(191 days)
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. This device is for use in adults only.
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. This device is for use in adults only.
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® 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 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 LogiCal® 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.
The provided document is a 510(k) summary for the HemoDraw® Plus Closed Blood Sampling Set with LogiCal®/TranStar® Transducer System. It describes non-clinical testing performed to establish substantial equivalence to predicate devices. This type of document generally focuses on engineering and bench testing rather than clinical study data involving human interpretation of medical images or data. Therefore, many of the requested categories are not applicable.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that "All testing met pre-established specifications," but it does not detail the specific quantitative acceptance criteria or the exact reported performance values for each test. It only lists the categories of evaluations performed.
| Category | Acceptance Criteria (Not explicitly stated, but implied as "met pre-established specifications") | Reported Device Performance (Implied as "met" criteria) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993 standards (e.g., passing tests for systemic toxicity, cytotoxicity, etc.) | Met |
| Packaging | Package integrity after climatic stress and simulated distribution | Met |
| Device Performance | No leakage, proper pressure containment, cycle test performance, vacuum performance, frequency response, correct assembly | Met |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for each non-clinical test. It states "a worst case packaging configuration" for packaging tests, implying at least one configuration was tested. The data provenance is internal testing by Smiths Medical ASD, Inc. (the applicant), based on the context of a 510(k) submission. These are non-clinical bench and lab tests, not clinical data with provenance like country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The evaluations described are non-clinical engineering and biological tests (e.g., leakage, pressure containment, cytotoxicity), not expert-interpreted medical images or data. Ground truth is established by objective measurements against engineering specifications and standard biological testing protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 are used for human expert interpretation in clinical studies, typically for creating a consensus ground truth. The tests performed are objective bench and lab tests.
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 is not applicable. MRMC studies are clinical trials used to compare the performance of human readers, often with and without AI assistance, on medical cases. The provided document details non-clinical bench and lab testing of a blood sampling and pressure monitoring system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device (closed blood sampling set and pressure transducer system), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests described is established by:
- Engineering Specifications: For device performance tests like leakage, pressure containment, cycle test, vacuum, frequency response, and assembly, the device's performance is measured against pre-defined engineering design specifications.
- Standardized Biological Testing: For biocompatibility tests, the ground truth is determined by the results of tests performed according to ISO 10993 standards, which dictate acceptable levels of toxicity, sensitization, etc.
8. The sample size for the training set
This is not applicable. The device is a physical medical device, not an AI or machine learning system that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
§ 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).