(20 days)
Not Found
Not Found
No
The summary describes a physical medical device (catheter) and contains no mention of software, algorithms, AI, or ML.
No
The device is a catheter intended to pass fluids to and from the urinary bladder, which is a diagnostic/management function, not directly therapeutic.
No
The device description states its intended use is to pass fluids to and from the urinary bladder, which indicates a therapeutic or facilitative purpose, not a diagnostic one. There is no mention of disease detection, monitoring, or diagnosis.
No
The device description explicitly mentions "Silicone Foley Balloon Catheter" and "Nelation Catheter," which are physical hardware components used for urinary catheterization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "pass fluids to and from the urinary bladder." This describes a device used in vivo (within the body) for a therapeutic or diagnostic procedure directly on the patient.
- Device Description: The device is a "Silicone Foley Balloon Catheter and Nelation Catheter." These are physical devices inserted into the body.
- Lack of IVD Characteristics: The description does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or other substances to perform tests on samples.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a medical device used for a procedure directly on the patient's urinary system.
N/A
Intended Use / Indications for Use
The Silicone Foley Balloon Catheter and Nelation Catheter are intended for use as urinary catheters to pass fluids to and from the urinary bladder.
Product codes
78 EZL, 78 GBM
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
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
Not Found
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
Image /page/0/Picture/0 description: The image shows a logo with a stylized depiction of three curved lines, possibly representing waves or abstract figures. To the left of the logo, the text "DEPARTMENT OF HEALTH" is arranged vertically, with the letters stacked on top of each other. The text is oriented to be read from bottom to top, following the curve of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 1998
Re: K980919
Ms. Karen U. Salinas Regulatory Consultant FortuneMedical Instrument Corporation c/o Holland & Associates 3722 Ave. Sausalito Irvine, CA 92606
100% Silicone 2-way Foley Balloon Catheter Dated: March 10, 1998 Received: March 11, 1998 Regulatory Class: II 21 CFR 876.5130/Procode: 78 EZL and 78 GBM
Dear Ms. Salinas:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmam.html".
Sincerely yours.
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
510(k) number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
All Silicone 2-Way Foley Balloon Catheter All Silicone 3-Way Foley Balloon Catheter All Silicone Nelation Catheter
Indications for Use:
The Silicone Foley Balloon Catheter and Nelation Catheter are intended for use as urinary catheters to pass fluids to and from the urinary bladder.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use_
Rober R. Sattler/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 4804 510(k) Number