The subject device consists of a handle section, a sheath section. The snare head section. The snare head section is inserted into the sheath section and is extended and retracted by operating the three-ring handle section.

The sheath section and the snare head section are inserted in the gastrointestinal tract through an endoscope. The snare head is extended from the sheath to resect target polyps. This resection is performed with high-frequency current.

AI/ML Overview

This document is a 510(k) premarket notification for the AcuSnare Polypectomy Snare. It's not a study report that includes typical acceptance criteria and performance data for AI/ML devices. Instead, it demonstrates substantial equivalence to predicate devices for a conventional medical device. Therefore, I cannot extract the information requested as it is not present in the provided text.

Here is why your specific information requests cannot be fulfilled:

A table of acceptance criteria and the reported device performance: This document doesn't define acceptance criteria in terms of a study's statistical endpoints (e.g., sensitivity, specificity, AUC) or report quantitative performance metrics like a standalone AI/ML study would. The acceptance criteria for this device are implicitly tied to demonstrating that it performs as intended and is as safe and effective as the predicate devices through non-clinical testing.
Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML model for this type of device. The testing described is non-clinical (e.g., tensile strength, shelf life).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert review is mentioned, as this is not an AI/ML diagnostic or prognostic device.
Adjudication method: Not applicable for the reasons above.
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. This is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not a software algorithm.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable. This is not an AI/ML model.
How the ground truth for the training set was established: Not applicable.

Instead, the document focuses on comparing the AcuSnare Polypectomy Snare to existing predicate devices based on:

Intended Use: The device is used endoscopically for the removal and cauterization of sessile and pedunculated polyps from the gastrointestinal tract. This is compared to the predicate devices' stated uses.
Technological Characteristics: Comparison of physical attributes like configuration, snare material, sheath material, handle material, length, FR size, sterility, sterilization method, reusability, and compatibility with electrosurgical units.
Non-Clinical Testing: A list of tests performed to demonstrate the device's performance and safety, including:
- Shelf Life Testing
- Package Integrity Testing
- Tensile tests (snare to catheter, catheter to handle, snare head to drive cable joint, snare wire to cannula joint, handle/cannula/drive cable joint, pin to handle joint)
- IEC 60601-1, IEC 60601-2-2, and IEC 60601-2-18 standards compliance (related to electrical safety for electrosurgical equipment)
- Biocompatibility testing (ISO 10993-1)

The "study" that proves the device meets acceptance criteria, in this context, refers to the non-clinical testing summarized in {5} and the comparison to predicate devices in {4}. The acceptance criteria are implicitly met if these tests show performance equivalent to or better than the predicate devices, and that the device is safe and effective for its stated intended use. The document concludes that the modifications to the subject device have been adequately addressed through Design Control Processes and do not affect the safety or effectiveness.

Summary

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August 24, 2018

Wilson-Cook Medical, Inc Theresa de Prat Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, North Carolina 27105

Re: K173673

Trade/Device Name: AcuSnare Polypectomy Snare Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: FDI Dated: July 10, 2018 Received: July 11, 2018

Dear Theresa de Prat:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Glenn B. Bell -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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Indications for Use

510(k) Number (if known) K173673

Device Name AcuSnare Polypectomy Snare

Indications for Use (Describe)

This device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Name:	Wilson-Cook Medical, Inc. /Cook Endoscopy
Address:	4900 Bethania Station Road
	Winston-Salem, North Carolina 27105
Phone:	(336) 744-0157
Fax:	(336) 201-5994
Contact:	Theresa de Prat, Regulatory Affairs Specialist I
Date:	November 30, 2017

Device Identification
Trade Name:	AcuSnare Polypectomy Snare
Common Name:	Polypectomy Snare
Regulation Number:	876.4300
Classification Name:	Endoscopic electrosurgical unit and accessories.
Product Code:	FDI
Regulatory Class:	Class II
Classification Panel:	Gastroenterology and urology
Classification Name:	snare, flexible
Predicate Devices:	Rotatable Polypectomy Snare (POS-1) K851958; cleared July 25, 1985Single Use Electrosurgical Snare (SD-400) K172734; cleared December 7, 2017

Intended Use:

This subject device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract.

Device Description:

Substantial Equivalence:

Minor changes were made to the first predicate device Rotatable Polypectomy Snare (K851958) and second predicate Single Use Electrosurgical Snares SD-400(K172734). These changes include updating the intended use to the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract, adding additional stainless-steel types to snare head materials of construction,

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and a new snare head shape configuration ("needle-tip"), and a different thermoplastic for the handle of the subject device.

	(Subject Device)AcuSnare PolypectomySnare	(1st Predicate K851958)Wilson-Cook MedicalRotatable PolypectomySnare	(2nd PredicateK172734)Single UseElectrosurgical SnareSD-400.
Intended Use	This device is usedendoscopically in theremoval and cauterizationof sessile polyps andpedunculated polyps fromwithin the gastrointestinaltract.	To snare and removepolyps from the colon.	These instruments havebeen designed to beused with an Olympusendoscope for theremoval and/orcauterization ofdiminutive polyps,sessile polyps,pedunculated polypsand tissue from withinthe GI tract.
Classification Name:	Snare Flexible	Same	Same
Common/Usual Name:	Polypectomy Snare	Polypectomy Snare	Snares
Trade/or ProprietaryName	AcuSnare PolypectomySnare	Rotatable PolypectomySnare (POS-1)	Single UseElectrosurgical Snares(SD-400)
Class:	Class II	Same	Same
Product Code	FDI	FGX	FGX
Configuration:	Oval, hexagon, needle-tip	Oval, crescent andhexagon	Hexagon
Snare Material:	#304 /#302 / #303Stainless Steel	#304 Stainless Steel	Stainless Steel
Sheath Material:	Teflon (PTFE)	Teflon (PTFE)	Fluorocarbon polymer
Handle Material:	PC	Unknown	ABS
Length:	240 cm	240 cm	230 cm
Catheter FR Size:	7 FR	7 FR	Unknown
Sterile/non-sterile:	Sterile	Sterile	Sterile
Sterilization method:	Ethylene Oxide	Same	Same
Reusable/Single Use:	Single Use	Reusable	Single Use
Used withElectrosurgical Unit:	Yes	Yes	Yes

Comparison table of subject device and predicate device:

Summary of non-clinical testing:

The following non-clinical testing was conducted to demonstrate the performance of the subject device and confirmed that the subject device performs as intended.

Shelf Life Testing ●
Package Integrity Testing ●
Tensile test snare to catheter ●

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Tensile test catheter to handle
Snare head to drive cable joint
Snare wire to cannula joint
. Handle/Cannula/Drive Cable joint
. Pin to Handle Joint
. IEC 60601-1: 2006 + A12: 2014- Medical electrical equipment – Part 1: General requirements for basic safety and essential performance of High Frequency Surgical Equipment and High frequency Surgical Accessories
. IEC 60601-2-2: 2017 - Medical Electrical Equipment - Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories
IEC 60601-2-18: 2009 Medical electrical equipment Part 2-18: Particular requirements for the ● basic safety and essential performance of endoscopic equipment

Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1. "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process" and per ISO 10993-1:2009, Biological evaluation of medical devices-Evaluation and testing within risk management process.

Conclusion:

We believe that the subject device is substantially equivalent to the predicate device in terms of intended use, key operating principles, materials and technological characteristics. We consider the risks associated with the modifications to the subject device to have been adequately addressed through our Design Control Processes and do not affect safety or effectiveness of the device.

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).