The AcuSnare Polypectomy Snare - Duckbill (ASDB) device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract.

Device Description

The AcuSnare Polypectomy Snare - Duckbill (ASDB) is a sterile, single use device compatible with the accessory channel of endoscope. This type endoscopic polypectomy device is designed to connect to an electrosurgical unit via an active cord accessory and the drive cable delivers energy through the snare head to cut and/or cauterize tissue as described in the instructions for use. The device consists of a handle, sheath, drive cable and wire loop snare head. The sheath is comprised of polytetrafluoroethylene (PTFE) and is offered in 7 Fr. (2.3 mm) diameter and 240 cm length models. The snare head is available in the shape of a duckbill configuration and offered in a 15 mm or 25 mm width. The stainless-steel drive cable and snare head pass through the sheath and the three ring (polycarbonate) handle allows the user to extend and retract the snare through the distal tip of the sheath.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the AcuSnare Polypectomy Snare - Duckbill (ASDB). This is for a device intended for polypectomy (removal of polyps) during endoscopy. The document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study as described in the provided text:

Key Takeaways from the Document:

This is a Special 510(k) submission, indicating minor modifications to an already cleared device (AcuSnare Polypectomy Snare - K173673).
The primary change is the addition of a new duckbill shape configuration and associated cannula components.
The manufacturer claims this change does not alter the method of operation or intended use of the device.
Performance Data: The document states that a Risk Analysis (DFMECA) was completed, and Design Verification and/or Validation testing was performed to address the impact of modifications. The conclusion is that these tests provide "reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness and demonstrate that the AcuSnare Polypectomy Snare - Duckbill (ASDB) meets the performance requirements to fulfill the intended use of the device."

Important Note: The provided text does not contain detailed information about specific acceptance criteria, quantitative performance metrics, or a formal clinical study with a test set, ground truth, or expert review. The focus of this 510(k) is on demonstrating substantial equivalence through design validation and verification of the modifications rather than a de novo extensive performance study.

Given the information, here's an attempt to answer your questions, highlighting where specific details are not provided in the document:

A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from 510(k) context)	Reported Device Performance (from text)
Safety and Effectiveness:	"Results from design validation and/or verification testing provide reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness and demonstrate that the AcuSnare Polypectomy Snare - Duckbill (ASDB) meets the performance requirements to fulfill the intended use of the device."
Functional Equivalence:	"The subject device is substantially equivalent to the predicate device with respect to the intended use, operating mechanism, materials and technological characteristics."The modification (duckbill shape) "does not change the method of operation or the intended use of the device."
Risk Mitigation:	"The Risk Analysis was completed to access the impact of modifications made to the cleared device using the Design Failure Modes, Effects and Criticality Analysis (DFMECA) method.""We believe risks associated with the modifications to the subject device have been adequately addressed through our Design Control Processes."
Biocompatibility (Inferred):	Not explicitly stated but implied by substantial equivalence and design control. The device components (PTFE sheath, stainless steel drive cable and snare head) are likely the same as the predicate and would have undergone biocompatibility testing in the predicate's clearance. The text mentions "materials" are equivalent.
Sterility (Inferred):	Not explicitly stated but common for such devices. The device is described as "sterile, single use." This would have been established with the predicate device and verified for the modified device.
Mechanical Performance (e.g., cutting, cauterization efficacy, durability of snare):	Not detailed. The text states "Design verification and/or validation testing was performed." These tests would have covered the physical properties and functional performance of the modified duckbill snare to ensure it effectively cuts and cauterizes polyps as intended, at least equivalently to the predicate. Specific metrics (e.g., force to cut, temperature profile, number of cycles) are not provided.

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 a sample size for a clinical "test set" in the context of human patients or a specific dataset.
- The "testing" mentioned refers to design verification and validation testing. This typically involves laboratory-based tests on device samples, not patient data.
- Provenance is not applicable as this describes device design testing, not clinical data analysis.
- The submission is a regulatory filing, not a peer-reviewed research paper detailing a study's methodology.
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 applicable and not provided. As explained above, the submission describes design verification and validation testing of the device itself, not a study involving human interpretation of data where expert ground truth would be established.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not applicable and not provided. Adjudication methods are relevant for studies where multiple human readers or algorithms interpret medical images or data against a consensus ground truth. This submission focuses on engineering and design testing.
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 comparative effectiveness study was not done (or at least, not reported in this document).
- This device is a physical medical instrument (polypectomy snare), not an AI or imaging-based diagnostic tool. Therefore, a study on human reader improvement with AI assistance is entirely irrelevant to this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the "design verification and validation testing," the "ground truth" would be established against engineering specifications, industry standards, and the performance characteristics of the predicate device. For instance, a test might verify that the snare loop can open to a specified diameter, or that it can effectively cut a tissue phantom without breaking, matching the performance of the predicate. This is functional and safety performance, not clinical ground truth.
The sample size for the training set
- This information is not applicable and not provided. Training sets are used for machine learning algorithms. This document solely concerns a physical medical device.
How the ground truth for the training set was established
- This information is not applicable and not provided.

In summary, the provided document is a regulatory submission for a minor device modification. It details the device, its intended use, and states that design verification and validation testing were conducted to confirm that the modifications do not raise new safety or effectiveness concerns and that the device meets performance requirements equivalent to the predicate. It does not provide details on clinical study methodologies or quantitative performance metrics typically found in clinical trials or AI/diagnostic device studies.

Summary

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July 18, 2019

Wilson-Cook Medical, Inc. Doris Hawks Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, North Carolina 27105

K191048 Re:

Trade/Device Name: AcuSnare Polypectomy Snare - Duckbill Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: Class II Product Code: FDI Dated: April 18, 2019 Received: April 19, 2019

Dear Doris Hawks:

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

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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 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 medical devices and radiation-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.

for

Shanil P. Haugen, Ph.D. Acting Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191048

Device Name AcuSnare Polypectomy Snare - Duckbill

Indications for Use (Describe)

The AcuSnare Polypectomy Snare - Duckbill (ASDB) 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)

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

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Wilson-Cook Medical, Inc. 4900 Bethania Station Road, Winston-Salem, NC 27105, USA. Phone:336.744.0157 Fax: 336-201-5994 www.cookmedical.com

Special 510k - Summary 008.

April 18, 2019

Applicant Information

Applicant:	Wilson-Cook Medical, Inc. /Cook Endoscopy
	4900 Bethania Station Road
	Winston-Salem, North Carolina 27105
Contact:	Doris A. Hawks, Global Regulatory Affairs Specialist
Phone:	(336) 744-0157 ext. 396293
Fax:	(336) 201-5994

Device Information

Trade Name:	AcuSnare Polypectomy Snare - Duckbill
Common Name:	Polypectomy Snare
Classification Name:	Endoscopic electrosurgical unit and accessories
Regulation Number:	21 CFR 876.4300
Product Code:	FDI
Classification:	Class II,
Review Panel:	Gastroenterology-Urology

Predicate Device
Name:	AcuSnare Polypectomy Snare
510(k) Number:	K173673
Date:	Cleared August 24, 2018

Device Description

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polytetrafluoroethylene (PTFE) and is offered in 7 Fr. (2.3 mm) diameter and 240 cm length models. The snare head is available in the shape of a duckbill configuration and offered in a 15 mm or 25 mm width. The stainless-steel drive cable and snare head pass through the sheath and the three ring (polycarbonate) handle allows the user to extend and retract the snare through the distal tip of the sheath.

Intended Use

The AcuSnare Polypectomy Snare - Duckbill (ASDB) device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract.

Substantial Equivalence

Minor design changes were made to the predicate AcuSnare Polypectomy Snare cleared to market via K173673. These changes include adding a new duckbill shape configuration along with cannula components required to manually form the snare into a duckbill shape. Configuration of the snare does not change the method of operation or the intended use of the device. The subject device is substantially equivalent to the predicate device with respect to the intended use, operating mechanism, materials and technological characteristics

Performance Data

The Risk Analysis was completed to access the impact of modifications made to the cleared device using the Design Failure Modes, Effects and Criticality Analysis (DFMECA) method. Design verification and/or validation testing was performed as a result of this risk analysis assessment. Results from design validation and/or verification testing provide reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness and demonstrate that the AcuSnare Polypectomy Snare - Duckbill (ASDB) meets the performance requirements to fulfill the intended use of the device.

Conclusion

We believe risks associated with the modifications to the subject device have been adequately addressed through our Design Control Processes. We believe that the subject device is substantially equivalent to the predicate device in terms of intended use and performance characteristics (key operating principles, materials and technological characteristics).

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).