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510(k) Data Aggregation
(81 days)
The primary intended use of the Syringex Safety Syringe® is "a hypodermic needle and syringe intended to inject fluid into or withdraw fluid from the body".
The secondary intended use is that the sharps safety feature will help to reduce the number of sharps injuries by providing an immediate and mandatory elimination of the sharp by its safe, simple and easy retraction into the barrel of the syringe. The feature will help prevent sharps injuries when using the device for its primary intended use.
The Syringex Safety Syringe® is a retractable needle safety syringe. The syringe design employs a retractable mechanism that becomes engaged upon injection of the syringes contents. Withdrawal of the plunger retracts the needle into the syringe barrel, holding it securely in place. The plunger stem is broken off to prevent pushing the needle assembly forward. The syringe may be made in all sizes with needle gauges ranging from 18 to 30. The length of the needle is limited only by the length of the barrel in order to contain the needle. Available in lengths from 5/16" to 1 ½".
The document provided is a 510(k) summary for the Syringex Safety Syringe®, which is a medical device and not an AI/ML product. Therefore, many of the requested categories related to AI/ML device performance (like "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "sample size for training set," etc.) are not applicable to this document.
However, I can extract information related to the device's acceptance criteria and the studies that support its equivalence to a predicate device.
Here's the breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a formal table of "acceptance criteria" in the way an AI/ML device might have pre-defined metrics like sensitivity, specificity, or AUC thresholds. Instead, the performance is reported in comparison to the predicate device and relevant ISO standards.
| Acceptance Criterion (Implicit) | Reported Device Performance (Syringex Safety Syringe®) |
|---|---|
| Mechanical/Dimensional Equivalence to Predicate | |
| Barrel Length | 3.28" (Predicate: 3.41") |
| Barrel OD | 0.395" (Predicate: 0.467") |
| Barrel ID | 0.340" (Predicate: 0.38") |
| 3cc Scale Length | 2" (Predicate: 1.6") - Syringex has a longer scale and marks are easier to read. |
| Scale Markings | 0.1cc and numbers at ½cc markings (Predicate: 0.1cc and numbers at ½cc markings) |
| Functional Equivalence/Performance | |
| Maximum Capacity (relative to nominal) | Just over nominal +10% (conforms to ISO 7886-1 minimum requirement). (Predicate: About 53% more than nominal, >5 times ISO requirement) |
| Needle Engagement Pressure (Safety Feature) | Nominal engagement pressure just over 600 grams. (Predicate: Over 4200 grams, indicating Syringex is much less likely to cause tissue trauma during engagement). |
| Safety Feature Operation | Needle can be withdrawn directly from the patient into the barrel with one-handed technique, needle assembly secured with a snap mechanism (or canted). (Predicate: Requires hinged lock release with a second hand before withdrawal, potential for tissue trauma if attempted directly from injection site; requires broken plunger to be pushed into other end of barrel). |
| Needle Gauge/Length Range | 18 to 30G, 5/16" to 1 ½" (Predicate: 20 to 29G, ½" to 1 ½") |
| Biocompatibility/Sterilization/Pyrogenicity | All materials passed Tripartite or ISO 10993 specifications. Biocompatibility and pyrogenicity testing (LAL Test method) and sterilization to be performed on complete devices before release. |
| User Preference/Safety (Simulated Clinical Study) | All injections successfully completed. 100% of investigators had a positive response to the evaluation and preferred the Syringex syringe over the predicate. No injuries of any kind reported. |
| Overall Performance (Bench & Simulated Clinical Conclusions) | "In all cases the Syringex Safety Syringe® was either equivalent to or exceeded the performance of the SafeSnap Syringe" (Bench Tests). "In all cases during the simulated clinical tests performed by healthcare professionals the Syringex Safety Syringe® was determined to be either equivalent to or exceeded the performance of the SafeSnap syringe" (Simulated Clinical Tests). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Over 600 Syringex Safety Syringes® were tested.
- Data Provenance:
- Country of Origin: Not explicitly stated, but the study was conducted at "3 hospitals and a veterinary center," implying a domestic (US) location given the FDA submission.
- Retrospective or Prospective: Prospective, as it was a "simulated use study conducted... by a variety of doctors, nurses, physician's assistants and veterinarians."
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)
- Number of Experts: More than 60 investigators.
- Qualifications of Experts: "a variety of doctors, nurses, physician's assistants and veterinarians." No specific experience levels are provided, but these are healthcare professionals.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe an adjudication method for the simulated clinical test results. The assessment appears to be based on direct feedback ("positive response") and observed outcomes (successful injections, no reported injuries) from the individual investigators. It's not a consensus-based ground truth establishment in the typical sense for diagnostic devices.
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
- MRMC Study: Not applicable. This is a medical device, not an AI/ML diagnostic or assistive tool for human readers.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: Not applicable. This is a physical medical device; its performance inherently involves human interaction during use. Bench testing provides data on the device's inherent mechanical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For Bench Tests: Compliance with ISO 7886-1 standards and direct comparison of physical/mechanical parameters against the predicate device.
- For Simulated Clinical Tests: User feedback (preference, positive response) from healthcare professionals, successful completion of injections, and absence of reported injuries. This is essentially user satisfaction and immediate safety/efficacy observation within a simulated environment.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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