(48 days)
The PowrSyringe Aspirator is a piston syringe to inject fluids into, or aspirate fluids from, the body.
The PowrSyringe Aspirator is a single use manual hand-held general-purpose piston syringe with handles to inject fluids into, or aspirate fluid from. The PowrSyringe Aspirator handles allow the user to pull the plunger back within the barrel when the user squeezes the handles. Users may open the PowrSyringe Aspirator's handles to inject fluids back into the barrel.
The PowrSyringe Aspirator safety features include:
- Clear barrel for visualization of air bubbles.
- Minimum dead space between the plunger and barrel with the handles are fully squeezed.
- Handle design to prevent the plunger from being pulled out of the barrel during aspiration.
The provided document is a 510(k) Premarket Notification for the PowrSyringe Aspirator, a piston syringe.
Here's the breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functionality in intended use | Confirmed (Non-Clinical Testing) |
| Equivalence to predicate device | Confirmed (Non-Clinical Testing) |
| No new safety risks compared to predicate devices | Confirmed (Non-Clinical Testing) |
| Equivalence in indications for use | Confirmed (Comparison to Predicate Devices) |
| Equivalence in intended use | Confirmed (Comparison to Predicate Devices) |
| Equivalence in patient contact materials | Confirmed (Comparison to Predicate Devices) |
| Equivalence in design | Confirmed (Comparison to Predicate Devices) |
| Equivalence in function | Confirmed (Comparison to Predicate Devices) |
| Equivalence in performance | Confirmed (Comparison to Predicate Devices) |
| Equivalence in sterilization | Confirmed (Comparison to Predicate Devices) |
| Equivalence in safety | Confirmed (Comparison to Predicate Devices) |
| Clear barrel for visualization of air bubbles | Safety feature included |
| Minimum dead space between plunger and barrel when handles are fully squeezed | Safety feature included |
| Handle design to prevent plunger from being pulled out of the barrel during aspiration | Safety feature included |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The document states "Clinical testing: Not applicable." The performance testing mentioned is non-clinical. For non-clinical performance testing, the sample size is not specified in the provided text.
- Data Provenance: Not applicable, as no clinical human data was used for testing. The testing was non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no clinical testing involving human data and therefore no ground truth established by experts in this context.
4. Adjudication method for the test set:
- Not applicable. No clinical testing or expert adjudication was performed.
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. This device is a manual piston syringe, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical, manual piston syringe, not an algorithm.
7. The type of ground truth used:
- For the non-clinical performance testing, the ground truth would be based on engineering specifications, physical measurements, and functional requirements for a piston syringe, validated against established industry standards and the predicate devices' performance. The document doesn't explicitly state the specific "type" but implies objective physical and functional criteria.
8. The sample size for the training set:
- Not applicable. This device is a physical medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, this is not an AI algorithm.
§ 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).