(63 days)
No
The device description and performance studies focus on the physical characteristics and basic functionality of a catheter, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is described as a fluid conduit for urodynamic studies and is used to measure pressure, not to treat a condition or disease.
Yes
This device is used in urodynamic studies to calculate detrusor pressure from rectal pressure, which is a diagnostic measurement.
No
The device description clearly outlines a physical catheter with a balloon, made of polyvinyl chloride and latex, intended for insertion into the rectum. It requires inflation with sterile water and connection to a transducer, 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 provide a fluid conduit for urodynamic studies to calculate detrusor pressure from rectal pressure. This is a physiological measurement taken directly from the body, not a test performed on a sample taken from the body (like blood, urine, or tissue).
- Device Description: The device is a catheter with a balloon designed for insertion into the rectum. It's used in conjunction with equipment to measure pressure within the body.
- Lack of IVD Characteristics: There is no mention of analyzing a biological sample, reagents, or performing a test in vitro (outside the body).
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a physiological state, health, or disease. This device is used to directly measure a physiological parameter within the body.
N/A
Intended Use / Indications for Use
The Rüsch Urodynamic Rectal Balloon 2-way Catheter is intended to provide a fluid conduit for urodynamic studies, where the detrusor pressure is to be calculated from rectal pressure.
Product codes
FAP
Device Description
The Rusch Urodynamic Rectal Balloon 2-way Catheter consists of a double lumen polyvinyl chloride tube upon which is affixed a latex balloon, with a radiopaque stripe.
To use, the balloon is inflated with sterile water using a luer taper syringe. The catheter is then connected to a transducer, and can be used in conjunction with equipment for calculating the detrusor pressure necessary to open the urinary sphincter).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Rectal
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
Biocompatibility testing has been completed based on the ISO 10993 matrix modified by FDA Blue Book Memo #G95/1.
Laboratory bench testing has been completed to section #6 of the FDA "510(k) Checklist for Urodynamic Catheters":
Tensile Testing Balloon Burst Testing
The device's performance in these tests is comparable with that of the Rüsch Urodynamic Rectal Balloon Catheter (K952573).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1620 Urodynamics measurement system.
(a)
Identification. A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
Image /page/0/Picture/0 description: The image shows a handwritten string of alphanumeric characters. The string appears to be "K962472". The characters are written in a bold, black font, and the handwriting is somewhat stylized. The image is a close-up of the string, and the background is white.
AUG 27 1996
Image /page/0/Picture/2 description: The image shows the logo for RUSCH, a company specializing in international group regulatory affairs. The logo features the company name in bold, sans-serif font, with the word "RUSCH" appearing prominently at the top. Below the company name, the words "INTERNATIONAL Group Regulatory Affairs" are written in a smaller font. The text "A Subsidiary of Teleflex Incorporated (USA)" is at the bottom of the logo.
all Pines Park ffrev, NH 03452 603) 532-7706 FAX (603) 532-8211 or 6108
510(k) SUMMARY
[As required by 21 CFR 807.92]
1. Submitter and Contact Person
Neil R. Armstrong Group Regulatory Affairs Manager Rüsch International Tall Pines Park Jaffrey NH 03452 (603) 532 7706 Tel: (603) 532 8211 Fax:
Device Name 2.
Trade Name Rüsch Urodynamic Rectal Balloon 2-way Catheter
Common Name Urodynamic Rectal 2-way Catheter
Classification Name Accessory to Urodynamics Measurement System 78 FAP; 21 CFR 876.1620; Class II medical device
3. Comparison Devices
Rüsch Urodynamic Rectal Balloon Catheter - K952573 Porges Urodynamic Rectal Balloon Catheter - Preamendment Cook Urological Urodynamic Rectal Balloon Catheter - K912451
4. Description of Device
The Rusch Urodynamic Rectal Balloon 2-way Catheter consists of a double lumen polyvinyl chloride tube upon which is affixed a latex balloon, with a radiopaque stripe.
To use, the balloon is inflated with sterile water using a luer taper syringe. The catheter is then connected to a transducer, and can be used in conjunction with equipment for calculating the detrusor pressure necessary to open the urinary sphincter).
1
Intended Use ર .
The Rüsch Urodynamic Rectal Balloon 2-way Catheter is intended to provide a fluid conduit for urodynamic studies, where the detrusor pressure is to be calculated from rectal pressure.
Summary of Technological Characteristics 6.
The Rusch Urodynamic Rectal Balloon 2-way Catheter is manufactured of the same materials and by the same processes (including sterilization) as the Rüsch Urodynamic Rectal Balloon Catheter - K952573.
The Rüsch Urodynamic Rectal Balloon 2-way Catheter has a double lumen shaft design similar to the Porges Urodynamic Rectal Balloon Catheter (Preamendment) and the Cook Urological Urodynamic Rectal Balloon Catheter (K912451).
7. Summary of Performance Data
Biocompatibility testing has been completed based on the ISO 10993 matrix modified by FDA Blue Book Memo #G95/1.
Laboratory bench testing has been completed to section #6 of the FDA "510(k) Checklist for Urodynamic Catheters":
Tensile Testing Balloon Burst Testing
The device's performance in these tests is comparable with that of the Rüsch Urodynamic Rectal Balloon Catheter (K952573).