(90 days)
The Mallya Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information from compatible reusable and disposable pen injectors.
The device is made of two parts to be assembled onto a pen injector. The Mallya base part (about 6 x 3 x 2 cm) which clips around the body of the injection pen and the Mallya button (about 2.5 x Ø2 cm) that slips over the injection pen button. A USB cable, necessary to charge the MALLYA device, and a reset key are also provided in the package.
This is a description of the Mallya Injection Pen Adapter, K222689. The document is for a 510(k) premarket notification, indicating it's a medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Electromagnetic Compatibility and Electrical Safety | IEC 60601-1 and appropriate collateral requirements (IEC 60601-2 and IEC 60601-1-11) | Not explicitly stated "met," but implied to have been conducted as "Data on the following testing were generated verifying the design of the device." This implies successful completion. |
| Performance (Bench Testing) | ISO 11608-1 (as a guide) | Not explicitly stated "met," but implied to have been conducted as "Data on the following testing were generated verifying the design of the device." This implies successful completion, and specific sub-criteria are listed below. |
| Performance (Dose Accuracy) | Dose accuracy of pen is not affected by Mallya | Implied successful completion as "Dose accuracy of Mallya dose recording has been assessed and verified during Design Verification." and listed as part of performance data. |
| Performance (Recording and Transmission Accuracy) | Recording and transmission Accuracy | Implied successful completion as "Dose accuracy of Mallya dose recording has been assessed and verified during Design Verification." and listed as part of performance data. |
| Performance (Dose Prime Differentiation) | Dose Prime Differentiation | Listed as part of performance data, implying successful evaluation. |
| Performance (Complete Dose Notification) | Complete Dose Notification | Listed as part of performance data, implying successful evaluation. |
| Performance (Incomplete Injection Identification) | Incomplete Injection Identification | Listed as part of performance data, implying successful evaluation. |
| Performance (Physical Interaction with pen) | Force to mount, maintain, and remove Mallya | Listed as part of performance data, implying successful evaluation. |
| Biocompatibility | ISO 10993-1 and FDA guidance; permanent contact with intact skin | Not explicitly stated "met," but implied to have been conducted as "Data on the following testing were generated verifying the design of the device." This implies successful completion. |
| Lifetime | Operational/Function for 2 years (Use Lifetime) following storage for up to two years (Shelf Life) | The product met test criteria to verify it will operate/function for 2 years (Use Lifetime) following storage for up to two years (Shelf Life). |
| Cybersecurity | Cybersecurity Testing and Software Verification and Validation per FDA Guidelines | Not explicitly stated "met," but implied to have been conducted as "Data on the following testing were generated verifying the design of the device." This implies successful completion. |
| Human Factors | HF Validation per FDA guidance | Not explicitly stated "met," but implied to have been conducted as "Data on the following testing were generated verifying the design of the device." This implies successful completion. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size used for the test set (e.g., number of injections, number of devices tested). It mentions "Bench testing on performance, using ISO 11608-1 as a guide" and "Design Verification." It does not provide information on the country of origin of the data or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document does not provide details on the number of experts or their qualifications for establishing ground truth for the test set. The tests appear to be primarily engineering and performance-based (bench testing, dose accuracy assessments) rather than involving subjective expert interpretation of medical images or conditions.
4. Adjudication method for the test set
The document does not discuss any adjudication method (e.g., 2+1, 3+1). The nature of the tests (bench testing, electrical safety, lifetime, etc.) suggests objective measurements rather than subjective assessments requiring adjudication.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The Mallya Injection Pen Adapter is a device that captures and transmits dosing information; it is not an AI-powered diagnostic or assistive tool for human readers interpreting medical cases. Therefore, the concept of improving human readers with AI assistance does not apply to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone mechanism for capturing and transmitting data from an injection pen. Its performance (e.g., dose recording accuracy, transmission accuracy) would inherently be "standalone" in the sense that the device performs these functions automatically without direct human intervention in the data capture and transmission process itself. However, it requires a human to operate the injection pen. The specific "standalone" performance details (like sensitivity, specificity, accuracy metrics typically associated with algorithms) are not presented in this summary beyond general statements of accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth for most of the performance tests would be objective physical measurements or established engineering standards. For example:
- Dose accuracy: The ground truth would be the actual dose dialed and delivered by the injection pen, measured precisely using calibrated equipment.
- Recording and transmission accuracy: The ground truth would be the known, actual dose input/occurrence, compared to what the Mallya device records and transmits.
- Electrical safety/EMC: Ground truth is defined by compliance with the referenced IEC standards.
- Lifetime: Ground truth is reaching or exceeding the specified operational and shelf life under test conditions.
8. The sample size for the training set
The document does not mention any "training set." This type of device does not typically involve machine learning or AI models that require training data in the conventional sense. Its functionality is based on sensing physical rotation and transmitting data, rather than learning patterns from a dataset.
9. How the ground truth for the training set was established
As there is no mention of a training set or machine learning components, this question is 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).