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510(k) Data Aggregation
(81 days)
Automatically Retractable Safety Syringe (with fixed needle) (5cc/ml 22×1-1/4) is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient.
The Automatically Retractable Safety Syringe (with fixed needle) 5cc/ml 22×11/4 is a piston syringe. The device is intended for medical purposes and 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 the body. Automatically Retractable Safety Syringe (with fixed needle) (5cc/ml 22×11/4") works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. The needle retracting mechanism is activated by a spring action mechanism after injection is completed, while the exposed needle remains safety inside the empty syringe barrel for disposal.
The provided document describes a 510(k) premarket notification for an Automatically Retractable Safety Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria for device performance in the way typically seen for diagnostic algorithms.
Therefore, the requested information elements related to specific performance metrics (e.g., sensitivity, specificity), sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, and ground truth types are not applicable to this document's content.
However, I can extract the acceptance criteria and a summary of how the device meets them based on the equivalence testing performed to satisfy the 510(k) submission.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implied by the comparison to the predicate device and relevant industry standards. The reported device performance is that it meets these criteria, demonstrating equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical/Physical Performance: | |
| Delivery Accuracy (per ISO 7886-1:1993/Corrigendum 1:1995) | Conforms to ISO 7886-1:1993/Corrigendum 1:1995 |
| Needle Cover Strength (<15N) | Meets criteria (<15N) |
| Hub/Needle Bond Strength (40N) | Meets criteria (40N) |
| Biocompatibility (per ISO 10993-1) | Conforms to ISO 10993-1 |
| Material Composition (Equivalent to Predicate) | Materials are equivalent to predicate (Polypropylene, Isoprene rubber, Stainless steel, Silicon dioxide) |
| Lubricant Amount/cm² (<0.25mg/cm²) | Meets criteria (<0.25mg/cm²) |
| Design & Function (Equivalent to Predicate): | |
| Retraction mechanism after injection | Activated by syringe user, contaminated needle retracts inside syringe |
| Single-Use, Disposable, Non-reusable | Single-use, disposable, non-reusable |
| Intended Use (IM and SC injection of medication) | Same as predicate in purpose and function |
| Safety Feature (Active, manually activated) | Active safety feature, manually activated by users |
| Sterilization Method (Gamma Sterilization) | Gamma Sterilization |
| Barrel Marking Specs (per ISO 7886-1:1993/Corrigendum 1:1995) | Conforms to ISO 7886-1:1993/Corrigendum 1:1995 |
| Gradation Legibility (0.2ml) | 0.2ml |
| Barrel Transparency (Clear) | Clear |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission focuses on demonstrating substantial equivalence through comparison of design, intended use, and similar safety and performance testing to the predicate device. Details about the specific sample sizes or data provenance for these tests are not included.
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 is not applicable as the document describes a medical device (syringe) rather than a diagnostic algorithm that requires expert-established ground truth. The "ground truth" here is compliance with established standards and performance metrics for the device itself, verified through engineering and biocompatibility testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reasons as #3.
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 syringe, not an AI-assisted diagnostic tool.
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 syringe, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by international standards (e.g., ISO 7886-1:1993, ISO 10993-1) and the performance characteristics of the legally marketed predicate device (VanishPoint™ Syringe K970803). The device demonstrates "conformance" to these standards and "similarity" to the predicate.
8. The sample size for the training set
This is not applicable as the document describes a medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as #8.
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