(29 days)
k9910497
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the physical characteristics and intended use of a wire guide.
No
The device is a wire guide intended to assist in cannulation and bridging strictures during ERCP, which is an instrumental device used in a medical procedure, not a device that directly provides therapy.
No.
The device's intended use is to assist in cannulation and aid in bridging strictures during ERCP, which are interventional procedures, not diagnostic ones. It performs a mechanical function, not an analytical or diagnostic one.
No
The device description explicitly states it is a "wire guide," which is a physical medical device used in procedures. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP." This describes a procedure performed within the body (in vivo), not a test performed on samples outside the body (in vitro).
- Device Description: The description details a physical wire guide used for navigation within anatomical structures. This is consistent with an in vivo medical device.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Tracer Metro Smart Wire Guide is a medical device used for a procedural purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Tracer Metro Smart Wire Guide is intended to assist in cannulation of the billary and pancreatic ducts and to aid in bridging difficult strictures during ERCP.
Product codes (comma separated list FDA assigned to the subject device)
OCY
Device Description
The proposed Tracer Metro Smart Wire Guide is a modification to existing wire guides currently marketed by Wilson-Cock. The Tracer Metro Smart Wire Guide is .035" 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
billary 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Wilson-Cook Wire Guide (k9910497)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Wilson-Cook Medical, Inc. Ms. Marge Walls-Walker Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105
JUL 2 7 2015
K033754 Re:
Trade/Device Name: TRACER METRO SMART WIRE GUIDE Modification to Wilson-Cook Wire Guide Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY Dated (Date on orig SE ltr): November 25, 2003 Received (Date on orig SE ltr): December 1, 2003
Dear Ms. Walls-Walker,
This letter corrects our substantially equivalent letter of December 30, 2003.
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
1
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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 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 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/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -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
2
510(k) Number (if known): _K_033 75 4
Device Name: Wilson-Cook Tracer Metro Smart Wire Guide
Indications for Use:
The Tracer Metro Smart Wire Guide is intended to assist in cannulation of the billary and The Tracer Metro Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE-FF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Only
(Per 21 CFR § 801.109
OR
Over-the-Counter_
Nancyc Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices,
510(k) Number K033754
3
DEC 3 0 2003
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