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510(k) Data Aggregation
(178 days)
The Fresenius PUNCTUR-GUARD® Fistula Needle Set is indicated for use as a nonimplantable (less than 30 days use) vascular access device for temporary cannulation in procedures requiring an extracorporeal circuit. The set includes a needlestick prevention device using PUNCTUR-GUARD® technology. The features of this device may aid in the prevention of needlestick injury. This device is intended for single use only.
The Fresenius PUNCTUR-GUARD® Fistula Needle Set is a non-implantable vascular access device for temporary cannulation in procedures requiring an extracorporeal circuit. It includes a needlestick prevention device using PUNCTUR-GUARD® technology.
Fresenius PUNCTUR-GUARD® Fistula Needle Set: Acceptance Criteria & Study Summary
This document addresses the acceptance criteria and study proving the Fresenius PUNCTUR-GUARD® Fistula Needle Set meets those criteria, as detailed in the provided 510(k) Premarket Notification.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied as passing specific tests for safety and performance, demonstrating equivalence to predicate devices. The reported device performance indicates that all tested samples for each criterion "passed". The key performance criteria and results are:
| Acceptance Criteria (Test) | Reported Device Performance (Result) |
|---|---|
| ISO 10993-1 Biocompatibility | Passed |
| Sheath Removal Force | All samples passed |
| Penetration Testing | All samples passed |
| Tubing Tensile Strength | All samples passed |
| Tubing/Luer Bond Strength | All samples passed |
| Tubing/Third Wing Bond Strength | All samples passed |
| Wing Body/Third Wing Disassembly Force | All samples passed |
| Front Cannula/Wing Body Bond Strength | All samples passed |
| Blunting Member/Third Wing Bond Strength | All samples passed |
| Safety Feature Activation Torque Testing | All samples passed |
| Lock Force - Spring Arm | All samples passed |
| Positive Pressure Leak Testing | All samples passed |
| Negative Pressure Leak Testing | All samples passed |
| Tip to Tip Distance Testing | All samples passed |
| Rate Flow vs. Pressure Drop (for each gauge size) | Maximum recommended flow rate for each gauge size: |
| 17G ≤200 ml/min | |
| 16G ≤300 ml/min | |
| 15G ≤400 ml/min | |
| 14G ≤600 ml/min |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample size for each test set. It repeatedly mentions "All samples passed," indicating that multiple units were tested for each criterion. The data provenance is internal to Fresenius Medical Care North America and is retrospective, as the tests were conducted as part of design verification prior to the 510(k) submission. No specific country of origin for the data is mentioned beyond the company's location in Lexington, MA, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the submitted document. The "ground truth" for the performance tests relies on established engineering and medical device standards (e.g., ISO 10993-1 for biocompatibility) and internal design specifications, not expert consensus on interpretations of medical data. The evaluation of test results would be conducted by qualified internal engineers and quality personnel, whose specific qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective, quantitative measurements against predefined specifications. There is no subjective interpretation requiring an adjudication method like 2+1 or 3+1. A "pass" or "fail" is determined based on adherence to the established test limits.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a medical device (fistula needle set) and not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI assistance evaluation is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm or software. Its performance is evaluated through physical and material tests, not standalone algorithm performance.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests are the pre-defined technical specifications and established regulatory standards (e.g., ISO 10993-1, internal limits for bond strength, flow rate, etc.). These are objective benchmarks against which the device's physical and functional properties are measured.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context. The design and manufacturing processes are validated through design verification and process validation, not through training a data model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device. The specifications for manufacturing and performance are established through engineering design, risk assessment, and adherence to relevant industry standards and regulatory requirements.
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