FreedomEdge Syringe Infusion System

K214045 · Repro-Medical System, Inc., Dba Koru Medical Systems · FRN · Apr 29, 2022 · General Hospital

Device Facts

• Record ID: K214045
• Device Name: FreedomEdge Syringe Infusion System
• Applicant: Repro-Medical System, Inc., Dba Koru Medical Systems
• Product Code: FRN · General Hospital
• Decision Date: Apr 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

FreedomEdge Syringe Infusion System is a single-channel, volumetric, non-electric ambulatory infusion pump. It consists of a reusable syringe driver, Precision Flow Rate Tubing, and HIgH-Flo Subcutaneous Safety Needle Sets. The driver uses a constant force negator spring mechanism to apply pressure to a BD 20mL or 30mL syringe plunger. Flow rate is controlled by the combination of tubing restriction (F-number) and medication viscosity. Used in home, hospital, or ambulatory settings by patients or clinicians. The device delivers immunoglobulins, pegcetacoplan, or antibiotics. Healthcare providers select tubing and needle configurations based on drug-specific infusion time and flow rate tables provided in the labeling. The system is purely mechanical; it contains no software, electronics, or alarms. It benefits patients by enabling controlled, ambulatory administration of prescribed therapies.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-1), human factors/usability studies, sterilization validation (ISO 11137-2), and performance testing of flow rate accuracy in accordance with FDA guidance for infusion pumps.

Technological Characteristics

Non-electric, ambulatory, volumetric infusion pump. Materials: Molded ABS housing, medical-grade PVC tubing, stainless steel needles, polypropylene needle wings. Principle: Constant force negator spring. Connectivity: None. Sterilization: Gamma radiation (SAL 10^-6) for tubing/needles; driver is non-sterile. Form factor: Syringe driver for 20/30mL syringes.

Indications for Use

Indicated for adult and pediatric patients for subcutaneous infusion of human plasma-derived immunoglobulins (Cuvitru, Gammagard Liquid, Hizentra) and EMPAVELI (pegcetacoplan), and intravenous infusion of antibiotics (Ertapenem, Meropenem, Oxacillin, Tobramycin) in home, hospital, or ambulatory settings.

Regulatory Classification

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.

Predicate Devices

• FreedomEdge® Syringe Infusion System (K211206)

Submission Summary (Full Text)

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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

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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 [phone] 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

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# 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: [phone] Fax: [phone]

Contact Person Christopher Pazdan Vice President, Quality Assurance and Regulatory Affairs Phone: [phone] Email: [e-mail]

Application Correspondent Kachi Enyinna Regulatory Consultant to Koru Medical Systems Phone: [phone] Email: [e-mail]

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,
- 2. Precision Flow Rate Tubing™ and

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- 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

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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.

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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:

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| | Predicate Device<br>(K211206) | Subject Device |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | FreedomEdge® Syringe Infusion System | FreedomEdge® Syringe Infusion System |
| | Modified Indications for<br>Use | Modified Indications for<br>Use |
| Indications | The FreedomEdge® Syringe Infusion System is<br>indicated for the intravenous or subcutaneous<br>infusion of medications and fluids in the home,<br>hospital, or ambulatory settings when<br>administered according to the approved biologic<br>or drug product labeling. The FreedomEdge®<br>Syringe Infusion System is specifically indicated<br>for the subcutaneous infusion of the following<br>human plasma-derived immunoglobulins when<br>used according to the FDA approved biologic<br>labeling: Cuvitru®, Immune Globulin Infusion<br>(Human) 20% (manufactured by Takeda®);<br>Gammagard Liquid®, Immune Globulin Infusion<br>(Human) 10% (manufactured by Takeda®);<br>Hizentra®, Immune Globulin Subcutaneous<br>(Human) 20% Liquid (manufactured by CSL<br>Behring®) and Hizentra®, Immune Globulin<br>Subcutaneous (Human) 20% Liquid<br>(manufactured by CSL Behring®) Single-use<br>pre-filled syringe for subcutaneous<br>administration.<br>The FreedomEdge® Syringe Infusion System<br>with the FreedomEdge® Syringe Driver and<br>Precision Flow Rate Tubing™, is specifically<br>indicated for the intravenous infusion of the<br>following antibiotics when used according to the<br>FDA approved drug product labeling: ertapenem,<br>meropenem, oxacillin, and tobramycin.<br>The FreedomEdge® Syringe Infusion System<br>consists of the following components:<br>• FreedomEdge® Syringe Driver<br>• Precision Flow Rate Tubing™<br>• HIgH-Flo Subcutaneous Safety Needle<br>Sets™<br>• HIgH-Flo Super26™ Subcutaneous<br>Needle Sets are specifically indicated for<br>the subcutaneous infusion of the<br>following human plasma-derived<br>immunoglobulins: Cuvitru®, Immune<br>Globulin Infusion (Human) 20% | The FreedomEdge® Syringe Infusion System<br>consists of the following components:<br>• FreedomEdge® Syringe Driver<br>• Precision Flow Rate Tubing™<br>• HIgH-Flo Subcutaneous Safety Needle<br>Sets™<br>• HIgH-Flo Super26™ Subcutaneous<br>Needle Sets are specifically indicated for<br>the subcutaneous infusion of the<br>following human plasma-derived<br>immunoglobulins: Cuvitru®, Immune<br>Globulin Infusion (Human) 20%<br>(manufactured by Takeda®); Hizentra®,<br>Immune Globulin Subcutaneous<br>(Human) 20% Liquid (manufactured by<br>CSL Behring®); Hizentra®, Immune<br>Globulin Subcutaneous (Human) 20%<br>Liquid (manufactured by CSL Behring®)<br>Single-use pre-filled syringe for<br>subcutaneous administration.<br>The FreedomEdge® Syringe Infusion<br>System is indicated for use with the BD®<br>20 ml syringe (US Reference number:<br>302830), BD 30 ml syringe (US<br>Reference number: 302832) and<br>Hizentra® 20 ml prefilled syringe (NDC<br>44206-458-96).<br>For Immunoglobulin Administration:<br>The Freedom Integrated Syringe Infusion<br>System is specifically indicated for the<br>subcutaneous infusion of the following human<br>plasma-derived immunoglobulins when used<br>according to the FDA approved biologic<br>labeling: Cuvitru®, Immune Globulin Infusion<br>(Human) 20% (manufactured by Takeda®);<br>Gammagard Liquid®, Immune Globulin<br>Infusion (Human) 10% (manufactured by<br>Takeda®); Hizentra®, Immune Globulin |
| | Predicate Device<br>(K211206)<br>FreedomEdge® Syringe Infusion System | Subject Device<br>FreedomEdge® Syringe Infusion System |
| | Modified Indications for<br>Use | Modified Indications for<br>Use |
| | (manufactured by Takeda®); Hizentra®,<br>Immune Globulin Subcutaneous (Human)<br>20% Liquid (manufactured by CSL<br>Behring®); Hizentra®, Immune Globulin<br>Subcutaneous (Human) 20% Liquid<br>(manufactured by CSL Behring®) Single-<br>use pre-filled syringe for subcutaneous<br>administration. | Subcutaneous (Human) 20% Liquid<br>(manufactured by CSL Behring®) and<br>Hizentra®, Immune Globulin Subcutaneous<br>(Human) 20% Liquid (manufactured by CSL<br>Behring®) Single-use pre-filled syringe for<br>subcutaneous administration in the home,<br>hospital, or ambulatory settings when<br>administered according to the approved biologic<br>or drug product labeling. |
| | The FreedomEdge® Syringe Infusion System is<br>indicated for use with the BD® 20 mL syringe<br>(US Reference number: 302830*), BD 30 mL<br>syringe (US Reference number: 302832**), and<br>20 mL single-use pre-filled syringe (NDC 44206-<br>458-96).<br>*Model no. 301031 is the non-sterile version of<br>BD® 20 ml syringe sold by BD<br>**model no. 301033 is the non-sterile version of<br>BD® 30 ml syringe. | For EMPAVELI™ (pegcetacoplan)<br>Administration:<br>The Freedom Integrated Syringe Infusion<br>System is specifically indicated for the<br>subcutaneous infusion with EMPAVELI™<br>(pegcetacoplan) in the home, hospital, or<br>ambulatory setting when administered according<br>to the approved drug product labeling.<br>For Intravenous Antibiotic Administration:<br>The Freedom Integrated Syringe Infusion<br>System with the FreedomEdge® Syringe Driver<br>and Precision Flow Rate TubingTM, is<br>specifically indicated for the intravenous<br>infusion of the following antibiotics when used<br>according to the FDA approved drug product<br>labeling:<br>Ertapenem, Meropenem, Oxacillin, and<br>Tobramycin. |
| Prescription or<br>Over the<br>Counter | Prescription | Prescription |
| Intended<br>Population | Adult and pediatric | Adult and pediatric |
| Environment<br>of Use | Hospital, ambulatory, or home | Hospital, ambulatory, or home |

# Table 1. Indications for Use Comparison

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# 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

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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<br>K211206 | Subject Device<br>(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<br>Needle Sets (24G, 26G) | 3. HIgH-Flo™ Subcutaneous Safety<br>Needle Sets (24G, 26G) |
| 4. HIgH-FLO Super26™ Subcutaneous<br>Needle Sets | 4. HIgH-FLO Super26™ Subcutaneous<br>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.

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

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

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| Technological<br>Characteristics | FreedomEdge® Syringe Infusion System<br>(K211206) | FreedomEdge® Syringe Infusion System<br>(Subject Device) | Comparison |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Needle Butterfly<br>Wings Material | HIgH-Flo™ Subcutaneous Safety Needle<br>Set<br>Polypropylene<br>HIgH-FLO Super26™ Subcutaneous<br>Needle Sets<br>Polypropylene with blue colorant<br>(541790C Translucent blue, Marvel<br>Industries, Inc.) | HIgH-Flo™ Subcutaneous Safety Needle<br>Set<br>Polypropylene<br>HIgH-FLO Super26™ Subcutaneous<br>Needle Sets<br>Polypropylene with blue colorant<br>(541790C Translucent blue, Marvel<br>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<br>utilizing a nylon pouch (P/N 317050), for<br>single patient use. | Tubing and Needle Sets packaged sterile<br>utilizing a nylon pouch (P/N 317050), for<br>single patient use. | Same |
| Prescription<br>required | Yes | Yes | Same |
| Intended<br>Population | Adult, Pediatric | Adult, Pediatric | Same |
| System<br>Accuracy | Flow rates will fall between the minimum<br>and maximum predicted values as<br>specified in the IFU. | Flow rates will fall between the minimum<br>and maximum predicted values as<br>specified in the IFU. | Same |
| Sterilization<br>Method | Syringe Driver is non-sterile; Needle Sets<br>& Tubing sterilized via Gamma SAL 10-6 | Syringe Driver is non-sterile; Needle Sets<br>& Tubing sterilized via Gamma SAL 10-6 | Same |
| Needle Set<br>Configurations<br>Available | 24 Gauge: Available as a single-needle<br>set, as well as 2-needle, 3-needle, 4-<br>needle set; through use of a Y-connector,<br>5- needle, 6-needle, 7-needle and 8-needle<br>sets may also be assembled.<br><br>26 Gauge: Available as a single-needle<br>set, as well as 2-needle, 3-needle, 4-<br>needle, 5-needle, and 6-needle sets;<br>through use of a Y-connector, 7-needle<br>and 8-needle sets may also be assembled. | 24 Gauge: Available as a single-needle<br>set, as well as 2-needle, 3-needle, 4-<br>needle set; through use of a Y-connector,<br>5- needle, 6-needle, 7-needle and 8-needle<br>sets may also be assembled.<br><br>26 Gauge: Available as a single-needle<br>set, as well as 2-needle, 3-needle, 4-<br>needle, 5-needle, and 6-needle sets;<br>through use of a Y-connector, 7-needle<br>and 8-needle sets may also be assembled. | Same |
| | Needle 24 G 26 G Super26 | Needle 24 G 26 G Super26 | Same |

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| Technological<br>Characteristics | FreedomEdge® Syringe Infusion<br>System<br>(K211206) | | | FreedomEdge® Syringe Infusion<br>System<br>(Subject Device) | | | Comparison | | |
|----------------------------------------------------|------------------------------------------------------|----------------------------------|----------------------------------|-------------------------------------------------------------|---|----------------------------------|----------------------------------|----------------------------------|--|
| Residual<br>Volumes for<br>HIgH-Flo<br>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<br>(with Y-<br>connector) | 0.5 ml | 1.8 ml | 5 | 2.0 ml<br>(with Y-<br>connector) | 0.5 ml | 1.8 ml | |
| | 6 | 2.3 ml<br>(with Y-<br>connector) | 0.6 ml | 2.1 ml | 6 | 2.3 ml<br>(with Y-<br>connector) | 0.6 ml | 2.1 ml | |
| | 7 | 2.7 ml<br>(with Y-<br>connector) | 0.9 ml<br>(with Y-<br>connector) | 2.7 ml<br>(With Y-<br>connector) | 7 | 2.7 ml<br>(with Y-<br>connector) | 0.9 ml<br>(with Y-<br>connector) | 2.7 ml<br>(With Y-<br>connector) | |
| | 8 | 1.0 ml<br>(with Y-<br>connector) | 1.0 ml<br>(with Y-<br>connector) | 3.0 ml<br>(With Y-<br>connector) | 8 | 1.0 ml<br>(with Y-<br>connector) | 1.0 ml<br>(with Y-<br>connector) | 3.0 ml<br>(With Y-<br>connector) | |

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# 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<br>performance testing in accordance with the intended use of the device and in<br>accordance with the FDA Guidance "Infusion Pumps Total Product Life Cycle" |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | The materials used in the Administration Set (tubing and needles) for the<br>FreedomEdge® Syringe Infusion System comply with the International Standard<br>ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and<br>Testing Within a Risk Management Process," as recognized by FDA and FDA<br>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.<br><br>Testing was conducted for the following tests:<br>Cytotoxicity Sensitization Irritation…