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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

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.

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1. Medi-SIS Syringe Infusion System was designed for general drug and solution infusion uses with the limitation being the volume of drug to be infused. The routes of administration include those of the similar size syringes, (i.e. intravenous infusions and subcutaneous infusions) ... ....................................................................................................................................
2. The administration set is intended for single patient use only.
3. The Medi-SIS driver can be reused up to 5,000 times.
4. The Medi-SIS system is intended for general infusion use. The Medi-SIS Syringe Infusion System is not limited to any specific type of therapy.
   4.1 The Medi-SIS Syringe Infusion System is not intended for the delivery of blood, blood products or TPN solutions.

The Medi-SIS Syringe Infusion System consists of a plastic, spring driven infusion pump and various administration sets. Two models of the Medi-SIS pump have been developed to accommodate 20 and 60 ml syringes.

The provided documentation describes the I-Flow Medi-SIS Syringe Infusion System, specifically regarding a change in labeling to include Sherwood Monoject Syringes in addition to the previously approved Becton-Dickinson® brand syringes. The submission (K972173) is a 510(k) summary rather than a full study report, and therefore much of the information typically found in a comprehensive clinical or performance study is not present. However, it does provide performance test data related to the device's function.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a separate section. However, it implicitly assesses performance against the "labeled delivery time" of the device and states that performance within ±15% of the labeled time is considered acceptable. It also notes that slower delivery rates (even beyond this range) might not affect safety or efficacy for certain drug types.

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