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The FreedomEdge® Syringe Infusion System is indicated for the intravenous or subcutaneous infusion of medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The FreedomEdge® Syringe Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) and Hizentra®. Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration.

The FreedomEdge® Syringe Infusion System with the FreedomEdge® Syringe Driver and Precision Flow Rate Tubing™, is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling: ertapenem, oxacillin, and tobramycin.

The FreedomEdge® Syringe Infusion System consists of the following components:

• FreedomEdge® Syringe Driver ●
• Precision Flow Rate Tubing™ ●
• HIgH-Flo Subcutaneous Safety Needle SetsTM ●
• HIgH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the subcutaneous infusion ● of the following human plasma-derived immunoglobulins: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration.

The FreedomEdge® Syringe Infusion System is indicated for use with the BD® 20 mL syringe (US Reference number: 302830), BD 30 mL syringe (US Reference number: 302832), and Hizentra® 20 mL single-use prefilled syringe (NDC 442096-458-96).

The FreedomEdge® Syringe Infusion System is a single-channel, volumetric infusion pump. The FreedomEdge® Syringe Infusion System consists of four primary components:

• 1. FreedomEdge® Syringe Driver,
• 2. Precision Flow Rate Tubing™ and
• 3. HIgH-Flo Subcutaneous Safety Needle Set™, or
• 4. HIgH-Flo Super26TM Subcutaneous Safety Needle Set

FreedomEdge® Syringe Driver: 1.
The FreedomEdge® Syringe Driver (non-sterile) in combination with Precision Flow Rate Tubing™ (sterile) and HIgH-Flo Safety Needle Sets (sterile) makes up the FreedomEdge® Syringe Infusion System. The FreedomEdge® Syringe Driver is a nonsterile, reusable non-electric driver that infuses certain immunoglobulins subcutaneously and antibiotic solutions intravenously to patients.

The FreedomEdge® driver is an ambulatory device designed to accommodate a BD Luer-Lok™ 20mL syringe, Catalog No.: 302830 and 301031, BD Luer-Lok™ 30mL syringe. Catalog No.: 301033 and Hizentra® 20 ml prefilled syringe. The pump uses a constant force spring mechanism to apply pressure to the plunger-end syringe.

The FreedomEdge® Syringe Infusion System is assembled by loading the syringe with tubing into the Freemdom60® driver.

Precision Flow Rate Tubing™: 2.
The Freedom Integrated Syringe System includes a range of Freedom Precision Flow Rate Tubing™ (provided sterile). The tubing ranges from F0.5 to F2400. Each F-number provides a different level of flow restriction, which, when combined with the viscosity of the medication, provides a controlled delivery in an all-mechanical system. The tubing sets connect at one end to the syringe being used and on the other end to the Subcutaneous Safety Needle Sets or directly on venous catheters for intravenous infusions as needed.

3. HIgH-Flo Needles Sets:

The HIgH-Flo Subcutaneous Safety Needle SetsTM
The HIgH-Flo Subcutaneous Safety Needle Sets™ (provided sterile) are used to administer drugs to the subcutaneous layers using small needles attached to the skin. Subcutaneous needles come in different lengths to administer immunoglobulins and antibiotics per the indications for use.

Subcutaneous Safety Needle Sets comes in multiple configurations (1, 2, 3, 4, 5, 6 needle sites). Needles are available in 4mm. 6mm. 9mm. 12mm. and 14mm lengths combined with 24 or 26 Gauge. Using the Y -Connector, the patient can have up to 8 sites for drug delivery.

The HIgH- Flo Subcutaneous Safety Needle Sets™ also allow each needle to be enclosed between the wings after use.

The HIgH-Flo Super26TM Subcutaneous Needle Sets
The HIgH-Flo Super26™ Subcutaneous Needle Sets are sterile, non-pyrogenic, single use. Subcutaneous Administration Sets, comprised of a Super 26-gauge needle assembly, combined with 24-gauge needle tubing and are intended for the delivery of medication to the subcutaneous tissue in accordance with the indication for use statement. Each set consists of a sterile infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set is a 90- degree, 26-gauge stainless steel needle, mounted to a butterfly winged safety closure on one end which is used to close the set upon completion. The other end consists of a luer lock which connects to PVC medical grade tubing. Additionally, each tubing set is equipped with a slide clamp used to stop flow, immediately as needed. HIgH-Flo Super 26™ Subcutaneous Needle Sets are available as a single set, as well as 2-needle, 3-needle, 5-needle, 6-needle, sets; through use of a Y-connector, 7-needle and 8 needle sets may also be assembled.

Here's an analysis of the acceptance criteria and supporting study details based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states that "Clinical evaluation was not required to support submission and determination of substantial equivalence." Therefore, there is no test set of patient data and consequently, no sample size or data provenance related to patient cases. All testing mentioned is non-clinical performance testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Since no clinical outcome data was used, no experts were used to establish ground truth in a clinical context for a test set. The "ground truth" for performance seems to have been established through engineering and laboratory testing protocols adhering to relevant industry standards and FDA guidance.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This type of study would involve human interpretation of medical images or data, with and without AI assistance, which is not relevant for an infusion pump system.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is a mechanical infusion system without "algorithm-only" performance in the sense of a diagnostic AI system predicting outcomes. Its performance is assessed through its mechanical and flow characteristics.

7. Type of Ground Truth Used:

The ground truth used is primarily engineering specifications, regulatory standards (e.g., ISO, AAMI, ASTM), and theoretical calculations. For instance, flow rate accuracy is compared against predicted minimum and maximum values derived from physical principles and drug product labeling. Biocompatibility relies on established biological evaluation standards.

8. Sample Size for the Training Set:

Not applicable. As a mechanical medical device, it does not involve machine learning algorithms that require a "training set" in the computational sense. Development and testing are based on engineering principles and prototypes.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for a machine learning algorithm. The "ground truth" for the device's design and performance specifications would have been established through a combination of engineering design principles, regulatory requirements, risk analysis, and material science, all validated through non-clinical performance testing.

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