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

• FreedomEdge® Infusion Pump
• Precision Flow Rate Tubing™
• High-Flo SubQ Needle Sets™

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 FreedomEdge Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins in the home, hospital, or ambulatory settings when administered 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®)
• Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid 20ml Single-use pre-filled syringe (manufactured by CSL Behring®)

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

For RYSTIGGO® (rozanolixizumab-noli) Administration:
The FreedomEdge Infusion System is specifically indicated for the subcutaneous infusion of RYSTIGGO® (rozanolixizumab-noli) when administered according to the approved drug product labeling.

For Intravenous Antibiotic Administration:
The FreedomEdge Infusion Pump and Precision Flow Rate Tubing are 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 Infusion System is a non-electrically powered, mechanical infusion system which is intended for subcutaneous or intravenous administration of drug products in a home, ambulatory, or clinical setting. The infusion system includes the FreedomEdge Infusion Pump, the High-Flo SubQ Needle Sets, and the Precision Flow Rate Tubing Sets. The infusion system is designed to be used with sterile, single use syringes (not manufactured or sold by Koru Medical Systems) as the drug reservoir. There have been no significant changes to the technological features (e.g., material, design, energy source, packaging, sterility, manufacturing method) since the previous clearance.

The fundamental operating principle of the FreedomEdge Infusion System is based on the Hagen-Poiseuille equation. The syringe containing the drug to be infused is connected to the flow rate control tubing and the subcutaneous needle set or venous access device and inserted into the pump. The syringe pusher of the pump applies a constant force to the plunger of the syringe. The infusion sets generate a defined amount of resistance which determines the flow rate. Flow rates are modeled using the Hagen-Poiseuille equation and verified at the boundary conditions for the system.

The design and operating principles of the system and its components have not been significantly modified since the device was first cleared. The same test methods were used as in prior submissions. Acceptance criteria were generated for Rystiggo using the same flow rate prediction model as used in prior submissions.

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The Freedom60 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: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); 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 Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by Grifols®) in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling.

The Freedom60 Infusion System with the Freedom60® Infusion Pump 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 Freedom60 Infusion System consists of the following devices:

• Freedom60® Infusion Pump

• Precision Flow Rate Tubing

• High-Flo Subcutaneous Needle Sets

• HigH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, lmmune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®)

The Freedom60 Infusion System is indicated for use with the following syringes:

• · BD® 50 ml syringe
• · Medline® 60 ml Syringe
• · Hizentra® 50 ml Prefilled Syringe

The Freedom60 Infusion System is a non-powered infusion system that includes a mechanical infusion pump, subcutaneous needle sets, and tubing sets. The infusion pump exerts a constant force on the medication through the tubing. The tubing set and needle set produce a certain amount of resistance, which moderates the flow rate. The tubing sets and needle sets are provided in a range of sizes and device options (number of needle gauge, tubing diameter, etc). The healthcare provider prescribes the tubing/needle sets based on the intended flow rate and dosage of the drug being administered.

The infusion pump is compatible with specific syringe types. An adapter is included as part of this submission to enable compatibility with certain pre-filled syringes that are compatible for use with the Freedom60 infusion system are the BD 50ml syringe, the Medline 60 ml syringe, and the Hizentra 50 ml pre-filled syringe.

The infusion pump and pre-filled syringe adapter are reusable. The infusion sets are are terminally sterilized via gamma radiation. The Freedom60 Infusion System is manufactured from materials with an established history of biological safety, and is not manufactured with latex or natural rubber.

The provided text is a 510(k) Summary for a medical device (Freedom60 Infusion Pump and associated components). It describes the device, its intended use, and the non-clinical testing performed to establish substantial equivalence to a predicate device. However, it does not contain information about the specific acceptance criteria, reported device performance in a table, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, as these typically relate to AI/ML device submissions.

The document refers to mechanical/fluidic performance testing for an infusion pump, not an AI/ML diagnostic system. Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria and study details from this document.

For context, I will outline the information that would be present if this were an AI/ML device submission, and then explain why it's not applicable here based on the provided text.

Information NOT available in the provided document (as it's not an AI/ML device):

1. Table of acceptance criteria and reported device performance: This document refers to flow rate verification, reliability/use life verification, dose accuracy, and fitment. It does not provide a table with specific numerical acceptance criteria (e.g., minimum sensitivity, specificity) and corresponding achieved performance metrics (e.g., actual sensitivity, specificity values), which are common for AI/ML diagnostic devices.
2. Sample sizes used for the test set and data provenance: The document mentions "non-clinical testing" and "verification and validation testing" but does not specify sample sizes in terms of patient cohorts or image sets, nor does it mention data provenance (e.g., country of origin, retrospective/prospective), as would be detailed for AI/ML models.
3. Number of experts used to establish the ground truth for the test set and their qualifications: This is irrelevant here because the device is a mechanical infusion pump. Ground truth for an AI/ML diagnostic device usually involves expert annotations (e.g., radiologists, pathologists).
4. Adjudication method for the test set: Not applicable, as there's no diagnostic ground truth being established by experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable, as this is a mechanical device, not an AI-assisted diagnostic tool. MRMC studies evaluate the impact of AI on human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no standalone AI algorithm.
7. The type of ground truth used: For this device, the "ground truth" would be established through engineering measurements of flow rates, dose accuracy, and mechanical reliability against design specifications, not clinical outcomes, pathology, or expert consensus on medical images/data.
8. The sample size for the training set: Not applicable, as this describes a device that undergoes physical manufacturing and testing based on engineering principles, not an AI/ML model that is trained on a dataset.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

What the document does state about testing:

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section (Page 7) states:

• Testing Performed:
  • Flow rate verification
  • Reliability/use life verification
  • Dose accuracy and fitment
  • Human factors validation (per IEC 62366-1 and FDA Guidance)
• Clinical Testing: "Clinical testing is not applicable for this submission." This further confirms it's not an AI/ML diagnostic.
• Conclusion: "All verification and validation testing was successfully completed. The non-clinical testing performed demonstrates that the device is as safe and effective as the legally marketed predicate device meets that the device meets the performance requirements set out as part of the design control process."

In summary, the provided document details the regulatory clearance of a mechanical infusion system, not an AI/ML-driven device. Therefore, the specific acceptance criteria and study details relevant to AI/ML performance (such as sensitivity, specificity, expert ground truth, MRMC studies) are not present and cannot be extracted.

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