(120 days)
The BioValve Insulin Delivery System (BIDS) is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
BioValve Technologies proposes to market a disposable pump for the basal and bolus delivery of insulin.
Here's an analysis of the provided text regarding the acceptance criteria and study for the BioValve Insulin Delivery Systems (BIDS):
Overall Assessment:
The provided document set is a 510(k) summary and the FDA's clearance letter for the BioValve Insulin Delivery Systems (BIDS). This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy or determining specific performance metrics against pre-defined acceptance criteria in the same way a clinical trial for a new drug or an AI-powered diagnostic might.
Therefore, many of the requested elements for a detailed study report (like sample sizes, ground truth establishment, MRMC studies, standalone performance metrics, etc.) are not present in this type of regulatory submission. The "performance data" mentioned in the 510(k) summary refers to demonstrating that the device functions equivalently to its predicate, often through bench testing and engineering comparisons, not necessarily through a clinical study with detailed statistical outcomes.
Acceptance Criteria and Device Performance Study Analysis
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness equivalent to predicate devices | Stated to be "substantially equivalent" to predicate devices like the Insulet iXL Diabetes Management System (K031373) and other Insulin Infusion Pumps/Subcutaneous Insulin Infusion Sets in terms of performance. |
| Ability to deliver insulin at set and variable rates | The device is "indicated for the continuous delivery of insulin, at set and variable rates." Performance data supports that "the performance of the pumps is equivalent to the predicate devices." |
| Absence of electronic power/components/software control | Confirmed: "this device does not use electronic power or components nor is it software controlled." |
| Compliance with general controls (GMP, labeling, registration, etc.) | FDA's clearance letter explicitly states: "You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820)." |
Explanation:
The acceptance criteria are not explicitly listed in numerical targets (e.g., "accuracy > 95%"). Instead, the primary acceptance criterion is substantial equivalence to existing legally marketed devices, particularly the Insulet iXL Diabetes Management System (K031373). The reported device performance is that it meets this substantial equivalence. The "performance data" mentioned is to demonstrate this equivalence, likely through engineering tests, comparison of materials, and functional testing to show it operates similarly for continuous insulin delivery.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided documents. In a 510(k) for a mechanical device like this, the "test set" would typically refer to bench testing or engineering verification rather than a clinical dataset of patients.
- Data Provenance: Not specified. Again, for this type of device, the "provenance" would relate to where the engineering tests were conducted, not patient data from a specific country or whether it was retrospective/prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable/specified. This type of regulatory submission for a simple mechanical device typically relies on engineering and functional testing, not expert consensus on ground truth labels for a dataset.
- Qualifications of Experts: Not applicable/specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/specified. Adjudication methods like "2+1" or "3+1" are used for resolving disagreements in expert labeling of data, which is not relevant for this type of device submission.
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
- MRMC Study: No. This is a non-AI, mechanical insulin pump. MRMC studies are specific to evaluating diagnostic algorithms, often AI-powered, and their impact on human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No. This device is a mechanical pump and does not involve an "algorithm" in the sense of a software-based diagnostic or decision support tool. Its performance is inherent in its mechanical function.
7. The Type of Ground Truth Used
- Type of Ground Truth: For a device like this, the "ground truth" for its performance would be based on engineering specifications and validated functional tests. This would include parameters like:
- Accuracy of insulin delivery (flow rate, dose per actuation).
- Reliability (consistent performance over time, resistance to occlusion).
- Safety (leakage, biocompatibility of materials).
- These are validated against established industry standards and the performance of predicate devices. It is not "expert consensus," "pathology," or "outcomes data" in the context of clinical diagnostics.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. As this is not an AI/ML device, there is no "training set" in the computational learning sense. The device is designed, built, and tested based on engineering principles.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable. There is no training set for this mechanical device.
Summary of what the documents do tell us:
The 510(k) summary and FDA letter confirm that the BioValve Insulin Delivery Systems (BIDS) achieved substantial equivalence to predicate devices. This means the FDA determined that the device is as safe and effective as other legally marketed insulin infusion pumps. This determination was based on "Performance Data" which, in this context, refers to engineering and functional testing demonstrating that the BIDS operates similarly to existing devices for its intended use (continuous insulin delivery at set and variable rates), despite having different technological characteristics (no electronic power or software).
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).