(123 days)
The FreedomEdge® Syringe Infusion System is intended for the intravenous or subcutaneous infusion of medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling.
Intended population: adults and pediatrics.
The FreedomEdge® Syringe Infusion System consists of the following components:
- FreedomEdge® Syringe Driver
- Precision Flow Rate Tubing™
- HIgH-Flo Subcutaneous Safety Needle Sets™
- HIgH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration.
The FreedomEdge® Syringe Infusion System is indicated for use with the BD® 20 ml syringe (US Reference number: 302830), BD 30 ml syringe (US Reference number: 302832) and Hizentra® 20 ml prefilled syringe (NDC 44206-458-96).
For Immunoglobulin Administration:
The Freedom Integrated Syringe Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) and Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling.
For EMPAVELI™ (pegcetacoplan) Administration:
The Freedom Integrated Syringe Infusion System is specifically indicated for the subcutaneous infusion with EMPAVELI™ (pegcetacoplan) in the home, hospital, or ambulatory setting when administered according to the approved drug product labeling.
For Intravenous Antibiotic Administration:
The Freedom Integrated Syringe Infusion System with the FreedomEdge® Syringe Driver and Precision Flow Rate Tubing™, is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling:
Ertapenem, Meropenem, Oxacillin, and Tobramycin.
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:
The FreedomEdge® Syringe Driver (non-sterile) in combination with Precision Flow Rate Tubing™ (sterile) and HIgH-Flo Safety Needle Sets (sterile) makes up the FreedomEdge® Syringe Infusion System. The FreedomEdge® Syringe Driver is a nonsterile, reusable non-electric driver that infuses immunoglobulins and Pegcetacoplan subcutaneously and antibiotic solutions intravenously to patients.
The FreedomEdge® driver is an ambulatory device designed to accommodate a BD Luer-Lok™ 20mL syringe. Catalog No.: 302830 and 301031. BD Luer-Lok™ 30mL syringe, Catalog No.: 301033 and Hizentra® 20 ml prefilled syringe. The pump uses a constant force spring mechanism to apply pressure to the plunger-end syringe.
The FreedomEdge® Syringe Infusion System is assembled by loading the syringe with tubing into the FreedomEdge® driver.
-
Precision Flow Rate Tubing™:
The FreedomEdge® Syringe Infusion System includes a range of Freedom Precision Flow Rate Tubing™ (provided sterile). The tubing ranges from F0.5 to F2400. Each Fnumber provides a different level of flow restriction, which, when combined with the viscosity of the medication, provides a controlled delivery in an all-mechanical system. The tubing sets connect at one end to the syringe being used and on the other end to the Subcutaneous Safety Needle Sets or directly on venous catheters for intravenous infusions as needed. -
HIgH-Flo Needles Sets:
The HIgH-Flo Subcutaneous Safety Needle Sets™
The HIgH-Flo Subcutaneous Safety Needle Sets™ (provided sterile) are used to administer drugs to the subcutaneous layers using small needles attached to the skin. Subcutaneous needles come in different lengths to administer immunoglobulins, pegcetacoplan, and antibiotics.
Subcutaneous Safety Needle Sets come in multiple configurations (1, 2, 3, 4, 5, 6 needle sites). Needles are available in 4mm, 6mm, 9mm, 12mm, and 14mm lengths combined with 24 or 26 Gauge. Using the Y-Connector, the patient can have up to 8 sites for drug delivery.
The HIgH- Flo Subcutaneous Safety Needle Sets™ also allow each needle to be enclosed between the wings after use.
The HIgH-Flo Super26TM Subcutaneous Needle Sets
The HIgH-Flo Super26TM Subcutaneous Needle Sets are sterile, non-pyrogenic, single use, Subcutaneous Administration Sets, comprised of a Super 26-gauge needle assembly, combined with 24-gauge needle tubing and are intended for the delivery of medication to the subcutaneous tissue. Each set consists of a sterile infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set is a 90degree, 26-gauge stainless steel needle, mounted to a butterfly winged safety closure on one end which is used to close the set upon completion. The other end consists of a luer lock which connects to PVC medical grade tubing. Additionally, each tubing set is equipped with a slide clamp used to stop flow, immediately as needed. HIgH-Flo Super 26TM Subcutaneous Needle Sets are available as a single set, as well as 2-needle, 3needle, 4-needle, 5-needle, 6-needle, sets; through use of a Y-connector, 7-needle and 8 needle sets may also be assembled.
The provided text describes a 510(k) premarket notification for a medical device called the FreedomEdge® Syringe Infusion System. This submission aims to expand the indications for use of an existing predicate device (K211206) to include the subcutaneous infusion of EMPAVELI™ (pegcetacoplan) in addition to already cleared immunoglobulins and antibiotics.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a "table of acceptance criteria" in the traditional sense of numerical targets that the device needs to meet for each performance metric. Instead, it outlines performance data collected to demonstrate safety and effectiveness. The primary "acceptance criterion" for this 510(k) is demonstrating substantial equivalence to the predicate device, especially for the new indication (EMPAVELI™ infusion). The performance data cited are studies designed to ensure the device performs safely and effectively for its intended use, matching the existing predicate's performance and supporting the new use.
Here's a summary of the reported device performance and how it relates to general acceptance in a 510(k) context:
| Acceptance Criteria (Inferred from 510(k) Requirements) | Reported Device Performance |
|---|---|
| Flow Rate Accuracy for EMPAVELI™ | Tables provided for "HIgH-Flo 26G with Precision Tubing - Max-Min Flow Rate Per Site (ml/hr/site)" and "HIgH-Flo 26G with Precision Tubing - Max-Min Flow Rate Total (ml/hr)" for various tubing configurations (F500 to F2400) and 1-2 needles. The "HIgH-Flo 26G with Precision Tubing – Min-Max Infusion Times (minutes)" table is also provided. The text states: "The EMPAVELI™ label states that typical infusion time is approximately 30 minutes (if using 2 infusion sites) or approximately 60 minutes (if using one infusion site). Based on assessment of EMPAVELI™ labeling there is no identified patient risk for going faster or slower than this approximate infusion time." This implies the device's flow rates (and thus infusion times) for EMPAVELI™ fall within a clinically acceptable range. |
| Flow Rate Accuracy for Immunoglobulins (Hizentra®, Cuvitru®, Gammagard® Liquid) | Multiple tables for "Selected Flow Rate Combinations" with HIgH-Flo Subcutaneous Safety Needle Sets (Standard 26G and 24G) and Precision Flow Rate Tubing for different drug volumes (e.g., 10ml, 20ml, 40ml, 50ml, 60ml, 100ml) and number of sites (1, 2, 3, 4). These tables provide "Total Flow Rate (ml/hr)", "Flow rate/site (ml/hr)", "Vol/site (ml)", and "Time" for various configurations. They include notes like "Suggested start Peds", "Suggested start Adult", and "6th Infusion of biologic and beyond", indicating the device can achieve desired infusion rates for various clinical scenarios. Separate comprehensive tables are provided for Hizentra® 20 ml Prefilled Syringe with HIgH-Flo 26G, HIgH-Flo Super26, and HIgH-Flo 24G at various precision tubing settings and 1-8 needles, showing min-max flow rates per site (ml/hr/site). |
| Biocompatibility | Materials comply with ISO 10993-1 and FDA Blue Book Memorandum #G95-1. Testing was conducted for Cytotoxicity, Sensitization, and Irritation. |
| Human Factors and Usability | Studies conducted per FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" (February 3, 2016) with intended user population, use environment, and scenarios. Results demonstrate device validation for intended use. |
| Reprocessing, Cleaning | Compliance/testing with AAMI TIR12:2010, AAMI TIR30:2011(R)2016, FDA guidance "Reprocessing Medical Devices in Health Care Settings", ISO 17664:2017, ANSI/AAMI/ISO 11737-1:2018. NAMSA Technical Memorandum US033689 Rev. 1 was reviewed. |
| Packaging | Compliance with 11607-1:2019 "Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems." Tubing and needle sets are packaged sterile using a nylon pouch. |
| Sterility | Compliance with ISO 11137-2:2013 "Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose." Needle sets and tubing are sterilized via Gamma SAL 10-6. |
| MR Safety | Compliance with ASTM F2503-13, "Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment." |
| Overall Safety and Effectiveness | A safety assurance case was provided, addressing device requirements, risk identification/mitigation, and reliability over service life, as recommended by FDA guidance. Non-clinical data supports safety, and performance testing demonstrates the device meets specifications, performing "as safely and as effectively as the predicate device". |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document extensively discusses performance testing, particularly for flow rates. However, it does not specify the sample size used for the various tests (e.g., how many syringe infusion systems were tested, how many individual flow rate measurements were taken).
The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated. The testing was conducted "in accordance with the intended use of the device and in accordance with the FDA Guidance 'Infusion Pumps Total Product Life Cycle'," suggesting it was likely laboratory-based performance testing, prospectively designed to meet regulatory requirements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This section is not applicable as the device is an infusion system, not an AI or diagnostic device that relies on expert interpretation to establish a ground truth for a test set. The "ground truth" here is the physical performance (e.g., flow rate, biocompatibility) measured against engineering specifications and regulatory standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable for the same reasons as point 3. The performance testing of a physical medical device does not typically involve expert adjudication of results in the way image interpretation or AI diagnosis does.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable as the device is not an AI-assisted diagnostic or decision support system. It is a physical medical device (infusion system), and therefore, MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is not an algorithm. It is a physical infusion system that operates with a human user in the loop (for setup, drug preparation, monitoring, etc.) but its core function (drug delivery) is mechanical.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" for performance testing is established by:
- Engineering specifications and regulatory standards: Flow rates are measured against predicted values and in consideration of drug manufacturer's labeling.
- Biocompatibility standards: ISO 10993-1 and FDA guidelines are used.
- Human factors guidance: FDA guidance for human factors and usability engineering is applied.
- Reprocessing/Sterility standards: ISO and AAMI standards define acceptable levels.
- Drug labeling: The performance data correlates the device's flow rates with the parameters specified in the FDA-approved labeling for the indicated drugs (immunoglobulins, EMPAVELI, antibiotics).
The "ground truth" is therefore a combination of validated technical performance measurements against established engineering and regulatory benchmarks, informed by drug-specific dosing and infusion parameters.
8. The sample size for the training set
This section is not applicable as the device is not an AI or machine learning system that requires a "training set."
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as point 8.
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Repro-Medical System, Inc., dba Koru Medical Systems % Kachi Enyinna Consultant 510K Technology Group LLC 17 Orchard Terrace East Arlington, Massachusetts 02474
Re: K214045
Trade/Device Name: FreedomEdge Syringe Infusion System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: March 22, 2022 Received: March 23, 2022
Dear Kachi Enyinna:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
April 29, 2022
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Courtney H. Lias, Ph.D. Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
FreedomEdge® Syringe Infusion System
Indications for Use (Describe)
The FreedomEdge® Syringe Infusion System consists of the following components:
- FreedomEdge® Syringe Driver
- Precision Flow Rate Tubing™
- HIgH-Flo Subcutaneous Safety Needle SetsTM ●
- HIgH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the following ● human plasma-derived immunoglobulins: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration.
The FreedomEdge® Syringe Infusion System is indicated for use with the BD® 20 ml syringe (US Reference number: 302330), BD 30 ml syringe (US Reference number: 302832) and Hizentra® 20 ml prefilled syringe (NDC 44206-458-96).
For Immunoglobulin Administration:
The Freedom Integrated Syringe Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling.
For EMPAVELI™ (pegcetacoplan) Administration:
The Freedom Integrated Syringe Infusion System is specifically indicated for the subcutaneous infusion with EMPAVELI™ (negcetacoplan) in the home, hospital, or ambulatory setting when administered according to the approved drug,
For Intravenous Antibiotic Administration:
The Freedom Integrated Syringe Infusion System with the FreedomEdge® Syringe Driver and Precision Flow Rate Tubing™, is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling:
Ertapenem, Meropenem, Oxacillin, and Tobramycin.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
I. SUBMITTER
Repro-Med Systems, Inc. dba Koru Medical Systems 24 Carpenter Road Chester, NY 10918 USA
Ph: (800) 624-9600 Fax: (845) 469-5518
Contact Person Christopher Pazdan Vice President, Quality Assurance and Regulatory Affairs Phone: (708) 870-6294 Email: cpazdan@korumedical.com
Application Correspondent Kachi Enyinna Regulatory Consultant to Koru Medical Systems Phone: (617) 870-4055 Email: kachi@510ktech.com
Date Prepared: December 23, 2021
II. DEVICE
Name of Device: FreedomEdge® Syringe Infusion System Common or Usual Name: Infusion Pump Classification Name: Pump, Infusion (21CFR 880.5725) Regulatory Class: II Product Code: FRN, FPA, PKP
III. PREDICATE DEVICE
FreedomEdge® Syringe Infusion System (K211206)
This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The FreedomEdge® Syringe Infusion System is a single-channel, volumetric infusion pump. The FreedomEdge® Syringe Infusion System consists of four primary components:
-
- FreedomEdge® Syringe Driver,
-
- Precision Flow Rate Tubing™ and
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-
- HIgH-Flo Subcutaneous Safety Needle Set™, or
-
- HIgH-Flo Super26TM Subcutaneous Safety Needle Set
1. FreedomEdge® Syringe Driver:
The FreedomEdge® Syringe Driver (non-sterile) in combination with Precision Flow Rate Tubing™ (sterile) and HIgH-Flo Safety Needle Sets (sterile) makes up the FreedomEdge® Syringe Infusion System. The FreedomEdge® Syringe Driver is a nonsterile, reusable non-electric driver that infuses immunoglobulins and Pegcetacoplan subcutaneously and antibiotic solutions intravenously to patients.
The FreedomEdge® driver is an ambulatory device designed to accommodate a BD Luer-Lok™ 20mL syringe. Catalog No.: 302830 and 301031. BD Luer-Lok™ 30mL syringe, Catalog No.: 301033 and Hizentra® 20 ml prefilled syringe. The pump uses a constant force spring mechanism to apply pressure to the plunger-end syringe.
The FreedomEdge® Syringe Infusion System is assembled by loading the syringe with tubing into the FreedomEdge® driver.
2. Precision Flow Rate Tubing™:
The FreedomEdge® Syringe Infusion System includes a range of Freedom Precision Flow Rate Tubing™ (provided sterile). The tubing ranges from F0.5 to F2400. Each Fnumber provides a different level of flow restriction, which, when combined with the viscosity of the medication, provides a controlled delivery in an all-mechanical system. The tubing sets connect at one end to the syringe being used and on the other end to the Subcutaneous Safety Needle Sets or directly on venous catheters for intravenous infusions as needed.
3. HIgH-Flo Needles Sets:
The HIgH-Flo Subcutaneous Safety Needle Sets™
The HIgH-Flo Subcutaneous Safety Needle Sets™ (provided sterile) are used to administer drugs to the subcutaneous layers using small needles attached to the skin. Subcutaneous needles come in different lengths to administer immunoglobulins, pegcetacoplan, and antibiotics.
Subcutaneous Safety Needle Sets come in multiple configurations (1, 2, 3, 4, 5, 6 needle sites). Needles are available in 4mm, 6mm, 9mm, 12mm, and 14mm lengths combined with 24 or 26 Gauge. Using the Y-Connector, the patient can have up to 8 sites for drug delivery.
The HIgH- Flo Subcutaneous Safety Needle Sets™ also allow each needle to be enclosed between the wings after use.
The HIgH-Flo Super26TM Subcutaneous Needle Sets
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The HIgH-Flo Super26TM Subcutaneous Needle Sets are sterile, non-pyrogenic, single use, Subcutaneous Administration Sets, comprised of a Super 26-gauge needle assembly, combined with 24-gauge needle tubing and are intended for the delivery of medication to the subcutaneous tissue. Each set consists of a sterile infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set is a 90degree, 26-gauge stainless steel needle, mounted to a butterfly winged safety closure on one end which is used to close the set upon completion. The other end consists of a luer lock which connects to PVC medical grade tubing. Additionally, each tubing set is equipped with a slide clamp used to stop flow, immediately as needed. HIgH-Flo Super 26TM Subcutaneous Needle Sets are available as a single set, as well as 2-needle, 3needle, 4-needle, 5-needle, 6-needle, sets; through use of a Y-connector, 7-needle and 8 needle sets may also be assembled.
The purpose of this premarket notification is to request a modification to the indications for use to include the addition of the drug EMPAVELI™ (pegcetacoplan) injection 1080/20 mL solution (manufactured by Apellis®) for subcutaneous infusion using the FreedomEdge® Syringe Infusion System.
V. INDICATIONS FOR USE
INTENDED USE
The FreedomEdge® Syringe Infusion System is intended for the intravenous or subcutaneous infusion of medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling.
Intended population: adults and pediatrics.
INDICATIONS FOR USE
The FreedomEdge® Syringe Infusion System consists of the following components:
- FreedomEdge® Syringe Driver
- Precision Flow Rate Tubing™ ●
- HIgH-Flo Subcutaneous Safety Needle Sets™ ●
- . HIgH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration.
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The FreedomEdge® Syringe Infusion System is indicated for use with the BD® 20 ml syringe (US Reference number: 302830), BD 30 ml syringe (US Reference number: 302832) and Hizentra® 20 ml prefilled syringe (NDC 44206-458-96).
For Immunoglobulin Administration:
The Freedom Integrated Syringe Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) and Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling.
For EMPAVELITM (pegcetacoplan) Administration:
The Freedom Integrated Syringe Infusion System is specifically indicated for the subcutaneous infusion with EMPAVELI™ (pegcetacoplan) in the home, hospital, or ambulatory setting when administered according to the approved drug product labeling.
For Intravenous Antibiotic Administration:
The Freedom Integrated Syringe Infusion System with the FreedomEdge® Syringe Driver and Precision Flow Rate Tubing™, is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling:
Ertapenem, Meropenem, Oxacillin, and Tobramycin.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Indications for Use Comparison
The table below includes a comparison of the indications for use between the new device and that of the predicate device:
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| Predicate Device(K211206) | Subject Device | |
|---|---|---|
| FreedomEdge® Syringe Infusion System | FreedomEdge® Syringe Infusion System | |
| Modified Indications forUse | Modified Indications forUse | |
| Indications | 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.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% | 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 byCSL Behring®); Hizentra®, ImmuneGlobulin Subcutaneous (Human) 20%Liquid (manufactured by CSL Behring®)Single-use pre-filled syringe forsubcutaneous administration.The FreedomEdge® Syringe InfusionSystem is indicated for use with the BD®20 ml syringe (US Reference number:302830), BD 30 ml syringe (USReference number: 302832) andHizentra® 20 ml prefilled syringe (NDC44206-458-96).For Immunoglobulin Administration:The Freedom Integrated Syringe InfusionSystem is specifically indicated for thesubcutaneous infusion of the following humanplasma-derived immunoglobulins when usedaccording to the FDA approved biologiclabeling: Cuvitru®, Immune Globulin Infusion(Human) 20% (manufactured by Takeda®);Gammagard Liquid®, Immune GlobulinInfusion (Human) 10% (manufactured byTakeda®); Hizentra®, Immune Globulin |
| Predicate Device(K211206)FreedomEdge® Syringe Infusion System | Subject DeviceFreedomEdge® Syringe Infusion System | |
| Modified Indications forUse | Modified Indications forUse | |
| (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 for subcutaneousadministration. | Subcutaneous (Human) 20% Liquid(manufactured by CSL Behring®) andHizentra®, Immune Globulin Subcutaneous(Human) 20% Liquid (manufactured by CSLBehring®) Single-use pre-filled syringe forsubcutaneous administration in the home,hospital, or ambulatory settings whenadministered according to the approved biologicor drug product labeling. | |
| 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. | For EMPAVELI™ (pegcetacoplan)Administration:The Freedom Integrated Syringe InfusionSystem is specifically indicated for thesubcutaneous infusion with EMPAVELI™(pegcetacoplan) in the home, hospital, orambulatory setting when administered accordingto the approved drug product labeling.For Intravenous Antibiotic Administration:The Freedom Integrated Syringe InfusionSystem with the FreedomEdge® Syringe Driverand Precision Flow Rate TubingTM, isspecifically indicated for the intravenousinfusion of the following antibiotics when usedaccording to the FDA approved drug productlabeling:Ertapenem, Meropenem, Oxacillin, andTobramycin. | |
| 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 the EMPAVELI™ (pegcetacoplan) injection 1080/20 mL solution (manufactured by Apellis®) for use with the infusion system. The difference between the subject device and predicate device infusion system is the inclusion of the
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EMPAVELI™ (pegcetacoplan) injection 1080/20 mL solution into the indications for use.
Compatibility of the EMPAVELI™ (pegcetacoplan) injection 1080/20 mL solution with the FreedomEdge® infusion system specifically has been verified through performance testing. The change to device indications do not significantly affect safety or effectiveness as the changes do not create new risks or sigmificantly modify existing risk. The change in indications for use does not raise different questions of safety and effectiveness and, therefore, does not preclude a meaningful comparison with the predicate device.
The routes of administration for the system, intravenous, and subcutaneous were cleared in the predicate device.
Discussions of differences in intended population
The intended population for the subject device is identical to the predicate device. EMPAVELI™ is specifically indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Discussions of differences in environment of use
The environment of use for the subject device is identical to the predicate device.
Device configuration
The table below compares configuration of the infusion system between the subject device and that of the predicate device:
| PredicateK211206 | Subject Device(unknown) |
|---|---|
| FreedomEdge® Syringe Infusion System | FreedomEdge® Syringe Infusion System |
| 1. The FreedomEdge® Syringe Driver | 1. The FreedomEdge® Syringe Driver |
| 2. Precision Flow Rate Tubing™ | 2. Precision Flow Rate Tubing™ |
| 3. HIgH-Flo™ Subcutaneous SafetyNeedle Sets (24G, 26G) | 3. HIgH-Flo™ Subcutaneous SafetyNeedle Sets (24G, 26G) |
| 4. HIgH-FLO Super26™ SubcutaneousNeedle Sets | 4. HIgH-FLO Super26™ SubcutaneousNeedle Sets |
Table 2. Device Configuration Comparison
Discussions of differences in system configuration
The FreedomEdge® Syringe Infusion System (subject device) configuration is identical to the predicate device. There is no change to the system as a result of the IFU medication.
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Table 3 presents a tabular comparison of the technological characteristics between the proposed device and predicate device with an assessment of differences between subject device and predicate device and why the differences do not introduce new or different questions of safety and effectiveness.
| TechnologicalCharacteristics | FreedomEdge® Syringe InfusionSystem(K211206) | FreedomEdge® Syringe InfusionSystem(Subject Device) | Comparison |
|---|---|---|---|
| Spring Type | Negator | Negator | Same |
| Winding ofSpring | FreedomEdge® syringe driver: Manuallever used to tension negator constantforce spring | FreedomEdge® syringe driver: Manuallever used to tension negator constantforce spring | Same |
| On / Off Control | Manual switch | Manual switch | Same |
| Housing | Molded ABS | Molded ABS | Same |
| Syringe Type | BD® 20 mL syringe (US Referencenumber: 302830)BD® 30 mL syringe (US Referencenumber: 302832)20 mL single-use pre-filled syringe (NDC44206-458-96). | BD® 20 mL syringe (US Referencenumber: 302830)BD® 30 mL syringe (US Referencenumber: 302832)20 mL single-use pre-filled syringe (NDC44206-458-96). | Same |
| Tubing Length(inches) | 20 | 20 | Same |
| TubingDiameter(inches) | HIgH-FloTM Subcutaneous Safety NeedleSets (24G and 26G)$0.0190 \pm 0.001"$HIgH-FLO Super26TM SubcutaneousNeedle Sets$0.033 + 0.002"/-0.001"$ | HIgH-FloTM Subcutaneous Safety NeedleSets (24G and 26G)$0.0190 \pm 0.001"$HIgH-FLO Super26TM SubcutaneousNeedle Sets$0.033 + 0.002"/-0.001"$ | Same |
| Tubing Material | Medical Grade PVC Plastic | Medical Grade PVC Plastic | Same |
| Needle Material | Stainless Steel | Stainless Steel | Same |
| Needle Gauge | 24 Gauge Needle Sets26 Gauge Needle Sets | 24 Gauge Needle Sets26 Gauge Needle Sets | Same |
| Table 3. Comparison of Predicate and Subject Device | ||
|---|---|---|
| -- | -- | ----------------------------------------------------- |
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| TechnologicalCharacteristics | FreedomEdge® Syringe Infusion System(K211206) | FreedomEdge® Syringe Infusion System(Subject Device) | Comparison |
|---|---|---|---|
| Needle ButterflyWings Material | HIgH-Flo™ Subcutaneous Safety NeedleSetPolypropyleneHIgH-FLO Super26™ SubcutaneousNeedle SetsPolypropylene with blue colorant(541790C Translucent blue, MarvelIndustries, Inc.) | HIgH-Flo™ Subcutaneous Safety NeedleSetPolypropyleneHIgH-FLO Super26™ SubcutaneousNeedle SetsPolypropylene with blue colorant(541790C Translucent blue, MarvelIndustries, Inc.) | Same |
| Needle Lengths | 4, 6, 9, 12, 14 | 4, 6, 9, 12, 14 | Same |
| Needle Usage | Single Use | Single Use | Same |
| Packaging | Tubing and Needle Sets packaged sterileutilizing a nylon pouch (P/N 317050), forsingle patient use. | Tubing and Needle Sets packaged sterileutilizing a nylon pouch (P/N 317050), forsingle patient use. | Same |
| Prescriptionrequired | Yes | Yes | Same |
| IntendedPopulation | Adult, Pediatric | Adult, Pediatric | Same |
| SystemAccuracy | Flow rates will fall between the minimumand maximum predicted values asspecified in the IFU. | Flow rates will fall between the minimumand maximum predicted values asspecified in the IFU. | Same |
| SterilizationMethod | Syringe Driver is non-sterile; Needle Sets& Tubing sterilized via Gamma SAL 10-6 | Syringe Driver is non-sterile; Needle Sets& Tubing sterilized via Gamma SAL 10-6 | Same |
| Needle SetConfigurationsAvailable | 24 Gauge: Available as a single-needleset, as well as 2-needle, 3-needle, 4-needle set; through use of a Y-connector,5- needle, 6-needle, 7-needle and 8-needlesets may also be assembled.26 Gauge: Available as a single-needleset, as well as 2-needle, 3-needle, 4-needle, 5-needle, and 6-needle sets;through use of a Y-connector, 7-needleand 8-needle sets may also be assembled. | 24 Gauge: Available as a single-needleset, as well as 2-needle, 3-needle, 4-needle set; through use of a Y-connector,5- needle, 6-needle, 7-needle and 8-needlesets may also be assembled.26 Gauge: Available as a single-needleset, as well as 2-needle, 3-needle, 4-needle, 5-needle, and 6-needle sets;through use of a Y-connector, 7-needleand 8-needle sets may also be assembled. | Same |
| Needle 24 G 26 G Super26 | Needle 24 G 26 G Super26 | Same |
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| TechnologicalCharacteristics | FreedomEdge® Syringe InfusionSystem(K211206) | FreedomEdge® Syringe InfusionSystem(Subject Device) | Comparison | ||||||
|---|---|---|---|---|---|---|---|---|---|
| ResidualVolumes forHIgH-FloNeedle Sets | 1 | 0.4 ml | 0.1 ml | 0.4 ml | 1 | 0.4 ml | 0.1 ml | 0.4 ml | |
| 2 | 0.7 ml | 0.2 ml | 0.7 ml | 2 | 0.7 ml | 0.2 ml | 0.7 ml | ||
| 3 | 1.1 ml | 0.3 ml | 1.1 ml | 3 | 1.1 ml | 0.3 ml | 1.1 ml | ||
| 4 | 1.4 ml | 0.4 ml | 1.4 ml | 4 | 1.4 ml | 0.4 ml | 1.4 ml | ||
| 5 | 2.0 ml(with Y-connector) | 0.5 ml | 1.8 ml | 5 | 2.0 ml(with Y-connector) | 0.5 ml | 1.8 ml | ||
| 6 | 2.3 ml(with Y-connector) | 0.6 ml | 2.1 ml | 6 | 2.3 ml(with Y-connector) | 0.6 ml | 2.1 ml | ||
| 7 | 2.7 ml(with Y-connector) | 0.9 ml(with Y-connector) | 2.7 ml(With Y-connector) | 7 | 2.7 ml(with Y-connector) | 0.9 ml(with Y-connector) | 2.7 ml(With Y-connector) | ||
| 8 | 1.0 ml(with Y-connector) | 1.0 ml(with Y-connector) | 3.0 ml(With Y-connector) | 8 | 1.0 ml(with Y-connector) | 1.0 ml(with Y-connector) | 3.0 ml(With Y-connector) |
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VII. PERFORMANCE DATA
The following performance data/non-clinical testing was provided in support of the substantial equivalence determination for the FreedomEdge® Syringe Infusion System. The infusion system does not contain software, electrical components, or alarms.
| Device Performance | The essential performance requirements of the device were verified 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", within a Risk Management Process and are considered to be biocompatible.Testing was conducted for the following tests:Cytotoxicity Sensitization Irritation |
| Human Factors | Human factors studies were completed per the FDA Guidance "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." |
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Safety Assurance
A safety assurance case is provided for the FreedomEdge® Syringe Infusion System, as recommended in the FDA guidance document, "Infusion Pumps Total Product Life Cycle."
The stated goal of the safety assurance case is:
-
. The FreedomEdge® Syringe Infusion System is adequately safe for its intended use.
The assurance case defined the device system/configurations, including the indications for use, system definition, operational description, device user and patient populations, and device use conditions and environments. The supporting assurance arguments covered the following attributes: -
Device requirements are adequate, and design is adequately verified and validated.
-
Device associated risks are completely identified and adequately mitigated.
-
Device is adequately reliable to ensure safety over its service life.
The following specific evidence was included within the assurance case to demonstrate that the subject device is verified and validated for its intended use and to demonstrate substantial equivalence to the predicate devices:
Device Performance
The essential performance requirements of the device were verified through performance testing in accordance with the intended use of the device and in accordance with the FDA Guidance "Infusion Pumps Total Product Life Cycle
The FreedomEdge® Syringe Infusion System includes directions for the selection of Precision Tubing Sets, HIgH-Flo Subcutaneous Needle Sets, and HIgH-FLO Super26 Subcutaneous Needle Sets combinations in order to achieve desired infusion rates for each
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of the indicated human plasma-derived immunoglobulin solutions and Pegcetacoplan solutions, in accordance with the following tables:
EMPAVELI™ 20 ml syringe Selected Flow Rate Combinations
The following tables indicate the max-min predicated flow rates per site with HIgH-Flo Subcutaneous Safety Needles Sets™ (Standard 26G) when used in combination with KORU Precision Flow Rate Tubing™ and the FreedomEdge® Syringe Infusion System with a 20 ml BD syringe for the subcutaneous use of EMPAVEL™.
To determine the appropriate flow rate tubing and subcutaneous needle configuration, the prescriber should refer to drug package insert for the approximate maximum and minimum indicated infusion times.
HIgH-Flo 26G with Precision Tubing - Max-Min Flow Rate Per Site (ml/hr/site)
| F500 | F600 | F900 | F1200 | F2400 | |
|---|---|---|---|---|---|
| 1 needle | 18 - 42.2 | 19.4 - 45.8 | 22.3 - 53.6 | 22.9 - 58 | 27.7 - 72.9 |
| 2 needles | 12.6 - 27.2 | 13.4 - 30.3 | 16.3 - 37.4 | 16.9 - 41.9 | 22.8 - 59.4 |
HIgH-Flo 26G with Precision Tubing - Max-Min Flow Rate Total (ml/hr)
| F600 | F900 | F1200 | F2400 | ||
|---|---|---|---|---|---|
| 1 needle | 18.6 - 42.2 | 19.4 - 45.8 | 22.3 - 53.6 | 22.9 - 58 | 27.7 - 72.9 |
| 2 needles | 25.2 - 54.3 | 26.7 - 60.5 | 32.5 - 74.9 | 33.8 - 83.7 | 45.5 - 118.7 |
HIgH-Flo 26G with Precision Tubing – Min-Max Infusion Times (minutes)
| F500 | F600 | F900 | F1200 | F2400 | |
|---|---|---|---|---|---|
| 1 needle | 47 (28-65) | 44 (26 - 62) | 38 (22 - 54) | 37 (21 - 52) | 30 (16-43) |
| 2 needles | 35 (22-48) | 35 (22 - 48) | 27 (16-37) | 25 (14 - 36) | 18 (10 - 26) |
The EMPAVELI™ label states that typical infusion time is approximately 30 minutes (if using 2 infusion sites) or approximately 60 minutes (if using one infusion site). Based on assessment of EMPAVELI™ labeling there is no identified patient risk for going faster or slower than this approximate infusion time.
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Selected Flow Rate Combinations
Select Combinations of Flow Rates with HIgH-Flo Subcutaneous Safety Needle Sets™ (Standard 26G and 24G) when used in combination with Precision Flow Rate Tubing™ for use with Hizentra®, Cuvitru®, and Gammagard® Liquid.
Note: The following tables are only for the subcutaneous use of the immunoglobulin listed.
| Hizentra – FreedomEdge® with 20 ml syringe | |||||||
|---|---|---|---|---|---|---|---|
| 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 |
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| Cuvitru - with FreedomEdge® with 30 mlsyringe | |||||||
|---|---|---|---|---|---|---|---|
| 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 |
| 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-Flo needle sets: The first number of needles, the next two numbers refer to the needle gauge, and the last two numbers refer to the needle length (mm).
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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 Super26™) when used in combination with KORU Precision Flow Rate Tubing™ and the FreedomEdge® Syringe Infusion System with a 20 ml syringe for the subcutaneous use of Hizentra CIDP.
To determine the appropriate flow rate tubing and subcutaneous needle configuration, please refer to drug package insert for the maximum indicated flow rate and volume per infusion site for initial and subsequent infusions.
| 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/19/Picture/5 description: The image shows a rectangle divided into two equal parts. The top part of the rectangle is gray, while the bottom part is light blue. The rectangle is enclosed by a black border.
Exceeds drug manufacturer's maximum indicated flow rate.
Subsequent infusions after 6th infusion only.
HIgH-Flo Super26 with Precision Tubing – Nominal Flow Rate Per Site (ml/hr/site)
| 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 - 36.9 |
| 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 - 32.9 |
| 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 - 29.6 |
Image /page/19/Picture/10 description: The image shows a rectangle divided into two sections. The top section is colored gray, while the bottom section is light blue. The rectangle is outlined with a black border.
Exceeds drug manufacturer's maximum indicated flow rate.
Subsequent infusions after 6th infusion only.
{20}------------------------------------------------
| 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 - 156.3 |
| 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/20/Picture/2 description: The image shows a rectangle divided into two equal parts. The top part of the rectangle is gray, while the bottom part is light blue. The rectangle is outlined in black.
Exceeds drug manufacturer's maximum indicated flow rate. Subsequent infusions after 6th infusion only.
Clinical Evaluation
Clinical evaluation was not required to support submission and determination of substantial equivalence.
VIII. CONCLUSIONS
The FreedomEdge® Syringe Infusion System is substantially equivalent to the commercially available predicate device in terms of function, safety, performance, intended use, technology/principles of operation and mechanical properties. The non-clinical data support the safety of the device and performance testing demonstrate that the FreedomEdge® Syringe Infusion System meets the established specifications necessary for consistent performance to achieve its intended use as safely and as effectively as the predicate device and reference device and confirmed that the technological differences between the proposed device and predicate device do not raise different questions of safety or effectiveness. Based on performance testing results, the FreedomEdge® Syringe Infusion System, performs as intended and performs comparably to the predicate device that is currently marketed for the same intended use.
§ 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).