
2
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
3
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______________________________________________________________________________________________________________________________________________________________