(87 days)
The HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System is a hemodynamic pressure monitoring and blood sampling system designed to allow easy withdrawal of blood samples from an arterial or central venous pressure monitoring line while maintaining a completely closed system.
The HemoDraw® Plus Closed Blood Sampling Set with TranStar® Pressure Monitoring System is a hemodynamic pressure monitoring and blood sampling system designed to allow easy withdrawal of blood samples from an arterial or central venous pressure monitoring line while maintaining a completely closed system.
The HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System is a closed blood Sampling System designed to allow easy and safe withdrawal of blood samples from an arterial and central venous invasive pressure monitoring line. The LogiCal® Pressure Transducer mounting plate is intended for uses with the HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System. The LogiCal® monitoring set provides isolation between the fluid path connection to the patient and the transducer diaphragm. This set includes a flush device that is intended for use in invasive blood pressure measurements that require continuous flow to maintain catheter patency. The flush device provides a controlled and constant fluid infusion at a rate determined by the patient's blood pressure and the fluid source pressure. With a total fluid source pressure equal to 300mmHg, the flush device delivers an average flow rate of 3ml/hour. The device is supplied with a vented cap on the zeroing stopcock; this vented cap will allow air and saline to pass through and therefore can be kept in place when priming. To prevent the introduction of air into the system; after priming the vented cap should be replaced with a nonvented cap. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.
The HemoDraw® Plus Closed Blood Sampling Set with TranStar® Pressure Monitoring System is a closed blood Sampling System designed to allow easy and safe withdrawal of blood samples from an arterial and venous invasive pressure monitoring line. The TranStar® Pressure Transducer mounting plate is intended for uses with the HemoDraw® Closed Blood Sampling Set with TranStar® Pressure Monitoring System. The TranStar® disposable monitoring set provides isolation between the fluid path connection to the patient and the transducer diaphragm. This set includes a flush device that is intended for use in invasive blood pressure measurements that require continuous flow to maintain catheter patency. The flush device provides a controlled and constant fluid infusion at a rate determined by the patient's blood pressure and the fluid source pressure. With a total fluid source pressure equal to 300mmHg, the flush device delivers an average flow rate of 3ml/hour. The device is supplied with a porous plug on the zeroing stopcock; this porous plug will allow air and saline to pass through and therefore can be kept in place when priming. To prevent the introduction of air into the system; after priming the porous plug should be replaced with a nonvented cap. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.
This document describes a 510(k) premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific performance metrics and acceptance criteria in the way a clinical trial might.
Therefore, many of the requested details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, specific efficacy or accuracy metrics, and details on training sets) are not applicable or not provided within this type of regulatory submission. The submission is primarily concerned with bench testing and validation against established engineering standards and existing regulatory guidance.
Here's a breakdown of the information that can be extracted or deduced from the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
For the type of device (Extravascular Blood Pressure Transducer) and the nature of this 510(k) submission (design update and labeling changes), the "acceptance criteria" are primarily based on demonstrating compliance with relevant international standards and ensuring that the minor changes do not compromise the safety and effectiveness established by the predicate device. Specific quantitative performance metrics with defined acceptance thresholds (e.g., accuracy, sensitivity, specificity) for the device as a whole are not explicitly presented as they would be in a clinical study report for a diagnostic device.
The reported device performance is that "All testing met pre-established specifications."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Luer Taper Conical Fittings | Bench Testing per ISO 594-1: 1986 (general requirements for conical fitting with a 6% (Luer) taper for syringes, needles, and certain other medical equipment). Met requirements. |
| Luer Lock Fittings | Bench Testing per ISO 594-2: 1998 (requirements for lock fittings for conical fitting with a 6% (Luer) taper for syringes, needles, and certain other medical equipment). Met requirements. |
| Sterility | Sterilization/Microbiology Validation per ISO 11135, AAMI TIR28, and ISO 11747 to ensure product sterility to the end user (SAL 10-6). Ensured product sterility. |
| MR Compatibility | Material Bench Testing to ensure the HemoDraw® Plus Closed Blood Sampling System device materials met MR compatibility specifications. Met MR compatibility specifications (leading to "MR Conditional" labeling). |
| Design Validation/Human Factors | Design Validation / Human Factors per ISO 62366 (usability engineering for medical devices). Performance acceptable for intended use. |
| Biocompatibility | Biocompatibility assessment per ISO 10993-1. Materials are biocompatible to the indicated patient population. |
| Overall Intended Performance | "All testing met pre-established specifications, and successfully demonstrated that the HemoDraw® Plus Closed Blood Sampling Set with TranStar® and LogiCal® Pressure Monitoring Systems performed as intended." The device is considered "as safe, as effective, and perform as well as or better than the predicate devices" for hemodynamic pressure monitoring and blood sampling while maintaining a closed system. The proposed changes (distal stopcock, expanded patient population, MR conditional labeling) do not raise new questions of safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided document. The testing described is primarily bench testing against engineering standards for components and system integrity, not a clinical trial with a "test set" of patient data.
- Data Provenance: The document refers to "Bench Testing" and "Validation" conducted by Smiths Medical. There is no mention of country of origin for patient data or retrospective/prospective data collection, as this is not a study involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This concept is not applicable here. The "ground truth" for demonstrating substantial equivalence and meeting safety/effectiveness standards in this context comes from adherence to established international standards (e.g., ISO, AAMI) and internal company specifications, rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set
- Not applicable, as there isn't a "test set" of cases requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is typical for diagnostic imaging AI systems and is not relevant for a blood sampling and pressure monitoring system's safety and effectiveness evaluation for a 510(k) submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Not applicable. This device is a physical medical device, not an AI algorithm. "Standalone performance" in this context refers to the device's functional performance as evaluated through bench testing and validation against engineering specifications, which was indeed done.
7. The Type of Ground Truth Used
- For this device, the "ground truth" is defined by established international engineering standards (e.g., ISO 594-1, ISO 594-2, ISO 11135, AAMI TIR28, ISO 11747, ISO 62366, ISO 10993-1) and the manufacturer's internal specifications derived from these standards and the predicate device's performance. There is no reference to pathology, outcomes data, or expert consensus on patient cases for determining the device's fundamental safety and performance characteristics in this submission.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable (see point 8).
§ 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).