(60 days)
The BSI BIOTRANS is used to convert hemodynamic pressure waveforms into electrical signals which can be displayed using separate monitoring equipment. As such, its Indications for Use are identical to those for Medex's MX 860 and MX 960. BIOTRANS cables are used to make an electrical connection between the sensor and monitor. Their use is identical to that of cables manufactured by Utah Medical Products, Inc.
The BSI BIOTRANS Sensor Base is used to convert hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals which can be displayed using separate monitoring equipment.
The BIOTRANS Pressure Monitoring System consists of the sterile, single-use BIOTRANS Pressure Monitoring Kit (subject of a separate 510k) and BIOTRANS Reusable Sensor Base and Monitor Adapter Cables. The Base consists of a rugged silicon-based piezoresistive pressure sensor mounted on a rigid plastic support. A standard Wheatstone Bridge circuit etched into the sensor is used to detect pressure changes applied to the sensor and convert them to electronic signals for display on standard monitoring equipment.
The sensor is electrically isolated from the patient by a dielectric gel and two elastomeric diaphragms. The physiologic pressure waveform is conveyed from the patient catheter via a fluid-filled pathway to the single-use dome diaphragm. The dome diaphragm is mechanically coupled to the reusable pressure sensor diaphragm for pressure monitoring. The diaphragms make intimate contact during use permitting transfer of the pressure waveform to the transducer, with fluid contact occurring on the patient side of the disposable dome diaphragm. A 25 cm (10") Sensor cable permanently wired to the sensor transmits the electronic signal from the transducer to the patient monitor via the appropriate Monitor Adapter Cable.
The integral Sensor cables terminate in 5 different electrical adapters compatible with 5 common brands of Monitor Cables (Utah Medical, Baxter International, Medex, Abbott, and Ohmeda.) Monitor Adapter Cables designed for specific use with all major monitor suppliers are available from BSI.
The Base features built-in organizer/mounting systems compatible with standard manifold clamps for pole-mount applications.
Here's a breakdown of the acceptance criteria and the study details for the BSI BIOTRANS™ Reusable Sensor Base:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Standard) | Reported Device Performance |
|---|---|
| American National Standard for Blood Pressure Transducers, ANSI/AAMI BP22-1994 compliance | "BSI's BIOTRANS meets, or exceeds, the performance requirements indicated in the American Standard for Blood Pressure Transducers, ANSI/AAMI BP22-1994." |
| "The snap fit configuration meets all electrical requirements listed in the ANSI/AAMI BP22-1994 standard." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for a "test set" in the context of human subjects or cases. The performance evaluation appears to be based on meeting the requirements of the ANSI/AAMI BP22-1994 standard. The data provenance is not specified beyond this.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The performance is assessed against a technical standard (ANSI/AAMI BP22-1994), not against expert interpretations of cases.
4. Adjudication Method for the Test Set
Not applicable. There's no mention of an adjudication process for a test set, as the evaluation is based on compliance with a technical standard.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study was not done. The device is a physical transducer, and the evaluation focuses on its technical performance against a standard, not human interpretational accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The evaluation provided focuses on the device's inherent technical performance (e.g., electrical requirements, conversion of pressure waveforms) in a standalone capacity, without human intervention in its core function as a transducer.
7. The Type of Ground Truth Used
The "ground truth" for the device's acceptance is based on adherence to the American National Standard for Blood Pressure Transducers, ANSI/AAMI BP22-1994. This is a technical standard that defines performance requirements for such devices.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware component (pressure transducer), not an AI/machine learning algorithm. Therefore, there is no "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this hardware device.
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).