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510(k) Data Aggregation
(246 days)
The Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. It is not intended for use in coronary arteries.
The subject Neurovascular Access System Family consists of sterile, single-use catheters and accessories that are used together to facilitate the insertion and guidance of an appropriately sized interventional device into a selected vessel in the peripheral and neurovasculature. The Neurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, Peel Away Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths to accommodate physician preferences and anatomical variations. The distal end of the catheter is coated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distal tip that is visible under fluoroscopy.
This document is a 510(k) Summary for a medical device called the "Neurovascular Access System Family." It details the device's characteristics, intended use, and compares it to legally marketed predicate devices to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Name | Objective | Test Method / Standard or Guidance | Acceptance Criteria (Implied by "Pass") | Reported Device Performance |
|---|---|---|---|---|
| Visual Surface Requirements | To demonstrate that the device meets the visual surface requirements. | ISO 10555-1 2013, Section 4.4 | Device meets visual surface requirements. | Pass |
| Dimensional Verification | To demonstrate that the device meets the dimensional requirements. | ISO 10555-1 2013, Section 4.5 | Device meets dimensional requirements. | Pass |
| Liquid Leakage Under Pressure | To demonstrate that the device passes the liquid leakage under pressure test. | ISO 10555-1 2013, Section 4.7.1, Annex C | Device passes liquid leakage test. | Pass |
| Hub Aspiration Air Leakage | To demonstrate that the device passes the hub aspiration air leakage test. | ISO 10555-1 2013, Section 4.7.2, Annex D | Device passes hub aspiration test. | Pass |
| Simulated Use and Usability | To demonstrate that the device passes testing specified in the simulated use test protocol. Simulated use testing includes usability assessment with multiple physicians. | FDA guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions", April 2023 | Device passes simulated use and usability protocols. | Pass |
| Flex Fatigue | To demonstrate that the device passes the flex fatigue test. | FDA guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions", April 2023 | Device passes flex fatigue test. | Pass |
| Torque Test | To demonstrate the torque strength of the device. | FDA guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" April 2023 | Device demonstrates adequate torque strength. | Pass |
| Tip Deflection | To demonstrate that the tip deflection is comparable to the predicate device. | FDA Guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" April 2023 | Tip deflection is comparable to predicate. | Pass |
| Device Removal Forces | To demonstrate that the removal forces are comparable to the predicate device. | FDA Guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" April 2023 | Removal forces are comparable to predicate. | Pass |
| Peak Tensile Strength Testing | To demonstrate that the device passes the peak tensile strength testing including all bonds and joints. | ISO 10555-1 2013, Section 4.6, Annex B | Device passes peak tensile strength testing. | Pass |
| Flow Rate | To demonstrate that the flow rate is comparable to the predicate device. | ISO 10555-1 2013: Section 4.9 | Flow rate is comparable to predicate. | Pass |
| Corrosion Resistance | To demonstrate that the device has no visual evidence of corrosion. | ISO 10555-1 2013, Section 4.5, Annex A | No visual evidence of corrosion. | Pass |
| Radiopacity | To demonstrate that the distal marker band is clearly visible under typical fluoroscopic imaging conditions. | ISO 10555-1 2013, Section 4.2; ASTM F640-12 | Distal marker band is clearly visible. | Pass |
| Kink Resistance | To demonstrate that shaft kink resistance is comparable to the predicate device and clinically relevant for the intended anatomical locations for use. | FDA Guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" | Shaft kink resistance is comparable to predicate and clinically relevant. | Pass |
| Particulates and Coating Integrity | To demonstrate the quantity and size of particles generated during simulated use are comparable to the predicates and reference devices. | FDA Guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" | Particulates and coating integrity are comparable to predicates. | Pass |
| Dynamic Burst | To demonstrate that the device withstands dynamic burst strength. | ISO 10555-1 2103, Annex G | Device withstands dynamic burst strength. | Pass |
| Static Burst | To demonstrate that the device passes static burst pressure as specified in the test protocol. | ISO 10555-1 2013, Section F | Device passes static burst pressure. | Pass |
| Shelf Life | Repeated bench tests after accelerated aging to demonstrate that the device performance is maintained over the proposed shelf-life (6 months). | ASTM D4332-22, ASTM D4169-22, ASTM F1980-21, ASTM F1886 / F1866M-16, ASTM 2096-11 (2019), ASTM F88/F88M:21 | Device performance maintained over 6-month shelf-life. | Pass |
Biocompatibility Tests:
| Test Name | Objective (Implied) | Test Method / Standard or Guidance | Acceptance Criteria (Implied by "Results") | Reported Device Performance |
|---|---|---|---|---|
| Cytotoxicity | Assess cell toxicity. | ISO 10993-5 | No reactivity observed. | Non-cytotoxic |
| Sensitization | Assess potential for allergic reactions. | ISO10993-10 | No evidence of delayed dermal contact sensitization. | Non-sensitizing |
| Intracutaneous Reactivity | Assess localized irritation. | ISO 10993-23 | Scores from test article extracts were acceptable (<1.0 for sesame seed oil). | Non-irritant |
| Acute Systemic Toxicity | Assess systemic toxic effects. | ISO 10993-11 | No mortality or evidence of systemic toxicity. | Non-toxic |
| Material Mediated Pyrogenicity | Assess fever-inducing substances. | ISO 10993-11 | No rabbit temperature rise ≥ 0.5 °C. | Non-pyrogenic |
| Hemolysis - Direct Contact and Extract Method | Assess red blood cell damage. | ISO 10993-4 | Mean blank corrected % hemolysis < 2%. | Non-hemolytic |
| Complement Activation | Assess immune system activation. | ISO 10993-4 | Results within acceptable range compared to controls. | Not a Sc5b-9 complement activator |
| Thrombogenicity | Assess potential for blood clot formation. | ISO 10993-4 | No adverse effects/clinical signs, no thrombus score ≥ 2, similar to comparator/negative controls in PTT and platelet/leukocyte counts. | Non-thrombogenic |
Sterility Testing:
| Test Name | Objective (Implied) | Test Method / Standard or Guidance | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| Sterilization Validation | Ensure device is sterile. | ISO 11135:2014 | Sterility Assurance Level (SAL) of 1x10⁻⁶ achieved. | Pass |
| EO and ECH Residuals | Ensure residuals are below toxic levels. | ISO 10993-7:2008 | Residuals below specified limits. | Pass |
| Bacterial Endotoxin Levels | Ensure endotoxin levels are safe. | FDA's sterility guidance | Levels below 2.15 EU/device. | Pass |
| Shelf-Life (Sterility) | Maintain sterility over proposed shelf-life. | (Implicitly part of validation) | Sterility maintained over 6 months. | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists "Performance Data" in Section VII and "Biocompatibility" in Section VIII.
- Performance Data: The specific sample sizes for each performance test (e.g., visual, dimensional, burst, fatigue) are not explicitly stated in this summary table. The document only indicates "Pass" for each test. The methods refer to ISO standards and FDA guidance documents, which typically define appropriate sample sizes for such tests.
- Biocompatibility Data: Similarly, the sample sizes for the various biocompatibility tests (e.g., number of cells, animals for in vivo tests) are not explicitly stated.
- Data Provenance: The document does not provide information on the country of origin of the data or whether the studies were retrospective or prospective. These are typically bench and laboratory tests performed by the manufacturer or contract labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- For the "Simulated Use and Usability" test, the objective states an "usability assessment with multiple physicians." The exact number of physicians and their specific qualifications are not provided in this summary.
- For all other tests, ground truth is established by objective measurements against specified standards (ISO, ASTM, FDA guidance), rather than expert consensus on images or outcomes. Therefore, "experts" in the sense of clinical reviewers establishing ground truth for diagnostic accuracy are not applicable here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device is an access catheter, and the performance criteria are based on engineering, mechanical, and biological testing, not on interpretation of clinical data requiring adjudication by experts.
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), not an AI diagnostic algorithm. Therefore, MRMC studies and the concept of human readers improving with AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (catheter), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device's performance testing is based on:
- Established Industry Standards: ISO 10555-1, ISO 10993 series, ASTM standards.
- FDA Guidance Documents: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions."
- Objective Measurements: Such as dimensional measurements, pressure thresholds, tensile strength, flow rates, visual inspection for corrosion or particulates, and biological responses in biocompatibility tests.
- Simulated Use: Involving usability assessment (implied to be clinical feedback from physicians during simulated use).
Essentially, the ground truth is adherence to predefined physical, chemical, mechanical, and biological specifications and performance metrics.
8. The sample size for the training set
Not applicable. This is a medical device, not a machine learning model that requires training data.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of medical device submission.
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