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The piston syringe, made available in a 5cc size, of this 510(k) notification. known as the Brannon PortSyringe (BPS), 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 BPS is manufactured with identical material as the predicate piston syringe.
Sealing of the conduit with the fluid collection needle allows the pistonplunger unit and the barrel to function as a conventional syringe. Functional operation simply requires that one compression fits a hypodermic needle of any gauge to the distal nozzle tip of the barrel. One is then able to aspirate body fluids as the predicate piston syringe. After a given amount of fluid is aspirated into the barrel of the syringe, a minimal amount will suffice, a plurality of vacuum specimen tubes can be inserted into the tube-holder. The vacuum specimen tubes are advanced over the sleeved needle while stabilizing the tube-holder. In so doing, the vacuum within the specimen tube induces the piston-plunger unit to advance distally as the aspirated fluid is transferred to the vacuum specimen tube proximally.
The provided text describes a medical device, the Brannon PortSyringe (BPS), and a basic study conducted to demonstrate its safety and effectiveness. However, it does not fit the typical format of a modern AI/device performance study with clearly defined acceptance criteria, statistical rigor, and detailed ground truth establishment.
Based on the provided information, here's an attempt to extract and synthesize the requested details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device is safe for use in clinical settings. (Implied: No significant adverse events, improved safety over traditional methods) | "Traditionally cumbersome phlebotomy procedures were made safer" with the BPS. The device meets "all of the biocompatibility and performance standards (efficacy) of the predicate piston syringe and predicate BSCD." Manufactured with identical materials as the predicate. |
| Effectiveness/Efficacy: Device performs its intended function effectively (fluid aspiration and transfer to vacuum specimen tubes/bottles). | "Improved efficiency, proficiency, and patient comfort." "Works safely and effectively as outlined in the Premarket Notification 510(k)." "Fluid aspiration through the distal nozzle tip of the syringe barrel and subsequent transfer of the fluid aspirate through the piston-plunger unit and into a plurality of vacuum specimen tubes." "Was used during consecutive aspirations and fluid transfers to vacuum specimen tubes at the bench and there were no failures." |
| Substantial Equivalence: Device is substantially equivalent to predicate piston syringes and blood specimen collection devices (BSCDs). | "The Brannon PortSyringe is claimed to be substantially equivalent to a predicate piston syringe." "Indicated use, fluid aspiration and transfer of the fluid aspirate to vacuum specimen tubes and bottles, is identical to the predicate piston syringe and the predicate BSCD." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The study involved "intensive care patients requiring multiple blood samples." We don't know the exact number of patients or the number of blood draws/device uses.
- Data Provenance: Prospective clinical trial conducted at the University of Iowa Hospitals and Clinics (UIHC) in January 1989. The data comes from the United States.
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 study appears to be a clinical observation/evaluation rather than one relying on expert consensus for "ground truth" in the way a diagnostic imaging study might. The "truth" here would be the successful and safe collection of blood samples, assessed by the clinicians performing the procedure.
4. Adjudication Method for the Test Set
Not applicable/not described. This was a direct clinical performance study, not one requiring independent adjudication of findings from multiple observers.
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
No, an MRMC comparative effectiveness study was not done. This device is not an AI-powered diagnostic tool, but rather a physical medical device for fluid aspiration and transfer.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this question is not relevant. The Brannon PortSyringe is a physical medical device, not an algorithm. Its performance inherently involves human interaction.
7. The Type of Ground Truth Used
The "ground truth" for this device can be interpreted as:
- Successful Aspiration and Transfer: The ability to effectively and reliably aspirate fluid and transfer it to vacuum specimen tubes or blood culture bottles without failure.
- Safety: The absence of complications or adverse events during the procedure, and a perceived improvement in safety compared to traditional methods.
- Clinical Performance/Outcomes: Improved efficiency, proficiency, and patient comfort as observed by clinicians in a real-world setting.
- Bench Testing: Zero failures during consecutive aspirations and fluid transfers to vacuum specimen tubes at the bench.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI model 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 an AI model.
Summary of the Study:
The study was a clinical trial conducted at the University of Iowa Hospitals and Clinics in January 1989, titled "Safe, Simple & Efficient Fluid Extraction." It involved intensive care patients who required multiple blood samples. The study evaluated the Brannon PortSyringe (BPS) in a real-world clinical setting, assessing its safety and effectiveness compared to traditional phlebotomy procedures.
The study's findings, as reported, indicated that the BPS made "traditionally cumbersome phlebotomy procedures... safer with improved efficiency, proficiency, and patient comfort." It also stated that the device met "all of the biocompatibility and performance standards (efficacy) of the predicate piston syringe and predicate BSCD" and was manufactured with identical materials to the predicate piston syringe. Bench testing further demonstrated no failures during consecutive aspirations and fluid transfers.
The conclusion drawn was that the Brannon PortSyringe could be used safely and effectively in a manner identical to predicate devices, thus establishing its substantial equivalence. The document functions as a 510(k) summary, aiming to demonstrate substantial equivalence to legally marketed predicate devices rather than providing a detailed statistical analysis of a novel diagnostic or therapeutic effect.
§ 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).