(89 days)
The intended use of the Amersham Health Needle Guard is to withdraw medications from a vial or ampule and to inject these medications subcutaneously, intramuscularly, intravenously, or via I.V. access ports. This device may aid in the prevention of needlestick injury.
The Amersham Health Needle Guard is a sterile, single use hypodermic needle designed to be used in conjunction with a disposable 3ml synnge. The device consists of six basic constituents, a Stainless Steel needle bonded to a Nylon hub, a Polypropylene cannula cover, a Nylon Luer attachment connected to a Polysulfone Luer hub used to connect to a syringe, and a PETG Protective sleeve. Once the Amersham Health Needle Guard is attached to a syringe, the cannula cover is removed, exposing the needle. In this condition the needle can be inserted into a vial or ampule to withdraw medication into the syringe or to administer the medication through injection. Once the needle is withdrawn from the patient, the sleeve is pushed forward to the locked safety position for disposal. The sharps safety feature is an active safety feature
The provided text describes the Amersham Health Needle Guard and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria for performance metrics (like accuracy, sensitivity, specificity, etc.) nor detailed results of a study proving the device meets such criteria. The study mentioned is primarily "simulated use testing" to assess the safety feature.
Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided document.
Here's the breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
The document generally states that the device "meets our specifications for hypodermic needles" and that "there were no unexpected risks in use of this device." However, specific numerical acceptance criteria for the safety feature's effectiveness (e.g., "X% reduction in needlestick injuries") are not provided.
Reported Device Performance:
The document states that "simulated use testing was conducted to determine the effectiveness of the safety feature mechanism in preventing accidental sharp object injuries" and that "based on the testing results and findings we have concluded that there were no unexpected risks in use of this device." No quantitative performance metrics (e.g., number of successful activations, percentage of avoided needlesticks during simulation) are reported.
| Acceptance Criteria (Generic as specific criteria not provided) | Reported Device Performance (Generic as specific performance not provided) |
|---|---|
| Device meets specifications for hypodermic needles. | Device "meets our specifications for hypodermic needles." |
| Safety feature effectively prevents accidental sharp object injuries. | "No unexpected risks in use of this device" based on simulated use testing. |
| Usability of "Instructions for Use". | "Determined the usability of the 'Instructions for Use'." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text for the simulated use testing. The document mentions "simulated use testing was conducted" but does not give a number of trials, users, or instances.
- Data Provenance: The simulated use testing was conducted, implying it's prospective, but the location/country of origin is not specified.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- Number of Experts: Not applicable/Not specified. The "ground truth" for the simulated use testing appears to be the observation of the device's safety feature performing its intended function without unexpected risks, rather than an assessment requiring multiple human experts.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not specified. Since there's no mention of multiple experts or subjective assessments, an adjudication method like 2+1 or 3+1 is not indicated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This type of study is for evaluating human performance with and without AI assistance, which is not relevant for a needle guard device.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: Not applicable. This device is a physical medical device, not an algorithm. Its "safety feature" is mechanical, not software-based in a way that would have standalone algorithmic performance.
7. Type of Ground Truth Used
- Type of Ground Truth: Observational assessment during "simulated use testing." The "effectiveness" and safety were determined by direct observation in a simulated environment, rather than expert consensus on complex images, pathology, or long-term outcomes data.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an AI/ML algorithm.
In summary, the provided documentation focuses on establishing substantial equivalence through non-clinical bench testing (compliance with ISO and ASTM standards) and a general "simulated use testing" for the safety feature. It lacks the quantitative performance metrics and study details typically associated with acceptance criteria for diagnostic or AI-powered devices.
§ 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).