(463 days)
Not Found
No
The summary describes a mechanical aspiration needle and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
Explanation: The device is an aspiration needle used for biopsy, which is a diagnostic procedure, not a therapeutic one. It is designed to collect tissue for analysis, not to treat a condition.
No
This device is an aspiration needle used for biopsy, which is a procedure to collect tissue samples. While the samples may subsequently be used for diagnosis, the device itself is a tool for sample collection, not for analysis or diagnosis.
No
The device description clearly outlines physical components like a needle, catheter, handle, and sheath, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "aspiration biopsy in the biliary system." This describes a procedure performed on the patient to collect a sample, not a test performed on a sample outside the body to diagnose a condition.
- Device Description: The description details a needle and catheter system designed for physical insertion into the body to obtain a sample. This is consistent with a surgical or procedural device, not an IVD.
- Lack of IVD Characteristics: There is no mention of reagents, assays, analysis of biological samples in vitro, or any other components or processes typically associated with IVD devices.
Therefore, the Howell Biliary Aspiration Needle is a medical device used for a biopsy procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended for aspiration biopsy in the biliary system.
Product codes
FCK
Device Description
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 stylet is nitinol.
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
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.
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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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.
1
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 (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.
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
2
Indications for Use
510(k) Number (if known)
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: 336.744.0157 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: | (336) 744-0157 |
| Fax: | (336) 201-5994 |
| 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 | |
| Devices: | Wilson-Cook Biliary Aspiration Needle (K895900) |
| Description of the | |
| 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 | |
| stylet is nitinol. | |
| Intended Use: | The Howell Biliary Aspiration Needle is used for aspiration biopsy in the |
| biliary system. | |
| Technological | |
| 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. |