Used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3 cm in the upper GI tract, bleeding ulcers, arteries less than 2 mm, and polyps less than 1.5 cm in diameter in the GI tract. This device is not intended for the repair of GI tract lumenal perforations.

Device Description

The Wilson-Cook Endoscopic Clipping Device is comprised of an introducer with a locking handle and one (1) pre-loaded clip. The introducer is used to deploy the clip and is not left in the patient. The clip is left in the patient to accomplish hemostasis.

AI/ML Overview

The provided text describes the Wilson-Cook Endoscopic Clipping Device and its 510(k) submission for premarket notification. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics typically seen for AI/ML devices or novel technologies requiring extensive clinical trials.

Based on the provided information, here's an analysis:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the way a performance study for an AI algorithm would. Instead, the basis for approval is "substantial equivalence" to a predicate device. The performance is described qualitatively.

Criterion Type	Acceptance Criteria (from document)	Reported Device Performance (from document)
Intended Use	To be substantially equivalent to the predicate device's intended use.	"Used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3 cm in the upper GI tract, bleeding ulcers, arteries less than 2 mm, and polyps less than 1.5 cm in diameter in the GI tract. This device is not intended for the repair of GI tract lumenal perforations." (This is identical to the predicate device's intended use, with the exception of the predicate's mention of "anchoring to affix jejunal feeding tubes," which is notably absent from the subject device's intended use.)
Design	To be substantially equivalent to the predicate device's design.	"The Wilson-Cook Endoscopic Clipping Device is substantially equivalent to the referenced predicate device with respect to design..."
Materials of Construction	To be substantially equivalent to the predicate device's materials.	"The Wilson-Cook Endoscopic Clipping Device is substantially equivalent to the referenced predicate device with respect to ... materials of construction..."
Safety and Effectiveness	To perform in accordance with its intended use and be safe and effective.	"The Wilson-Cook Endoscopic Clipping Device underwent simulated use testing and biocompatibility testing. Test results provide reasonable assurance the device will perform in accordance with its intended use." "Being similar to predicate devices with respect to intended use and technology, and having test results that indicate the device will perform in accordance with its intended use, the Wilson-Cook Endoscopic Clipping Device meets the requirements for 510(k) substantial equivalence."
Sterility	Sterile, Disposable (consistent with predicate)	"Sterile, Disposable"

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

The document mentions "simulated use testing and biocompatibility testing," but does not provide any specific sample sizes or details about the test set used for these studies. There is no information on data provenance (e.g., country of origin, retrospective/prospective). This type of information is typically not included in a 510(k) summary focused on substantial equivalence for a mechanical device unless human clinical data was explicitly required, which it wasn't here.

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

This is not applicable as the device is a mechanical clipping device, not a diagnostic AI/ML device that requires expert-established ground truth for interpretation. The "ground truth" for this device would be its functional performance (e.g., successful clip deployment, hemostatic ability in a model) rather than a clinical interpretation. The document does not mention any expert review in this context.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as #3. There is no mention of an adjudication method as there's no diagnostic output or interpretation requiring consensus among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance

This is not applicable. The device is a physical endoscopic clipping device, not an AI or imaging device involving human readers or AI assistance.

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

This is not applicable. The device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be based on engineering performance specifications and simulated use testing (e.g., successful deployment, clip closing force, material integrity, biocompatibility). It is implied that the device met these engineering and material standards, which are considered sufficient for demonstrating substantial equivalence based on the "simulated use testing and biocompatibility testing" mentioned. No pathology or outcomes data is explicitly detailed in this summary.

8. The Sample Size for the Training Set

This is not applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable for the same reasons as #8.

Summary

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RE: PREMARKET NOTIFICATION FOR THE WILSON-COOK ENDOSCOPIC CLIPPING DEVICE

N 023903

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 1.

pg 1 of 2

FEB 2 0 2003

Submitted By:

Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem, NC 27105

Device Description:

Trade Name:	Wilson-Cook Endoscopic Clipping Device
Common/Usual Name:	Endoscopic Clipping Device
Classification Name/Code:	Clip, Hemostatic / MCH
Classification:	FDA has classified similar devices as Class II. This devicefalls within the purview of the Gastroenterology andUrology Device Panel.
Performance Standards:	To the best of our knowledge, performance standardsfor this device do not exist.
Intended Use:	Used for endoscopic clip placement within thegastrointestinal tract for the purpose of endoscopicmarking, hemostasis for mucosal/submucosal defectsless than 3 cm in the upper GI tract, bleeding ulcers,arteries less than 2 mm, and polyps less than 1.5 cm indiameter in the GI tract. This device is not intended forthe repair of GI tract lumenal perforations.

Predicate Device:

PREDICATEDEVICE	MANUFACTURER	DOCUMENTCONTROLNUMBER
Olympus EndoscopicClipping Device	Olympus America, Inc	K990687

Substantial Equivalence:

The Wilson-Cook Endoscopic Clipping Device is substantially equivalent to the referenced predicate device with respect to design, materials of construction and intended use.

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K023903 Py202

NOTIFICATION FOR THE WILSON-COOK ENDOSCOPIC RE: PREMARKET CLIPPING DEVICE

DEVICECHARACTERISTIC	Wilson-CookEndoscopic ClippingDevice[Subject of 510(K)]	OlympusEndoscopic ClippingDevice
510(k) Number	Not assigned	K990687
Intended Use	Used for endoscopic clipplacement within thegastrointestinal tract for thepurpose of endoscopicmarking, hemostasis formucosal/ submucosaldefects less than 3 cm inthe upper GI tract, bleedingulcers, arteries less than 2mm, and polyps less than1.5 cm in diameter in theGI tract. This device is notintended for the repair ofGI tract lumenalperforations.	Used for endoscopic clipplacement within thegastrointestinal (GI) tractfor the purpose ofendoscopic marking,hemostasis in the upper GItract formucosal/submucosal defects< 3 cm, bleeding ulcers andarteries < 2 mm, polyps <1.5 cm in diameter, andanchoring to affix jejunalfeeding tubes to the wall ofthe small bowel. This deviceis not intended for therepair of GI tract.
Sterility	Sterile, Disposable	Sterile, Disposable

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

Discussion of Tests and Test Results:

The Wilson-Cook Endoscopic Clipping Device underwent simulated use testing and biocompatibility testing. Test results provide reasonable assurance the device will perform in accordance with its intended use.

Conclusions Drawn from Tests:

Being similar to predicate devices with respect to intended use and technology, and having test results that indicate the device will perform in accordance with its intended use, the Wilson-Cook Endoscopic Clipping Device meets the requirements for 510(k) substantial equivalence.

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Image /page/2/Picture/1 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 an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 25, 2015

Wilson-Cook Medical, Inc. GI Endoscopy Margaret J. Posner Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105

Re: K023903

Trade/Device Name: Wilson-Cook Endoscopic Clipping Device Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated (Date on orig SE ltr): November 16, 2002 Received (Date on orig SE ltr): November 22, 2002

Dear Margaret J. Posner,

This letter corrects our substantially equivalent letter of February 20, 2003.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

{3}------------------------------------------------

Page 2 -

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _ 19_ of _ 19

510(k) Number (if known): _K ○ノろイクフ

Device Name: __ Wilson-Cook Endoscopic Clipping Device

Indications for Use:

Used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal/ submucosal defects less than 3 cm in the upper Gl tract, bleeding ulcers, arteries less than 2 mm, and polyps less than 1.5 cm in diameter in the GI tract. This device is not intended for the repair of GI tract lumenal perforations.

(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

David A. Syverson

(Division Sign-Off) Division of Reproductive, I and Radiological Devices 510(k) Number

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.