(50 days)
For percutaneous drainage of abscess, nephrostomy and other fluids.
Uresil General Purpose Drainage Catheters
This is a 510(k) premarket notification for a medical device (Uresil Percutaneous Drainage Catheters), which typically relies on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria for device performance. Therefore, the provided text does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, as one would expect for a novel AI/software device.
The document is an FDA clearance letter based on substantial equivalence to pre-amendment devices, indicating that the device is a well-established type of medical product.
To answer your specific questions based on the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable. The document is a 510(k) clearance letter based on substantial equivalence, not a performance study against specific acceptance criteria for a new device.
- Sample sized used for the test set and the data provenance: Not applicable. No test set or clinical study data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment is described.
- Adjudication method: Not applicable. No test set or ground truth establishment is described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical medical catheter, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical catheter.
- The type of ground truth used: Not applicable. No ground truth is described.
- The sample size for the training set: Not applicable. This is a physical medical catheter, not an AI/software device requiring a training set.
- How the ground truth for the training set was established: Not applicable. This is a physical medical catheter.
In summary, the provided document is a regulatory approval for a physical medical device (catheter) under the 510(k) pathway, which focuses on substantial equivalence. It does not involve the type of performance study and acceptance criteria evaluation typically associated with novel diagnostic devices, especially AI/software-based ones.
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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
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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)
§ 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.