FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Integrated Catch-Up Freedom Syringe Driver Infusion System (ICFSDIS), which includes the FREEDOM60® and FreedomEdge® syringe pumps, is indicated for the intravenous infusion of medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The ICFSDIS is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Hizentra, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring); Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Shire); and Cuvitry Immune Globulin Infusion (Human) 20% (manufactured by Shire). The ICFSDIS is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling: meropenem, ertapenem, oxacillin, and tobramycin.

The FreedomEdge® Syringe Infusion System is indicated for use with the BD 20 ml (model no. 302830/301031) or BD 30 ml (model no. 30103) syringe. The Freedom60 Syringe Infusion System is indicated for use with the BD 60 ml syringe (model no. 309653).

Device Description

1. Freedom60® Syringe Driver: The Freedom60 Syringe Infusion driver in combination with RMS Freedom60 Precision Flow Rate Tubing™ (sterile) and RMS HIgH-Flo Subcutaneous Safety Needle Sets (sterile) makes up the Freedom60 infusion system. The Freedom60® driver is a non-sterile, reusable non-electric driver that infuses immunoglobulins subcutaneously and antibiotic solutions intravenously to patients.
  The Freedom60® driver is an ambulatory device designed to accommodate a BD Luer-Lok™ 60mL Syringe (Catalog No.: 8881-560125, BD 309653), and fluid volumes ranging from 10cc to 60cc may be used. The pump uses a constant force spring mechanism to apply pressure to the plunger-end svringe.

The Freedom60 system is assembled by loading the prefilled syringe with tubing into the Freemdom60 driver.

1. FreedomEdge® Syringe Driver: The FreedomEdge® Syringe Infusion driver is used with a syringe in an infusion system for administering therapeutic fluids. The infusion system or related kits can include, in addition to the pump assembly, a luer connector or disc luer connector for connecting the syringe to components of the infusion system, an RMS Precision Flow Rate Tubing™ (sterile) and RMS HIgH-Flo Subcutaneous Safety Needle Sets (sterile) for administering the therapeutic fluid subcutaneously into a patient's body.
  The FreedomEdge® driver is a portable device designed to accommodate BD Luer-Lok™ 20mL syringe, Catalog No.: 302830 and 301031 or BD Luer-Lok™ 30mL, Catalog No.: 301033. The pump uses a constant force spring mechanism to apply pressure to the plunger- end syringe.

The FreedomEdge® is comprised of housing that has a distal end and a proximal end. The housing comprises an expandable base with a first base section and a second base section. wherein the first base section is in sliding engagement with the second base section such that the first base section and the second base section move relative to each other between a closed position and an expanded position. The base in the expanded position is adapted to seat a syringe with the plunger.

There is also an expandable cover consisting of a first cover section and a second cover section, wherein the first cover section is in sliding engagement with the second cover section. The cover is pivotally connected to the base at a position allowing the cover to open and close in a sliding motion of the second base section, which is relative to the first base section moving together.

When the cover is in the closed position, a pusher is in sliding engagement with the base. The pusher is in position to contact the head of the plunger and a puller is in position with the sliding engagement of the base. There is a spring at the first end portion and a second end portion. The first end portion is connected to the puller, while the second end portion is connected to the pusher and a set of linkages pivotally coupled to the cover and the puller.

The pivots of the linkages are located to move the puller towards the distal end when the cover is lowered and move the puller towards the proximal end when the cover is raised. Moving the puller towards the distal end by lowering the cover when the syringe is seated in the base causes the pusher to contact and exert force on the head of the plunger, thereby causing ejection of any fluid contents in the syringe barrel.

1. Precision Flow Rate Tubing Set:
  The Freedom60 Infusion system includes a range of Freedom Precision Flow Rate Tubing™. 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.
1. High-Flo Needles set: The HIgH-FloTM Subcutaneous Safety Needle Sets are used to administer drugs to the subcutaneous layers using small needles attached to the skin. Typical uses are to administer immunoglobulins and antibiotics and for such applications subcutaneous needles come in different lengths.
  Subcutaneous Safety Needle Sets comes in multiple configurations (single, double, tri, and quad). Needles are available in 4mm, 6mm, 9mm, 12mm 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 trapped between the wings after use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Integrated Catch-up Freedom Syringe Driver Infusion System.

It's important to note that the provided text is a 510(k) Summary, which is designed to demonstrate substantial equivalence to a legally marketed predicate device, rather than a detailed clinical study report proving the device alone meets specific effectiveness criteria through a groundbreaking study. The focus here is on bench testing and compatibility, not human performance or effect size with AI. Therefore, many of your requested points related to human readers, experts, and training sets for an AI/machine learning device are not applicable to this particular document.

Acceptance Criteria and Device Performance for Integrated Catch-up Freedom Syringe Driver Infusion System

Based on the provided 510(k) summary, the "acceptance criteria" are primarily demonstrated through performance testing, specifically flow rate testing, and drug-device compatibility testing. The summary doesn't explicitly state quantitative acceptance limits for all parameters, but rather "results showed acceptable" or provides tables of achieved flow rates as evidence of performance.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter / Aspect	Acceptance Criteria (Implied)	Reported Device Performance	Study that Proves Acceptance
Safety Assurance	Device is safe for intended use; risks identified, controlled, mitigated.	Safety assurance case provided (design-FMEA, use-FMEA) demonstrating safety. Risks related to operation, hardware/mechanical, use/performance, environment/chemical, and errors are identified and controlled.	FMEA documents and safety assurance case.
Drug-Device Compatibility (Immunoglobulins: Hizentra, Cuvitru)	No adverse effects on drug characteristics (appearance, particulates, protein concentration, IgG fragments/polymers/aggregates, anti-complementary activity, density, Fc-function).	Results "showed acceptable" for all listed characteristics for Hizentra and Cuvitru.	Validated test methods for drug-device compatibility.
Flow Rate Performance (Hizentra, Cuvitru, Gammagard Liquid - Subcutaneous)	Achieve desired infusion rates for indicated immunoglobulin fluids.	Detailed tables provided showing achieved flow rates (total and per site) and infusion times for various drug volumes, flow tubes, and needle sets. (See Tables 1-6 in input text for specific values). Devices maintained a constant pressure of 13.5psi and automatically decrease flow with increasing resistance.	Detailed flow rate testing.
Mechanical System Performance	Consistent pressure delivery; automatic flow rate adjustment to resistance.	Operates at a constant pressure of 13.5 psi. Automatically decreases flow rate if resistance increases, reaching an equilibrium.	Inherent design and functionality described under "Technological Characteristics," and supported by flow rate testing results.

Important Note on "Acceptance Criteria": This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device. For areas like drug-device compatibility, the statement "results showed acceptable" implies that the performance met internal benchmarks or recognized standards for maintaining the integrity and efficacy of the drugs. For flow rates, the tables themselves represent the demonstrated performance characteristics under specific conditions, which are then used to inform safe and effective use.

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

Sample Size for Test Set: The document does not specify a numerical sample size for the "test set" in terms of how many individual devices, tests, or samples of drugs were used. It refers to "detailed flow rate testing" and "drug-device compatibility testing" without providing the number of units tested or repetitions.
Data Provenance: The studies appear to be retrospective in the sense that they are laboratory/bench tests conducted by the manufacturer, rather than prospective clinical trials with human subjects. The country of origin of the data is not explicitly stated but is implicitly from the manufacturer, Repro-med Systems, Inc., DBA RMS Medical Products, located in Chester, New York, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This document describes the performance of a mechanical infusion pump system through bench testing and compatibility studies. There is no mention of human experts or ground truth establishment in the context of diagnostic interpretation, as would be relevant for an AI/machine learning device. The "ground truth" for flow rates and drug compatibility comes from physical measurements and chemical analyses, not expert consensus.

4. Adjudication Method for the Test Set

Not Applicable. As there are no human experts involved in establishing a "ground truth" for interpretation, no adjudication method is relevant or mentioned. The data is quantitative from laboratory measurements.

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

Not Applicable. This is a mechanical infusion pump, not an AI/machine learning diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

Not Applicable. This device is a mechanical pump, not an algorithm. Its performance is inherently "standalone" in mechanical function, but "human-in-the-loop" applies to its operation by a user, not its analytical process.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing is based on:
- Direct Physical Measurements: For flow rates (mL/hr) and time taken (hours:minutes), measured during the detailed flow rate testing.
- Chemical and Biological Assays: For drug-device compatibility (e.g., measuring protein concentration, particulate count, Fc-function of immunoglobulins).
- Engineering Analysis: For the safety assurance case (FMEA documents).

8. The Sample Size for the Training Set

Not Applicable. This device does not involve a "training set" in the context of machine learning or AI. The design and validation are based on engineering principles, material science, and physical testing, not data training.

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

Not Applicable. See point 8.

Summary

Regulation Number and Section

§ 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).