(36 days)
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Not Found
No
The provided text does not mention AI, ML, or any related concepts or technologies. The device description is focused on a physical medical device for drainage and temperature monitoring.
No
The device is used for drainage and monitoring, not for treating a disease or condition.
Yes
The device monitors temperature, which can be used to diagnose conditions like fever.
No
The device description explicitly mentions a "Foley Catheter with Temperature Sensors," which are physical hardware components. The intended use also describes drainage of the urinary bladder, a function performed by the physical catheter.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "drainage of the urinary bladder and monitoring of temperature." This describes a device that interacts directly with the patient's body (in vivo) for therapeutic (drainage) and monitoring purposes.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside the body (in vitro).
The DeRoyal Exac-Temp and Clini-Temp Foley Catheter with Temperature Sensors is a medical device used within the body for drainage and temperature monitoring, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
DeRoyal Exac-Temp and Clini-Temp Foley Catheter with Temperature Sensors are to be used for drainage of the urinary bladder and monitoring of temperature.
Product codes
78 EYC
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
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
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Key Metrics
Not Found
Predicate Device(s)
Not Found
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.
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 0 2 2004
Ms. Sharon Cook Regulatory Affairs Group Manager DeRoyal 200 DeBusk Lane POWELL TN 37849
Re: K041416
Trade/Device Name: Exac Temp Foley Catheter and Clini-Temp Foley Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EYC Dated: May 26, 2004 Received: May 27, 2004
Dear Ms. Cook:
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 electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oogin many of substantial equivalence of your device to a legally premarket notincation. The PDF anding
marketed predication. The 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 If you desire specific advise to your in the following numbers, based on the regulation number at the top of the 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 Additionally, for questions on may please note the regulation entitled, "Misbranding Other or Compliance as (svej sation" (21CFR Part 807.97) you may obtain. Other general of recreence to premarked notification on the Act may be obtained from the Division of Small information on your responsibility and Consumer Assistance at its toll-free number (800) 638-2041 or Mandracturers, International and Solaess http://www.fda.gov/cdrl/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
2
510(k):KO-14162 510(k): KO 11910-11910-11-11-11-11-11-11-11-11-11-11-11-11-11-11-11-11-11-11-11-11-11-11-11 Sensor.
Intended Use: DeRoyal Exac-Temp and Clini-Temp Foley Catheter with Intended Use: DeRoyal Exac-Temp and Olik Temp Pully Forest Press.
Temperature Sensors are to be used for drainage of the urinary bladder and I omporature Constoring of temperature.
Nancy Broadon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological
and Radiological Devices
510(k) Number .
Prescription Use (Per 21 CFR 801.109)