(189 days)
The proposed device is intended for use in the drainage and/or collection and/or measurement of urine. Generally drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.
The Kendall DOVER Silver Hydrogel Coated Silicone Foley Catheter is a sterile, single patient use, urinary drainage catheter extruded from 100% vulcanized silicone material. It is coated with a lubricious hydrophilic topcoat containing an inorganic silver releasing polymer.
This document is a 510(k) summary for the Kendall DOVER Silver Hydrogel Coated Silicone Foley Catheter, submitted to the FDA. It does not describe an AI device or specific performance criteria for such a device. Instead, it outlines the substantial equivalence of this catheter to a predicate device and details nonclinical testing related to biocompatibility.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets them in the context of AI device performance. The document does not contain any of the following:
- A table of acceptance criteria and the reported device performance: There are no performance metrics or acceptance criteria for an AI device in this document.
- Sample size used for the test set and the data provenance: Not applicable as no AI device performance study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document primarily focuses on:
- Device Description: A sterile, single-patient use, urinary drainage catheter made from 100% vulcanized silicone material, coated with a lubricious hydrophilic topcoat containing an inorganic silver releasing polymer.
- Intended Use: Drainage, collection, and/or measurement of urine, typically via urethral insertion, but also suprapubic or nephrostomy tract placement.
- Substantial Equivalence: Claimed to be substantially equivalent to the Kendall DOVER Foley Catheter predicate device.
- Nonclinical Testing: Biocompatibility testing demonstrated compliance with ISO 10993-1 and FDA modified matrix (memorandum G95-1).
- FDA's Determination: The FDA determined substantial equivalence, but specifically stated that no claims regarding the effectiveness of the inorganic silver ion releasing polymer to reduce microbial adherence or urinary tract infections could be made due to a lack of microbial adherence data.
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JUN 1 1 2003
510(k) Summary
Kendall DOVER Silver Hydrogel Coated Silicone Foley Catheter
In accordance with section 513(I) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:
Tyco Healthcare/Kendall 15 Hampshire Street Mansfield, MA 02048 Date Prepared: November 20, 2002
-
- Contact Person
David A. Olson Vice President, Regulatory Affairs (508) 261-8530
- Contact Person
2. Name of Medical Device
Urological catheter and accessories Classification Name: Urinary Drainage Catheter, Silicone Foley Common or Usual Name:
3. Identification of Legally Marketed Device
The proposed Kendall DOVER Silver Hydrogel Coated Silicone Foley Catheter is substantially equivalent in intended use, function and mode of operation to the DOVER Silicone Foley Catheter, which was marketed prior to May 28, 1976.
4. Device Description
The Kendall DOVER Silver Hydrogel Coated Silicone Foley Catheter is a sterile, single patient use, urinary drainage catheter extruded from 100% vulcanized silicone material. It is coated with a lubricious hydrophilic topcoat containing an inorganic silver releasing polymer.
5. Device Intended Use
The proposed device is intended for use in the drainage and/or collection and/or measurement of urine. Generally drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.
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K024010
Page 2 of 2
Product Comparison
The Kendall DOVER Silver Hydrogel Coated Silicone Foley Catheter is substantially equivalent to the Kendall DOVER Foley Catheter predicate device as each product is intended to pass fluids to or from the urinary tract.
Nonclinical Testing
Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized symbol that resembles three curved lines, possibly representing a stylized human figure or a symbol of health and well-being. The logo is simple and clean, with a focus on the text and the central symbol.
Public Health Service
JUN 1 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David A. Olson Vice President, Regulatory Affairs Tyco Healthcare 15 Hampshire Street MANSFIELD MA 02048
Re: K024010
Trade/Device Name: Kendall Dover Silver Hydrogel Coated Silicone Foley Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Codes: 78 EZL and KOD Dated: March 13, 2003 Received: March 14, 2003
Dear Mr. Olson:
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). Specifically, your device is substantially equivalent to Kendall DOVER Silicone Foley Catheter. Given that you have not provided any microbial adherence data, you may not make any claims regarding the effectiveness of the inorganic silver ion releasing polymer to reduce microbial adherence to the device or to reduce urinary tract infections in the patients treated with the device. 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 (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.
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Page 2 - Mr. David Olson
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); 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.
This letter will allow you to continue marketing your device as described in your Section 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 Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx, | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
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 Statement
KO24010 510(k) Number (if known):
Device Name: Kendall Dover Silver Hydrogel Coated Silicone Foley Catheter
Indications for Use:
The proposed device is intended for use in the drainage and/or collection and/or measurement of urine. Generally drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.
Please Do Not Write Below This Line - Continue On Another Page If Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Use
(Per 21 CFR 801.109)
OR
Over-The-Counter
Caulyn Y. Neuland for N. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K024010
§ 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.