Howell Biliary Introducer Needle

K160890 · Wilson-Cook Medical, Inc. · FCG · Jun 14, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K160890
• Device Name: Howell Biliary Introducer Needle
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Jun 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

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

Device Story

Howell Biliary Introducer Needle is a sterile, single-use device for aspiration biopsy in the biliary system. It consists of a luer slip handle, outer catheter sheath, inner catheter with needle, stylet, and syringe with stopcock. The device is 200 cm long and is introduced to the biopsy site through the Howell Biliary Introducer. It is intended for use by clinicians in a medical setting. The device functions as a manual instrument to collect tissue samples via aspiration. The clinician uses the needle to access the biliary site and the syringe to apply suction for biopsy collection. The collected sample aids in diagnostic decision-making.

Clinical Evidence

Bench testing only. Design verification and validation testing were performed following a DFMEA risk analysis to assess the impact of device modifications. Results demonstrate that the device performs as intended and is substantially equivalent to the predicate.

Technological Characteristics

Sterile, single-use manual biopsy instrument. Components include luer slip handle, outer catheter sheath, inner catheter with needle, stylet, and syringe with stopcock. Length: 200 cm. No electronic or software components.

Indications for Use

Indicated for patients requiring aspiration biopsy in the biliary system.

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 Aspiration Biopsy Needle (K961897)

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

June 14, 2017

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

Re: K160890

> Trade/Device Name: Howell Biliary Introducer Needle Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: II Product Code: FCG Dated: March 30. 2016 Received: March 31, 2016

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. 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

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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.

For

Sincerely yours.

Charles Viviano -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) K160890

Device Name Howell Biliary Introducer Needle

Indications for Use (Describe)

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

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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Image /page/3/Picture/1 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in large, white, sans-serif font, with a registered trademark symbol to the right of the word. Below the word "COOK" is a red rectangle with the word "MEDICAL" in white, sans-serif font. The background of the image is also red.

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

# 510(k) Summary

| Name: | Wilson-Cook Medical, Inc. /Cook Endoscopy |
|----------|------------------------------------------------|
| Address: | 4900 Bethania Station Road |
| | Winston Salem, NC 27105 |
| Phone: | [phone] ext. 6174 |
| Fax: | [phone] |
| Contact: | Ashley Howard, Regulatory Affairs Specialist L |
| Date: | March 31, 2016 |

### Device Name

| Trade Name: | Howell Biliary Introducer Needle |
|----------------------|--------------------------------------------|
| Common Name: | Biliary Aspiration Needle |
| Classification Name: | Gastroenterology-Urology biopsy instrument |
| | 21 CFR 876.1075, FCG, Class II |

# Predicate Device

Wilson-Cook Aspiration Biopsy Needle (K961897)

# Intended Use

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

# Device Description

The Howell Biliary Introducer Needle is a modification to the Wilson-Cook Aspiration Biopsy Needle cleared to market via 510(k) K961897. The modified Howell Biliary Introducer Needle is a sterile, single use device that consists of a luer slip handle, outer catheter sheath, inner catheter with needle, stylet, syringe with stopcock, and MLLA hub. The Howell Biliary Introducer Needle is 200 cm long. The Howell Biliary Introducer Needle is introduced to the biopsy site

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through the Howell Biliary Introducer, covered by K961897. There have been no modifications to the Howell Biliary Introducer.

# Substantial Equivalence

Minor design changes were made to the predicate Wilson Cook Aspiration Biopsy Needle cleared to market via K961897. These changes include modifications as follows: material change for the stylet component, addition of a syringe with stopcock, and change in expiry date. The modified device is substantially equivalent to the predicate with respect to the intended use, key operating principles, materials and the technological characteristics.

# Performance Data

The Risk Analysis was completed to assess the impact of modifications to the cleared device using the Design Failure Modes and Effects Analysis (DFMEA) method. Design verification and/or validation testing was performed as a result of this risk analysis assessment. Results from design validation and/or verification testing provide reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness.

#### Conclusion

We believe risks associated with the modifications to the subject device to be adequately addressed through our Design Control Processes. We believe that the subject device is substantially equivalent to the named predicate in terms of its intended use and performance characteristics tested.