FREEDOM Integrated Syringe Infusion System

K200176 · Repro-Med Systems, Inc. Dba Koru Medical Systems · FRN · Dec 15, 2021 · General Hospital

Device Facts

• Record ID: K200176
• Device Name: FREEDOM Integrated Syringe Infusion System
• Applicant: Repro-Med Systems, Inc. Dba Koru Medical Systems
• Product Code: FRN · General Hospital
• Decision Date: Dec 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The FREEDOM® Integrated 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

Single-channel, volumetric, non-electric, ambulatory infusion pump; uses constant force spring mechanism to apply pressure to BD 50mL syringe plunger. System includes FREEDOM60 Syringe Driver, Precision Flow Rate Tubing, and HIgH-Flo Subcutaneous Safety Needle Sets (standard or Super26). Tubing sets provide flow restriction based on medication viscosity; connects to needle sets or venous catheters. Used in home, hospital, or ambulatory settings by patients or clinicians. Healthcare providers select tubing/needle configuration based on drug-specific flow rate tables to ensure delivery within manufacturer-specified limits. System provides controlled, mechanical delivery of immunoglobulins and antibiotics; benefits patients by enabling ambulatory/home-based therapy.

Clinical Evidence

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

Technological Characteristics

Non-electric, spring-driven volumetric infusion pump. Materials: Molded ABS housing, medical-grade PVC tubing, stainless steel needles, polypropylene needle wings. Sterilization: Gamma radiation (SAL 10^-6). Connectivity: None (mechanical). Software: None.

Indications for Use

Indicated for subcutaneous infusion of human plasma-derived immunoglobulins (Cutaquig, Cuvitru, Gammagard Liquid, Hizentra, Xembify) and intravenous infusion of antibiotics (ertapenem, meropenem, oxacillin, tobramycin) in adults and pediatrics 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

• 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-Med Systems, Inc., dba KORU Medical Systems Kachi Enyinna Vice President of Global Commercialization 24 Carpenter Road Chester, New York 10918

December 15, 2021

Re: K200176

Trade/Device Name: FREEDOM Integrated Syringe Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, FPA, PKP Dated: March 30, 2021 Received: March 30, 2021

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/ofpmn/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

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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 (OS) 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 provisions (Sections (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) K200176

#### Device Name

FREEDOM® Integrated Syringe Infusion System

Indications for Use (Describe)

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: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by Grifols®) in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling.

The FREEDOM Integrated Syringe Infusion System with the FREEDOM60® 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 Freedom Integrated Syringe Infusion System consists of the following components:

- FREEDOM60® Syringe Driver
- Precision Flow Rate Tubing™M
- 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: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®).

The FREEDOM60® Syringe Driver is indicated for use with the BD® 50 ml syringe (US Reference number 309653).

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 510(K) SUMMARY K200176

#### 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: November 12, 2021

#### II. DEVICE

Name of Device: FREEDOM® Integrated 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 This predicate has not been subject to a design-related recall.

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

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

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#### IV. DEVICE DESCRIPTION

The FREEDOM® Integrated Syringe Infusion System is a single-channel, volumetric infusion pump. The FREEDOM60® Integrated Syringe Infusion System consists of four primary components:

- 1. FREEDOM60® 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. FREEDOM60® Syringe Driver:

The FREEDOM60® Syringe Driver in combination with Precision Flow Rate Tubing™ (sterile) and HIgH-Flo Subcutaneous Safety Needle Sets (sterile) makes up the Freedom Integrated Syringe Infusion system. The FREEDOM60® Syringe Driver is a non- sterile, reusable non-electric driver that infuses immunoglobulins subcutaneously and antibiotic solutions intravenously to patients.

The FREEDOM60® Syringe Driver is an ambulatory device designed to accommodate a BD Luer- Lok™ 50mL Syringe (Catalog No.: 8881-560125, BD 309653), and fluid volumes ranging from 10cc to 60cc may be used. The pump uses a constant force spring mechanism to apply pressure to the plunger-end syringe.

The Freedom Integrated Syringe System is assembled by loading the syringe with tubing into the Freemdom60® driver.

#### 2. Precision Flow Rate Tubing™:

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.

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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 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.

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 (FREEDOM60®) 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 two new drugs, Xembify and Cutaquig, 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 Super26™ 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

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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 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 FREEDOM® Integrated 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 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: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by Grifols®) in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The Freedom Integrated Syringe Infusion System with the FREEDOM60® 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 Freedom Integrated Syringe Infusion System consists of the following components:

- FREEDOM60® 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: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution

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(manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); and Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®).

The FREEDOM60® Syringe Driver is indicated for use with the BD® 50 ml syringe (US Reference number 309653).

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. 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>(K200176) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Integrated Catch-Up FREEDOM Syringe<br>Driver Infusion System | FREEDOM® Integrated Syringe Infusion<br>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 | The Freedom Integrated Syringe Infusion System<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: Cutaquig®,<br>Immune Globulin Subcutaneous (Human) 16.5%<br>Solution (manufactured by Octapharma®);<br>Cuvitru®, Immune Globulin Infusion (Human)<br>20% (manufactured by Takeda®); Gammagard<br>Liquid®, Immune Globulin Infusion (Human)<br>10% (manufactured by Takeda®); Hizentra®,<br>Immune Globulin Subcutaneous (Human) 20%<br>Liquid (manufactured by CSL Behring®); and<br>Xembify®, Immune Globulin Subcutaneous<br>(Human) 20% Liquid (manufactured by<br>Grifols®) in the home, hospital, or ambulatory<br>settings when administered according to the<br>approved biologic or drug product labeling. The |
| | 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 | Freedom Integrated Syringe Infusion System<br>with the FREEDOM60® 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 |
| | to the FDA approved drug product labeling:<br>meropenem, ertapenem, oxacillin, and<br>tobramycin. | FDA approved drug product labeling: ertapenem,<br>meropenem, oxacillin, and tobramycin. The<br>Freedom Integrated Syringe Infusion System |
| | The FreedomEdge® Syringe Infusion System is<br>indicated for use with the BD 20 ml (model no. | |
| | Predicate Device<br>(K162613)<br>Integrated Catch-Up FREEDOM Syringe<br>Driver Infusion System | Subject Device<br>(K200176)<br>FREEDOM® Integrated Syringe Infusion<br>System |
| | Current configuration | New configuration |
| | Current Indications for Use<br>as cleared August 31, 2017 | Modified Indications for<br>Use |
| | 302830/301031) or BD 30 ml (model no. 301033) syringe. The FREEDOM60® Syringe Infusion System is indicated for use with the BD 60 ml syringe (model no. 309653). | consists of the following components:<br>• FREEDOM60® Syringe Driver<br>• Precision Flow Rate Tubing™<br>• HIgH-Flo Subcutaneous Safety Needle Sets™<br>• HIgH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins:<br>Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); and Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) |
| | | The FREEDOM60® Syringe Driver is indicated for use with the BD® 50 ml syringe (US Reference number 309653). |
| 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 |
| Predicate | Subject Device | |
| K162613 | K200176 | |
| Integrated Catch-Up Freedom Syringe | FREEDOM® Integrated Syringe Infusion | |
| Driver Infusion System | System | |
| 1. The FREEDOM60® Syringe Driver<br>2. The FreedomEdge® Syringe Driver<br>3. Precision Flow Rate Tubing™<br>4. HIgH-Flo™ Subcutaneous Safety Needle<br>Sets (24G, 26G) | 1. The FREEDOM60® Syringe Driver<br>2. Precision Flow Rate Tubing™<br>3. HIgH-Flo™ Subcutaneous Safety Needle<br>Sets (24G, 26G)<br>4. HIgH-FLO Super26™ Subcutaneous<br>Needle Sets | |

### 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 FREEDOM® Integrated Syringe Infusion System is not identical to the predicate device. The submission expands on the currently cleared indications for use to include the addition of two new drugs, Xembify and Cutaquig, and the HIgH-Flo Super26™ Subcutaneous Needle Set to the infusion system. The difference between the subject device and predicate device infusion systems are the inclusion of the of two new drugs, Xembify and Cutaquig and the HIgH-Flo Super 26TM Subcutaneous Needle Set into the indications for use.

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Compatibility of Xembify and Cutaquig and HIgH-Flo Super26™ with the FREEDOM60® Integrated Syringe Infusion System specifically, has been verified through performance testing. The FREEDOM® Integrated Syringe Infusion System will include a second needle set, the HIgH-Flo Super26™ 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 FREEDOM60® 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

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:

## 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, FREEDOM® Integrated Syringe Infusion System. The main difference is that the subject device is re-configured and packaged with only one syringe driver (FREEDOM60® Syringe Driver) instead of the two syringe drivers (FREEDOM60®

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Syringe 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 Super26TM 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 flow rates between 24 gauge and 26 gauge needle sets. Both needle sets are intended for the delivery of medication to the subcutaneous tissue. The HIgH-Flo Super26™ is cleared for use with the FREEDOM60® Syringe Driver. The methods for HIgH-Flo Super26TM 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, predicate device, and reference 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) | FREEDOM Integrated Syringe<br>Infusion System<br>(K200176) | Comparison |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Spring Type | Negator | Negator | Same |
| Winding of Spring | FREEDOM60® Syringe Driver:<br>Manual knob used to tension<br>negator constant force spring<br>FreedomEdge® Syringe Driver:<br>Manual lever used to tension<br>negator constant force spring | FREEDOM60® Syringe Driver:<br>Manual knob used to tension<br>negator constant force spring | Same winding of spring for FREEDOM60®. |
| On / Off Control | Manual switch | Manual switch | Same |
| Housing | Molded ABS | Molded ABS | Same |
| Syringe Type | FREEDOM60®<br>BD 50 mL syringe (model no.<br>309653)<br>FreedomEdge®<br>BD® 20 mL syringe (US<br>Reference number: 302830)<br>BD 30 mL syringe (US<br>Reference number: 302832) | FREEDOM60®<br>BD 50 mL syringe (model no.<br>309653) | Same |
| Technological<br>Characteristics | Integrated Catch-up<br>FREEDOM Syringe Driver<br>Infusion System (ICSDIS,<br>known as Freedom Infusion<br>System)<br>(K162613) | FREEDOM Integrated Syringe<br>Infusion System<br>(K200176) | Comparison |
| Tubing Length<br>(inches) | 20 | 20 | Same |
| Tubing Diameter<br>(inches) | $0.033 + 0.002"/-0.001"$ | $0.033 + 0.002"/-0.001"$ | 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 |
| Needle Butterfly<br>Wings Material<br>(HIgH-FloTM<br>Subcutaneous<br>Safety Needle Set) | Polypropylene | Polypropylene | Same |
| Needle Lengths | 4, 6, 9, 12, 14 | 4, 6, 9, 12, 14 | Same |
| Needle Usage | Single Use | Single Use | Same…