(33 days)
A general purpose hand-held mechanical device intended for the subcutaneous injection of Insulin and other approved drugs. The device is designed for use with disposable 1ml non-fixed needle syringe and to accommodate self use in the home by the patient in order to aid and support compliance with the recommended treatment regime.
A hand-held general purpose mechanical injection device for the sub-cutaneous injection of Insulin and other approved medicines.
The provided text describes a 510(k) submission for the "Autoject®2 Non-Fixed Needle type" syringe introducer. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a comprehensive study with defined performance metrics and ground truth.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable in the context of this 510(k) summary. The submission focuses on demonstrating equivalence to an existing device, the Autoject® 2 (Fixed Needle type), by highlighting similarities in design, intended use, and general performance.
Here's a breakdown of the information as it relates to the provided text:
Acceptance Criteria and Device Performance
Since this is a 510(k) submission for substantial equivalence, formal "acceptance criteria" as would be set for a novel device proving its efficacy and safety are not explicitly stated within the provided text. The primary acceptance criterion for the FDA in this context is the demonstration of substantial equivalence to a predicate device.
The document states: "The Autoject® 2 (Non-fixed Needle type) is visually identical to and has the same area of intended use i.e. for the sub-cutaneous injection of medicament, as the current 510(K) approved Autoject® 2 (Fixed Needle type) device to which substantial equivalence is claimed."
The specific performance aspect mentioned is "dose accuracy."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Autoject® 2 (Fixed Needle type) | Claimed to be substantially equivalent in principle, design concepts, applications, and performance. |
| Dose Accuracy (implicit) | "Due to a small amount of residual drug being left in the space between the syringe and the needle hub the dose accuracy results show a slightly lower level of performance. However, if this residue is taken into account the performance of both types of devices are extremely close." |
Study Details
The document mentions "NON-CLINICAL TRIAL DATA" and references "the study carried out in Australia." However, the details of this study are very limited in the provided text.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text.
- Data Provenance: A study was "carried out in Australia." It's not specified if it was retrospective or prospective.
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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. The provided text does not describe a study involving expert-established ground truth for a test set in the way you might find for a diagnostic or AI device. The study mentioned is for a mechanical injection device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No information on adjudication methods for a test set is provided as this is not a diagnostic device or a study requiring such an approach.
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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
- No. This is a mechanical injection device. MRMC studies and AI assistance for human readers are entirely irrelevant to this device and its 510(k) submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a mechanical injection device. The concept of an "algorithm only" or "human-in-the-loop" performance study does not apply.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for a mechanical device like this would likely relate to objective physical measurements (e.g., dose delivered, injection depth, force required) rather than expert consensus on diagnostic interpretations, pathology, or outcomes data in the typical sense. The text mentions "dose accuracy results," implying quantitative measurements.
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The sample size for the training set
- Not Applicable. This is a mechanical device, not a machine learning algorithm requiring a training set.
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How the ground truth for the training set was established
- Not Applicable. As above, no training set for an algorithm is involved.
§ 880.6920 Syringe needle introducer.
(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).