The NCompass Nitinol Stone Extractor is a single-use, sterile, disposable device. The extractor is a stone retrieval device consisting of nitinol basket with a 1.5 cm wide diameter when fully expanded and a 2.4 Fr shaft diameter sheath. The device is packaged with a Touhy-Borst adapter accessory.

AI/ML Overview

The NCompass Nitinol Stone Extractors are intended for extraction of stones or debris during biliary surgical procedures.

Here's an analysis of the provided text regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Category	Specific Test	Acceptance Criteria	Reported Device Performance
Biocompatibility	Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity	Materials are biocompatible (per ISO 10993-1)	All materials found to be biocompatible.
Mechanical Properties	Dimensional and Compatibility Evaluation	Met pre-determined acceptance criteria	All pre-determined acceptance criteria were met.
Mechanical Properties	Radiopacity Evaluation	Met pre-determined acceptance criteria	All pre-determined acceptance criteria were met.
Performance	Multiple Stone Retrieval Testing	Met pre-determined acceptance criteria	All pre-determined acceptance criteria were met.
Mechanical Properties	Tensile Test: Basket Formation	Met pre-determined acceptance criteria	All pre-determined acceptance criteria were met.
Mechanical Properties	Tensile Test: Basket Coil	Met pre-determined acceptance criteria	All pre-determined acceptance criteria were met.
Mechanical Properties	Tensile Test: Basket Sheath	Met pre-determined acceptance criteria	All pre-determined acceptance criteria were met.
Mechanical Properties	Tensile Test: Basket Sheath to Handle Connection	Met pre-determined acceptance criteria	All pre-determined acceptance criteria were met.
Mechanical Properties	Tensile Test: Basket Assembly to Shaft Connection	Met pre-determined acceptance criteria	All pre-determined acceptance criteria were met.
Mechanical Properties	Tensile Test: Cannula to Basket Coil Connection	Met pre-determined acceptance criteria	All pre-determined acceptance criteria were met.

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

The document does not explicitly state the sample sizes used for each of the listed tests. The provenance of the data (country of origin, retrospective/prospective) is also not specified. These are typically details found in the full test reports, not a 510(k) summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided in the document. The tests performed are primarily engineering and material science tests, not clinical studies requiring expert ground truth establishment in the traditional sense (e.g., for diagnostic accuracy).

4. Adjudication Method for the Test Set:

This information is not applicable/provided. The tests described are objective engineering and performance tests, not those that typically require adjudication by multiple experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through non-clinical performance and material testing.

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

Not applicable. The device is a medical instrument (stone extractor), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

For the tests described (biocompatibility, dimensional, radiopacity, mechanical, multiple stone retrieval), the "ground truth" would be established by:

Established standards and specifications: For biocompatibility, ISO 10993-1 is explicitly mentioned. For dimensional, tensile, and radiopacity tests, there would be internal design specifications and recognized test methods.
Physical measurements and objective observations: Test results are compared against predefined numerical or qualitative criteria.

8. The Sample Size for the Training Set:

Not applicable. The device is a medical instrument, not an AI or machine learning model that requires a training set.

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

Not applicable. As above, there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 7, 2017

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

Re: K173009

Trade/Device Name: NCompass Nitinol Stone Extractors Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Class II Product Code: LOR Dated: September 27, 2017 Received: September 27, 2017

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. 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

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manufacturing practice requirements as set forth in the quality systems (OS) 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 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.

Benjamin R. Fisher -S

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) K173009

Device Name NCompass Nitinol Stone Extractors

Indications for Use (Describe)

The NCompass Nitinol Stone Extractors are intended for extraction of stones or debris during biliary surgical procedures.

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

NCompass Nitinol Stone Extractors (21 CFR §876.5010) Date Prepared: September 27, 2017

Submitted By:

Applicant:	Cook Incorporated
Contact:	Colin Jacob
Applicant Address:	Cook IncorporatedP.O. Box 489750 Daniels WayBloomington, IN 47402
Contact Phone Number:	(812) 335-3575 x 104965
Contact Fax Number:	(812) 332-0281

Contact Fax Number:

Device Information:

Trade Name:	NCompass Nitinol Stone Extractor
Common Name:	Dislodger, Stone, Biliary
Classification Name/Panel:	Gastroenterology/Urology
Regulation:	21 CFR § 876.5010
Regulation Name:	Biliary Catheter and Accessories
Product Code:	LQR

Predicate Device:

트 Wittich Nitinol Stone Basket (K902944)

Device Description:

Indications for Use:

The NCompass Nitinol Stone Extractors are intended for extraction of stones or debris during biliary surgical procedures.

Comparison to Predicate:

The NCompass Nitinol Stone Extractors and the predicate device, Wittich Nitinol Stone Basket (K902944), have the same intended use; they also share similar indications for use and principle

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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, sans-serif, uppercase letters in the top portion of the logo. Below that, the word "MEDICAL" is in white, sans-serif, uppercase letters in a smaller font size.

of operation. The differences in technological characteristics do not raise different questions of safety and/or effectiveness when compared to the predicate device.

Substantial Equivalence Comparison

		PREDICATE DEVICE	SUBJECT DEVICE
		Wittich Nitinol Stone Basket(K902944)	NCompass Nitinol Stone Extractor
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 stones or debris duringbiliary surgical procedures.
One-time Use		Yes	IDENTICAL TO PREDICATE
Duration of Use		Limited (≤ 24 hours)	IDENTICAL TO PREDICATE
Principle of Operation		Basket deployment from sheath into ananatomical duct	IDENTICAL TO PREDICATE
Imaging Technique to VisualizeDevice		Fluoroscopy	NC3 model: IDENTICAL TOPREDICATENCT4 model: Choledochoscope Imaging
Basket	Fluoroscopic RadiopaqueMaterial	Tungsten/Rhenium band(located on sheath tip)	Stainless Steel(located only on NC3 basket tip)
	Tip Material	None (tipless)	NC3 model: Stainless steelNCT4 model: None (tipless)
	Wire Material	Nitinol (nickel andtitanium alloy)	IDENTICAL TO PREDICATE
	Wire Configuration	6-wire bulb shape	12-wire and 16-wire bulb shape
	Length (cm)	4.5	NC3 model: 1.9-2.3NCT4 model: 2.1-2.5
	Outer Diameter whenDeployed (cm)	2	1.5
Catheter / Sheath	Material	Radiopaque tetrafluoroethylene	Braided stainless steel tubing coatedwith Polytetrafluoroethylene (PTFE),fluorinated ethylene propylene (FEP),and Polyimide
	Length (cm)	24	115
	Outer Diameter (Fr)	12	2.4
Additional Components		Dilator, introducer sheath	Handle, Touhy-Borst Adapter
Packaging		Polyethylene-Polyester/Tyvek	IDENTICAL TO PREDICATE
Sterilization Method		Ethylene Oxide	IDENTICAL TO PREDICATE
Sterility Assurance Level (SAL)		10-6	IDENTICAL TO PREDICATE

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Image /page/5/Picture/0 description: The image is the logo for Cook Medical. The logo consists of the word "COOK" in large, white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font on a darker red background.

Technological Characteristics:

The subject devices, NCompass Nitinol Stone Extractors, were 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.
Dimensional and Compatibility Evaluation (Accelerated Aged) 트
Radiopacity Evaluation (Accelerated Aged) .
. Multiple Stone Retrieval Testing (Zero Time)
Tensile Test: Basket Formation (Accelerated Aged) 트
. Tensile Test: Basket Coil (Accelerated Aged)
. Tensile Test: Basket Sheath (Accelerated Aged)
트 Tensile Test: Basket Sheath to Handle Connection (Accelerated Aged)
트 Tensile Test: Basket Assembly to Shaft Connection (Accelerated Aged)
Tensile Test: Cannula to Basket Coil Connection (Accelerated Aged) 트

Conclusion:

For these tests, all pre-determined acceptance criteria were met. The results of these tests show that the NCompass Nitinol Stone Extractors meet the design input requirements based on the intended use. Furthermore, these results support the conclusion that the NCompass Nitinol Stone Extractors do not raise new 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.