(201 days)
KORU HIgH-Flo Super26™ Subcutaneous Safety Needle Set, K180843
No
The device description and performance studies focus on mechanical and fluid dynamics principles, with no mention of AI or ML algorithms for control, analysis, or decision-making.
Yes
The device is an infusion system used to administer medications and fluids, which directly fulfills a therapeutic purpose.
No
Explanation: The "Intended Use/Indications for Use" section clearly states that the FreedomEdge® Syringe Infusion System is "indicated for the intravenous or subcutaneous infusion of medications and fluids." It functions as an infusion pump, delivering substances to the body, rather than identifying or analyzing a medical condition, which is the purpose of a diagnostic device.
No
The device description clearly lists multiple hardware components including a syringe driver, tubing, and needle sets.
Based on the provided text, the FreedomEdge® Syringe Infusion System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "intravenous or subcutaneous infusion of medications and fluids." This describes a device used to deliver substances into the body, not to perform tests on samples taken from the body.
- Device Description: The description details a "single-channel, volumetric infusion pump" and its components (driver, tubing, needle sets). These are all components of a system designed for drug delivery, not for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances within those samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
In summary, the FreedomEdge® Syringe Infusion System is a medical device for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FreedomEdge® Syringe Infusion System is indicated for the intravenous or subcutaneous infusion of medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The FreedomEdge® Syringe Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) and Hizentra®. Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration.
The FreedomEdge® Syringe Infusion System with the FreedomEdge® Syringe Driver and Precision Flow Rate Tubing™, is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling: ertapenem, oxacillin, and tobramycin.
The FreedomEdge® Syringe Infusion System consists of the following components:
- FreedomEdge® Syringe Driver ●
- Precision Flow Rate Tubing™ ●
- HIgH-Flo Subcutaneous Safety Needle SetsTM ●
- HIgH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the subcutaneous infusion ● of the following human plasma-derived immunoglobulins: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration.
The FreedomEdge® Syringe Infusion System is indicated for use with the BD® 20 mL syringe (US Reference number: 302830), BD 30 mL syringe (US Reference number: 302832), and Hizentra® 20 mL single-use prefilled syringe (NDC 442096-458-96).
Product codes (comma separated list FDA assigned to the subject device)
FRN, FPA, PKP
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
-
- HIgH-Flo Subcutaneous Safety Needle Set™, or
-
- HIgH-Flo Super26TM Subcutaneous Safety Needle Set
FreedomEdge® Syringe Driver: 1.
The FreedomEdge® Syringe Driver (non-sterile) in combination with Precision Flow Rate Tubing™ (sterile) and HIgH-Flo Safety Needle Sets (sterile) makes up the FreedomEdge® Syringe Infusion System. The FreedomEdge® Syringe Driver is a nonsterile, reusable non-electric driver that infuses certain immunoglobulins subcutaneously and antibiotic solutions intravenously to patients.
The FreedomEdge® driver is an ambulatory device designed to accommodate a BD Luer-Lok™ 20mL syringe, Catalog No.: 302830 and 301031, BD Luer-Lok™ 30mL syringe. Catalog No.: 301033 and Hizentra® 20 ml prefilled syringe. The pump uses a constant force spring mechanism to apply pressure to the plunger-end syringe.
The FreedomEdge® Syringe Infusion System is assembled by loading the syringe with tubing into the Freemdom60® driver.
Precision Flow Rate Tubing™: 2.
The Freedom Integrated Syringe System includes a range of Freedom Precision Flow Rate Tubing™ (provided sterile). The tubing ranges from F0.5 to F2400. Each F-number provides a different level of flow restriction, which, when combined with the viscosity of the medication, provides a controlled delivery in an all-mechanical system. The tubing sets connect at one end to the syringe being used and on the other end to the Subcutaneous Safety Needle Sets or directly on venous catheters for intravenous infusions as needed.
3. HIgH-Flo Needles Sets:
The HIgH-Flo Subcutaneous Safety Needle SetsTM
The HIgH-Flo Subcutaneous Safety Needle Sets™ (provided sterile) are used to administer drugs to the subcutaneous layers using small needles attached to the skin. Subcutaneous needles come in different lengths to administer immunoglobulins and antibiotics per the indications for use.
Subcutaneous Safety Needle Sets comes in multiple configurations (1, 2, 3, 4, 5, 6 needle sites). Needles are available in 4mm. 6mm. 9mm. 12mm. and 14mm lengths combined with 24 or 26 Gauge. Using the Y -Connector, the patient can have up to 8 sites for drug delivery.
The HIgH- Flo Subcutaneous Safety Needle Sets™ also allow each needle to be enclosed between the wings after use.
The HIgH-Flo Super26TM Subcutaneous Needle Sets
The HIgH-Flo Super26™ Subcutaneous Needle Sets are sterile, non-pyrogenic, single use. Subcutaneous Administration Sets, comprised of a Super 26-gauge needle assembly, combined with 24-gauge needle tubing and are intended for the delivery of medication to the subcutaneous tissue in accordance with the indication for use statement. Each set consists of a sterile infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set is a 90- degree, 26-gauge stainless steel needle, mounted to a butterfly winged safety closure on one end which is used to close the set upon completion. The other end consists of a luer lock which connects to PVC medical grade tubing. Additionally, each tubing set is equipped with a slide clamp used to stop flow, immediately as needed. HIgH-Flo Super 26™ Subcutaneous Needle Sets are available as a single set, as well as 2-needle, 3-needle, 5-needle, 6-needle, sets; through use of a Y-connector, 7-needle and 8 needle sets may also be assembled.
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. Prescription Use Only.
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 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 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 FreedomEdge 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 devices. 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." |
Key results:
The nonclinical data support the safety of the device and performance testing demonstrate that the FreedomEdge® Syringe Infusion System meets the established specifications necessary for consistent performance to achieve its intended use as safely and as effectively as the predicate device and confirmed that the technological differences between the proposed device and predicate device do not raise different questions of safety or effectiveness. Based on performance testing results, the FreedomEdge® Syringe Infusion System, performs as intended and performs comparably to the predicate device that is currently marketed for the same intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Integrated Catch-Up FREEDOM Syringe Driver Infusion System, K162613
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
KORU HIgH-Flo Super26™ Subcutaneous Safety Needle Set, K180843
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Repro-Medical System, Inc., dba Koru Medical Systems Kachi Eniyinna Consultant 24 Carpenter Road Chester, New York 10918
Re: K211206
Trade/Device Name: FreedomEdge(R) Syringe Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, FPA, PKP Dated: October 4, 2021 Received: October 4, 2021
Dear Kachi Eniyinna:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices
1
or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Carolyn Dorgan Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name FreedomEdge® Syringe Infusion System
Indications for Use (Describe)
The FreedomEdge® Syringe Infusion System is indicated for the intravenous or subcutaneous infusion of medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The FreedomEdge® Syringe Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) and Hizentra®. Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration.
The FreedomEdge® Syringe Infusion System with the FreedomEdge® Syringe Driver and Precision Flow Rate Tubing™, is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling: ertapenem, oxacillin, and tobramycin.
The FreedomEdge® Syringe Infusion System consists of the following components:
- FreedomEdge® Syringe Driver ●
- Precision Flow Rate Tubing™ ●
- HIgH-Flo Subcutaneous Safety Needle SetsTM ●
- HIgH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the subcutaneous infusion ● of the following human plasma-derived immunoglobulins: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration.
The FreedomEdge® Syringe Infusion System is indicated for use with the BD® 20 mL syringe (US Reference number: 302830), BD 30 mL syringe (US Reference number: 302832), and Hizentra® 20 mL single-use prefilled syringe (NDC 442096-458-96).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
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510(K) SUMMARY K211206
I. SUBMITTER
Repro-Med Systems, Inc. dba Koru Medical Systems 24 Carpenter Road Chester, NY 10918 USA
Ph: (800)624-9600 Fax: (845)469-5518
Contact Person Charles Ryan Director, Regulatory Affairs Phone: (845) 610-5564 Email: cryan@korumedical.com
Application Correspondent Kachi Enyinna Regulatory Consultant to Koru Medical Systems Phone: (617) 870-4055 Email: kachi@510ktech.com
Date Prepared: October 2, 2021
II. DEVICE
Name of Device: FreedomEdge® Syringe Infusion System Common or Usual Name: Infusion Pump Classification Name: Pump, Infusion (21CFR 880.5725) Regulatory Class: II Product Code: FRN, FPA, PKP
III. PREDICATE DEVICE
Predicate Device: Integrated Catch-Up FREEDOM Syringe Driver Infusion System, K162613
Reference Device: KORU HIgH-Flo Super26™ Subcutaneous Safety Needle Set, K180843.
IV. DEVICE DESCRIPTION
5
The FreedomEdge® Syringe Infusion System is a single-channel, volumetric infusion pump. The FreedomEdge® Syringe Infusion System consists of four primary components:
-
- FreedomEdge® Syringe Driver,
-
- Precision Flow Rate Tubing™ and
-
- HIgH-Flo Subcutaneous Safety Needle Set™, or
-
- HIgH-Flo Super26TM Subcutaneous Safety Needle Set
FreedomEdge® Syringe Driver: 1.
The FreedomEdge® Syringe Driver (non-sterile) in combination with Precision Flow Rate Tubing™ (sterile) and HIgH-Flo Safety Needle Sets (sterile) makes up the FreedomEdge® Syringe Infusion System. The FreedomEdge® Syringe Driver is a nonsterile, reusable non-electric driver that infuses certain immunoglobulins subcutaneously and antibiotic solutions intravenously to patients.
The FreedomEdge® driver is an ambulatory device designed to accommodate a BD Luer-Lok™ 20mL syringe, Catalog No.: 302830 and 301031, BD Luer-Lok™ 30mL syringe. Catalog No.: 301033 and Hizentra® 20 ml prefilled syringe. The pump uses a constant force spring mechanism to apply pressure to the plunger-end syringe.
The FreedomEdge® Syringe Infusion System is assembled by loading the syringe with tubing into the Freemdom60® driver.
Precision Flow Rate Tubing™: 2.
The Freedom Integrated Syringe System includes a range of Freedom Precision Flow Rate Tubing™ (provided sterile). The tubing ranges from F0.5 to F2400. Each F-number provides a different level of flow restriction, which, when combined with the viscosity of the medication, provides a controlled delivery in an all-mechanical system. The tubing sets connect at one end to the syringe being used and on the other end to the Subcutaneous Safety Needle Sets or directly on venous catheters for intravenous infusions as needed.
3. HIgH-Flo Needles Sets:
The HIgH-Flo Subcutaneous Safety Needle SetsTM
The HIgH-Flo Subcutaneous Safety Needle Sets™ (provided sterile) are used to administer drugs to the subcutaneous layers using small needles attached to the skin. Subcutaneous needles come in different lengths to administer immunoglobulins and antibiotics per the indications for use.
Subcutaneous Safety Needle Sets comes in multiple configurations (1, 2, 3, 4, 5, 6 needle sites). Needles are available in 4mm. 6mm. 9mm. 12mm. and 14mm lengths combined
6
with 24 or 26 Gauge. Using the Y -Connector, the patient can have up to 8 sites for drug delivery.
The HIgH- Flo Subcutaneous Safety Needle Sets™ also allow each needle to be enclosed between the wings after use.
The HIgH-Flo Super26TM Subcutaneous Needle Sets
The HIgH-Flo Super26™ Subcutaneous Needle Sets are sterile, non-pyrogenic, single use. Subcutaneous Administration Sets, comprised of a Super 26-gauge needle assembly, combined with 24-gauge needle tubing and are intended for the delivery of medication to the subcutaneous tissue in accordance with the indication for use statement. Each set consists of a sterile infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set is a 90- degree, 26-gauge stainless steel needle, mounted to a butterfly winged safety closure on one end which is used to close the set upon completion. The other end consists of a luer lock which connects to PVC medical grade tubing. Additionally, each tubing set is equipped with a slide clamp used to stop flow, immediately as needed. HIgH-Flo Super 26™ Subcutaneous Needle Sets are available as a single set, as well as 2-needle, 3-needle, 5-needle, 6-needle, sets; through use of a Y-connector, 7-needle and 8 needle sets may also be assembled.
The purpose of this premarket notification is to request a modification for the cleared infusion system. The major modifications to the current device are as follows:
-
- Device Configuration
- Removal of syringe driver The Subject device will only a. include use of only one syringe driver (FreedomEdge) instead of two syringe drivers cleared for use in the predicate device.
- Addition of second needle set -- The HIgH-FLO Super26 b. Subcutaneous Needle cleared under K180843 is added for use with the system.
-
- Update Indication for Use The purpose of the device application is to expand the currently cleared indications for use to include the addition of Hizentra 20ml Prefilled syringe and HIgH-Flo Super26TM Subcutaneous Needle Set into the indications for use.
-
- Addition of Blue Colorant to Needle Butterfly Wings Addition of a blue colorant to the HIgH-Flo Super26™ Subcutaneous Safety Needle Sets. The blue colorant (541790C Translucent blue, Marvel Industries, Inc.) was added to the Super26TM needle hub assembly to help distinguish between the HIgH-Flow Subcutaneous Safety Needle Sets and HIgH-Flo Super26TM Subcutaneous Safety Needle Sets.
-
- Update Sterile Barrier (Packaging material) sterile devices will be packaged in a nylon film pouch, which once sealed, serves as the sterile barrier. The pouch material was updated from LDPE pouch, P/N 317036 to
7
Nylon pouch, P/N 317050.
-
- Flow Rate Accuracy the flow rate accuracy between the subject device and predicate device has changed from +/-8% to predicted minimum to maximum flow rates within those labeled per the Hizentra package insert for each combination of needle set and tubing.
V. INDICATIONS FOR USE
INTENDED USE
The FreedomEdge® Syringe Infusion System is intended for the intravenous or subcutaneous infusion of certain medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling and the indications for use statement below.
Intended population: adults and pediatrics.
INDICATIONS FOR USE
The FreedomEdge® Syringe Infusion System is indicated for the intravenous or subcutaneous infusion of medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The FreedomEdge® Syringe Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cuvitru®, Immune Globulin Infusion(Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) and Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use prefilled syringe for subcutaneous administration.
The FreedomEdge® Syringe Infusion System with the FreedomEdge® Syringe Driver and Precision Flow Rate Tubing™, is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling: ertapenem, meropenem, oxacillin, and tobramycin.
The FreedomEdge® Syringe Infusion System consists of the following components:
- FreedomEdge® Syringe Driver
- Precision Flow Rate Tubing™ .
- HIgH-Flo Subcutaneous Safety Needle Sets™ .
- HIgH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®);
8
Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration.
The FreedomEdge® Syringe Infusion System is indicated for use with the BD® 20 mL syringe (US Reference number: 302830), BD 30 mL syringe (US Reference number: 302832), and 20 mL single-use pre-filled syringe (NDC 44206-458-96).
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Indications for Use Comparison
The table below includes a comparison of the indications for use between the new device and that of the predicate device:
| | Predicate Device
(K162613) | Subject Device
(K211206) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Integrated Catch-Up FREEDOM Syringe
Driver Infusion System | FreedomEdge® 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
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
to the FDA approved drug product labeling: | The FreedomEdge® Syringe Infusion System is
indicated for the intravenous or subcutaneous
infusion of medications and fluids in the home,
hospital, or ambulatory settings when
administered according to the approved biologic
or drug product labeling. The FreedomEdge®
Syringe Infusion System is specifically indicated
for the subcutaneous infusion of the following
human plasma-derived immunoglobulins when
used according to the FDA approved biologic
labeling: Cuvitru®, Immune Globulin Infusion
(Human) 20% (manufactured by Takeda®);
Gammagard Liquid®, Immune Globulin Infusion
(Human) 10% (manufactured by Takeda®);
Hizentra®, Immune Globulin Subcutaneous
(Human) 20% Liquid (manufactured by CSL
Behring®) and Hizentra®, Immune Globulin
Subcutaneous (Human) 20% Liquid
(manufactured by CSL Behring®) Single-use
pre-filled syringe for subcutaneous
administration |
| Predicate Device
(K162613) | Subject Device
(K211206) | |
| Integrated Catch-Up FREEDOM Syringe
Driver Infusion System | FreedomEdge® Syringe Infusion System | |
| Current configuration | New configuration | |
| Current Indications for Use
as cleared August 31, 2017 | Modified Indications for
Use | |
| meropenem, ertapenem, oxacillin, and
tobramycin.
The FreedomEdge® Syringe Infusion System is
indicated for use with the BD 20 ml (model no.
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). | The FreedomEdge® Syringe Infusion System
with the FreedomEdge® Syringe Driver and
Precision Flow Rate Tubing™, is specifically
indicated for the intravenous infusion of the
following antibiotics when used according to the
FDA approved drug product labeling: ertapenem,
meropenem, oxacillin, and tobramycin.
The FreedomEdge® Syringe Infusion System
consists of the following components:
• FreedomEdge® Syringe Driver
• Precision Flow Rate Tubing™
• HIgH-Flo Subcutaneous Safety Needle
Sets™
• HIgH-Flo Super26™ Subcutaneous
Needle Sets are specifically indicated for
the subcutaneous infusion of the
following human plasma-derived
immunoglobulins: Cuvitru®, Immune
Globulin Infusion (Human) 20%
(manufactured by Takeda®); Hizentra®,
Immune Globulin Subcutaneous (Human)
20% Liquid (manufactured by CSL
Behring®); Hizentra®, Immune Globulin
Subcutaneous (Human) 20% Liquid
(manufactured by CSL Behring®)
Single-use pre-filled syringe for
subcutaneous administration.
The FreedomEdge® Syringe Infusion System is
indicated for use with the BD® 20 mL syringe
(US Reference number: 302830*), BD 30 mL
syringe (US Reference number: 302832**), and
20 mL single-use pre-filled syringe (NDC 44206-
458-96).
*Model no. 301031 is the non-sterile version of
BD® 20 ml syringe sold by BD
**model no. 301033 is the non-sterile version of
BD® 30 ml syringe. | |
| | Predicate Device
(K162613)
Integrated Catch-Up FREEDOM Syringe
Driver Infusion System | Subject Device
(K211206)
FreedomEdge® Syringe Infusion System |
| | Current configuration | New configuration |
| | Current Indications for Use
as cleared August 31, 2017 | Modified Indications for
Use |
| 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 |
Table 1. Indications for Use Comparison
9
10
Justification of differences in Indications for Use of Subject and Predicate Device
The indications for use statement for the FreedomEdge® Syringe Infusion System is not identical to the predicate device. The submission expands on the currently cleared indications for use to include a 20mL Hizentra Pre-Filled Syringe and the HIgH-Flo Super26™ Subcutaneous Needle Set to the infusion system. The difference in in between the subject device and predicate device infusion system are the inclusion of the 20mL Hizentra Pre-Filled Syringe and the HIgH-Flo Super 26™ Subcutaneous Needle Set into the indications for use.
Compatibility of prefilled syringe and HIgH-Flo Super26™ with the FreedomEdge infusion system specifically has been verified through performance testing. The FreedomEdge Syringe Infusion System will include a second needle set, the HIgH-Flo Super26TM Subcutaneous Needle Sets, in addition to the HIgH-Flo Subcutaneous Safety Needle Sets™. The HIgH-Flo Super26™ Subcutaneous Needle Set is cleared for use with the FreedomEdge syringe driver and Precision Flow Rate Tubing™ and intended for the intravenous or subcutaneous infusion of medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The change to device indications do not significantly affect safety or effectiveness as the changes do not create new risks or significantly modify existing risk. The change in indications for use does not raise different questions of safety and effectiveness and, therefore, does not preclude a meaningful comparison with the predicate device.
The routes of administration for the system, intravenous, and subcutaneous were cleared in the predicate device.
Discussions of differences in intended population The intended population for the subject device is identical to the predicate device.
Discussions of differences in environment of use
11
The environment of use for the subject device is identical to the predicate device.
Device configuration
The table below includes a comparison of the infusion system configuration between the new device and that of the predicate device:
| Predicate | Subject Device |
|---|---|
| K162613 | K211206 |
| Integrated Catch-Up Freedom Syringe | |
| Driver Infusion System | FreedomEdge® Syringe Infusion System |
| 1. The Freedom60® Syringe Driver | 1. The FreedomEdge® Syringe Driver |
| 2. The FreedomEdge® Syringe Driver | 2. Precision Flow Rate Tubing™ |
| 3. Precision Flow Rate Tubing™ | 3. HIgH-Flo™ Subcutaneous Safety Needle |
| Sets (24G, 26G) | |
| 4. HIgH-Flo™ Subcutaneous Safety Needle | |
| Sets (24G, 26G) | 4. HIgH-FLO Super26™ Subcutaneous |
| Needle Sets |
Table 2. Device Configuration Comparison
Discussions of differences in system configuration
The Subject device utilizes the same components from predicate device to form the subject device, FreedomEdge® Syringe Infusion System. The main difference is that the subject device is re-configured and packaged with only one syringe driver (FreedomEdge svringe driver) instead of the two svringe drivers (FREEDOM60™ svringe driver and FreedomEdge™ syringe driver) cleared for use in the predicate device. Also, in addition, the new configuration will include use of the HIgH-Flow Super26 Subcutaneous Needle in addition to the HIgH-Flo™ Subcutaneous Safety Needles Sets. The HIgH-Flo Super26™, as part of the subject device is similar to the HIgH-Flo Subcutaneous Safety Needle Sets™ but specifically used for higher flow rates. Both needle sets are intended for the delivery of medication to the subcutaneous tissue. The HIgH-Flo Super26™ is cleared for use with the FreedomEdge® syringe driver. The methods for HIgH-Flo Super26™ has been shown to be substantially equivalent in K180843, as a reference device.
The devices are furthermore, similar in technological characteristics with respect to providing intravenous or subcutaneous infusion of medications and fluids. While there are minor technological differences between the subject and predicate device, these differences do not introduce new or different questions of safety and effectiveness, as confirmed through the results of performance testing.
Table 3 and Table 4 presents a tabular comparison of the technological characteristics between the proposed device, and predicate device with an assessment of differences between them and why the difference between the subject device and predicate device do not introduce new or different questions of safety and effectiveness.
12
| Technological
Characteristics | Integrated Catch-up
FREEDOM Syringe Driver
Infusion System (ICSDIS,
known as Freedom Infusion
System)
(K162613) | FreedomEdge™ Syringe
Infusion System
(K211206) | 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 | FreedomEdge syringe driver:
Manual lever used to tension
negator constant force spring | Same winding of spring for FreedomEdge. |
| On / Off Control | Manual switch | Manual switch | Same |
| Housing | Molded ABS | Molded ABS | Same |
| Syringe Type | FreedomEdge
BD® 20 mL syringe (US
Reference number: 302830)
BD 30 mL syringe (US
Reference number: 302832)
FREEDOM60®
BD 50 mL syringe (model no.
309653) | BD® 20 mL syringe (US
Reference number: 302830)
BD 30 mL syringe (US Reference
number: 302832)
20 mL single-use pre-filled syringe
(NDC 44206-458-96). | Different.
Indications for Use now includes single use
pre-filled syringe whereas the predicate does
not. Syringe comes pre-filled with approved
drug, Hizentra, ready to use in FreedomEdge
syringe driver. Use of pre-filled syringe does
not change intended use of infusion system
device nor does it raise new questions of safety
and effectiveness. |
| Technological
Characteristics | Integrated Catch-up
FREEDOM Syringe Driver
Infusion System (ICSDIS,
known as Freedom Infusion
System)
(K162613) | FreedomEdge™ Syringe
Infusion System
(K211206) | Comparison |
| | | | BD 50 mL syringe is indicated for Freedom60
syringe driver only and therefore not part of
Subject device. |
| Tubing Length
(inches) | 20 | 20 | Same |
| Tubing Diameter
(inches) | $0.033 +0.002"/-0.001"$ | $0.033 +0.002"/-0.001"$ | Same |
| Tubing Material | Medical Grade PVC Plastic | Medical Grade PVC Plastic | Same |
| Needle Material | Stainless Steel | Stainless Steel | Same |
| Needle Gauge | 24 Gauge Needle Sets
26 Gauge Needle Sets | 24 Gauge Needle Sets
26 Gauge Needle Sets | Same |
| Needle Butterfly
Wings Material
(HIgH-Flo™
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 |
| Technological
Characteristics | Integrated Catch-up
FREEDOM Syringe Driver
Infusion System (ICSDIS,
known as Freedom Infusion
System)
(K162613) | FreedomEdge™ Syringe
Infusion System
(K211206) | Comparison |
| Packaging | Tubing and Needle Sets
packaged sterile utilizing an
LDPE pouch (P/N 317036), for
single patientuse. | 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
by packaging performance testing with respect
to packaging validation at baseline and shelf-
life. The difference in the material do notraise
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 |
| Technological
Characteristics | Integrated Catch-up
FREEDOM Syringe Driver
Infusion System (ICSDIS,
known as Freedom Infusion
System)
(K162613) | FreedomEdge™ Syringe
Infusion System
(K211206) | Comparison |
| | | | 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
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 |
Table 3. Comparison of Predicate and Subject Device
13
14
15
16
| Technological
Characteristics | Integrated Catch-up
FREEDOM Syringe Driver
Infusion System (ICSDIS,
known as Freedom Infusion
System)
(K162613) | FreedomEdge™ Syringe
Infusion System
(K211206) | Comparison | | | | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|----------------------------------|------|----------------------------------|----------------------------------|------|
| Residual Volumes
for HIgH-Flo
Needle Sets | Needle 24 G | 26 G | Needle 24 G | 26 G | | | |
| | 1 | 0.4 ml | 0.1 ml | 1 | 0.4 ml | 0.1 ml | |
| | 2 | 0.7 ml | 0.2 ml | 2 | 0.7 ml | 0.2 ml | |
| | 3 | 1.1 ml | 0.3 ml | 3 | 1.1 ml | 0.3 ml | |
| | 4 | 1.4 ml | 0.4 ml | 4 | 1.4 ml | 0.4 ml | |
| | 5 | 2.0 ml
(with Y-
connector) | 0.5 ml | 5 | 2.0 ml
(with Y-
connector) | 0.5 ml | Same |
| | 6 | 2.3 ml
(with Y-
connector) | 0.6 ml | 6 | 2.3 ml
(with Y-
connector) | 0.6 ml | |
| | 7 | 2.7 ml
(with Y-
connector) | 0.9 ml
(With Y-
connector) | 7 | 2.7 ml
(with Y-
connector) | 0.9 ml
(with Y-
connector) | |
| | 8 | 1.0 ml
with Y-
connector | 0.9 ml
(With Y-
connector) | 8 | 1.0 ml
(with Y-
connector) | 1.0 ml
(with Y-
connector) | |
17
| Technological
Characteristics | HIgH-FloTM Subcutaneous
Safety Needle Sets (26G)
(K162613) | HIgH-FLO Super26TM
Subcutaneous Needle Sets
(K211206) | Comparison |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tubing Diameter
(inches) | $0.033 \pm 0.002"/0.001"$ | $0.0190 \pm 0.001"$ | Different.
With the addition of the Super26, the main
difference is the tubing diameter of the Super26
( $0.0190 \pm 0.001"$ ) 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-Flo™ Subcutaneous
Safety Needle Sets (26G)
(K162613) | HIgH-FLO Super26™
Subcutaneous Needle Sets
(K211206) | 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
Super26 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. |
| Technological
Characteristics | HIgH-Flo™ Subcutaneous
Safety Needle Sets (26G)
(K162613) | HIgH-FLO Super26™
Subcutaneous Needle Sets
(K211206) | 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
2 – Needle Set
3 – Needle Set
4 – Needle Set
5 – Needle Set
6 – Needle Set
w/Y-connector
7 – Needle Set
8 – Needle Set | 1 – Needle Set
2 – Needle Set
3 – Needle Set
4 – Needle Set
5 – Needle Set
6 – Needle Set
w/Y-connector
7 – Needle Set
8 – Needle Set | Same |
| Residual Volume
for the multiple
needle
configurations | Needle | Super26 | Different.
When using a 60 ml dose, the increased residual
volume between the HIgH-Flo Super26 and the
predicate device (HIgH-Flo Subcutaneous
Safety Needle Set) ranges from 0.5% for a 1 leg
needle set to 3.3% for an 8-leg needle set (4 |
| | 26 G | | |
| | 1 0.1 ml | 1 0.4 ml | |
| | 2 0.2 ml
3 0.3 ml | 2 0.7 ml
3 1.1 ml | |
| Technological
Characteristics | HIgH-Flo™ Subcutaneous
Safety Needle Sets (26G)
(K162613) | HIgH-FLO Super26™
Subcutaneous Needle Sets
(K211206) | Comparison |
| 4 | 0.4 ml | 1.4 ml | legs x 2). Residual volumes are stated in the
IFU. This change does not raise new questions
of safety and effectiveness. Residual volumes
are stated in the IFU. |
| 5 | 0.5 ml | 1.8 ml | |
| 6 | 0.6 ml | 2.1 ml | |
| 7 | 0.9 ml
(With Y-
connector) | 2.7 ml
(With Y-connector) | |
| 8 | 0.9 ml
(With Y-
connector) | 3.0 ml
(With Y-connector) | |
Table 4. Comparison of HIgH-Flo Super26 needle set and 26G HIgH-Flo needle set
18
19
20
21
Discussions of differences in needle sets
The subject device utilizes the same fundamental scientific technology as the predicate device. The Super26 uses a 24G tubing set and a 26G needle. The main difference between Super26 and the 26 gauge HIgH-Flo Subcutaneous Needle Set is the tubing diameter of the Super26, which provides greater flexibility for the patient to use higher viscosity medications during infusion per the drug manufacturer's recommended limits. The diameter of the tubing used in the subject device (HlgH-FloSuper26™M Sub-Q Needle Sets) with 26G needles is 0.033 inches, which is different from the predicate's 0.019 inches.
Also, the Super26 uses a Y connector with 7 and 8 legs while the 24G uses a Y connector with 5, 6, 7 and 8 Legs. The Y connector has ~. 2 mL residual volume. Bench testing was conducted in K180843 to verify that the product performance of the subject device and predicate device are substantially equivalent. Any differences between HIgH-Flo Super26 needle set and 26G HIgH-Flo needle set do not raise different questions of safety and effectiveness.
As shown in the predicate device comparison chart in Table 4, HIgH-Flo Super26™ Subcutaneous Needle Sets have the same technological characteristics as the predicate device.
The HIgH-Flo Super26TM Subcutaneous Needle Sets are considered as substantially equivalent to the legally marketed predicate device.i.e., K162613 and demonstrated to be as safe and effective as legally marketed devices.
VII. PERFORMANCE DATA
The following performance data/non-clinical testing was provided in support of the substantial equivalence determination for the FreedomEdge Syringe Infusion System. The infusion system does not contain software, electrical components, or alarms.
| Device Performance | The essential performance requirements of the device were verified 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
FreedomEdge 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
|
22
| • 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
devices.
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 FreedomEdge Syringe Infusion System, as recommended in the FDA guidance document, "Infusion Pumps Total Product Life Cycle."
The only changes introduced in this 510(k) do not impact the associated risks or reliability in the Safety Assurance Case as compared to the predicate. Therefore only evidence to support changes to the device requirements to ensure adequate verification were needed to support substantial equivalence.
Device Performance
The essential performance requirements of the device were verified through performance
23
testing in accordance with the intended use of the device and in accordance with the FDA Guidance "Infusion Pumps Total Product Life Cycle
The FreedomEdge® Syringe Infusion System includes directions for the selection of Precision Tubing Sets, HIgH-Flo Subcutaneous Needle Sets, and HIgH-FLO Super26 Subcutaneous Needle Sets combinations in order to achieve desired infusion rates for each of the indicated human plasma-derived immunoglobulin solutions, in accordance with the following tables:
Selected Flow Rate Combinations
Select Combinations of Flow Rates with HIgH-Flo Subcutaneous Safety Needle Set™ (Standard 26G and 24G) when used in combination with Precision Flow Rate Tubing™ for use with Hizentra®, Cuvitru®, and Gammagard® Liquid.
Note: The following tables are only for the subcutaneous use of the immunoglobulin listed.
24
| Hizentra – FreedomEdge® with 20 ml syringe | |||||||
|---|---|---|---|---|---|---|---|
| Drug | |||||||
| volume (ml) | Flow Rate | ||||||
| Tubing | HIgH-Flo | ||||||
| Needle Set* | Total Flow | ||||||
| Rate (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 and |
| beyond | |||||||
| 100 | F2400 | RMS42609 | 85.5 | 21.4 | 25 | 1:10 | 6th Infusion of biologic and |
| beyond(NEEDS TWO | |||||||
| SYRINGES) | |||||||
| 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 and |
| beyond |
| Cuvitru – with FreedomEdge® with 20 ml
| syringe | |||||||
|---|---|---|---|---|---|---|---|
| Drug | |||||||
| volume (ml) | Flow Rate | ||||||
| Tubing | HIgH-Flo | ||||||
| Needle Set* | Total Flow | ||||||
| Rate (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 under |
| 40kg | |||||||
| 20 | F275 | RMS12609 | 12.1 | 12.1 | 20 | 1:39 | 1st Two Infusions patients under |
| 40kg | |||||||
| 20 | F600 | RMS22609 | 25.7 | 12.8 | 10 | 0:47 | 1st Two Infusions patients under |
| 40kg | |||||||
| 50 | F600 | RMS22609 | 25.7 | 12.8 | 25 | 1:57 | 1st Two Infusions patients over |
| 40kg | |||||||
| 60 | F1200 | RMS22609 | 37.1 | 18.6 | 30 | 1:37 | Subsequent Infusions |
| 60 | F2400 | RMS22409 | 110.5 | 55.4 | 30 | 0:32 | Subsequent Infusions |
| 60 | F1200 | RMS12409 | 55.3 | 55.3 | 60 | 1:05 | Subsequent Infusions |
| 100 | F2400 | RMS42409 | 132.8 | 33.2 | 25 | 0:45 | Subsequent Infusions |
| Cuvitru – with FreedomEdge® with 30 ml syringe | |||||||
| 20 | F500 | RMS22609 | 12.9 | 12.9 | 20 | 1:32 | 1st Two Infusions patients under |
| 40kg | |||||||
| 30 | F900 | RMS22609 | 24.6 | 12.3 | 15 | 1:13 | 1st Two Infusions patients under |
| 40kg | |||||||
| 30 | F2400 | RMS12609 | 21.2 | 21.2 | 30 | 1:24 | Maintenance Infusions |
| 30 | F1200 | RMS12409 | 42.1 | 42.1 | 30 | 0:42 | Maintenance Infusions |
25
| Gammagard Liquid – with FreedomEdge® with 20 ml syringe | |||||||
|---|---|---|---|---|---|---|---|
| Drug | |||||||
| volume | |||||||
| (ml) | Flow Rate | ||||||
| Tubing | HIgH-Flo | ||||||
| Needle Set* | Total Flow | ||||||
| Rate (ml/hr) | Flow rate/site | ||||||
| (ml/hr) | Vol/site | ||||||
| (ml) | Time | NOTES: | |||||
| 20 | F45 | RMS12609 | 14.2 | 14.2 | 20 | 1:24 | Patients under 40kg (Initial) |
| 60 | F120 | RMS22609 | 39.8 | 19.9 | 30 | 1:30 | Patients over 40kg (Initial) |
| 100 | F420 | RMS42609 | 119.1 | 29.8 | 25 | 0:50 | Patients over 40kg (maintenance infusions) |
| Gammagard Liquid - with FreedomEdge® with 20 ml syringe | |||||||
| 20 | F120 | RMS22609 | 30 | 15 | 10 | 0:40 | Patients under 40kg(Initial) |
| 30 | F180 | RMS22609 | 39.8 | 19.9 | 15 | 0:45 | Patients over 40kg (Initial) |
| 30 | F120 | RMS12609 | 27 | 27 | 30 | 1:06 | Patients over 40kg (Maintenance) |
*HIgH-Floneedle sets: The first number of needles, the next two numbers refer to the needle gauge, and the last two numbers refer to the needle length (mm).
26
Hizentra® 20 ml Prefilled Syringe Selected Flow Rate Combinations
The following tables indicate the min-max predicated flow rates per site with HIgH-Flo Subcutaneous Safety Needles Sets™ (Standard 26G, 24G and Super26TM) when used in combination with KORU Precision Flow Rate Tubing™ and the FreedomEdge® Syringe Infusion System with a 20 ml syringe for the subcutaneous use of Hizentra CIDP (+/- 15%).
To determine the appropriate flow rate tubing and subcutaneous needle configuration, please refer to drug package insert for the maximum indicated flow rate and volume per infusion site for initial and subsequent infusions.
| F120 | F180 | F275 | F420 | F500 | F600 | F900 | F1200 | F2400 | |
|---|---|---|---|---|---|---|---|---|---|
| 1 needle | 7 - 12.9 | 9.7 - 15.4 | 13.1 - 21.2 | 16.7 - 28.7 | 19.9 - 30.5 | 21.6 - 33.9 | 27.3 - 42 | 28.8 - 45.9 | 35.7 - 55.6 |
| 2 needles | 3.8 - 7.1 | 5.4 - 8.7 | 7.6 - 12.6 | 10.1 - 18.2 | 12.6 - 19.6 | 14 - 22.5 | 19.2 - 30.3 | 20.7 - 34.6 | 28.7 - 46.9 |
| 3 needles | 2.6 - 4.9 | 3.7 - 6 | 5.4 - 8.9 | 7.3 - 13.3 | 9.3 - 14.5 | 10.3 - 16.9 | 14.8 - 23.7 | 16.2 - 27.7 | 24 - 40.6 |
| 4 needles | 2 - 3.7 | 2.9 - 4.6 | 4.2 - 6.9 | 5.7 - 10.5 | 7.3 - 11.5 | 8.2 - 13.5 | 12.1 - 19.5 | 13.3 - 23.2 | 20.6 - 35.8 |
| 5 needles | 1.6 - 3 | 2.3 - 3.8 | 3.4 - 5.7 | 4.7 - 8.7 | 6 - 9.5 | 6.8 - 11.2 | 10.2 - 16.5 | 11.2 - 19.9 | 18.1 - 32 |
| 6 needles | 1.3 - 2.5 | 1.9 - 3.2 | 2.9 - 4.8 | 3.9 - 7.4 | 5.1 - 8.1 | 5.8 - 9.6 | 8.8 - 14.4 | 9.8 - 17.4 | 16.1 - 28.9 |
| 7 needles | 1.1 - 2.2 | 1.7 - 2.7 | 2.5 - 4.1 | 3.4 - 6.4 | 4.5 - 7.1 | 5.1 - 8.4 | 7.7 - 12.7 | 8.6 - 15.5 | 14.5 - 26.4 |
| 8 needles | 1 - 1.9 | 1.5 - 2.4 | 2.2 - 3.7 | 3 - 5.7 | 4 - 6.3 | 4.5 - 7.5 | 6.9 - 11.4 | 7.7 - 13.9 | 13.2 - 24.2 |
HIgH-Flo 26G with Precision Tubing – Min-Max Flow Rate Per Site (ml/hr/site)
Image /page/26/Picture/5 description: The image shows a simple graphic divided into two rectangular sections. The top section is colored in a neutral gray, while the bottom section is a light blue. A thick black line separates the two colored areas, creating a clear visual distinction between them.
Exceeds drug manufacturer's maximum indicated flow rate. Subsequent infusions after 6th infusion only.
HIgH-Flo Super26 with Precision Tubing – Nominal Flow Rate Per Site (ml/hr/site)
| F120 | F180 | F275 | F420 | F500 | F600 | F900 | F1200 | F2400 | |
|---|---|---|---|---|---|---|---|---|---|
| 1 needle | 7.6 - 14.2 | 10.8 - 17.4 | 15.3 - 25.3 | 20.4 - 36.6 | 25.5 - 39.5 | 28.2 - 45.4 | 38.8 - 61.3 | 41.9 - 70 | 58.3 - 95.5 |
| 2 needles | 4 - 7.5 | 5.7 - 9.3 | 8.3 - 13.9 | 11.4 - 21.1 | 14.7 - 23 | 16.5 - 27.1 | 24.3 - 39.2 | 26.7 - 46.7 | 41.7 - 72.5 |
| 3 needles | 2.7 - 5.1 | 3.9 - 6.3 | 5.7 - 9.6 | 7.9 - 14.8 | 10.3 - 16.2 | 11.6 - 19.3 | 17.7 - 28.9 | 19.6 - 35 | 32.5 - 58.4 |
| 4 needles | 2 - 3.9 | 2.9 - 4.8 | 4.3 - 7.3 | 6.1 - 11.4 | 7.9 - 12.5 | 9 - 15 | 13.9 - 22.8 | 15.5 - 28 | 26.6 - 48.9 |
| 5 needles | 1.6 - 3.1 | 2.4 - 3.9 | 3.5 - 5.9 | 4.9 - 9.3 | 6.4 - 10.2 | 7.3 - 12.3 | 11.4 - 18.9 | 12.8 - 23.4 | 22.5 - 42.1 |
| 6 needles | 1.4 - 2.6 | 2 - 3.2 | 2.9 - 5 | 4.1 - 7.8 | 5.4 - 8.6 | 6.2 - 10.4 | 9.7 - 16.1 | 10.9 - 20 | 19.5 - 36. |
| 7 needles | 1.2 - 2.2 | 1.7 - 2.8 | 2.5 - 4.3 | 3.6 - 6.7 | 4.7 - 7.4 | 5.4 - 9 | 8.4 - 14 | 9.5 - 17.5 | 17.2 - 32. |
| 8 needles | 1 - 2 | 1.5 - 2.4 | 2.2 - 3.8 | 3.1 - 5.9 | 4.1 - 6.6 | 4.7 - 7.9 | 7.5 - 12.4 | 8.4 - 15.6 | 15.4 - 29. |
Image /page/26/Picture/9 description: The image shows a simple graphic with two stacked rectangles. The top rectangle is filled with a solid gray color, while the bottom rectangle is filled with a light blue color. The rectangles are separated by a black line, creating a clear distinction between the two colored areas.
Exceeds drug manufacturer's maximum indicated flow rate. Subsequent infusions after 6th infusion only.
27
| F120 | F180 | F275 | F420 | F500 | F600 | F900 | F1200 | F2400 | |
|---|---|---|---|---|---|---|---|---|---|
| 1 needle | 8 - 15.1 | 11.5 - 18.7 | 16.8 - 28.2 | 23.2 - 43 | 29.9 - 47.1 | 33.8 - 55.8 | 50.3 - 81.7 | 55.6 - 98 | 88.8 - 156.2 |
| 2 needles | 4 - 7.7 | 5.9 - 9.6 | 8.7 - 14.7 | 12.2 - 23 | 16 - 25.4 | 18.2 - 30.5 | 28.3 - 46.7 | 31.7 - 57.7 | 55.3 - 102.8 |
| 3 needles | 2.7 - 5.2 | 4 - 6.5 | 5.9 - 10 | 8.3 - 15.7 | 11 - 17.4 | 12.5 - 21 | 19.7 - 32.7 | 22.2 - 40.9 | 40.2 - 76.6 |
| 4 needles | 2 - 3.9 | 3 - 4.9 | 4.5 - 7.5 | 6.3 - 11.9 | 8.3 - 13.2 | 9.5 - 16 | 15.1 - 25.2 | 17 - 31.7 | 31.5 - 61.1 |
| 5 needles | 1.6 - 3.1 | 2.4 - 3.9 | 3.6 - 6.1 | 5.1 - 9.6 | 6.7 - 10.7 | 7.7 - 12.9 | 12.2 - 20.4 | 13.8 - 25.8 | 26 - 50.8 |
| 6 needles | 1.4 - 2.6 | 2 - 3.3 | 3 - 5.1 | 4.2 - 8.1 | 5.6 - 8.9 | 6.4 - 10.8 | 10.3 - 17.2 | 11.7 - 21.8 | 22 - 43.4 |
| 7 needles | 1.2 - 2.2 | 1.7 - 2.8 | 2.6 - 4.3 | 3.6 - 6.9 | 4.8 - 7.7 | 5.5 - 9.3 | 8.9 - 14.9 | 10.1 - 18.9 | 19.2 - 38 |
| 8 needles | 1 - 2 | 1.5 - 2.5 | 2.3 - 3.8 | 3.2 - 6.1 | 4.2 - 6.7 | 4.9 - 8.2 | 7.8 - 13.1 | 8.9 - 16.6 | 17 - 33.7 |
HIgH-Flo 24G with Precision Tubing - Min-Max Flow Rate Per Site (ml/hr/site)
Image /page/27/Picture/2 description: The image shows a simple illustration of a rectangular shape divided into two sections. The top section is colored in gray, while the bottom section is colored in light blue. The rectangle is outlined with a thick black border, providing a clear separation between the two colored sections.
Exceeds drug manufacturer's maximum indicated flow rate. Subsequent infusions after 6th infusion only.
Clinical Evaluation
Clinical evaluation was not required to support submission and determination of substantial equivalence.
VIII. CONCLUSIONS
The FreedomEdge® Syringe Infusion System is substantially equivalent to the commercially available predicate device in terms of function, safety, performance, intended use, technology/principles of operation and mechanical properties. The nonclinical data support the safety of the device and performance testing demonstrate that the FreedomEdge® Syringe Infusion System meets the established specifications necessary for consistent performance to achieve its intended use as safely and as effectively as the predicate device and confirmed that the technological differences between the proposed device and predicate device do not raise different questions of safety or effectiveness. Based on performance testing results, the FreedomEdge® Syringe Infusion System, performs as intended and performs comparably to the predicate device that is currently marketed for the same intended use.