(201 days)
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).
The FreedomEdge® Syringe Infusion System is a single-channel, volumetric infusion pump. The FreedomEdge® Syringe Infusion System consists of four primary components:
-
- FreedomEdge® Syringe Driver,
-
- Precision Flow Rate Tubing™ and
-
- HIgH-Flo Subcutaneous Safety Needle Set™, or
-
- 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.
- 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 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.
Here's an analysis of the acceptance criteria and supporting study details based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Flow Rate Accuracy | Flow rates will fall between the minimum and maximum predicted values as specified in the IFU. | This is a change from the predicate device, which had an accuracy of +/- 8%. The new approach provides a range based on theoretical calculations for each combination of needle and tubing set, ensuring it falls within biologic labeling requirements. |
| Material Biocompatibility | Complies with ISO 10993-1, including Cytotoxicity, Sensitization, and Irritation testing. | Ensures materials in contact with fluids/tissue are safe. |
| Human Factors | Studies conducted with intended user population, use environment, and scenarios; results demonstrate validation per intended use. | Confirms user interface and device design are intuitive and safe for users. |
| Reprocessing/Cleaning | Complies with AAMI TIR12, AAMI TIR30, FDA guidance on reprocessing, and ISO 17664, ISO 11737-1. | Ensures the device can be safely reprocessed (for reusable components) and sterilized. |
| Packaging Integrity | Complies with ISO 11607-1:2019. | Confirms that packaging maintains sterility. The material was changed from LDPE to nylon, but this was supported by testing. |
| Sterility | Complies with ISO 11137-2:2013 (Gamma SAL 10-6). | Verifies the sterility of the disposable components. |
| MR Safety | Complies with ASTM F2503-13. | Ensures the device is safe for use in a Magnetic Resonance environment. |
| Functionality with Hizentra Prefilled Syringe | Performance testing verified compatibility and safety. | Supports the expanded indication for use with this specific prefilled syringe. |
| Functionality with HIgH-FLO Super26™ Subcutaneous Needle Set | Bench testing confirmed substantial equivalence in performance to the predicate device. | Supports the expanded indication for use with this new needle set, demonstrating it does not raise new safety or effectiveness questions despite differences in tubing diameter. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states that "Clinical evaluation was not required to support submission and determination of substantial equivalence." Therefore, there is no test set of patient data and consequently, no sample size or data provenance related to patient cases. All testing mentioned is non-clinical performance testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Since no clinical outcome data was used, no experts were used to establish ground truth in a clinical context for a test set. The "ground truth" for performance seems to have been established through engineering and laboratory testing protocols adhering to relevant industry standards and FDA guidance.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study would involve human interpretation of medical images or data, with and without AI assistance, which is not relevant for an infusion pump system.
6. Standalone (Algorithm Only) Performance:
Not applicable. The device is a mechanical infusion system without "algorithm-only" performance in the sense of a diagnostic AI system predicting outcomes. Its performance is assessed through its mechanical and flow characteristics.
7. Type of Ground Truth Used:
The ground truth used is primarily engineering specifications, regulatory standards (e.g., ISO, AAMI, ASTM), and theoretical calculations. For instance, flow rate accuracy is compared against predicted minimum and maximum values derived from physical principles and drug product labeling. Biocompatibility relies on established biological evaluation standards.
8. Sample Size for the Training Set:
Not applicable. As a mechanical medical device, it does not involve machine learning algorithms that require a "training set" in the computational sense. Development and testing are based on engineering principles and prototypes.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for a machine learning algorithm. The "ground truth" for the device's design and performance specifications would have been established through a combination of engineering design principles, regulatory requirements, risk analysis, and material science, all validated through non-clinical performance testing.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: (800)624-9600 Fax: (845)469-5518
Contact Person Charles Ryan Director, Regulatory Affairs Phone: (845) 610-5564 Email: cryan@korumedical.com
Application Correspondent Kachi Enyinna Regulatory Consultant to Koru Medical Systems Phone: (617) 870-4055 Email: kachi@510ktech.com
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:
-
- FreedomEdge® Syringe Driver,
-
- Precision Flow Rate Tubing™ and
-
- HIgH-Flo Subcutaneous Safety Needle Set™, or
-
- 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
{6}------------------------------------------------
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:
-
- 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.
-
- 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.
-
- 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.
-
- 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.
-
- 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(K162613) | Subject Device(K211206) | |
|---|---|---|
| Integrated Catch-Up FREEDOM SyringeDriver Infusion System | FreedomEdge® Syringe Infusion System | |
| Current configuration | New configuration | |
| Current Indications for Useas cleared August 31, 2017 | Modified Indications forUse | |
| Indications | The Integrated Catch-Up FREEDOM SyringeDriver Infusion System (ICFSDIS), whichincludes the FREEDOM60® and FreedomEdge®syringe pumps, is indicated for the intravenous orsubcutaneous infusion of medications and fluidsin the home, hospital, or ambulatory settingswhen administered according to the approvedbiologic or drug product labeling. The ICFSDISis specifically indicated for the subcutaneousinfusion of the following human plasma-derivedimmunoglobulins when used according to theFDA approved biologic labeling: Hizentra,Immune Globulin Subcutaneous (Human) 20%Liquid (manufactured by CSL Behring);Gammagard Liquid, Immune Globulin Infusion(Human) 10% (manufactured by Shire); andCuvitru Immune Globulin Infusion (Human) 20%(manufactured by Shire). The ICFSDIS isspecifically indicated for the intravenous infusionof the following antibiotics when used accordingto the FDA approved drug product labeling: | The FreedomEdge® Syringe Infusion System isindicated for the intravenous or subcutaneousinfusion of medications and fluids in the home,hospital, or ambulatory settings whenadministered according to the approved biologicor drug product labeling. The FreedomEdge®Syringe Infusion System is specifically indicatedfor the subcutaneous infusion of the followinghuman plasma-derived immunoglobulins whenused according to the FDA approved biologiclabeling: 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 CSLBehring®) and Hizentra®, Immune GlobulinSubcutaneous (Human) 20% Liquid(manufactured by CSL Behring®) Single-usepre-filled syringe for subcutaneousadministration |
| Predicate Device(K162613) | Subject Device(K211206) | |
| Integrated Catch-Up FREEDOM SyringeDriver Infusion System | FreedomEdge® Syringe Infusion System | |
| Current configuration | New configuration | |
| Current Indications for Useas cleared August 31, 2017 | Modified Indications forUse | |
| meropenem, ertapenem, oxacillin, andtobramycin.The FreedomEdge® Syringe Infusion System isindicated for use with the BD 20 ml (model no.302830/301031) or BD 30 ml (model no. 301033)syringe. The FREEDOM60 Syringe InfusionSystem is indicated for use with the BD 60 mlsyringe (model no. 309653). | The FreedomEdge® Syringe Infusion Systemwith the FreedomEdge® Syringe Driver andPrecision Flow Rate Tubing™, is specificallyindicated for the intravenous infusion of thefollowing antibiotics when used according to theFDA approved drug product labeling: ertapenem,meropenem, oxacillin, and tobramycin.The FreedomEdge® Syringe Infusion Systemconsists of the following components:• FreedomEdge® Syringe Driver• Precision Flow Rate Tubing™• HIgH-Flo Subcutaneous Safety NeedleSets™• HIgH-Flo Super26™ SubcutaneousNeedle Sets are specifically indicated forthe subcutaneous infusion of thefollowing human plasma-derivedimmunoglobulins: Cuvitru®, ImmuneGlobulin Infusion (Human) 20%(manufactured by Takeda®); Hizentra®,Immune Globulin Subcutaneous (Human)20% Liquid (manufactured by CSLBehring®); Hizentra®, Immune GlobulinSubcutaneous (Human) 20% Liquid(manufactured by CSL Behring®)Single-use pre-filled syringe forsubcutaneous administration.The FreedomEdge® Syringe Infusion System isindicated for use with the BD® 20 mL syringe(US Reference number: 302830*), BD 30 mLsyringe (US Reference number: 302832**), and20 mL single-use pre-filled syringe (NDC 44206-458-96).*Model no. 301031 is the non-sterile version ofBD® 20 ml syringe sold by BD**model no. 301033 is the non-sterile version ofBD® 30 ml syringe. | |
| Predicate Device(K162613)Integrated Catch-Up FREEDOM SyringeDriver Infusion System | Subject Device(K211206)FreedomEdge® Syringe Infusion System | |
| Current configuration | New configuration | |
| Current Indications for Useas cleared August 31, 2017 | Modified Indications forUse | |
| Prescription orOver theCounter | Prescription | Prescription |
| IntendedPopulation | Adult and pediatric | Adult and pediatric |
| Environmentof 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 SyringeDriver 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 NeedleSets (24G, 26G) |
| 4. HIgH-Flo™ Subcutaneous Safety NeedleSets (24G, 26G) | 4. HIgH-FLO Super26™ SubcutaneousNeedle 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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| TechnologicalCharacteristics | Integrated Catch-upFREEDOM Syringe DriverInfusion System (ICSDIS,known as Freedom InfusionSystem)(K162613) | FreedomEdge™ SyringeInfusion System(K211206) | Comparison |
|---|---|---|---|
| Spring Type | Negator | Negator | Same |
| Winding of Spring | FREEDOM60® syringe driver:Manual knob used to tensionnegator constant force springFreedomEdge syringe driver:Manual lever used to tensionnegator constant force spring | FreedomEdge syringe driver:Manual lever used to tensionnegator 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 | FreedomEdgeBD® 20 mL syringe (USReference number: 302830)BD 30 mL syringe (USReference number: 302832)FREEDOM60®BD 50 mL syringe (model no.309653) | BD® 20 mL syringe (USReference number: 302830)BD 30 mL syringe (US Referencenumber: 302832)20 mL single-use pre-filled syringe(NDC 44206-458-96). | Different.Indications for Use now includes single usepre-filled syringe whereas the predicate doesnot. Syringe comes pre-filled with approveddrug, Hizentra, ready to use in FreedomEdgesyringe driver. Use of pre-filled syringe doesnot change intended use of infusion systemdevice nor does it raise new questions of safetyand effectiveness. |
| TechnologicalCharacteristics | Integrated Catch-upFREEDOM Syringe DriverInfusion System (ICSDIS,known as Freedom InfusionSystem)(K162613) | FreedomEdge™ SyringeInfusion System(K211206) | Comparison |
| BD 50 mL syringe is indicated for Freedom60syringe driver only and therefore not part ofSubject device. | |||
| Tubing Length(inches) | 20 | 20 | Same |
| Tubing Diameter(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 Sets26 Gauge Needle Sets | 24 Gauge Needle Sets26 Gauge Needle Sets | Same |
| Needle ButterflyWings Material(HIgH-Flo™SubcutaneousSafety 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 |
| TechnologicalCharacteristics | Integrated Catch-upFREEDOM Syringe DriverInfusion System (ICSDIS,known as Freedom InfusionSystem)(K162613) | FreedomEdge™ SyringeInfusion System(K211206) | Comparison |
| Packaging | Tubing and Needle Setspackaged sterile utilizing anLDPE pouch (P/N 317036), forsingle patientuse. | Tubing and Needle Sets packagedsterile utilizing a nylon pouch (P/N317050), for single patient use. | Different.Sterile barrier pouch material was updated. Thepredicate pouch is made of LDPE materialwhile Subject device uses nylon material. Thedifference in packaging material is supportedby packaging performance testing with respectto packaging validation at baseline and shelf-life. The difference in the material do notraisedifferent questions of safety and effectiveness. |
| Prescriptionrequired | Yes | Yes | Same |
| IntendedPopulation | Adult, Pediatric | Adult, Pediatric | Same |
| System Accuracy | +/- 8% | Flow rates will fall between theminimum and maximum predictedvalues as specified in the IFU. | DifferentThe flow rate accuracy between the subjectdevice and predicate device has changed. Theflow rate accuracy for K162613 was +/-8%.The subject device provides minimum tomaximum flow rate range based on theoreticalcalculations for each combination of needleand tubing set. A combination of tubing andneedle set will not be included in theinstructions for use for the viable options for |
| TechnologicalCharacteristics | Integrated Catch-upFREEDOM Syringe DriverInfusion System (ICSDIS,known as Freedom InfusionSystem)(K162613) | FreedomEdge™ SyringeInfusion System(K211206) | Comparison |
| patients if the minimum or maximum flow rateis outside of the requirements set forth in thebiologic's labeling. The difference in thepredicated flow rates for each combination ofneedle and tubing set do not raise differentquestions of safety and effectiveness. | |||
| SterilizationMethod | Syringe Driver is non-sterile;Needle Sets & Tubing sterilizedvia Gamma SAL 10-6 | Syringe Driver is non-sterile;Needle Sets & Tubing sterilizedvia Gamma SAL 10-6 | Same |
| Needle SetConfigurationsAvailable | 24 Gauge: Available as asingle-needle set, as well as 2-needle, 3-needle, 4-needle set;through use of a Y-connector, 5-needle, 6-needle, 7-needle and8-needle sets may also beassembled.26 Gauge: Available as asingle-needle set, as well as 2-needle, 3-needle, 4-needle, 5-needle, and 6-needle sets;through use of a Y-connector, 7-needle and 8-needle sets mayalso be assembled. | 24 Gauge: Available as a single-needle set, as well as 2-needle, 3-needle, 4-needle set; through useof a Y-connector, 5-needle, 6-needle, 7-needle and 8-needle setsmay also be assembled.26 Gauge: Available as a single-needle set, as well as 2-needle, 3-needle, 4-needle, 5-needle, and 6-needle sets; through use of a Y-connector, 7-needle and 8-needlesets may also be assembled. | Same |
Table 3. Comparison of Predicate and Subject Device
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| TechnologicalCharacteristics | Integrated Catch-upFREEDOM Syringe DriverInfusion System (ICSDIS,known as Freedom InfusionSystem)(K162613) | FreedomEdge™ SyringeInfusion System(K211206) | Comparison | ||||
|---|---|---|---|---|---|---|---|
| Residual Volumesfor HIgH-FloNeedle Sets | Needle 24 G | 26 G | Needle 24 G | 26 G | |||
| 1 | 0.4 ml | 0.1 ml | 1 | 0.4 ml | 0.1 ml | ||
| 2 | 0.7 ml | 0.2 ml | 2 | 0.7 ml | 0.2 ml | ||
| 3 | 1.1 ml | 0.3 ml | 3 | 1.1 ml | 0.3 ml | ||
| 4 | 1.4 ml | 0.4 ml | 4 | 1.4 ml | 0.4 ml | ||
| 5 | 2.0 ml(with Y-connector) | 0.5 ml | 5 | 2.0 ml(with Y-connector) | 0.5 ml | Same | |
| 6 | 2.3 ml(with Y-connector) | 0.6 ml | 6 | 2.3 ml(with Y-connector) | 0.6 ml | ||
| 7 | 2.7 ml(with Y-connector) | 0.9 ml(With Y-connector) | 7 | 2.7 ml(with Y-connector) | 0.9 ml(with Y-connector) | ||
| 8 | 1.0 mlwith Y-connector | 0.9 ml(With Y-connector) | 8 | 1.0 ml(with Y-connector) | 1.0 ml(with Y-connector) |
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| TechnologicalCharacteristics | HIgH-FloTM SubcutaneousSafety Needle Sets (26G)(K162613) | HIgH-FLO Super26TMSubcutaneous Needle Sets(K211206) | Comparison |
|---|---|---|---|
| Tubing Diameter(inches) | $0.033 \pm 0.002"/0.001"$ | $0.0190 \pm 0.001"$ | Different.With the addition of the Super26, the maindifference is the tubing diameter of the Super26( $0.0190 \pm 0.001"$ ) which allows for faster flowrates vs. the predicate device. The Super26 isdesigned and cleared for use with the Subjectdevice under K180843. This difference does notraise different questions of safety andeffectiveness and have been verified throughperformance testing. |
| Tubing Material | Medical Grade PVC Plastic | Medical Grade PVC Plastic | Same |
| Needle Material | Stainless Steel | Stainless Steel | Same |
| Needle Gauge | 26 | 26 | Same |
| Needle Length(mm) | 4, 6, 9, 12, 14 | 4, 6, 9, 12, 14 | Same |
| TechnologicalCharacteristics | HIgH-Flo™ SubcutaneousSafety Needle Sets (26G)(K162613) | HIgH-FLO Super26™Subcutaneous Needle Sets(K211206) | Comparison |
| SterilizationMethod | Gamma | Gamma | Same |
| Packaging | Tubing and Needle Setspackaged sterile utilizing anLDPE pouch (P/N 317036),for single patient use. | Tubing and Needle Sets packagedsterile utilizing a nylon pouch (P/N317050), for single patient use. | DifferentSterile barrier material is changed from LDPEto a nylon material pouch. Change in packagingmaterial is supporting by non-clinicalperformance testing and sterilization validation.Packaging is able to maintain sterile barrier ofdevice components. The proposed change isrestricted to the pouch material only. No changehas been made to the infusion pump system as aresult of the change. The difference inpackaging material does not affect safety andeffectiveness. |
| Needle ButterflyWings Material | Polypropylene | Polypropylene with blue colorant(541790C Translucent blue, MarvelIndustries, Inc.) | DifferentThe only difference is that blue colorant wasadded to the needle butterfly wings of theSuper26 so the user could easily identify theproduct. The proposed change is restricted tothe needle butterfly wing only. No change hasbeen made to the infusion pump system as aresult of the change (addition of blue colorant).This change is considered minor and does notaffect safety and effectiveness of the device. |
| TechnologicalCharacteristics | HIgH-Flo™ SubcutaneousSafety Needle Sets (26G)(K162613) | HIgH-FLO Super26™Subcutaneous Needle Sets(K211206) | Comparison |
| Appropriate biocompatibility testing wasperformed to support use of blue colorant. SeeSection 16 for full biocompatibility testing. | |||
| 26 Gauge NeedleSet ConfigurationsAvailable (26Gauge only) | 1 – Needle Set2 – Needle Set3 – Needle Set4 – Needle Set5 – Needle Set6 – Needle Setw/Y-connector7 – Needle Set8 – Needle Set | 1 – Needle Set2 – Needle Set3 – Needle Set4 – Needle Set5 – Needle Set6 – Needle Setw/Y-connector7 – Needle Set8 – Needle Set | Same |
| Residual Volumefor the multipleneedleconfigurations | Needle | Super26 | Different.When using a 60 ml dose, the increased residualvolume between the HIgH-Flo Super26 and thepredicate device (HIgH-Flo SubcutaneousSafety Needle Set) ranges from 0.5% for a 1 legneedle set to 3.3% for an 8-leg needle set (4 |
| 26 G | |||
| 1 0.1 ml | 1 0.4 ml | ||
| 2 0.2 ml3 0.3 ml | 2 0.7 ml3 1.1 ml | ||
| TechnologicalCharacteristics | HIgH-Flo™ SubcutaneousSafety Needle Sets (26G)(K162613) | HIgH-FLO Super26™Subcutaneous Needle Sets(K211206) | Comparison |
| 4 | 0.4 ml | 1.4 ml | legs x 2). Residual volumes are stated in theIFU. This change does not raise new questionsof safety and effectiveness. Residual volumesare stated in the IFU. |
| 5 | 0.5 ml | 1.8 ml | |
| 6 | 0.6 ml | 2.1 ml | |
| 7 | 0.9 ml(With Y-connector) | 2.7 ml(With Y-connector) | |
| 8 | 0.9 ml(With Y-connector) | 3.0 ml(With Y-connector) |
Table 4. Comparison of HIgH-Flo Super26 needle set and 26G HIgH-Flo needle set
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Discussions of differences in needle sets
The subject device utilizes the same fundamental scientific technology as the predicate device. The Super26 uses a 24G tubing set and a 26G needle. The main difference between Super26 and the 26 gauge HIgH-Flo Subcutaneous Needle Set is the tubing diameter of the Super26, which provides greater flexibility for the patient to use higher viscosity medications during infusion per the drug manufacturer's recommended limits. The diameter of the tubing used in the subject device (HlgH-FloSuper26™M Sub-Q Needle Sets) with 26G needles is 0.033 inches, which is different from the predicate's 0.019 inches.
Also, the Super26 uses a Y connector with 7 and 8 legs while the 24G uses a Y connector with 5, 6, 7 and 8 Legs. The Y connector has ~. 2 mL residual volume. Bench testing was conducted in K180843 to verify that the product performance of the subject device and predicate device are substantially equivalent. Any differences between HIgH-Flo Super26 needle set and 26G HIgH-Flo needle set do not raise different questions of safety and effectiveness.
As shown in the predicate device comparison chart in Table 4, HIgH-Flo Super26™ Subcutaneous Needle Sets have the same technological characteristics as the predicate device.
The HIgH-Flo Super26TM Subcutaneous Needle Sets are considered as substantially equivalent to the legally marketed predicate device.i.e., K162613 and demonstrated to be as safe and effective as legally marketed devices.
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 throughperformance testing in accordance with the intended use of the device and inaccordance with the FDA Guidance "Infusion Pumps Total Product Life Cycle" |
|---|---|
| Biocompatibility | The materials used in the Administration Set (tubing and needles) for theFreedomEdge Syringe Infusion System comply with the International StandardISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation andTesting Within a Risk Management Process,” as recognized by FDA and FDABlue Book Memorandum #G95-1 "Use of International Standard ISO-10993,'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", withina Risk Management Process and are considered to be biocompatible.Testing was conducted for the following tests:•Cytotoxicity•Sensitization |
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| • Irritation | |
|---|---|
| Human Factors | Human factors studies were completed per the FDA Guidance "ApplyingHuman Factors and Usability Engineering to Medical Devices" (February 3,2016). The human factors studies were conducted with the intended userpopulation, use environment and use scenarios to simulate clinical conditions.Results of the human factors testing demonstrate validation of the device per theintended use. |
| Reprocessing,Cleaning | AAMI TIR12:2010 – Designing, testing, and labeling reusable medical devicesfor reprocessing in health care facilities: A guide for medical devicemanufacturers.AAMI TIR30:2011(R)2016 – A compendium of processes, materials, testmethods, and acceptance criteria for cleaning reusable medical devices.Reprocessing Medical Devices in Health Care Settings: Validation Methods andLabeling, Document issued on March 17, 2015 amended June 9, 2017, U.S.Department of Health and Human Services, Food and Drug Administration,Center for Devices and Radiological Health, Office of Device Evaluations.ISO 17664:2017 – Processing of healthcare products – Information to beprovided by the medical device manufacturer for the processing of medicaldevices.ANSI/AAMI/ISO 11737-1:2018 – Sterilization of health care products –Microbiological methods – Part 1: Determination of the population ofmicroorganisms on product.NAMSA Technical Memorandum US033689 Rev. 1, Review and Comparisonof the Koru Medical Systems Syringe Drive products to determine the Worst-Case Design for Cleaning and Low Level Disinfection Efficacy Studies. |
| Packaging | 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1:Requirements for materials, sterile barrier systems and packaging systems |
| Sterility | ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2:Establishing the sterilization dose. |
| MR Safety | ASTM F2503-13, "Standard Practice for Marking Medical Devices and OtherItems for Safety in the Magnetic Resonance Environment." |
Safety Assurance
A safety assurance case is provided for the FreedomEdge Syringe Infusion System, as recommended in the FDA guidance document, "Infusion Pumps Total Product Life Cycle."
The only changes introduced in this 510(k) do not impact the associated risks or reliability in the Safety Assurance Case as compared to the predicate. Therefore only evidence to support changes to the device requirements to ensure adequate verification were needed to support substantial equivalence.
Device Performance
The essential performance requirements of the device were verified through performance
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testing in accordance with the intended use of the device and in accordance with the FDA Guidance "Infusion Pumps Total Product Life Cycle
The FreedomEdge® Syringe Infusion System includes directions for the selection of Precision Tubing Sets, HIgH-Flo Subcutaneous Needle Sets, and HIgH-FLO Super26 Subcutaneous Needle Sets combinations in order to achieve desired infusion rates for each of the indicated human plasma-derived immunoglobulin solutions, in accordance with the following tables:
Selected Flow Rate Combinations
Select Combinations of Flow Rates with HIgH-Flo Subcutaneous Safety Needle Set™ (Standard 26G and 24G) when used in combination with Precision Flow Rate Tubing™ for use with Hizentra®, Cuvitru®, and Gammagard® Liquid.
Note: The following tables are only for the subcutaneous use of the immunoglobulin listed.
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| Hizentra – FreedomEdge® with 20 ml syringe | |||||||
|---|---|---|---|---|---|---|---|
| Drugvolume (ml) | Flow RateTubing | HIgH-FloNeedle Set* | Total FlowRate (ml/hr) | Flow rate/site(ml/hr) | Vol/site(ml) | Time | NOTES: |
| 10 | F120 | RMS12609 | 8.2 | 8.2 | 10 | 1:12 | Suggested start Peds |
| 10 | F180 | RMS12609 | 10.5 | 10.5 | 10 | 0:57 | Suggested start Peds |
| 20 | F275 | RMS22609 | 17.1 | 8.5 | 10 | 1:10 | Suggested start Peds |
| 20 | F600 | RMS22609 | 29.6 | 14.8 | 10 | 0:40 | Suggested start Peds |
| 40 | F600 | RMS32609 | 33.9 | 11.3 | 13.3 | 1:10 | Suggested start Adult |
| 40 | F900 | RMS32609 | 44.3 | 14.8 | 13.3 | 0:54 | Suggested start Adult |
| 60 | F900 | RMS42609 | 49 | 12.3 | 15 | 1:13 | Suggested start Adult |
| 50 | F2400 | RMS32609 | 72.2 | 24.1 | 16.67 | 0:41 | 6th Infusion of biologic andbeyond |
| 100 | F2400 | RMS42609 | 85.5 | 21.4 | 25 | 1:10 | 6th Infusion of biologic andbeyond(NEEDS TWOSYRINGES) |
| Hizentra - with FreedomEdge® with 30 ml syringe | |||||||
| 20 | F600 | RMS22609 | 22.5 | 11.2 | 10 | 0:53 | Suggested start Peds |
| 30 | F900 | RMS22609 | 28.3 | 14.2 | 15 | 1:03 | Suggested start Adult |
| 30 | F2400 | RMS22609 | 41.9 | 20.9 | 15 | 0:42 | 6th Infusion of biologic andbeyond |
| Cuvitru – with FreedomEdge® with 20 mlsyringe | |||||||
|---|---|---|---|---|---|---|---|
| Drugvolume (ml) | Flow RateTubing | HIgH-FloNeedle Set* | Total FlowRate (ml/hr) | Flow rate/site(ml/hr) | Vol/site(ml) | Time | NOTES: |
| 10 | F275 | RMS12609 | 12.1 | 12.1 | 10 | 0:49 | 1st Two Infusions patients under40kg |
| 20 | F275 | RMS12609 | 12.1 | 12.1 | 20 | 1:39 | 1st Two Infusions patients under40kg |
| 20 | F600 | RMS22609 | 25.7 | 12.8 | 10 | 0:47 | 1st Two Infusions patients under40kg |
| 50 | F600 | RMS22609 | 25.7 | 12.8 | 25 | 1:57 | 1st Two Infusions patients over40kg |
| 60 | F1200 | RMS22609 | 37.1 | 18.6 | 30 | 1:37 | Subsequent Infusions |
| 60 | F2400 | RMS22409 | 110.5 | 55.4 | 30 | 0:32 | Subsequent Infusions |
| 60 | F1200 | RMS12409 | 55.3 | 55.3 | 60 | 1:05 | Subsequent Infusions |
| 100 | F2400 | RMS42409 | 132.8 | 33.2 | 25 | 0:45 | Subsequent Infusions |
| Cuvitru – with FreedomEdge® with 30 ml syringe | |||||||
| 20 | F500 | RMS22609 | 12.9 | 12.9 | 20 | 1:32 | 1st Two Infusions patients under40kg |
| 30 | F900 | RMS22609 | 24.6 | 12.3 | 15 | 1:13 | 1st Two Infusions patients under40kg |
| 30 | F2400 | RMS12609 | 21.2 | 21.2 | 30 | 1:24 | Maintenance Infusions |
| 30 | F1200 | RMS12409 | 42.1 | 42.1 | 30 | 0:42 | Maintenance Infusions |
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| Gammagard Liquid – with FreedomEdge® with 20 ml syringe | |||||||
|---|---|---|---|---|---|---|---|
| Drugvolume(ml) | Flow RateTubing | HIgH-FloNeedle Set* | Total FlowRate (ml/hr) | Flow rate/site(ml/hr) | Vol/site(ml) | Time | NOTES: |
| 20 | F45 | RMS12609 | 14.2 | 14.2 | 20 | 1:24 | Patients under 40kg (Initial) |
| 60 | F120 | RMS22609 | 39.8 | 19.9 | 30 | 1:30 | Patients over 40kg (Initial) |
| 100 | F420 | RMS42609 | 119.1 | 29.8 | 25 | 0:50 | Patients over 40kg (maintenance infusions) |
| Gammagard Liquid - with FreedomEdge® with 20 ml syringe | |||||||
| 20 | F120 | RMS22609 | 30 | 15 | 10 | 0:40 | Patients under 40kg(Initial) |
| 30 | F180 | RMS22609 | 39.8 | 19.9 | 15 | 0:45 | Patients over 40kg (Initial) |
| 30 | F120 | RMS12609 | 27 | 27 | 30 | 1:06 | Patients over 40kg (Maintenance) |
*HIgH-Floneedle sets: The first number of needles, the next two numbers refer to the needle gauge, and the last two numbers refer to the needle length (mm).
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Hizentra® 20 ml Prefilled Syringe Selected Flow Rate Combinations
The following tables indicate the min-max predicated flow rates per site with HIgH-Flo Subcutaneous Safety Needles Sets™ (Standard 26G, 24G and Super26TM) when used in combination with KORU Precision Flow Rate Tubing™ and the FreedomEdge® Syringe Infusion System with a 20 ml syringe for the subcutaneous use of Hizentra CIDP (+/- 15%).
To determine the appropriate flow rate tubing and subcutaneous needle configuration, please refer to drug package insert for the maximum indicated flow rate and volume per infusion site for initial and subsequent infusions.
| F120 | F180 | F275 | F420 | F500 | F600 | F900 | F1200 | F2400 | |
|---|---|---|---|---|---|---|---|---|---|
| 1 needle | 7 - 12.9 | 9.7 - 15.4 | 13.1 - 21.2 | 16.7 - 28.7 | 19.9 - 30.5 | 21.6 - 33.9 | 27.3 - 42 | 28.8 - 45.9 | 35.7 - 55.6 |
| 2 needles | 3.8 - 7.1 | 5.4 - 8.7 | 7.6 - 12.6 | 10.1 - 18.2 | 12.6 - 19.6 | 14 - 22.5 | 19.2 - 30.3 | 20.7 - 34.6 | 28.7 - 46.9 |
| 3 needles | 2.6 - 4.9 | 3.7 - 6 | 5.4 - 8.9 | 7.3 - 13.3 | 9.3 - 14.5 | 10.3 - 16.9 | 14.8 - 23.7 | 16.2 - 27.7 | 24 - 40.6 |
| 4 needles | 2 - 3.7 | 2.9 - 4.6 | 4.2 - 6.9 | 5.7 - 10.5 | 7.3 - 11.5 | 8.2 - 13.5 | 12.1 - 19.5 | 13.3 - 23.2 | 20.6 - 35.8 |
| 5 needles | 1.6 - 3 | 2.3 - 3.8 | 3.4 - 5.7 | 4.7 - 8.7 | 6 - 9.5 | 6.8 - 11.2 | 10.2 - 16.5 | 11.2 - 19.9 | 18.1 - 32 |
| 6 needles | 1.3 - 2.5 | 1.9 - 3.2 | 2.9 - 4.8 | 3.9 - 7.4 | 5.1 - 8.1 | 5.8 - 9.6 | 8.8 - 14.4 | 9.8 - 17.4 | 16.1 - 28.9 |
| 7 needles | 1.1 - 2.2 | 1.7 - 2.7 | 2.5 - 4.1 | 3.4 - 6.4 | 4.5 - 7.1 | 5.1 - 8.4 | 7.7 - 12.7 | 8.6 - 15.5 | 14.5 - 26.4 |
| 8 needles | 1 - 1.9 | 1.5 - 2.4 | 2.2 - 3.7 | 3 - 5.7 | 4 - 6.3 | 4.5 - 7.5 | 6.9 - 11.4 | 7.7 - 13.9 | 13.2 - 24.2 |
HIgH-Flo 26G with Precision Tubing – Min-Max Flow Rate Per Site (ml/hr/site)
Image /page/26/Picture/5 description: The image shows a simple graphic divided into two rectangular sections. The top section is colored in a neutral gray, while the bottom section is a light blue. A thick black line separates the two colored areas, creating a clear visual distinction between them.
Exceeds drug manufacturer's maximum indicated flow rate. Subsequent infusions after 6th infusion only.
HIgH-Flo Super26 with Precision Tubing – Nominal Flow Rate Per Site (ml/hr/site)
| F120 | F180 | F275 | F420 | F500 | F600 | F900 | F1200 | F2400 | |
|---|---|---|---|---|---|---|---|---|---|
| 1 needle | 7.6 - 14.2 | 10.8 - 17.4 | 15.3 - 25.3 | 20.4 - 36.6 | 25.5 - 39.5 | 28.2 - 45.4 | 38.8 - 61.3 | 41.9 - 70 | 58.3 - 95.5 |
| 2 needles | 4 - 7.5 | 5.7 - 9.3 | 8.3 - 13.9 | 11.4 - 21.1 | 14.7 - 23 | 16.5 - 27.1 | 24.3 - 39.2 | 26.7 - 46.7 | 41.7 - 72.5 |
| 3 needles | 2.7 - 5.1 | 3.9 - 6.3 | 5.7 - 9.6 | 7.9 - 14.8 | 10.3 - 16.2 | 11.6 - 19.3 | 17.7 - 28.9 | 19.6 - 35 | 32.5 - 58.4 |
| 4 needles | 2 - 3.9 | 2.9 - 4.8 | 4.3 - 7.3 | 6.1 - 11.4 | 7.9 - 12.5 | 9 - 15 | 13.9 - 22.8 | 15.5 - 28 | 26.6 - 48.9 |
| 5 needles | 1.6 - 3.1 | 2.4 - 3.9 | 3.5 - 5.9 | 4.9 - 9.3 | 6.4 - 10.2 | 7.3 - 12.3 | 11.4 - 18.9 | 12.8 - 23.4 | 22.5 - 42.1 |
| 6 needles | 1.4 - 2.6 | 2 - 3.2 | 2.9 - 5 | 4.1 - 7.8 | 5.4 - 8.6 | 6.2 - 10.4 | 9.7 - 16.1 | 10.9 - 20 | 19.5 - 36. |
| 7 needles | 1.2 - 2.2 | 1.7 - 2.8 | 2.5 - 4.3 | 3.6 - 6.7 | 4.7 - 7.4 | 5.4 - 9 | 8.4 - 14 | 9.5 - 17.5 | 17.2 - 32. |
| 8 needles | 1 - 2 | 1.5 - 2.4 | 2.2 - 3.8 | 3.1 - 5.9 | 4.1 - 6.6 | 4.7 - 7.9 | 7.5 - 12.4 | 8.4 - 15.6 | 15.4 - 29. |
Image /page/26/Picture/9 description: The image shows a simple graphic with two stacked rectangles. The top rectangle is filled with a solid gray color, while the bottom rectangle is filled with a light blue color. The rectangles are separated by a black line, creating a clear distinction between the two colored areas.
Exceeds drug manufacturer's maximum indicated flow rate. Subsequent infusions after 6th infusion only.
{27}------------------------------------------------
| F120 | F180 | F275 | F420 | F500 | F600 | F900 | F1200 | F2400 | |
|---|---|---|---|---|---|---|---|---|---|
| 1 needle | 8 - 15.1 | 11.5 - 18.7 | 16.8 - 28.2 | 23.2 - 43 | 29.9 - 47.1 | 33.8 - 55.8 | 50.3 - 81.7 | 55.6 - 98 | 88.8 - 156.2 |
| 2 needles | 4 - 7.7 | 5.9 - 9.6 | 8.7 - 14.7 | 12.2 - 23 | 16 - 25.4 | 18.2 - 30.5 | 28.3 - 46.7 | 31.7 - 57.7 | 55.3 - 102.8 |
| 3 needles | 2.7 - 5.2 | 4 - 6.5 | 5.9 - 10 | 8.3 - 15.7 | 11 - 17.4 | 12.5 - 21 | 19.7 - 32.7 | 22.2 - 40.9 | 40.2 - 76.6 |
| 4 needles | 2 - 3.9 | 3 - 4.9 | 4.5 - 7.5 | 6.3 - 11.9 | 8.3 - 13.2 | 9.5 - 16 | 15.1 - 25.2 | 17 - 31.7 | 31.5 - 61.1 |
| 5 needles | 1.6 - 3.1 | 2.4 - 3.9 | 3.6 - 6.1 | 5.1 - 9.6 | 6.7 - 10.7 | 7.7 - 12.9 | 12.2 - 20.4 | 13.8 - 25.8 | 26 - 50.8 |
| 6 needles | 1.4 - 2.6 | 2 - 3.3 | 3 - 5.1 | 4.2 - 8.1 | 5.6 - 8.9 | 6.4 - 10.8 | 10.3 - 17.2 | 11.7 - 21.8 | 22 - 43.4 |
| 7 needles | 1.2 - 2.2 | 1.7 - 2.8 | 2.6 - 4.3 | 3.6 - 6.9 | 4.8 - 7.7 | 5.5 - 9.3 | 8.9 - 14.9 | 10.1 - 18.9 | 19.2 - 38 |
| 8 needles | 1 - 2 | 1.5 - 2.5 | 2.3 - 3.8 | 3.2 - 6.1 | 4.2 - 6.7 | 4.9 - 8.2 | 7.8 - 13.1 | 8.9 - 16.6 | 17 - 33.7 |
HIgH-Flo 24G with Precision Tubing - Min-Max Flow Rate Per Site (ml/hr/site)
Image /page/27/Picture/2 description: The image shows a simple illustration of a rectangular shape divided into two sections. The top section is colored in gray, while the bottom section is colored in light blue. The rectangle is outlined with a thick black border, providing a clear separation between the two colored sections.
Exceeds drug manufacturer's maximum indicated flow rate. Subsequent infusions after 6th infusion only.
Clinical Evaluation
Clinical evaluation was not required to support submission and determination of substantial equivalence.
VIII. CONCLUSIONS
The FreedomEdge® Syringe Infusion System is substantially equivalent to the commercially available predicate device in terms of function, safety, performance, intended use, technology/principles of operation and mechanical properties. The nonclinical data support the safety of the device and performance testing demonstrate that the FreedomEdge® Syringe Infusion System meets the established specifications necessary for consistent performance to achieve its intended use as safely and as effectively as the predicate device and confirmed that the technological differences between the proposed device and predicate device do not raise different questions of safety or effectiveness. Based on performance testing results, the FreedomEdge® Syringe Infusion System, performs as intended and performs comparably to the predicate device that is currently marketed for the same intended use.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).