(29 days)
No
The summary describes a mechanical accessory for ERCP procedures and makes no mention of AI or ML.
No
The device is described as an "accessory to be used with endoscopic biliary devices to lock the wire guide(s) in place during ERCP procedures," which indicates it facilitates a therapeutic procedure but is not therapeutic itself.
No
The device is an accessory used to secure a wire guide during ERCP procedures, which are therapeutic and not primarily diagnostic. It helps maintain access for other therapies rather than diagnosing a condition itself.
No
The device description clearly states it is a "one-piece integrated system" that "secures onto the accessory channel of an endoscope," indicating it is a physical hardware device.
Based on the provided information, the Wilson-Cook USW Cap and Wire Lock Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an accessory used during ERCP procedures to lock wire guides in place. This is a procedural device used in vivo (within the body) to facilitate a medical procedure.
- Device Description: The description reinforces its use as an accessory that attaches to an endoscope and secures wire guides. This is consistent with a procedural device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device's function is purely procedural, assisting in the mechanics of an ERCP.
N/A
Intended Use / Indications for Use
The Wilson-Cook USW Cap and Wire Lock Device is an accessory to be used with endoscopic biliary devices to lock the wire guide(s) in place during ERCP procedures. The device is supplied sterile and is intended for single use only.
Product codes
OCY
Device Description
The proposed USW Cap and Wire Guide Locking Device is and one-piece integrated system that secures onto the accessory channel of an endoscope. The access port in the center of the cap allows access of wire quides and other biliary accessories. The wire quide lock allows the practitioner to lock the wire guide in place for continued ductal access while proceeding with other ERCP therapies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Microvasive RX Locking Device and Biopsy Cap System (K010610)
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Wilson-Cook Medical GI Endoscopy Ms. Marge Walls-Walker Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105
JUL 2 7 2015
Re: K040137
Trade/Device Name: Wilson-Cook USW Cap and Wire Lock Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY Dated (Date on orig SE ltr): January 19, 2004 Received (Date on orig SE ltr): January 22, 2004
Dear Ms. Walls-Walker,
This letter corrects our substantially equivalent letter of February 20, 2004.
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): _KO4(1/37
Device Name: Wilson-Cook USW Cap and Wire Lock
Indications for Use:
The Wilson-Cook USW Cap and Wire Lock Device is an accessory to be used The Wilson Occh Cook Copy on one guide(s) in place during ERCP procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE-IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
11:24 : 16 :
Prescription Use Only_
(Per 21 CFR § 801.109
OR
(Division Sign-Off)
Division of Reproductive, Abdominal,
Radiological Devices
Division of
and Radiological Devices
510(k) Number K040837
Over-the-Counter______________________________________________________________________________________________________________________________________________________________
3
FEB 2 0 2004
ATTACHMENT D: 510(k) Summary of Safety and Effectiveness
SPONSOR:
CONTACT/SUBMITTER:
DATE OF SUBMISSION:
DEVICE:
Trade Name: Common Name: Classification:
PREDICATE DEVICES:
INTENDED USE:
DEVICE DESCRIPTION:
Wilson-Cook Medical 4900 Bethania Station Road Winston-Salem, NC 27105
Marge Walls-Walker Requlatory Affairs Specialist [336] -744-0157 Ex.290
January 15, 2004
USW Cap and Wire Lock
USW Cap and Wire Lock Endoscope Cap and Wire Lock Endoscope and/or Accessories 21 CFR § 876.1500. 78 KOG
Microvasive RX Locking Device and Biopsy Cap System (K010610)
This device is an accessory to be used with endoscopic biliary devices to lock the wire guide(s) in place during ERCP procedures. The device is supplied sterile and is intended for single use only.
The proposed USW Cap and Wire Guide Locking Device is and one-piece integrated system that secures onto the accessory channel of an endoscope. The access port in the center of the cap allows access of wire quides and other biliary accessories. The wire quide lock allows the practitioner to lock the wire guide in place for continued ductal access while proceeding with other ERCP therapies.
We believe the proposed device to be substantially equivalent to currently marketed Endoscope Locking and Biopsy Cap Systems.
We believe the proposed device to be substantially equivalent to the named predicates in terms of Intended Use and performance characteristics tested.
PERFORMANCE DATA:
COMPARISON OF CHARACTERISITICS: