(189 days)
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.
Not Found
No
The summary describes a physical medical device (a catheter) with a specific coating and material. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is described as a urinary drainage catheter, which collects and measures urine, rather than treating a medical condition.
No
The device is described as a urinary drainage catheter, used for the collection and measurement of urine, which are functions related to treatment and monitoring, not diagnosis. It does not mention any diagnostic capabilities or the generation of diagnostic information from images or other data.
No
The device description clearly states it is a physical catheter made of silicone material, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the drainage, collection, and measurement of urine. This is a physical process performed on the body (or collecting a bodily fluid for physical measurement), not a diagnostic test performed in vitro (outside the body) to detect diseases or conditions.
- Device Description: The device is a catheter, which is a physical tool for drainage. It doesn't contain reagents or components typically used for chemical or biological analysis of a sample.
- Lack of Diagnostic Information: The description focuses on the physical function of the device (drainage, collection, measurement) and its material properties. There is no mention of analyzing the urine for diagnostic markers or providing diagnostic information.
- No Mention of IVD-related activities: The document does not mention any activities related to in vitro diagnostics, such as analyzing samples, detecting analytes, or providing diagnostic results.
Therefore, the Kendall DOVER Silver Hydrogel Coated Silicone Foley Catheter is a medical device used for a physical procedure (drainage and collection of urine), not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
78 EZL and KOD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract (bladder, urethra, nephrostomy tract)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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.
2
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.
3
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
4
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