The Wilson-Cook Mini Basket Extraction Basket is a sterile, single use device used through the accessory channel of endoscopes. The device consists of basket, catheter, and handle components. The basket component is constructed of monofilament metal wires and a helical design. The catheter is 200 cm in total length with a working length of 182 cm and 5 Fr diameter. The catheter is composed of Polytetrafluoroethylene (PTFE). The handle is a pin-vice design composed of polycarbonate with an acetal side arm fitting. The device is not compatible with any mechanical lithotripter.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called the "Wilson-Cook Mini Basket Extraction Basket" (K182381). This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) application.

Therefore, the information provided in this document is not a study that proves the device meets specific acceptance criteria in the way a clinical trial would for an AI/algorithm-based device. Instead, it demonstrates the device's technical performance and equivalence to a predicate device.

Given this context, I will address your request by interpreting "acceptance criteria" as the performance tests conducted to establish equivalence and "proof" as the results of those non-clinical tests. Since this is a physical medical device and not an AI or algorithm-based product, many of your specific questions regarding AI-related performance measures (e.g., sample size for AI test sets, number of experts for ground truth, MRMC studies) are not applicable.

Here's an adaptation of your requested information based on the provided document:

Device Name: Wilson-Cook Mini Basket Extraction Basket
FDA 510(k) Number: K182381
Device Type: Biliary Catheter and Accessories (Physical Medical Device, not AI/Algorithm)

1. Table of Acceptance Criteria and Reported Device Performance

For this physical medical device, "acceptance criteria" are implied by the successful completion of the listed performance tests, which are standard for such devices to demonstrate functionality and safety in comparison to a predicate. The document states that these tests "confirmed that the subject device performs as intended."

Acceptance Criteria (Implied by Test Type)	Reported Device Performance
Stone and Foreign Body Capture (Demonstrate ability to capture intended targets)	Testing was conducted and confirmed the basic performance of the device as intended.
Tensile Strength (Ensure device withstands forces during use without breaking)	Testing was conducted and confirmed the basic performance of the device as intended.
Functional Performance (Overall performance of basket, catheter, handle components)	Testing was conducted and confirmed the basic performance of the device as intended.
Shelf Life (Maintain performance over time)	Testing was conducted and confirmed the basic performance of the device as intended.
Biocompatibility (Safety of materials in contact with body)	Performed in accordance with FDA Guidance ISO 10993-1 and ISO 10993-1:2009. (Implies satisfactory results as part of clearance).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample sizes (e.g., number of devices, number of stones tested) for each non-clinical test. This level of detail is typically found within the full 510(k) submission, not the summary letter.
Data Provenance: The studies were conducted by Wilson-Cook Medical, Inc. / Cook Endoscopy. These are non-clinical (benchtop/laboratory) tests, not human studies. The data provenance is internal to the manufacturer's testing facilities. It is inherently "retrospective" in the sense that the testing was completed before the submission.

3. Number of Experts and Qualifications for Ground Truth

This question is not applicable as this is a physical medical device submission, not an AI/algorithm device requiring expert human readers to establish ground truth for image interpretation or similar AI-specific performance metrics. Performance was assessed through engineering and material science tests.

4. Adjudication Method for the Test Set

This question is not applicable as this is a physical medical device submission. Adjudication methods like 2+1 or 3+1 are used for expert consensus on challenging cases, primarily in clinical studies involving interpretation (e.g., radiology for AI). The tests performed here are objective engineering tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. MRMC studies are used to evaluate the comparative effectiveness of different diagnostic methods, typically involving human readers interpreting images, possibly with AI assistance. This submission is for a physical device used for stone extraction, not an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the Loop) Performance

Not applicable. This section relates to AI/algorithm performance. The Wilson-Cook Mini Basket is a physical device that is used by a human endoscopist. There is no "algorithm only" performance for this type of product.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be defined by engineering specifications, material properties, and physical standards for stone capture, tensile strength, and functional operation. For example, a successful "stone capture" test would be defined by the physical retention of the stone within the basket under specified conditions, rather than a clinical outcome or expert diagnosis. Biocompatibility used established ISO standards.

8. Sample Size for the Training Set

Not applicable. This question pertains to AI/machine learning models which require training data. This is a physical medical device. Manufacturing processes and design iterations occur, but there isn't a "training set" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, this pertains to AI/machine learning. For a physical device, functional parameters and material specifications are validated through established engineering and quality control procedures during design and manufacturing.

Summary

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October 30, 2018

Wilson-Cook Medical, Inc. Tiffanny A. Thomas Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105

Re: K182381

Trade/Device Name: Wilson-Cook Mini Basket Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: LQR Dated: August 30, 2018 Received: August 31, 2018

Dear Tiffanny A. Thomas:

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 mav, 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 avare 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.

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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 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.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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,

Image /page/1/Picture/7 description: The image shows the FDA logo on the left side. On the right side, the text "Jeffrey W. Cooper -S 2018.10.30 15:35:40 -04"" is displayed. The text appears to be a signature or timestamp associated with the FDA logo.

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) K182381

Device Name Wilson-Cook Mini Basket

Indications for Use (Describe)

Used for endoscopic removal of biliary stones, pancreatic stones, and foreign bodies.

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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Submitted By:

Submission: Applicant: Contact: Applicant Address:

Traditional 510(k) Premarket Notification Wilson-Cook Medical, Inc. / Cook Endoscopy Tiffanny A. Thomas Wilson-Cook Medical, Inc. / Cook Endoscopy 4900 Bethania Station Road Winston-Salem, North Carolina 27105

Contact Phone Number: (336) 744-0157 ext.396680 Contact Fax Number: (336) 201-5994

Device Information

Trade Name:	Wilson-Cook Mini Basket
Common Name:	Dislodger, Stone, Biliary
Classification Name:	Biliary Catheter and Accessories
Regulation Number:	21 CFR 876.5010,
Product Code:	LQR
Device Class:	Class II
Review Panel:	Gastroenterology-Urology

Predicate Device

Name:	Non-Lithotripsy Extraction Basket
510(k) Number:	K171969
Date:	Cleared March 28, 2018

Device Description

Intended Use

Used for endoscopic removal of biliary stones, pancreatic stones, and foreign bodies.

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Comparison to Predicate Device

The Wilson-Cook Mini Basket Extraction Basket has the same principles of operation, direct patient contacting materials and fundamental technology as the predicate device. The modifications to the subject device include a more specific intended use, a smaller catheter diameter, dimensional changes to the basket and material change on the injection hub/side arm fitting. These changes do not raise new questions of safety or effectiveness.

Summary of Non-Clinical Testing

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

Stone and Foreign Body Capture Testing .
Tensile Testing .
. Functional Testing
Shelf Life Testing .

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 the risks associated with the modifications to the subject device were adequately addressed through our Design Control Processes and do not affect safety or effectiveness of the device. The information and data contained in this notification supports a determination of substantial equivalence.

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.