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510(k) Data Aggregation
(144 days)
These syringes are intended for use by health care professionals for general purpose fluid aspiration/injection. The devices contain a piston locking mechanism which aids in the prevention of the accidental reuse of the syringe.
The SOLOGARD® LOCKING PLUS Syringe is a sterile, single-use, disposable hypodermic syringe with a plunger locking feature to prevent the accidental reuse of the syringe. It is manufactured in sizes of 1, 2.5, 3, 5, & 10 ml with a LuerLock connector and is supplied without needle.
The provided text describes the SOLOGARD® LOCKING PLUS Syringe, asserting its equivalence to a predicate device. However, the document does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and the study that proves the device meets them.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific pass/fail acceptance criteria values. It broadly states "Results indicated that the device performance was equivalent to that of the predicate device." While this is a summary of the performance, it does not provide quantitative or qualitative criteria for what constitutes success in the tests mentioned (fluid flow, dynamometer, simulated use).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fluid Flow | Equivalent to predicate device |
| Dynamometer | Equivalent to predicate device |
| Simulated Use | Equivalent to predicate device |
| (Specific criteria, e.g., flow rate values, force thresholds, successful lock engagements, are not provided in the document.) | (Specific performance values are not provided in the document.) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "engineering analyses of the fluid flow and dynamometer and simulated use testing" but does not specify the sample size (number of syringes) used for these tests. The data provenance is not explicitly mentioned (e.g., country of origin). It's a general submission for FDA clearance in the USA. Given the context, the testing would likely have been conducted in a controlled lab setting, possibly in the USA, as part of the manufacturer's (SafeGard Medical Products, Inc.) development and validation process. The studies appear to be prospective in nature, as they were conducted to demonstrate the syringe's performance for this specific 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable to this type of device submission. The SOLOGARD® LOCKING PLUS Syringe is a mechanical device, and its performance is evaluated through engineering and functional tests rather than requiring expert interpretation of results like medical imaging or diagnostic tests.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used when there's an ambiguity in interpreting data, often in clinical studies with human assessors. For engineering and functional tests of a syringe, the results are objectively measured (e.g., flow rate, force readings, successful locking mechanism engagement), and thus, an adjudication method in this sense is not needed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where multiple human readers interpret cases, and the AI's impact on their performance is assessed. The SOLOGARD® LOCKING PLUS Syringe is a medical instrument (hypodermic syringe) without a diagnostic or interpretive component.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this is not applicable. The device is a physical syringe, not an algorithm. The "locking feature" is a mechanical design element, not an AI or software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the SOLOGARD® LOCKING PLUS Syringe's performance would be established by objective engineering measurements and functional testing results. For example:
- Fluid Flow: Measured flow rates and pressures under specified conditions.
- Dynamometer: Measured forces required for plunger depression and locking mechanism engagement/disengagement (if applicable, though the goal is prevention of withdrawal).
- Simulated Use: Demonstrating the consistent and reliable engagement of the plunger locking feature under conditions simulating clinical use, preventing subsequent withdrawal and accidental reuse.
The "ground truth" here is adherence to design specifications and established performance characteristics of the predicate device, demonstrated through physical testing.
8. The Sample Size for the Training Set
This question is not applicable. The SOLOGARD® LOCKING PLUS Syringe is a mechanical device, not one developed using machine learning or AI that would require a "training set" of data. Its design and performance are based on engineering principles and physical testing.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" for this type of medical device.
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