Howell Biliary Aspiration Needle

K153763 · Wilson-Cook Medical, Inc. · FCK · Apr 6, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K153763
• Device Name: Howell Biliary Aspiration Needle
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: FCK · Gastroenterology, Urology
• Decision Date: Apr 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Howell Biliary Aspiration Needle is used for aspiration biopsy in the biliary system.

Device Story

Howell Biliary Aspiration Needle is a sterile, single-use device for aspiration biopsy in the biliary system. Device consists of luer slip handle with adjustment wheel, outer catheter sheath, needle catheter with needle, and nitinol stylet with winged hub. Compatible with endoscopes having minimum 2.8 mm accessory channel; 200 cm length. Operated by clinicians during endoscopic procedures. Device facilitates tissue sampling via aspiration; output is collected biopsy material for diagnostic evaluation. Benefits include minimally invasive access to biliary system for tissue acquisition.

Clinical Evidence

No clinical data. Performance demonstrated via non-clinical bench testing confirming the device meets performance requirements for its intended use.

Technological Characteristics

Sterile, single-use biopsy instrument. Materials: PTFE catheter, stainless steel needle, nitinol stylet. Dimensions: 200 cm length. Compatibility: endoscopes with minimum 2.8 mm accessory channel. Features: luer slip handle with adjustment wheel, winged hub. Mechanical operation.

Indications for Use

Indicated for aspiration biopsy in the biliary system for patients requiring such procedures.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Predicate Devices

• Wilson-Cook Biliary Aspiration Needle (K895900)

Submission Summary (Full Text)

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

April 6, 2017

Wilson-Cook Medical, Inc. Ashley Howard Regulatory Affairs Specialist I 4900 Bethania Station Road Winston Salem, NC 27105

Re: K153763

Trade/Device Name: Howell Biliary Aspiration Needle Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-Urology-Biopsy Instrument Regulatory Class: II Product Code: FCK Dated: April 3, 2017 Received: April 4, 2017

Dear Ashley Howard:

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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For 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)

K153763

Device Name Howell Biliary Aspiration Needle

Indications for Use (Describe)

This device is intended for aspiration biopsy in the biliary system.

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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COOK ENDOSCOPY 4900 bethania station road WINSTON-SALEM, NC 27105 U.S.A. PHONE: [phone] TOLL FREE: 800.245.4707 WWW.COOKMEDICAL.COM

## 6. 510 (k) Summary

| Name: | Wilson-Cook Medical, Inc. /Cook Endoscopy |
|-----------------------------------|-------------------------------------------------------------------------------------------------|
| Address: | 4900 Bethania Station Road |
| | Winston-Salem, North Carolina 27105 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Ashley Howard, Regulatory Affairs Specialist I |
| Date: | December 30, 2015 |
| Trade Name: | Howell Biliary Aspiration Needle |
| Common Name: | Biliary Aspiration Needle |
| Classification Name: | Gastroenterology-Urology biopsy instrument (21 CFR 876.1075, Product |
| | Code FCK) |
| Legally Marketed<br>Devices: | Wilson-Cook Biliary Aspiration Needle (K895900) |
| Description of the<br>Device: | The Howell Biliary Aspiration Needle is a sterile, single use device that |
| | consists of a luer slip handle with adjustment wheel, outer catheter sheath, |
| | needle catheter with needle, stylet and winged hub. The device is |
| | compatible with endoscopes with a minimum accessory channel of |
| | 2.8 mm. The Howell Biliary Aspiration Needle is 200 cm long. The |
| | catheter is comprised of PTFE while the needle is stainless steel and the<br>stylet is nitinol. |
| Intended Use: | The Howell Biliary Aspiration Needle is used for aspiration biopsy in the |
| | biliary system. |
| Technological<br>Characteristics: | The Howell Biliary Aspiration Needle has the same technological |
| | characteristics as the Wilson-Cook Biliary Aspiration Needle (K895900) |
| | in terms of general design and function, but has minor differences in terms |
| | of handle mechanism and the addition of a stylet. |
| Performance Data: | Performance testing consisting of non-clinical bench testing demonstrates |
| | that the Howell Biliary Aspiration Needle met the performance |
| | requirements to fulfill the intended use of the device. The device is |
| | substantially equivalent to the cleared predicate device. |