(29 days)
For percutaneous drainage of abscesses, nephrostomy and other fluids.
Not Found
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a General Purpose Drainage Catheter, stating its substantial equivalence to predicate devices and allowing it to be marketed.
It does not contain details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or the nature of test sets.
- The number or qualifications of experts used for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Types of ground truth used (pathology, outcomes data, etc.).
- Training set sample size or how its ground truth was established.
Therefore, I cannot fulfill your request for this specific information based on the text provided.
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Food and Drug Administration 9200 Corporate Boutevard Rockville MD 20850
DEC 2 0 2005
Mr. Matthew Mahon Manager, RA/QA UreSil, LLC 5418 W. Touhy Ave SKOKIE IL 60077
RE: K053245
Trade/Device Name: General purpose drainage catheter Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE and LJE; 79 GBO and GBX Dated: November 18, 2005 Received: November 23, 2005
Dear Mr. Mahon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your booties is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the enorstate) to regary manufate of the Medical Device Amendments, or to devices that have been May 20, 1770, all onlinent add on aversions 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 do not require approval or a provisions of the Act. The general controls provisions of the Act de nec, subjos to the generaliation, 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 (Premarket If your device is elassilled (500 as in additional controls. Existing major regulations affecting your Apploval), it thay oc solose to sour aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA acrroo built of rether announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I Rase be advisour and I Dr vior that your device complies with other requirements of the Act or any FDA lias made a decemination and your as a so be other Federal agencies. You must comply with all the r catal statues and regalations administed to registration and listing (21 CFR Part 807); labeling Act s requirements, medding, but not manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); good manaracting product radiation control product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equire and thus, per premarket notification. The IDA Inding of sabstantial vice 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
r the regulation of the fitter following purphers, based on the regulatio If you desire specific advice for your device on our loosing ong the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Nisotanants of the sunder the Act from the 807.97). You may obtain other general information on your reply.
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _ Device Name: General Purpose Drainage Catheter Indications for Use:
For percutaneous drainage of abscesses, nephrostomy and other fluids.
Over-The-Counter Use Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR
PLEASE DO NOT WDITE PELOW THIS (21 CFR 801 Subpart C) (P) EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel R. Syverson
(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .
§ 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.