The Urology Monopolar Snare for tissue transection is intended to be used in the urological tract for tissue transection for histopathologic examination.

Device Description

The Urology Monopolar Snare for tissue transection is intended to be used in the urological tract for tissue transection for histopathologic examination.

The Urology Monopolar Snare is a sterile device and consists of single lumen catheter attached to a 3-ring handle at the proximal end. The Urological Snare incorporates a braided stainless steel wire in a loop or hexagonal configuration that is attached to a stainless steel drive-wire and is extendable and retractable with respect to the catheter distal tip. The Urological snare is a Monopolar radio frequency device. The handle contains an active cord connection to make the connection to an electrosurgical generator.

The Urology Monopolar Snare is intended for single patient use only. The packaging consists of a peel pouch technology to preserve the sterile condition prior to use.

AI/ML Overview

The US Endoscopy Urology Monopolar Snare is a sterile, single-patient use device intended for tissue transection in the urological tract for histopathologic examination. It operates by entrapping tissue with a braided stainless steel wire in a loop or hexagonal configuration and applying monopolar radio frequency current to resect the tissue and provide hemostasis.

1. Table of acceptance criteria and the reported device performance:

The provided document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a numerical format. Instead, it relies on substantial equivalence to predicate devices and general performance statements.

Acceptance Criteria (Implied)	Reported Device Performance
Performs as intended	"The performance data found in this submission shows that the US Endoscopy Urology Monopolar Snare performs as intended."
No new issues of safety or effectiveness compared to predicates	"The US Endoscopy Monopolar Snare operates comparably to the listed predicate device and raises no new issues of safety or effectiveness."
Substantially equivalent to predicate devices (US Endoscopy Flexible Snare K924105 and Cook Urological Endosnare K923031)	"The data presented in this submission shows that the US Endoscopy Urology Monopolar Snare performs as intended and in a manner that is substantially equivalent to the predicate devices."
Sterile	"Yes" (stated in Device Comparison Table)
Single Patient Use	"Single Patient" (stated in Device Comparison Table)
Uses Monopolar Radio Frequency current	"Monopolar Radio Frequency current" (stated in Device Comparison Table)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify the sample size used for the test set or information about data provenance (e.g., country of origin, retrospective or prospective). The submission largely relies on a comparison to predicate devices, implying that testing may have focused on demonstrating equivalence rather than a large-scale clinical trial with a defined test set.

3. 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):

This information is not provided in the document. Given the nature of a 510(k) submission for a medical device cleared via substantial equivalence, detailed expert reviews for establishing ground truth on a specific test set are typically not a primary focus, unlike software or AI-driven diagnostic devices.

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

The document does not describe any adjudication method for a test set.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical instrument and does not involve human readers or AI assistance in its operation, therefore, such a study would not be applicable.

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

A standalone performance study for an algorithm was not done. This device is a physical surgical instrument, not an algorithm.

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

The document does not explicitly state the type of ground truth used for performance evaluation. Given the device's function involves tissue transection for histopathologic examination, it can be inferred that the ultimate "ground truth" for successful tissue removal and histopathology would likely be confirmed by pathology (i.e., whether the resected tissue is suitable for examination and the procedure achieved its goal of removing targeted tissue). However, the submission does not detail this.

8. The sample size for the training set:

The concept of a "training set" is not applicable to this device. It is a physical instrument, not an AI or machine learning algorithm that requires training data.

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

Not applicable, as there is no training set for this type of device.

Summary

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9 2011 -

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510(K) EXECUTIVE SUMMARY FOR UNITED STATES ENDOSCOPY GROUP, INC'S UROLOGY MONOPOLAR SNARE

Device Description:

The Urology Monopolar Snare for tissue transection is intended to be used in the urological tract for tissue transection for histopathologic examination.

The Urology Monopolar Snare is intended for single patient use only. The packaging consists of a peel pouch technology to preserve the sterile condition prior to use.

Functional Technology:

The Urology Monopolar Snare for tissue transection is intended to be used in the urological tract for tissue transection for histopathologic examination.

The only assembly required is the attachment of the radio frequency current cord to the device and to an appropriate electrosurgical generator.

When tissue transection in the urological tract is desired, the snare is used to entrap the tissue and applies radio frequency current to resect the targeted tissue and provide hemostasis. The tissue specimen is then removed per standard fluid & specimen evacuation or grasping techniques.

Intended Use:

The Urology Monopolar Snare for tissue transection is intended to be used in the urological tract for tissue transection for histopathologic examination.

Substantial Equivalence:

The device that is substantially equivalent to US Endoscopy's Urology Monopolar Snare is US Endoscopy Flexible Snare, cleared on 11-24-1992 under 510(k) Accession number K924105 and the Cook Urological Endosnare cleared on 6-07-1993 under 510(k) Accession number K923031.

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Device Comparison TableFeatures	ProposedUrology MonopolarSnare	Flexible SnareUS Endoscopy510(k) K924105	Cook MedicalEndosnare510(k) 923031
Indications forUse	The UrologyMonopolar Snare fortissue transection isintended to be usedin the urologicaltract for tissuetransection forhistopathologicexamination.	The snare is used inflexible endoscopy tograsp, dissect and transecttissue during endoscopicprocedures forhistopathologicexamination.	This device isintended to removebladder tumors andcoagulate the area inwhich the tumor wasremoved for patientswith superficialpapillary tumors of theurinary bladder.
Mode ofOperation	Stainless steel cabletransection viaMonopolar current andmechanical means	Stainless steel cabletransection via Monopolarcurrent and mechanicalmeans	Stainless steel wiretransection viaMonopolar current andmechanical means.
Sterile	Yes	Yes	Yes
Where used	Urology	Gastroenterology	Urology
Usage	Single Patient	Single Patient	Single Patient
Energy used/delivered	Monopolar RadioFrequency current	Monopolar Radio Frequencycurrent	Monopolar RadioFrequency current

The US Endoscopy Urology Monopolar Snare is comparable to the US Endoscopy Flexible Snare device and the Cook Urological Endosnare in intended use and mode of operation.

Technological Characteristics: The US Endoscopy Monopolar Snare operates comparably to the listed predicate device and raises no new issues of safety or effectiveness.

Performance Standards: Although no performance standards or special controls have been developed under Section 514 of the FDC Act for this device, US Endoscopy has elected to test the Urology Monopolar Snare against the standards referenced in this submission.

Performance Data: The performance data found in this submission shows that the US Endoscopy Urology Monopolar Snare performs as intended.

Conclusion: The data presented in this submission shows that the US Endoscopy Urology Monopolar Snare performs as intended and in a manner that is substantially equivalent to the predicate devices.

Device Comparison Table

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6 Silver Spring, MD 20993-0002

Mr. Carroll L. Martin Regulatory Manager US Endoscopy Group, Inc. 5976 Heisley Road MENTOR OH 44060

MAY - 9 2011

Re: K103611
Trade/Device Name: Urology Monopolar Snare Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FDI Dated: April 14, 2011 Received: April 15, 2011

Dear Mr. Martin:

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 w 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 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 of medical device-related

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Herbert Remmer MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CONFIDENTIAL United States Endoscopy Group, Inc. 510(k) Premiarket Notification: Traditional Urology Monopolar Snare for tissue transection

Page _ of

INDICATIONS FOR USE

510(k) Number (if known): _

Device Name: Urology Monopolar Snare

Indications for Use:

The Urology Monopolar Snare for tissue transection is intended to be used in the urological tract for tissue transection for histopathologic examination.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 Prescription Use _ (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Hela Roun

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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).