(69 days)
The BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe is intended for aspiration and injection of fluids.
The BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe device is a sterile two-piece piston syringe designed to deliver a single fixed dose. It features a permanently attached hypodermic needle and auto-disable feature that prevents reuse of the syringe by locking the plunger rod in place after injection. The SoloShot™ Mini Syringe consists of a syringe barrel, a one-piece plunger rod (without rubber stopper), a clip affixed to the plunger rod and a integral needle is protected with a shield cover. The clip activates the auto-disabled feature, preventing re-use of the syringe is individually blister packaged and ETO sterilized to SAL of 10-6 .
The provided document is a 510(k) summary for the BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe, which is a medical device. This type of document is used to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific performance criteria in a clinical setting in the way a diagnostic AI device might.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth are not applicable to this type of device and submission. This is a syringe, and its performance is evaluated through bench testing, biocompatibility, and sterilization, not through clinical trials where human readers or AI algorithms analyze data for diagnostic purposes.
Here's an attempt to answer the questions based on the provided document, highlighting what is applicable and what isn't:
1. A table of acceptance criteria and the reported device performance
The document states that "In all instances, the BD SoloShot™ Mini Syringe functioned as intended and results observed met the predefined acceptance criteria." However, the exact numerical acceptance criteria for each test and the precise numerical results are not provided in this summary. The summary only lists the types of tests performed.
| Acceptance Criterion (Type of Test) | Reported Device Performance |
|---|---|
| Leakage | Met predefined acceptance criteria |
| Dose Accuracy | Met predefined acceptance criteria |
| Dead Space | Met predefined acceptance criteria |
| Maximum Usable Capacity | Met predefined acceptance criteria |
| Activation Forces | Met predefined acceptance criteria |
| Cannula Pull Force | Met predefined acceptance criteria |
| Shield Pull Force | Met predefined acceptance criteria |
| Deactivation Volume/Force to defeat the auto-destruct feature | Met predefined acceptance criteria |
| Scale Mark Permanency | Met predefined acceptance criteria |
| Package Integrity | Met predefined acceptance criteria |
| Biocompatibility (Cytotoxicity, Hemolysis, Acute Systemic Toxicity, Intracutaneous Reactivity, Sensitization, Pyrogenicity, Chemical Extractables Analysis, Primary Dermal Irritation) | Passed ISO 10993 testing; Non-pyrogenic, Non-Toxic |
| Sterilization (Ethylene Oxide) | Requalification of sterilization validation met SAL 10-6 |
| Compliance to Standards (ISO 10993-1, ISO 11135, ISO 7886-3, ISO 7886-1, ISO 7864, ISO 9626, ISO 6009) | Functioned as intended and results met predefined acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. These tests are "bench performance" tests, not clinical studies involving patient data. The "sample size" would refer to the number of syringes tested for each performance characteristic, which is typically standard practice for device validation but not detailed here.
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 is not applicable to this type of device. "Ground truth" in the context of expert consensus is relevant for diagnostic devices that interpret images or other patient data. For a syringe, performance is measured against objective physical and chemical standards, not expert interpretation of patient-related data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used in studies where there is subjective interpretation (e.g., by experts) to resolve disagreements. Here, the performance is measured objectively.
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 is not applicable. An MRMC study is relevant for diagnostic devices, particularly those involving human readers and AI assistance. This device is a syringe, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical device (syringe), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, "ground truth" refers to established engineering, chemical, and biological standards (e.g., ISO standards for sterility, biocompatibility, and physical performance). The device's performance is measured against these objective standards.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of a syringe's performance evaluation. Training sets are used in machine learning for AI algorithms.
9. How the ground truth for the training set was established
This is not applicable. As there is no training set for a syringe, there is no ground truth to establish for it.
§ 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).