(440 days)
No
The summary describes a mechanical biopsy needle and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is described as an introducer needle used for aspiration biopsy, which is a diagnostic procedure, not a therapeutic treatment.
Yes
The device is used for aspiration biopsy, which is a diagnostic procedure to collect tissue samples for examination.
No
The device description explicitly details physical components like a needle, catheter, handle, syringe, and stylet, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "aspiration biopsy in the biliary system." This describes a procedure performed directly on a patient to obtain a tissue sample.
- Device Description: The device is a needle and associated components designed for physically accessing and collecting a sample from within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a physiological state, health, or disease. This device is used to obtain the sample, not to analyze it.
Therefore, the Howell Biliary Introducer Needle is a surgical or procedural device, not an IVD.
N/A
Intended Use / Indications for Use
The Howell Biliary Introducer Needle is used for aspiration biopsy in the biliary system.
Product codes
FCG
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 through the Howell Biliary Introducer, covered by K961897. There have been no modifications to the Howell Biliary Introducer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three heads in profile, facing right. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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: 336.744.0157 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: | (336) 744-0157 ext. 6174 |
| Fax: | (336) 201-5994 |
| 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
4
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.