(74 days)
The InsoSAFE™ Bak'SNAP™ Retractable Insulin Safety Syringe is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe intended for subcutaneous injection of insulin into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
The InsoSAFE™ Bak'SNAP™ Retractable Insulin Safety Syringe is a sterile, singleuse, disposable and non-reusable, manual, retractable safety syringe intended for injection of insulin into the body, while reducing the risk of sharps injuries and the potential for syringe reuse. It is a sterile, single-use, with a pre-attached single lumen hypodermic needle. Syringe volumes include 1 mL, 0.5 mL, and 0.3 mL. Needles range in size from 25G to 29G, with lengths of 3/8 inch to 1/2 inches. The InsoSAFE™ is provided individually wrapped, in shelf boxes of 100 units.
The provided text describes a 510(k) submission for the InsoSAFE™ Bak'SNAP™ Retractable Insulin Safety Syringe. This document details the device's characteristics, intended use, and claims of substantial equivalence to predicate devices. It explicitly mentions "Verification and validation testing presented in this premarket notification includes testing to demonstrate conformance to standards and testing according to FDA guidance, 'Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions for Medical Devices with Sharps Injury Protection Features, December 2002'".
However, the document does not provide any specific acceptance criteria or detailed study results that prove the device meets these criteria. It states that testing was done to conform to standards and FDA guidance, but the actual results, sample sizes, ground truth establishment, or expert involvement are not included in this summary.
Therefore, I cannot populate the requested table or provide information about the study's specifics as those details are not present in the provided text.
Specifically, the following information is missing from the provided text:
- A table of acceptance criteria and the reported device performance: Not present.
- Sample sizes used for the test set and the data provenance: Not present. The text only mentions "testing" without any numbers or data source details.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth is mentioned for a diagnostic or AI device. This is a medical device (syringe), not a diagnostic or AI product.
- Adjudication method for the test set: Not applicable as no ground truth establishment is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI or diagnostic imaging device.
- If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no ground truth for performance is detailed.
- The sample size for the training set: Not applicable, as this is a physical medical device, not a machine learning model.
- How the ground truth for the training set was established: Not applicable, as this is a physical medical 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).