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.

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.

AI/ML Overview

The provided documents describe the Wilson-Cook Needle Knife Papillotome and its 510(k) submission. However, the information available is limited regarding acceptance criteria and a structured study proving the device meets these criteria. Medical device 510(k) submissions, especially from this era (1997), typically focus on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies with detailed acceptance criteria as one might expect for a novel AI device today.

Based on the provided text, here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Established through a history of use in other similar medical devices for patient-contacting materials.
Sterility	Validated EO cycle, following AAMI Overkill Method to SAL 10-6.
Functional Performance	Functional testing conducted per approved protocol. All samples were deemed acceptable, with test specifications met.
Dimensional Specifications	Samples subjected to dimensional analysis; all deemed acceptable.
Visual Inspection	Samples subjected to visual inspection; all deemed acceptable.
Intended Use	Substantially equivalent to the predicate device for accessing the common bile duct when standard cannulation methods have been exhausted.

Missing Information: Specific quantitative acceptance criteria (e.g., "tensile strength must be > X N," "insertion force must be < Y N," "failure rate for particular function must be < Z%"). The document states "test specifications were met" but does not detail what those specifications were.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document states "Samples were subjected to visual, dimensional, and functional analysis." However, the exact number of samples used for this functional and dimensional testing is not specified.
Data Provenance: Not applicable in the context of device testing described. The testing appears to be internal engineering and bench testing, not clinical data from patients. There is no mention of country of origin or whether a retrospective/prospective study was conducted for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable as the document describes a physical medical device (papillotome) and its engineering/bench testing for substantial equivalence, not an AI or diagnostic device that requires expert consensus for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable for the same reasons as point 3. There is no mention of adjudicating expert opinions for a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. This device is a surgical instrument, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the physical attributes and performance (e.g., sterility, biocompatibility, functional testing), the "ground truth" would be established by engineering specifications, validated test protocols, and recognized standards (like AAMI for sterility) rather than clinical ground truth (pathology, expert consensus). Biocompatibility was established by "history of use in other similar medical devices," which serves as a form of established safety.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/algorithm device.

9. How the ground truth for the training set was established

This question is not applicable. There is no "training set" as this is not an AI/algorithm device.

Summary of Device and Evidence:

The Wilson-Cook Needle Knife Papillotome is a surgical instrument used to access the common bile duct.
The 510(k) submission focused on demonstrating substantial equivalence to a predicate device (ENDOVATIONS, INC. .035" PRE-CUT NEEDLE KNIFE) by comparing intended use and key device characteristics (materials, dimensions, sterility).
Evidence for meeting general safety and effectiveness relied on internal "functional testing conducted per approved protocol," visual and dimensional analysis, and validation of sterility processes. Biocompatibility was established by prior use of similar materials.
The document does not contain details typical of an AI device submission, such as specific performance metrics like sensitivity/specificity for a diagnostic task, expert review, clinical study data with patient outcomes, or detailed sample sizes for such studies. The regulatory approval (K972674) was based on a finding of substantial equivalence.

Summary

{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:

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.

DEVICECHARACTERISTIC	WILSON-COOKNEEDLE KNIFEPAPILLOTOME[Subject of 510(K)]	ENDOVATIONS, INC..035" PRE-CUTNEEDLE KNIFE(K934315)
Intended Use	Accessing the common bileduct when standardcannulation methods havebeen exhausted.	Accessing the common bileduct when standardcannulation methods havebeen 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)

Over-The-Counter Use _

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).