(394 days)
The urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.
The Haematuria Foley catheter has a spiral reinforced shaft and eliminates collapse during suctioning from the bladder. The material is exactly the same as the already approved marketed foley catheter. It is available with a variety of tips, Standard, Dufour and Couvelaire.
The provided text is a 510(k) summary for a medical device (Euromedical Haematuria Foley Catheter) seeking clearance from the FDA. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics in the way a clinical trial for a novel drug or high-risk device might.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present within this document.
Here's an explanation of why this information is missing in this context and what is typically found in a 510(k) summary:
- Substantial Equivalence: The core of a 510(k) submission is to show that a new device is "substantially equivalent" to a predicate device already on the market. This typically involves demonstrating similar technological characteristics and intended use, often through bench testing and material comparisons, rather than large-scale clinical trials designed to prove efficacy or safety against pre-defined acceptance criteria.
- Acceptance Criteria & Device Performance: The document provides a comparison table highlighting the identical materials and similar characteristics (sizes, coating, catheter material) to the predicate device. This comparison serves as a de-facto "performance" measure, indicating that because the new device is materially and functionally similar to an already approved device, its performance will be equivalent and acceptable.
- Clinical Studies: The text does not mention any clinical studies with human subjects, let alone the details of study design, sample sizes, expert ground truth, or adjudication methods. For a Class II device like a Foley catheter, substantial equivalence can often be demonstrated without such extensive clinical trials, especially if a clear predicate exists and the changes are minor or well-understood.
- Standalone Performance/Human-in-the-loop: These concepts are relevant for AI/ML-driven devices or complex diagnostic tools, which is not the case for a Foley catheter.
- Ground Truth: For a physical medical device like a catheter, "ground truth" isn't established in the same way as for diagnostic AI. Performance is typically assessed through engineering tests (e.g., burst pressure, material strength, flow rates) to ensure it meets manufacturing specifications and is safe for its intended use.
In summary, based solely on the provided text, the answer to your request is that the information regarding acceptance criteria, detailed study design, sample sizes, expert qualifications, true ground establishment, and MRMC studies is not available. The document focuses on demonstrating substantial equivalence through comparison with a predicate device.
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SEP 1 6 1998
510(K) SUMMARY (as required by 807.92(c))
Submitter of 510(k): Requlatory & Marketing Services, Inc. (RMS) 3234 Ella Lane New Port Richey, FL 34655
| Phone: | 813-376-4154 |
|---|---|
| Fax: | 813-376-7186 |
Euromedical Foley Catheter
Euromedical Haematuria Foley Catheter
Contact Person:
Ed Ransom or Pat Lamb
Date of Summary:
August 11,1998
Trade Name:
Classification Name: Haematuria Foley Catheter
Predicate Device:
Device Description/ Comparison:
The Haematuria Foley catheter has a spiral reinforced shaft and eliminates collapse during suctioning from the bladder. The material is exactly the same as the already approved marketed foley catheter. It is available with a variety of tips, Standard, Dufour and Couvelaire.
| Materials | EuromedicalHaematuria | EuromedicalFoley Catheter |
|---|---|---|
| Sizes, fr | 16, 18, 20, 22, 24 | Same |
| coating | silicone | same |
| Catheter | natural latex | same |
| Tip Configuration | Couvelaire, Defour andStandard Tips | Standard Tip |
| Sterilization | ETO |
Intended Use:
The urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.
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Image /page/1/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUM" are arranged in a circular fashion around the left side of the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP | 6 1998
Euromedical Industries SDN. BHD. c/o Mr. Ed Ransom RMS Regulatory & Marketing Services, Inc. P.O. Box 1108 Elfers, FL 34680
Re: K973076 Euromedical Haematuria Foley Catheter Dated: August 7, 1998 Received: August 10, 1998 Regulatory Class: II 21 CFR 876.5130/Procode: 78 EZL
Dear Mr. Ransom:
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 II (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 requirements, as set forth in the Ouality 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 i submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product 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 marketed 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 retro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion 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/cdrb/dsmaldsmamain.html".
Sincerely yours
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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510(k) Number (if known): K973076
Haematuria Foley Catheter Device Device Name:
Indications For Use:
The urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-()if) Division of Rep. 8 1. Beach 19 Countal, ENT, and Radiologics
510(k) Number .... . . . . . .......
Prescription Use
(Per 21 CFR 801.109)
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Over-The-Counter Use_
William Uhr
(Optional Format 1-2-96)
(Division Sign-Off) Division of Reproductive, Abdominal, ENA, and Radiological Devices 510(k) Number
§ 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.