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510(k) Data Aggregation
(71 days)
The Merit Syringe is used to inject fluids into, and withdraw fluids from, the body.
The Merit Syringe contains a calibrated hollow barrel into which is inserted a closely fitted movable plunger and tip or O-Ring. The barrel contains an ISO 594-2 compliant fixed male luer connector, which is compatible with ISO 594-2 compliant female luer hubs.
The provided document describes the acceptance criteria and the study conducted for the Merit Syringe, which is a medical device used to inject and withdraw fluids from the body.
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the Merit Syringe complies with the FDA recognized consensus standards ISO 7886-1 and ISO 594-2. The performance data for biocompatibility is also mentioned.
| Acceptance Criteria (from ISO 7886-1 and ISO 594-2) | Reported Device Performance |
|---|---|
| ISO 7886-1: | Met acceptance criteria sufficient for its intended use. |
| Cleanliness | Met (implied by compliance with standard) |
| Graduated Scale | Met (implied by compliance with standard) |
| Limits for acidity or alkalinity | Met (implied by compliance with standard) |
| Barrel | Met (implied by compliance with standard) |
| Limits for extractable metals | Met (implied by compliance with standard) |
| Piston/Plunger Assembly | Met (implied by compliance with standard) |
| Lubricant | Met (implied by compliance with standard) |
| Nozzle | Met (implied by compliance with standard) |
| Tolerance on Graduated Capacity | Met (implied by compliance with standard) |
| Performance - Freedom from air and liquid leakage past piston | Met (implied by compliance with standard) |
| ISO 594-2: | Met acceptance criteria sufficient for its intended use. |
| Gauging | Met (implied by compliance with standard) |
| Unscrewing torque | Met (implied by compliance with standard) |
| Liquid leakage | Met (implied by compliance with standard) |
| Ease of assembly | Met (implied by compliance with standard) |
| Air leakage | Met (implied by compliance with standard) |
| Resistance to overriding | Met (implied by compliance with standard) |
| Separation force | Met (implied by compliance with standard) |
| Stress cracking | Met (implied by compliance with standard) |
| Biocompatibility (based on ISO 10993-1, 4, 5, 7, 10, 11; AAMI/ANSI ST72; ASTM F756-08; USP 37 NF 32 ): | Met acceptance criteria. |
| Cytotoxicity | Performed and compliant |
| Sensitization | Performed and compliant |
| Irritation | Performed and compliant |
| Acute Systemic Toxicity | Performed and compliant |
| Pyrogenicity | Performed and compliant |
| Hemolysis | Performed and compliant |
| Ethylene oxide sterilization residuals | Performed and compliant (ISO 10993-7) |
| Sterilization dose (Radiation) | Performed and compliant (ISO 11137-2) |
| Packaging integrity (for sterile devices) | Performed and compliant (ISO 11607-1, ASTM D4169-14, ASTM F1980-07, ISO 2233:2000) |
| Bacterial Endotoxins | Performed and compliant (AAMI/ANSI ST72) |
| Pyrogen Test | Performed and compliant (United States Pharmacopeia 37, National Formulary 32, 2014 ) |
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 explicitly state the sample sizes used for each specific test described under ISO 7886-1, ISO 594-2, or the biocompatibility tests. It broadly mentions "A battery of tests was performed." Nor does it specify the country of origin of the data or whether the tests were retrospective or prospective. It is implied these were prospective tests conducted on manufactured units of the Merit Syringe.
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 information is not provided. The compliance is based on meeting the established acceptance criteria of recognized consensus standards (ISO standards) and FDA guidance, rather than ground truth established by human experts in the context of diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests are based on objective measurements and compliance with specified standards, not on human interpretation requiring adjudication.
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
Not applicable. This device is a piston syringe, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical medical device (syringe), not an algorithm. The performance evaluation is based on bench testing and material compatibility, which is analogous to "standalone" performance for a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is defined by the acceptance criteria specified within the referenced international consensus standards and FDA guidance documents (e.g., ISO 7886-1, ISO 594-2, ISO 10993 series). Compliance means the device's physical and biological properties meet these pre-defined, objectively measurable standards.
8. The sample size for the training set
Not applicable. There is no "training set" as this is a physical device undergoing performance and biocompatibility testing, not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned for this type of device submission.
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