The NCircle Nitinol Tipless Stone Extractor is intended for the manipulation, entrapment, and extraction of calculi and other foreign bodies in the salivary ducts, and to minimize migration during intracorporeal lithotripsy and/or other interventional procedures.

The NGage Nitinol Stone Extractor is intended for the manipulation, entrapment, and extraction of calculi and other foreign bodies in the salivary ducts, and to minimize migration during intracorporeal lithotripsy and/or other interventional procedures.

Device Description

The NCircle Nitinol Tipless Stone Extractor and NGage Nitinol Stone Extractor are sterile, single use baskets which are used to manipulate, entrap, and extract calculi and other foreign bodies in the salivary ducts and to minimize migration during intracorporeal lithotripsy and/or other interventional procedures. The NCircle or NGage will be inserted into a salivary duct under direct visualization through a sialendoscope or introducer sheath to reach the calculi or other foreign body. The device can then snare the object and withdraw it from the body or help to maintain its position during lithotripsy prior to removal. The NCircle and NGage devices are intended for short-term use.

AI/ML Overview

The provided 510(k) summary for the Cook Incorporated NCircle Nitinol Tipless Stone Extractor and NGage Nitinol Stone Extractor describes the device's technical characteristics and intended use, and states that substantial equivalence was determined based on comparisons to predicate devices and verification testing. However, it does not contain details of specific acceptance criteria or a study that directly proves the device meets those criteria in a clinical or performance study setting with human data.

Instead, the submission focuses on design, material, processing, and intended use equivalence to predicate devices, along with engineering verification tests.

Here's an breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly defined in terms of measurable performance thresholds.	Substantially equivalent to predicate devices based on design, materials, and processing.
Verification Testing:
Tensile testing (basket wires)	Performed to demonstrate reliable design and performance.
Tensile testing (sheath to handle)	Performed to demonstrate reliable design and performance.
Biocompatibility testing	Performed to demonstrate reliable design and performance.
Tensile testing (basket assembly to handle)	Performed to demonstrate reliable design and performance.
Mechanical integrity testing	Performed to demonstrate reliable design and performance.
Sterilization testing	Performed to demonstrate reliable design and performance.

Explanation: The document states that "To demonstrate reliable design and performance," the listed verification tests were presented. It implies that successful completion of these tests (meeting internal specifications or industry standards not detailed here) served as the acceptance criteria for the engineering aspects. There are no performance metrics like sensitivity, specificity, or successful stone extraction rates from a clinical study mentioned.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable. The document refers to engineering verification testing, not a clinical or performance study with a "test set" of patients or images. The "test set" for the engineering tests would refer to the number of devices or components tested, which is not specified.
Data Provenance: Not applicable. No clinical data is presented, so no country of origin or retrospective/prospective nature is mentioned.

3. 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)

Not applicable. No ground truth based on expert review of clinical cases is mentioned or implied. The verification tests performed are laboratory-based engineering tests.

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

Not applicable. There is no clinical "test set" requiring adjudication.

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. This device is a physical medical instrument (stone extractor), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effectiveness is not relevant.

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

No. This device is a physical medical instrument, not an algorithm.

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

The "ground truth" for this submission focuses on engineering specifications and regulatory compliance. It relies on:
- Predicate device characteristics: The technological characteristics are stated to be "identical in design, materials, and processing" to prior devices.
- Internal engineering specifications/standards: Successful completion of tensile, biocompatibility, mechanical integrity, and sterilization tests. The specific standards or acceptance limits for these tests are not provided in the summary.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device's development as it is a physical medical device, not a machine learning model.

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

Not applicable. No training set for a machine learning model is involved.

Summary of Device Acceptance Approach in K120468:

The 510(k) submission for the NCircle and NGage stone extractors relies on demonstrating substantial equivalence to existing legally marketed predicate devices. This equivalence is established through:

Direct comparison of technological characteristics: The new devices are stated to be "identical in design, materials, and processing" to their predicate counterparts (NCircle Tipless Stone Extractor and NGage Nitinol Stone Extractor).
Comparison of intended use: The stated intended uses are also substantially equivalent to the KSEA Sialoendoscopy accessory stone basket and the predicate Cook Medical devices.
Engineering verification testing: A series of laboratory tests (tensile, biocompatibility, mechanical integrity, sterilization) were conducted to demonstrate "reliable design and performance." The specific acceptance criteria for these tests are not detailed in the summary, but their successful completion contributed to establishing the safety and effectiveness for substantial equivalence.

This approach is typical for many Class II medical devices where a direct predicate device exists, and the new device does not introduce new technological aspects or different intended uses that would necessitate extensive new clinical data or performance studies with human subjects.

Summary

{0}------------------------------------------------

K120468

Cook Incorporated Traditional 510(k) Premarket Notification NCircle Nitinol Tipless Stone Extractor, NGage Nitinol Stone Extractor 15 February 2012

5. 510(k) Summary

Cook Incorporated NCircle Nitinol Tipless Stone Extractor, NGage Nitinol Stone Extractor 510(k) Summarv 21 CFR 807.92

Submitter Information 1.

Applicant:

Cook Incorporated

Address:

750 Daniels Way P.O. Box 489 Bloomington, IN 47402

Phone Number: Fax Number:

Contact: Contact Address:

Susanne Galin, RAC Cook Incorporated 750 Daniels Way

(800) 468-1379

(812) 332-0281

Contact Phone Number: Contact Fax Number:

(812) 339-2235 x2296 (812) 332-0281

Bloomington, IN 47404

Device Information 2.

Trade Name: NCircle Nitinol Tipless Stone Extractor NGage Nitinol Stone Extractor Common Name: Endoscope and accessories Classification: Class II Regulation: 21 CFR § 876. 1500 Endoscope and accessories Product Code: GCJ (Laparoscope, general and plastic surgery) 6

JUL 6 2012

{1}------------------------------------------------

3. Predicate Devices

)で

KSEA Sialoendoscopes and Accessories (Karl Storz Endoscopy - America, Inc., K012527) NCircle Tipless Stone Extractor (Cook Medical, Class II 510(k) exempt under ProCode FFL) NGage Nitinol Stone Extractor (Cook Medical, Class II 510(k) exempt under ProCode FFL)

Comparison to Predicates: 4.

The technological characteristics of the NCircle Tipless Stone Extractor and the NGage Nitinol Stone Extractors in both their proposed and predicate form are identical in design, materials, and processing.

The intended use of the proposed devices are substantially equivalent in basic design and intended use to the KSEA Sialoendoscopy accessory stone basket manufactured by Karl Storz Endoscopy - America, Inc.

No new technological aspects are being introduced with the proposed devces.

5. Device Description

{2}------------------------------------------------

Intended Use 6.

The NCircle Nitinol Tipless Stone Extractor is intended for manipulation, entrapment, and extraction of calculi and other foreign bodies in the salivary ducts and to minimize migration during intracorporeal lithotripsy and/or other lithotripsy procedures.

The NGage Nitinol Stone Extractor is intended for manipulation, entrapment, and extraction of calculi and other foreign bodies in the salivary ducts and to minimize migration during intracorporeal lithotripsy and/or other lithotripsy procedures.

Technological Characteristics 7.

The NCircle Nitinol Tipless Stone Extractor consists of a 15 cm long, 1.5 Fr diameter sheath, inside which is a nitinol basket that can be exposed at the distal end. The nitinol wire forms a basket with 4 struts, crossing at the distal end, which constitutes the "tipless" design. The proximal end consists of a handle with a lever which operates both the exposure (opening) of the basket and the retraction (closure) of the basket. When fully in the open position, the basket is 1 cm in diameter.

The NGage Nitinol Stone Extractor consists of a 115 cm length, 1.7 Fr diameter sheath, Exposed at the distal end of the sheath is a nitinol basket with three struts. The basket is open at the distal end. The proximal end consists of a handle with a lever which operates the opening and closing of the basket (the basket does not retract into the sheath as does the NCircle). When fully in the open position, the basket is 0.8 cm in diameter.

To demonstrate reliable design and performance of the NCircle Nitinol Tipless Stone Extractor and the NGage Nitinol Stone Extractor, the following verification testing and information was presented:

· Tensile testing (basket wires)
· Tensile testing (sheath to handle)
· Biocompatibility testing
· Tensile testing (basket assembly to handle)
· Mechanical integrity testing
· Sterilization testing

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Cook Medical % Ms. Susanne Galin, RAC Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47402-0489

6 2012 JUL

Re: K120468

Trade/Device Name: NCircle Nitinol Tipless Stone Extractor and NGage Nitinol Stone Extractor

Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: June 20, 2012 Received: June 21, 2012

Dear Ms. Galin:

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 for about in 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). and Cosmeter for (110) that the device, subject to the general controls provisions of the Act. The r ou may, merelore, manns of the Act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adviteration. 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 If your device is elaborited (boo acon). 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 Flease be advised that I Dri 3 issuance or our device complies with other requirements of the Act that I Dri has made a assoc regulations administered by other Federal agencies. You must

{4}------------------------------------------------

Page 2-Ms. Susanne Galin, RAC

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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. 1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Elinm
Melvin R. Feldheim, M.D.

Malvina B. Eydelman M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Cook Incorporated Traditional 510(k) Premarket Notification NCircle Nitinol Tipless Stone Extractor, NGage Nitinol Stone Extractor 15 February 2012

Indications for Use Statement 4.

510(k) Number (if known): _K 120468

Device Name: NCircle Nitinol Tipless Stone Extractor, NGage Nitinol Stone Extractor

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

uation (ODE)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K120468

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.