(212 days)
Not Found
Not Found
No
The device description is for a standard Foley catheter and does not mention any AI or ML components or functionalities.
No
The device is used to drain fluids to and from the urinary tract, which is a supportive function rather than a therapeutic one aiming to treat or cure a medical condition.
No
The device description states its use is for draining fluids from the urinary tract and inflating/deflating a balloon, without mentioning any diagnostic capabilities.
No
The device description clearly describes a physical catheter with a silicone shaft, balloon, lumens, eye holes, and connecting funnel, indicating it is a hardware device.
Based on the provided information, the Rüsch Brillant Silicone Foley is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "drain fluids to and from the urinary tract." This is a direct interaction with the patient's body for therapeutic or diagnostic purposes related to fluid management, not for examining specimens in vitro (outside the body).
- Device Description: The description details a physical device (catheter) used for drainage and balloon inflation within the urinary tract. It does not describe reagents, instruments, or systems used to examine specimens like blood, urine, or tissue samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVDs are devices used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Rüsch Brillant Silicone Foley is a medical device used for drainage within the body.
N/A
Intended Use / Indications for Use
The Rüsch Brillant Silicone Foley is used to drain fluids to and from the urinary tract.
Product codes (comma separated list FDA assigned to the subject device)
78 EZL
Device Description
The Rusch Brillant Silicone catheter is of the retention type, commonly called a Foley catheter. The device is a single use, disposable, sterile with retention balloon, which is attached to the silicone shaft. One lumen is for draining fluids to and from the urinary tract. The second lumen is to inflate and deflate the balloon with sterile water. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. Sterile water is used for inflation and deflation of the balloon. The distal end has two opposite eye holes, which are used for drainage. On the opposing end of the shaft, are a connecting funnel and a Luer activated valve. Pediatric sizes of this product are used with a stylet that is inserted prior to the catheter placement. This product is available in sizes 8 Fr to 26 Fr.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary 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)
Not Found
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.
Not Found
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
510 (k) Summary
Submitter Name, Address, and Date of Submission. 1.
Mr. James R. Whitney Group Regulatory Affairs Associate JAN - 8 1998 Willy Rüsch AG Group Tall Pines Park Jaffrey, New Hampshire 03452
(603) 532-7706 Telephone:
..
Same as above Contact :
Name of the Device, Common, Proprietary (if Known), and 2. Classification.
Classification Name: Urological Catheter
Common Name: Foley Catheter
Proprietary Name: Rüsch Brillant Silicone Foley
Identification of the legally marketed device to which 3. the submitter claims equivalence.
The Rusch Brillant Silicone Foley is substantially equivalent to the Porgés.
4 . Description of the Device.
The Rusch Brillant Silicone catheter is of the retention type, commonly called a Foley catheter. The device is a single use, disposable, sterile with retention balloon, which is attached to the silicone shaft. One lumen is for draining fluids to and from the urinary tract. The second lumen is to inflate and deflate the balloon with sterile water. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. Sterile water is used for inflation and deflation of the balloon. The distal end has two opposite eye holes, which are used for drainage. On the opposing end of the shaft, are a connecting funnel and a Luer activated valve. Pediatric sizes of this product are used with a stylet that is
inserted prior to the catheter placement. This product is available in sizes 8 Fr to 26 Fr.
1
Intended Use of the Device. 5.
The Rusch Brillant Silicone Foley is used to drain fluids to and from the urinary tract.
Summary of Technological Characteristics. ର .
The following technological characteristics are the same as or equivalent to predicate devices:
The silicone catheter with silicone balloon, ported distal tip, and silicone funnel is equivalent to predicate devices.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 8 1998
Mr. James R. Whitney Group Regulatory Affairs Associate Rüsch International Tall Pines Park Jaffrey, New Hampshire 03452
Re: K972184 Rüsch Brilliant Silicone Folev Catheter Dated: December 8, 1997 Received: December 9, 1997 Regulatory class: II 21 CFR §876.5130/Product codes 78 EZL
Dear Mr. Whitney:
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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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. Intelling, and prohibitions 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Fallure 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 does not affect any obligation you might have under sections 531 through 542 of the Act for-devices under Radiation Control provisions, Tor other Federal laws or regulations.
This letter will allow you to begin marketing 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, "Misbanding 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/cdrh/dsmamain.html".
Sincerely yours,
William Yu
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
3
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
۔۔۔ ﮨ
The Rüsch Brillant Silicone Foley is used to drain fluids to and from the urinary tract.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Dobeat D thing/ (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K972184 |
| Prescription Use | / (Per 21 CFR 801.109) |
|---|---|
| ------------------ | --------------------------------------------------------------------------------------------------------------------------------- |
OR
| Over-The-Counter Use | ____________________ |
|---|---|
| ---------------------- | ---------------------- |