(60 days)
The device is for the subcuraneous injection of insulin.
The Unifine range of Syringes is designed for the subcutaneous injection of insulin.
The Unifica range if syringes are ldentical to that of the Orientan range of syringss manufactured by B Braun. The syringes are manufactured, packed and mentised by B Braun and supplied to Owen Mumford for sale or distribution. No re-packaging roworking or modifications are made to the systems or packaging by Owen Mumford, The are supplied in three sizes (0.3ml, 0.5ml) in boxes of 100. The individual syringes are supplied in peel pouches and are sterilised using Ethylone Oxide.
This document is a 510(k) summary for the Unifine Insulin Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance as typically seen in AI/ML device submissions. Therefore, many of the requested categories about acceptance criteria, study details, ground truth, and expert involvement are not applicable or cannot be extracted from this specific filing.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The provided document does not contain a table of acceptance criteria or reported device performance in the context of a new study to demonstrate safety and effectiveness. Instead, it asserts substantial equivalence to a predicate device based on manufacturing identity.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No formal test set or corresponding study data is presented in this 510(k) summary to evaluate a new device's performance. The basis for clearance is substantial equivalence.
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. No ground truth establishment by experts for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 is a medical device clearance for an insulin syringe, not an AI/ML product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device and 510(k) Basis:
- Device Name: Unifine (Insulin syringes)
- Intended Use: Subcutaneous injection of insulin.
- Substantial Equivalence Claim: The Unifine syringes are stated to be identical to the Omnican Insulin Syringe manufactured and distributed by B. Braun (K962084). Owen Mumford Inc. sells and distributes these syringes without re-packaging, re-working, or modifications.
- Regulatory Conclusion: The FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. This determination is based on the claim of product identity with a previously cleared device, not on new performance study data.
§ 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).