(110 days)
No
The summary describes a standard urinary catheter with a temperature sensor and a silver coating. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML. The performance studies focus on biocompatibility, not algorithmic performance.
No
The device is described as an indwelling urinary drainage catheter for collection of urine and temperature monitoring. It performs a supportive function (drainage and monitoring) rather than actively treating a disease or condition. The "therapeutic" aspect is not highlighted in its intended use, which is primarily diagnostic and supportive.
Yes
The device is intended for "simultaneous monitoring of the body core temperature," indicating that it provides information about the patient's physiological state, which can be used for diagnostic purposes.
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 of urine from the urinary bladder and simultaneous monitoring of body core temperature. This is a direct interaction with the body for therapeutic (drainage) and monitoring purposes.
- Device Description: The device is a catheter inserted into the body.
- Lack of IVD Characteristics: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis on a specimen outside the body.
The device is a medical device, specifically a catheter, used for in-vivo procedures (within the body).
N/A
Intended Use / Indications for Use
The proposed catheters are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals. General drainage is accomplished by inserting the catheter through the urethra and into the urine bladder. The catheter is retained in the bladder by inflation of balloon. Drainage is sometimes accomplished by suprapubic or other placement of the catheter.
Product codes
78 EZL
Device Description
The Tyco Healthcare/Kendall DOVER® Silver Temperature Sensing Foley Catheter is a sterile, single use, indwelling urinary drainage catheter extruded from 100% vulcanized silicone material, The catheter is coated with a lubricious hydrophilic topcoat containing an inozoa dinother releasing polymer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary bladder
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)
Nonclinical Testing: Biocompatibility testing has demonstrated that the proposed device meets the requirements of guidelines presented in the 10993 ISO Standard, Part1, with the FDA modified matrix presented in memorandum G95-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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K042709
page 1 of 2
JAN | 8 2005
510(k) Summary
Tvco Healthcare/Kendall DOVER® Silver Temperature Sensing Foley Catheter
In accordance with section 513(l) 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: September 28, 2004
1. Contact Person
Wei Zhao Senior Specialist, Regulatory Affairs Tyco Healthcare/Kendall Telephone: (508) 261-8404 Fax: (508)261-8461
2. Name of Medical Device
| Classification Name: | Catheter, Retention Type, Balloon |
|---|---|
| Common or Usual Name: | Urinary Drainage Silicone Foley Catheter |
| with Temperature Sensor | |
| Trade Name: | Tyco Healthcare/Kendall DOVER® Silver Temperature |
| Sensing Foley Catheter |
3. Identification of Legally Marketed Device
The proposed DOVER® Silver Temperature Sensing Foley Catheter is identical in intended uses, function and mode of operation to the currently marketed DOVER® 100% Silicone Foley Catheter with Temperature sensor and DOVER® Silver Hydrogel Coated Silicone Foley Catheter. DOVER® 100% Silicone Foley Catheter with Temperature sensor was cleared for marketing under 510(k) K933400. DOVER® Silver Hydrogel Coated Silicone Foley Catheter was cleared for marketing under 510(k) K024010.
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K042709
Page 2 of 2
4. Device Description
The Tyco Healthcare/Kendall DOVER® Silver Temperature Sensing Foley Catheter is a sterile, single use, indwelling urinary drainage catheter extruded from 100% vulcanized silicone material, The catheter is coated with a lubricious hydrophilic topcoat containing an inozoa dinother releasing polymer.
4. Device Intended Use
The proposed device is intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals. General drainage is accomplished by inserting the catheter through the urethra and into the bladder. The catheter is retained in the bladder by inflation of balloon. Efficacy of the DOVER® Silver Temperature Sensing Foley Catheter in preventing urinount infection during the catheterization has not been established. This device is not intended to be used as a treatment for active urinary tract infection.
5. Product Comparison
The proposed DOVER® Silver Temperature Sensing Foley Catheter is substantially equivalent to the Tyco healthcare/Kendall DOVER® 100% Silicone Foley Catheter with Temperature sensor as each product is intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature. Also the proposed device is substantially equivalent to the Tyco healthcare/Kendall DOVER® Silver Hydrogel Coated Silicone Folect Catheter as each product has a Foley catheter with same silver hydrogel coating and is intended for use in the drainage/collection of urine from the urinary bladder.
6. Nonclinical Testing
Biocompatibility testing has demonstrated that the proposed device meets the requirements of guidelines presented in the 10993 ISO Standard, Part1, with the FDA modified matrix presented in memorandum G95-1.
End of Document
Confidential
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
JAN 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Wei Zhao Senior Regulatory Specialist Tyco Healthcare/Kendall 15 Hampshire Street MANSFIELD MA 02048
Re: K042709
Trade/Device Name: DOVER® Silver Temperature Sensing Foley Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EZL Dated: December 23, 2004 Received: December 27, 2004
Dear Ms. Zhao:
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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elections as on product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsmaldsmamain.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
Indication for Use Statement
510 (k) Number (if known):
Device Name:
Tyco Healthcare/Kendall DOVER® Silver Temperature Sensing Foley Catheter
Indications for Use:
The proposed catheters are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals. General drainage is accomplished by inserting the catheter through the urethra and into the urine bladder. The catheter is retained in the bladder by inflation of balloon. Drainage is sometimes accomplished by suprapubic or other placement of the catheter.
Please DO NOT Write Below This Line - Continue On Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
Tomil C. Lynn
(Division Sign-Off)
ion of Reproductive, Abdominal and Radiological Dev 510(k) Number