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510(k) Data Aggregation
(73 days)
The Merit Medical 20 mL Syringe is used to inject fluids into, or withdraw fluids from, the body.
The Merit 20 mL Syringe contains a calibrated hollow barrel into which is inserted a closely fitted movable plunger and tip or seal. The barrel contains an ISO 594-1/2 compliant fixed male luer connector, which is compatible with ISO 594-1/2 compliant female luer hubs.
This document describes the 510(k) summary for the "Merit 20 mL Syringe". The acceptance criteria and the study proving the device meets these criteria are related to the performance of syringes as defined by international standards, especially after a minor material change to the silicone plunger tip/seal.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| ISO 7886-1:1993, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| ISO 11135:2014, Sterilization of health care products – Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| FDA guidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995 | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medical devices - Part 4: Selection of tests for interaction with blood | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| ISO 10993-5:2009, Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| ISO 10993-7:2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed type hypersensitivity | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| ISO 10993-11:2006, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| ASTM F756-08:2008, Standard Practice for Assessment of Hemolytic Properties of Materials | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| United States Pharmacopeia 37, National Formulary 32, 2014 Pyrogen Test | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| AAMI TIR 28:2009, Product adoption and process equivalency for ethylene oxide sterilization | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| ISO 594-2:1998, Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment – Part 2: Lock fittings | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It only mentions that "Design verification testing of the subject 20 mL Syringe was conducted."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing described focuses on compliance with international standards for device performance and biocompatibility, rather than clinical evaluation with expert-established ground truth.
4. Adjudication method for the test set
This information is not provided. The testing appears to be objective, based on established standards, rather than requiring expert 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
This is not applicable as the device is a medical syringe, not an AI-powered diagnostic tool, and the submission does not mention any MRMC study or AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a medical syringe, not an algorithm.
7. The type of ground truth used
The "ground truth" in this context is defined by international standards and guidance documents for syringe performance, sterility, and biocompatibility. The tests conducted verify the physical, chemical, and biological properties of the device against these established criteria.
8. The sample size for the training set
This is not applicable as the device is a medical syringe undergoing physical and biological testing, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons mentioned in point 8.
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