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510(k) Data Aggregation
(140 days)
SimPro™ Now is for Clean Intermittent Catheterization-CIC treatment and is indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.
GentleCath™ Hydrophilic is for Clean Intermittent Catheterization-CIC treatment and is indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.
The proposed devices: SimProTM Now and GentleCath™ Hydrophilic are a range of sterile, singleuse, urinary catheters designed as an intermittent pathway for drainage of the bladder. The catheters are available in a variety of lengths and French sizes to accommodate individual anatomy of both male and female users. Both Nelaton (straight tip) and Tiemann (Coudé tip) designs are available. Each catheter is individually packaged together with a sterile water sachet (packet) and an insertion guide. The water sachet is provided for wetting of the hydrophilic surface and is to be broken immediately before use in order to soak the tubing. The insertion guide is provided to minimize touching the catheter shaft directly during insertion and retraction.
Acceptance Criteria and Device Performance for SimPro™ Now and GentleCath™ Hydrophilic Catheters
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes non-clinical performance data for the SimPro™ Now and GentleCath™ Hydrophilic catheters. The acceptance criteria for these tests are generally stated as "All tests met the pre-determined acceptance criteria." While specific numerical acceptance criteria are not detailed in the provided text for each test, the document confirms that the device did meet these criteria. The table below summarizes the tests performed and the reported performance.
| Acceptance Criteria Category | Specific Test Performed | Reported Device Performance |
|---|---|---|
| Biocompatibility | Chemical characterization | Met pre-determined acceptance criteria based on ISO 10993-1:2018(E) and FDA Guidance "Use of International Standard ISO 10993-1." |
| Cytotoxicity | Met pre-determined acceptance criteria based on ISO 10993-1:2018(E) and FDA Guidance "Use of International Standard ISO 10993-1." | |
| Irritation | Met pre-determined acceptance criteria based on ISO 10993-1:2018(E) and FDA Guidance "Use of International Standard ISO 10993-1." | |
| Sensitization | Met pre-determined acceptance criteria based on ISO 10993-1:2018(E) and FDA Guidance "Use of International Standard ISO 10993-1." | |
| Acute Systemic Toxicity | Met pre-determined acceptance criteria based on ISO 10993-1:2018(E) and FDA Guidance "Use of International Standard ISO 10993-1." | |
| Subacute Systemic Toxicity | Met pre-determined acceptance criteria based on ISO 10993-1:2018(E) and FDA Guidance "Use of International Standard ISO 10993-1." | |
| Genotoxicity | Met pre-determined acceptance criteria based on ISO 10993-1:2018(E) and FDA Guidance "Use of International Standard ISO 10993-1." | |
| Pyrogenicity | Met pre-determined acceptance criteria based on ISO 10993-1:2018(E) and FDA Guidance "Use of International Standard ISO 10993-1." | |
| Sterile Barrier & Packaging | Packaging validation testing (e.g., ISO 11607-1, ISO 11607-2, ASTM F 1929-15) | Met pre-determined acceptance criteria. (Specifically mentioned: Sterile barrier systems confirmed, seal leaks by dye penetration, performance testing of shipping containers, conditioning, seal strength, packaging for terminally sterilized medical devices requirements). |
| Sterilization Validation | Sterilization process validation (e.g., ISO 11137-1, ISO 11137-2, ISO 11135, ISO 10993-7) | Met pre-determined acceptance criteria. (Specifically mentioned: Requirements for development, validation, and routine control of sterilization process, establishing sterilization dose, ethylene oxide sterilization, ethylene oxide sterilization residuals). |
| Shelf Life & Performance (ISO 20696:2018 & Internal Methods) | Flow rate (Annex E of ISO 20696:2018) | Met pre-determined acceptance criteria. |
| Peak tensile force (Annex H of ISO 20696:2018) | Met pre-determined acceptance criteria. | |
| Connector security (internal test method) | Met pre-determined acceptance criteria. | |
| Kink stability (internal test method) | Met pre-determined acceptance criteria. | |
| Friction (internal test method) | Met pre-determined acceptance criteria. | |
| Water retention (internal test method) | Met pre-determined acceptance criteria. | |
| Coefficient of friction (internal test method) | Met pre-determined acceptance criteria. | |
| Packaging sterile integrity (internal test method) | Met pre-determined acceptance criteria. | |
| Primary package seal strength (internal test method) | Met pre-determined acceptance criteria. | |
| Catheter soaking time prior to use (internal test method) | Met pre-determined acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the test sets in each non-clinical performance test. However, it indicates that testing was performed according to various ISO and ASTM standards, which typically prescribe minimum sample sizes for their respective tests.
The data provenance is non-clinical bench testing. There is no information provided about the country of origin of the data, as it relates to laboratory testing rather than patient data. The tests are inherently prospective in nature for device qualification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable. The study described is a non-clinical bench study, not involving human interpretation or ground truth established by experts in a clinical context. The "ground truth" for these tests is defined by the technical specifications and requirements outlined in the referenced ISO and ASTM standards.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human assessment of data. Since this is a non-clinical bench study, such methods are not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No data from human clinical studies has been included to support the substantial equivalence of the proposed SimPro™ Now and GentleCath™ Hydrophilic." Therefore, there is no information on the effect size of human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance was done as this is a physical medical device (catheter) and not an AI/software as a medical device.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is established by:
- International Standards: ISO 10993 series for biological safety, ISO 11607 series and ASTM standards for packaging, ISO 11137 and ISO 11135 for sterilization, and ISO 20696:2018 for urethral catheters.
- Internal Test Methods: Developed by the manufacturer to verify specific performance properties (e.g., connector security, kink stability, friction, water retention, coefficient of friction, packaging sterile integrity, primary package seal strength, catheter soaking time). These internal methods would have their own defined acceptance criteria.
8. The Sample Size for the Training Set
This question is not applicable. As stated, this is a non-clinical bench study for a physical medical device and does not involve AI or machine learning, and therefore no "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this type of device qualification.
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