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510(k) Data Aggregation
(168 days)
The Symetrex™ Long Term Hemodialysis Catheter with Sideholes is a symmetric tip dual lumen catheter designed for chronic hemodialysis and apheresis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement.
Long term, greater than 30 days, vascular access for Hemodialysis and Apheresis treatments.
The Symetrex™ Long Term Hemodialysis Catheter with Sideholes is a chronic, 15.5 French, dual lumen, radiopaque catheter made of polyurethane. It has a polyester retention cuff and two female luer adapters. The retention cuff promotes tissue ingrowth to anchor the catheter in the subcutaneous tunnel. The luer adapters are identical in color to indicate the reversibility of this catheter. This catheter features symmetrical side channels with a distal tip configuration designed to separate the intake flow from the output flow in both directions.
Here's a breakdown of the acceptance criteria and study information for the Symetrex™ Long Term Hemodialysis Catheter with Sideholes, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily demonstrated through equivalence to the predicate device and compliance with various ISO and ASTM standards. The document doesn't explicitly state quantitative acceptance criteria in all cases, but rather reports the device performance against established standards through "performance testing."
Key performance aspects are outlined in the comparison to the predicate device and in the performance standards section.
| Performance Aspect | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Recirculation | Less than 1% recirculation in forward and reverse flow (implied by predicate's performance) | Symetrex™ Long Term Hemodialysis Catheter with Sideholes has less than 1% recirculation in forward and reverse flow when tested in vitro. |
| Priming Volumes | Match predicate device for various tip-to-cuff lengths (e.g., 2.1cc for 19cm, 2.3cc for 23cm, etc.) | Matches predicate device:19cm: 2.1cc23cm: 2.3cc28cm: 2.5cc33cm: 2.6cc37cm: 2.8cc42cm: 3.2cc |
| Physical/Mechanical | Compliance with ISO 10555-1 (e.g., Air Leak, Catheter Leak, Extension-Hub, Extrusion-Hub, Gravity Flow) | "Performance testing was performed in accordance with... ISO 10555-1" for Air Leak, Catheter Leak, Extension-Hub, Extrusion-Hub, Gravity Flow. (Implies compliance, but no specific values are given.) |
| Packaging | Compliance with ISO 11607-1 and ISO 11607-2 (e.g., Shipping and Shelf Life testing) | "Performance testing was performed in accordance with... ISO 11607-1" and "ISO 11607-2" for Shipping and Shelf Life testing. (Implies compliance.) |
| Luer Fittings | Compliance with ISO 594-1 (Gauging) and ISO 594-2 (Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking) | "Performance testing was performed in accordance with... ISO 594-1" for Gauging, and "ISO 594-2" for Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking. (Implies compliance.) |
| Biocompatibility | Compliance with various ISO 10993 series and ASTM standards for blood-contacting implants with permanent exposure (> 30 days) | "Biocompatibility was performed... per ISO 10993-1 for a blood implant device with permanent exposure (i.e. > 30 days). Biocompatibility was performed on the final, finished device." Specific tests listed (Hemocompatibility, Genotoxicity, Cytotoxicity, Irritation/Intracutaneous, Acute Systemic Toxicity, Implantation, Additional Testing) were conducted. (Implies satisfactory results based on these standards.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the performance testing (test set) for the device. It also does not provide information on data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are primarily in vitro (Recirculation) or bench/laboratory testing (physical, mechanical, packaging, luer fittings, biocompatibility).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The studies described are non-clinical, benchtop, and in vitro tests governed by engineering and scientific standards, rather than clinical trials requiring expert-established ground truth in the medical diagnostic sense.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable and therefore not provided in the document. The studies are non-clinical hardware tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document pertains to a physical medical device (catheter), not an AI-powered diagnostic system. Therefore, the concept of "human readers improve with AI" is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical catheter, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the non-clinical performance testing and biocompatibility studies, the "ground truth" is established by:
- Engineering and Scientific Standards: Compliance with relevant ISO and ASTM standards (e.g., ISO 10555-1 for intravascular catheters, ISO 11607-1 for packaging, ISO 594-1/2 for luer fittings, and various ISO 10993 parts for biocompatibility).
- Measurement and Comparison: Direct measurement of physical properties (e.g., priming volumes) and comparison to the predicate device.
- Established Test Methods: In vitro testing for recirculation rates.
8. The Sample Size for the Training Set
This information is not applicable as there is no "training set" in the context of this physical medical device. The device is not learning-based.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this physical medical device.
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