(50 days)
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Not Found
No
The 510(k) summary describes a general-purpose drainage catheter and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is used for drainage, which is a procedure to remove fluids, but it is not described as directly treating a disease or condition. Drainage is often a supportive or preparatory step rather than a therapeutic intervention itself.
No
The device is described as a "drainage catheter" for "percutaneous drainage of abscess, nephrostomy and other fluids," which indicates a therapeutic rather than a diagnostic function.
No
The device description clearly states "Uresil General Purpose Drainage Catheters," which are physical medical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For percutaneous drainage of abscess, nephrostomy and other fluids." This describes a procedure performed on the patient's body to remove fluids.
- Device Description: The device is a "General Purpose Drainage Catheter." Catheters are used for insertion into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with specimens outside the body.
Therefore, this device is a medical device used for a therapeutic or interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For percutaneous drainage of abscess, nephrostomy and other fluids.
Product codes
78 FGE, 79 GBO, 79 GBX, 78 LJE
Device Description
Uresil General Purpose Drainage Catheters
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
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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 shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN" around the top half of the circle. The bottom half of the circle is obscured. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 1997
Mr. Lev Melinyshyn Director of Operations Uresil, L.P. 5418 W. Touhy Avenue Skokie, Illinois 60077 ... Re: K972583 Uresil® Percutaneous Drainage Catheters Dated: June 24, 1997 Received: July 10, 1997 Regulatory class: II, and unclassified ... ... 21 CFR §876.5010/Product code: 78 FGE 21 CFR §878.4200/Product codes: 79 GBO, 79 GBX Unclassified/Product code: 78 LJE
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 (OS) 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 marked 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 question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "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,
Lillian Yin, 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
INDICATIONS FOR USE | | | | Page 1 of 5
510(k) Number: K972583
Device Name: Uresil General Purpose Drainage Catheters
Indications for Use:
For percutaneous drainage of abscess, nephrostomy and other fluids.
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f/n: indusc02
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert P. Satling
(Division Sign Off)
(Division Sign-Off) Division of Reproductive. Abdominal, ENT, and Radiological Device 510(k) Number .
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)