(114 days)
Coude Foley catheter / or Tiemann Foley Catheter/ is all silicone Foley catheter 2-way intended for urological use only. Indicated for routine drainage of the urinary bladder.
Maximum recommended indwelling time is not more than 30 days.
Prescription Use ONLY (Part 21 CFR 801 Subpart D)
Coude Foley catheter / or Tiemann Foley catheter is all silicone Foley catheter 2-way.
This document is a 510(k) summary for a medical device (Coude Foley catheter / or Tiemann Foley catheter). It primarily focuses on the regulatory clearance process, specifically demonstrating substantial equivalence to a predicate device.
Therefore, the provided text does not contain information about acceptance criteria, device performance metrics, study designs (sample sizes, ground truth establishment, expert qualifications, adjudication methods), or any comparative effectiveness studies as requested in the prompt.
The document states the "Indications for Use" for the device, which is "for routine drainage of the urinary bladder" with a "Maximum recommended indwelling time is not more than 30 days." However, these are indications, not performance metrics or acceptance criteria.
To answer your request, I would need a different type of document, such as a clinical study report, a performance testing report, or a detailed technical specification for the device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Zoya Lee Regulatory Affairs Degania Silicone, Ltd. Degania BET Emek Hayarden 15130 ISRAEL
MAR 1 1 2011
Re: K103371
Trade/Device Name: Coude Foley catheter / or Tiemann Foley catheter Regulation Number: 21 CFR 8876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: March 4, 2011 Received: March 4, 2011
Dear Ms. Lee:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting of medical device-related
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adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Hubert Lemur MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Document No : | Traditional 510(k) submissionK103371 | Predicate device510(k) K063442 |
|---|---|---|
| Version: 2 | COUDE/OR TIEMANNCATHETER | Degania Silicone, Ltd |
| Replace: Special 510(k)submission, version 1 |
Indications for Use
510(k) Number K103371
Device Name: Coude Foley catheter / or Tiemann Foley catheter
Indications for Use:
Coude Foley catheter / or Tiemann Foley Catheter/ is all silicone Foley catheter 2-way intended for urological use only. Indicated for routine drainage of the urinary bladder.
Maximum recommended indwelling time is not more than 30 days.
Prescription Use ONLY (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.