The Wittich Nitinol Stone Basket is intended for placement through a percutaneous tract for removal of stones (calculi) or stone fragments from anatomic structures such as the gallbladder, biliary tract, renal pelvis, and ureter.

Device Description

The Wittich Nitinol Stone Basket is comprised of a basket catheter with a loading sleeve, an introducer sheath, and a dilator. The basket is designed with a six-wire bulb configuration and is manufactured from nitinol wire. The nitinol wires are soldered together to a stylet wire which is secured inside the basket catheter shaft. The loading sleeve is used to support the insertion of the basket catheter into the introducer sheath.

The introducer sheath is manufactured from radiopaque fluorinated ethylene propylene and is designed with a radiopaque tip near the distal end of the introducer for tip visibility. Additionally, the distal end of the introducer sheath is angled to facilitate directional control. The matched dilator is manufactured from polyethylene tubing and is tapered for a smooth transitional fit within the matched introducer sheath.

AI/ML Overview

The provided text describes the Cook Incorporated Wittich Nitinol Stone Basket, a medical device for removing stones from anatomical structures. The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria or extensive clinical study results for a new AI-powered device.

Therefore, much of the requested information regarding AI-specific criteria, human reader studies, and large-scale data provenance is not available in the provided text. The document primarily details mechanical and biocompatibility testing for a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (if available)	Reported Device Performance
Dimensional and Compatibility	Adequate for clinical use (general)	Testing showed that dimensions and component compatibility was adequate for clinical use.
Multiple Stone Retrieval Testing	Able to track, deploy, and retrieve a simulated stone (approx. 8 mm diameter) ten times through a 90-degree bent tube without damage to the test article. (Per FDA 510(k) Checklist for Mechanical Lithotripters and Stone Dislodgers)	The Basket Catheter with Loading Sleeve and the Introducer Sheath was able to track, deploy, and retrieve a simulated stone (approximately eight (8) mm in diameter) ten times through a tube bent at approximately ninety degrees, without damage to the test article.
Basket Catheter Shaft, Basket-to-Basket Shaft Solder Joint, and Hub-To-Shaft Joint Tensile	Peak load greater than or equal to 10 N (in accordance with JIS T 3244:2011)	Testing showed the peak load of catheter shaft section was greater than or equal to 10 N.
Basket Catheter Single Loop and Silicone Sphere to Basket Wire Joint Tensile	Peak load greater than or equal to 10 N (in accordance with JIS T 3244:2011)	Testing showed the peak load of a single loop of the basket catheter and silicone sphere to basket wire joint was greater than or equal to 10 N.
Introducer Sheath Shaft, Introducer Sheath Hub-to-Shaft Tensile	Peak load greater than or equal to 15 N (in accordance with BS EN ISO 11070: 2014)	Testing showed the peak load of the introducer sheath shaft and introducer sheath hub-to-shaft bond were greater than or equal to 15 N.
Introducer Distal Tip Bond Tensile	Peak load greater than or equal to 15 N (in accordance with BS EN ISO 11070)	Testing showed the peak load of shaft-to-tip was greater than or equal to 15 N.
Radiopacity Testing	Radiopacity determined to be non-inferior to the selected comparative device (following ASTM F6540-12)	The radiopacity of the Wittich Nitinol Stone Basket introducer sheath was determined to be non-inferior to the radiopacity of the selected comparative device.
Introducer Sheath Kink Radius	Kink radius less than or equal to 30 mm	Testing showed the kink radius was less than or equal to 30 mm.
Dilator Shaft/Hub-to-Shaft Tensile	Peak load of dilator shaft greater than or equal to 10 N, and hub-to-shaft greater than or equal to 15 N (in accordance with BS EN ISO 11070)	Testing showed the peak load of the dilator shaft and the hub-to-shaft were greater than or equal to 10N and 15 N, respectively.
Biocompatibility	Met cytotoxicity, sensitization, intracutaneous irritation, and acute systemic toxicity requirements (Per ISO 10993-1 and FDA guidance)	Testing for cytotoxicity, sensitization, intracutaneous irritation, and acute systemic toxicity demonstrated the biocompatibility of the subject devices. All pre-determined acceptance criteria were met. The results of these tests showed that the subject devices met the design input requirements based on the intended use, and support the conclusion that these devices do not raise new questions of safety or effectiveness and support a determination of substantially equivalence to the predicate device.

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

The document describes in-vitro (bench) testing simulating conditions. It does not refer to a "test set" in the context of clinical data for an AI algorithm.

Sample Size: Not explicitly stated as a number of "samples" in a dataset sense. Instead, tests were performed a certain number of times (e.g., "ten times" for stone retrieval) or on individual components. The "test article" refers to the device itself or its components.
Data Provenance: Not applicable as it is laboratory bench testing, not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This is not applicable as the studies described are bench tests for a physical medical device, not a performance evaluation of an AI algorithm using expert-labeled data. The performance criteria are based on engineering standards and simulated physical properties, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable for bench testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a physical stone retrieval basket, not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This submission is for a physical medical device, not an AI algorithm. The performance described is for the device operating independently in a simulated environment.

7. The Type of Ground Truth Used

The "ground truth" for these tests refers to established engineering standards, material properties, and physical performance metrics. For example:
- Tensile strength is measured against a standard (e.g., peak load in Newtons).
- Radiopacity is compared to a comparative device.
- Stone retrieval capability is measured by the ability to retrieve a simulated stone under specified conditions.
- Biocompatibility is assessed against recognized ISO standards and FDA guidance for toxicology (cytotoxicity, sensitization, irritation, systemic toxicity).

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable. This is not an AI algorithm.

Summary

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December 12, 2017

Cook Incorporated Erum B. Nasir Regulatory Affairs Team Lead 750 Daniels Way, P.O. Box 489 Bloomington, IN 47404

Re: K170898

Trade/Device Name: Wittich Nitinol Stone Basket Regulation Number: 21 CFR& 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: LQR, FFFL Dated: November 8, 2017 Received: November 9, 2017

Dear Erum B. Nasir:

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,

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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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K170898

Device Name Wittich Nitinol Stone Basket

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary Section 1.0

Wittich Nitinol Stone Basket 21 CFR, §876.5010 Date Prepared: December 10, 2017

Submitted By:

Submission:	Traditional 510(k) Premarket Notification
Applicant:	Cook Incorporated
Contact:	Erum B. Nasir, MS
Applicant Address:	Cook Incorporated750 Daniels WayBloomington, IN 47404
Contact Phone Number:	(812) 335-3575 x102607
Contact Fax Number:	(812) 332-0281
Device Information:
Trade Name:	Wittich Nitinol Stone Basket
Common Name:	Dislodger, Stone, Biliary
	Dislodger, Stone, Basket, Ureteral, Metal
Classification Name:	Biliary Catheter and AccessoriesUreteral Stone Dislodger
Regulation:	21 CFR, §876.501021 CFR, §876.4680 (510(k) exempt)
Product Code:	LQRFFL (510(k) exempt)
Device Class:	II
Classification Panel:	Gastroenterology/Urology

Predicate De vices:

The Wittich Nitinol Stone Basket is substantially equivalent to the predicate device, the Wittich Nitinol Stone Basket (K902944) cleared for market by FDA on September 12, 1990.

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

De vice Description:

Intended Use :

Comparison to Predicates:

The Wittich Nitinol Stone Basket and the predicate device, Wittich Nitinol Stone Basket (K902944), are substantially equivalent in that these devices are identical in principles of operation and fundamental technologies. The differences between the subject device and the predicate device, including materials, dimensions, and minor modification to the indications for use, do not raise any new issues of safety or effectiveness. The substantial equivalence of the modified subject device is supported by testing.

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		Wittich Nitinol Stone Basket(K902944)	Wittich Nitinol Stone Basket(Subject of this submission)
			21 CFR §876.5010 & 21 CFR§876.4680
Regulation Number		21 CFR § 876.5010	§876.4680
Product Code		LQR	LQR & FFL
Classification		Class II	Identical
Intended Use/Indications for Use		Used for nonoperative removalof stones fromthe biliary tract,renal pelvis and ureter	Intended for placement througha percutaneous tract forremoval of stones (calculi) orstone fragments fromanatomicstructures such as thegallbladder, biliary tract, renalpelvis and ureter
Basket	Shaft	Polyethylene	Identical
	Basket Wire	Nitinol wire	Identical
	Shrink Tube	Gray Slate, Semi-Rigid	Identical
	Loading Sleeve	Tetrafluoroethylene	Identical
	Solder	Allstate	Identical
		Silweld Solder	Identical
	Sphere	Tevdek Suture	Silicone Elastomer
	Notched Cannula	Stainless Steel	Identical
	Stylet Wire	Stainless Steel	Identical
	Inner Coil	Stainless Steel	Identical
	Outer Diameter(cm)	2.0	1.8 and 2.2
Length (cm)	4.5	2.5 and 4.5
IntroducerSheath	Shaft	Radiopaque FluorinatedEthylene Propylene	Identical
	Connector Cap	Polyamide Nylon 6	Identical
	Adapter	Polyamide Nylon 6	Identical
	Adhesive	Loctite	Identical
	Distal End	Tungsten/Rhenium Band	Fluorinated Ethylene PropyleneTungsten
	Outer Diameter(Fr)	12	8.5 and 12.0
	Length (cm)	24	24 and 50
	Dilator	Shaft	Polyethylene
		Adapter	High Density Polyethylene
Cap		Acetal	Identical
Packaging		Polyethylene-Polyester/Tyvek	Identical
Sterilization		Ethylene oxide	Identical
Sterility Assurance Level (SAL)		10-6	Identical

Table 2.0-1 Substantial Equivalence Comparison

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Test Data:

The following tests have been performed to demonstrate that the application device met applicable design and performance requirements:

Dimensional and Compatibility (Basket Catheter, Introducer, and Dilator) -. Testing showed that dimensions and component compatibility was adequate for clinical use.
Multiple Stone Retrieval Testing Testing performed per FDA 510(k) Checklist . for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and Urology showed the Basket Catheter with Loading Sleeve and the Introducer Sheath was able to track, deploy, and retrieve a simulated stone (approximately eight (8) mm in diameter) ten times through a tube bent at approximately ninety degrees, without damage to the test article.
. Basket Catheter Shaft, Basket-to Basket Shaft Solder Joint, and Hub-To-Shaft Joint Tensile – Testing in accordance with JIS T 3244:2011 showed the peak load of catheter shaft section was greater than or equal to 10 N.
. Basket Catheter Single Loop and Silicone Sphere to Basket Wire Joint Tensile Testing - Testing in accordance with JIS T 3244:2011 showed the peak load of a single loop of the basket catheter and silicone sphere to basket wire joint was greater than or equal to 10 N.
Introducer Sheath Shaft, Introducer Sheath Hub-to-Shaft Testing in accordance . with BS EN ISO 11070: 2014 showed the peak load of the introducer sheath shaft and introducer sheath hub-to-shaft bond were greater than or equal to 15 N.
. Introducer Distal Tip Bond Tensile – Testing in accordance with BS EN ISO 11070 showed the peak load of shaft-to-tip was greater than or equal to 15 N.
Radiopacity Testing following the method described in ASTM F6540-12, ● "Standard Test Methods for Determining Radiopacity for Medical Use" showed the radiopacity of the Wittich Nitinol Stone Basket introducer sheath was determined to be non-inferior to the radiopacity of the selected comparative device.
. Introducer Sheath Kink Radius - Testing showed the kink radius was less than or equal to 30 mm.
Dilator Shaft/Hub-to-Shaft Tensile – Testing in accordance with BS EN ISO 11070 showed the peak load of the dilator shaft and the hub-to-shaft were greater than or equal to 10N and 15 N, respectively.

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Biocompatibility testing Per ISO 10993-1 and FDA guidance, testing for . cytotoxicity, sensitization, intracutaneous irritation, and acute systemic toxicity demonstrated the biocompatibility of the subject devices.
For these tests, all pre-determined acceptance criteria were met. The results of these tests showed that the subject devices met the design input requirements based on the intended use, and support the conclusion that these devices do not raise new questions of safety or effectiveness and support a determination of substantially equivalence to the predicate device.

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.