(150 days)
The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
The TruWave Disposable Pressure Transducer is a sterile, single-use device that is used to monitor intravascular, intracranial, and intrauterine pressures. The pressure transducer has a straight, flow-through design across the pressure sensor, and is available with or without the integral flush device. The pressure sensor is a pressure sensitive silicon chip with two electrodes for excitation voltage and two electrodes for signal output. A transparent fluid path with an integral stopcock at one end and an integral flush device (either 3mL or 30mL) at the other end encloses the sensor. The enclosure of the TruWave Disposable Pressure Transducer has a pathway for air to enter the housing and acts as a vent. A disposable cable (available in 10-inch/25 cm and 48-inch/120 cm lengths) attached to the pressure transducer housing interfaces with an Edwards Lifesciences reusable cable that is specifically wired for the monitor being used. The TruWave Disposable Pressure Transducer can be mounted on the patient's arm using an arm strap or it may be mounted on an IV pole in a holder. The TruWave Disposable Pressure Transducer may be a component in various pressure monitoring kits or systems.
The provided text describes a 510(k) premarket notification for a medical device, the TruWave Disposable Pressure Transducer. The information primarily focuses on demonstrating substantial equivalence to a predicate device through various non-clinical tests.
However, the question asks for details related to acceptance criteria, device performance, and study information that would typically be found in a clinical study report or a more detailed performance study. The provided document does not contain a table of acceptance criteria with reported device performance metrics in a quantitative sense, nor does it detail a clinical study with human patients, ground truth establishment by experts, or MRMC studies.
Instead, the document states: "All device acceptance criteria were met. Results of non-clinical testing show that the subject device TruWave Disposable Pressure Transducer meets its intended use and demonstrate that the device is as safe, as effective, and performs as well as the predicate device." It then lists types of non-clinical testing performed.
Therefore,Based on the provided text, the following information can be extracted regarding acceptance criteria and the study:
1. A table of acceptance criteria and the reported device performance:
The document states "All device acceptance criteria were met" and that the non-clinical testing demonstrated the device "meets its intended use and demonstrate that the device is as safe, as effective, and performs as well as the predicate device." However, a specific table outlining quantitative acceptance criteria and their corresponding reported device performance values is not provided in the excerpt. The text mentions several types of testing performed to demonstrate equivalence and safety/effectiveness.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993-1:2018) | Compliance demonstrated. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1, IEC 60601-2-37, and IEC 60601-1-2 standards. |
| Electromagnetic Immunity (EMI) | Complies with IEC 60601-1, IEC 60601-2-37, and IEC 60601-1-2 standards. |
| Electrical Safety (ANSI/AAMI BP22:1994, IEC 60601-2-34:2011) | Defibrillator challenge, dielectric strength, liquid ingress, and leakage current tests performed and met. |
| Device Performance (ANSI/AAMI BP22:1994, IEC 60601-2-34:2011) | Accuracy, excitation/signal impedance, light sensitivity, symmetry, and overpressure tests conducted and met. |
| Magnetic Resonance (MR) Safety (ASTM F2503-20) | Performed and met standards. |
| Mechanical Testing (ANSI/AAMI BP22:1994, Edwards' design requirements) | Performed and met requirements. |
| Usability/Human Factors | Evaluated by healthcare provider users. Output implied to be satisfactory as acceptance criteria were met. |
2. Sample size(s) used for the test set and the data provenance:
The document refers to "non-clinical testing" and does not specify sample sizes in terms of number of devices or data points for each test category. No information on data provenance (e.g., country of origin, retrospective or prospective) is provided, as these are non-clinical (laboratory/bench) tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The testing described is non-clinical performance and safety testing against established standards, not a clinical study requiring expert consensus for ground truth. The "usability/human factors" evaluation was performed by "healthcare provider users," but without details on the number or specific qualifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and not provided, as it pertains to clinical studies with expert reviewers and not the non-clinical testing described.
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:
This information is not applicable and not provided. The device is a physical pressure transducer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided, as the device is a physical pressure transducer, not an algorithm.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" relates to compliance with established international and national standards (e.g., ISO 10993-1, IEC 60601 series, ANSI/AAMI BP22, ASTM F2503) and the manufacturer's internal design requirements. This is based on standardized measurement and testing protocols, not expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set:
This information is not applicable and not provided. The described tests are for device verification and validation, not for training a model or algorithm.
9. How the ground truth for the training set was established:
This information is not applicable and not provided, as there is no "training set" in the context of the reported non-clinical device testing.
§ 870.2870 Catheter tip pressure transducer.
(a)
Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.(b)
Classification. Class II (performance standards).