(155 days)
Not Found
Not Found
No
The description details a standard mechanical Foley catheter with no mention of AI or ML components or functionalities.
No
Explanation: A therapeutic device is used to treat a disease or illness. This device is used to drain fluids, which is a supportive function, not a direct treatment.
No
The device, a catheter, is used for draining fluids, which is a therapeutic function, not for diagnosing a condition.
No
The device description clearly describes a physical catheter made of silicone with lumens, a balloon, eye holes, and a connecting funnel, which are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device function: The Rusch-BRILLANT Balloon Catheter is used to drain fluids to and from the urinary tract. This is a direct intervention on the body, not an examination of a specimen taken from the body.
- Intended Use: The intended use clearly states its purpose is for drainage, not for analyzing a sample for diagnostic purposes.
Therefore, based on the provided information, this device falls under the category of a general medical device used for drainage, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Rusch-BRILLANT Balloon Catheter is used to drain the fluids to and from the urinary tract.
Product codes
78 EZL
Device Description
The silicon catheter is a balloon retention type, commonly called a Foley catheter. The device is a single use, disposable, sterile, with a retention balloon, which is attached to the silicone two lumen shaft. One lumen is for drainage and the other lumen for inflation and deflation of the balloon. 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. This product is used with a wire stylet that is inserted prior to catheter placement. This product is available in 6F.
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
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Key Metrics
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Predicate Device(s)
Porgés FOLYSIL Catheter
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
K971643
oct. 7, 1997
510 K Summary
[As required by 21 CFR 807.92]
- Submitter Name, Address, and Date of Submission. 1.
Mr. James R. Whitney Group Regulatory Affairs Associate 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.
Urological Catheter Classification Name:
Common Name: Foley Catheter
Proprietary Name: Rüsch-BRILLANT Balloon Catheter.
- Identification of the legally marketed device to which the 3. submitter claims equivalence.
The Rüsch-BRILLANT Balloon Catheter is substantially equivalent to the Porgés FOLYSIL Catheter.
Description of the Device. 4 .
The silicon catheter is a balloon retention type, commonly called a Foley catheter. The device is a single use, disposable, sterile, with a retention balloon, which is attached to the silicone two lumen shaft. One lumen is for drainage and the other lumen for inflation and deflation of the balloon. 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.
This product is used with a wire stylet that is inserted prior to catheter placement. This product is available in 6F.
1
Intended Use of the Device. 5.
The Rusch-BRILLANT Balloon Catheter is used to drain the fluids to and from 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, ported distal tip and silicone hub is equivalent to predicate devices.
2
Image /page/2/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the edge. Inside the circle is a stylized emblem consisting of three curved shapes that resemble wings or waves. The emblem is black, and the background is white. The image appears to be a scan or photocopy, as the edges are slightly blurred.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 7 1997
Mr. James R. Whitney Group Regulatory Affairs Associate Rusch International Tall Pines Park Jaffrey, New Hampshire 03452
Re: K971643
Rusch-BRILLANT Balloon Catheter Dated: August 26, 1997 Received: August 28, 1997 Regulatory class: II 21 CFR §876.5130/Product code: 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 Modical 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, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions and adulteration.
If your device is classified (see above) into either 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. Failure to comply with the GMP regulation may result in regulatory action. 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, 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 (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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/cdrh/dsmamain.html".
Sincerely yours,
University years,
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
Enclosure
3
510(k) Number (if known):_
Device Name:_Rüsch-BRILLANT Bailoon Catheter
Indications for Use:
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The Rusch-BRILLANT Balloon Catheter 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)
Robert R. Rathbun
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices K971643
510(k) Number.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use___
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