Search Results
Found 1 results
510(k) Data Aggregation
(180 days)
SnapLock Catheter/Syringe Adapter is intended to be used in conjunction with 19 and 20 Ga. Arrow Pain Management Catheters to facilitate access to the catheter so that an infusion device may be used. Please refer to applicable Arrow Pain Manager Catheter IFU for complete catheter instructions for use.
The Arrow Epidural Catheter permits access to the administration of epidural anesthetic. The epidural catheter is intended for use up to 72 hours.
The Arrow FlexBlock Continuous Peripheral Nerve Block Kit Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.
The Arrow SnapLock Catheter Adapter serves as the connecting link between the anesthesia catheter and an infusion device. The adapters facilitate delivery of the desired substance through the adapter-catheter system, into the patient.
Arrow markets two versions of the SnapLock Adapter. The non-stimulating version is used with epidural and peripheral nerve block catheters and the stimulating version includes an integral electrical connector or tab for use with stimulating Peripheral Nerve Block catheters. Both versions of the adapters are included as accessories in their respective kits. The non-stimulating version is also available separately as a replacement component.
The provided text is a 510(k) summary for the Arrow SnapLock Catheter Adapter. It describes the device, its intended use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. The document outlines performance testing for the new device to show it meets specific "acceptance criteria." However, it is not a study that proves a device meets acceptance criteria in the context of medical AI/imaging devices, which typically involves clinical studies with human readers, ground truth establishment, and statistical analysis of performance metrics like sensitivity, specificity, AUC, etc.
The acceptance criteria and performance data described here are for mechanical and material properties of a medical device (a catheter adapter), not for an AI/imaging diagnostic device. Therefore, many of the requested points in the prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this document's content.
Here's an interpretation based on the provided document, addressing the applicable points:
Device: Arrow SnapLock Catheter Adapter (a non-AI medical device; specifically, an adapter for pain management and nerve block catheters)
Purpose of the Study (as described in the document): To demonstrate substantial equivalence to predicate devices through performance testing related to mechanical properties, material biocompatibility, and functional aspects.
1. A table of acceptance criteria and the reported device performance
The document provides tables for Biocompatibility Testing and Performance Testing with their respective acceptance criteria and results.
Table 1: Biocompatibility Testing Acceptance Criteria and Results
| Test | Acceptance Criteria | Results |
|---|---|---|
| Cytotoxicity - L929 MEM Elution Assay | Grade of 0, 1, or 2 (not more than 50% of cells round, devoid of intracytoplasmic granules, no extensive cell lysis) | Acceptable |
| Sensitization - Kligman Maximization Assay | Non-irritant if difference between test article mean score and vehicle control mean score is 1.0 or less. | Acceptable |
| Irritation - Intracutaneous Injection Assay | Grade of 1, 0 or less using the Kligman scoring system. | Acceptable |
| Acute Systemic Toxicity - Systemic Injection Test | Does not induce a significantly greater biological reaction than the control. | Acceptable |
| Acute Systemic Toxicity - Material Mediated Test | No rabbit shows an individual rise in temperature of 0.5°C or more above baseline temperature. | Acceptable |
| Hemocompatibility - Rabbit Blood Hemolysis (Complete) ASTM Test | Hemolytic index above negative control article and negative control article extract is <5%. | Acceptable |
| Genotoxicity - Mouse Lymphoma Mutagenesis Assay | IMF is less than the Global Evaluation Factor (GEF) 128 X 10-6. | Acceptable |
| Genotoxicity - Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay with Confirmation – ISO | Not a positive response if at least one strain does not exhibit a reproducible and statistically significant increase (p<0.05) and a two-fold (for TA98, TA100, and WP2 strains) or three-fold (for TA1535 and TA1537 strains) increase in numbers of mutants over its concurrent negative control. | Acceptable |
| Subacute Systemic Toxicity | Animals treated with test article show similar biological reactivity (clinical observations, body weights, morbidity/moribundity, gross/histopathological evaluation) to control article. | Acceptable |
Table 2: Performance Testing Acceptance Criteria and Results
| Test | Acceptance Criteria | Results |
|---|---|---|
| Closing Force – SnapLock Adapter to Catheter body | Non-Next Gen: No greater than 17lb force (75N) to close with 19Ga or 20Ga catheter. Next Gen: No greater than 12lb force (53.8N) to close with 19Ga or 20Ga catheter. | Pass |
| Opening Force – SnapLock Adapter to Catheter Body | Not possible to open without retaining tab failure; minimum 10lb force (44.48N) required for tab to fail. | Pass |
| Component Compatibility/Interaction | Allow easy insertion of mating catheter. | Pass |
| Tensile Force – SnapLock Adapter to Catheter Body | ≥ 5N (1.12lbf) at failure. | Pass |
| Leakage – SnapLock adapter to catheter body | No leak when pressurized to 25 psi (172 kPa) for 30 seconds in a closed system. | Pass |
| Occlusion – SnapLock Adapter to Catheter Body | Shall not occlude the catheter when locked in mating position. | Pass |
| Spontaneous Partial Opening Test | Must remain closed, with retaining tab in place for 72 hours after full closure over mating catheter. | Pass |
| Flow Rate – Continuous Flow SnapLock | Minimum 60mL/hour (1mL/min) when tested by deionized or distilled water under 69 kPa (10psi). | Pass |
| Flow Rate - Single Shot or Bolus | Minimum 3.47 mL/min with 20mL syringe using deionized or distilled water. | Pass |
| Aspiration | Fluid presence visually verified when deionized or distilled water drawn through adapter. | Pass |
| Leakage, Maximum Duration at Continuous Pressure | No leak over 72 hours when continuous pressure is 1 psi in occluded setup. | Pass |
| Weld Force | Minimum 20lb force (88.96N) for weld joint between catheter insertion component and female housing to fail. | Pass |
| Conical Fittings | Luer version: Comply with applicable sections of BS 6196. Neuraxial version: Meet requirements of AAMI/CN6:2016 (ISO 80369-6). | Pass |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as a number of devices (e.g., "N=XX devices"). The document generally states "All samples passed the established acceptance criteria" for performance tests. For biocompatibility, it refers to standard biological response tests on test articles (extracts of the device material, or the material itself) using in vitro (cell cultures) and in vivo (animal models like mice, rabbits) setups. The number of animals or specific replicates would be in the detailed test reports, not typically summarized in a 510(k).
- Data Provenance: Not applicable in the context of clinical data. This is laboratory-based performance and biocompatibility testing of a physical device.
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)
- Not Applicable. This is not an AI/imaging device requiring expert human interpretations for ground truth. Ground truth for these mechanical and material tests is established by objective physical measurements (e.g., force, flow rate, pressure, visual inspection for leakage/occlusion, and standardized lab test results according to ISO and ASTM standards), not by human expert consensus or clinical diagnosis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No human adjudication process is described or implied, as the "ground truth" is derived from objective physical and biological test methods.
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, not applicable. This is not an AI-assisted diagnostic device, so MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm. The "standalone performance" here refers to the physical device's performance measured against engineering and biocompatibility standards. The tables provided (Biocompatibility and Performance Testing) are essentially the "standalone performance" evaluation for this physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" is based on objective physical and chemical/biological measurements against predefined engineering and biocompatibility standards (e.g., ISO 10993, BS 6196, AAMI/CN6:2016). For example, "tensile force" is measured by a machine, "leakage" is observed against a pressure standard, and "cytotoxicity" is assessed by a laboratory assay against defined cell viability criteria.
8. The sample size for the training set
- Not Applicable. This is not a device that uses machine learning, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for machine learning, the question of its ground truth establishment is irrelevant.
Ask a specific question about this device
Page 1 of 1