(121 days)
FEELject NEEDLES is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
FEELject NEEDLES is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. . The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) The needle cap covers intended to provide physical protection to the needle tube.
The provided text describes a 510(k) premarket notification for a disposable hypodermic needle named FEELject NEEDLES, seeking substantial equivalence to a predicate device. The information focuses on the regulatory submission process and general device characteristics, not on a detailed study proving performance against specific acceptance criteria.
Therefore, many of the requested sections about a detailed study simply cannot be filled from the provided text.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Passed (device is non-toxic) |
| Sterility | Passed (sterilized by EtO gas) |
| General Performance (Fluid injection/aspiration) | Performs in a substantially equivalent manner to the predicate device |
| Pyrogenicity | Passed (device is non-pyrogenic) |
Missing Information:
- Specific quantitative limits or thresholds for "acceptance criteria" for biocompatibility, sterility, or pyrogenicity are not provided. The document only states that tests were performed and the device passed or met the requirements.
- Detailed performance metrics or quantitative results for fluid injection/aspiration are not provided. The phrase "performs in a substantially equivalent manner" is used.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information:
- Sample size for the test set: Not mentioned.
- Data provenance: Not mentioned.
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 / Missing Information:
- This type of expert-driven ground truth establishment is typically relevant for diagnostic or image-analysis devices. For a hypodermic needle, "ground truth" would be objective measurements and qualitative assessments from bench testing and manufacturing standards, not expert adjudication in the same sense.
- No experts are mentioned as being involved in establishing ground truth for the performance tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable / Missing Information:
- Adjudication methods like 2+1 or 3+1 are used for subjective interpretations, often in clinical trials or image reading studies. This is not relevant for the type of bench testing described for a hypodermic needle.
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 / Missing Information:
- An MRMC study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. This device is a hypodermic needle, and no AI component or human interpretation study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable / Missing Information:
- This refers to AI algorithm performance. The FEELject NEEDLES is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the performance described, the ground truth would be based on standardized test methods and specifications for medical devices, specifically hypodermic needles. This includes established physical, chemical, and biological test methods to assess properties like biocompatibility, sterility, pyrogenicity, and mechanical integrity (e.g., sharpness, flow rate, hub-needle bond strength). The document implies adherence to these standards to achieve substantial equivalence.
Missing Information:
- Specific details of these standards or how individual ground truth values were established for each test are not provided.
8. The sample size for the training set
Not Applicable / Missing Information:
- Training sets are for machine learning algorithms. This device is a physical hypodermic needle, not an AI model.
9. How the ground truth for the training set was established
Not Applicable / Missing Information:
- As above, training sets are not applicable to this 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).