NCompass Nitinol Stone Extractors

K173009 · Cook Incorporated · LQR · Nov 7, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K173009
• Device Name: NCompass Nitinol Stone Extractors
• Applicant: Cook Incorporated
• Product Code: LQR · Gastroenterology, Urology
• Decision Date: Nov 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

NCompass Nitinol Stone Extractor is a single-use, sterile, disposable device for biliary stone/debris retrieval. Device consists of a nitinol basket (12 or 16-wire bulb shape) and a 2.4 Fr shaft diameter sheath. Operated by a physician during biliary surgical procedures; device is deployed from the sheath into the anatomical duct to capture stones. Visualization is achieved via fluoroscopy (NC3 model) or choledochoscope imaging (NCT4 model). The device includes a handle and Touhy-Borst adapter. By facilitating mechanical stone extraction, the device assists in clearing biliary obstructions, potentially reducing patient complications associated with retained stones.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993-1), dimensional/compatibility evaluation, radiopacity, multiple stone retrieval testing, and various tensile tests (basket formation, coil, sheath, and connection points) on accelerated aged samples. All pre-determined acceptance criteria were met.

Technological Characteristics

Nitinol (nickel-titanium alloy) basket; 12 or 16-wire bulb configuration. Sheath composed of braided stainless steel tubing coated with PTFE, FEP, and Polyimide. 2.4 Fr shaft diameter. Radiopaque markers (stainless steel on NC3 tip). Sterilized via Ethylene Oxide (SAL 10^-6). Single-use. Mechanical actuation via handle.

Indications for Use

Indicated for extraction of stones or debris during biliary surgical procedures in patients requiring such intervention.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Wittich Nitinol Stone Basket (K902944)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 Incorporated<br>P.O. Box 489<br>750 Daniels Way<br>Bloomington, IN 47402 |
| Contact Phone Number: | [phone] x 104965 |
| Contact Fax Number: | [phone] |

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:

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.

# 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<br>(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 stones<br>from the biliary tract, renal pelvis and<br>ureter | For extraction of stones or debris during<br>biliary 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 an<br>anatomical duct | IDENTICAL TO PREDICATE |
| Imaging Technique to Visualize<br>Device | | Fluoroscopy | NC3 model: IDENTICAL TO<br>PREDICATE<br>NCT4 model: Choledochoscope Imaging |
| Basket | Fluoroscopic Radiopaque<br>Material | Tungsten/Rhenium band<br>(located on sheath tip) | Stainless Steel<br>(located only on NC3 basket tip) |
| | Tip Material | None (tipless) | NC3 model: Stainless steel<br>NCT4 model: None (tipless) |
| | Wire Material | Nitinol (nickel and<br>titanium alloy) | IDENTICAL TO PREDICATE |
| | Wire Configuration | 6-wire bulb shape | 12-wire and 16-wire bulb shape |
| | Length (cm) | 4.5 | NC3 model: 1.9-2.3<br>NCT4 model: 2.1-2.5 |
| | Outer Diameter when<br>Deployed (cm) | 2 | 1.5 |
| Catheter / Sheath | Material | Radiopaque tetrafluoroethylene | Braided stainless steel tubing coated<br>with Polytetrafluoroethylene (PTFE),<br>fluorinated ethylene propylene (FEP),<br>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.