(128 days)
For subcutaneous and intramuscular use.
The function of the NMT Safety Syringe is to provide a safe and reliable method of injecting medication into a patient that also protects the user from potential needlesticks.
The NMT Safety Syringe functions as a conventional hypodermic syringe except for its ability to retract the contaminated needle inside the syringe immediately after the completion of the patient injection. Complete delivery of the syringe contents activates the retraction mechanism.
The NMT Safety Syringe is a standard piston syringe with integral needle. The syringe incorporates automatic retraction technology that enables contaminated needles to be withdrawn, safely inside the body of the syringe when the syringe plunger is fully depressed.
The NMT Safety Syringe is available as a 3cc syringe with 20 to 25g needles.
Here's a summary of the acceptance criteria and study information for the NMT Safety Syringe, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Device Function: Injection of Medication | Safe and reliable method of injecting medication into a patient. | Functions as a conventional hypodermic syringe for injecting medication. Explicitly deemed "safe and reliable" for this purpose by the manufacturer. |
| Device Function: Protection from Needlesticks | Protects the user from potential needlesticks. | The contaminated needle is automatically withdrawn inside the syringe immediately after the completion of patient injection, activated by complete delivery of syringe contents. This protects the user from accidental needlesticks that occur between removing the needle from the patient and disposing of the syringe. |
| Equivalence to Predicate Device | Either equivalent to, or exceeds the performance of the VanishPoint™ syringe (K946219) across key operations. | Bench testing was conducted to evaluate: |
- Dead space in the device
- Graduated capacity
- Forces involved with the operation of the retraction mechanism
- Pressure rating of the devices under worst-case static loading.
In all cases, the NMT Safety Syringe was either equivalent to, or exceeded the performance of the VanishPoint™ syringe. |
| One-handed Operation | Designed for one-handed operation. | The NMT Safety Syringe is stated to be designed for one-handed operation, similar to the predicate device. |
| Retraction Mechanism | Utilizes springs to retract the needle when the plunger is fully depressed. | The device incorporates automatic retraction technology that enables contaminated needles to be withdrawn, safely inside the body of the syringe when the syringe plunger is fully depressed. It utilizes springs for this mechanism, similar to the predicate device. Complete delivery of syringe contents activates the retraction mechanism. |
| Intended Use | Subcutaneous and intramuscular use. | Explicitly stated in the "Indications for Use" section for "subcutaneous and intramuscular use." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the bench testing. It only states that "Bench testing has been conducted to examine the key operations."
- Data Provenance: The bench testing appears to be conducted by the manufacturer, New Medical Technology Ltd. The contact details for the submitter are "New Medical Technology Ltd., Oakbank Park, Livingston, Scotland, EH53 OTH, UK." This suggests the testing was performed in the UK and is prospective in nature, as it was conducted specifically to demonstrate equivalence for this 510(k) submission.
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 study described is bench testing, which typically does not involve human expert adjudication in the same way clinical studies with diagnostic devices do. The "ground truth" for the performance metrics (e.g., dead space, forces, pressure rating) would be established through engineering measurements and adherence to design specifications and industry standards.
4. Adjudication method for the test set
This information is not applicable as the described study is bench testing, not a clinical study requiring adjudication of expert interpretations.
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
There is no MRMC comparative effectiveness study mentioned. This device is a physical medical device (safety syringe), not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the NMT Safety Syringe is a physical medical device, not an algorithm. Therefore, "standalone algorithm performance" is not relevant to its evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the bench testing would be engineering measurements and objective performance metrics compared against predefined design specifications, industry standards, and the performance of the predicate device (VanishPoint™ syringe). For example, dead space would be measured, retraction forces would be quantified, and pressure resistance would be tested.
8. The sample size for the training set
This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that 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, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).