(149 days)
Medline's urethral catheter is intended for use in the drainage of fluid from the urinary tract.
Not Found
This document is a letter from the FDA regarding a 510(k) premarket notification for a medical device, specifically the "Medline PVC Urethral Catheter."
It is crucial to understand that this document is not a study proving the device meets acceptance criteria.
Instead, it's a regulatory approval letter based on the device demonstrating substantial equivalence to existing legally marketed predicate devices. This means the FDA has determined the new device is as safe and effective as a device already on the market, but it doesn't typically involve new clinical studies with detailed acceptance criteria and performance reporting in the same way a PMA (Premarket Approval) application or a clinical trial for a novel device would.
Therefore, I cannot provide the information requested in your prompt because this document does not contain a study that proves the device meets specific acceptance criteria in the manner you've described.
Here's why and what information is available (or not available) in this document:
- Acceptance Criteria and Reported Device Performance: This document does not list acceptance criteria or reported device performance in a table format. The FDA's 510(k) process relies on demonstrating substantial equivalence, which often involves comparing technical specifications, materials, and intended use to a predicate device, rather than explicit performance metrics against acceptance criteria from a new study.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set Size, and Ground Truth for Training Set: None of this information is available in this regulatory approval letter. These details would typically be found in the premarket notification submission itself (which is not provided here) if a study was conducted as part of the substantial equivalence demonstration, or more commonly in a PMA application.
What the document does state:
- Device Name: Medline PVC Urethral Catheter
- Intended Use: "Medline's urethral catheter is intended for use in the drainage of fluid from the urinary tract."
- Regulation Number/Name: 21 CFR §876.5130, Urological catheter and accessories
- Regulatory Class: II
- Product Code: EZD
- 510(k) Number: K100302
- Determination: The FDA "determined the device is substantially equivalent... to legally marketed predicate devices."
In summary, this document is a regulatory approval, not a scientific study report. It confirms market clearance based on substantial equivalence, but it does not detail performance data, study design, or acceptance criteria in the way your request describes.
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Image /page/0/Picture/0 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Matt Clausen Regulatory Affairs Medline Industries, Inc. One Medline Place MUNDELEIN IL 60060-4486
JUL. = 2 2010
Re: K100302
Trade/Device Name: Medline PVC Urethral Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: June 25, 2010 Received: June 28, 2010
Dear Mr. Clausen:
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting 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:
Medline PVC Urethral Catheter
Indications for Use:
Medline's urethral catheter is intended for use in the drainage of fluid from the urinary tract.
Prescription Use xx (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) .
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) | |
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| Division of Reproductive, Abdominal and | |
| Radiological Devices | |
| 510(k) Number | K100302 |
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§ 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.