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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 |
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(248 days)
The Arterial Pressure Monitoring Set Tray is intended for arterial blood pressure monitoring and blood sampling in adult and pediatric patients.
- 5.0 French catheters are intended for patients aged 12 years and older
The Arterial Pressure Monitoring Set/Tray consists of a pressure monitoring catheter, wire guide, access needle, and syringe. The catheter is inserted into the vasculature using the Seldinger technique. The subject device is sterilized by ethylene oxide and intended for one-time use.
The subject device catheter is a single lumen intravascular catheter manufactured from nylon tubing and is designed with a pre-molded proximal winged hub. The catheter is 5.0 French with a length of 15 centimeters and has an endhole diameter of 0.035 inches. Additionally, the catheter is manufactured with one-centimeter incremental ink markings along the shaft. The wire guide is manufactured from stainless steel, has an outer diameter of 0.035 inches, and a length of 50 centimeters. The access needle is manufactured from stainless steel. Additional set configurations may contain convenience accessories, including lidocaine, PVP ointment, silk suture, Monoject needles, thumb scalpel, gauze, drapes, a filter straw, and ChloraPrep antiseptic.
The provided document is a 510(k) premarket notification for a medical device (Arterial Pressure Monitoring Set/Tray). It focuses on demonstrating substantial equivalence to a predicate device through comparison of features and performance testing.
Crucially, this document does NOT describe the acceptance criteria or studies for an AI/ML-driven device. The device in question is a physical catheter set, not a software algorithm. Therefore, the questions related to AI/ML device performance (like expert readers, MRMC studies, ground truth establishment for training/test sets, etc.) are not applicable to this submission.
The document discusses physical performance testing for the catheter. I will extract the details that are relevant to physical device testing rather than AI/ML performance, as per the document's content.
Here's the breakdown based on the provided text, addressing the applicable points:
Acceptance Criteria and Study for Arterial Pressure Monitoring Set/Tray (Physical Device)
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Triteria | Reported Device Performance |
|---|---|---|
| Catheter Shaft Tensile (Aged) | Peak tensile load for shaft section ≥ 10 N (in accordance with BS EN ISO 10555-1:2013) | The acceptance criterion was met. |
| Catheter Hub-to-Shaft Tensile (Aged) | Peak tensile load for hub-to-shaft section ≥ 10 N (in accordance with BS EN ISO 10555-1:2013) | The acceptance criterion was met. |
| Catheter Liquid Leakage (Aged) | No part of the catheter shall leak liquid (when tested in accordance with Annex C of BS EN ISO 10555-1) | The acceptance criterion was met. |
| Catheter Air Leakage (Aged) | No air shall enter the hub (when tested in accordance with Annex D of BS EN ISO 10555-1) | The acceptance criterion was met. |
| Catheter Kink Length (Aged) | Catheter shall not kink (flowrate reduced by 50%) at a specified kink (circumferential) length (in accordance with Annex B of BS EN 13868) | The acceptance criterion was met. |
| Catheter Gravity Flow Rate (Time-Zero) | Flow rate shall be a minimum of 90% of the flow rate stated by the manufacturer (in accordance with Annex E of BS EN ISO 10555-1) | The acceptance criterion was met. |
| Visual Inspection & Dimensional Analysis | Catheter dimensions are within specified tolerances and catheter and wire guide are compatible. | Test was conducted to demonstrate criteria met. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of units/samples used for each performance test (e.g., how many catheters were subjected to tensile testing). It only states that the device "was subjected to applicable testing."
- Data Provenance: Not specified in terms of country of origin. The tests are described as "Performance Testing" and "Biocompatibility Testing" conducted by the manufacturer, Cook Incorporated. The context suggests these are internal validation tests. The tests are prospective in the sense that they were designed and performed to validate the new device design.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of "ground truth" established by human experts in the context of the physical performance tests described (e.g., tensile strength, leakage, flow rate). These are objective engineering measurements.
4. Adjudication Method for the Test Set
- Not Applicable. As this is a physical device subject to objective engineering tests, there is no need for adjudication by multiple experts. The success or failure of a test is based on measurable criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study is relevant to imaging diagnostics or AI-assisted interpretation, which is not the nature of this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
- Objective Measurement/Standard Compliance: For the performance tests, the "ground truth" is adherence to predefined engineering specifications and compliance with relevant ISO/BS EN standards. For biocompatibility, the "ground truth" is demonstration of non-toxicity as per ISO 10993-1 and FDA guidance.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical device, not a machine learning model. There is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As no training set exists for this type of device.
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