The Wilson-Cook 10 Shot Multi-Band Ligator consists of a friction fit adapter for attachment to the distal tip of an endoscope, a barrel preloaded with ten (10) ligation bands, a trigger cord and handle for band deployment, an irrigation adapter and a loading catheter. This device is designed for attachment to the end of an endoscope for ligating esophageal varices or hemorrhoids. Once assembled and attached the endoscope is advanced to the desired banding site and individual bands are deployed via manipulation of the deployment handle and trigger cord. The multi-band feature allows for serial ligations, which reduces the need to remove the endoscope for reloading. This device is supplied non-sterile and is intended for single use only.

AI/ML Overview

This submission focuses on establishing substantial equivalence to a predicate device rather than meeting specific performance acceptance criteria through a dedicated study. Therefore, many of the requested elements (like sample size for test/training sets, expert qualifications, and MRMC studies) are not applicable or explicitly stated in this type of submission.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not specify numerical "acceptance criteria" in the traditional sense (e.g., a specific percentage success rate, accuracy, etc.) nor does it report specific quantitative device performance against such criteria. Instead, it aims to demonstrate substantial equivalence to a predicate device by comparing design, materials, and intended use, and by confirming adequate functional testing.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (as stated in the submission)
Intended Use: Match predicate device's intended use (ligation of esophageal varices or internal hemorrhoids).	Matches Predicate: "Used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids." (Same as predicate)
Components: Similar components and functionality, with a difference in number of bands.	Similar Components: Non-Patient Contacting Loading Catheter, Irrigation Adapter, Trigger Cord, Deployment Handle. Difference: 10 Ligation Bands vs. 6 in predicate.
Patient Contacting Materials: Identical to predicate device.	Identical Materials: Friction Fit Adapter (Polyurethane), Barrel (Polycarbonate), Trigger Cord (Vectran), Bands (Latex Rubber).
Method of Use: Identical to predicate device.	Identical Method: "Friction Fit adapter and barrel with ligation bands mounted to the distal tip of the endoscope. Band release from the barrel accomplished by trigger cord and deployment handle."
Biocompatibility: Established for patient-contacting materials.	"Biocompatibility has been established for the patient contacting materials through a history of use in other similar medical devices and as applicable biocompatibility test results."
Functional Testing: Results comparable to predicate device.	"This product line has been subjected to functional testing as appropriate for this modification. All results were comparable to results obtained for the predicate device hence establishing the safety and effectiveness for this product line extension."

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

Sample Size: Not specified. The submission refers to "functional testing" but does not provide details on the number of tests performed or the sample size of devices used in this testing.
Data Provenance: Not specified. The context suggests internal testing by the manufacturer (Wilson-Cook Medical Inc.) to demonstrate comparability with their own predicate device. It is a retrospective comparison to the results of the predicate device.

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

Not Applicable. This type of premarket notification for substantial equivalence does not typically involve external experts establishing ground truth for a test set in the way an AI/diagnostic device study would. The assessment is primarily based on engineering and materials comparison, and functional testing to confirm the device operates as intended and is comparable to the predicate.

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

Not Applicable. There is no indication of a test set requiring adjudication in this submission.

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

No. An MRMC study was not conducted as this is a medical device for therapeutic intervention (ligation), not a diagnostic or AI-powered device involving "human readers" or "AI assistance."

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

No. This is not an AI algorithm; it's a mechanical/manual device. Therefore, standalone algorithm performance is not applicable.

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

Functional Comparability to Predicate Device: The "ground truth" or basis for acceptance is primarily the established safety and effectiveness of the existing predicate device. The new device's functional performance, materials, and intended use are compared to this known predicate. Biocompatibility relies on "history of use in other similar medical devices" and "applicable biocompatibility test results" (which are not detailed here).

8. The sample size for the training set

Not Applicable. This is not an AI device, so there is no "training set."

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

Not Applicable. As there is no training set for an AI model, this question is not relevant to this submission.

Summary

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PREMARKET NOTIFICATION FOR THE WILSON-COOK 10 SHOT RE: MULTI-BAND LIGATOR

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 。

中国中

JAN 20 1998

Submitted By:

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

Device Description:

Trade Name:	Wilson-Cook Ten Shot Multi-Band Ligator
Common/Usual Name:	Band Ligator
Classification Name/Code:	Ligator, Hemorrhodial, 78 FHNLigator, Esophageal 78 MND
Classification:	FDA has classified similar devices as Class II, as per 21CFR § 876.4400. This device falls within the purview ofthe Gastroenterology and Urology Device Panel.
Performance Standards:	To the best of our knowledge, performance standards forthis device do not exist.
Intended Use:	Used to endoscopically ligate esophageal varices at or above thegastroesophagel junction or to ligate internal hemorrhoids.

Predicate Device:

PREDICATE DEVICE	MANUFACTURER	DOCUMENT CONTROLNUMBER
Wilson-Cook Six ShotMulti-Band Ligator	Wilson-Cook Medical Inc.	K944220/A

Substantial Equivalence:

The Wilson-Cook 10 Shot Multi-Band Ligator is substantially equivalent to the referenced predicate device with respect to design, materials of construction and intended use.

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PREMARKET NOTIFICATION

PREMARKET NOTIFICATION FOR THE WILSON-COOK 10 SHOT RE: MULTI-BAND LIGATOR

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (continued) 。

DEVICECHARACTERISTIC	Wilson-Cook10 Shot Multi-Band Ligator[Subject of 510(K)]	Wilson-CookMulti-Band Ligator(K944220/A)
Intended Use	Used to endoscopically ligateesophageal varices at or abovethe gastroesopahgeal junctionor to ligate internalhemorrhoids.	Used to endoscopically ligateesophageal varices at or abovethe gastroesopahgeal junctionor to ligate internalhemorrhoids.
Components	1) Non-Patient ContactingLoading Catheter2) Irrigation Adapter3) Barrel with 10 LigationBands4) Trigger Cord5) Deployment Handle	1) Non-Patient ContactingLoading Catheter2) Irrigation Adapter3) Barrel with 6 LigationBands4) Trigger Cord5) Deployment Handle
Patient Contacting Materials	Friction Fit Adapter:PolyurethaneBarrel: PolycarbonateTrigger Cord: VectranBands: Latex Rubber	Friction Fit Adapter:PolyurethaneBarrel: PolycarbonateTrigger Cord: VectranBands: Latex Rubber
Method of Use	Friction Fit adapter and barrelwith ligation bands mounted tothe distal tip of the endoscope.Band release from the barrelaccomplished by trigger cordand deployment handle.	Friction Fit adapter and barrelwith ligation bands mounted tothe distal tip of the endoscope.Band release from the barrelaccomplished by trigger cordand deployment handle.
Bands	Multiple bands can performserial ligations withoutremoval of the endoscope forreloading of bands.	Multiple bands can performserial ligations withoutremoval of the endoscope forreloading of bands.

Testing:

Biocompatibility has been established for the patient contacting materials through a history of use in other similar medical devices and as applicable biocompatibility test results. This product line has been subjected to functional testing as appropriate for this modification. All results were comparable to results obtained for the predicate device hence establishing the safety and effectiveness for this product line extension.

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Image /page/2/Picture/0 description: The image shows a seal for the Department of Health & Human Services USA. The seal is circular and features an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 20 1998

Ms. Paula Joyce Regulatory Affairs Manager Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-Salem, NC 27105

Re: K974018

Wilson-Cook 10 Shot Multi-band Ligator Dated: October 17, 1997 Received: October 22, 1997 Regulatory Class: II 21 CFR 876.4400/Procode: 78 FHN, 78 MND

Dear Ms. Joyce:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have decemined the device is substantially equivalent (for the indications 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, 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 misbranion.

If your device is classified (see above) into either class II (Special Controls) or 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 marked 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 yitro 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 of titled, "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/cdrh/dsmamain.html".

Sincerely yours,

W. Liao Yu

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

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K974018

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510(k) Number (if known): INITIAL 510(k) SUBMISSION UNKNOWN

WILSON-COOK TEN SHOT MULTI-BAND LIGATOR Device Name:

Indications For Use:

Used to endoscopically ligate esophageal varices at or above the gastroesophagea1 junction or to ligate internal hemorrhoids.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Riker D. Sitting/
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices K97 4018 510(k) Number _

Prescription Use I (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.