(55 days)
Not Found
Not Found
No
The device description and intended use focus on the physical properties and function of a wire guide for urological procedures. There is no mention of AI, ML, image processing, or any data-driven analysis or decision-making capabilities.
No
The device, a Cook Urological Wire Guide, is used to facilitate access and placement of other devices during urological procedures. It does not directly treat or cure a disease or condition.
No
Explanation: The device is a wire guide used for access and placement of other devices during urological procedures. Its function is interventional, not diagnostic, as it does not gather or analyze information about a patient's condition to identify a disease or medical problem.
No
The device description clearly outlines physical components like wires, coils, coatings, and packaging, indicating it is a hardware medical 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 clearly states that the wire guides are used during urological procedures for accessing the ureter, establishing a tract, and assisting in device placement. This is an in vivo use, meaning it's used within the living body.
- Device Description: The description details a physical device used for manipulation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests outside the body on samples taken from the body. This device is used inside the body during a surgical procedure.
N/A
Intended Use / Indications for Use
Cook Urological Wire Guides are used for ureteral access, to establish a tract, and assist in the placement, replacement, and exchange of devices during urological procedures. For the Roadrunner Wire Guides the intended use also includes use in a torturous or kinked ureter, traversing a large stone in route to the kidney, or in cases demanding enhanced control and high radiopacity. These wire guides are not intended for PTCA use.
Product codes
OCY
Device Description
Cook Wire Guides are designed to be used during Urological procedures where use of a wire quide is warranted. The wire quides consists of a single piece of wire tightly wound into coils from tip to tip. Two additional wires are present inside the coils, one called a flat safety wire and the other a round wire. Some of the wire guides are coated with a polymer sleeve, some with PTFE, some are stainless steel, and some are hydrophilically coated. Several variations of Cook Wire Guides are available. The wire quided sterile in peel-open packages and are intended for onetime use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureter
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
K082536 Page 1/1
510(k) SUMMARY
| Submitted by: | Cindy Foote
Regulatory Affairs Specialist
Cook Urological, Incorporated
1100 West Morgan Street
Spencer, Indiana 47460 | OCT 27 2008 |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device:
Trade Name:
Proposed Classification Name: | Cook Wire Guides
Endoscopic Guidewire, Gastroenterology-Urology
21 CFR Parts 876.1500
Class II, OCY | |
Predicate Devices:
The Cook Wire Guides are identical with respect to indications for use and technology to existing Cook Wire Guides currently on the market. Cook Wire Guides are identical with respect in technology to wire quides manufactured for Cook Urological, Incorporated by Cook Incorporated and Lake Region Manufacturing. The wire guide's marketed and distributed by Cook Incorporated have a different intended use than the wire guides' marketed and distributed by Cook Urological, Incorporated due to the different disciplines each of the companies represent.
Device Description:
Cook Wire Guides are designed to be used during Urological procedures where use of a wire quide is warranted. The wire quides consists of a single piece of wire tightly wound into coils from tip to tip. Two additional wires are present inside the coils, one called a flat safety wire and the other a round wire. Some of the wire guides are coated with a polymer sleeve, some with PTFE, some are stainless steel, and some are hydrophilically coated. Several variations of Cook Wire Guides are available. The wire quided sterile in peel-open packages and are intended for onetime use.
Substantial Equivalence:
The Cook Wire Guides are comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.
Test Data:
Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards. Testing data and information are included in this submission.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The text is in all caps and is oriented to follow the circular shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 2008
Ms. Cindy Foote Regulatory Affairs Specialist Cook Urological, Incorporated 1100 W. Morgan Street SPENCER IN 47460
Re: K082536
Trade/Device Name: Cook Wire Guides Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY Dated: October 17, 2008 Received: October 22, 2008
Dear Ms. Foote:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Page 2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
loque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K082536 Cook Wire Guide Follow-up Responses
Indications for Use
082536
510(k) Number (if known):
Cook Wire Guides:
Indications for Use:
Cook Urological Wire Guides are used for ureteral access, to establish a tract, and assist in the placement, replacement, and exchange of devices during urological procedures. For the Roadrunner Wire Guides the intended use also includes use in a torturous or kinked ureter, traversing a large stone in route to the kidney, or in cases demanding enhanced control and high radiopacity. These wire guides are not intended for PTCA use.
Prescription Use? X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert Lemmer
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number