(691 days)
No
The device description and performance studies focus on mechanical components and flow rate accuracy, with no mention of AI or ML.
Yes.
The device administers medications (immunoglobulins and antibiotics) for therapeutic purposes, directly contributing to patient treatment.
No
The device is described as an "infusion system" and a "volumetric infusion pump" used for delivering medications (immunoglobulins and antibiotics) to patients. It does not perform diagnostic functions such as identifying or analyzing medical conditions.
No
The device description explicitly lists multiple hardware components: FREEDOM60® Syringe Driver, Precision Flow Rate Tubing™, and HIgH-Flo Subcutaneous Safety Needle Sets™. It is described as a "single-channel, volumetric infusion pump."
Based on the provided information, the Freedom Integrated Syringe Infusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Freedom Integrated Syringe Infusion System is designed to infuse medications (immunoglobulins and antibiotics) into the patient's body, either subcutaneously or intravenously. It is a drug delivery system.
- Intended Use: The intended use clearly states the device is for the "subcutaneous infusion" and "intravenous infusion" of specific medications. This is a therapeutic function, not a diagnostic one.
- Device Components: The components (syringe driver, tubing, needle sets) are all designed for the physical delivery of substances into the body.
The device's purpose is to administer treatment, not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The FREEDOM® Integrated Syringe Infusion System is intended for the intravenous or subcutaneous infusion of medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling.
The Freedom Integrated Syringe Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by Grifols®) in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The FREEDOM Integrated Syringe Infusion System with the FREEDOM60® Syringe Driver and Precision Flow Rate Tubing™, is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling: ertapenem, meropenem, oxacillin, and tobramycin.
The Freedom Integrated Syringe Infusion System consists of the following components:
- FREEDOM60® Syringe Driver
- Precision Flow Rate Tubing™
- HIgH-Flo Subcutaneous Safety Needle SetsTM
- HIgH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); and Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®).
The FREEDOM60® Syringe Driver is indicated for use with the BD® 50 ml syringe (US Reference number 309653).
Product codes
FRN, FPA, PKP
Device Description
The FREEDOM® Integrated Syringe Infusion System is a single-channel, volumetric infusion pump. The FREEDOM60® Integrated Syringe Infusion System consists of four primary components:
- FREEDOM60® Syringe Driver,
- Precision Flow Rate Tubing™ and
- HIgH-Flo Subcutaneous Safety Needle Set™, or
- HIgH-Flo Super26TM Subcutaneous Safety Needle Set
The FREEDOM60® Syringe Driver: The FREEDOM60® Syringe Driver in combination with Precision Flow Rate Tubing™ (sterile) and HIgH-Flo Subcutaneous Safety Needle Sets (sterile) makes up the Freedom Integrated Syringe Infusion system. The FREEDOM60® Syringe Driver is a non-sterile, reusable non-electric driver that infuses immunoglobulins subcutaneously and antibiotic solutions intravenously to patients.
The FREEDOM60® Syringe Driver is an ambulatory device designed to accommodate a BD Luer-Lok™ 50mL Syringe (Catalog No.: 8881-560125, BD 309653), and fluid volumes ranging from 10cc to 60cc may be used. The pump uses a constant force spring mechanism to apply pressure to the plunger-end syringe. The Freedom Integrated Syringe System is assembled by loading the syringe with tubing into the Freemdom60® driver.
Precision Flow Rate Tubing™: The Freedom Integrated Syringe System includes a range of Freedom Precision Flow Rate Tubing™ (provided sterile). The tubing ranges from F0.5 to F2400. Each F-number provides a different level of flow restriction, which, when combined with the viscosity of the medication, provides a controlled delivery in an all-mechanical system. The tubing sets connect at one end to the syringe being used and on the other end to the Subcutaneous Safety Needle Sets or directly on venous catheters for intravenous infusions as needed.
HIgH-Flo Needles 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 and antibiotics. 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and pediatric
Intended User / Care Setting
Home, hospital, or ambulatory settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data/non-clinical testing was provided in support of the substantial equivalence determination for the FREEDOM60® Integrated Syringe Infusion System. The infusion system does not contain software, electrical components, or alarms.
Device Performance: The essential performance requirements of the device were verified through performance testing in accordance with the intended use of the device and in accordance with the FDA Guidance "Infusion Pumps Total Product Life Cycle".
Biocompatibility: The materials used in the Administration Set (tubing and needles) for the FREEDOM60® Integrated Syringe Infusion System comply with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA and FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", within a Risk Management Process and are considered to be biocompatible. Testing was conducted for the following tests: Cytotoxicity, Sensitization, Irritation.
Human Factors: Human factors studies were completed per the FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" (February 3, 2016). The human factors studies were conducted with the intended user population, use environment and use scenarios to simulate clinical conditions. Results of the human factors testing demonstrate validation of the device per the intended use.
Reprocessing, Cleaning: AAMI TIR12:2010 – Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers. AAMI TIR30:2011(R)2016 – A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, 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 be provided by the medical device manufacturer for the processing of medical. ANSI/AAMI/ISO 11737-1:2018 – Sterilization of health care products – Microbiological methods - Part 1: Determination of the population of microorganisms on product. NAMSA Technical Memorandum US033689 Rev. 1, Review and Comparison of 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 Other Items for Safety in the Magnetic Resonance Environment."
Safety Assurance: A safety assurance case is provided for the FREEDOM60® Integrated 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 FREEDOM60® Integrated 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 FREEDOM60® Integrated 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.
Clinical Evaluation: Clinical evaluation was not required to support submission and determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right of this symbol, there is a blue square with the letters 'FDA' in white. Further to the right, the words 'U.S. FOOD & DRUG' are written in a larger, bold blue font, with the word 'ADMINISTRATION' underneath in a smaller blue font.
Repro-Med Systems, Inc., dba KORU Medical Systems Kachi Enyinna Vice President of Global Commercialization 24 Carpenter Road Chester, New York 10918
December 15, 2021
Re: K200176
Trade/Device Name: FREEDOM Integrated Syringe Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, FPA, PKP Dated: March 30, 2021 Received: March 30, 2021
Dear Kachi Enyinna:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ofpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic provisions (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (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
2
Indications for Use
510(k) Number (if known) K200176
Device Name
FREEDOM® Integrated Syringe Infusion System
Indications for Use (Describe)
The Freedom Integrated Syringe Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by Grifols®) in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling.
The FREEDOM Integrated Syringe Infusion System with the FREEDOM60® Syringe Driver and Precision Flow Rate Tubing™, is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling: ertapenem, meropenem, oxacillin, and tobramycin.
The Freedom Integrated Syringe Infusion System consists of the following components:
- FREEDOM60® Syringe Driver
- Precision Flow Rate Tubing™M
- HIgH-Flo Subcutaneous Safety Needle SetsTM
- HIgH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®).
The FREEDOM60® Syringe Driver is indicated for use with the BD® 50 ml syringe (US Reference number 309653).
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY K200176
I. SUBMITTER
Repro-Med Systems, Inc. dba Koru Medical Systems 24 Carpenter Road Chester, NY 10918 USA
Ph: (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: November 12, 2021
II. DEVICE
Name of Device: FREEDOM® Integrated Syringe Infusion System Common or Usual Name: Infusion Pump Classification Name: Pump, Infusion (21CFR 880.5725) Regulatory Class: II Product Code: FRN, FPA, PKP
III. PREDICATE DEVICE
Predicate Device: Integrated Catch-Up FREEDOM Syringe Driver Infusion System, K162613 This predicate has not been subject to a design-related recall.
Reference Device: KORU HIgH-Flo Super26™ Subcutaneous Safety Needle Set, K180843.
This reference device has not been subject to a design-related recall.
4
IV. DEVICE DESCRIPTION
The FREEDOM® Integrated Syringe Infusion System is a single-channel, volumetric infusion pump. The FREEDOM60® Integrated Syringe Infusion System consists of four primary components:
-
- FREEDOM60® Syringe Driver,
-
- Precision Flow Rate Tubing™ and
-
- HIgH-Flo Subcutaneous Safety Needle Set™, or
-
- HIgH-Flo Super26TM Subcutaneous Safety Needle Set
1. FREEDOM60® Syringe Driver:
The FREEDOM60® Syringe Driver in combination with Precision Flow Rate Tubing™ (sterile) and HIgH-Flo Subcutaneous Safety Needle Sets (sterile) makes up the Freedom Integrated Syringe Infusion system. The FREEDOM60® Syringe Driver is a non- sterile, reusable non-electric driver that infuses immunoglobulins subcutaneously and antibiotic solutions intravenously to patients.
The FREEDOM60® Syringe Driver is an ambulatory device designed to accommodate a BD Luer- Lok™ 50mL Syringe (Catalog No.: 8881-560125, BD 309653), and fluid volumes ranging from 10cc to 60cc may be used. The pump uses a constant force spring mechanism to apply pressure to the plunger-end syringe.
The Freedom Integrated Syringe System is assembled by loading the syringe with tubing into the Freemdom60® driver.
2. Precision Flow Rate Tubing™:
The Freedom Integrated Syringe System includes a range of Freedom Precision Flow Rate Tubing™ (provided sterile). The tubing ranges from F0.5 to F2400. Each F-number provides a different level of flow restriction, which, when combined with the viscosity of the medication, provides a controlled delivery in an all-mechanical system. The tubing sets connect at one end to the syringe being used and on the other end to the Subcutaneous Safety Needle Sets or directly on venous catheters for intravenous infusions as needed.
3. HIgH-Flo Needles Sets:
The HIgH-Flo Subcutaneous Safety Needle SetsTM
The HIgH-Flo Subcutaneous Safety Needle Sets™ (provided sterile) are used to administer drugs to the subcutaneous layers using small needles attached to the skin. Subcutaneous needles come in different lengths to administer immunoglobulins and antibiotics.
5
Subcutaneous Safety Needle Sets comes in multiple configurations (1, 2, 3, 4, 5, 6 needle sites). Needles are available in 4mm, 6mm, 9mm, 12mm, and 14mm lengths combined with 24 or 26 Gauge. Using the Y-Connector, the patient can have up to 8 sites for drug delivery.
The HIgH- Flo Subcutaneous Safety Needle Sets™ also allow each needle to be enclosed between the wings after use.
The HIgH-Flo Super26TM Subcutaneous Needle Sets
The HIgH-Flo Super26TM Subcutaneous Needle Sets are sterile, non-pyrogenic, single use, Subcutaneous Administration Sets, comprised of a Super 26-gauge needle assembly, combined with 24-gauge needle tubing and are intended for the delivery of medication to the subcutaneous tissue. Each set consists of a sterile infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set is a 90degree, 26-gauge stainless steel needle, mounted to a butterfly winged safety closure on one end which is used to close the set upon completion. The other end consists of a luer lock which connects to PVC medical grade tubing. Additionally, each tubing set is equipped with a slide clamp used to stop flow, immediately as needed. HIgH-Flo Super 26TM Subcutaneous Needle Sets are available as a single set, as well as 2-needle, 3needle, 4-needle, 5-needle, 6-needle, sets; through use of a Y-connector, 7-needle and 8 needle sets may also be assembled.
The purpose of this premarket notification is to request a modification for the cleared infusion system. The major modifications to the current device are as follows:
1. Device Configuration
- Removal of syringe driver The Subject device will only a. include use of only one syringe driver (FREEDOM60®) instead of two syringe drivers cleared for use in the predicate device.
- Addition of second needle set The HIgH-FLO Super26 b. Subcutaneous Needle cleared under K180843 is added for use with the system.
-
- Update Indication for Use The purpose of the device application is to expand the currently cleared indications for use to include the addition of two new drugs, Xembify and Cutaquig, and HIgH-Flo Super26TM Subcutaneous Needle Set into the indications for use.
-
- Addition of Blue Colorant to Needle Butterfly Wings Addition of a blue colorant to the HIgH-Flo Super26™ Subcutaneous Safety Needle Sets. The blue colorant (541790C Translucent blue, Marvel Industries, Inc.) was added to the Super26™ needle hub assembly to help distinguish between the HIgH-Flow Subcutaneous Safety Needle Sets and HIgH-Flo Super26TM Subcutaneous Safety Needle Sets.
-
- Update Sterile Barrier (Packaging material) sterile devices will be
6
packaged in a nylon film pouch, which once sealed, serves as the sterile barrier. The pouch material was updated from LDPE pouch, P/N 317036 to Nylon pouch, P/N 317050.
-
- Flow Rate Accuracy the flow rate accuracy between the subject device and predicate device has changed from +/-8% to predicted minimum to maximum flow rates within those labeled per the Hizentra package insert for each combination of needle set and tubing.
V. INDICATIONS FOR USE
INTENDED USE
The FREEDOM® Integrated Syringe Infusion System is intended for the intravenous or subcutaneous infusion of medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling.
Intended population: adults and pediatrics.
INDICATIONS FOR USE
The Freedom Integrated Syringe Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by Grifols®) in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The Freedom Integrated Syringe Infusion System with the FREEDOM60® Syringe Driver and Precision Flow Rate Tubing™, is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling: ertapenem, meropenem, oxacillin, and tobramycin.
The Freedom Integrated Syringe Infusion System consists of the following components:
- FREEDOM60® Syringe Driver
- Precision Flow Rate Tubing™ ●
- HIgH-Flo Subcutaneous Safety Needle Sets™ .
- HIgH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the ● subcutaneous infusion of the following human plasma-derived immunoglobulins: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution
7
(manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); and Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®).
The FREEDOM60® Syringe Driver is indicated for use with the BD® 50 ml syringe (US Reference number 309653).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
Indications for Use Comparison
The table below includes a comparison of the indications for use between the new device and that of the predicate device:
| | Predicate Device
(K162613) | Subject Device
(K200176) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Integrated Catch-Up FREEDOM Syringe
Driver Infusion System | FREEDOM® Integrated Syringe Infusion
System |
| | Current configuration | New configuration |
| | Current Indications for Use
as cleared August 31, 2017 | Modified Indications for
Use |
| Indications | The Integrated Catch-Up FREEDOM Syringe
Driver Infusion System (ICFSDIS), which
includes the FREEDOM60® and FreedomEdge®
syringe pumps, 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 ICFSDIS
is specifically indicated for the subcutaneous
infusion of the following human plasma-derived
immunoglobulins when used according to the | The Freedom Integrated Syringe Infusion System
is specifically indicated for the subcutaneous
infusion of the following human plasma-derived
immunoglobulins when used according to the
FDA approved biologic labeling: Cutaquig®,
Immune Globulin Subcutaneous (Human) 16.5%
Solution (manufactured by Octapharma®);
Cuvitru®, Immune Globulin Infusion (Human)
20% (manufactured by Takeda®); Gammagard
Liquid®, Immune Globulin Infusion (Human)
10% (manufactured by Takeda®); Hizentra®,
Immune Globulin Subcutaneous (Human) 20%
Liquid (manufactured by CSL Behring®); and
Xembify®, Immune Globulin Subcutaneous
(Human) 20% Liquid (manufactured by
Grifols®) in the home, hospital, or ambulatory
settings when administered according to the
approved biologic or drug product labeling. The |
| | FDA approved biologic labeling: Hizentra,
Immune Globulin Subcutaneous (Human) 20%
Liquid (manufactured by CSL Behring);
Gammagard Liquid, Immune Globulin Infusion
(Human) 10% (manufactured by Shire); and
Cuvitru Immune Globulin Infusion (Human) 20%
(manufactured by Shire). The ICFSDIS is
specifically indicated for the intravenous infusion
of the following antibiotics when used according | Freedom Integrated Syringe Infusion System
with the FREEDOM60® Syringe Driver and
Precision Flow Rate Tubing™, is specifically
indicated for the intravenous infusion of the
following antibiotics when used according to the |
| | to the FDA approved drug product labeling:
meropenem, ertapenem, oxacillin, and
tobramycin. | FDA approved drug product labeling: ertapenem,
meropenem, oxacillin, and tobramycin. The
Freedom Integrated Syringe Infusion System |
| | The FreedomEdge® Syringe Infusion System is
indicated for use with the BD 20 ml (model no. | |
| | Predicate Device
(K162613)
Integrated Catch-Up FREEDOM Syringe
Driver Infusion System | Subject Device
(K200176)
FREEDOM® Integrated Syringe Infusion
System |
| | Current configuration | New configuration |
| | Current Indications for Use
as cleared August 31, 2017 | Modified Indications for
Use |
| | 302830/301031) or BD 30 ml (model no. 301033) syringe. The FREEDOM60® Syringe Infusion System is indicated for use with the BD 60 ml syringe (model no. 309653). | consists of the following components:
• FREEDOM60® Syringe Driver
• Precision Flow Rate Tubing™
• HIgH-Flo Subcutaneous Safety Needle Sets™
• HIgH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins:
Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); and Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) |
| | | The FREEDOM60® Syringe Driver is indicated for use with the BD® 50 ml syringe (US Reference number 309653). |
| Prescription or
Over the
Counter | Prescription | Prescription |
| Intended
Population | Adult and pediatric | Adult and pediatric |
| Environment
of Use | Hospital, ambulatory, or home | Hospital, ambulatory, or home |
| Predicate | Subject Device | |
| K162613 | K200176 | |
| Integrated Catch-Up Freedom Syringe | FREEDOM® Integrated Syringe Infusion | |
| Driver Infusion System | System | |
| 1. The FREEDOM60® Syringe Driver
2. The FreedomEdge® Syringe Driver
3. Precision Flow Rate Tubing™
4. HIgH-Flo™ Subcutaneous Safety Needle
Sets (24G, 26G) | 1. The FREEDOM60® Syringe Driver
2. Precision Flow Rate Tubing™
3. HIgH-Flo™ Subcutaneous Safety Needle
Sets (24G, 26G)
4. HIgH-FLO Super26™ Subcutaneous
Needle Sets | |
Table 1. Indications for Use Comparison
8
Justification of differences in Indications for Use of Subject and Predicate Device
The indications for use statement for the FREEDOM® Integrated Syringe Infusion System is not identical to the predicate device. The submission expands on the currently cleared indications for use to include the addition of two new drugs, Xembify and Cutaquig, and the HIgH-Flo Super26™ Subcutaneous Needle Set to the infusion system. The difference between the subject device and predicate device infusion systems are the inclusion of the of two new drugs, Xembify and Cutaquig and the HIgH-Flo Super 26TM Subcutaneous Needle Set into the indications for use.
9
Compatibility of Xembify and Cutaquig and HIgH-Flo Super26™ with the FREEDOM60® Integrated Syringe Infusion System specifically, has been verified through performance testing. The FREEDOM® Integrated Syringe Infusion System will include a second needle set, the HIgH-Flo Super26™ Subcutaneous Needle Sets, in addition to the HIgH-Flo Subcutaneous Safety Needle Sets™. The HIgH-Flo Super26™ Subcutaneous Needle Set is cleared for use with the FREEDOM60® Syringe Driver and Precision Flow Rate Tubing™ and intended for the intravenous or subcutaneous infusion of medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The change to device indications do not significantly affect safety or effectiveness as the changes do not create new risks or significantly modify existing risk. The change in indications for use does not raise different questions of safety and effectiveness and, therefore, does not preclude a meaningful comparison with the predicate device.
The routes of administration for the system, intravenous, and subcutaneous were cleared in the predicate device.
Discussions of differences in intended population
The intended population for the subject device is identical to the predicate device.
Discussions of differences in environment of use
The environment of use for the subject device is identical to the predicate device.
Device configuration
The table below includes a comparison of the infusion system configuration between the new device and that of the predicate device:
Table 2. Device Configuration Comparison
Discussions of differences in system configuration
The Subject device utilizes the same components from predicate device to form the subject device, FREEDOM® Integrated Syringe Infusion System. The main difference is that the subject device is re-configured and packaged with only one syringe driver (FREEDOM60® Syringe Driver) instead of the two syringe drivers (FREEDOM60®
10
Syringe Driver and FreedomEdge® Syringe driver) cleared for use in the predicate device. Also, in addition, the new configuration will include use of the HIgH-Flow Super26TM Subcutaneous Needle in addition to the HIgH-Flo Subcutaneous Safety Needles Sets™. The HIgH-Flo Super26™, as part of the subject device is similar to the HIgH-Flo Subcutaneous Safety Needle Sets™ but specifically used for flow rates between 24 gauge and 26 gauge needle sets. Both needle sets are intended for the delivery of medication to the subcutaneous tissue. The HIgH-Flo Super26™ is cleared for use with the FREEDOM60® Syringe Driver. The methods for HIgH-Flo Super26TM has been shown to be substantially equivalent in K180843, as a reference device.
The devices are furthermore, similar in technological characteristics with respect to providing intravenous or subcutaneous infusion of medications and fluids. While there are minor technological differences between the subject and predicate device, these differences do not introduce new or different questions of safety and effectiveness, as confirmed through the results of performance testing.
Table 3 and Table 4 presents a tabular comparison of the technological characteristics between the proposed device, predicate device, and reference device with an assessment of differences between them and why the difference between the subject device and predicate device do not introduce new or different questions of safety and effectiveness.
11
| Technological
Characteristics | Integrated Catch-up
FREEDOM Syringe Driver
Infusion System (ICSDIS,
known as Freedom Infusion
System)
(K162613) | FREEDOM Integrated Syringe
Infusion System
(K200176) | Comparison |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Spring Type | Negator | Negator | Same |
| Winding of Spring | FREEDOM60® Syringe Driver:
Manual knob used to tension
negator constant force spring
FreedomEdge® Syringe Driver:
Manual lever used to tension
negator constant force spring | FREEDOM60® Syringe Driver:
Manual knob used to tension
negator constant force spring | Same winding of spring for FREEDOM60®. |
| On / Off Control | Manual switch | Manual switch | Same |
| Housing | Molded ABS | Molded ABS | Same |
| Syringe Type | FREEDOM60®
BD 50 mL syringe (model no.
309653)
FreedomEdge®
BD® 20 mL syringe (US
Reference number: 302830)
BD 30 mL syringe (US
Reference number: 302832) | FREEDOM60®
BD 50 mL syringe (model no.
309653) | Same |
| Technological
Characteristics | Integrated Catch-up
FREEDOM Syringe Driver
Infusion System (ICSDIS,
known as Freedom Infusion
System)
(K162613) | FREEDOM Integrated Syringe
Infusion System
(K200176) | Comparison |
| 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 Sets
26 Gauge Needle Sets | 24 Gauge Needle Sets
26 Gauge Needle Sets | Same |
| Needle Butterfly
Wings Material
(HIgH-FloTM
Subcutaneous
Safety Needle Set) | Polypropylene | Polypropylene | Same |
| Needle Lengths | 4, 6, 9, 12, 14 | 4, 6, 9, 12, 14 | Same |
| Needle Usage | Single Use | Single Use | Same |
| Packaging | Tubing and Needle Sets
packaged sterile utilizing an
LDPE pouch (P/N 317036), for
single patient use. | Tubing and Needle Sets packaged
sterile utilizing a nylon pouch (P/N
317050), for single patient use. | Different.
Sterile barrier pouch material was updated. The
predicate pouch is made of LDPE material
while Subject device uses nylon material. The
difference in packaging material is supported |
| Technological
Characteristics | Integrated Catch-up
FREEDOM Syringe Driver
Infusion System (ICSDIS,
known as Freedom Infusion
System)
(K162613) | FREEDOM Integrated Syringe
Infusion System
(K200176) | Comparison |
| | | | by packaging performance testing with respect
to packaging validation at baseline and shelf-
life. The difference in the material do not raise
different questions of safety and effectiveness. |
| Prescription
required | Yes | Yes | Same |
| Intended
Population | Adult, Pediatric | Adult, Pediatric | Same |
| System Accuracy | +/- 8% | Flow rates will fall between the
minimum and maximum predicted
values as specified in the IFU. | Different
The flow rate accuracy between the subject
device and predicate device has changed. The
flow rate accuracy for K162613 was +/-8%.
The subject device provides minimum to
maximum flow rate range based on theoretical
calculations for each combination of needle
and tubing set. A combination of tubing and
needle set will not be included in the
instructions for use for the viable options for
patients if the minimum or maximum flow rate
is outside of the requirements set forth in the
biologic's labeling. The difference in the
predicated flow rates for each combination of |
| Technological
Characteristics | Integrated Catch-up
FREEDOM Syringe Driver
Infusion System (ICSDIS,
known as Freedom Infusion
System)
(K162613) | FREEDOM Integrated Syringe
Infusion System
(K200176) | Comparison |
| | | | needle and tubing set do not raise different
questions of safety and effectiveness. |
| Sterilization
Method | 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 Set
Configurations
Available | 24 Gauge: Available as a
single-needle set, as well as 2-
needle, 3-needle, 4- needle set;
through use of a Y-connector, 5-
needle, 6-needle, 7-needle and
8-needle sets may 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-needle sets may
also be assembled. | 24 Gauge: Available as a single-
needle set, as well as 2-needle, 3-
needle, 4- needle set; through use
of a Y-connector, 5- needle, 6-
needle, 7-needle and 8-needle sets
may 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-needle
sets may also be assembled. | Same |
| Residual Volumes
for HIgH-Flo
Needle Sets | Needle 24 G 26 G | Needle 24 G 26 G | Same |
| | 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 | |
Table 3. Comparison of Predicate and Subject Device
12
13
14
15
| Technological
Characteristics | Integrated Catch-up
FREEDOM Syringe Driver
Infusion System (ICSDIS,
known as Freedom Infusion
System)
(K162613) | | FREEDOM Integrated Syringe
Infusion System
(K200176) | | Comparison | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------|------------------------------------------------------------|---|----------------------------------|----------------------------------|--|
| | 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 | |
| | 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 ml
with Y-
connector | 0.9 ml
(With Y-
connector) | 8 | 1.0 ml
(with Y-
connector) | 1.0 ml
(with Y-
connector) | |
16
| Technological
Characteristics | HIgH-Flo™ Subcutaneous
Safety Needle Sets (26G)
(predicate) | HIgH-FLO Super26™
Subcutaneous Needle Sets
(reference) | Comparison |
|------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tubing Diameter
(inches) | $0.0190 \pm 0.001"$ | $0.033 \pm 0.002"/0.001"$ | Different.
With the addition of the Super26™, the main
difference is the tubing diameter of the Super26
(0.0190 ± 0.001") which allows for faster flow
rates vs. the predicate device. The Super26 is
designed and cleared for use with the Subject
device under K180843. This difference does not
raise different questions of safety and
effectiveness and have been verified through
performance 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 |
| Technological
Characteristics | HIgH-FloTM Subcutaneous
Safety Needle Sets (26G)
(predicate) | HIgH-FLO Super26TM
Subcutaneous Needle Sets
(reference) | Comparison |
| Sterilization
Method | Gamma | Gamma | Same |
| Packaging | Tubing and Needle Sets
packaged sterile utilizing an
LDPE pouch (P/N 317036),
for single patient use. | Tubing and Needle Sets packaged
sterile utilizing a nylon pouch (P/N
317050), for single patient use. | Different
Sterile barrier material is changed from LDPE
to a nylon material pouch. Change in packaging
material is supporting by non-clinical
performance testing and sterilization validation.
Packaging is able to maintain sterile barrier of
device components. The proposed change is
restricted to the pouch material only. No change
has been made to the infusion pump system as a
result of the change. The difference in
packaging material does not affect safety and
effectiveness. |
| Needle Butterfly
Wings Material | Polypropylene | Polypropylene with blue colorant
(541790C Translucent blue, Marvel
Industries, Inc.) | Different
The only difference is that blue colorant was
added to the needle butterfly wings of the
Super26TM so the user could easily identify the
product. The proposed change is restricted to
the needle butterfly wing only. No change has
been made to the infusion pump system as a
result of the change (addition of blue colorant).
This change is considered minor and does not
affect safety and effectiveness of the device. |
Table 4. Comparison of HIgH-Flo Super26 needle set and 26G HIgH-Flo needle set
17
18
| Technological
Characteristics | HIgH-Flo™ Subcutaneous
Safety Needle Sets (26G)
(predicate) | HIgH-FLO Super26™
Subcutaneous Needle Sets
(reference) | Comparison | | |
|-----------------------------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | Appropriate biocompatibility testing was
performed to support use of blue colorant. See
Section 16 for full biocompatibility testing. | | |
| 26 Gauge Needle
Set Configurations
Available (26
Gauge only) | 1 – Needle Set | 1 - Needle Set | Same | | |
| | 2 - Needle Set | 2 - Needle Set | | | |
| | 3 - Needle Set | 3 - Needle Set | | | |
| | 4 – Needle Set | 4 - Needle Set | | | |
| | 5 - Needle Set | 5 - Needle Set | | | |
| | 6 - Needle Set | 6 - Needle Set | | | |
| | w/Y-connector | w/Y-connector | | | |
| | 7 - Needle Set | 7 - Needle Set | | | |
| | 8 - Needle Set | 8 - Needle Set | | | |
| Residual Volume
for the multiple
needle
configurations | Needle | 26 G | Needle | Super26 | Different. |
| | 1 | 0.1 ml | 1 | 0.4 ml | When using a 60 ml dose, the increased residual
volume between the HIgH-Flo Super26 and the |
| | 2 | 0.2 ml | 2 | 0.7 ml | predicate device (HIgH-Flo Subcutaneous
Safety Needle Set) ranges from 0.5% for a 1 leg |
| | 3 | 0.3 ml | 3 | 1.1 ml | needle set to 3.3% for an 8-leg needle set (4 |
| Technological
Characteristics | HIgH-Flo™ Subcutaneous
Safety Needle Sets (26G)
(predicate) | | HIgH-FLO Super26™
Subcutaneous Needle Sets
(reference) | | Comparison |
| | 4 | 0.4 ml | 4 | 1.4 ml | legs x 2). Residual volumes are stated in the
IFU. This change does not raise new questions
of safety and effectiveness. Residual volumes
are stated in the IFU. |
| | 5 | 0.5 ml | 5 | 1.8 ml | |
| | 6 | 0.6 ml | 6 | 2.1 ml | |
| | 7 | 0.9 ml
(With Y-
connector) | 7 | 2.7 ml
(With Y-connector) | |
| | 8 | 0.9 ml
(With Y-
connector) | 8 | 3.0 ml
(With Y-connector) | |
19
20
Discussions of differences in needle sets
The reference 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 who use higher viscosity medications during infusion per the drug manufacturer's recommended limits. The diameter of the tubing used in the subject device (HIgH-FloSuper26TM 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 FREEDOM60® Integrated Syringe Infusion System. The infusion system does not contain software, electrical components, or alarms.
| Device Performance | The essential performance requirements of the device were verified through
performance testing in accordance with the intended use of the device and in
accordance with the FDA Guidance "Infusion Pumps Total Product Life Cycle" |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | The materials used in the Administration Set (tubing and needles) for the
FREEDOM60® Integrated Syringe Infusion System comply with the
International Standard ISO 10993-1 "Biological Evaluation of Medical Devices –
Part 1: Evaluation and Testing Within a Risk Management Process," as
recognized by FDA and FDA Blue Book Memorandum #G95-1 "Use of
International Standard ISO-10993, 'Biological Evaluation of Medical Devices
Part 1: Evaluation and Testing", within a Risk Management Process and are
considered to be biocompatible.
Testing was conducted for the following tests:
• Cytotoxicity
|
| | Sensitization Irritation |
| Human Factors | Human factors studies were completed per the FDA Guidance "Applying
Human Factors and Usability Engineering to Medical Devices" (February 3,
2016). The human factors studies were conducted with the intended user
population, use environment and use scenarios to simulate clinical conditions.
Results of the human factors testing demonstrate validation of the device per the
intended use. |
| Reprocessing,
Cleaning | AAMI TIR12:2010 – Designing, testing, and labeling reusable medical devices
for reprocessing in health care facilities: A guide for medical device
manufacturers.
AAMI TIR30:2011(R)2016 – A compendium of processes, materials, test
methods, and acceptance criteria for cleaning reusable medical devices.
Reprocessing Medical Devices in Health Care Settings: Validation Methods and
Labeling, 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 be
provided by the medical device manufacturer for the processing of medical
ANSI/AAMI/ISO 11737-1:2018 – Sterilization of health care products –
Microbiological methods - Part 1: Determination of the population of
microorganisms on product.
NAMSA Technical Memorandum US033689 Rev. 1, Review and Comparison
of 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 Other
Items for Safety in the Magnetic Resonance Environment." |
21
Safety Assurance
A safety assurance case is provided for the FREEDOM60® Integrated 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:
22
-
The FREEDOM60® Integrated 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 FREEDOM60® Integrated 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 Sets™ (Standard 26G and 24G) when used in combination with Precision Flow Rate Tubing™ for use with Cutaquig®, Xembify®, Gammagard® Liquid, Hizentra® PI, and Hizentra® CIPD.
Note: The following tables are only for the subcutaneous use of the immunoglobulin listed.
23
Cutaquig® 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 FREEDOM60® Integrated Syringe Infusion System with a 50 ml syringe for the subcutaneous use of Cutaquig.
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 | 6.6 - 13.5 | 9 - 16.2 | 12.3 - 22.3 | ||||||
| 2 needles | 3.5 - 7.5 | 5 - 9.1 | 7.1-13.2 | 9.5-19.1 | 11.8-20.6 | 13.1 - 23.7 | |||
| 3 needles | 2.4 - 5.2 | 3.5-6.3 | 5 - 9.4 | 6.8 - 14 | 8.6 - 15.2 | 9.7-17.8 | 13.8 - 24.9 | ||
| 4 needles | 1.8 - 3.9 | 2.7-4.9 | 3.9-7.3 | 5.3 - 11 | 6.8 - 12 | 7.7-14.2 | 11.3 - 20.5 | 12.4 - 24.4 | |
| 5 needles | 1.5 - 3.2 | 2.2-3.9 | 3.2-6 | 4.3 - 9.1 | 5.6 - 10 | 6.4 - 11.8 | 9.5 - 17.4 | 10.5 - 20.9 | |
| 6 needles | 1.2-2.7 | 1.8-3.3 | 2.7-5 | 3.7-7.7 | 4.8 - 8.5 | 5.4 - 10.1 | 8.2-15.1 | 9.1 - 18.3 |
HIgH-Flo 26G with Precision Tubing - Min-Max Flow Rate Per Site (ml/hr/site)
Image /page/23/Picture/5 description: The image shows a simple graphic divided into two rectangular sections. The top section is filled with a solid gray color, while the bottom section is filled with a light blue color. A thick black line separates the two colored sections. The overall composition is clean and minimalist.
Exceeds drug manufacturer's maximum indicated flow rate. Subsequent infusions after 6th infusion only.
| F120 | F180 | F275 | F420 | F500 | F600 | F900 | F1200 | F2400 | |
|---|---|---|---|---|---|---|---|---|---|
| 1 needle | 7.1 -15 | 10.1 -18.3 | |||||||
| 2 needles | 3.7-7.9 | 5.3 -9.7 | 7.8 -14.6 | 10.6 -22.1 | 13.7-24.2 | ||||
| 3 needles | 2.5 -5.4 | 3.6 - 6.6 | 5.3 -10.1 | 7.4 -15.5 | 9.6 -17.1 | 10.9-20.3 | |||
| 4 needles | 1.9- 4.1 | 2.8 -5 | 4.1 -7.7 | 5.7-12 | 7.4 -13.2 | 8.4 -15.8 | 13 -24 | ||
| 5 needles | 1.5 -3.3 | 2.2- 4.1 | 3.3- 6.2 | 4.6 -9.7 | 6 -10.7 | 6.9-12.9 | 10.7-19.8 | 12-24.6 | |
| 6 needles | 1.3 -2.7 | 1.9-3.4 | 2.7-5.2 | 3.8-8.2 | 5.1 -9.1 | 5.8 -10.9 | 9.1 -16.9 | 10.2-21.1 |
HIgH-Flo Super26 with Precision Tubing - Min-Max Flow Rate Per Site (ml/hr/site)
Image /page/23/Picture/9 description: The image shows a rectangular shape divided into two sections. The top section is filled with a gray color, while the bottom section is filled with a light blue color. The rectangle is outlined with a thick black border, providing a clear separation between the shape and its background. The image is simple and uses only a few colors.
Exceeds drug manufacturer's maximum indicated flow rate. Subsequent infusions after 6th infusion only.
24
| F120 | F180 | F275 | F420 | F500 | F600 | F900 | F1200 | F2400 | |
|---|---|---|---|---|---|---|---|---|---|
| 1 needle | 7.4 - 15.9 | 10.8 - 19.7 | |||||||
| 2 needles | 3.8 - 8.1 | 5.5 - 10.1 | 8.2 - 15.5 | 11.4 - 24.2 | |||||
| 3 needles | 2.5 - 5.5 | 3.7 - 6.8 | 5.5 - 10.5 | 7.7 - 16.5 | 10.2 - 18.3 | 11.7 - 22.1 | |||
| 4 needles | 1.9 - 4.1 | 2.8 - 5.1 | 4.2 - 7.9 | 5.9 - 12.6 | 7.8 - 13.9 | 8.9 - 16.8 | |||
| 5 needles | 1.5 - 3.3 | 2.2 - 4.1 | 3.3 - 6.4 | 4.7 - 10.1 | 6.3 - 11.2 | 7.2 - 13.6 | 11.4 - 21.5 | ||
| 6 needles | 1.3 - 2.8 | 1.9 - 3.4 | 2.8 - 5.3 | 3.9 - 8.5 | 5.2 - 9.4 | 6 - 11.4 | 9.6 - 18.1 | 10.9 - 22.9 |
Image /page/24/Picture/2 description: The image shows a rectangle divided into two sections. The top section is filled with a gray color, while the bottom section is filled with a light blue color. The rectangle is outlined with a thick black border, providing a clear separation between the two colored sections. The image is simple and abstract, focusing on the contrast between the gray and light blue colors.
Exceeds drug manufacturer's maximum indicated flow rate.
Subsequent infusions after 6th infusion only.
25
Xembify® 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 FREEDOM60® Integrated Syringe Infusion System with a 50 ml syringe for the subcutaneous use of Xembify.
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 | 3.7-9.4 | 5-11.2 | 6.9-15.5 | 8.7-20.9 | 10.4-22.2 | 11.3-24.7 | |||
| 2 needles | 2-5.2 | 2.8-6.3 | 4-9.2 | 5.3-13.3 | 6.6-14.3 | 7.3-16.4 | 10-22.1 | ||
| 3 needles | 1.4-3.6 | 1.9-4.4 | 2.8-6.5 | 3.8-9.7 | 4.8-10.5 | 5.4-12.3 | 7.7-17.3 | 8.4-20.2 | |
| 4 needles | 1-2.7 | 1.5-3.4 | 2.2-5.1 | 3-7.6 | 3.8-8.4 | 4.3-9.8 | 6.3-14.2 | 6.9-16.9 | |
| 5 needles | 0.8-2.2 | 1.2-2.7 | 1.8-4.1 | 2.4-6.3 | 3.1-6.9 | 3.5-8.2 | 5.3-12.1 | 5.9-14.5 | 9.4-23.3 |
| 6 needles | 0.7-1.9 | 1-2.3 | 1.5-3.5 | 2.1-5.4 | 2.7-5.9 | 3-7 | 4.6-10.5 | 5.1-12.7 | 8.4-21.1 |
HIgH-Flo 26G with Precision Tubing – Min-Max Flow Rate Per Site (ml/hr/site)
Image /page/25/Picture/5 description: The image is a solid gray color. The top of the image has a black bar. The gray color fills the rest of the image.
Exceeds drug manufacturer's maximum indicated flow rate.
HIgH-Flo 24G with Precision Tubing - Min-Max Flow Rate Per Site (ml/hr/site)
| F120 | F180 | F275 | F420 | F500 | F600 | F900 | F1200 | F2400 | |
|---|---|---|---|---|---|---|---|---|---|
| 1 needle | 4.2-11 | 6 -13.6 | 8.8 -20.5 | ||||||
| 2 needles | 2.1 -5.6 | 3.1 -7 | 4.6 -10.7 | 6.4 -16.8 | 8.4 -18.5 | 9.5 -22.2 | |||
| 3 needles | 1.4 -3.8 | 2.1 - 4.7 | 3.1 -7.3 | 4.3 -11.5 | 5.7-12.7 | 6.5 -15.3 | 10.3 -23.8 | ||
| 4 needles | 1.1 -2.9 | 1.6 -3.6 | 2.3 -5.5 | 3.3 - 8.7 | 4.3 -9.6 | 5 -11.7 | 7.9-18.3 | 8.9-23.1 | |
| 5 needles | 0.9-2.3 | 1.3 -2.9 | 1.9- 4.4 | 2.6 -7 | 3.5 -7.8 | 4 -9.4 | 6.4 -14.9 | 7.2-18.8 | |
| 6 needles | 0.7-1.9 | 1 -2.4 | 1.6 -3.7 | 2.2-5.9 | 2.9- 6.5 | 3.4 -7.9 | 5.4 -12.6 | 6.1 -15.9 |
Image /page/25/Picture/9 description: The image is a gray square with a black border. The gray color fills the majority of the square, while the black border outlines the perimeter. The border appears to be of uniform thickness on all sides of the square.
Exceeds drug manufacturer's maximum indicated flow rate.
26
Cuvitru® PI Flow Rate Combinations
The following tables indicate the nominal predicted flow rates per site with HIgH-Flo Subcutaneous Safety Needle Sets™ (Standard 26G, 24G and Super26™) when used in combination with KORU Precision Flow Rate Tubing™ and FREEDOM60® Integrated Syringe Infusion System with a 50 ml syringe for the subcutaneous use of Cuvitru (±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 | 10.4 | 14.0 | 18.5 | 21.0 | 22.7 | 27.3 | 28.6 | 35.3 | |
| 2 needles | 12.0 | 14.1 | 15.7 | 20.4 | 21.9 | 31.0 | |||
| 3 needles | 10.6 | 12.0 | 16.3 | 17.7 | 27.6 | ||||
| 4 needles | 13.6 | 14.9 | 24.8 |
HIgH-Flo 26G with Precision Tubing - Nominal Flow Rate Per Site (ml/hr/site)
Image /page/26/Picture/5 description: The image shows a table with two rows and one column. The top row is gray, and the bottom row is light blue. The table is simple and does not contain any text or other elements.
Outside of drug manufacturer's indicated flow rate (min/max) 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 | 12.0 | 17.0 | 24.1 | 28.5 | 31.6 | 41.2 | 44.3 | ||
| 2 needles | 14.0 | 17.1 | 19.4 | 27.3 | 30.1 | 50.4 | |||
| 3 needles | 12.3 | 14.0 | 20.4 | 22.8 | 42.0 | ||||
| 4 needles | 11.0 | 16.3 | 18.3 | 36.0 |
Image /page/26/Picture/9 description: The image is divided into two rectangular sections. The top section is filled with a solid gray color. The bottom section is filled with a light blue color.
Outside of drug manufacturer's indicated flow rate (min/max)
Subsequent infusions after 6th infusion only.
HIgH-Flo 24G with Precision Tubing - Nominal Flow Rate Per Site (ml/hr/site)
| F120 | F180 | F275 | F420 | F500 | F600 | F900 | F1200 | F2400 | |
|---|---|---|---|---|---|---|---|---|---|
| 1 needle | 10.0 | 13.1 | 19.3 | 28.9 | 35.5 | 40.5 | 57.8 | ||
| 2 needles | 10.1 | 15.6 | 19.5 | 22.5 | 33.7 | 38.1 | |||
| 3 needles | 10.7 | 13.4 | 15.6 | 23.8 | 27.1 | 59.3 | |||
| 4 needles | 10.2 | 11.9 | 18.4 | 21.0 | 48.0 |
Image /page/26/Picture/14 description: The image shows a rectangle divided into two equal parts. The top part of the rectangle is gray, while the bottom part is a light blue color. The rectangle is outlined in black.
Outside of drug manufacturer's indicated flow rate (min/max)
Subsequent infusions after 6th infusion only.
27
Gammagard Liquid® Selected Flow Rate Combinations
The following tables indicate the nominal predicted flow rates per site with HIgH-Flo Subcutaneous Safety Needle Sets™ (Standard 26G and 24G) when used in combi- nation with KORU Precision Flow Rate Tubing™ and FREEDOM60® Integrated Syringe Infusion System with a 50 ml syringe for the subcutaneous use of Gammagard Liquid (+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.
40 kg and greater BW
| F120 | F180 | F275 | F420 | F500 | F600 | F900 | F1200 | F2400 | |
|---|---|---|---|---|---|---|---|---|---|
| 1 needle | |||||||||
| 2 needles | 22.4 | 28.6 | |||||||
| 3 needles | 15.5 | 20.1 | 29.1 | ||||||
| 4 needles | 11.9 | 15.4 | 22.6 | ||||||
| 5 needle | 9.6 | 12.5 | 18.5 | 27.8 | |||||
| 6 needles | 8.1 | 10.6 | 15.7 | 23.7 | 29.3 | ||||
| 7 needles | 7.0 | 9.1 | 13.6 | 20.7 | 25.7 | 29.5 | |||
| 8 needles | 6.1 | 8.0 | 12.0 | 18.4 | 22.8 | 26.3 |
HIgH-Flo 26G with Precision Tubing - Nominal Flow Rate Per Site (ml/hr/site)
Image /page/27/Picture/6 description: The image is 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. A thick black line separates the two rectangles.
Exceeds drug manufacturer's maximum indicated flow rate Subsequent infusions after 6th infusion only.
Under 40 kg BW
HIgH-Flo 26G with Precision Tubing – Nominal Flow Rate Per Site (ml/hr/site)
| F120 | F180 | F275 | F420 | F500 | F600 | F900 | F1200 | F2400 | |
|---|---|---|---|---|---|---|---|---|---|
| 1 needle | |||||||||
| 2 needles | |||||||||
| 3 needles | 15.5 | 20.1 | |||||||
| 4 needles | 11.9 | 15.4 | |||||||
| 5 needle | 9.6 | 12.5 | 18.5 | ||||||
| 6 needles | 8.1 | 10.6 | 15.7 | ||||||
| 7 needles | 7.0 | 9.1 | 13.6 | ||||||
| 8 needles | 6.1 | 8.0 | 12.0 | 18.4 |
Image /page/27/Picture/11 description: The image shows a rectangle divided into two 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.
28
Hizentra® PI Flow Rate Combinations
The following tables indicate the nominal predicted flow rates per site with HIgH-Flo Subcutaneous Safety Needle Sets™ (Standard 26G, 24G and Super26™) when used in combination with KORU Precision Flow Rate Tubing™ and FREEDOM60® Integrated Syringe Infusion System with a 50 ml syringe for the subcutaneous use of Hizentra PI (±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 | 8.2 | 10.2 | 13.7 | 18.1 | 20.6 | 22.2 | |||
| 2 needles | 4.6 | 5.8 | 8.3 | 11.7 | 13.8 | 15.3 | 20.0 | 21.4 | |
| 3 needles | 3.2 | 4.1 | 5.9 | 8.6 | 10.4 | 11.7 | 16.0 | 17.4 | |
| 4 needles | 2.4 | 3.1 | 4.6 | 6.9 | 8.4 | 9.5 | 13.3 | 14.6 | 24.3 |
| 5 needle | 2.0 | 2.6 | 3.8 | 5.7 | 7.0 | 8.0 | 11.4 | 12.6 | 22.2 |
| 6 needles | 1.6 | 2.2 | 3.2 | 4.8 | 6.0 | 6.9 | 9.9 | 11.1 | 20.3 |
| 7 needles | 1.4 | 1.9 | 2.8 | 4.2 | 5.2 | 6.0 | 8.8 | 9.9 | 18.8 |
| 8 needles | 1.2 | 1.6 | 2.4 | 3.7 | 4.7 | 5.4 | 8.0 | 8.9 | 17.4 |
HIgH-Flo 26G with Precision Tubing – Nominal Flow Rate Per Site (ml/hr/site)
Image /page/28/Picture/5 description: The image shows a simple graphic divided into two rectangular sections. The top section is filled with a solid gray color, while the bottom section is filled with a light blue color. A thick black line separates the two colored sections, creating a clear visual distinction between them. The composition is clean and minimalist, focusing on the contrast between the two colors and the dividing line.
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 | 9.2 | 11.7 | 16.6 | 23.6 | |||||
| 2 needles | 4.8 | 6.3 | 9.3 | 13.8 | 16.8 | 19.0 | |||
| 3 needles | 3.3 | 4.3 | 6.4 | 9.7 | 12.0 | 13.8 | 20.0 | 22.3 | |
| 4 needles | 2.5 | 3.3 | 4.9 | 7.5 | 9.3 | 10.8 | 16.0 | 17.9 | |
| 5 needle | 2.0 | 2.6 | 4.0 | 6.1 | 7.7 | 8.8 | 13.3 | 15.0 | |
| 6 needles | 1.7 | 2.2 | 3.3 | 5.2 | 6.5 | 7.5 | 11.4 | 12.9 | |
| 7 needles | 1.4 | 1.9 | 2.9 | 4.5 | 5.6 | 6.5 | 10.0 | 11.3 | 24.7 |
| 8 needles | 1.3 | 1.7 | 2.5 | 3.9 | 5.0 | 5.8 | 8.8 | 10.1 | 22.4 |
Image /page/28/Picture/9 description: The image shows a simple graphic with two stacked rectangles. The top rectangle is filled with a gray color, while the bottom rectangle is filled with a light blue color. Both rectangles are outlined with a thick black border, creating a clear separation between the two shapes.
Exceeds drug manufacturer's maximum indicated flow rate Subsequent infusions after 6th infusion only.
29
| F120 | F180 | F275 | F420 | F500 | F600 | F900 | F1200 | F2400 | |
|---|---|---|---|---|---|---|---|---|---|
| 1 needle | 9.8 | 12.8 | 18.9 | ||||||
| 2 needles | 5.0 | 6.6 | 9.9 | 15.2 | 19.1 | 22.0 | |||
| 3 needles | 3.4 | 4.5 | 6.7 | 10.4 | 13.1 | 15.2 | 23.3 | ||
| 4 needles | 2.5 | 3.4 | 5.1 | 7.9 | 10.0 | 11.7 | 18.0 | 20.6 | |
| 5 needles | 2.0 | 2.7 | 4.1 | 6.4 | 8.1 | 9.4 | 14.7 | 16.8 | |
| 6 needles | 1.7 | 2.3 | 3.4 | 5.4 | 6.8 | 7.9 | 12.4 | 14.2 | |
| 7 needles | 1.5 | 1.9 | 2.9 | 4.6 | 5.8 | 6.8 | 10.7 | 12.3 | |
| 8 needles | 1.3 | 1.7 | 2.6 | 4.0 | 5.1 | 6.0 | 9.4 | 10.8 |
HIgH-Flo 24G with Precision Tubing – Nominal Flow Rate Per Site (ml/hr/site)
Image /page/29/Picture/2 description: The image shows a rectangular shape divided into two sections. The top section is filled with a gray color, while the bottom section is filled with a light blue color. The entire shape is outlined with a thick black border, creating a clear separation between the colored sections and the surrounding background.
Exceeds drug manufacturer's maximum indicated flow rate
Subsequent infusions after 6th infusion only.
30
Hizentra® CIDP Selected Flow Rate Combinations
The following tables indicate the nominal predicted flow rates per site with HIgH-Flo Subcutaneous Safety Needle Sets™ (Standard 26G, 24G and Super26™) when used in combination with KORU Precision Flow Rate Tubing™ and FREEDOM60® Integrated Syringe Infusion System with a 50 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 | 8.2 | 10.2 | 13.7 | 18.1 | 20.6 | 20.6 | 26.7 | 28.0 | 34.6 |
| 2 needles | 4.6 | 5.8 | 8.3 | 11.7 | 13.8 | 15.3 | 20.0 | 20.0 | 30.3 |
| 3 needles | 3.2 | 4.1 | 5.9 | 8.6 | 10.4 | 11.7 | 16.0 | 17.4 | 27.0 |
| 4 needles | 2.4 | 3.1 | 4.6 | 6.9 | 8.4 | 9.5 | 13.3 | 14.6 | 24.3 |
| 5 needle | 2.0 | 2.6 | 3.8 | 5.7 | 7.0 | 8.0 | 11.4 | 12.6 | 22.2 |
| 6 needles | 1.6 | 2.2 | 3.2 | 4.8 | 6.0 | 6.9 | 9.9 | 11.1 | 20.3 |
| 7 needles | 1.4 | 1.9 | 2.8 | 4.2 | 5.2 | 6.0 | 8.8 | 9.9 | 18.8 |
| 8 needles | 1.2 | 1.6 | 2.4 | 3.7 | 4.7 | 5.4 | 8.0 | 8.9 | 17.4 |
HIgH-Flo 26G with Precision Tubing - Nominal Flow Rate Per Site (ml/hr/site)
Image /page/30/Picture/5 description: The image shows a simple graphic divided into two rectangular sections. The top section is filled with a solid gray color, while the bottom section is filled with a light blue color. A thick black line separates the two colored sections. The image is cropped to show only a portion of the rectangles.
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 | 9.2 | 11.7 | 16.6 | 23.6 | 27.9 | 30.9 | 40.4 | 43.4 | 2400 |
| 2 needles | 4.8 | 6.3 | 9.3 | 13.8 | 16.8 | 19.0 | 26.8 | 29.5 | 49.3 |
| 3 needles | 3.3 | 4.3 | 6.4 | 9.7 | 12.0 | 13.8 | 20.0 | 22.3 | 41.1 |
| 4 needles | 2.5 | 3.3 | 4.9 | 7.5 | 9.3 | 10.8 | 16.0 | 17.9 | 35.2 |
| 5 needle | 2.0 | 2.6 | 4.0 | 6.1 | 7.7 | 8.8 | 13.3 | 15.0 | 30.8 |
| 6 needles | 1.7 | 2.2 | 3.3 | 5.2 | 6.5 | 7.5 | 11.4 | 12.9 | 27.4 |
| 7 needles | 1.4 | 1.9 | 2.9 | 4.5 | 5.6 | 6.5 | 10.0 | 11.3 | 24.7 |
| 8 needles | 1.3 | 1.7 | 2.5 | 3.9 | 5.0 | 5.8 | 8.8 | 10.1 | 22.4 |
Image /page/30/Picture/9 description: The image shows a rectangle divided into two equal parts. The top part is gray, and 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.
31
| F120 | F180 | F275 | F420 | F500 | F600 | F900 | F1200 | F2400 | |
|---|---|---|---|---|---|---|---|---|---|
| 1 needle | 9.8 | 12.8 | 18.9 | 28.3 | 34.8 | 39.7 | |||
| 2 needles | 5.0 | 6.6 | 9.9 | 15.2 | 19.1 | 22.0 | 33.0 | 37.3 | |
| 3 needles | 3.4 | 4.5 | 6.7 | 10.4 | 13.1 | 15.2 | 23.3 | 26.5 | |
| 4 needles | 2.5 | 3.4 | 5.1 | 7.9 | 10.0 | 11.7 | 18.0 | 20.6 | 47.0 |
| 5 needle | 2.0 | 2.7 | 4.1 | 6.4 | 8.1 | 9.4 | 14.7 | 16.8 | 39.5 |
| 6 needles | 1.7 | 2.3 | 3.4 | 5.4 | 6.8 | 7.9 | 12.4 | 14.2 | 34.0 |
| 7 needles | 1.5 | 1.9 | 2.9 | 4.6 | 5.8 | 6.8 | 10.7 | 12.3 | 29.9 |
| 8 needles | 1.3 | 1.7 | 2.6 | 4.0 | 5.1 | 6.0 | 9.4 | 10.8 | 26.7 |
HIgH-Flo 24G with Precision Tubing – Nominal Flow Rate Per Site (ml/hr/site)
Image /page/31/Picture/2 description: The image shows a simple graphic of 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 thick black border.
Exceeds drug manufacturer's maximum indicated flow rate Subsequent infusions after 6th infusion only.
32
Clinical Evaluation
Clinical evaluation was not required to support submission and determination of substantial equivalence.
VIII. CONCLUSIONS
The FREEDOM60® Integrated 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 FREEDOM60® 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, predicate device and reference device do not raise different questions of safety or effectiveness. Based on performance testing results, the FREEDOM60® Integrated Syringe Infusion System, performs as intended and performs comparably to the predicate device that is currently marketed for the same intended use.