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The piston syringe, made available in a 3cc size, of this 510(k) notification, known as the Brannon Pedi PortSyringe (BPPS), is a combination of two legally marketed devices; (1) a piston syringe and (2) a blood specimen collection device (BSCD). The BSCD is integral with the plunger unit of the piston syringe with the BSCD communicating with the fluid chamber of the piston syringe via a centrally disposed and substantially narrow conduit. The fluid collection needle is sealed by a rubber sleeve. Appreciate that the needle is not manufactured by the applicant nor a manufacturing firm identified by the Applicant, but rather purchased from an FDA recognized manufacturer/distributor. Further appreciate that the BPPS is manufactured with identical material as the predicate piston syringe.
The provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in the prompt. The text describes a 510(k) premarket notification for the Brannon Pedi PortSyringe (BPPS), which aims to demonstrate substantial equivalence to a predicate device. This type of submission generally relies on demonstrating that the new device is as safe and effective as a legally marketed predicate, rather than providing extensive de novo clinical trial data with predefined acceptance criteria.
However, based on the available information, I can infer and extract some details.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria. Instead, it aims to demonstrate equivalence to predicate devices regarding safety and effectiveness.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: | |
| Biocompatibility | Meets all biocompatibility standards of the predicate piston syringe and predicate BSCD. Manufactured with identical material. |
| Functionality (Aspiration and Fluid Transfer) | Allows aspiration of body fluids and subsequent transfer to vacuum specimen tubes/bottles. Functionally operates as a conventional syringe. |
| Patient Comfort | Improved patient comfort compared to traditionally cumbersome phlebotomy procedures. |
| Effectiveness/Efficacy: | |
| Same Intended Use as Predicate | Intended use (fluid aspiration and transfer to vacuum specimen tubes and bottles) is identical to the predicate piston syringe and predicate BSCD. |
| Efficiency of Fluid Extraction | Improved efficiency in phlebotomy procedures. |
| Proficiency in Use | Improved proficiency in phlebotomy procedures. |
| Safe Usage in Clinical Setting | Used safely and effectively in a clinical trial. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The study involved "intensive care patients requiring multiple blood samples." The exact number of patients or samples is not provided.
- Data Provenance: Prospective clinical trial conducted at the University of Iowa Hospitals and Clinics (UIHC) in January 1989. (Country of origin: USA)
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The clinical trial report focuses on the safety and effectiveness of the device in practice, rather than establishing ground truth for a diagnostic task.
4. Adjudication Method for the Test Set
This information is not provided. No adjudication method is mentioned as the study was not focused on diagnostic accuracy requiring such methods.
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 was not an MRMC study. This device is a medical instrument (syringe), not an AI diagnostic tool. Therefore, the concept of human readers improving with AI assistance does not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
This was not a standalone algorithm study. The device is a physical instrument for fluid collection, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is primarily observational and clinical assessment of:
- Safe operation: No adverse events, proper functioning.
- Effective fluid collection: Successful aspiration and transfer of fluids.
- Improved clinical outcomes/experience: Enhanced efficiency, proficiency, and patient comfort.
- Equivalence to predicate device function.
It's not a diagnostic "ground truth" derived from pathology or expert consensus on images.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical instrument, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no "training set" for this type of device.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).