K Number
K214045
Device Name
FreedomEdge Syringe Infusion System
Date Cleared
2022-04-29

(123 days)

Product Code
Regulation Number
880.5725
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
Device Description
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.
More Information

Not Found

No
The device description explicitly states it is a "non-electric driver that infuses... using a constant force spring mechanism to apply pressure". There is no mention of any computational or algorithmic components that would suggest AI/ML.

Yes

Explanation: The device is intended for the infusion of medications and fluids, including immunoglobulins and antibiotics, which are used to treat medical conditions. This aligns with the definition of a therapeutic device as something used to treat or alleviate a disease or condition.

No
The device is described as a "single-channel, volumetric infusion pump" intended for the "intravenous or subcutaneous infusion of medications and fluids." Its purpose is to deliver substances to the patient, not to diagnose a condition.

No

The device description clearly outlines multiple hardware components including a syringe driver, tubing, and needle sets. It is described as a "single-channel, volumetric infusion pump."

Based on the provided information, the FreedomEdge® Syringe Infusion System is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
  • FreedomEdge® Function: The FreedomEdge® Syringe Infusion System is designed to infuse medications and fluids directly into the patient's body (intravenously or subcutaneously). It is a delivery system for therapeutic substances, not a device that analyzes biological samples.

The intended use and device description clearly indicate its purpose is to administer drugs and fluids, which falls under the category of a therapeutic or drug delivery device, not an IVD.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

FRN, FPA, PKP

Device Description

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,
    1. Precision Flow Rate Tubing™ and
    1. HIgH-Flo Subcutaneous Safety Needle Set™, or
    1. 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 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 26TM Subcutaneous Needle Sets are available as a single set, as well as 2-needle, 3-needle, 4-needle, 5-needle, 6-needle, sets; through use of a Y-connector, 7-needle and 8 needle sets may also be assembled.

The purpose of this premarket notification is to request a modification to the indications for use to include the addition of the drug EMPAVELI™ (pegcetacoplan) injection 1080/20 mL solution (manufactured by Apellis®) for subcutaneous infusion using the FreedomEdge® Syringe Infusion System.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult and pediatric

Intended User / Care Setting

Home, hospital, or ambulatory settings

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Device Performance: The essential performance requirements of the device were verified through performance testing in accordance with the intended use of the device and in accordance with the FDA Guidance "Infusion Pumps Total Product Life Cycle"
Biocompatibility: The materials used in the Administration Set (tubing and needles) for the FreedomEdge® Syringe Infusion System comply with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA and FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", within a Risk Management Process and are considered to be biocompatible. Testing was conducted for the following tests: Cytotoxicity Sensitization Irritation
Human Factors: Human factors studies were completed per the FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" (February 3, 2016). The human factors studies were conducted with the intended user population, use environment and use scenarios to simulate clinical conditions. Results of the human factors testing demonstrate validation of the device per the intended use.
Reprocessing, Cleaning: AAMI TIR12:2010 – Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers. AAMI TIR30:2011(R)2016 - A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Document issued on March 17, 2015 amended June 9, 2017, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluations. ISO 17664:2017 – Processing of healthcare products - Information to be provided by the medical device manufacturer for the processing of medical devices. ANSI/AAMI/ISO 11737-1:2018 – Sterilization of health care products – Microbiological methods - Part 1: Determination of the population of microorganisms on product. NAMSA Technical Memorandum US033689 Rev. 1, Review and Comparison of the Koru Medical Systems Syringe Drive products to determine the Worst- Case Design for Cleaning and Low Level Disinfection Efficacy Studies.
Packaging: 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
Sterility: ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose.
MR Safety: ASTM F2503-13, "Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment."

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K211206

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo includes the Department of Health & Human Services seal on the left. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".

Repro-Medical System, Inc., dba Koru Medical Systems % Kachi Enyinna Consultant 510K Technology Group LLC 17 Orchard Terrace East Arlington, Massachusetts 02474

Re: K214045

Trade/Device Name: FreedomEdge Syringe Infusion System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: March 22, 2022 Received: March 23, 2022

Dear Kachi Enyinna:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

April 29, 2022

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Courtney H. Lias, Ph.D. Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

Device Name

FreedomEdge® Syringe Infusion System

Indications for Use (Describe)

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 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: 302330), 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®) 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™ (negcetacoplan) in the home, hospital, or ambulatory setting when administered according to the approved drug,

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

I. SUBMITTER

Repro-Med Systems, Inc. dba Koru Medical Systems 24 Carpenter Road Chester, NY 10918 USA

Ph: (800) 624-9600 Fax: (845) 469-5518

Contact Person Christopher Pazdan Vice President, Quality Assurance and Regulatory Affairs Phone: (708) 870-6294 Email: cpazdan@korumedical.com

Application Correspondent Kachi Enyinna Regulatory Consultant to Koru Medical Systems Phone: (617) 870-4055 Email: kachi@510ktech.com

Date Prepared: December 23, 2021

II. DEVICE

Name of Device: FreedomEdge® Syringe Infusion System Common or Usual Name: Infusion Pump Classification Name: Pump, Infusion (21CFR 880.5725) Regulatory Class: II Product Code: FRN, FPA, PKP

III. PREDICATE DEVICE

FreedomEdge® Syringe Infusion System (K211206)

This predicate has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

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,
    1. Precision Flow Rate Tubing™ and

5

    1. HIgH-Flo Subcutaneous Safety Needle Set™, or
    1. 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

6

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 purpose of this premarket notification is to request a modification to the indications for use to include the addition of the drug EMPAVELI™ (pegcetacoplan) injection 1080/20 mL solution (manufactured by Apellis®) for subcutaneous infusion using the FreedomEdge® Syringe Infusion System.

V. INDICATIONS FOR USE

INTENDED USE

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.

INDICATIONS FOR USE

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.

7

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 EMPAVELITM (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.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Indications for Use Comparison

The table below includes a comparison of the indications for use between the new device and that of the predicate device:

8

| | Predicate Device
(K211206) | Subject Device |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | FreedomEdge® Syringe Infusion System | FreedomEdge® Syringe Infusion System |
| | Modified Indications for
Use | Modified Indications for
Use |
| Indications | 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,
meropenem, 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
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% | 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 |
| | Predicate Device
(K211206)
FreedomEdge® Syringe Infusion System | Subject Device
FreedomEdge® Syringe Infusion System |
| | Modified Indications for
Use | Modified Indications for
Use |
| | (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. | 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. |
| | 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
20 mL single-use pre-filled syringe (NDC 44206-
458-96).
*Model no. 301031 is the non-sterile version of
BD® 20 ml syringe sold by BD
**model no. 301033 is the non-sterile version of
BD® 30 ml syringe. | 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 TubingTM, 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. |
| Prescription or
Over the
Counter | Prescription | Prescription |
| Intended
Population | Adult and pediatric | Adult and pediatric |
| Environment
of Use | Hospital, ambulatory, or home | Hospital, ambulatory, or home |

Table 1. Indications for Use Comparison

9

Justification of differences in Indications for Use of Subject and Predicate Device

The indications for use statement for the FreedomEdge® Syringe Infusion System is not identical to the predicate device. The submission expands on the currently cleared indications for use to include the EMPAVELI™ (pegcetacoplan) injection 1080/20 mL solution (manufactured by Apellis®) for use with the infusion system. The difference between the subject device and predicate device infusion system is the inclusion of the

10

EMPAVELI™ (pegcetacoplan) injection 1080/20 mL solution into the indications for use.

Compatibility of the EMPAVELI™ (pegcetacoplan) injection 1080/20 mL solution with the FreedomEdge® infusion system specifically has been verified through performance testing. The change to device indications do not significantly affect safety or effectiveness as the changes do not create new risks or sigmificantly modify existing risk. The change in indications for use does not raise different questions of safety and effectiveness and, therefore, does not preclude a meaningful comparison with the predicate device.

The routes of administration for the system, intravenous, and subcutaneous were cleared in the predicate device.

Discussions of differences in intended population

The intended population for the subject device is identical to the predicate device. EMPAVELI™ is specifically indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

Discussions of differences in environment of use

The environment of use for the subject device is identical to the predicate device.

Device configuration

The table below compares configuration of the infusion system between the subject device and that of the predicate device:

| Predicate
K211206 | Subject Device
(unknown) |
|------------------------------------------------------------|------------------------------------------------------------|
| FreedomEdge® Syringe Infusion System | FreedomEdge® Syringe Infusion System |
| 1. The FreedomEdge® Syringe Driver | 1. The FreedomEdge® Syringe Driver |
| 2. Precision Flow Rate Tubing™ | 2. Precision Flow Rate Tubing™ |
| 3. HIgH-Flo™ Subcutaneous Safety
Needle Sets (24G, 26G) | 3. HIgH-Flo™ Subcutaneous Safety
Needle Sets (24G, 26G) |
| 4. HIgH-FLO Super26™ Subcutaneous
Needle Sets | 4. HIgH-FLO Super26™ Subcutaneous
Needle Sets |

Table 2. Device Configuration Comparison

Discussions of differences in system configuration

The FreedomEdge® Syringe Infusion System (subject device) configuration is identical to the predicate device. There is no change to the system as a result of the IFU medication.

11

Table 3 presents a tabular comparison of the technological characteristics between the proposed device and predicate device with an assessment of differences between subject device and predicate device and why the differences do not introduce new or different questions of safety and effectiveness.

| Technological
Characteristics | FreedomEdge® Syringe Infusion
System
(K211206) | FreedomEdge® Syringe Infusion
System
(Subject Device) | Comparison |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Spring Type | Negator | Negator | Same |
| Winding of
Spring | FreedomEdge® syringe driver: Manual
lever used to tension negator constant
force spring | FreedomEdge® syringe driver: Manual
lever used to tension negator constant
force spring | Same |
| On / Off Control | Manual switch | Manual switch | Same |
| Housing | Molded ABS | Molded ABS | Same |
| Syringe Type | BD® 20 mL syringe (US Reference
number: 302830)
BD® 30 mL syringe (US Reference
number: 302832)
20 mL single-use pre-filled syringe (NDC
44206-458-96). | BD® 20 mL syringe (US Reference
number: 302830)
BD® 30 mL syringe (US Reference
number: 302832)
20 mL single-use pre-filled syringe (NDC
44206-458-96). | Same |
| Tubing Length
(inches) | 20 | 20 | Same |
| Tubing
Diameter
(inches) | HIgH-FloTM Subcutaneous Safety Needle
Sets (24G and 26G)
$0.0190 \pm 0.001"$
HIgH-FLO Super26TM Subcutaneous
Needle Sets
$0.033 + 0.002"/-0.001"$ | HIgH-FloTM Subcutaneous Safety Needle
Sets (24G and 26G)
$0.0190 \pm 0.001"$
HIgH-FLO Super26TM Subcutaneous
Needle Sets
$0.033 + 0.002"/-0.001"$ | Same |
| Tubing Material | Medical Grade PVC Plastic | Medical Grade PVC Plastic | Same |
| Needle Material | Stainless Steel | Stainless Steel | Same |
| Needle Gauge | 24 Gauge Needle Sets
26 Gauge Needle Sets | 24 Gauge Needle Sets
26 Gauge Needle Sets | Same |

Table 3. Comparison of Predicate and Subject Device
---------------------------------------------------------

12

| Technological
Characteristics | FreedomEdge® Syringe Infusion System
(K211206) | FreedomEdge® Syringe Infusion System
(Subject Device) | Comparison |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Needle Butterfly
Wings Material | HIgH-Flo™ Subcutaneous Safety Needle
Set
Polypropylene
HIgH-FLO Super26™ Subcutaneous
Needle Sets
Polypropylene with blue colorant
(541790C Translucent blue, Marvel
Industries, Inc.) | HIgH-Flo™ Subcutaneous Safety Needle
Set
Polypropylene
HIgH-FLO Super26™ Subcutaneous
Needle Sets
Polypropylene with blue colorant
(541790C Translucent blue, Marvel
Industries, Inc.) | Same |
| Needle Lengths | 4, 6, 9, 12, 14 | 4, 6, 9, 12, 14 | Same |
| Needle Usage | Single Use | Single Use | Same |
| Packaging | Tubing and Needle Sets packaged sterile
utilizing a nylon pouch (P/N 317050), for
single patient use. | Tubing and Needle Sets packaged sterile
utilizing a nylon pouch (P/N 317050), for
single patient use. | Same |
| Prescription
required | Yes | Yes | Same |
| Intended
Population | Adult, Pediatric | Adult, Pediatric | Same |
| System
Accuracy | Flow rates will fall between the minimum
and maximum predicted values as
specified in the IFU. | Flow rates will fall between the minimum
and maximum predicted values as
specified in the IFU. | Same |
| Sterilization
Method | Syringe Driver is non-sterile; Needle Sets
& Tubing sterilized via Gamma SAL 10-6 | Syringe Driver is non-sterile; Needle Sets
& Tubing sterilized via Gamma SAL 10-6 | Same |
| Needle Set
Configurations
Available | 24 Gauge: Available as a single-needle
set, as well as 2-needle, 3-needle, 4-
needle set; through use of a Y-connector,
5- needle, 6-needle, 7-needle and 8-needle
sets may also be assembled.

26 Gauge: Available as a single-needle
set, as well as 2-needle, 3-needle, 4-
needle, 5-needle, and 6-needle sets;
through use of a Y-connector, 7-needle
and 8-needle sets may also be assembled. | 24 Gauge: Available as a single-needle
set, as well as 2-needle, 3-needle, 4-
needle set; through use of a Y-connector,
5- needle, 6-needle, 7-needle and 8-needle
sets may also be assembled.

26 Gauge: Available as a single-needle
set, as well as 2-needle, 3-needle, 4-
needle, 5-needle, and 6-needle sets;
through use of a Y-connector, 7-needle
and 8-needle sets may also be assembled. | Same |
| | Needle 24 G 26 G Super26 | Needle 24 G 26 G Super26 | Same |

13

| Technological
Characteristics | FreedomEdge® Syringe Infusion
System
(K211206) | | | FreedomEdge® Syringe Infusion
System
(Subject Device) | | | Comparison | | |
|----------------------------------------------------|------------------------------------------------------|----------------------------------|----------------------------------|-------------------------------------------------------------|---|----------------------------------|----------------------------------|----------------------------------|--|
| Residual
Volumes for
HIgH-Flo
Needle Sets | 1 | 0.4 ml | 0.1 ml | 0.4 ml | 1 | 0.4 ml | 0.1 ml | 0.4 ml | |
| | 2 | 0.7 ml | 0.2 ml | 0.7 ml | 2 | 0.7 ml | 0.2 ml | 0.7 ml | |
| | 3 | 1.1 ml | 0.3 ml | 1.1 ml | 3 | 1.1 ml | 0.3 ml | 1.1 ml | |
| | 4 | 1.4 ml | 0.4 ml | 1.4 ml | 4 | 1.4 ml | 0.4 ml | 1.4 ml | |
| | 5 | 2.0 ml
(with Y-
connector) | 0.5 ml | 1.8 ml | 5 | 2.0 ml
(with Y-
connector) | 0.5 ml | 1.8 ml | |
| | 6 | 2.3 ml
(with Y-
connector) | 0.6 ml | 2.1 ml | 6 | 2.3 ml
(with Y-
connector) | 0.6 ml | 2.1 ml | |
| | 7 | 2.7 ml
(with Y-
connector) | 0.9 ml
(with Y-
connector) | 2.7 ml
(With Y-
connector) | 7 | 2.7 ml
(with Y-
connector) | 0.9 ml
(with Y-
connector) | 2.7 ml
(With Y-
connector) | |
| | 8 | 1.0 ml
(with Y-
connector) | 1.0 ml
(with Y-
connector) | 3.0 ml
(With Y-
connector) | 8 | 1.0 ml
(with Y-
connector) | 1.0 ml
(with Y-
connector) | 3.0 ml
(With Y-
connector) | |

14

VII. PERFORMANCE DATA

The following performance data/non-clinical testing was provided in support of the substantial equivalence determination for the FreedomEdge® Syringe Infusion System. The infusion system does not contain software, electrical components, or alarms.

| Device Performance | The essential performance requirements of the device were verified through
performance testing in accordance with the intended use of the device and in
accordance with the FDA Guidance "Infusion Pumps Total Product Life Cycle" |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | The materials used in the Administration Set (tubing and needles) for the
FreedomEdge® Syringe Infusion System comply with the International Standard
ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and
Testing Within a Risk Management Process," as recognized by FDA and FDA
Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", within a Risk Management Process and are considered to be biocompatible.

Testing was conducted for the following tests:
Cytotoxicity Sensitization Irritation |
| Human Factors | Human factors studies were completed per the FDA Guidance "Applying
Human Factors and Usability Engineering to Medical Devices" (February 3,
2016). The human factors studies were conducted with the intended user
population, use environment and use scenarios to simulate clinical conditions.
Results of the human factors testing demonstrate validation of the device per the
intended use. |
| Reprocessing,
Cleaning | AAMI TIR12:2010 – Designing, testing, and labeling reusable medical devices
for reprocessing in health care facilities: A guide for medical device
manufacturers.

AAMI TIR30:2011(R)2016 - A compendium of processes, materials, test
methods, and acceptance criteria for cleaning reusable medical devices.

Reprocessing Medical Devices in Health Care Settings: Validation Methods and
Labeling, Document issued on March 17, 2015 amended June 9, 2017, U.S.
Department of Health and Human Services, Food and Drug Administration,
Center for Devices and Radiological Health, Office of Device Evaluations.

ISO 17664:2017 – Processing of healthcare products - Information to be
provided by the medical device manufacturer for the processing of medical
devices.

ANSI/AAMI/ISO 11737-1:2018 – Sterilization of health care products –
Microbiological methods - Part 1: Determination of the population of
microorganisms on product. |
| | NAMSA Technical Memorandum US033689 Rev. 1, Review and Comparison
of the Koru Medical Systems Syringe Drive products to determine the Worst-
Case Design for Cleaning and Low Level Disinfection Efficacy Studies. |
| Packaging | 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1:
Requirements for materials, sterile barrier systems and packaging systems |
| Sterility | ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2:
Establishing the sterilization dose. |
| MR Safety | ASTM F2503-13, "Standard Practice for Marking Medical Devices and Other
Items for Safety in the Magnetic Resonance Environment." |

15

Safety Assurance

A safety assurance case is provided for the FreedomEdge® Syringe Infusion System, as recommended in the FDA guidance document, "Infusion Pumps Total Product Life Cycle."

The stated goal of the safety assurance case is:

  • . The FreedomEdge® Syringe Infusion System is adequately safe for its intended use.
    The assurance case defined the device system/configurations, including the indications for use, system definition, operational description, device user and patient populations, and device use conditions and environments. The supporting assurance arguments covered the following attributes:

  • Device requirements are adequate, and design is adequately verified and validated.

  • Device associated risks are completely identified and adequately mitigated.

  • Device is adequately reliable to ensure safety over its service life.

The following specific evidence was included within the assurance case to demonstrate that the subject device is verified and validated for its intended use and to demonstrate substantial equivalence to the predicate devices:

Device Performance

The essential performance requirements of the device were verified through performance testing in accordance with the intended use of the device and in accordance with the FDA Guidance "Infusion Pumps Total Product Life Cycle

The FreedomEdge® Syringe Infusion System includes directions for the selection of Precision Tubing Sets, HIgH-Flo Subcutaneous Needle Sets, and HIgH-FLO Super26 Subcutaneous Needle Sets combinations in order to achieve desired infusion rates for each

16

of the indicated human plasma-derived immunoglobulin solutions and Pegcetacoplan solutions, in accordance with the following tables:

EMPAVELI™ 20 ml syringe Selected Flow Rate Combinations

The following tables indicate the max-min predicated flow rates per site with HIgH-Flo Subcutaneous Safety Needles Sets™ (Standard 26G) when used in combination with KORU Precision Flow Rate Tubing™ and the FreedomEdge® Syringe Infusion System with a 20 ml BD syringe for the subcutaneous use of EMPAVEL™.

To determine the appropriate flow rate tubing and subcutaneous needle configuration, the prescriber should refer to drug package insert for the approximate maximum and minimum indicated infusion times.

HIgH-Flo 26G with Precision Tubing - Max-Min Flow Rate Per Site (ml/hr/site)

F500F600F900F1200F2400
1 needle18 - 42.219.4 - 45.822.3 - 53.622.9 - 5827.7 - 72.9
2 needles12.6 - 27.213.4 - 30.316.3 - 37.416.9 - 41.922.8 - 59.4

HIgH-Flo 26G with Precision Tubing - Max-Min Flow Rate Total (ml/hr)

F600F900F1200F2400
1 needle18.6 - 42.219.4 - 45.822.3 - 53.622.9 - 5827.7 - 72.9
2 needles25.2 - 54.326.7 - 60.532.5 - 74.933.8 - 83.745.5 - 118.7

HIgH-Flo 26G with Precision Tubing – Min-Max Infusion Times (minutes)

F500F600F900F1200F2400
1 needle47 (28-65)44 (26 - 62)38 (22 - 54)37 (21 - 52)30 (16-43)
2 needles35 (22-48)35 (22 - 48)27 (16-37)25 (14 - 36)18 (10 - 26)

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.

17

Selected Flow Rate Combinations

Select Combinations of Flow Rates with HIgH-Flo Subcutaneous Safety Needle Sets™ (Standard 26G and 24G) when used in combination with Precision Flow Rate Tubing™ for use with Hizentra®, Cuvitru®, and Gammagard® Liquid.

Note: The following tables are only for the subcutaneous use of the immunoglobulin listed.

Hizentra – FreedomEdge® with 20 ml syringe
Drug
volume (ml)Flow Rate
TubingHIgH-Flo
Needle Set*Total Flow
Rate (ml/hr)Flow rate/site
(ml/hr)Vol/site
(ml)TimeNOTES:
10F120RMS126098.28.2101:12Suggested start Peds
10F180RMS1260910.510.5100:57Suggested start Peds
20F275RMS2260917.18.5101:10Suggested start Peds
20F600RMS2260929.614.8100:40Suggested start Peds
40F600RMS3260933.911.313.31:10Suggested start Adult
40F900RMS3260944.314.813.30:54Suggested start Adult
60F900RMS426094912.3151:13Suggested start Adult
50F2400RMS3260972.224.116.670:416th Infusion of biologic and
beyond
100F2400RMS4260985.521.4251:106th Infusion of biologic and
beyond(NEEDS TWO
SYRINGES)
Hizentra - with FreedomEdge® with 30 ml syringe
20F600RMS2260922.511.2100:53Suggested start Peds
30F900RMS2260928.314.2151:03Suggested start Adult
30F2400RMS2260941.920.9150:426th Infusion of biologic and
beyond

| | Cuvitru - with FreedomEdge® with 20 ml
syringe | | | | | | | | | | | |
|---------------------|---------------------------------------------------|-------------------------|----------------------------|---------------------------|------------------|------|------------------------------------------|--|--|--|--|--|
| Drug
volume (ml) | Flow Rate
Tubing | HIgH-Flo
Needle Set* | Total Flow
Rate (ml/hr) | Flow rate/site
(ml/hr) | Vol/site
(ml) | Time | NOTES: | | | | | |
| 10 | F275 | RMS12609 | 12.1 | 12.1 | 10 | 0:49 | 1st Two Infusions patients under
40kg | | | | | |
| 20 | F275 | RMS12609 | 12.1 | 12.1 | 20 | 1:39 | 1st Two Infusions patients under
40kg | | | | | |
| 20 | F600 | RMS22609 | 25.7 | 12.8 | 10 | 0:47 | 1st Two Infusions patients under
40kg | | | | | |
| 50 | F600 | RMS22609 | 25.7 | 12.8 | 25 | 1:57 | 1st Two Infusions patients over
40kg | | | | | |
| 60 | F1200 | RMS22609 | 37.1 | 18.6 | 30 | 1:37 | Subsequent Infusions | | | | | |
| 60 | F2400 | RMS22409 | 110.5 | 55.4 | 30 | 0:32 | Subsequent Infusions | | | | | |
| 60 | F1200 | RMS12409 | 55.3 | 55.3 | 60 | 1:05 | Subsequent Infusions | | | | | |
| 100 | F2400 | RMS42409 | 132.8 | 33.2 | 25 | 0:45 | Subsequent Infusions | | | | | |

18

| Cuvitru - with FreedomEdge® with 30 ml

syringe
20F500RMS2260912.912.9201:321st Two Infusions patients under
40kg
30F900RMS2260924.612.3151:131st Two Infusions patients under
40kg
30F2400RMS1260921.221.2301:24Maintenance Infusions
30F1200RMS1240942.142.1300:42Maintenance Infusions
Gammagard Liquid – with FreedomEdge® with 20 ml syringe
Drug
volume (ml)Flow Rate
TubingHIgH-Flo
Needle Set*Total Flow
Rate (ml/hr)Flow rate/site
(ml/hr)Vol/site
(ml)TimeNOTES:
20F45RMS1260914.214.2201:24Patients under 40kg (Initial)
60F120RMS2260939.819.9301:30Patients over 40kg (Initial)
100F420RMS42609119.129.8250:50Patients over 40kg (maintenance infusions)
Gammagard Liquid – with FreedomEdge® with 20 ml syringe
20F120RMS226093015100:40Patients under 40kg(Initial)
30F180RMS2260939.819.9150:45Patients over 40kg (Initial)
30F120RMS126092727301:06Patients over 40kg (Maintenance)

*HIgH-Flo needle sets: The first number of needles, the next two numbers refer to the needle gauge, and the last two numbers refer to the needle length (mm).

19

Hizentra® 20 ml Prefilled Syringe Selected Flow Rate Combinations

The following tables indicate the min-max predicated flow rates per site with HIgH-Flo Subcutaneous Safety Needles Sets™ (Standard 26G, 24G and Super26™) when used in combination with KORU Precision Flow Rate Tubing™ and the FreedomEdge® Syringe Infusion System with a 20 ml syringe for the subcutaneous use of Hizentra CIDP.

To determine the appropriate flow rate tubing and subcutaneous needle configuration, please refer to drug package insert for the maximum indicated flow rate and volume per infusion site for initial and subsequent infusions.

F120F180F275F420F500F600F900F1200F2400
1 needle7 - 12.99.7 - 15.413.1 - 21.216.7 - 28.719.9 - 30.521.6 - 33.927.3 - 4228.8 - 45.935.7 - 55.6
2 needles3.8 - 7.15.4 - 8.77.6 - 12.610.1 - 18.212.6 - 19.614 - 22.519.2 - 30.320.7 - 34.628.7 - 46.9
3 needles2.6 - 4.93.7 - 65.4 - 8.97.3 - 13.39.3 - 14.510.3 - 16.914.8 - 23.716.2 - 27.724 - 40.6
4 needles2 - 3.72.9 - 4.64.2 - 6.95.7 - 10.57.3 - 11.58.2 - 13.512.1 - 19.513.3 - 23.220.6 - 35.8
5 needles1.6 - 32.3 - 3.83.4 - 5.74.7 - 8.76 - 9.56.8 - 11.210.2 - 16.511.2 - 19.918.1 - 32
6 needles1.3 - 2.51.9 - 3.22.9 - 4.83.9 - 7.45.1 - 8.15.8 - 9.68.8 - 14.49.8 - 17.416.1 - 28.9
7 needles1.1 - 2.21.7 - 2.72.5 - 4.13.4 - 6.44.5 - 7.15.1 - 8.47.7 - 12.78.6 - 15.514.5 - 26.4
8 needles1 - 1.91.5 - 2.42.2 - 3.73 - 5.74 - 6.34.5 - 7.56.9 - 11.47.7 - 13.913.2 - 24.2

HIgH-Flo 26G with Precision Tubing – Min-Max Flow Rate Per Site (ml/hr/site)

Image /page/19/Picture/5 description: The image shows a rectangle divided into two equal parts. The top part of the rectangle is gray, while the bottom part is light blue. The rectangle is enclosed by a black border.

Exceeds drug manufacturer's maximum indicated flow rate.

Subsequent infusions after 6th infusion only.

HIgH-Flo Super26 with Precision Tubing – Nominal Flow Rate Per Site (ml/hr/site)

F120F180F275F420F500F600F900F1200F2400
1 needle7.6 - 14.210.8 - 17.415.3 - 25.320.4 - 36.625.5 - 39.528.2 - 45.438.8 - 61.341.9 - 7058.3 - 95.5
2 needles4 - 7.55.7 - 9.38.3 - 13.911.4 - 21.114.7 - 2316.5 - 27.124.3 - 39.226.7 - 46.741.7 - 72.5
3 needles2.7 - 5.13.9 - 6.35.7 - 9.67.9 - 14.810.3 - 16.211.6 - 19.317.7 - 28.919.6 - 3532.5 - 58.4
4 needles2 - 3.92.9 - 4.84.3 - 7.36.1 - 11.47.9 - 12.59 - 1513.9 - 22.815.5 - 2826.6 - 48.9
5 needles1.6 - 3.12.4 - 3.93.5 - 5.94.9 - 9.36.4 - 10.27.3 - 12.311.4 - 18.912.8 - 23.422.5 - 42.1
6 needles1.4 - 2.62 - 3.22.9 - 54.1 - 7.85.4 - 8.66.2 - 10.49.7 - 16.110.9 - 2019.5 - 36.9
7 needles1.2 - 2.21.7 - 2.82.5 - 4.33.6 - 6.74.7 - 7.45.4 - 98.4 - 149.5 - 17.517.2 - 32.9
8 needles1 - 21.5 - 2.42.2 - 3.83.1 - 5.94.1 - 6.64.7 - 7.97.5 - 12.48.4 - 15.615.4 - 29.6

Image /page/19/Picture/10 description: The image shows a rectangle divided into two sections. The top section is colored gray, while the bottom section is light blue. The rectangle is outlined with a black border.

Exceeds drug manufacturer's maximum indicated flow rate.

Subsequent infusions after 6th infusion only.

20

F120F180F275F420F500F600F900F1200F2400
1 needle8 - 15.111.5 - 18.716.8 - 28.223.2 - 4329.9 - 47.133.8 - 55.850.3 - 81.755.6 - 9888.8 - 156.3
2 needles4 - 7.75.9 - 9.68.7 - 14.712.2 - 2316 - 25.418.2 - 30.528.3 - 46.731.7 - 57.755.3 - 102.8
3 needles2.7 - 5.24 - 6.55.9 - 108.3 - 15.711 - 17.412.5 - 2119.7 - 32.722.2 - 40.940.2 - 76.6
4 needles2 - 3.93 - 4.94.5 - 7.56.3 - 11.98.3 - 13.29.5 - 1615.1 - 25.217 - 31.731.5 - 61.1
5 needles1.6 - 3.12.4 - 3.93.6 - 6.15.1 - 9.66.7 - 10.77.7 - 12.912.2 - 20.413.8 - 25.826 - 50.8
6 needles1.4 - 2.62 - 3.33 - 5.14.2 - 8.15.6 - 8.96.4 - 10.810.3 - 17.211.7 - 21.822 - 43.4
7 needles1.2 - 2.21.7 - 2.82.6 - 4.33.6 - 6.94.8 - 7.75.5 - 9.38.9 - 14.910.1 - 18.919.2 - 38
8 needles1 - 21.5 - 2.52.3 - 3.83.2 - 6.14.2 - 6.74.9 - 8.27.8 - 13.18.9 - 16.617 - 33.7

HIgH-Flo 24G with Precision Tubing – Min-Max Flow Rate Per Site (ml/hr/site)

Image /page/20/Picture/2 description: The image shows a rectangle divided into two equal parts. The top part of the rectangle is gray, while the bottom part is light blue. The rectangle is outlined in black.

Exceeds drug manufacturer's maximum indicated flow rate. Subsequent infusions after 6th infusion only.

Clinical Evaluation

Clinical evaluation was not required to support submission and determination of substantial equivalence.

VIII. CONCLUSIONS

The FreedomEdge® Syringe Infusion System is substantially equivalent to the commercially available predicate device in terms of function, safety, performance, intended use, technology/principles of operation and mechanical properties. The non-clinical data support the safety of the device and performance testing demonstrate that the FreedomEdge® Syringe Infusion System meets the established specifications necessary for consistent performance to achieve its intended use as safely and as effectively as the predicate device and reference device and confirmed that the technological differences between the proposed device and predicate device do not raise different questions of safety or effectiveness. Based on performance testing results, the FreedomEdge® Syringe Infusion System, performs as intended and performs comparably to the predicate device that is currently marketed for the same intended use.