(218 days)
The CycloTech™ Cyclosporine Oral Solution Dispenser (Dispenser) is intended to dispense SangCya™ cyclosporine oral solution USP (for microdispersion) as well as display and store dose size, time to next dose, remaining available doses, and doses dispensed.
CycloTech™ is designed for use with a standard fifty (50) mL bottle. A disposable fluid path, fully enclosed by the outer plastic shell, has a 0.1 to 5.0 mL dose range with 0.1 mL per step resolution and an accuracy of plus or minus five percent (+ 5%) for dispensed volumes. This device has two (2) user buttons, a custom LCD display, one (1) year memory at two (2) doses per day (uploadable to a PC), six (6) months battery life using common AA-type alkaline batteries, and pump technology for a specified volume range.
Use of a pump mechanism and microcomputer allows control of fluid delivery. The primary system upon which this product is based is the gravimetric principle of fluid delivery. The pump mechanism is used to assist the microcomputer in measuring amounts of liquid cyclosporine as well as dispensing the medication. The microcomputer, taking into account fluid viscosity, is able to provide an accurate, reproducible amount of liquid medication.
CycloTech™ is comprised of a molded plastic case assembly with an interchangeable disposable fluid path assembly. The fluid path assembly will only accept the original container of cyclosporine oral solution obtained from the drug manufacturer (reservoir or medication supply bottle). The case assembly provides for setting or adjusting the amount of liquid delivered, for measuring time, and for storing data. This apparatus also provides visual and audio output to the user, a control processor for monitoring and recording the time and number of dispensed doses of medication, a method for alerting a user of the time for taking their dose(s) of medicine, and monitoring the amount of medication remaining in the fluid path and reservoir. Audio alarms for alerting a user are also included in the Dispenser. The control processor, via interface, may be linked with an external computer. A liquid dispensing valve assembly and pump are used for dispensing liquid medicines from the reservoir through the fluid path assembly.
The provided text describes the CycloTech™ Cyclosporine Oral Solution Dispenser and its regulatory submission. It mentions performance testing but does not provide detailed acceptance criteria or the specifics of a study proving those criteria were met in the format requested.
Here's a breakdown of what can be extracted and what is missing based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy: +/- 5% for dispensed volumes (stated in product description) | "Non-clinical performance testing results for CycloTech™ indicate accuracy and precision data met specified internal standards and are available for review." (The exact measured accuracy achieved is not provided.) |
| Resolution: 0.1 mL per step (stated in product description) | Implied achieved, no specific test results given. |
| Dose Range: 0.1 to 5.0 mL (stated in product description) | Implied achieved, no specific test results given. |
| Memory: Up to 1 year (12 months) for dosing time and dose sizes (stated in product description) | Implied achieved, no specific test results given. |
| Battery Life: 6 months using common AA-type alkaline batteries (stated in product description) | Implied achieved, no specific test results given. |
| Electrical Standards Compliance: FCC Part 15, Class B; EN60601-1-2 | Compliant |
| Biocompatibility Standards Compliance: Genotoxicity, subchronic toxicity, cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, and physiochemical analysis | Compliant |
Missing Information:
- Specific numerical acceptance criteria for accuracy and precision beyond the +/- 5% for dispensed volumes.
- The exact numerical performance results achieved in the tests (e.g., the measured accuracy, precision values). The document only states that "accuracy and precision data met specified internal standards."
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the device is a drug dispenser, and the performance criteria relate to physical dispensing characteristics, not interpretation of data by experts. The "ground truth" would be the actual dispensed volume compared to the target volume, or the actual time recorded compared to real-time.
4. Adjudication Method for the Test Set:
This information is not provided and is likely not applicable for this type of device where quantitative measurements are the primary outcome.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not provided and is not applicable to this type of device. An MRMC study typically involves human readers interpreting diagnostic images or data, often with and without AI assistance. This device is a drug dispenser, not a diagnostic tool.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
Yes, a standalone performance study was done. The document states: "Non-clinical performance testing results for CycloTech™ indicate accuracy and precision data met specified internal standards and are available for review." This refers to the device's inherent mechanical and computational ability to dispense accurately and precisely, without human intervention or interpretation as part of the primary performance metric.
7. Type of Ground Truth Used:
The ground truth used for this device would be physical measurements of dispensed volume, timing, and other mechanical/electrical parameters, as compared to the device's intended output. This is inferred from the mention of "accuracy and precision data" and the nature of the device (a liquid dispenser).
8. Sample Size for the Training Set:
This information is not provided. The device uses a microcomputer and pump mechanism, implying an algorithm to control fluid delivery, potentially developed using a "training set" of data to calibrate for fluid viscosity, but this is not explicitly detailed.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided. If a training set was used for calibration (e.g., for fluid viscosity compensation), the ground truth would likely have been established through highly accurate physical measurements of dispensed volumes under various conditions.
§ 880.6430 Liquid medication dispenser.
(a)
Identification. A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.