(130 days)
The Procedur-SF device is used to inject fluids into, or withdraw fluids from, the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
The Procedur-SF device is a piston safety syringe. The Procedur-SF device utilizes two syringes assembled in a plastic holder. The syringe plungers are connected by a pulley.
This looks like a 510(k) summary for a medical device called "Procedur-SF," which is a piston safety syringe. This document primarily focuses on the regulatory clearance process, specifically demonstrating "substantial equivalence" to predicate devices, rather than detailed performance study results with acceptance criteria.
Therefore, much of the requested information (like specific acceptance criteria, sample sizes for test sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and detailed training set information) is not present in the provided document. This is typical for a 510(k) summary, which generally doesn't include the granular details of performance testing unless it's a novel technology requiring extensive de novo clinical data.
However, I can extract what is available and indicate what is missing:
Here's an analysis of the provided 510(k) summary regarding the Procedur-SF safety syringe:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|
| Not explicitly stated in terms of quantitative criteria or benchmarks. The filing focuses on demonstrating substantial equivalence to predicate devices. | The device is deemed "substantially equivalent" to predicate devices (Becton Dickinson Single Use Hypodermic Syringes K980987 and Retractable Technologies, Inc. VanishPoint Safety Syringe K980069) for its intended use. This implies its performance characteristics, particularly regarding safety to reduce sharps injuries and prevent reuse, are comparable to these legally marketed devices. |
Missing Information: Typical acceptance criteria for a safety syringe might include:
- Force required for activation of the safety mechanism.
- Reliability of the safety mechanism (e.g., successful activation rate).
- Prevention of accidental needle sticks post-use.
- Prevention of syringe re-use.
- Fluid delivery/withdrawal accuracy.
- Compatibility with different needle gauges.
- Biocompatibility.
- Sterility assurance.
- Shelf life.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified in the provided document.
- Data Provenance: Not specified. Based on the 510(k) process, this would typically involve in-vitro (bench) testing, and potentially some limited human factors or simulated use testing, but the document does not detail the specifics of such studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable/not specified. The device is a physical medical device (syringe), not an AI/diagnostic tool requiring expert-established ground truth for image interpretation or diagnosis. Performance would be assessed through objective engineering and biological tests.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Performance testing for a syringe would involve objective measurements and observations rather than expert adjudication in the context of diagnostic interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, this type of study is not relevant for a safety syringe. MRMC studies are typically performed for diagnostic imaging devices or algorithms where human readers interpret cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: Not applicable. This device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not explicitly detailed. For a device like a safety syringe, "ground truth" would be established through:
- Engineering specifications and test standards: Conformance to established design parameters, material properties, and performance benchmarks (e.g., ASTM standards for medical devices).
- Bench testing: Objective measurements of mechanical properties, fluid dynamics, and safety mechanism functionality.
- Biocompatibility testing: Compliance with ISO 10993 standards.
- Sterility testing: Assurance of sterilization methods.
- Simulated use testing: To evaluate the safety mechanism's effectiveness in preventing sharps injuries and reuse under controlled conditions.
The document states the device "utilizes two syringes assembled in a plastic holder. The syringe plungers are connected by a pulley," implying a mechanical design to achieve the safety features.
8. The Sample Size for the Training Set
- Sample Size (Training Set): Not applicable. This is a physical device, not a machine learning algorithm that requires a "training set." Device design and development typically involve iterative prototyping and testing, rather than a formal "training set" in the AI sense.
9. How the Ground Truth for the Training Set was Established
- Ground Truth (Training Set): Not applicable.
Summary of What the Document Provides:
The provided 510(k) summary for the Procedur-SF safety syringe is a regulatory notification document. Its primary purpose is to demonstrate substantial equivalence to existing, legally marketed predicate devices (Becton Dickinson Single Use Hypodermic Syringes K980987 and Ret retractable Technologies, Inc. VanishPoint Safety Syringe K980069).
This means the applicant asserted that their device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The FDA's clearance (letter dated JAN 21 2005) indicates agreement with this assertion.
Therefore, the "study that proves the device meets the acceptance criteria" is implicitly the set of engineering, safety, and performance tests (not detailed in this summary but required for 510(k) submission) that allowed the FDA to determine substantial equivalence to devices that have already met safety and effectiveness standards. The specific quantitative results and acceptance criteria from those underlying tests are not included in this high-level summary.
§ 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).