(241 days)
1.0 The Medi-SIS Syringe Infusion System is indicated for the delivery of enteral fluids through clinically accepted routes of administration.
2.0 The Medi-SIS Administration Extension Set is intended for single patient use only.
3.0 The Medi-SIS Syringe Driver can be reused up to 5,000 times
The Medi-SIS Syringe Infusion System consists of a Syringe Driver (mechanical syringe pump), proprietary administration extension set, and compatible syringe.
The Medi-SIS Syringe Driver consists of a mechanical syringe pump assembly that is manufactured from plastic housings and end caps, and steel spring (mechanical force from the spring presses against the syringe plunger), and holds a 30mL or 60mL Becton Dickinson syringe (preamendment device) or a 30mL or 60mL Acacia syringe (K092986). The Medi-SIS Syringe Driver must be used in conjunction with a Medi-SIS Administration Extension Set, which controls the time the infusion will occur (by flow restrictor) for the entire volume of the filled syringe. The Medi-SIS Syringe Infusion System infuses fluids in a continuously decreasing rate and the user can calculate the average flow rate based from volume and time infused.
The Medi-SIS Syringe Driver is reusable and provided non-sterile.
The Medi-SIS Administration Set consists of various lengths of flexible non-DEHP PVC tubing. on/off clamp, flow restrictor, and male and female connectors. The male and female connectors meet Acacia's internal specifications for enteral applications to ensure cross connections do not occur between IV and Enteral infusions. Additional componentry may be added and configurations modified based on the needs of clinicians.
The following Administration Extension Sets will be available:
60mL Syringe Size, 1.0mL per minute delivery rate 60mL Syringe Size, 2.0mL per minute delivery rate 30mL Syringe Size, 0.5mL per minute delivery rate 30mL Syringe Size, 1.0mL per minute delivery rate 30mL Syringe Size. 2.0mL per minute delivery rate
The approximate residual volume for the syringe/administration set combination is approximately 2.20mL for all configurations. The Medi-SIS Administration Extension Set is provided sterile, single use, and non-pyrogenic.
The provided 510(k) summary (K111381) describes performance testing for the Medi-SIS Syringe Infusion System, specifically for the addition of enteral fluid delivery to its intended use.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Enteral fluid delivery within specified time | Met all of the predicate device's specifications. |
| Maximum residual volume | Approximate residual volume for syringe/administration set combination is approximately 2.20mL for all configurations (60mL syringe at 1.0mL/min, 60mL syringe at 2.0mL/min, 30mL syringe at 0.5mL/min, 30mL syringe at 1.0mL/min, 30mL syringe at 2.0mL/min). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (e.g., number of tests, number of devices) used for the non-clinical tests assessing enteral fluid delivery time and residual volume. It also does not specify the provenance of the data (country of origin, retrospective or prospective). It simply states that "non-clinical tests were performed."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The tests performed were non-clinical, evaluating device performance (fluid delivery and residual volume) against specifications, not requiring expert human interpretation or ground truth establishment in a medical context.
4. Adjudication Method for the Test Set
Not applicable. As the tests were non-clinical performance evaluations, no adjudication method (like 2+1 or 3+1 used for expert consensus in medical image analysis) was required.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on non-clinical performance, not human reader performance with or without AI assistance. The device is an infusion pump, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in a sense, a "standalone" performance study was done for the device itself, as the tests focused on the physical device's ability to deliver enteral fluids as specified. However, this isn't in the context of an "algorithm" or AI. The device's performance was evaluated independently of human interaction during the test, purely on its mechanical and fluid delivery capabilities.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests was based on predicate device specifications and internal Acacia specifications for performance. For example, enteral fluid delivery was verified against the specified time and the residual volume had a specific measurable value.
8. Sample Size for the Training Set
Not applicable. This device is an infusion pump, not an AI/machine learning device that requires a training set. The performance evaluation was based on non-clinical engineering tests.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There was no training set for this device.
§ 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).