(55 days)
The V-Go Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of insulin in one 24hour time period and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin. Specific basal rates are indicated for each model: V-Go 20 (20 Units/day or 0.83U/hr), V-Go 30 (30 Units/day or 1.25U/hr), and V-Go 40 (40 Units/day or 1.67U/hr).
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 adhesive backed foam pad. 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. Three device models (20, 30 and 40 Units/day) will be available. 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Valeritas V-Go™ Insulin Delivery Device:
Disclaimer: This document describes a medical device, and the information presented here is based solely on the provided text. For full details and medical advice, always refer to the official documentation and consult with healthcare professionals.
The Valeritas V-Go™ Insulin Delivery Device is a mechanical, self-contained, sterile, patient-fillable, single-use disposable insulin infusion device for the management of diabetes mellitus. It provides continuous basal insulin infusion and on-demand bolus dosing.
The approval for this device (K103825) relies on substantial equivalence to a predicate device (K100504), implying that its performance characteristics are similar. The primary difference for this submission is the qualification of NovoLog for use in the device, in addition to Humalog.
1. Table of Acceptance Criteria and Reported Device Performance
| Specification | Acceptance Criteria (Reported Performance) | Notes |
|---|---|---|
| Operational Specifications | ||
| Reservoir Volume (V-Go 20) | 560 µL (56 IU of insulin) | Implicit acceptance criterion derived from reported performance. The document doesn't explicitly state the "acceptance criterion" as a separate value, but rather the device's specified performance. |
| Reservoir Volume (V-Go 30) | 660 µL (66 IU of insulin) | Implicit acceptance criterion derived from reported performance. |
| Reservoir Volume (V-Go 40) | 760 µL (76 IU of insulin) | Implicit acceptance criterion derived from reported performance. |
| Basal Rate (V-Go 20) | 8.3 µL/hr (0.83 IU/hr is the stated intended use rate, 0.6 IU/hr is listed in the operational spec table. ) | The document lists 0.83U/hr in the intended use and 0.6IU/hr in the operational specification table. For the purpose of acceptance, it would likely be one or the other, or a range around one of them. For this table, I've primarily used the 'Operational Specifications' table data as it's presented as a direct specification. |
| Basal Rate (V-Go 30) | 12.5 µL/hr (1.25 IU/hr is the stated intended use rate, 1.2 IU/hr is listed in the operational spec table.) | Similar discrepancy as V-Go 20, using the operational spec table data. |
| Basal Rate (V-Go 40) | 16.7 µL/hr (1.67 IU/hr is the stated intended use rate, 1.8 IU/hr is listed in the operational spec table.) | Similar discrepancy as V-Go 20, using the operational spec table data. |
| Bolus Increments | 20 µL (2 IU) and 18 Actuations | Implicit acceptance criterion derived from reported performance. |
| Nominal Bolus Volume | 360 µL (36 IU) | Implicit acceptance criterion derived from reported performance. |
| Basal Volume (24 Hours) | V-Go 20: 200 µL (20 IU) | Implicit acceptance criterion derived from reported performance. |
| V-Go 30: 300 µL (30 IU) | ||
| V-Go 40: 400 µL (40 IU) | ||
| Accuracy | +/- 10% | Explicit acceptance criterion. The document states "Accuracy: +/- 10%" for all models. |
| Environmental Specifications | ||
| Temperature | +5 to +37°C | Implicit acceptance criterion from reported performance per AAMI ID26, IPX8. |
| Humidity | 20 - 90% | Implicit acceptance criterion from reported performance per AAMI ID26, IPX8. |
| Water Ingress Protection | IPX8 (submerged at 1 meter for 24 hours) | Implicit acceptance criterion from reported performance per AAMI ID26, IPX8. |
| Atmospheric Testing | 0-10,000 feet | Implicit acceptance criterion from reported performance per AAMI ID26, IPX8. |
| Biocompatibility | Materials passed all testing per ISO 10993-1 | Explicit acceptance criterion. |
| Drug Compatibility | Compatible with insulin for duration of use | Explicit acceptance criterion. Specifically, drug contact materials were tested and found compatible with insulin. |
| Sterilization | Sterilized to SAL of 10^-6 per ANSI/AAMI ST67:2003(R)2008 | Explicit acceptance criterion. |
| Pyrogen Testing | Pyrogen free using USP Bacterial Endotoxin Testing Gel Clot Method with acceptable maximum limit of 20EU/device | Explicit acceptance criterion. |
| Package Stability | Maintain sterility integrity for up to 36 months per AAMI/ISO 11607-1:2006 | Explicit acceptance criterion. |
| Drug Stability | Humalog stable for up to 24 hours (refrigerated/room temp) + 24 hours wear in V-Go | Explicit acceptance criterion. |
| NovoLog stable for up to 5 days (refrigerated) or 3 days (room temp) + 24 hours wear in V-Go | Explicit acceptance criterion. (This is the primary new claim of this 510(k) submission). | |
| EZ Fill Stability | Acceptable for filling Humalog and NovoLog for up to 30 days use | Explicit acceptance criterion. (This acceptance criterion is for the accessory device). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each non-clinical test (e.g., accuracy, environmental, biocompatibility, sterilization, package stability, drug stability). Instead, it refers to industry standards (e.g., AAMI ID26, ISO 10993-1, ANSI/AAMI ST67:2003(R)2008, USP , AAMI/ISO 11607-1:2006) which typically include statistically appropriate sample size considerations within their methodologies.
The data provenance is not specified in terms of country of origin. The studies are described as non-clinical performance data which are typically conducted in a laboratory setting, not directly on human patients. The drug stability section implies testing in the V-Go device.
The study type is retrospective in the sense that the data presented are results of completed non-clinical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device's clearance is based on non-clinical performance data and substantial equivalence to a predicate device. There is no mention of "ground truth" derived from human expert consensus for a test set in the context of diagnostic interpretation, as this is a drug delivery device, not a diagnostic imaging or AI device.
4. Adjudication Method for the Test Set
Not applicable, as no human expert adjudication is mentioned or implied for the non-clinical performance testing.
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
Not applicable. This is a drug delivery device and not an AI-assisted diagnostic or interpretation device that would involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This device is a mechanical insulin delivery device, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" implicitly refers to the established scientific and engineering standards and validated measurement methods used in laboratories to determine compliance with the specifications. For example:
- Accuracy: Measured insulin delivery rates/volumes compared to a precise reference.
- Environmental: Device function under defined temperature, humidity, pressure after exposure to specified conditions.
- Biocompatibility: Results of standardized tests on materials (e.g., cytotoxicity, irritation, sensitization).
- Sterilization: Results of sterilization cycle validation and biological indicator testing demonstrating a 10^-6 SAL.
- Drug Stability: Analytical chemistry methods to assess insulin degradation/potency over time when exposed to the device materials and typical usage conditions.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is a mechanical device, not an AI/machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/machine learning algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The device's performance is demonstrated through various non-clinical performance studies designed according to established medical device standards. These include:
- Operational Specifications Testing: This would involve testing the device's basal rate, bolus increments, reservoir volume, and overall volume delivery accuracy (stated as +/- 10%) under controlled laboratory conditions for all three models (V-Go 20, 30, 40).
- Environmental Testing: The device was tested for its ability to perform within specified temperature, humidity, water ingress protection (IPX8), and atmospheric pressure ranges, following standards like AAMI ID26.
- Biocompatibility Testing: Materials in contact with drug and skin were tested according to ISO 10993-1 to ensure safety.
- Sterilization and Pyrogen Testing: The sterilization process was validated to achieve a Sterility Assurance Level (SAL) of 10^-6 using Ethylene Oxide, following ANSI/AAMI ST67:2003(R)2008. The device was also confirmed pyrogen-free per USP .
- Package Stability Testing: The packaging was validated to maintain sterility for up to 36 months, adhering to AAMI/ISO 11607-1:2006.
- Drug Stability Testing: Crucially, Humalog and NovoLog insulin's stability was assessed within the V-Go device under various storage and wear conditions. This testing, especially for NovoLog, was a key component of this specific 510(k) submission. For NovoLog, it was shown to be stable for up to 5 days refrigerated or 3 days at room temperature, followed by 24 hours of wear. The EZ Fill accessory was also deemed acceptable for use with both insulins for up to 30 days.
The conclusion is that the "Results of performance testing demonstrated substantial equivalence of the V-Go Disposable Insulin Delivery System to the predicate 510(k) device." This implies that the device successfully met all the non-clinical performance acceptance criteria through these tests. No clinical performance data was deemed required for this specific submission to validate the intended uses and user needs, with design validation completed through human factors simulated use and clinical evaluation testing (though specifics of these are not detailed in the provided text).
§ 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).