(87 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device's intended use is for draining fluids from and to the urinary tract and for flushing/irrigating the urinary tract, which are functional purposes rather than therapeutic interventions despite benefiting a patient's health.
No.
The text describes the device as a Foley catheter used for draining, flushing, and irrigating the urinary tract, without any mention of diagnosis or diagnostic capabilities.
No
The device description clearly describes a physical catheter with lumens, a balloon, eye holes, and connecting funnels, indicating it is a hardware device.
Based on the provided information, this device 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 and, in the case of the three-way model, to flush and irrigate the urinary tract. This is a direct interaction with the body for therapeutic or diagnostic purposes related to the physical structure and function of the urinary tract.
- Device Description: The description details a physical catheter designed to be inserted into the urinary tract for drainage and irrigation. It's a mechanical device for manipulating fluids within the body.
- Lack of IVD Characteristics: IVD devices 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 of bodily fluids outside the body.
Therefore, the Rüsch Brillant Silicone Foley catheter is a medical device used in vivo (within the body) for drainage and irrigation, not an IVD.
N/A
Intended Use / Indications for Use
The Rüsch Brillant Two Way Silicone Foley is used to drain fluids to and from the urinary tract.
The Rüsch Brillant Three Way Silicone Foley is used to drain fluids to and from the urinary tract, and to flush and irrigate the urinary tract.
Product codes (comma separated list FDA assigned to the subject device)
78 EZL
Device Description
The Rusch Brillant Silicone catherer is of the balloon retention type, commonly called a Foley catheter. The device is single use, disposable, and sterile. The central lumen is for draining fluids to and from the urinary tract. The second lumcn is to inflate and deflate the balloon with sterile water. On models with a third lumen (commonly called a Threeway Catheter), it is used in conjunction with the central lumen for flushing or irrigating the urinary tract.
The distal end has eye holes, which are for drainage. On the opposing end of the shaft, are a connecting funnel (for a drainage bag, purchased separately) and a Luer activated valve.
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.
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Page 1 of 2
K993063
510(k) Summary
- Submitter Name, Address, and Date of Submission.
Mrs. Julie A. Beaumont Group Regulatory Affairs Technician Rüsch Inc. Tall Pines Park Jaffrey, New Hampshire 03452
Telephone: (603) 532-7706 Facsimile: (603) 532-6179 E-Mail: jbeaumont@tfx.com
Contact: Same as above
- 2 . Name of the Device, Common, Proprietary (if Known), and Classification. Classification Name: Urological Catheter
Common Name: Foley Catheter
Rusch Brillant Silicone Foley Proprietary Name:
- ਤੇ -Identification of the legally marketed device to which the submitter claims equivalence.
The Rüsch Brillant Silicone Foley is substantially equivalent to the Willy Rusch AG., Sherwood Medical, Kendall, Baxter, and Bard.
ず、 Description of the Device.
The Rusch Brillant Silicone catherer is of the balloon retention type, commonly called a Foley catheter. The device is single use, disposable, and sterile. The central lumen is for draining fluids to and from the urinary tract. The second lumcn is to inflate and deflate the balloon with sterile water. On models with a third lumen (commonly called a Threeway Catheter), it is used in conjunction with the central lumen for flushing or irrigating the urinary tract.
The distal end has eye holes, which are for drainage. On the opposing end of the shaft, are a connecting funnel (for a drainage bag, purchased separately) and a Luer activated valve.
1
Intended Use of the Device. 5.
The Rüsch Brillant Two Way Silicone Foley is used to drain fluids to and from the urinary tract. The Rüsch Brillant Three Way Silicone Foley is used to drain fluids to and from the urinary tract, and to flush and irrigate the urinary tract.
Summary of Technological Characteristics. 6.
The following technological characteristics are the same as or equivalent to predicate devices:
The silicone catheter with silicone balloon, distal tip, and inflation valve is equivalent to predicate device.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 1999
Ms. Julie A. Beaumont Group Regulatory Affairs Technician Rüsch International, Inc. Tall Pines Park Jaffrey, NH 03452
Re: K993063
Rüsch Brillant Silicone Foley Regulatory Class: II 21 CFR 876.5130/Procode: 78 EZL Dated: August 30, 1999 Received: September 13, 1999
Dear Ms. Beaumont:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device designed to the specifications provided in your 510(k) 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). 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 OS 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 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Julie A. Beaumont
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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Sartor
CAPT. R. with C. Schuler, M.D.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
4
Page 1 of 1
| 510(k) Number (if known): | K993063 |
|---|---|
| --------------------------- | --------- |
Device Name: Rüsch Brillant Silicone Foley
Indications for Use:
The Rüsch Brillant Two Way Silicone Foley is used to drain fluids to and from the urinary tract.
The Rüsch Brillant Three Way Silicone Foley is used to drain fluids to and from the urinary tract, and to flush and irrigate the urinary tract.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_V (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number.