(25 days)
Not Found
No
The summary describes a physical wire guide and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is intended to assist in cannulation and bridging strictures, which are procedural aids rather than direct therapeutic actions themselves.
No
The device is intended to assist in cannulation and bridging strictures, which are procedural aids, not diagnostic functions.
No
The device description explicitly states it is a physical wire guide, a modification to existing hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP." This describes a device used within the body for a procedural purpose (guiding instruments), not for testing samples outside the body to diagnose a condition.
- Device Description: The description of a "Wire Guide" with a specific diameter and compatibility with accessories aligns with a medical device used in procedures, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a medical device used for interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP.
Product codes
OCY
Device Description
The proposed Endoscopic Wire Guide is a modification to existing wire guides currently marketed by Wilson-Cook Medical, Inc. The Endoscopic Wire Guide is .025" in diameter and is compatible with a full range of Wilson-Cook accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary and pancreatic ducts
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes 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 (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
510(k) Summary
Sponsor:
Contact/Submitter:
Date of Submission
Trade Name: Common Name: Classification:
Predicate Device:
Intended Use:
Device Description:
Comparison of Characteristics:
Performance Data:
Wilson-Cook Medical, Inc/Cook Endoscopy 4900 Bethania Station Road Winston-Salem, NC 27105
9 2012
UCT
Doris A. Hawks Global Regulatory Affairs Specialist Phone: (336) 744-0157 Ext. 6293 Fax: (336) 201-5994 e-mail: doris.hawks@cookmedical.com
Axcess Soft Tip Wire Guide Wire Guide Endoscope Guidewire, Gastroenterology-Urology, Class II 21 CFR § 876.1500 78 OCY
Wilson-Cook Tracer Metro Smart Wire Guide (K033754)
Intended to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP.
The proposed Endoscopic Wire Guide is a modification to existing wire guides currently marketed by Wilson-Cook Medical, Inc. The Endoscopic Wire Guide is .025" in diameter and is compatible with a full range of Wilson-Cook accessories.
We believe the proposed device to be substantially equivalent to the currently market predicate device cleared via K033754.
We believe risks associated with the modifications to the subject device to be adequately addressed through our Design Control Processes. We believe the proposed device to be substantially equivalent to the named predicate in terms of its intended use, performance characteristics tested and biocompatibility.
AORTIC INTERVENTION CARDIOLOGY CRITICAL CARE ENDOSCOPY PERIPHERAL INTERVENTION UROLOGY WOMEN'S HEALTH
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ОСТ.
9 2012
Ms. Doris A. Hawks
Global Regulatory Affairs Specialist
Wilson-Cook Medical, Inc.
4900 Bethania Station Road
WINSTON-SALEM NC 27105
Re: K122816
Trade/Device Name: Endoscopic Wire Guide Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY Dated: September 13, 2012 Received: September 14, 2012
Dear Ms. Hawks:
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 medical
2
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicaiDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin K. Fisher
Benjamin D. Fisher, Ph.D.
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
3
Indications for Use
510(k) Number (if known): K 122 8 / 6 /
Device Name: Endoscopic Wire Guide
Indications for Use:
This device is intended to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP
Prescription Use > (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ,
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nogui M. Diaz
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K122816
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