(70 days)
The Haselmeier Pen is a hand-held mechanical device intended for the subcutaneous, self-administration of FDA-approved drugs and biologics. The Haselmeier Pen is designed to be used with 3.0 mL cartridges which are prefilled prior to an injection. The Haselmeier Pen is for use in the home environment to aid and support prescribed treatment and therapy.
The Haselmeier Pen is a self injection device for use as a reusable multiple dose delivery system for subcutaneous injections of FDA-approved drugs and biologics. A cartridge is loaded into the barrel of the pen and a needle attached. The user sets the dose required and delivers the dose by pressing down on the top of the dose button. After injection, the needle is removed from the pen and discarded.
The device is compatible with commercially available pen needles (supplied separately) that comply with: ISO 11608-2 2000 Pen-injectors for medical use - Part 2: Needles - Requirements and test method and 3-ml ISO type A cartridges (supplied separately), which meet ISO 11608-3 2000 Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test methods, with the following dimensions:
Overall cartridge length including aluminum cap: 63.9 mm ± 0.3 mm
Outside Cartridge Diameter: 11.94 mm MAX.
Inner Cartridge Diameter: 9.65 mm ± 0.1 mm measured at open end.
Maximum eccentricity of aluminum cap: 0.33 mm
The provided document is a 510(k) Premarket Notification for the Haselmeier Pen, an autoinjector. It states that the device has been demonstrated to perform as intended and is substantially equivalent to legally marketed devices. However, it does not contain specific acceptance criteria, detailed study results, or information regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or MRMC studies. The document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a detailed performance study against explicit criteria.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a summary of what information can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The implicit criteria are that it performs similarly to predicate devices. | "The Haselmeier Pen has been demonstrated to perform as intended." |
2. Sample size 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 specified.
- Data Provenance: Not specified. The document states "The Haselmeier Pen has been demonstrated to perform as intended," implying internal testing, but details are absent.
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/not specified. The document does not describe the establishment of ground truth for a test set in the context of expert review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not specified. There is no mention of an adjudication method as no expert review for a test set is described.
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 (autoinjector), not an AI diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device, not an algorithm. The "standalone performance" would relate to the device's mechanical function, which is described as "perform[ing] as intended," but specific test results are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/not specified in the sense of clinical ground truth for a diagnostic AI. For a mechanical device, "ground truth" would implicitly be its ability to accurately deliver a dose, be compatible with cartridges/needles, and function reliably. The document states the pen is compatible with ISO standards (ISO 11608-2 and ISO 11608-3) for needles and cartridges, implying these standards serve as the "ground truth" or performance benchmark for compatibility.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 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).