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510(k) Data Aggregation
(36 days)
The B-D insulin pen injector is designed for use by and for diabetics for the subcutaneous injection of a desired dose of insulin. The B-D insulin pen injection is designed for asse by and to freatment of diabetes.
The B-D Insulin pen injector is designed for use by and for diabetics for the subcutaneous injection of a desired dose of insulin. The pen injector uses a cartridge of insulin (supplied by others) and a single use, detachable and disposable pen needle (sold separately).
The product consists of three main mechanical assemblies: A dosing mechanism, vial retainer, and cap/clip assembly. The dose set knob can be adjusted to any two (2) unit increments between two (2) and sixty (60) units by rotating the dose set knob counter clockwise until the desired dose is set. The pen needle can then be inserted into the body and by pushing in the dose set knob, the clutch assembly rotates in the opposite direction (clockwise) and the lead screw moves forward causing pressure to build up in the cartingge and insulin to be dispensed through the injector needle. After repeated injections, the insulin cartridge becomes depleted and must be replaced. During cartridge replacement, the lead screw is reset by unlocking the retracting mechanism and returning the lead screw to its start position. A new cantridge can then be inserted into the vial retainer.
This document describes the B-D 3 ml Pen, an insulin injector for diabetics, and its performance evaluation.
1. Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against proposed ISO standards for dose accuracy and functionality.
| Acceptance Criteria (Proposed ISO Standards) | Reported Device Performance |
|---|---|
| Dose accuracy across various conditions (standard, cool, hot atmosphere, life-cycle, dry heat, cold storage, cyclical atmosphere) | Met proposed ISO standards for dose accuracy at all dose settings tested. Robust, repeatable, and consistent across environmental and mechanical challenges. |
| Functionality across various conditions (standard, cool, hot atmosphere, life-cycle, dry heat, cold storage, cyclical atmosphere) | Met proposed ISO standards for functionality. |
| Visual defects after exposure to environmental conditions and free falls | Examined for visual defects after exposure to dry heat, cold storage, cyclical atmosphere, and three one-meter free falls onto concrete. No specific findings regarding defects were reported in the provided text, but meeting overall ISO standards implies acceptable visual integrity. |
2. Sample Size and Data Provenance
The document does not explicitly state the exact sample sizes used for testing (e.g., number of pens tested, number of injections performed). The studies appear to be prospective as they involved testing the pens under controlled conditions. The country of origin of the data is not specified, but the submission is to the U.S. FDA.
3. Number of Experts and Qualifications
The document does not mention the use of experts to establish a ground truth for the test set. The evaluation seems to be based on objective measurements of dose accuracy and functionality in relation to the ISO standards.
4. Adjudication Method
No adjudication method is mentioned or implied, as the performance evaluation relies on objective measurements against predefined standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The device is a mechanical insulin injector, not an AI or imaging device that would typically involve human readers for interpretation.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The "Performance Summary" section details the testing of the B-D 3 ml Pen itself to assess its dose accuracy and functionality under various environmental and mechanical challenges. The results indicate the device's inherent performance.
7. Type of Ground Truth Used
The ground truth for the performance evaluation was based on objective measurements of dose accuracy and functionality against proposed ISO standards. This is a form of empirical measurement against pre-defined engineering and performance specifications.
8. Sample Size for the Training Set
This information is not applicable. The B-D 3 ml Pen is a mechanical device, not an AI model that requires a training set.
9. How Ground Truth for Training Set was Established
This information is not applicable, as there is no training set for a mechanical device.
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