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510(k) Data Aggregation
(83 days)
The Merit Syringe is used to inject fluids into, or withdraw fluids from, the body.
The Merit Syringe contains a calibrated hollow barrel into which is inserted a closely fitted movable plunger and tip. The barrel contains a fixed male luer connector, which is compatible with female luer hubs.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Merit Syringe, based on the given requirements:
The document does not contain information about a device that uses AI, or a device that specifically needs human readers to interpret its output. Thus, questions 2, 3, 4, 5, 6, 7, 8, and 9 from your prompt are not applicable to the provided text. The device described, the "Merit Syringe," is a mechanical medical device (a piston syringe) and its evaluation focuses on physical performance, material compatibility, and sterilization.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Material & Design | Same materials as predicate device (K152783): barrel (clear cyclo-olefin polymer), plunger (polycarbonate or ABS), seal (silicone), lubricant (silicone) | Met: Materials of the subject device are identical to the predicate device. |
| Biocompatibility | Endpoints previously evaluated under K152783: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility. (FDA Guidance, ISO 10993-1) | Met: Biocompatibility testing provided in K081361 demonstrated the biocompatibility of the subject device for the intended use, as materials are identical to the predicate (K152783). The specified biocompatibility endpoints were previously evaluated. |
| Sterilization | Sterility process cleared under K152783 (ISO 11135:2014, ISO 11607-1:2006, AAMI TIR 28:2009) | Met: The subject device was adopted into existing validated sterility processes (EO sterilization with a 3-year shelf life) per AAMI TIR 2009, with the process validated under K152783 using ISO 11135 and ISO 11607-1. |
| Performance Bench Testing | ISO 7886-1:2017 (Sterile hypodermic syringes for single use - Part 1: Syringes for manual use) | Met: Testing demonstrated that the subject device met the predetermined acceptance criteria and supports the 3-year shelf life. (For both general performance and dimensional accuracy of graduation lines). |
| Performance Bench Testing | ISO 594-2:1998 (Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment – Part 2: Lock fittings) | Met: Testing demonstrated that the subject device met the predetermined acceptance criteria and supports the 3-year shelf life. (Specific to luer lock connector performance). |
| Risk Management | ISO 14971:2007 (Medical devices – Application of risk management to medical devices) | Met: A risk analysis was conducted in accordance with ISO 14971:2007, and in all non-clinical testing, the predetermined acceptance criteria were met, leading to a conclusion of substantial equivalence. |
| Graduation Accuracy | Compliant with ISO 7886-1 | Met: Printed with accurate graduation lines that are compliant with ISO 7886-1. (This is a specific performance aspect within the broader ISO 7886-1 compliance). |
| Shelf Life | 3-year shelf life | Met: Results of performance testing demonstrate support for the 3-year shelf life. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This is a medical device (syringe) clearance based on bench testing to established standards and comparison to a predicate device, not on clinical study data involving patients or AI performance on a test set.
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)
Not applicable. Ground truth for a diagnostic device/AI is not relevant for a mechanical syringe. Performance is measured against engineering standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication is described for a syringe's performance against engineering standards.
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 not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm for a mechanical syringe.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for this device's performance is compliance with recognized international and FDA standards for syringes (e.g., ISO 7886-1, ISO 594-2) and biocompatibility standards (ISO 10993-1).
8. The sample size for the training set
Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. As above, no training set or ground truth in the context of AI/ML is relevant for this device.
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(291 days)
The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.
The ChemoCLAVE® Cytotoxic Medication Preparation and Delivery System devices are sterile, single use CSTDs, which prohibit the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system. The Spiros and ChemoClave components comprise the primary components of the ChemoClave CSTD System, which connect to form a closed fluid path for transfer of hazardous medications. The devices which include the ChemoClave component are vial access devices, bag access devices, adapters, and administration sets. The devices which include the mating Spiros component are syringes, adapters, and administration sets. The Spiros and the ChemoClave will each independently self-seal when they are disconnected from one another.
The provided text describes the ChemoCLAVE Cytotoxic Medication Preparation and Delivery System and its substantial equivalence to a predicate device. However, the document does not contain information about the acceptance criteria for an AI/ML powered device, nor does it detail a study that proves a device meets such criteria.
The context of the document is a 510(k) premarket notification for a medical device (ChemoCLAVE Cytotoxic Medication Preparation and Delivery System) that is not an AI/ML powered device. The "acceptance criteria" discussed in the document refer to the performance of this physical medical device in functional and performance tests like microbial ingress testing, emission testing, hazardous drug exposure testing, and sterility validation, to demonstrate substantial equivalence to an existing predicate device.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML powered device meets those criteria based on the given text. The provided text is about a traditional medical device, not an AI/ML system.
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