The Wilson-Cook Modified Multiple Band Ligator is used to ligate internal hemorrhoids. This device is supplied non-sterile and intended for single use only. The modification of the predicate Wilson-Cook Multiple Band Ligator (K944220/A) consists of a change to the handle in order to accommodate single-hand operation through an anoscope. In addition, the modified device comes preloaded with the barrel attached to the tip of the handle. The predicate device is designed for attachment to the end of an endoscope, while the modified Multiple Band Ligator is used in conjunction with an anoscope. The barrel and bands of the modified device are identical to the barrel and bands of the Wilson-Cook Multiple Band Ligator in the choice of the production and the specifications of each. The trigger cord is comprised of the same materials, however the trigger cord is slightly shorter in length for the modified devices, as the modified device comes preloaded and is used with an anoscope. Loading catheter and irrigation adapter are not needed.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study with performance metrics for the Wilson-Cook Modified Multiple Band Ligator. Instead, it focuses on the device's substantial equivalence to a predicate device and the process of design control, risk analysis, and design verification.

However, based on the provided text, we can infer some general information about design verification and what the acceptance criteria would have been for a device like this, even if the specific outcomes aren't quantified.

Here's a breakdown of what can be extracted and what cannot:

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

The document states: "All results obtained during our Design Verification met our predetermined acceptance criteria for this product line." This implies that acceptance criteria were established and met, but the specific criteria and the reported performance values are not provided in the text.

We can infer the types of criteria that would have been evaluated based on the description of the device modification and its function:

Acceptance Criteria Category (Inferred)	Reported Device Performance (Not Quantified)
Functional Performance:
- Ability to ligate hemorrhoids	Met predetermined criteria
- Single-hand operation through anoscope	Met predetermined criteria
- Trigger cord functionality	Met predetermined criteria
Dimensional Integrity:
- Barrel dimensions	Met predetermined criteria
- Band specifications	Met predetermined criteria
- Trigger cord length	Met predetermined criteria
Material/Biocompatibility:
- Biocompatibility of patient-contacting materials	Established through history and/or testing
Safety:
- Freedom from defects causing harm	Risk analysis performed and controls in place

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document only mentions "Design Verification" and "dimensional and functional testing" without detailing the number of units tested.
Data Provenance: Not specified, but generally, design verification testing for medical devices is conducted by the manufacturer (Wilson-Cook Medical Inc.) in a controlled environment. It is not a clinical study in this context, so concepts like "country of origin" for data are not applicable in the same way. The testing would be prospective in the sense that it's performed on the manufactured device models to ensure they meet specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not provided. "Ground truth" and expert consensus are terms typically used in clinical studies or studies evaluating diagnostic accuracy, especially for AI/ML devices. This document describes a modification to a physical medical device (a ligator) and its engineering-based design verification testing. The "ground truth" here is adherence to engineering specifications and functional performance.

4. Adjudication method for the test set:

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert opinions, typically in clinical evaluations or image interpretation studies. For design verification of a physical device, the "adjudication" is essentially the comparison of test results against predefined engineering acceptance criteria by qualified technicians or engineers.

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 information is not applicable and not provided. This device is a manual surgical tool, not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to this submission.

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

This information is not applicable and not provided. This is a physical, manually operated medical device. There is no "algorithm" to be evaluated in a standalone manner.

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

The "ground truth" for this device's verification is engineering specifications, functional requirements, and material properties. The device is tested to ensure it meets these predefined criteria. This is not derived from clinical outcomes, pathology, or expert consensus in the typical sense.

8. The sample size for the training set:

This information is not applicable and not provided. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable and not provided. As there is no training set, this question is not relevant.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The document states that a Design Verification process was conducted. This involved:

Risk Analysis: Identifying risks relative to performance requirements, including failure modes, effects, severity, potential causes, and rates of occurrence, along with design control elements to eliminate them.
Dimensional Testing: Measuring the physical properties of the modified device (e.g., barrel, bands, trigger cord length) to ensure they conform to specifications.
Functional Testing: Assessing the operational performance of the device, likely including its ability to ligate, the functionality of the trigger cord, and its compatibility with an anoscope for single-hand operation.
Biocompatibility Assurance: Establishing biocompatibility through a history of patient-contacting materials and/or specific biocompatibility test results.

The key statement is: "All results obtained during our Design Verification met our predetermined acceptance criteria for this product line." This indicates that a study (the Design Verification process) was performed, and the device successfully fulfilled the established criteria, although the specific details of those criteria and quantitative performance results are not openly provided in this 510(k) summary. The study essentially confirmed that the modified device's design (including changes to the handle, preloaded barrel, and trigger cord length) maintained the same safety and effectiveness profile as the predicate device.

Summary

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MAR 1 9 2002

510 (K) SUMMARY (Based on 21 CFR Part 807.92)

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

Device Description:

The Wilson-Cook Modified Multiple Band Ligator is used to ligate internal hemorrhoids. This device is supplied non-sterile and intended for single use only.

Trade Name:	Wilson-Cook Multiple Band Ligator
Common/Usual Name:	Multiple Band Ligator
Classification Name/Code:	Ligator, Hemorrhoidal, GU, 78 FHN
Classification:	FDA has classified similar devices asClass II, as per 21 CFR § 876.4400. Thisdevice falls within the purview of theGastroenterology and Urology DevicePanel.
Performance Standards:	To the best of our knowledge, performancestandards for this device do not exist.
Intended Use:	Used to ligate internal hemorrhoids.

Predicate Device:

PREDICATE DEVICE	MANUFACTURER	DOCUMENT CONTROL NUMBER
Wilson-Cook MultipleBand Ligator	Wilson-CookMedical	K944220/A

Substantial Equivalence:

The Wilson-Cook Modified Multiple Band Ligator is substantially equivalent to the referenced predicate device with respect to design, materials of construction and intended use.

DEVICECHARACTERISTIC	Wilson-Cook ModifiedMultiple Band Ligator[Subject of Special510(k)]	Wilson-CookMultiple Band Ligator(K944220/A)
Intended Use	Used to ligate internalhemorrhoids.	Used to ligateesophageal varices at orabove thegastroesophagealjunction and to ligateinternal hemorrhoids.
Sterility	Non-sterile, Disposable	Non-sterile, Disposable

the predicate Wilson-Cook Multiple Band The modification of Ligator (K944220/A) consists of a change to the handle in order accommodate single-hand operation through an anoscope. to In addition, the modified device comes preloaded with the barrel attached to the tip of the handle. The predicate device is designed for attachment to the end of an endoscope, while the

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510 (K) SUMMARY (continued)

modified Multiple Band Ligator is used in conjunction with an anoscope .

The barrel and bands of the modified device are identical to the burrer and bands Wilson-Cook Multiple Band Ligator in the chose of the production and the specifications of each. The trigger cord is comprised of the same materials, however the Crigger Cord ID ockparis slightly shorter in length for the vectrail string aacd in brights) - ar need to fit the length of modified devices, as a se the modified device comes production and an chaobeope. Doading catheter and irrigation adapter are not needed.

It is also important to note that both the predicate and the modified device share the same intended use, share similar methods of operation, and are comprised of the same raw materials.

Biocompatibility:

assurance of biocompatibility for for the patient -Reasonable keasonable as been established through a history of contacting mater 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 performance roquis. 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. All results obtained during our Design Verification met our predetermined acceptance criteria for this product line.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2002

Ms. Margaret J. Posner Regulatory Affairs Specialist Wilson-Cook Medical GI Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105 Re: K020526

Trade/Device Name: Wilson-Cook Multiple Band Ligator (Device Modification) Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: 78 FHN Dated: February 13, 2002 Received: February 19, 2002

Dear Ms. Posner:

We have reviewed your Section 510(k) premarket notification of intent to market the device 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 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) 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 that FDA has made 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 This letter will and in you ding of substantial equivalence of your device to a legally marketed nontheation. The I Dr Intelliges if cation 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 If you doshe specific ac-ripliance 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 of folor to premained 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 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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1
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510(k) Number (if known): _ KOZLES26

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Used to ligate internal hemorrhoids.

(Please do not Write Below This Line – Continue on Another Page, if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K020526
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Regulation Number and Section

§ 876.4400 Hemorrhoidal ligator.

(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.