(134 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, image processing, or any data related to training or testing of algorithms, which are typical indicators of AI/ML in medical devices. The intended use and anatomical site descriptions point towards a physical drainage device rather than a software-based diagnostic or analytical tool.
No
The intended use describes the device being used for drainage procedures, which are interventional and diagnostic rather than therapeutic.
No
The device is intended for drainage procedures (percutaneous nephrostomy, biliary, and abscess drainage) and other gastrointestinal and genitourinary procedures, which are interventional or therapeutic, not diagnostic.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. Without this information, it's impossible to ascertain if the device includes hardware components or is solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used in procedures like percutaneous nephrostomy, biliary and abscess drainage, and other gastrointestinal and genitourinary procedures. These are all in vivo procedures, meaning they are performed within the living body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. The description doesn't mention any such use or analysis of specimens.
Therefore, the device's intended use clearly places it as a device used within the body for medical procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
This device is intended for use in percutaneous nephrostomy, biliary und abscess drainage and other gastrointestinal and genitourinary procedures.
Product codes
78 FGE, 78 EZB
Device Description
Uresil® Guidewire
Mentions image processing
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Mentions AI, DNN, or ML
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the seal. The seal is simple and elegant, and it conveys a sense of authority and trustworthiness.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1997
Mr. Lev Melinyshyn Director of Operations UreSil, L.P. 5418 W. Touhy Avenue Skokie, Illinois 60077
Re: K972582
NOV 21 Uresil® Guidewire Dated: September 3, 1997 Received: September 18, 1997 Regulatory Class: II 21 CFR §876.5010/Product code: 78 FGE 21 CFR §876.5130/Product code: 78 EZB
Dear Mr. Melinyshyn:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation of the regulation of the "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
W.Liau Yu
Lillian Yiu, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Page__________________________________________________________________________________________________________________________________________________________________________
K972582 510(k) Number iif known):
Uresil Guidewire Device Name:_
Indications For Use:
.
This device is intended for use in percutaneous nephrostomy, biliary und abscess drainage and other gastrointestinal and genitourinary procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Rober R. Salling | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K972582 |
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |