(186 days)
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No
The summary describes a standard urinary catheter with temperature monitoring, and there are no mentions of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device's intended use is primarily for drainage/collection of urine and temperature monitoring, which are functions for support or diagnosis rather than directly treating a disease or condition. While necessary during surgical/post-surgical intervals, it doesn't fit the typical definition of a therapeutic device designed to cure or alleviate a medical problem.
No
Explanation: The device is described as a catheter for drainage/collection of urine and simultaneous monitoring of body core temperature. While temperature monitoring provides information, its primary stated purpose is not to diagnose a condition, but rather to collect fluid and monitor a physiological parameter during surgical or post-surgical intervals.
No
The device description clearly indicates the device is a catheter, which is a physical hardware component. The intended use also describes physical insertion and drainage.
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 and simultaneous monitoring of body core temperature. This is a direct interaction with the patient's body for therapeutic (drainage) and monitoring purposes.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used to diagnose, monitor, or screen for diseases or conditions.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples outside the body. The device is a catheter inserted into the body.
Therefore, this device falls under the category of a medical device used for drainage and monitoring, not an in vitro diagnostic.
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, such as a nephrostomy tract.
Product codes
EZL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
urinary bladder, urethra, nephrostomy tract
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: the department's name encircling the image and an abstract symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The symbol is a stylized representation of an eagle or bird-like figure with three wing-like shapes above a wavy line, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
T 16 2007
Dr. Wei Zhao Manager, Regulatory Affairs Tyco Healthcare The Kendall Company 15 Hampshire Street MANSFIELD MA 02048
Re: K071049
Trade/Device Name: Dover® 100% Silicone Foley Catheter with Temperature Sensor Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: August 27, 2007 Received: August 28, 2007
Dear Dr. 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 such 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.
1
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 (OS) 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 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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
2
Tyco Healthcare/Kendall DOVER® 100% Silicone Foley Catheter with Temperature Sensor
Indication for Use Statement
510 (k) Number (if known):
Device Name:
Tyco Healthcare/Kendall DOVER® 100% Silicone Foley Catheter with Temperature Sensor
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, 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 X___ OR OVER-The -Counter Use __ (Per 21 CFR 801.109)
Valind Hennen
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number