(46 days)
No
The device description and performance studies focus on mechanical components and operational functions, with no mention of AI, ML, image processing, or data-driven analysis.
Yes
The device is intended for endoscopic mucosal resection, which is a therapeutic procedure to remove abnormal tissue in the gastrointestinal tract. The "barrel allows introduction of an electrosurgical snare for endoscopic therapies," further indicating its therapeutic function.
No
Explanation: The device is described as a "Mucosectomy Device" used for endoscopic mucosal resection. Its function involves deploying bands and allowing the introduction of an electrosurgical snare for "endoscopic therapies," which are treatments, not diagnostic procedures.
No
The device description clearly outlines physical components (barrel, latex bands, Ligator handle) and their mechanical function (attached to endoscope, bands deployed by actuating handle). This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the Duette™ Multi-Band Mucosectomy Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic mucosal resection in the upper gastrointestinal tract." This is a surgical procedure performed directly on a patient's tissue, not a test performed on a sample of bodily fluid or tissue outside the body to diagnose a condition.
- Device Description: The description details a device used for physically manipulating tissue during an endoscopic procedure (ligation and allowing snare introduction). This aligns with a surgical or interventional device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are typically used to examine samples like blood, urine, tissue biopsies, etc., to provide information about a patient's health status, diagnose diseases, or monitor treatment. The Duette™ device is a tool used during a procedure to remove tissue, not to analyze it for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Duette™ Multi-Band Mucosectomy Device is intended for endoscopic mucosal resection in the upper gastrointestinal tract.
Product codes
78 KOG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper gastrointestinal tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Non-Clinical testing was performed on characteristics and operational functions of the Duette™ Multi-Band Mucosectomy Device deemed necessary to verify safety and performance.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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:
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.
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.
2
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.
3
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.xxxx
21 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) | 240-276-0115
240-276-0115
240-276-0120 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| 21 CFR 892.xxxx
Other | | 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
4
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
OR
Daniel A. Lipton
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Over-the-