(87 days)
The "Sigma Syringe Delivery System" is designed for the controlled intermittent administration of small volume intravenous fluid medications for the treatment of human or animal subjects. Its specific design characteristics limit the device's use to slow, non-rate critical, small volume parenteral applications, identical to the predicate devices.
The SIGMA Syringe Deliver Systems are syringe infusion pumps that operate using two principles for delivery - a spring and resistive tubing. The mechanical principle is produced by relaxing spring force. The devices are strictly mechanical in operation and do not require the execution of software. This type of infusion pump is used to pump fluids into a patient in a controlled manner. The models are designed specifically for the controlled, parenteral infusion of non-rate critical drugs and medications. The SIGMA infusers are best identified and described in Title 21, Part 880.5725, of the Code of Federal Regulations, as classification Class II, Infusion Pump.
The "SIGMA Syringe Infusion System" is a combination of three components : 1) an Infuser, 2) Rate-Control Extension Set and 3) syringes(supplied by the user). All three components act together as a system. The infuser acts as the energy force that pushes fluid from the syringe, the fluid reservoir, through a Rate-Control IV Extension Administration Set, that controls the rate of the fluid delivery to the patient.
The provided document outlines the safety and effectiveness of the SIGMA Syringe Delivery System based on non-clinical bench testing. It details acceptance criteria for infusion time and accuracy, and the studies conducted to demonstrate compliance.
1. Table of Acceptance Criteria and Reported Device Performance
The document presents infusion time and accuracy specifications for different syringe types used with the SIGMA Syringe Delivery System.
| Parameter | Acceptance Criteria (Target Values) | Reported Device Performance (Achieved) |
|---|---|---|
| Infusion Time | Overall System: 20-45 minutes (fastest infusion time ≥ 20 minutes, typical infusion time 25-40 minutes for non-rate critical drugs) | Multi-Doser Rev. I (60cc syringes): |
- B-D™ 60cc: Typical 35 mins, Range 25-45 mins (Average Flow Rate 18 ml/hr)
- Monoject™ 60cc: Typical 30 mins, Range 22-37 mins (Average Flow Rate 21 ml/hr)
Single-Doser R. I-10: Typical 25 minutes, Range 18-32 minutes
Single-Doser R. I-20: Typical 55 minutes, Range 40-70 minutes
Impact of factors on 60cc Multi-Doser Rev. I:
- Spring Force: Low force increased infusion time by 4% (Monoject) and 28% (B-D); High force decreased infusion time by 11% (Monoject) and increased by 2% (B-D). All still within specified range.
- High Temperature (82°F): Decreased infusion time by 12% (Monoject) and 15% (B-D). Averages: Monoject 25.3 mins, B-D 29.8 mins. Still within safe/effective range.
- Low Temperature (62°F): Increased infusion time by 20% (Monoject), decreased by 4% (B-D). Averages: Monoject 34.6 mins, B-D 33.5 mins. Still within safe/effective range.
- Negative Head Height (+24 inches): Decreased infusion time by 13% (Monoject & B-D). Averages: Monoject 24.9 mins, B-D 30.4 mins. Still within safe/effective range.
- Positive Head Height (-24 inches): Increased infusion time by 8% (Monoject) and 12% (B-D). Averages: Monoject 30.9 mins, B-D 39.1 mins. Still within safe/effective range. |
| Infusion Time Accuracy | Not explicitly stated as a separate acceptance criterion, but determined and reported for 95% confidence interval. | Multi-Doser Rev. I (60cc syringes): - B-D™ 60cc: ± 28.5%
- Monoject™ 60cc: ± 23% |
| Uncontrolled Flow | System meets ANSI/AAMI D26-1996 for uncontrolled flow protection; no free flow. | Test 1 (plunger removed, 5ft head height, 0 venous pressure): Flow rate significantly lower (at least 25% of nominal, e.g., 4 ml/hr for Monoject nominal 21 ml/hr).
Test 2 (Monoject/B-D 60cc, 4ft head height, 0 venous pressure, 10cc sterile water): One Monoject syringe showed very slow flow (4cc over 3 hours, 1.3 ml/hr).
Test 3 (syringes at 2ft level, 10cc sterile water): Zero flow in a 24-hour period. Conclusion: Uncontrolled flow could not occur with venous pressure and syringe friction. Even if it did occur (as in Test 1), the slow rate would not harm the patient. |
| Drop Test | Device remains fully functional after drop. | Dropped six times from six feet onto a hard tile/concrete floor; fully functional afterward. |
| Environmental Test | Device remains fully functional after liquid spill. | One liter of 5% Dextrose spilled on infuser and dried for 72 hours; fully functional afterward, no effect on performance. |
| Pull Test | Rate-Control Microbore Sets meet 4 lbs. of force. | Rate-Control Microbore Sets met the required 4 lbs. of force. |
2. Sample Size Used for the Test Set and the Data Provenance
The primary test set for the performance studies (Infusion Time, Accuracy, Uncontrolled Flow) involved:
- 18 Infusers for the "Effect of Spring Force" bench test (3 with low, 3 with nominal, 3 with high spring force for both Monoject 60cc and B-D 60cc syringes).
- Six Infusers for each temperature variation test (high and low temperatures).
- Six Infusers for each head height variation test (+24 inches and -24 inches).
- For the "Uncontrolled Flow" tests, specific details are given (e.g., "a 60cc syringe," "both 60cc Monoject™ and 60cc B-D™ syringes"). The exact number of syringes per test is not specified beyond "a" or "both."
- For the Drop Test: "Device" (singular implied, but typically multiple units would be tested for such a claim).
- For the Environmental Test: "One liter of solution...was spilled on the infuser" (singular implied).
- For the Pull Test: "The Rate-Control Microbore Sets are pull tested" (plural implies multiple sets, but specific number not given).
The data provenance is retrospective bench data, generated by the manufacturer (SIGMA) in a controlled laboratory setting. The location is not explicitly stated by country, but the context implies it is a US-based submission to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This document describes non-clinical bench testing of a mechanical medical device (syringe infusion pump), not studies involving image analysis or diagnostic tasks requiring expert clinical labeling of data. The ground truth for performance metrics like infusion time, flow rate, and accuracy was established through direct measurement using sterile water under controlled laboratory conditions, not through expert consensus.
4. Adjudication Method
Not applicable. As the studies are bench tests of mechanical performance, there is no need for expert adjudication of results. Measurements were taken and recorded directly.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not mention any MRMC comparative effectiveness study. The studies described are non-clinical bench tests of the device's mechanical performance in a standalone setting.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, all the described studies are standalone bench tests focusing on the device's intrinsic mechanical performance. The studies assessed the device's ability to maintain specified infusion times and accuracy under various conditions (spring force, temperature, head height), its resistance to uncontrolled flow, and its durability (drop test, environmental test, pull test). There is no "human-in-the-loop" component in the reported performance metrics.
7. The Type of Ground Truth Used
The ground truth used was direct physical measurement of:
- Infusion Time: Measured duration of fluid delivery.
- Infusion Volume/Rate: Calculated based on the volume delivered over time.
- Accuracy: Calculated as a percentage deviation from a target or expected value.
- Flow Rate: Measured volume over time.
- Uncontrolled Flow: Observation and measurement of fluid flow under simulated incorrect usage.
- Functionality: Assessment of continued operation after stress tests (drop, environmental).
- Force: Measurement of force required for pull tests.
The fluid used for these measurements was primarily sterile water, chosen because it represents the fastest flow variable, ensuring that drugs with higher viscosity would not infuse faster than the established minimum infusion time (20 minutes).
8. The Sample Size for the Training Set
Not applicable. The SIGMA Syringe Delivery System is a mechanical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design is based on mechanical principles and engineering, not data-driven training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the described device and studies.
§ 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).