FreedomEdge(R) Syringe Infusion System

K211206 · Repro-Medical System, Inc., Dba Koru Medical Systems · FRN · Nov 9, 2021 · General Hospital

Device Facts

• Record ID: K211206
• Device Name: FreedomEdge(R) Syringe Infusion System
• Applicant: Repro-Medical System, Inc., Dba Koru Medical Systems
• Product Code: FRN · General Hospital
• Decision Date: Nov 9, 2021
• 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 certain medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling and the indications for use statement below. Intended population: adults and pediatrics.

Device Story

FreedomEdge Syringe Infusion System is a single-channel, volumetric, all-mechanical ambulatory infusion pump. It uses a constant force negator spring mechanism to apply pressure to a syringe plunger. System components include the FreedomEdge Syringe Driver, Precision Flow Rate Tubing (F0.5 to F2400), and HIgH-Flo Subcutaneous Safety Needle Sets (24G/26G) or HIgH-Flo Super26 Subcutaneous Needle Sets. The device is non-electric and contains no software or alarms. It is operated by patients or clinicians in home, hospital, or ambulatory settings. Flow rates are controlled by the combination of tubing flow restriction and medication viscosity. Healthcare providers select specific tubing/needle configurations based on drug labeling to achieve desired infusion rates. The system provides a mechanical method for controlled drug delivery, benefiting patients by enabling ambulatory administration of immunoglobulins and antibiotics.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993-1), human factors/usability engineering, packaging validation (ISO 11607-1), and sterilization validation (ISO 11137-2).

Technological Characteristics

Mechanical, non-electric, single-channel volumetric infusion pump. Materials: Molded ABS housing, medical-grade PVC tubing, stainless steel needles, polypropylene needle butterfly wings. Energy source: Constant force negator spring. Dimensions: 20-inch tubing. Sterilization: Gamma radiation (SAL 10^-6). Connectivity: None (standalone).

Indications for Use

Indicated for intravenous or subcutaneous infusion of medications and fluids in home, hospital, or ambulatory settings per drug/biologic labeling. Specifically indicated for subcutaneous infusion of human plasma-derived immunoglobulins (Cuvitru, Gammagard Liquid, Hizentra) and intravenous infusion of antibiotics (ertapenem, meropenem, oxacillin, tobramycin). Compatible with BD 20mL/30mL syringes and Hizentra 20mL pre-filled syringes. For use in adult and pediatric populations.

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

• Integrated Catch-Up FREEDOM Syringe Driver Infusion System (K162613)

Reference Devices

• KORU HIgH-Flo Super26™ Subcutaneous Safety Needle Set (K180843)

Submission Summary (Full Text)

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Repro-Medical System, Inc., dba Koru Medical Systems Kachi Eniyinna Consultant 24 Carpenter Road Chester, New York 10918

Re: K211206

Trade/Device Name: FreedomEdge(R) Syringe Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, FPA, PKP Dated: October 4, 2021 Received: October 4, 2021

Dear Kachi Eniyinna:

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.

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 801; medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Carolyn Dorgan Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors 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)

K211206

Device Name FreedomEdge® Syringe Infusion System

### Indications for Use (Describe)

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, 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 SetsTM ●
- 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 single-use prefilled syringe (NDC 442096-458-96).

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------|
| <div><span style="font-size:20px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div>□ Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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## 510(K) SUMMARY K211206

#### I. SUBMITTER

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

Ph: [phone] Fax: [phone]

Contact Person Charles Ryan Director, Regulatory Affairs Phone: [phone] Email: [e-mail]

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

Date Prepared: October 2, 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

Predicate Device: Integrated Catch-Up FREEDOM Syringe Driver Infusion System, K162613

Reference Device: KORU HIgH-Flo Super26™ Subcutaneous Safety Needle Set, K180843.

#### IV. DEVICE DESCRIPTION

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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

#### FreedomEdge® Syringe Driver: 1.

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 certain immunoglobulins 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 Freemdom60® driver.

#### Precision Flow Rate Tubing™: 2.

The Freedom Integrated Syringe System includes a range of Freedom Precision Flow Rate Tubing™ (provided sterile). The tubing ranges from F0.5 to F2400. Each F-number provides a different level of flow restriction, which, when combined with the viscosity of the medication, provides a controlled delivery in an all-mechanical system. The tubing sets connect at one end to the syringe being used and on the other end to the Subcutaneous Safety Needle Sets or directly on venous catheters for intravenous infusions as needed.

#### 3. HIgH-Flo Needles Sets:

## The HIgH-Flo Subcutaneous Safety Needle SetsTM

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 and antibiotics per the indications for use.

Subcutaneous Safety Needle Sets comes in multiple configurations (1, 2, 3, 4, 5, 6 needle sites). Needles are available in 4mm. 6mm. 9mm. 12mm. and 14mm lengths combined

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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 Super26™ 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 in accordance with the indication for use statement. 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 26™ Subcutaneous Needle Sets are available as a single set, as well as 2-needle, 3-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 for the cleared infusion system. The major modifications to the current device are as follows:

- 1. Device Configuration
- Removal of syringe driver The Subject device will only a. include use of only one syringe driver (FreedomEdge) instead of two syringe drivers cleared for use in the predicate device.
- Addition of second needle set -- The HIgH-FLO Super26 b. Subcutaneous Needle cleared under K180843 is added for use with the system.
- 2. Update Indication for Use The purpose of the device application is to expand the currently cleared indications for use to include the addition of Hizentra 20ml Prefilled syringe and HIgH-Flo Super26TM Subcutaneous Needle Set into the indications for use.
- 3. Addition of Blue Colorant to Needle Butterfly Wings Addition of a blue colorant to the HIgH-Flo Super26™ Subcutaneous Safety Needle Sets. The blue colorant (541790C Translucent blue, Marvel Industries, Inc.) was added to the Super26TM needle hub assembly to help distinguish between the HIgH-Flow Subcutaneous Safety Needle Sets and HIgH-Flo Super26TM Subcutaneous Safety Needle Sets.
- 4. Update Sterile Barrier (Packaging material) sterile devices will be packaged in a nylon film pouch, which once sealed, serves as the sterile barrier. The pouch material was updated from LDPE pouch, P/N 317036 to

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Nylon pouch, P/N 317050.

- 5. Flow Rate Accuracy the flow rate accuracy between the subject device and predicate device has changed from +/-8% to predicted minimum to maximum flow rates within those labeled per the Hizentra package insert for each combination of needle set and tubing.
#### V. INDICATIONS FOR USE

### INTENDED USE

The FreedomEdge® Syringe Infusion System is intended for the intravenous or subcutaneous infusion of certain medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling and the indications for use statement below.

Intended population: adults and pediatrics.

## INDICATIONS FOR USE

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 prefilled 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% (manufactured by Takeda®);

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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 20 mL single-use pre-filled syringe (NDC 44206-458-96).

#### 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:

| | Predicate Device<br>(K162613) | Subject Device<br>(K211206) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Integrated Catch-Up FREEDOM Syringe<br>Driver Infusion System | FreedomEdge® Syringe Infusion System |
| | Current configuration | New configuration |
| | Current Indications for Use<br>as cleared August 31, 2017 | Modified Indications for<br>Use |
| Indications | The Integrated Catch-Up FREEDOM Syringe<br>Driver Infusion System (ICFSDIS), which<br>includes the FREEDOM60® and FreedomEdge®<br>syringe pumps, is indicated for the intravenous or<br>subcutaneous infusion of medications and fluids<br>in the home, hospital, or ambulatory settings<br>when administered according to the approved<br>biologic or drug product labeling. The ICFSDIS<br>is specifically indicated for the subcutaneous<br>infusion of the following human plasma-derived<br>immunoglobulins when used according to the<br>FDA approved biologic labeling: Hizentra,<br>Immune Globulin Subcutaneous (Human) 20%<br>Liquid (manufactured by CSL Behring);<br>Gammagard Liquid, Immune Globulin Infusion<br>(Human) 10% (manufactured by Shire); and<br>Cuvitru Immune Globulin Infusion (Human) 20%<br>(manufactured by Shire). The ICFSDIS is<br>specifically indicated for the intravenous infusion<br>of the following antibiotics when used according<br>to the FDA approved drug product labeling: | 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 |
| Predicate Device<br>(K162613) | Subject Device<br>(K211206) | |
| Integrated Catch-Up FREEDOM Syringe<br>Driver Infusion System | FreedomEdge® Syringe Infusion System | |
| Current configuration | New configuration | |
| Current Indications for Use<br>as cleared August 31, 2017 | Modified Indications for<br>Use | |
| meropenem, ertapenem, oxacillin, and<br>tobramycin.<br>The FreedomEdge® Syringe Infusion System is<br>indicated for use with the BD 20 ml (model no.<br>302830/301031) or BD 30 ml (model no. 301033)<br>syringe. The FREEDOM60 Syringe Infusion<br>System is indicated for use with the BD 60 ml<br>syringe (model no. 309653). | 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%<br>(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®)<br>Single-use pre-filled syringe for<br>subcutaneous administration.<br>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. | |
| | Predicate Device<br>(K162613)<br>Integrated Catch-Up FREEDOM Syringe<br>Driver Infusion System | Subject Device<br>(K211206)<br>FreedomEdge® Syringe Infusion System |
| | Current configuration | New configuration |
| | Current Indications for Use<br>as cleared August 31, 2017 | Modified Indications for<br>Use |
| 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 a 20mL Hizentra Pre-Filled Syringe and the HIgH-Flo Super26™ Subcutaneous Needle Set to the infusion system. The difference in in between the subject device and predicate device infusion system are the inclusion of the 20mL Hizentra Pre-Filled Syringe and the HIgH-Flo Super 26™ Subcutaneous Needle Set into the indications for use.

Compatibility of prefilled syringe and HIgH-Flo Super26™ with the FreedomEdge infusion system specifically has been verified through performance testing. The FreedomEdge Syringe Infusion System will include a second needle set, the HIgH-Flo Super26TM Subcutaneous Needle Sets, in addition to the HIgH-Flo Subcutaneous Safety Needle Sets™. The HIgH-Flo Super26™ Subcutaneous Needle Set is cleared for use with the FreedomEdge syringe driver and Precision Flow Rate Tubing™ and 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. The change to device indications do not significantly affect safety or effectiveness as the changes do not create new risks or significantly 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.

Discussions of differences in environment of use

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

## Device configuration

The table below includes a comparison of the infusion system configuration between the new device and that of the predicate device:

| Predicate | Subject Device |
|---------------------------------------------------------------|------------------------------------------------------------|
| K162613 | K211206 |
| Integrated Catch-Up Freedom Syringe<br>Driver Infusion System | FreedomEdge® Syringe Infusion System |
| 1. The Freedom60® Syringe Driver | 1. The FreedomEdge® Syringe Driver |
| 2. The FreedomEdge® Syringe Driver | 2. Precision Flow Rate Tubing™ |
| 3. Precision Flow Rate Tubing™ | 3. HIgH-Flo™ Subcutaneous Safety Needle<br>Sets (24G, 26G) |
| 4. HIgH-Flo™ Subcutaneous Safety Needle<br>Sets (24G, 26G) | 4. HIgH-FLO Super26™ Subcutaneous<br>Needle Sets |

Table 2. Device Configuration Comparison

## Discussions of differences in system configuration

The Subject device utilizes the same components from predicate device to form the subject device, FreedomEdge® Syringe Infusion System. The main difference is that the subject device is re-configured and packaged with only one syringe driver (FreedomEdge svringe driver) instead of the two svringe drivers (FREEDOM60™ svringe driver and FreedomEdge™ syringe driver) cleared for use in the predicate device. Also, in addition, the new configuration will include use of the HIgH-Flow Super26 Subcutaneous Needle in addition to the HIgH-Flo™ Subcutaneous Safety Needles Sets. The HIgH-Flo Super26™, as part of the subject device is similar to the HIgH-Flo Subcutaneous Safety Needle Sets™ but specifically used for higher flow rates. Both needle sets are intended for the delivery of medication to the subcutaneous tissue. The HIgH-Flo Super26™ is cleared for use with the FreedomEdge® syringe driver. The methods for HIgH-Flo Super26™ has been shown to be substantially equivalent in K180843, as a reference device.

The devices are furthermore, similar in technological characteristics with respect to providing intravenous or subcutaneous infusion of medications and fluids. While there are minor technological differences between the subject and predicate device, these differences do not introduce new or different questions of safety and effectiveness, as confirmed through the results of performance testing.

Table 3 and Table 4 presents a tabular comparison of the technological characteristics between the proposed device, and predicate device with an assessment of differences between them and why the difference between the subject device and predicate device do not introduce new or different questions of safety and effectiveness.

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| Technological<br>Characteristics | Integrated Catch-up<br>FREEDOM Syringe Driver<br>Infusion System (ICSDIS,<br>known as Freedom Infusion<br>System)<br>(K162613) | FreedomEdge™ Syringe<br>Infusion System<br>(K211206) | Comparison |
|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Spring Type | Negator | Negator | Same |
| Winding of Spring | FREEDOM60® syringe driver:<br>Manual knob used to tension<br>negator constant force spring<br><br>FreedomEdge syringe driver:<br>Manual lever used to tension<br>negator constant force spring | FreedomEdge syringe driver:<br>Manual lever used to tension<br>negator constant force spring | Same winding of spring for FreedomEdge. |
| On / Off Control | Manual switch | Manual switch | Same |
| Housing | Molded ABS | Molded ABS | Same |
| Syringe Type | FreedomEdge<br>BD® 20 mL syringe (US<br>Reference number: 302830)<br>BD 30 mL syringe (US<br>Reference number: 302832)<br>FREEDOM60®<br>BD 50 mL syringe (model no.<br>309653) | BD® 20 mL syringe (US<br>Reference number: 302830)<br>BD 30 mL syringe (US Reference<br>number: 302832)<br>20 mL single-use pre-filled syringe<br>(NDC 44206-458-96). | Different.<br>Indications for Use now includes single use<br>pre-filled syringe whereas the predicate does<br>not. Syringe comes pre-filled with approved<br>drug, Hizentra, ready to use in FreedomEdge<br>syringe driver. Use of pre-filled syringe does<br>not change intended use of infusion system<br>device nor does it raise new questions of safety<br>and effectiveness. |
| Technological<br>Characteristics | Integrated Catch-up<br>FREEDOM Syringe Driver<br>Infusion System (ICSDIS,<br>known as Freedom Infusion<br>System)<br>(K162613) | FreedomEdge™ Syringe<br>Infusion System<br>(K211206) | Comparison…