(282 days)
The V-Go Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 20 Units of insulin in one 24hour time period (0.83U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin.
The V-Go 30 Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 30 Units of insulin in one 24hour time period (1.25U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin.
The V-Go 40 Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 40 Units of insulin in one 24hour time period (1.67U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin.
The Valeritas V-Go Disposable Insulin Delivery Device is a mechanical (no electronics), self-contained, sterile, patient fillable, single-use disposable insulin infusion device with an integrated stainless steel subcutaneous needle. It is designed for the subcutaneous infusion of insulin for the management of diabetes mellitus in persons requiring insulin. After filling the V-Go with insulin using the EZ Fill, the device is secured to the patient's skin over the infusion site with an adhesivebacked foam pad, which is attached to the back of the pump. Once activated, the V-Go delivers a continuous infusion of insulin at a fixed rate. The device also allows the user to initiate bolus injections to supplement their daily basal insulin requirements. Three device models (20, 30 and 40 Units/day) will be available to address the different basal and bolus requirements of each patient. A window in the top of the pump allows the user to see into the reservoir to check the drug and to monitor the progress of the infusion.
The Valeritas V-Go Disposable Insulin Delivery Device is a mechanical, self-contained, sterile, patient-fillable, single-use disposable insulin infusion device designed for the subcutaneous infusion of insulin for the management of diabetes mellitus. It comes in three models (V-Go 20, V-Go 30, and V-Go 40) which offer different basal rates and on-demand bolus dosing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Operational Specifications | Acceptance Criteria | V-Go 20 Reported Performance | V-Go 30 Reported Performance | V-Go 40 Reported Performance |
|---|---|---|---|---|
| Reservoir Volume | Not explicitly stated as acceptance criteria, but reported values are: | 560 (56 µL of insulin) | 660 (66 µL of insulin) | 760 (76 µL of insulin) |
| Basal Rate | Not explicitly stated as acceptance criteria, but reported values are: | 8.3 (0.83 IU/hr) | 12.5 (1.25 IU/hr) | 16.7 (1.67 IU/hr) |
| Bolus Increments | Not explicitly stated as acceptance criteria, but reported values are: | 2U, 18 Actuations | 2U, 18 Actuations | 2U, 18 Actuations |
| Nominal Bolus Volume | Not explicitly stated as acceptance criteria, but reported values are: | 36U (36 IU) | 36U (36 IU) | 36U (36 IU) |
| Basal Volume (24 Hours) | Not explicitly stated as acceptance criteria, but reported values are: | 20U (20 IU) | 30U (30 IU) | 40U (40 IU) |
| Accuracy | +/- 10% | +/- 10% | +/- 10% | +/- 10% |
| Temperature | +5 to +37°C | Passed | Passed | Passed |
| Humidity | 20 - 90% | Passed | Passed | Passed |
| Water Ingress Protection (IPX8) | Submerged at 1 meter for 24 hours | Passed | Passed | Passed |
| Atmospheric Testing | 0-10,000 feet | Passed | Passed | Passed |
| Biocompatibility | Compliant with ISO 10993-1 | Passed | Passed | Passed |
| Drug Compatibility with Insulin | Stable for duration of use | Passed | Passed | Passed |
| Sterilization (SAL 10⁻⁶) | Compliant with ANSI/AAMI ST67:2003(R)2008 | Passed | Passed | Passed |
| Pyrogen Free | USP Bacterial Endotoxin Testing Gel Clot Method, max limit 20EU/device | Passed | Passed | Passed |
| Packaging Stability | Maintain sterility integrity for up to 36 months per AAMI/ISO 11607-1:2006 | Passed | Passed | Passed |
| Drug Stability (Humalog in V-Go) | Stable for up to 24 hours storage + 24 hours wear | Passed | Passed | Passed |
| EZ Fill Compatibility with Humalog | Acceptable for filling for up to 30 days use | Passed | Passed | Passed |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes for each non-clinical performance test. It broadly states "Results of performance testing demonstrated substantial equivalence". No information on data provenance (country of origin, retrospective/prospective) for these tests is provided, as they are non-clinical (device performance tests, not patient data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The tests performed are non-clinical, evaluating physical and operational specifications of a medical device against established standards and internal criteria. They do not involve expert consensus on medical diagnoses or interpretations.
4. Adjudication Method for the Test Set:
Not applicable. The tests are objective measurements of device performance against predefined criteria or standards, not subjective interpretations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical performance data is required to validate the intended uses and user needs of the system. Design validation is completed by human factors simulated use and clinical evaluation testing." This indicates the focus was on non-clinical performance and human factors, rather than a direct comparison of human reader performance with and without AI assistance. The device is a mechanical insulin delivery system, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the non-clinical performance data described (e.g., accuracy, environmental specifications, biocompatibility, sterilization, packaging stability, drug stability) represents standalone testing of the device's inherent performance characteristics. There is no "algorithm" in the sense of AI; the device is mechanical. These tests evaluate the device itself without human intervention affecting its core function.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical tests is based on:
- Engineering specifications and design requirements: For parameters like reservoir volume, basal rate, bolus increments, and nominal bolus volume.
- Industry standards and regulations: Such as AAMI ID26, IPX8 for water ingress, ISO 10993-1 for biocompatibility, ANSI/AAMI ST67:2003(R)2008 for sterilization, USP for pyrogen testing, and AAMI/ISO 11607-1:2006 for packaging stability.
- Validated laboratory testing methods: To assess accuracy, environmental resilience, and material compatibility.
For drug stability, the ground truth is established by testing the stability of Humalog insulin within the device and the EZ Fill accessory over specified durations.
8. The Sample Size for the Training Set:
Not applicable. The device is a mechanical insulin delivery system, not an AI/ML algorithm that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there's no AI/ML algorithm, there's no training set or corresponding ground truth establishment process in that context.
§ 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).