Search Results
Found 1 results
510(k) Data Aggregation
(94 days)
BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX
The BSI BIOTRANS Pressure Monitoring Kits are designed for use with BIOTRANS Sensor Bases. Kits containing integral 3- and 40 cc/hr flush device are designed for use in physiologic pressure measurements where continuous flow is required to maintain catheter patency. The 40 cchr flush devices are included in Kits designed for neonatal applications in conjunction with a properly calibrated fluid delivery purnp.
The BIOTRANS Pressure Monitoring Systems consist of the sterile, single-use BIOTRANS Pressure Monitoring Kits and reusable BIOTRANS Reusable Sensor Bases and Monitor Adapter Cables. The single-use BIOTRANS Pressure Monitoring Kits provide the sterile fluid pathway components that deliver IV solution to maintain catheter patency via the administration set components. transducer dome assembly and extension set, and convey the hemodynamic waveform from the patient's catheter to the reusable sensor (provided separately). The pressure waveform is conveyed to the sensor via two compliant diaphragms which are brought into intimate contact during set up of the device by the end-user. All fluid contact occurs within the sterile single-use kit components.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meet American National Standard for Blood Pressure Transducers (ANSI/AAMI BP22-1994) performance and safety requirements. | The BIOTRANS domes, when affixed to the BIOTRANS reusable sensor bases, meet American National Standard for Blood Pressure Transducers (ANSI/AAMI BP22-1994) performance and safety requirements. After exposure to pressures up to 4000 mm Hg, as required, BIOTRANS sensors meet accuracy and safety requirements, indicating adequate protection from overpressure. |
| Meet FDA and ISO biocompatibility requirements (ISO-10993-1 and G95-1). | All dome assembly materials meet the FDA and ISO biocompatibility requirements listed in ISO-10993-1 and G95-1. All other materials are either currently employed in legally marketed products with identical blood exposure, or are used in the fabrication of devices with a long history of safe and effective use for identical applications. |
| Meet tensile and leak test requirements listed in International Standard ISO 8536-4 Infusion equipment for medical use- Part 4: Infusion sets for single use. | All bonded joints meet tensile and leak test requirements listed in International Standard ISO 8536-4 Infusion equipment for medical use- Part 4: Infusion sets for single use. |
| History of complaints for administration sets (comparable to those marketed in US). | BSI's administration sets have been marketed in Asia and Europe for over 5 years with no history of complaints. They are of identical design to administration sets currently marketed in the US. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for testing each individual criterion (e.g., number of domes tested for pressure performance, number of materials tested for biocompatibility, number of bonded joints tested for tensile/leak).
- Provenance: The document implies that parts of the testing were conducted to meet US (ANSI/AAMI) and international (ISO) standards. The administration sets' performance history is cited for "Asia and Europe." The testing appears to be retrospective in the sense that it evaluates the manufactured device against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The performance data is based on engineering testing against established performance and safety standards (ANSI/AAMI, ISO) for medical devices, rather than expert interpretation of a test set.
4. Adjudication Method for the Test Set:
Not applicable. The evaluation is based on meeting predefined technical specifications and standards, not on expert consensus or adjudication of interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes a technical evaluation of the device's performance against established industry standards.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done:
Yes, the study describes a standalone evaluation of the device's physical and functional performance (e.g., meeting pressure requirements, biocompatibility, leak tests) without human interaction influencing the core performance metrics.
7. The Type of Ground Truth Used:
The ground truth used consists of established performance and safety standards for medical devices, specifically:
- American National Standard for Blood Pressure Transducers (ANSI/AAMI BP22-1994)
- FDA and ISO biocompatibility requirements (ISO-10993-1 and G95-1)
- International Standard ISO 8536-4 Infusion equipment for medical use- Part 4: Infusion sets for single use.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical monitoring kit, not an AI/algorithm-based device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1