(231 days)
The Stiletto Extended Dwell Catheter is inserted into a patient's vascular system for short-term use (
The Stiletto Extended Dwell Catheter (EDC) is a sterile, single use device designed to allow users to sample blood and/or administer fluids over a short duration (
Here's a breakdown of the acceptance criteria and study information for the "Stiletto Extended Dwell Catheter" based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Standard / Requirement | Test Name | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| ISO 7864 | Needle Surface and Sharpness | Passed | Passed |
| ISO 9626 | Needle Surface and Sharpness | Passed | Passed |
| ISO 10555-1 | Needle Surface and Sharpness | Passed | Passed |
| Internal Requirement | Dimensions – Needle Effective Length | Passed | Passed |
| ISO 10555-5 | Catheter to Needle Bevel Heel Lie Distance | Passed | Passed |
| ISO 10555-1 | Radiopacity | Passed | Passed |
| ASTM F640 | Needle Cap Removal Force | Passed | Passed |
| Internal Requirement | Needle Cap Removal Force | Passed | Passed |
| ISO 10555-5 | Flashback Detection | Passed | Passed |
| ANSI/AAMI HE75 | Assembly Force/Safety Activation Force | Passed | Passed |
| ISO 23908 | Assembly Force/Safety Activation Force | Passed | Passed |
| Internal Requirement | Insertion Tool Withdrawal Force | Passed | Passed |
| Internal Requirement | Catheter Kink Diameter | Passed | Passed |
| FDA Guidance Document | Dimensions – Catheter Effective Length | Passed | Passed |
| ISO 10555-5 | Dimensions – Catheter OD | Passed | Passed |
| ISO 10555-1 | Ink Permanence | Passed | Passed |
| ISO 10555-1 | Leak | Passed | Passed |
| Internal Requirement | Pump Flow | Passed | Passed |
| Internal Requirement | Assembly Tensile – Cannula – PEEK to Stainless Steel | Passed | Passed |
| ISO 23908 | Needle Safety Override Force | Passed | Passed |
| ANSI/AAMI HE75 | Needle Safety Override Force | Passed | Passed |
| ISO 7864 | Assembly Tensile – Needle to Top Case | Passed | Passed |
| ISO 9626 | Needle Tubing Stiffness | Passed | Passed |
| Internal Requirement | Assembly Tensile – Cannula – Stainless Steel to Thumb Slide | Passed | Passed |
| ISO 9626 | Cannula Resistance to Breakage | Passed | Passed |
| ISO 9626 | Needle Resistance to Breakage | Passed | Passed |
| ISO 10555-5 | Needle Loosening | Passed | Passed |
| FDA Guidance Document | Priming Volume | Passed | Passed |
| Internal Requirement | Gravity Flow | Passed | Passed |
| Internal Requirement | Catheter Collapse | Passed | Passed |
| Internal Requirement | Dimensions – Catheter Outer Diameter (Optical Micrometer) | Passed | Passed |
| ISO 10555-1 | Assembly Tensile – Catheter Shaft to Core Hub | Passed | Passed |
| ISO 10555-1 | Catheter Shaft Tensile | Passed | Passed |
| ISO 10555-1 | Catheter Burst | Passed | Passed |
| ISO 80369 | Luer/Hub Evaluations Per ISO 80369 | Passed | Passed |
| Biocompatibility | |||
| Cytotoxicity | MEM Elution | Non-cytotoxic | Non-cytotoxic |
| Sensitization | Magnusson-Kligman Maximization | Non-sensitizer | Non-sensitizer |
| Irritation | Intracutaneous Reactivity | Non-irritant | Non-irritant |
| Systemic Toxicity (Acute) | Systemic Injection | Non-toxic | Non-toxic |
| Pyrigenicity | Material Mediated Pyrogen | Non-pyrogenic | Non-pyrogenic |
| Hemolysis | Hemolysis (indirect) | Non-hemolytic | Non-hemolytic |
| Hemolysis | Hemolysis (direct) | Non-hemolytic | Non-hemolytic |
| Hemocompatibility | Partial Thromboplastin Time | Minimal Activator | Minimal Activator |
| Hemocompatibility | Complement Activation | Similar to Comparison Device | Similar to Comparison Device |
| Hemocompatibility | Dog Thrombogenicity | Equivocal | Equivocal |
| Implantation | Implantation | Non-irritant | Non-irritant (with rationalization from previous testing) |
| Toxicity (various) and Carcinogenicity | Chemical evaluation of leachates and Toxicological Risk Assessment | MOS > 1 for all compounds and populations | MOS > 1 for all compounds and populations |
| Particulate Matter | Sizing and Counting Particulate Matter: Light Obscuration Method | Acceptable per USP and Legally Marketed Comparative Device | Acceptable per USP and Legally Marketed Comparative Device |
2. Sample Size Used for the Test Set and the Data Provenance
The provided text details bench testing and biocompatibility testing. It does not describe a clinical test set in the traditional sense of patient data.
- Bench Testing: The specific sample sizes for each bench test are not provided in the document. The provenance is implied to be laboratory testing of the device itself.
- Biocompatibility Testing: The sample sizes for these tests are not explicitly stated, but they would typically involve material samples of the device components. The provenance is implied to be laboratory testing in accordance with ISO 10993 standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The study relies on objective bench test measurements and established biological safety protocols, not subjective expert assessment of a test set in the context of diagnostic or interpretive performance.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication method described as the performance is based on objective measurements against standards.
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
Not applicable. This is a medical device (catheter) and the provided documentation focuses on its physical and biological performance, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This document is about a physical medical device (catheter), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- International Standards: Adherence to various ISO and ASTM standards (e.g., ISO 10555-1, ISO 10555-5, ISO 9626, ISO 7864, ISO 80369, ASTM F640, ANSI/AAMI HE75, ISO 23908).
- FDA Guidance Documents: Compliance with specific FDA guidance.
- Internal Requirements: Company-defined performance specifications.
- Biocompatibility Standards: Adherence to ISO 10993 series and USP for particulate matter.
- Predicate Device Comparison: Performance is often benchmarked against the "PowerGlide Pro™ Midline Catheter" (K162377) to demonstrate substantial equivalence, particularly in terms of flow rates and other functional characteristics.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a training set as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set involved. The evaluation is based on direct physical and biological testing of the device itself.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).