(74 days)
No
The description details a physical medical device (Foley catheter) and its components, with no mention of software, algorithms, or AI/ML capabilities. The performance studies are bench tests of physical properties.
No.
The device, a Foley catheter, is used to pass fluids to and from the urinary tract and for drainage, not for treating a disease or condition.
No
The device is a Foley catheter used to pass fluids to and from the urinary tract, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components like a catheter, lubricating jelly, and a balloon, indicating it is a hardware medical 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 "pass fluids to and from the urinary tract." This describes a direct interaction with the body for therapeutic or diagnostic purposes within the body, not for testing samples outside the body.
- Device Description: The description details a physical catheter designed for insertion into the urinary tract. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, laboratory procedures, or any other elements typically associated with in vitro diagnostics.
IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device is used inside the body for fluid management.
N/A
Intended Use / Indications for Use
The Rusch Simplastic Foley Catheterization Set contains: one Rüsch Simplastic Foley Catheter one pack of lubricating ielly. The Rusch Simplastic Foley Catheter is intended to be used to pass fluids to and from the urinary tract. A pack of lubricating jelly is intended to assist insertion of the catheter through the urethra.
Product codes
78 KOD
Device Description
The Rusch Simplastic Foley Catheterization Set contains a pack of lubricating jelly and a Rüsch Simplastic Foley Catheter. The Rusch Simplastic Foley Catheters used in the kit will be available: in 2 way and 3 way formats in various sizes from 12 - 26 F.G. in two hardnesses with various sizes of balloon with various tip and eye configurations. Common features of all the catheters are: a clear polyvinyl chloride tube, a radiopaque stripe of BaSO loaded PVC is fully encapsulated in the tube wall, a latex balloon attached by adhesive bonding, a funnel connected to the main lumen and a luer activated valve for filling and emptying the balloon.
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)
Laboratory bench testing has been completed to section #XI of the FDA "Draft Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters": drainage lumen flow rate balloon resistance to rupture pullout resistance of inflated balloon maintenance of balloon inflation over extended time manufacturing tolerances for tip, balloon and shaft deflation after period of inflation biocompatibility testing for patient contacting materials
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
DEC 1 7 1996
Image /page/0/Picture/1 description: The image shows the logo for RUSCH International Group Regulatory Affairs, a subsidiary of Teleflex Incorporated (USA). The text "RUSCH." is in large, bold, black letters. Below that, the words "INTERNATIONAL" and "Group Regulatory Affairs" are in smaller, bold, black letters. The text "A Subsidiary of Teleflex Incorporated (USA)" is in even smaller, black letters. The text "P172" is in the upper right corner of the image.
Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108
510(k) SUMMARY
[As required by 21 CFR 807.92]
Submitter and Contact Person 1.
Neil R. Armstrong Group Regulatory Affairs Manager Rüsch International Tall Pines Park Jaffrey NH 03452 Tel: (603) 532 7706 (603) 532 8211 Fax:
2. Device Name
Trade Name Rüsch Simplastic Foley Catheterization Set
Common Name Urological Catheter
Classification Name Catheter. Urological 78 KOD 21 CFR 876.5130; Class II medical device
3. Comparison Devices
Rüsch Simplastic Foley Catheter - Preamendment Urotec/Franklin Soft Simplastic Catheters - K851684 Inmed Foley Catheterization Trav - K832363
Description of Device 4.
The Rusch Simplastic Foley Catheterization Set contains a pack of lubricating jelly and a Rüsch Simplastic Foley Catheter.
The Rusch Simplastic Foley Catheters used in the kit will be available:
in 2 way and 3 way formats in various sizes from 12 - 26 F.G. in two hardnesses with various sizes of balloon with various tip and eye configurations.
1
5100173 P2022
Common features of all the catheters are: a clear polyvinyl chloride tube, a radiopaque stripe of BaSO loaded PVC is fully encapsulated in the tube wall, a latex balloon attached by adhesive bonding, a funnel connected to the main lumen and a luer activated valve for filling and emptying the balloon.
న్. Intended Use
The Rusch Simplastic Foley Catheterization Set contains:
one Rüsch Simplastic Foley Catheter
one pack of lubricating ielly.
The Rusch Simplastic Foley Catheter is intended to be used to pass fluids to and from the urinary tract. A pack of lubricating jelly is intended to assist insertion of the catheter through the urethra.
Summary of Technological Characteristics 6.
The Rusch Simplastic Foley Catheterization Set is manufactured from the same materials and by the same processes (including sterilization) as the Rüsch Simplastic Foley Catheter (preamendment) and Urotec/Franklin Soft Simplastic Catheters (K851684), and contains the same "gel" pack as the Inmed Folev Catheterization Trav (K832363).
Sterile catheters have been biocompatibility tested in accordance with ISO 10993 and the FDA "Blue Book Memo" #G95/1.
7. Summary of Performance Data
Laboratory bench testing has been completed to section #XI of the FDA "Draft Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters":
drainage lumen flow rate balloon resistance to rupture pullout resistance of inflated balloon maintenance of balloon inflation over extended time manufacturing tolerances for tip, balloon and shaft deflation after period of inflation biocompatibility testing for patient contacting materials