(3 days)
The BD SoloShot™ IX Syringe is intended for the Aspiration and Injection of fluids.
The BD SoloShot™ IX Syringes are intended for the aspiration and injection of fluids.
The Modified Device, the subject of this 510(k), the BD SoloShot™ IX Syringe has been modified from the Predicate Device by changing to a 2-piece piston syringe. The syringe consists of a syringe barrel and one-piece plunger rod without the rubber stopper. The SoloShot™ IX Syringe has an identical permanently attached needle and identical autodisable feature. This syringe is individually blister packaged and ETO sterilized to SAL of 10-6. The intended use of the modified device remains the same as the predicate; for aspiration and injection of fluids.
The provided text describes a 510(k) submission for the BD SoloShot™ IX Syringe, which is a modified version of the predicate device, the BD Single-Fil™ Syringe. The submission focuses on demonstrating substantial equivalence to the predicate device through design verification tests.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state specific acceptance criteria values in a table format. It generally states that "Design Verification tests were performed based on the risk analysis performed and the results of these tests demonstrate that the BD SoloShot™ IX Syringe performed in an equivalent manner to the predicate device and is safe and effective when used as intended."
To infer acceptance criteria, one would consider the performance aspects of syringes, which typically include:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device | "performed in an equivalent manner to the predicate device" |
| Safety | "is safe... when used as intended" |
| Effectiveness | "is... effective when used as intended" |
| Proper Aspiration of Fluids | Performance expected for "aspiration and injection of fluids" |
| Proper Injection of Fluids | Performance expected for "aspiration and injection of fluids" |
| Integrity of Auto-disable Feature | "identical auto-disable feature" indicates it performs as the predicate |
| Material Compatibility | "manufactured of the same materials" as the predicate |
| Sterility Assurance Level (SAL) | "ETO sterilized to SAL of 10⁻⁶" (for modified device), "SAL of 10⁻⁶" (for predicate during characterization) |
2. Sample size 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 the sample size used for the design verification tests. It also does not provide information on the country of origin of the data or whether the study was retrospective or prospective.
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 type of information is generally not applicable to a medical device like a syringe, where performance is evaluated through engineering tests rather than expert interpretation of data (e.g., medical images). Therefore, there were no experts used to establish ground truth in the sense of clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads). Since this is a submission for a syringe and its performance is assessed through design verification tests, adjudication methods are not relevant or mentioned.
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
An MRMC comparative effectiveness study is not mentioned as this submission is for a syringe, not an AI-assisted diagnostic tool. Therefore, the concept of AI assistance and improvement of human readers is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This submission is for a physical medical device (syringe), not an algorithm or software. Therefore, the concept of standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" or standard for comparison is the performance of the predicate device and established engineering specifications for syringe function, sterility, and material compatibility. The document states that performance was determined by "Design Verification tests" that demonstrated "equivalent manner to the predicate device."
8. The sample size for the training set
The concept of a "training set" doesn't apply to this type of medical device submission. Training sets are relevant for machine learning or AI models, which are not involved here.
9. How the ground truth for the training set was established
As there is no training set for a machine learning model, this question is not applicable to the provided document. The "ground truth" for the device's acceptable performance is based on its ability to function equivalently to the predicate device through engineering design verification.
§ 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).