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510(k) Data Aggregation
(261 days)
The Arterial Pressure Monitoring Set/Tray is intended for arterial blood pressure monitoring and blood sampling in adult and pediatric patients.
- 2.5 French catheters are intended for patients from birth and older
- 3.0 and 4.0 French catheters are intended for patients 1 year and older
The Arterial Pressure Monitoring Set/Tray is comprised of a pressure monitoring catheter, wire guide, entry access needle, and syringe. Certain sets are also available with a dilator and/or other convenience components. The catheter is manufactured from polyurethane, ethylene-vinyl acetate, or polyethylene tubing and is designed with a pre-molded winged hub. Catheters are manufactured 2.5, 3.0, and 4.0 French in size with endhole diameters of 0.015, 0.018, and 0.021 inches, respectively. The wire guide is manufactured from stainless steel coils, a safety wire, a mandril wire, and All-State solder. The access needle is manufactured from stainless steel. The dilator is manufactured from polyethylene and has a pre-molded proximal hub. Other convenience accessories include syringes, lidocaine solution, PVP ointment, antiseptic, Monoject needles, a scalpel, gauze, drapes, and needle holders. The Arterial Pressure Monitoring Set/Tray is sterilized by ethylene oxide and intended for one-time use.
This document describes the performance testing of the Arterial Pressure Monitoring Set/Tray to demonstrate its substantial equivalence to a predicate device. It does not describe a study involving an AI/algorithmic device or human readers. Therefore, several of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from the provided text.
1. Table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Catheter Shaft Tensile (Time Zero and Aged) | Peak tensile load for shaft section: ≥ 5 N for 2.5 and 3.0 Fr catheters; ≥ 10 N for 4.0 and 5.0 Fr catheters (in accordance with BS EN ISO 10555-1:2013). | Acceptance criteria were met. |
| Catheter Hub-to-Shaft Tensile (Time Zero and Aged) | Peak tensile load for hub-to-shaft section: ≥ 5 N for 2.5 and 3.0 Fr catheters; ≥ 10 N for 4.0 and 5.0 Fr catheters (in accordance with BS EN ISO 10555-1:2013). | Acceptance criteria were met. |
| Catheter Liquid Leakage (Time Zero and Aged) | No part of the catheter shall leak liquid (in accordance with Annex C of BS EN ISO 10555-1). | Acceptance criterion was met. |
| Catheter Air Leakage (Time Zero and Aged) | No air shall enter the hub (in accordance with Annex D of BS EN ISO 10555-1). | Acceptance criterion was met. |
| Catheter Kink Length (Time Zero and Aged) | The catheter shall not kink (flowrate reduced by 50%) at a specified kink (circumferential) length (in accordance with Annex B of BS EN 13868). | Acceptance criterion was met. |
| Catheter Flow Rate (Time-Zero) | Minimum of 90% of the flow rate stated by the manufacturer (in accordance with Annex E of BS EN ISO 10555-1). | Acceptance criterion was met. |
| Visual Inspection, Dimensional Verification, Compatibility (Time-Zero, Aged) | Catheter dimensions are within specified tolerances, and the catheter and wire guide are compatible. | Test was conducted. |
| Wire Guide Corrosion (Time-Zero) | No evidence of corrosion that could affect functional performance (in accordance with Annex B of BS EN ISO 11070:2014). | Acceptance criterion was met. |
| Wire Guide Fracture (Time-Zero) | The wire guide shall not fracture when wound around an appropriate former (in accordance with Annex F of BS EN ISO 11070). | Acceptance criterion was met. |
| Wire Guide Flex (Time-Zero) | No signs of defects or damage, including flaking or material loss (in accordance with Annex G of BS EN ISO 11070). | Acceptance criterion was met. |
| Wire Guide Tensile (Time-Zero) | Peak tensile load to failure: ≥ 5 N for O.D. ≥ 0.55 mm and < 0.75 mm; ≥ 10 N for O.D. ≥ 0.75 mm (in accordance with Annex H of BS EN ISO 11070). | Acceptance criterion was met. |
| Dilator Hub-to-Shaft Tensile (Time Zero and Aged) | Peak tensile load for hub-to-shaft section: ≥ 5 N for 3.0 Fr dilators; ≥ 10 N for 3.5, 4.0, 5.0, and 5.5 Fr dilators (in accordance with BS EN ISO 11070). | Acceptance criterion was met. |
| Biocompatibility | Cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity, implantation, and hemocompatibility testing performed per ISO 10993-1 and FDA guidance. | Testing was performed. |
| Sterilization Testing (EO/ECH Residuals) | Residual levels of ethylene oxide (EO) and ethylene chlorohydrin (ECH) no greater than maximum limits specified in ANSI/AAMI/ISO 10993-7:2008(R)2012. | Evaluated and verified. |
| Packaging Visual Inspection (simulated distribution) | No package shall display damage that will compromise sterility of its contents. | Acceptance criterion was met. |
| Packaging Destructive Inspection (simulated distribution) | Components inside the package shall show no signs of damage that would interfere with the performance of the product. | Acceptance criterion was met. |
| Packaging Bubble Test (simulated distribution) | No signs of pin holes or imperfect seals indicated by bubbles created from pressurized air leaking into the surrounding solution. | Acceptance criterion was met. |
| Packaging Seal Strength Test | Seal strength shall not be less than 1.2 N per 15 mm (0.46 lbf/in). Mean seal force - 3σ shall meet or exceed 0.50 lbf/in (per EN 868-5:1999). | Acceptance criterion was met. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This is a testing report for a medical device and does not involve AI or algorithmic analysis of a test set with data provenance. The tests are bench tests performed on physical device samples.
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.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for this device's performance is based on established engineering standards (e.g., ISO, EN standards) for material properties (tensile strength, leakage, kink resistance, corrosion, fracture, flex, etc.) and direct physical testing against those standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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