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510(k) Data Aggregation
(293 days)
The Medovate SAFIRA system is intended for use by trained clinicians to administer local anaesthetic below a specified pressure threshold to a target nerve bundle for regional anaesthesia.
The Medovate SAFIRA device is an infiltration pump used to infuse local anesthetic drugs into the body as part of a Regional Anaesthesia procedure.
The SAFIRA device consists of a sterile, single-use plastic Syringe (20mL capacity) fitted with a custom collar and plunger, a non-sterile reusable Driver, and a non-sterile reusable Operator. SAFIRA is a battery powered motorized syringe driver for use in delivering anaesthetic via injection during a Peripheral Nerve Block (PNB) Procedure.
The user fills the syringe with the fluid of choice, then locks the filled Syringe into the Driver, where the specially designed Syringe Plunger rack mates with the Driver Gear. When the SAFIRA Syringe is attached to the Driver, the collar locks the Syringe to the Driver housing, and the Plunger engages with the Driver Gear to advance or retract the Syringe Plunger.
The female Luer or NRFit connection of a sterile, single-use needle set (not supplied by Medovate) is attached to the standard male Luer or NRFit fitting on the SAFIRA Syringe. The Operator (Foot Pedal or Palm Operator) connector is plugged into the receptacle on the Driver, ready for use.
The Driver contains non-replaceable AAA batteries which power a small DC motor which in turn controls the movement of the Syringe Plunger.
The Operator consists of 2 color-coded controls; when the user applies pressure to the appropriate control (green = infuse, yellow = aspirate), the motor activates the Plunger movement mechanism to move the Plunger forwards (infuse/inject) or backwards (aspirate).
The Driver is designed to deliver fluid at a maximum flow rate of 0.5mL/sec. The motor is designed with an overpressure safety feature, which causes the Plunger movement to stop if the pressure in the syringe exceeds 17psi ±3psi regardless of whether the "infuse" control of the operator is depressed.
The provided text describes the Medovate SAFIRA device, an infiltration pump for administering local anesthetic during regional anesthesia. It details the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence for regulatory clearance.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than explicitly listing acceptance criteria for a new performance study of the exact same metrics. However, it does highlight key performance aspects and differences between the proposed device (SAFIRA, K230083) and the predicate device (unmodified SAFIRA, K153599).
The "Performance Equivalence" section of the table on page 6 effectively serves as a comparison of performance parameters.
Criteria | Predicate Device (Unmodified SAFIRA - K153599) | Proposed Device (SAFIRA - K230083) | Comments |
---|---|---|---|
Maximum Infusion Flow Rate | 0.5ml/sec (30mL/min) using 22G needle set | 0.5ml/sec (30ml/min) using compatible needle set | Identical |
Maximum Infusion Pressure | 13psi (±2psi) | 17psi (±3psi) | Difference to predicate. The pressure limit has been increased, however there is no impact on safety and no new risks have been introduced. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions "system verification testing" and a "Human Factors Study" as part of the performance testing. However, it does not specify the sample size used for these test sets, nor does it detail the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
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)
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in any testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method used for a test set.
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
The provided text does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was conducted. The device is an infusion pump, not an AI-assisted diagnostic tool, so such a study would not be applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device described is a physical infusion pump with a user interface, not software or an algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply. The device's operation inherently involves human interaction (filling the syringe, attaching the needle, operating the controls).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Maximum Infusion Pressure" and "Maximum Infusion Flow Rate," the ground truth would be based on engineering specifications and measurements from instruments calibrated to measure fluid pressure and flow rate. For the Human Factors Study, the ground truth would likely be established by expert observations of user interaction and predefined usability metrics rather than medical outcomes.
8. The sample size for the training set
The provided text does not mention a training set in the context of machine learning or AI. The SAFIRA device is a hardware-based infusion pump, not an AI model.
9. How the ground truth for the training set was established
Since there is no mention of a training set for machine learning, this question is not applicable.
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