(30 days)
Not Found
No
The device description and intended use focus on a mechanical and electrical device for surgical incision, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used to make incisions in the papilla, which is a therapeutic intervention to facilitate cannulation of the biliary tree.
No
The device description indicates it is used for surgical incisions and cannulation, which are therapeutic procedures, not diagnostic ones.
No
The device description clearly outlines physical components (tubing, needle, handle, cutting wire) and its function involves physical interaction with tissue via electrocautery, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Wilson-Cook Needle Knife Papillotome is a surgical instrument used within the body (in vivo) to access the common bile duct by making incisions in the papilla. It is a therapeutic and procedural device, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states it's for "accessing the common bile duct when standard cannulation methods have been exhausted," which is a procedural action, not a diagnostic one.
- Device Description: The description details its physical components and how it's used to make incisions, further confirming its role as a surgical tool.
Therefore, the Wilson-Cook Needle Knife Papillotome falls under the category of a surgical or procedural device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Wilson-Cook Needle Knife Papillotome is used for accessing the common bile duct when standard cannulation methods have been exhausted. This device is supplied sterile and is intended for single use only.
Product codes
79 GEI, 78 KNS
Device Description
The Wilson-Cook Needle Knife Papillotome consists of a single lumen tubing, 23 gauge needle, and a papillotome handle. This device is designed for insertion through the accessory channel of an endoscope. The catheter is advanced through the accessory channel positioning the needle knife near the papillary orifice. The device is connected to an electrocautery unit via an active cord. The current from the electrocautery unit is passed through the cutting wire to the distal end of the papillotome thus allowing the needle knife to make small incisions in the papilla. Once the appropriate incision has been made the needle knife may be retracted allowing cannulation of the biliary tree.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
common bile duct
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)
Testing: Biocompatibility has been established for the patient contacting materials through a history of use in other similar medical devices. Functional testing conducted per approved protocol. Samples were subjected to visual, dimensional, and functional analysis. All samples were deemed acceptable, in that test specifications were met.
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.
Not Found
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
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
K 9726 74 Pg 183
Page 9 of 11
PREMARKET NOTIFICATION FOR THE WILSON-COOK NEEDLE RE: KNIFE PAPILLOTOME
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS ್ಕೋ
AUG | 5 10077
Submitted By:
Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem, NC 27105
Device Description:
The Wilson-Cook Needle Knife Papillotome consists of a single lumen tubing, 23 gauge needle, and a papillotome handle. This device is designed for insertion through the accessory channel of an endoscope. The catheter is advanced through the accessory channel positioning the needle knife near the papillary orifice. The device is connected to an electrocautery unit via an active cord. The current from the electrocautery unit is passed through the cutting wire to the distal end of the papillotome thus allowing the needle knife to make small incisions in the papilla. Once the appropriate incision has been made the needle knife may be retracted allowing cannulation of the biliary tree.
| Trade Name: | Wilson-Cook Needle Knife Papillotome |
|---|---|
| Common/Usual Name: | Needle Knife Papillotome |
| Classification Name: | Device, Electrosurgical, Cutting and Coagulation & Accessories; 79 GEI |
| Classification: | FDA has classified similar devices as Class II, per 21 CFR § 878.4400. This device falls within the purview of the Gastroenterology and Urology Devices Panel. |
| Performance Standards: | To the best of our knowledge, performance standards for this device do not exist. |
| Sterility: | Validated EO cycle, following the AAMI Overkill Method to SAL 10 -6 . |
| Intended Use: | The Wilson-Cook Needle Knife Papillotome is used for accessing the common bile duct when standard cannulation methods have been exhausted. |
| Predicate Device: |
Predicate Device:
1
K 9 726 74
Page 10 of 11
PREMARKET NOTIFICATION FOR THE WILSON-COOK NEEDLE RE: KNIFE PAPILLOTOME
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (continued) J.
| DEVICE
CHARACTERISTIC | WILSON-COOK
NEEDLE KNIFE
PAPILLOTOME
[Subject of 510(K)] | ENDOVATIONS, INC.
.035" PRE-CUT
NEEDLE KNIFE
(K934315) |
|----------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Intended Use | Accessing the common bile
duct when standard
cannulation methods have
been exhausted. | Accessing the common bile
duct when standard
cannulation methods have
been exhausted. |
| Introducer Catheter/Sheath | Polytetrafluoroethylene | Polytetrafluoroethylene |
| Handle Style | 3-Ring | 3-Ring |
| Needle | 304 Stainless Steel | 304 Stainless Steel |
| Needle Gauge | 23 GA | 23 GA |
| Needle Extension | 4 mm | 4 mm |
| Outer Sheath | 5 French | .035" |
| Distal Tip | $1\frac{1}{2}$ " Radius Curve | $1\frac{1}{2}$ " Radius Curve |
| Length | 200 cm | 210 cm |
| Number of Lumens | 1 | 2 |
| Sterility | Sterile, disposable | Sterile, disposable |
Testing:
Biocompatibility has been established for the patient contacting materials through a history of use in other similar medical devices.
Functional testing conducted per approved protocol. Samples were subjected to visual, dimensional, and functional analysis. All samples were deemed acceptable, in that test specifications were met.
2
Image /page/2/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract, curved shapes that resemble human figures or flowing lines. The overall design is simple and conveys a sense of government authority and public service.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 1997
Ms. Linda Hensley Regulatory Affairs Specialist Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-Salem, North Carolina 27105 Re: K972674
Wilson-Cook Needle Knife Papillotome Dated: July 11, 1997 ...... . . Received: July 16, 1997 Regulatory Class: II 21 CFR §876.4300/Product Code: 78 KNS
Dear Ms. Hensley:
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 use stated in the enclosure) to 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, 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class 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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 Radiation Control provisions, or other Federal laws or regulations.
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/edrhidsmain.html".
Sincerely yours.
W. D'Liau Yzu
William D'Lieu, Ph.D.
Lillian Yin, Ph.D. 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
15972674 510(k) Number (if known):
Device Name: Wilson-Cook Needle Knife Papillotome
Indications For Use: The Wilson-Cook Needle Knife Papillotome is used for accessing the common bile duct when standard cannulation methods have been exhausted. This device is supplied sterile and is 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)
Peter R. Sather
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K172274
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)