The Nathanson Transcystic Bile Duct Stone Exploration Pack is a pre-assembled device comprising of a cholangiography catheter, a flatwire stone basket, "Y" Tuohy-Borst adapter, and a connecting tube assembly with a stopcock. The device is used in a healthcare facility/hospital environment during common bile duct exploration procedures. The subject device requires a transcystic surgical approach by a clinician for the removal of bile duct stones. When complete removal of common bile duct stones cannot be achieved, alternative approaches such as endoscopic retrograde cholangiography with sphincterotomy (ERCP) may be considered. The subject device is provided sterile and for single-use only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Nathanson Transcystic Bile Duct Stone Exploration Pack". The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a comparative effectiveness study involving AI or human readers.

Therefore, the requested information about acceptance criteria, study design for proving device performance (especially for AI/human reader studies), sample sizes for test/training sets, expert involvement, and ground truth establishment, cannot be found or inferred from the provided document as it relates to a traditional premarket notification for a mechanical medical device, not an AI/ML software.

However, I can extract the acceptance criteria and performance as presented for the mechanical and biocompatibility testing of the device, which is relevant to a non-AI medical device.

Here's the information that can be extracted relevant to the provided text:

Acceptance Criteria and Reported Device Performance (for a Traditional Medical Device)

The document outlines acceptance criteria and corresponding test results for various components and aspects of the Nathanson Transcystic Bile Duct Stone Exploration Pack.

1. Table of Acceptance Criteria and Reported Device Performance:

Test Category	Specific Test	Acceptance Criteria	Reported Device Performance
Biocompatibility	ISO 10993-1	Testing for cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity to ensure biocompatibility.	"Test results indicated that all materials are biocompatible."
Catheter	Tip to Shaft Tensile (Zero Time and Three Year Accelerated Aging)	Tensile load at failure should be greater than or equal to 10 N.	"Test results met predetermined criteria."
	Hub to Shaft Tensile (Zero Time and Three Year Accelerated Aging)	Tensile load at failure should be greater than or equal to 10 N.	"Test results met predetermined criteria."
	Kink and Leakage (Zero Time)	Test articles shall not kink at a kink length of 188 mm. No leakage from the Tuohy-Borst Y-Connector during flow evaluation.	"Test results met predetermined criteria."
	Radiopacity (Zero Time and Three Year Accelerated Aging)	The radiopacity of each test article catheter shaft shall fall along the gradient of an aluminum X-ray step wedge gauge.	"Test results met predetermined criteria."
Flatwire Extractor	Proximal Solder Connection Tensile (Zero Time)	Tensile load at failure should be greater than or equal to 10 N.	"Test results met predetermined criteria."
	Distal Basket Assembly Tensile (Zero Time)	Tensile load at failure should be greater than or equal to 10 N.	"Test results met predetermined criteria."
	Basket Deployment & Retrieval (Zero Time)	Test articles shall successfully track, deploy, and retrieve a simulated stone through a tube bent at approximately 90 degrees, without damage to the test article.	"Test results met predetermined criteria."
Catheter & Flatwire Extractor	Dimensional & Surface Analysis (Zero Time)	The specified dimensional and specification requirement for each test article shall be met.	"Test results met predetermined criteria."
Extension Tube	Hub to Shaft Tensile	The peak tensile load that the Female Luer Lock Adapter to extension tube connection and Male Luer Lock Adapter to extension tube connection shall be greater than or equal to 4.9 N.	"Test results met predetermined criteria."
Overall Conclusion	All Tests	All pre-determined acceptance criteria for all tests.	"For these tests, all pre-determined acceptance criteria were met. The results of these tests show that the Nathanson Transcystic Bile Duct Stone Exploration Pack meets the design input requirements based on the intended use."

2. Sample size used for the test set and the data provenance:

The document does not specify the exact sample sizes for the physical and biocompatibility tests. It refers to "test articles" but does not quantify them.
The only reference to a "study" is a retrospective clinical study from 2007 (Taylor et al, 2007).
- Sample Size: 160 consecutive patients.
- Data Provenance: Not explicitly stated (e.g., country of origin), only that it's a "retrospective study."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not provided for this type of device submission. The test results are based on engineering specifications and laboratory testing, not expert interpretation of medical images or data.
The clinical study mentioned is a retrospective review of patient outcomes, not an expert panel establishing ground truth for a new device's performance.

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

This information is not applicable and not provided. Adjudication methods are typically used in clinical trials or studies where human assessment or interpretation is involved in determining an outcome, which is not the primary focus of this 510(k) submission's testing section.

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:

No, an MRMC comparative effectiveness study was not done. This is a mechanical medical device, not an AI-powered diagnostic tool. The document focuses on physical and chemical properties and a retrospective clinical review of outcomes.

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

No, this is not applicable. There is no algorithm or AI component in this device.

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

For the physical tests: The "ground truth" is defined by engineering specifications and pre-determined acceptance criteria based on established standards (e.g., ISO 10993-1, force measurements in Newtons, length in mm).
For the clinical study mentioned: The "ground truth" is patient outcomes data (e.g., successful common bile duct exploration, need for additional intervention, major morbidity, biliary leak, stricture).

8. The sample size for the training set:

Not applicable. This document describes a mechanical medical device, not an AI/ML algorithm requiring training data.

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

Not applicable. As above, no training set for an AI/ML algorithm is involved.

Summary

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March 1, 2018

Cook Incorporated Colin Jacob Capital Equipment Specialist, Regulatory Affairs 750 Daniels Way, P.O. Box 489 Bloomington, Indiana 47402

Re: K171915

Trade/Device Name: Nathanson Transcystic Bile Duct Stone Exploration Pack Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: LOR Dated: February 2, 2018 Received: February 5, 2018

Dear Colin Jacob:

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 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); 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.

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be against a white background. The letters are clearly legible and evenly spaced.

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) K171915

Device Name

Nathanson Transcystic Bile Duct Stone Exploration Pack

Indications for Use (Describe)

The Nathanson Transcystic Bile Duct Stone Exploration Pack is intended for extraction of bile duct stones via laparoscopic transcystic approach.

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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510(k) Summary

COOK INCORPORATED OOMINGTON, IN 47404 U.S WWW.COOKMEDICAL.C

Nathanson Transcystic Bile Duct Stone Exploration Pack (21 CFR §807.92) Date Prepared: February 28, 2018

Submitted By:

Applicant: Contact: Secondary Contact: Applicant Address:

Cook Incorporated Colin Jacob Hui Ouyang, PhD, RAC Cook Incorporated P.O. Box 489 750 Daniels Way Bloomington, IN 47402 (812) 335-3575 x 104965 (812) 332-0281

Contact Phone Number: Contact Fax Number:

Device Information:

Trade Name: Nathanson Transcystic Bile Duct Stone Exploration Pack Common Name: Dislodger, Stone, Biliary Gastroenterology/Urology Classification Panel: Classification Name: Biliary Catheter and Accessories Regulation Class: Class II 21 CFR § 876.5010 Regulation: Product Code: LOR

Predicate Device:

Wittich Nitinol Stone Basket (K902944)

Device Description:

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COOK INCORPORATED 750 DANIELS WAY LOOMINGTON, IN 47404 U.S.A. WWW.COOKMEDICAL.COM

Indications for Use:

The Nathanson Transcystic Bile Duct Stone Exploration Pack is intended for extraction of bile duct stones via laparoscopic transcystic approach.

Comparison to Predicate:

The Nathanson Transcystic Bile Duct Exploration Pack and the predicate device, Wittich Nitinol Stone Basket (K902944), have the same intended use and share similar indication for use and principles of operation. The differences in technological characteristics do not raise different questions of safety and/or effectiveness when comparing to the predicate.

Substantial Equivalence Comparison:

		PREDICATE DEVICE	SUBJECT DEVICE
		Wittich Nitinol Stone Basket(K902944)	Nathanson Transcystic Bile DuctStone Exploration Pack
	Regulation Number	21 CFR § 876.5010	IDENTICAL TO PREDICATE
	Product Code	LQR	IDENTICAL TO PREDICATE
	Classification	II	IDENTICAL TO PREDICATE
	Indications for Use	For nonoperative removal of stonesfrom the biliary tract, renal pelvis andureter	For extraction of bile duct stones viatranscystic approach.
	One-time Use	Yes	IDENTICAL TO PREDICATE
	Duration of Use	Limited (≤ 24 hours)	IDENTICAL TO PREDICATE
	Imaging Technique toVisualize Catheter In Situ	Fluoroscopy	IDENTICAL TO PREDICATE
	Surgical Approach	Nonoperative	Transcystic Surgical
	Compatible Instrument	Not specified	Laparoscopic cholangiographyinstrument clamp with a minimum 6Fr working channel
	Allowing flushing of saline andcontrast material throughcatheter	No	Yes
Basket	Material	Nitinol(nickel and titanium alloy)	Stainless steel
	Wire Configuration	six-wire bulb shape	four-wire bulb shape
	Length (cm)	4.5	2.3
	Outer Diameter whenDeployed (cm)	2	IDENTICAL TO PREDICATE
Catheter / Sheath	Material	Radiopaque tetrafluoroethylene	Radiopaque nylon
	Ink Markers	No	Yes
	Length (cm)	24 (introducer sheath)	70 (catheter component)
	Outer Diameter (Fr)	12	5.5

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Image /page/5/Picture/1 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, bold letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, bold letters on a red background. The logo is simple and clean, and the red and white colors are eye-catching.

COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON, IN 47404 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM

	PREDICATE DEVICE	SUBJECT DEVICE
	Wittich Nitinol Stone Basket(K902944)	Nathanson Transcystic Bile DuctStone Exploration Pack
Additional AssemblyComponents	dilator	"Y" Tuohy-Borst adapter,connecting tube, stopcock
Packaging	Polyethylene-Polyester/Tyvek	IDENTICAL TO PREDICATE
Sterilization Method	Ethylene Oxide	IDENTICAL TO PREDICATE
Sterility Assurance Level(SAL)	10-6	IDENTICAL TO PREDICATE

Substantial Equivalence Comparison (continued):

Technological Characteristics:

The subject device, Nathanson Transcystic Bile Duct Stone Exploration Pack, was subjected to applicable testing to assure reliable design and performance under the testing parameters. The tests are listed below:

. Biocompatibility - Per ISO 10993-1, testing for cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity were performed to ensure the biocompatibility of the subject device set. Test results indicated that all materials are biocompatible.
' Catheter
- Tip to Shaft Tensile (Zero Time and Three Year Accelerated Aging) Tensile load at 0 failure should be greater than or equal to 10 N. Test results met predetermined criteria.
- ロ Hub to Shaft Tensile (Zero Time and Three Year Accelerated Aging) - Tensile load at failure should be greater than or equal to 10 N. Test results met predetermined criteria.
- Kink and leakage (Zero Time) Test articles shall not kink at a kink length of 188 mm. Furthermore, there shall be no leakage from the Tuohy-Borst Y-Connector during flow evaluation of the catheter assembly. Test results met predetermined criteria.
- Radiopacity (Zero Time and Three Year Accelerated Aging) The radiopacity of ロ each test article catheter shaft shall fall along the gradient of an aluminum X-ray step wedge gauge. Test results met predetermined criteria.

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Image /page/6/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, sans-serif font in the upper portion of the logo. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font.

COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON, IN 47404 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM

Flatwire Extractor ■
- ם Proximal Solder Connection Tensile (Zero Time) - Tensile load at failure should be greater than or equal to 10 N. Test results met predetermined criteria.
- Distal Basket Assembly Tensile (Zero Time) Tensile load at failure should be ロ greater than or equal to 10 N. Test results met predetermined criteria.
- ם Basket Deployment & Retrieval (Zero Time) - Test articles shall successfully track, deploy, and retrieve a simulated stone through a tube bent at approximately 90 degrees, without damage to the test article. Test results met predetermined criteria.
. Catheter & Flatwire Extractor
- Dimensional & Surface Analysis (Zero Time) the specified dimensional and ロ specification requirement for each test articles shall be met. Test results met predetermined criteria.
. Extension Tube
- ם Hub to Shaft Tensile - The peak tensile load that the Female Luer Lock Adapter to extension tube connection and Male Luer Lock Adapter to extension tube connection shall be greater than or equal to 4.9 N. Test results met predetermined criteria.
. Clinical Study
- ロ A 2007 retrospective study evaluated 160 consecutive patients with bile duct stones (Taylor et al, 2007). The Nathanson Trancystic Bile Duct Stone Exploration Pack (previously known as Nathanson Basket Kit) was used for transcystic exploration when 1 cm diameter stones were observed in the common bile duct. 131 cases (82%) achieved successful laparoscopic common bile duct exploration (LCBDE). 29 cases required additional intervention (i.e., ERCP) to achieve clearance at the time of surgery. Major morbidity occurred in 13.8%, including biliary leak in 7.5% and one late biliary stricture (0.6%).

Conclusion:

For these tests, all pre-determined acceptance criteria were met. The results of these tests show that the Nathanson Transcystic Bile Duct Stone Exploration Pack meets the design input requirements based on the intended use. Furthermore, these results support the conclusion that the Nathanson Transcystic Bile Duct Stone Exploration Pack does not raise different questions of safety or effectiveness and support 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.