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The FreedomEdge® Syringe Infusion System is intended 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.

Intended population: adults and pediatrics.

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

• FreedomEdge® Syringe Driver
• Precision Flow Rate Tubing™
• HIgH-Flo Subcutaneous Safety Needle Sets™
• 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 prefilled syringe (NDC 44206-458-96).

For Immunoglobulin Administration:
The Freedom Integrated 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 in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling.

For EMPAVELI™ (pegcetacoplan) Administration:
The Freedom Integrated Syringe Infusion System is specifically indicated for the subcutaneous infusion with EMPAVELI™ (pegcetacoplan) in the home, hospital, or ambulatory setting when administered according to the approved drug product labeling.

For Intravenous Antibiotic Administration:
The Freedom Integrated 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, Meropenem, Oxacillin, and Tobramycin.

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

1. FreedomEdge® Syringe Driver:
   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 immunoglobulins and Pegcetacoplan 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 FreedomEdge® driver.

2. Precision Flow Rate Tubing™:
   The FreedomEdge® Syringe Infusion System includes a range of Freedom Precision Flow Rate Tubing™ (provided sterile). The tubing ranges from F0.5 to F2400. Each Fnumber 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 Sets™
   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, pegcetacoplan, and antibiotics.

Subcutaneous Safety Needle Sets come 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 Super26TM 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. 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 90degree, 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 26TM Subcutaneous Needle Sets are available as a single set, as well as 2-needle, 3needle, 4-needle, 5-needle, 6-needle, sets; through use of a Y-connector, 7-needle and 8 needle sets may also be assembled.

The provided text describes a 510(k) premarket notification for a medical device called the FreedomEdge® Syringe Infusion System. This submission aims to expand the indications for use of an existing predicate device (K211206) to include the subcutaneous infusion of EMPAVELI™ (pegcetacoplan) in addition to already cleared immunoglobulins and antibiotics.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a "table of acceptance criteria" in the traditional sense of numerical targets that the device needs to meet for each performance metric. Instead, it outlines performance data collected to demonstrate safety and effectiveness. The primary "acceptance criterion" for this 510(k) is demonstrating substantial equivalence to the predicate device, especially for the new indication (EMPAVELI™ infusion). The performance data cited are studies designed to ensure the device performs safely and effectively for its intended use, matching the existing predicate's performance and supporting the new use.

Here's a summary of the reported device performance and how it relates to general acceptance in a 510(k) context:

The "HIgH-Flo 26G with Precision Tubing – Min-Max Infusion Times (minutes)" table is also provided. The text states: "The EMPAVELI™ label states that typical infusion time is approximately 30 minutes (if using 2 infusion sites) or approximately 60 minutes (if using one infusion site). Based on assessment of EMPAVELI™ labeling there is no identified patient risk for going faster or slower than this approximate infusion time." This implies the device's flow rates (and thus infusion times) for EMPAVELI™ fall within a clinically acceptable range. |
| Flow Rate Accuracy for Immunoglobulins (Hizentra®, Cuvitru®, Gammagard® Liquid) | Multiple tables for "Selected Flow Rate Combinations" with HIgH-Flo Subcutaneous Safety Needle Sets (Standard 26G and 24G) and Precision Flow Rate Tubing for different drug volumes (e.g., 10ml, 20ml, 40ml, 50ml, 60ml, 100ml) and number of sites (1, 2, 3, 4). These tables provide "Total Flow Rate (ml/hr)", "Flow rate/site (ml/hr)", "Vol/site (ml)", and "Time" for various configurations. They include notes like "Suggested start Peds", "Suggested start Adult", and "6th Infusion of biologic and beyond", indicating the device can achieve desired infusion rates for various clinical scenarios.

Separate comprehensive tables are provided for Hizentra® 20 ml Prefilled Syringe with HIgH-Flo 26G, HIgH-Flo Super26, and HIgH-Flo 24G at various precision tubing settings and 1-8 needles, showing min-max flow rates per site (ml/hr/site). |
| Biocompatibility | Materials comply with ISO 10993-1 and FDA Blue Book Memorandum #G95-1. Testing was conducted for Cytotoxicity, Sensitization, and Irritation. |
| Human Factors and Usability | Studies conducted per FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" (February 3, 2016) with intended user population, use environment, and scenarios. Results demonstrate device validation for intended use. |
| Reprocessing, Cleaning | Compliance/testing with AAMI TIR12:2010, AAMI TIR30:2011(R)2016, FDA guidance "Reprocessing Medical Devices in Health Care Settings", ISO 17664:2017, ANSI/AAMI/ISO 11737-1:2018. NAMSA Technical Memorandum US033689 Rev. 1 was reviewed. |
| Packaging | Compliance with 11607-1:2019 "Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems." Tubing and needle sets are packaged sterile using a nylon pouch. |
| Sterility | Compliance with ISO 11137-2:2013 "Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose." Needle sets and tubing are sterilized via Gamma SAL 10-6. |
| MR Safety | Compliance with ASTM F2503-13, "Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment." |
| Overall Safety and Effectiveness | A safety assurance case was provided, addressing device requirements, risk identification/mitigation, and reliability over service life, as recommended by FDA guidance. Non-clinical data supports safety, and performance testing demonstrates the device meets specifications, performing "as safely and as effectively as the predicate device". |

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document extensively discusses performance testing, particularly for flow rates. However, it does not specify the sample size used for the various tests (e.g., how many syringe infusion systems were tested, how many individual flow rate measurements were taken).

The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated. The testing was conducted "in accordance with the intended use of the device and in accordance with the FDA Guidance 'Infusion Pumps Total Product Life Cycle'," suggesting it was likely laboratory-based performance testing, prospectively designed to meet regulatory requirements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable as the device is an infusion system, not an AI or diagnostic device that relies on expert interpretation to establish a ground truth for a test set. The "ground truth" here is the physical performance (e.g., flow rate, biocompatibility) measured against engineering specifications and regulatory standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This section is not applicable for the same reasons as point 3. The performance testing of a physical medical device does not typically involve expert adjudication of results in the way image interpretation or AI diagnosis does.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable as the device is not an AI-assisted diagnostic or decision support system. It is a physical medical device (infusion system), and therefore, MRMC studies are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This section is not applicable as the device is not an algorithm. It is a physical infusion system that operates with a human user in the loop (for setup, drug preparation, monitoring, etc.) but its core function (drug delivery) is mechanical.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, the "ground truth" for performance testing is established by:

• Engineering specifications and regulatory standards: Flow rates are measured against predicted values and in consideration of drug manufacturer's labeling.
• Biocompatibility standards: ISO 10993-1 and FDA guidelines are used.
• Human factors guidance: FDA guidance for human factors and usability engineering is applied.
• Reprocessing/Sterility standards: ISO and AAMI standards define acceptable levels.
• Drug labeling: The performance data correlates the device's flow rates with the parameters specified in the FDA-approved labeling for the indicated drugs (immunoglobulins, EMPAVELI, antibiotics).

The "ground truth" is therefore a combination of validated technical performance measurements against established engineering and regulatory benchmarks, informed by drug-specific dosing and infusion parameters.

8. The sample size for the training set

This section is not applicable as the device is not an AI or machine learning system that requires a "training set."

9. How the ground truth for the training set was established

This section is not applicable for the same reasons as point 8.

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