(74 days)
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.
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.
This document is a 510(k) summary for a medical device (Rüsch Simplastic Foley Catheterization Set). It does not describe an AI/ML powered medical device, nor does it present a study proving the device meets acceptance criteria in the manner typically associated with such devices (e.g., performance metrics like sensitivity, specificity, AUC). Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to regulatory guidance through laboratory bench testing.
Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth, expert adjudication, MRMC studies, and separate standalone performance is not applicable to this document.
However, I can extract the relevant information about the "Summary of Performance Data" as presented:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Criterion (Acceptance Criteria Implicitly based on FDA Guidance) | Reported Device Performance |
|---|---|
| Drainage lumen flow rate | Completed (Pass) |
| Balloon resistance to rupture | Completed (Pass) |
| Pullout resistance of inflated balloon | Completed (Pass) |
| Maintenance of balloon inflation over extended time | Completed (Pass) |
| Manufacturing tolerances for tip, balloon and shaft | Completed (Pass) |
| Deflation after period of inflation | Completed (Pass) |
| Biocompatibility testing for patient contacting materials | Completed (Pass) |
Note: The document states "Laboratory bench testing has been completed," implying successful adherence to the standards outlined in the FDA "Draft Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters." Specific numerical acceptance values are not provided in this summary, but are implicitly met by the completion of testing as per guidance.
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document refers to "Laboratory bench testing" which typically involves a specific number of units, but this number is not disclosed in the summary.
- Data Provenance: This is bench test data generated in a laboratory setting, not patient-derived data from any specific country. The study is a prospective laboratory evaluation of manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This is not a study involving human interpretation or expert consensus for ground truth. Performance is assessed against physical and material engineering specifications and regulatory guidance.
4. Adjudication Method for the Test Set
- Not applicable. Performance is assessed through objective laboratory measurements against defined standards, not through expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not an MRMC study. It is laboratory bench testing of a physical medical device.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Yes, in a sense that the device's technical specifications and physical performance were evaluated independently without human intervention or interpretation of results beyond standard laboratory procedure. However, this terminology is typically used for AI algorithms. For a physical device, this refers to its intrinsic performance as measured.
7. Type of Ground Truth Used
- The "ground truth" for this type of device evaluation is based on pre-defined engineering specifications, material properties, and performance standards outlined in regulatory guidance (e.g., FDA "Draft Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters") and biocompatibility standards (ISO 10993 and FDA "Blue Book Memo" #G95/1).
8. Sample Size for the Training Set
- Not applicable. This document describes the testing of a medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set for an AI/ML algorithm is mentioned.
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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.
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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
§ 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.