The Wilson-Cook Modified Ultrasound Biopsy Needle is used for soft tissue biopsy through the accessory channel of an ultrasound endoscope. This device is supplied sterile and intended for single use only.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets criteria in the typical format of a modern performance study. Instead, it describes a "Special 510(k)" for a device modification, relying on substantial equivalence to predicate devices and internal design verification.

Here's an analysis based on the information provided, highlighting the absence of typical performance study data for AI devices:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "All results obtained during our Design Verification met our predetermined acceptance criteria for this product line." However, it does not quantify these acceptance criteria or the specific results. The criteria are likely related to mechanical function, dimensional accuracy, sterilization effectiveness, and biocompatibility, rather than diagnostic accuracy as would be seen with an AI device.

Therefore, a table of acceptance criteria and reported device performance cannot be fully constructed from the provided text for a device's diagnostic performance. The document only generically confirms that internal design verification met pre-determined criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Design Verification" activities were conducted, including "dimensional and functional testing." However, it does not specify the sample size of devices or materials tested, nor does it provide information on the provenance of any data (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to the type of device and study described. This is a biopsy needle, and the "ground truth" for its performance would be its ability to collect tissue, its mechanical integrity, and its biocompatibility, not a diagnostic interpretation that would require expert consensus.

4. Adjudication Method for the Test Set

Not applicable. There is no diagnostic "test set" in the context of expert adjudication for this medical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices to assess how AI assistance impacts human reader performance. The device described is a physical biopsy needle, not an AI diagnostic tool.

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

No, a standalone performance study was not done. This concept is for AI algorithms, and the Wilson-Cook Ultrasound Biopsy Needle is a physical medical instrument.

7. The Type of Ground Truth Used

The ground truth implicitly used for this device's performance would be:

Mechanical and Dimensional Specifications: Verification that the device's dimensions and mechanical properties (e.g., ability to cut, deploy, retract) meet engineering drawings and functional requirements.
Biocompatibility Standards: Confirmation that the materials meet established biocompatibility requirements through testing and/or documented history of safe use.
Sterility Testing: Verification that the device is sterile.

There is no mention of pathology, outcomes data, or expert consensus in relation to diagnostic performance, as the device's function is to obtain a biopsy, not to interpret it.

8. The Sample Size for the Training Set

Not applicable. This device is a physical instrument, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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OCT 1 9 2001

RE: SPECIAL 510(K): DEVICE MODIFICATION FOR THE WILSON-COOK ULTR BIOPSY NEEDLE

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS l.

Submitted By:

Wilson-Cook Medical Inc. 4900 Bethania Station Road & 5951 Grassy Creek Boulevard Winston-Salem, NC 27105

Device Description:

Trade Name:	Wilson-Cook Ultrasound Biopsy Needle
Common/Usual Name:	Ultrasound Biopsy Needle
Classification Name/Code:	Set, Biopsy Needle and Needle, GU, 78 FCG
Classification:	FDA has classified similar devices as Class II, asper 21 CFR § 876.1075. This device falls withinthe purview of the Gastroenterology and UrologyDevice Panel.
Performance Standards:	To the best of our knowledge, performancestandards for this device do not exist.
Intended Use:	Used for soft tissue biopsy through the accessorychannel of an ultrasound endoscope.

Predicate Device:

PREDICATE DEVICE	MANUFACTURER	DOCUMENT CONTROLNUMBER
ProAct Biopsy Needle	ProAct Ltd.	K926559/A
Wilson-Cook UltrasoundNeedle	Wilson-Cook Medical Inc.	K934356

Substantial Equivalence:

The Wilson-Cook Modified Ultrasound Biopsy Needle is substantially equivalent to the referenced predicate devices with respect to design, materials of construction and intended use.

Biopsy Needle in the side-cutting This device is identical to the ProAct configuration of the needle, as well as the echogenic needle tip. In addition, both of these devices operate in the same manner in order to obtain biopsies.

The modified Ultrasound Biopsy Needle and the predicate Wilson-Cook Ultrasound Needle are both used endoscopically, employing ultrasound technology to quide the needle. The patient-contacting materials of these devices differ slightly, with the sheath of the predicate being polytetrafluoroethylene and the sheath of the modified device being PEEK. In addition, the stylet of the predicate is comprised of ANSI Grade 304 Stainless Steel while the modified device stylet is comprised of Titanium Nickel (Nitinol). Applicable biocompatibility data is included.

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K06 3356
Page 2 of 2

RE: SPECIAL 510(K): DEVICE MODIFICATION FOR THE WILSON-COOK ULTR BIOPSY NEEDLE

DEVICECHARACTERISTIC	Wilson-Cook ModifiedUltrasound BiopsyNeedle[Subject of Special510(k)]	ProAct BiopsyNeedle(K926559/A)	PredicateWilson-CookUltrasound Needle(K934356)
Intended Use	Used for soft tissuebiopsy through theaccessory channel of anultrasound endoscope.	Used forpercutaneous,intra-operative, orthrough alaparoscopebiopsies.	Used for aspirationbiopsy to diagnoseand stage GI lesions,providing samplingby employingultrasoundtechnology to guidethe needle.
Sterility	Sterile, Disposable	Sterile, Disposable	Sterile, Disposable

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (continued) l.

Biocompatibility:

Reasonable assurance of biocompatibility for the patient-contacting materials has been established through a 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, Design Verification activities for the subject of this special 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 21 CFR Part 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 were conducted. A l l results obtained during our Design Verification met our predetermined acceptance criteria for this product line.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol featuring a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH &" which is arranged in a semi-circular fashion. The text is in all caps.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2001

Re: K013356

Trade/Device Name: Wilson-Cook Ultrasound Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II

Product Code: 78 FCG Dated: September 28, 2001 Received: October 10, 2001

Dear Ms. Posner:

Ms. Margaret J. Posner

Wilson-Cook Medical

GI Endoscopy

Regulatory Affairs Specialist

4900 Bethania Station Road

WINSTON-SALAM NC 27105

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your booker only of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreated of 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) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 r read of acrease a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Nancy C. Snogdon

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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Page __ 12__ of ___ 12__

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ____Wilson-Cook Ultrasound Biopsy Needle

Indications for Use:

Used for soft tissue biopsy through the accessory channel of an ultrasound endoscope.

(Please do not Write Below This Line – Continue on another Page, if Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	OR	Over-The-Counter
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

Nancy C Brogdon

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number	K013356
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Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.