(130 days)
The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.
The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes age 12 and older by calculating an insulin dose or carbohydrate intake based on user entered data. Prior to use, a healthcare professional must provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software.
The InPen System consists of a manually-controlled pen injector and an app containing a logbook and a dose (bolus) calculator.
The InPen is a manual pen injector containing a non-replaceable battery and electronics to communicate via Bluetooth® with the app on an iOS® mobile device. The intended dose is manually set by the user by rotating a dose knob. The insulin is injected by manually depressing the dose knob which causes the piston in the insulin cartridge to expel the intended dose. The InPen is provided in two different models for compatibility with the available U-100 insulin cartridges, i.e. Humalog®, Novolog®, and Fiasp®. The device is provided with Instructions For Use and a Quick Start Guide. The device is used with sterile needles and U-100 insulin cartridges (supplied separately).
The app is designed to manage the wireless transfer of insulin dose data from the InPen, log insulin dose data, and provide a dose calculator to aid mealtime insulin dose calculations. The insulin dose calculations provided by the app are meant for patients undergoing multiple daily injection (MDI) therapy. The InPen app is not intended to serve as an accessory to an insulin pump.
The provided text describes a 510(k) premarket notification for the InPen System, focusing on its substantial equivalence to a previously cleared predicate device (K160629). It primarily addresses the device's compatibility with an additional insulin cartridge (Fiasp®) and the InPen app's dose calculator.
Based on the provided information, I can extract the following details regarding acceptance criteria and performance study:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present a table of "acceptance criteria" for the entire InPen System in the typical sense of quantitative targets. Instead, it demonstrates continued conformance to existing standards and principles for both the pen injector and the app.
Here's a summary of the attributes compared and the reported performance, indicating that the new device meets the same standards as the predicate:
| Attribute | Acceptance Criteria (Implied / Standard) | Reported Device Performance |
|---|---|---|
| InPen Pen Injector | ||
| Classification | Class II - FMF - 21 CFR §880.5860 | Same (Subject Device is Class II - FMF - 21 CFR §880.5860) |
| Indications For Use | Same as predicate, with added Fiasp® compatibility | Fiasp® compatibility does not raise new safety/effectiveness questions. Labeling updated to mitigate errors. |
| Cartridge Volume | 3 ml (300 units) | Same |
| Drug | U-100 insulin | Same |
| Syringe Type | Piston Syringe | Same |
| Single Patient Use | Yes | Same |
| Reusable Device | Yes | Same |
| Dose Accuracy | Meets ISO 11608-1 requirements | Meets ISO 11608-1 requirements |
| Biocompatibility | Meets ISO 10993-1 requirements | Meets ISO 10993-1 requirements |
| Maximum Dose | 30 Units | Same |
| User Feedback | Audible and tactile clicks per increment | Same |
| Dose Dialing | Two-way | Same |
| Battery | Non-rechargeable | Same |
| Electronics | Folded Flex Circuit | Same |
| Software | Yes | Same |
| Dose Delivery | Mechanical | Same |
| Unit Increments | Half-Unit increments after 0.5 Unit | Same |
| Dimensions | 6.5″ x ø0.6″ | Same |
| Weight | 35 grams | Same |
| Fluid Pathway Contact | None | Same |
| Dose Calculator Communication | Yes | Same |
| InPen App | ||
| Classification | Class II - NDC - 21 CFR §868.1890 | Same (Subject Device is Class II - NDC - 21 CFR §868.1890) |
| Indications For Use | Same as predicate | Same (No changes to app) |
| Prescription Use | Yes | Same |
| User Group | Diabetes patients with MDI therapy | Same |
| Communication with insulin pumps | No | Same |
| Software Level of Concern | Major | Same |
| Wireless Connectivity | Bluetooth Low Energy (BLE) | Same |
| Control or affect blood glucose measurements | No | Same |
| Control or affect insulin delivery | No | Same |
| Reports, graphs, and Electronic Log Book | Yes | Same |
| Meal Size Entry | Grams of carbohydrates | Same |
| Insulin Dose Calculator | Calculates doses for meals & corrections, accounts for IOB | Same |
| Carbohydrate Calculator | Calculates carbohydrate intake based on user data | Same |
| Manual Dose Entry | Yes | Same |
| InPen Dose Entry | Yes | Same |
| Tracking of residual bolus insulin to mitigate stacking | Yes | Same |
| Operating platform | Android and iOS platforms | Same |
| UI Standards | Android and iOS standards | Same |
2. Sample size used for the test set and the data provenance:
- InPen Pen Injector (Fiasp® compatibility):
- Sample Size: Not explicitly stated as a number of devices or injections. The compliance is demonstrated by "demonstrating conformance to ISO 11608-1...and Part 2" and "hazard analysis according to ISO 14971". This typically involves a defined number of test units and test conditions as specified by the ISO standards.
- Data Provenance: Not specified, but generally, ISO standard testing is conducted in controlled laboratory environments. No indication of retrospective or prospective human clinical data.
- Labeling Changes Validation:
- Sample Size: Not explicitly stated but mentions "human factors testing." Human factors testing involves a representative user sample, but the specific number is not provided.
- Data Provenance: Not specified. This would typically be prospective data collected during human factors studies.
- InPen Dose Calculator (Fiasp® compatibility):
- Sample Size: Not applicable. The compatibility was shown through "clinical literature review." No new test set was used for this aspect of the calculator.
- Data Provenance: Clinical literature (specifically referencing "Mudaliar et al (1999)").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the InPen Pen Injector and Labeling Changes: Not explicitly stated. For ISO standard compliance, the "ground truth" is typically the standard itself, validated by accredited testing labs or internal quality assurance. For human factors, experts review the results, but their specific number and qualifications are not detailed.
- For the InPen Dose Calculator: No new "ground truth" was established based on expert consensus for the Fiasp® compatibility beyond the existing clinical literature review. The "ground truth" for the original algorithm would have been established during the predicate device's clearance, likely through clinical trials and medical expert validation, but this information is not in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe any adjudication method (like 2+1 or 3+1 refereeing) for establishing ground truth or evaluating performance. The assessment relies on compliance with ISO standards, hazard analysis, human factors testing, and clinical literature review.
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:
- No MRMC comparative effectiveness study was done or is mentioned in the provided text. The InPen System is not an AI-assisted diagnostic tool where "human readers" (e.g., radiologists) would be evaluating cases with or without AI assistance. The dose calculator is a direct calculation tool, not an AI interpretation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, for the InPen Pen Injector's compatibility with Fiasp®: Conformance to ISO 11608-1 (Part 1 and Part 2) is a standalone performance test of the device's mechanical and functional aspects, independent of a human user in a clinical setting at the time of testing.
- Yes, for the InPen Dose Calculator's compatibility with Fiasp®: The assessment was based on "clinical literature review," which is an algorithm-only (or calculation-principle-only) evaluation against existing clinical understanding, without direct human-in-the-loop testing for this specific change. The app's calculator algorithm itself performs independently once parameters are set.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- InPen Pen Injector: Conformance to ISO 11608-1 standards (which define precision, accuracy, and other physical characteristics of injection systems) and ISO 14971 (risk management). These are engineering and safety standards, representing an accepted "ground truth" for device performance characteristics.
- Labeling Changes: Likely human factors engineering principles and results of user testing, representing the "ground truth" for usability and clarity.
- InPen Dose Calculator: Clinical literature review (specifically mentioning Mudaliar et al (1999) for duration of insulin action). This implies the "ground truth" for the dose calculation algorithm's underlying physiological models and parameters is derived from established medical knowledge and clinical research.
8. The sample size for the training set:
- The document describes a 510(k) submission for a device change (Fiasp® compatibility) and the app remaining unchanged. There is no mention of a "training set" in the context of machine learning or AI algorithm development for the current submission. The InPen dose calculator, as described, performs calculations based on user-entered data and pre-programmed parameters (target BG, I:C ratio, ISF) provided by a healthcare professional, rather than being an adaptive AI model trained on a dataset. The original algorithm for the predicate device would have been developed and validated, but details about its training set are not in this document.
9. How the ground truth for the training set was established:
- As noted above, no "training set" for a machine learning algorithm is discussed in this submission. For the underlying principles of the dose calculator, the "ground truth" for its rules and parameters would have been established through established medical guidelines, clinical trials, and medical expertise during the development of the original algorithm for the predicate device. The current submission relies on the existing algorithm and its previous validation, plus a literature review for Fiasp® compatibility, not a new training process.
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).