(51 days)
The Unifine Pentip are intended for the subcutaneous injection of drugs from prefilled cartridges used in conjunction with variable dose delivery systems such as Pen Injectors. Its intended use is substantially equivalent to that of the BD Microfine.
The Unifine Pentip is single use, disposable hypodermic single lumen needle designed for use with multidose injection devices that use prefilled cartridges.
The protective paper is removed from the Pentip which is then screwed onto the device cartridge housing and then used in the prescribed manner.
One of the main uses of the Pentip is for use with pen Injectors for the delivery of insulin which is supplied in the form of prefilled cartridges. The patient places a fresh Pentip needle onto the Pen Injector, dials a dose, inserts the Pentip into the skin and delivers the dose.
The Owen Mumford Unifine Pentip is visually and mechanically extremely similar to the BD Microfine Pentip to which substantial equivalence is claimed.
I am sorry, but the provided text does not contain the detailed study information required to fill out the table and answer all the questions about acceptance criteria and device performance.
The document is a 510(k) submission for the Unifine Pentip, claiming substantial equivalence to the Becton Dickinson Microfine Pentip. While it states that the performance is "substantially equivalent," it does not provide specific acceptance criteria, quantitative performance metrics, or details about a study conducted to demonstrate this equivalence.
Here's a breakdown of what cannot be extracted from the provided text:
- Acceptance Criteria Table: No specific criteria (e.g., success rate, accuracy, failure rate) are mentioned.
- Reported Device Performance: No quantitative performance data is provided for the Unifine Pentip.
- Sample size for the test set: Not mentioned.
- Data provenance (country, retrospective/prospective): Not mentioned.
- Number of experts used for ground truth: Not applicable, as no such study is described.
- Qualifications of experts: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not mentioned.
- Effect size of human reader improvement: Not applicable.
- Standalone (algorithm only) performance study: Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable, as no study establishing ground truth is described.
- Sample size for the training set: Not applicable, as this is a physical medical device, not an AI algorithm.
- How ground truth for training set was established: Not applicable.
The document focuses on regulatory approval based on substantial equivalence to an existing marketed device, citing similarity in design, intended use, and operational principles, and noting that the product has been marketed in Europe without adverse reports. It does not include a detailed clinical or performance study with quantified acceptance criteria as might be expected for an AI/algorithm-based device.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).