The Duette TM Multi-Band Mucosectomy Device has a ligation component consisting of a barrel with latex bands and a Ligator handle. This barrel is attached to the distal end of an endoscope and bands are deployed by actuating the handle. The barrel allows introduction of an electrosurgical snare for endoscopic therapies.

AI/ML Overview

This document describes a medical device called the Duette™ Multi-Band Mucosectomy Device and its 510(k) submission to the FDA. The submission focuses on substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics. Therefore, I cannot provide the requested information in its entirety because the provided text does not contain the specific acceptance criteria, study details, and performance data you've asked for.

Here’s what I can extract and what is missing, based on the provided text:

Missing Information:

The provided text does not contain any information regarding:

A table of acceptance criteria and reported device performance.
Sample sizes used for test sets.
Data provenance (country of origin, retrospective/prospective).
Number and qualifications of experts for ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
Standalone algorithm performance.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for either test or training sets.
Sample size for training sets.
How ground truth for training set was established.

Information Extracted from the Provided Text:

This 510(k) submission for the Duette™ Multi-Band Mucosectomy Device primarily relies on non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than on clinical studies with performance metrics against acceptance criteria.

A table of acceptance criteria and the reported device performance:
- Not provided. The document states, "Non-Clinical testing was performed on characteristics and operational functions of the Duette™ Multi-Band Mucosectomy Device deemed necessary to verify safety and performance." However, specific acceptance criteria or performance metrics from these non-clinical tests are not disclosed in this document.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document refers to "non-clinical testing," implying bench or laboratory tests, not clinical human-subject test sets with data provenance.
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):
- Not applicable/Not provided. Since the document only mentions non-clinical testing, there is no mention of human experts defining ground truth for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. As above, no clinical test set is described.
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:
- Not applicable/Not provided. This device is a mechanical Mucosectomy Device, not an AI or imaging diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not provided. This is a mechanical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not provided. For the non-clinical testing, ground truth would likely refer to engineering specifications or validated test methods, but details are not given.
The sample size for the training set:
- Not applicable/Not provided. This is a mechanical device, not an AI or software device that would have a "training set."
How the ground truth for the training set was established:
- Not applicable/Not provided. As above, a training set is not relevant for this type of device.

Summary of the Device and Submission:

Device Name: Duette™ Multi-Band Mucosectomy Device
Intended Use: Endoscopic mucosal resection in the upper gastrointestinal tract.
Device Description: Ligation component (barrel with latex bands), Ligator handle. Attaches to an endoscope; bands deployed by actuating the handle. Allows introduction of an electrosurgical snare.
Submission Type: 510(k) Premarket Notification (K050578)
Basis for Clearance: Substantial Equivalence to predicate devices (Olympus Distal Attachment, K984358).
Testing Basis: Non-Clinical testing performed on "characteristics and operational functions... deemed necessary to verify safety and performance." No details on these tests, acceptance criteria, or results are provided in this excerpt.

This document is a 510(k) summary, which often provides less granular detail about studies compared to a full 510(k) submission or clinical trial report. The focus of this specific 510(k) is on the substantial equivalence of device design and intended use, supported by non-clinical testing, rather than a detailed clinical performance study with specific acceptance criteria as might be expected for novel diagnostic or AI-driven devices.

Summary

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COOK®

K050578
nd Ltd. Page 1 of 2

Cook Ireland L O'Halloran Road National Technological Park Limerick, IRELAND Phone: +353 61 334440 Fax: +353 61 334441 www.cookgroup.com

510(k) Summary

SPONSOR:

Cook Ireland Ltd. O'Halloran Road, National Technology Park, Limerick, Ireland

Contact Submitter:

Emmett Devereux QA/RA Manager Cook Ireland Limited O'Halloran Road National Technology Park Limerick, Ireland Phone: +353-61-334440 Fax: +353-61-334441 Email: edevereux@cook.ie

March 4, 2005 Date of Submission: Duette™M Device: Cook Ireland Duette TM Multi-Band Trade Name: Mucosectomy Device Common/Usual Name: Mucosectomy Device/EMR Device Endoscope and Accessories. 21 CFR§ 876.1500, Class: 78 KOG Predicate Device: Olympus Distal Attachment (MH and MAJ models) for Endoscopic Mucosal Resection, K984358 The Duette™ Multi-Band Mucosectomy Device Intended Use: is intended for endoscopic mucosal resection in

the upper gastrointestinal tract.

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COOK

Image /page/1/Picture/1 description: The image shows a handwritten note with the text "Ko 50578" on the first line and "Page 2 of 2" on the second line. The handwriting is somewhat rough, with the numbers and letters not perfectly formed. The note appears to be a page number or identification marker, possibly from a larger document.

Device Description:

Comparison of Characteristics:

The subject device is similar with respect to intended use and/or design features to the predicate devices in terms of section 510(k) substantial equivalence.

Test Data:

Non-Clinical testing was performed on characteristics and operational functions of the Duette™ Multi-Band Mucosectomy Device deemed necessary to verify safety and performance.

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Image /page/2/Picture/2 description: The image shows a circular logo with a stylized bird design in the center. The bird is depicted with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the upper half of the circle, following its curvature. The logo appears to be a simplified representation of the U.S. Department of Health and Human Services seal.

APR 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Emmett Devereux QA/RA Manager Cook Ireland Limited O'Halloran Road National Technology Park Limerick IRELAND

Re: K050578

R050578
Trade/Device Name: Duette™ Multi-Band Mucosectomy Device Regulation Number: 21 CFR® 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: KOG Dated: March 4, 2005 Received: March 7, 2005

Dear Mr. Devereux:

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 the enorosate) to 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 do not require apperal controls provisions of the Act. The general controls provisions of the Act device, subjoct to 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 (Premarket n your de rise is chase to such additional controls. Existing major regulations affecting your Apploral), It the 700 book 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 I Rase be actison that your device complies with other requirements of the Act or any FOA has made a decemination alla your crederal agencies. You must comply with all the I caral stares and regulating, but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, moduler on and in the practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); 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 Section 510(k) I his letter will anow you'lo begin mancung your avence of your device to a legally premarket notification. The PDA mainly of backamal 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 desire specific advice for your device on our laboring numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx21 CFR 884.xxxx	(Gastroenterology/Renal/Urology)(Obstetrics/Gynecology)ﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ(Radiology)	240-276-0115240-276-0115240-276-0120
21 CFR 892.xxxxOther		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premaket notification the Also, please note the regulation entimed, "Thisoration on your responsibilities under the Act from the 807.97). You may outlain other general missistance at its toll-free number (800)
Division of Small Manufacturers, International and Consumer Assistance at Manufacturers and Division of Small Manufactures, International and Collection://www.fda.gov/cdrh/dsmadsmamain.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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510(k) Number (if known): _KQ50578

Device Name: Duette™ Multi-Band Mucosectomy Device

Indications for Use:

The Duette™ Multi-Band Mucosectomy Device is intended for endoscopic mucosal resection in the upper gastrointestinal tract.

ﮨﮯ

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE-IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Only Counter_ (Per 21 CFR § 801.109

Daniel A. Lipton

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

Over-the-

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).