(107 days)
Insulin pen needle is intended for use with pen injector for subcutaneous injection of insulin.
Insulin pen needle is a single-use device, which consists of needle tube, needle shield, needle seat, needle seat protection cover, and seat seal paper. Needle gauge includes 29G, 30G, 31G, and 32G. Needle length can be produced to various sizes. After sterilization by EO, it's sterile, pyrogen free, and non-toxic. Its shelf life is 5-year.
The provided text describes a 510(k) submission for an insulin pen needle. This type of medical device is generally evaluated through non-clinical testing to demonstrate substantial equivalence to predicate devices, rather than through complex clinical studies with human participants, AI algorithms, or extensive ground truth establishment. Therefore, many of the requested categories are not applicable in this context.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Performance (ISO Compliance) | Conforms to ISO 11608-2 (Needle systems for medical use - Requirements and test methods - Part 2: Pen needles) | Bench tests prove compliance with ISO 11608-2 |
| Material Composition (Needle Tube) | Made of SUS 304 stainless steel | Made of SUS 304 stainless steel |
| Material Composition (Needle Seat, Shield, Protection Cover) | Made of PP | Made of PP |
| Material Composition (Needle Seat Seal) | Made of Dialysis paper | Made of Dialysis paper |
| Biocompatibility | Conforms to ISO 10993 (Biological evaluation of medical devices) | Biocompatibility tests prove compliance with ISO 10993 |
| Sterility | Sterility Assurance Level (SAL): 1x10^-6 | SAL: 1x10^-6, EtO Sterilization |
| Pyrogenicity | Pyrogen free | Reported as "pyrogen free" |
| Toxicity | Non-toxic | Reported as "non-toxic" |
| Shelf Life | 5-year shelf life | Reported as "5-year shelf life" |
| Labeling and Indications for Use | Meet FDA requirements for labeling and intended use | Meets FDA requirements, Intended for use with pen injector device for subcutaneous injection of insulin. |
Study Details (Based on available information)
1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly mentioned for specific test types, but implied to be sufficient for ISO compliance and biocompatibility testing. This typically involves a statistically relevant number of samples per test as outlined by the standards.
- Data Provenance: The device manufacturer is Tiger Medical Products Ltd. in Shanghai, China. The testing was conducted by or on behalf of the manufacturer, likely in China or by certified labs. The tests are non-clinical (bench and biocompatibility).
2. 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. This is a non-clinical device that relies on standardized performance and biocompatibility testing, not expert interpretation of diagnostic images or clinical outcomes. The "ground truth" is established by the specifications of the ISO standards and the verifiable results of the tests.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- None. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where human interpretation is involved. For this device, performance is measured against established engineering and biological standards.
4. 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 single-use insulin pen needle, not a diagnostic or AI-powered device involving human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device does not incorporate any algorithms or AI component.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Standardized Test Results/Compliance with ISO Standards and Biocompatibility Protocols. The "ground truth" for this device lies in its ability to meet the defined technical specifications of ISO 11608-2, ISO 9626, ISO 7864, and the biological safety requirements of ISO 10993. This is verified through laboratory testing (e.g., force measurements, flow rates, sterility tests, cytotoxicity assays).
7. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/ML device.
8. How the ground truth for the training set was established
- Not Applicable. There is no "training set" or corresponding ground truth to establish.
§ 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).