(211 days)
No
The device description focuses on a mechanical, non-electric system using a spring-loaded driver and flow controllers to achieve controlled flow rates. There is no mention of AI, ML, or any computational elements that would suggest the use of such technologies.
Yes
The device is described as an "infusion system" that delivers prescribed medications such as immunoglobulins and antibiotics subcutaneously or intravenously, which are therapeutic interventions.
No
The Insignis™ Syringe Infusion System is explicitly described as a portable mechanical infusion system intended to deliver fluids subcutaneously or intravenously. Its function is to administer medication, not to diagnose conditions.
No
The device description explicitly states the system consists of hardware components: the Insignis Syringe Driver, a syringe, and infusion sets (intravenous or subcutaneous). It is described as a "portable mechanical infusion system that operates without electricity."
Based on the provided text, the Insignis™ Syringe Infusion System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the subcutaneous or intravenous infusion of fluids and medications into a patient. This is a therapeutic or drug delivery function, not a diagnostic one.
- Device Description: The description details a mechanical system designed to deliver fluids at controlled flow rates. It describes components like a syringe driver, syringe, and infusion sets, all of which are consistent with a drug delivery system.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of disease.
Therefore, the Insignis™ Syringe Infusion System is a medical device for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Insignis™ 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®); 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 system is intended for use by clinicians and lay users. It is intended for use in adults and in adolescents ages 13-21. For adolescents, it is to be operated under the supervision of an adult after instruction is provided by a healthcare provider.
The Insignis TM Syringe Infusion System with the Insignis Syringe Driver and Intravenous Controller, is specifically indicated for the intravenous infusion of fluids such as 0.9% Sodium Chloride (normal saline) and the following antibiotics when used according to the FDA approved drug product labeling: vancomycin, ertapenem, meropenem, oxacillin, and tobramycin.
The Insignis™ Syringe Infusion System consists of the following components:
- · Insignis Syringe Driver
- Intravenous Controller
- · OneSett Subcutaneous Administration Set
The Insignis Syringe Driver is indicated for use with the BD® 50 ml syringe (US Reference number 309653)
Product codes (comma separated list FDA assigned to the subject device)
PKP, FRN, FPA
Device Description
The Insignis™ Syringe Infusion System is a portable mechanical infusion system that operates without electricity. The Insignis system is intended to deliver indicated fluids subcutaneously or intravenously, depending on the prescribed medicine type, route of administration, and dose. The Insignis system incorporates into its design, a means to maintain a constant nominal pressure (13.5 psi), a controlled flowrate within a restrictive tubing circuit and needles to ensure the desired flowrate of medication to the patient is achieved. The spring-loaded Insignis™ Syringe Driver a constant mechanical force to the plunger of a BD 50 mL syringe (ref. #309653), that dispenses fluid through a restricted flowrate tubing and / or needle set. The Insignis system can infuse the rated BD syringe volume of 0 - 50 mL. Through a selection of IHS products total flowrates of 8 mL/hr -250 mL/hr are available: application specific.
- A. For subcutaneous immunoglobulin (SCIg) administrations, the Insignis system includes the OneSett™ Subcutaneous Administration Set, which consists of a selectable rate flow controller connected in-line to an administration set comprised of 1 - 4 needle set configurations (6mm, 9mm, 12 mm, and 14mm lengths). The OneSett is dedicated to deliver 20% concentrate SCIg drugs at specific flowrates which meet the drug manufacturer's package inserts recommended flowrate limitations. The selectable rate flow controller controls the flowrate delivered to each subcutaneous needle site.
- B. For intravenous administrations, the Insignis system includes the Intravenous Controller, which consists of a selectable rate flow controller connected in-line to a tubing set. The Intravenous Controller is dedicated to delivering select antibiotics, and saline and dextrose solutions. Again, the selectable rate flow controller allows for selectable and controllable flowrates.
For administering the prescribed medications, the Insignis system requires that the user fill the syringe with the prescribed medications, connect the infusion set to the syringe, eliminate air from the fluid line, secure the syringe into the Insignis™ Syringe Driver, connect to the infusion set to the patient, and load the syringe driver to begin the infusion.
The system is comprised of the Insignis™ Syringe Driver, a syringe, and either intravenous or subcutaneous infusion sets. To elaborate: - a. The Insignis™ Syringe Driver provides the constant driving force to dispense fluids.
- b. The syringe is the reservoir that holds the fluids (manufactured by Becton & Dickinson).
- c. The infusion sets (intravenous or subcutaneous) form the fluid path and delivers the fluid to the patient at controlled flowrates.
The syringe driver and infusion set products are manufactured by IHS as shown below.
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
adults and in adolescents ages 13-21
Intended User / Care Setting
clinicians and lay users. It is intended for use in the 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
- Biocompatibility Testing: Performed in accordance with ISO 10993-1, including Cytotoxicity, Sensitization / Irritation, Implantation, Pyrogenicity / LAL, Acute Systemic Toxicity, Sub-Acute Systemic Toxicity, Hemocompatibility, and Extractables Chemical Characterization. Results demonstrated biocompatibility.
- Device Performance: Tests performed include:
- Packaging validation as per ISO 11607-1:2019
- Shelf-life studies as per ISO 11607-1:2019, ASTM-F1980-16
- Sterilization validation as per ISO 11137-2:2013
- Cleaning validation as per AAMI TIR12:2020, AAMI TIR30:2011
- Infusion system performance testing in accordance with FDA guidance "Infusion Pumps Total Product Life Cycle"
- Infusion system structural integrity testing
- Infusion system safety testing
- Infusion system PKP immunoglobulin drug compatibility testing of Hizentra® Immune Globulin Subcutaneous (Human 20%) Liquid and Xembify® Immune Globulin Subcutaneous Human-klhw 20% (including Anti-complementary (ACA), Fc Function, IgG Appearance, Protein Concentration, Density, Characterization of IgG fragments, polymers, and aggregates, pH)
- Infusion system antibiotic stability testing of Vancomycin Hydrochloride Solution.
- Safety Assurance Case Summary: Determined the system is acceptably safe for its intended use based on review of indications/contraindications, device description, verification/validation/reliability documents, FMEAs, Hazard Analyses, Risk Control Measures, and Infusion Pump Certainty Case (IPCC), and relevant clinical literature.
- Usability / Human Factors Testing: Conducted to confirm usability for intended user groups (nurses and caregivers).
Flowrate Performance: - Intravenous Infusion (IV Controller): Flow rates measured visually under bench testing conditions at 30-second intervals using the Insignis Syringe Driver, 50mL BD syringe, and Intravenous Controller.
- KVO (8ml/hr): 3.09 - 13.4 mL/hr (-61.4%, +67.5% deviation)
- 32 mL/hr: 30.7 - 37.6 mL/hr (-4.06%, +17.5% deviation)
- 65 mL/hr: 63.5 - 70 mL/hr (-2.36%, +7.69% deviation)
- 130 mL/hr: 125 - 143 mL/hr (-3.85%, +10% deviation)
- 192 mL/hr: 187 – 201 mL/hr (-2.6%, +4.69% deviation)
- 255 mL/hr: 248 - 264 mL/hr (-2.75%, +3.53% deviation)
- 265 mL/hr: 191 - 355 mL/hr (-27.9%, +34% deviation)
- Subcutaneous IgG Infusion (OneSett™ Subcutaneous Administration Set): Flow rates measured visually under bench testing conditions at 30-second intervals.
- Hizentra® for Primary Immunodeficiency (PI): Measured flow rate may vary ±36% from the dial labeled flow rate.
- Nominal Flowrate per Infusion Site (mL/hr/site): 10 (6.45 - 13.6), 15* (9.68 - 20.4). Not recommended above 15 mL/hr/site.
- Hizentra® for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Measured flow rate may vary ±36% from the dial labeled flow rate.
- Nominal Flowrate per Infusion Site (mL/hr/site): 10 (6.45 – 13.6), 15 (9.68 – 20.4), 20* (12.9 – 27.1), 25* (16.1 – 33.9), 30* (19.3 – 40.7), 35* (22.5 – 47.5). Not recommended above 35 mL/hr/site.
- Xembify® for Primary Immunodeficiency (PI): Measured flow rate may vary -48.4%, +9% from the dial labeled flow rate.
- Nominal Flowrate per Infusion Site (mL/hr/site): 10 (5.16 - 10.9), 15 (7.74 - 16.3), 20 (10.3 - 21.7). Not recommended above 20 mL/hr/site.
- Cuvitru® for Primary Immunodeficiency (PI): Measured flow rate may vary from the dial labeled flow rate.
- Nominal Flowrate per Infusion Site (mL/hr/site): Not recommended below 20 mL/hr/site. 20* (11.7 - 24.7 (-41.5%, +23.5%)), 25* (14.6 - 30.8 (-41.6%, +23.2%)), 30* (17.5 - 37.0 (-41.7%, +23.3%)), 35* (20.5 - 43.1 (-41.4%, +23.1%)), 40* (23.4 - 49.2 (-41.5%, +23%)). Not recommended above 40 mL/hr/site.
- Hizentra® for Primary Immunodeficiency (PI): Measured flow rate may vary ±36% from the dial labeled flow rate.
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.
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.
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
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 1, 2024
Innovative Health Sciences, LLC % Shepard Bentley Consultant Bentley Biomedical Consulting, LLC 28241 Crown Vallev Parkwav, Suite 510(k) Laguna Niguel, California 92677
Re: K232328
Trade/Device Name: Insignis™ Syringe Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: PKP, FRN, FPA Dated: January 29, 2024 Received: January 29, 2024
Dear Shepard Bentley:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
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Sincerely,
Jake K. Lindstrom -S
Jake Lindstrom, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K232328
Device Name Insignis™ Syringe Infusion System
Indications for Use (Describe)
The Insignis™ 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®); 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 system is intended for use by clinicians and lay users. It is intended for use in adults and in adolescents ages 13-21. For adolescents, it is to be operated under the supervision of an adult after instruction is provided by a healthcare provider.
The Insignis TM Syringe Infusion System with the Insignis Syringe Driver and Intravenous Controller, is specifically indicated for the intravenous infusion of fluids such as 0.9% Sodium Chloride (normal saline) and the following antibiotics when used according to the FDA approved drug product labeling: vancomycin, ertapenem, meropenem, oxacillin, and tobramycin.
The Insignis™ Syringe Infusion System consists of the following components:
- · Insignis Syringe Driver
- Intravenous Controller
- · OneSett Subcutaneous Administration Set
The Insignis 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) |
|---|
| ☑Prescription Use (Part 21 CFR 801 Subpart D) ☐Over-The-Counter Use (21 CFR 801 Subpart C) |
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K232328 510(k) Summary
1. 510(k) Number
2. Submitter
Shepard G. Bentley, RAC Innovative Health Sciences, LLC 1108 Kings Highway, Suite #4 Chester, NY 10918 (855) 680 - 0630
3. Date of Submission
January 29, 2024
4. General Information
Classification: Class II Trade Name: Insignis™ Syringe Infusion System Common Name: Infusion Pump
5. Regulation Numbers
- . 21 CFR §880.5725 Infusion Pump
- 21 CFR §880.5440 Intravascular Administration Set
6. Product Codes
- PKP, Immunoglobulin G (Igg) Infusion System
- FRN, Infusion Pump ●
- FPA, Intravascular Administration Set ●
7. Indications for Use
The Insignis™ 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®); 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 system is intended for use by clinicians and lay users. It is intended for use in adults and in adolescents ages 13-21.
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For adolescents, it is to be operated under the supervision of an adult after instruction is provided by a healthcare provider.
The Insignis TM Syringe Infusion System with the Insignis Syringe Driver and Intravenous Controller, is specifically indicated for the intravenous infusion of fluids such as 0.9% Sodium Chloride (normal saline) and dextrose solutions, and the following antibiotics when used according to the FDA approved drug product labeling: vancomycin, ertapenem, meropenem, oxacillin, and tobramycin.
The Insignis™ Syringe Infusion System consists of the following components:
- Insignis Syringe Driver
- Intravenous Controller
- · OneSett Subcutaneous Administration Set
The Insignis Syringe Driver is indicated for use with the BD® 50 ml syringe (US Reference number 309653).
8. Predicate Device
- K200176, FREEDOM Integrated Syringe Infusion System
9. Reference Devices
10. Device Description
The Insignis™ Syringe Infusion System is a portable mechanical infusion system that operates without electricity. The Insignis system is intended to deliver indicated fluids subcutaneously or intravenously, depending on the prescribed medicine type, route of administration, and dose. The Insignis system incorporates into its design, a means to maintain a constant nominal pressure (13.5 psi), a controlled flowrate within a restrictive tubing circuit and needles to ensure the desired flowrate of medication to the patient is achieved. The spring-loaded Insignis™ Syringe Driver a constant mechanical force to the plunger of a BD 50 mL syringe (ref. #309653), that dispenses fluid through a restricted flowrate tubing and / or needle set. The Insignis system can infuse the rated BD syringe volume of 0 - 50 mL. Through a selection of IHS products total flowrates of 8 mL/hr -250 mL/hr are available: application specific.
- A. For subcutaneous immunoglobulin (SCIg) administrations, the Insignis system includes the OneSett™ Subcutaneous Administration Set, which consists of a selectable rate flow controller connected in-line to an administration set comprised of 1 - 4 needle set configurations (6mm, 9mm, 12 mm, and 14mm lengths). The OneSett is dedicated to deliver 20% concentrate SCIg drugs at
6
specific flowrates which meet the drug manufacturer's package inserts recommended flowrate limitations. The selectable rate flow controller controls the flowrate delivered to each subcutaneous needle site.
- B. For intravenous administrations, the Insignis system includes the Intravenous Controller, which consists of a selectable rate flow controller connected in-line to a tubing set. The Intravenous Controller is dedicated to delivering select antibiotics, and saline and dextrose solutions. Again, the selectable rate flow controller allows for selectable and controllable flowrates.
For administering the prescribed medications, the Insignis system requires that the user fill the syringe with the prescribed medications, connect the infusion set to the syringe, eliminate air from the fluid line, secure the syringe into the Insignis™ Syringe Driver, connect to the infusion set to the patient, and load the syringe driver to begin the infusion.
The system is comprised of the Insignis™ Syringe Driver, a syringe, and either intravenous or subcutaneous infusion sets. To elaborate:
- a. The Insignis™ Syringe Driver provides the constant driving force to dispense fluids.
- b. The syringe is the reservoir that holds the fluids (manufactured by Becton & Dickinson).
- c. The infusion sets (intravenous or subcutaneous) form the fluid path and delivers the fluid to the patient at controlled flowrates.
The syringe driver and infusion set products are manufactured by IHS as shown below.
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Image /page/7/Picture/0 description: The image shows three medical devices. The first device is an intravenous controller, which consists of a tube with a dial and a blue clip. The second device is a OneSett Subcutaneous Administration Set, which is similar to the intravenous controller but has three additional tubes with blue clips. The third device is an Insignis Syringe Driver, which is a syringe with a clear plastic case.
1. Insignis™ Syringe Driver:
The syringe driver is designed to accommodate one (1) BD Luer-Lok™ graduated 50mL syringe (BD# 309653), prefilled, with fluid volumes between 1 and 50 mL, as determined by the syringe's graduations. The patient-contacting surfaces of the driver are comprised of ABS plastic (medical device grade, acrylonitrile butadiene styrene). The middle and front face sections of the syringe driver are compartments to accommodate and secure the 50 mL BD Syringe into place, by securing the syringe plunger and flanges in place, respectively. The syringe driver is lever and spring operated in which a lever press loads the constant force spring mechanism and applies the force onto the syringe plunger to dispense drug from the syringe and through the infusion set. The syringe driver is fitted with a safety lock tab enabling the user to stop the infusion immediately, if needed.
2. Subcutaneous Administration Sets:
The Subcutaneous Administration Sets include the OneSett™ Subcutaneous Administration Sets and is used for subcutaneous infusions. The devices are comprised of medical grade materials, such as clear polyurethane tubing and
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polycarbonate connectors, that are designed to consider fluid path resistance and flowrate. The tubing contains a safety clamp allowing the user to stop the infusion as needed. The devices are fitted with polyethylene luer caps to aid in sterility.
The devices contain surgical grade stainless steel needles offered within 1 – 4 set configurations with needles ranging from 6, 9, 12 and 14mm penetration lengths. The needles are designed as part of the fluid path. The needles are housed within a polypropylene butterfly that acts as a safety feature to protect the needle and the user before and after the infusion.
The OneSett device contains a selectable rate flow controller device, the controller, made of ABS. The controller enables the user to set the infusion flowrate continuously from 10 – 60 mL/hr per infusion site for 20% immunoglobulin medications, such as Hizentra. The flowrate dial indications are marked at 10, 15, 20, 25, 30, 40, 50 and 60 mL/hr per infusion site. The OneSett device may be connected directly to the syringe and into the syringe driver for use.
3. Intravenous Administration Set:
The Intravenous Controller is used for intravenous infusions. This device are comprised of medical grade materials, such as clear polyurethane tubing and polycarbonate connectors, that are designed to consider fluid path resistance and flowrate. The tubing contains a safety clamp allowing the user to stop the infusion as needed. The devices are fitted with polyethylene luer caps to aid in sterility. The devices are connected to the syringe driver and directly to a catheter (not provided by IHS) to administer drug to the patient.
The Intravenous Controller device contains a selectable rate flow controller device, the controller, made of ABS. The controller is an in-line control dial that enables the user to select a range of continuous infusion flowrates from KVO - 265 mL/hr as indicated by each dial printing: Keep Vein Open (KVO) (~8 mL/hr), 32. 65, 130, 192. 255 and 265 milliliters per hour flow rates. In a constant pressure infusion system, everything in the fluid path serves to decrease the flow rate. Resistance factors such as drug viscosity, catheter tubing resistance, and venous back pressure are compensated for by design in the Insignis™ Syringe Infusion System in order to provide the patient with the expected flow rate, as indicated on the flow dial. Compared to bench testing conditions, under clinical use the flow rates may be slower depending on the infusion parameters.
Mechanism of Action:
The Insignis™ Syringe Infusion System is a portable non-electric mechanical constant pressure syringe infusion system comprised of the Insignis™ Syringe Driver (pump) and
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infusion sets such as the OneSett™ Subcutaneous Administration Set, and Intravenous Controller. The Syringe Driver serves to apply a constant force (constant pressure) onto the fluid reservoir, a syringe (50 mL BD Luer-Lok™ Syringe SKU#309653, sold separately) to dispense the infusion therapy fluid through the infusion set. The infusion set used depends on the infusion therapy and route of administration. The Insignis Syringe Driver only applies a constant force onto the syringe to dispense the drug whereas the infusion sets control the flowrate of the infused fluid. The syringe driver is activated by pressing a lever to apply the constant force onto the syringe.
To simplify, the syringe holds the infusion fluid, the syringe driver propels the infusion fluid from the syringe, and the infusion sets deliver the infusion fluid from the syringe to the patient with a controlled flowrate.
The infusion system will respond to increasing infusion resistance by reducing the infusion flowrate, a natural feature of constant force infusion systems.
Infusion sets with multiple needles have their performance rated as flowrate per infusion site. The needle sets are designed to provide equal flowrate to each infusion site. The OneSett Subcutaneous Administration Sets and Intravenous Controller devices contain a flow controller that allows for multiple selectable flowrates within a single device.
The infusion sets contain standard luer lock connectors.
The OneSett devices contain a safety butterfly to protect the needle and the user.
11. Non-Clinical Performance Testing
This section summarizes the non-clinical testing performed to evaluate the Insignis Syringe Infusion System to ensure the device meets its intended use and design requirements. All assessments, including biocompatibility, device performance, safety assurance case, human factor/usability studies were used to support the substantial equivalence determination.
Biocompatibility Testing
The following biocompatibility studies were performed in accordance with ISO 10993-1:
- · Cytotoxicity
- · Sensitization / Irritation
- · Implantation
- · Pyrogenicity / LAL
- · Acute Systemic Toxicity
- · Sub-Acute Systemic Toxicity
- · Hemocompatibility
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- · Extractables Chemical Characterization
The results of biocompatibility testing demonstrated the Insignis system to be biocompatible.
Device Performance
The following tests were performed to verify the intended use and essential performance of the device were obtained:
- Packaging validation as per ISO 11607-1:2019
- Shelf-life studies as per ISO 11607-1:2019, ASTM-F1980-16 ●
- Sterilization validation as per ISO 11137-2:2013 ●
- . Cleaning validation as per AAMI TIR12:2020, AAMI TIR30:2011
- Infusion system performance testing in accordance with FDA guidance "Infusion ● Pumps Total Product Life Cycle"
- Infusion system structural integrity testing
- Infusion system safety testing
- . Infusion system PKP immunoglobulin drug compatibility testing of Hizentra® Immune Globulin Subcutaneous (Human 20%) Liquid and Xembify® Immune Globulin Subcutaneous Human-klhw 20%
- o Anti-complementary (ACA)
- o Fc Function
- IgG Appearance o
- Protein Concentration o
- Density о
- o Characterization of IgG fragments, polymers, and aggregates
- o pH
- Infusion system antibiotic stability testing of Vancomycin Hydrochloride Solution .
The performance tests performed, including device performance, integrity, sterilization, packaging, drug compatibility and cleaning studies were used to support the substantial equivalence determination.
Safety Assurance Case Summary
The Safety Assurance Case (SAC) for the Insignis™ Syringe Infusion System was undertaken with the top-level goal of determining whether or not the system is acceptably safe for its intended use. For its argument structure, the SAC reviewed the indications for use and contraindications for the intended use populations and intended use environments, the device description of the infusion system and its components applying its verification, validation and reliability documents, and examined the Failure Modes Effects Analyses (FMEAs), Hazard Analyses and Risk Control Measures that comprise its Risk Management Documentation that also incorporate a review of the current databases for adverse event reporting, and inclusive of an Infusion Pump Certainty Case (IPCC). The SAC further examined relevant clinical literature. The SAC concluded that the Insignis™ Syringe Infusion System is acceptably safe for its intended use.
11
Usability / Human Factors Testing
Usability and Human Factors testing was conducted with the Insignis system to provide confirmation of usability for intended user groups, including nurses and caregivers.
12. Comparison of Subject Device to Predicate Device
The table below compares the characteristics of the subject and predicate device to address substantial equivalency.
| ID | Specification
or Feature | Insignis™ Syringe Infusion
System (K232328) | FREEDOM Integrated
Syringe Infusion System
(K200176) | Explanation of Technological
Comparisons / Rationale for
Safety / Contrary to the
Predicate |
|-----|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Indications for
Use | Infusion of intravenous or
subcutaneous infusion of
medications in the home,
hospital, or ambulatory
settings. | Infusion of intravenous or
subcutaneous infusion of
medications in the home,
hospital, or ambulatory
settings. | Equivalent |
| 2. | Fluid Reservoir
Type | Syringe | Syringe | Equivalent |
| 3. | Fluid Reservoir
Volume | BD Syringe 0 - 50 mL | BD Syringe 0 - 50 mL | Equivalent |
| 4. | Vertical
Sensitivity | ~ 2.4% per foot | ~ 2.4% per foot | Equivalent |
| 5. | Operating
Mechanism | 2-Constant force springs | Constant force spring | Different
The designs differ in spring
configuration for fitment within
the devices. |
| 6. | Principle of
Action | Constant pressure acting on
calibrated variable flowrate
restrictions. | Constant pressure acting on
fixed flow rate restrictions. | Equivalent
Both designs share the same
PoA; however, the Insignis
system provides (selectable)
variable flowrate infusion sets.
See "Intravenous Administration
System Design" and
"Subcutaneous Administration
System Design". |
| 7. | Syringe
Mechanism | Plunger inserted into
mechanism.
• Positive syringe
flange lock | Plunger inserted into
mechanism. | Equivalent
The Insignis system is designed
so that it cannot be operated if
the syringe is not properly
secured, and thus eliminates
(violent) ejection that could
damage the mechanism or injure
the user. The Insignis system
leaves the syringe luer tip free
without applying the operating
force of the mechanism onto the |
| | | | | |
| | | | | syringe tip, which may break the
tip and cause syringe ejection or
drug leakage. |
| 8. | Spring Loading
Mechanism | Forward gradual force loading
Enables partial dosing Reduces complexity Reduces parts Reduces noise/impulses Scalability | Spring loaded mechanism | Different
The Insignis system gradually
loads force to prepare the
infusion without the use of
complex or error-prone
mechanisms and does create
noise when loading. The design
consists of less parts allowing for
scalability and reduced
complexity. Upon deactivation
the pressure is immediately
released, and the infusion stops
instantly without causing
damage to the mechanism or
alarming the user. The Insignis
system has the ability to deliver
up to 10 mL for each lever strok
allowing users to review infusion
status before proceeding. |
| 9. | System
Accuracy | Reference flowrate tables
within the IFU. Flowrates, per
device and infused fluid will
perform within a specified
range. | Flowrates will fall between the
minimum and maximum
predicted values as specified in
the IFU. | Equivalent |
| 10. | Operating
Pressure | 13.5 psi | 15.0 psi | Different
Both designs provide safe
infusion pressures, the Insignis
system has a lower operating
pressure. |
| 11. | Maximum
Pressure | 14.2 psi | 15.0 psi | Different
Both designs provide safe
maximum infusion pressures, the
Insignis system has a lower
maximum pressure. |
| 12. | Pressure Profile | Linear, no slope | Linear, no slope | Equivalent |
| 13. | Time to Reach
Steady State
Flowrate | 460 infusion set
combinations | Different
See "Subcutaneous
Administration System Design" |
| 32. | Temperature
Compensation | OneSett: Selectable rate flow
controller with ability to
compensate for temperature
adjustments.
3% mL/hr per °C
temperature adjustment | Fixed Rate Tubing
Fixed flow rate | Different
The Insignis system offers the
ability to adjust the flowrate in
response to ambient temperature
conditions. |
| 33. | Infusion Set
Tubing
Material | Polyurethane (TPU) | Polyvinyl chloride (PVC) | Different
The devices use different tubing
materials. |
| 34. | Infusion Set
Luer Fitting and
Connector
Material | Polycarbonate (PC)
OneSett contain: female Luer
lock
Intravenous Controller contain:
female and male Luer locks. | Polyvinyl chloride (PVC)
HIgH Flo Needle Sets contain:
female Luer lock
Precision Flow Rate Tubing
contain: female and male Luer
locks. | Different
The devices use different
connector materials. Both
materials are commonly used in
medical devices. |
| 35. | Infusion Set
Luer Cap
Materials | High density polyethylene
(HDPE) and Polypropylene
(PP) | Polypropylene (PP) | Different
The devices use different luer
cap materials. |
| 36. | Infusion Set
Adhesive
Material | Ultraviolet (UV) adhesives and
cyclohexanone | Ultraviolet (UV) adhesives | Different
The devices use different
adhesive materials. |
| 37. | Infusion Set
Slide Clamp
Material | Polypropylene (PP) | Polyethylene (PE) | Different
The devices use different slide
clamp materials. |
| 38. | Infusion Set
Packaging
Material | Polyethylene (PE) bag | Polyethylene (PE) bag | Equivalent |
| 39. | Infusion Set
Selectable Rate
Flow Controller
Material | Acrylonitrile butadiene styrene
(ABS) and medical silicone. | Does not contain selectable
rate flow controller. | Different
The Insignis system offers a
selectable rate flow controller
made of medical grade materials
and has undergone
biocompatibility assessments. |
| 40. | Infusion Set
Butterfly
Material | Polypropylene (PP)
Intravenous devices do not
contain butterflies | Polypropylene (PP) | Equivalent |
| 41. | Infusion Set
Needle | Stainless steel (SUS)
Intravenous devices do not
contain needle(s) | Stainless Steel (SUS) | Equivalent |
12
13
14
15
16
Operational Differences:
Both the Insignis Syringe Infusion System and the predicate device share the same scientific operating principles, technologies, and intended uses. Both devices offer a selection of infusion flow rates. The predicate device offers a selection of flow rates using combinations of tubing and needles. The Insignis system offers a selectable range of flow rates on a single device using a combination of tubing, needles and selectable rate flow controller. This configuration reduces packaging and provides greater flexibility for understanding the delivered flow rate, simplifying inventory management, and patients requiring varying infusion flow rates during or in between infusions. Both devices offer a selection of flow rates that are within the prescribing information recommendations of the infused medication.
Both devices operate using a constant force syringe driver mechanism. The predicate device uses an operating pressure of 15 psi, and the Insignis system uses an operating pressure of 13.5 psi. These operating pressures are considered safe and effective for their intended use. Both devices are activated by mechanically activating the constant force springs. The predicate device uses knob turning to activate the device and the Insignis system uses lever pressing. Both are commonly used ergonomic methods found in medical devices.
Both devices are indicated for use with the 50 mL BD syringe (#309653) and use constant force springs to achieve a constant pressure.
The differences in operational and flow rate selections do not raise no new questions on safety and effectiveness.
Physical Differences:
The Insignis system and predicate device vary in physical dimensions including the weight and size of the infusion pumps, the dimensions for needles and tubing, and residual volumes. The predicate device offers 26G and 24G needles and the Insignis system offers 26G needles. The Insignis system optimizes tubing and needle dimensions to achieve similar flow rates of a 24G needle within a 26G needle. The predicate device offers more needle site configurations, however the use of the selectable rate flow controller in the Insignis system obviates the need for additional needle sites as more great flexibility in flow rate selection is provided with this configuration. Physical differences between the Insignis system and predicate device are minor and raise no new questions on safety and effectiveness.
17
Material Differences:
The Insignis system uses polypropylene, polycarbonate, stainless steel, polyurethane, polyethylene, and acrylonitrile butadiene styrene materials. Some of these materials are different compared to the predicate device. These materials are commonly used in medical devices and have undergone the required biocompatibility assessments. The material differences raise no new questions on safety and effectiveness.
Both devices use radiation sterilization. The predicate device uses gamma radiation, and the Insignis system uses electron beam radiation. Both methods are suitable sterilization methods for medical devices. The electron beam method for the Insignis system has been validated and the devices were tested showing no change to device performance and integrity.
On the basis of the substantial equivalence comparisons, any differences between the subject and predicate devices raise no new questions of safety or effectiveness, and the subject and predicate devices may be considered substantially equivalent.
13. Flowrate Performance
The following sections contain the flow rate performance information for the Insignis Syringe Infusion System. The flow rate performances presented were measured visually under bench testing conditions at 30 second intervals through the depletion of a syringe. Flow rate was measured by visually assessing the change in volume in a graduated cylinder every 30 seconds. Please refer to the following sections for additional information on the flow rates achieved during testing. The flow rates state the minimum and maximum flow rate and the percent deviation from the dial labeled flow rate. Please note the minimum flow rate is rounded down and the maximum flow rate is rounded up to the nearest decimal.
Intravenous Infusion
Intravenous (IV) Controller: For intravenous infusions using the IV Controller for flow rates in the range of 30ml/hr to 250ml/hr, the parts required include: Insignis Syringe Driver, 50mL BD syringe, and the Intravenous Controller. The table below presents the measured flowrates for the Intravenous Controller. Flowrates presented were measured by visually assessing the change in volume in a graduated cylinder every 30 seconds, when using the InsignisTM Syringe Infusion System as intended.
| Controller Dial Labeled Flowrate
| (mL/hr) | Flowrate Performance (mL/hr)** | Flowrate Percent Deviation |
|---|---|---|
| KVO* | 3.09 - 13.4 | -61.4%, +67.5% |
| 32 | 30.7 - 37.6 | -4.06%, +17.5% |
| 65 | 63.5 - 70 | -2.36%, +7.69% |
| 130 | 125 - 143 | -3.85%, +10% |
18
| 192 | 187 – 201 | -2.6%, +4.69% |
|---|---|---|
| 255 | 248 - 264 | -2.75%, +3.53% |
| 265 | 191 - 355 | -27.9%, +34% |
- KVO (8ml/hr) is only recommended for medications such as saline and dextrose.
** See Flow Rate Compensation section.
Subcutaneous IgG Infusion
Flowrate performance data for the Insignis system when used with Hizentra®, Cuvitru®, and Xembify®.
Hizentra® for Primary Immunodeficiency (PI) Flowrates
The table below presents the measured flowrates for the OneSett™ Subcutaneous Administration Set when used with Hizentra® for Primary Immunodeficiency (PI). Flowrates presented were measured by visually assessing the change in volume in a graduated cylinder every 30 seconds, when using the Insignis™ Syringe Infusion System as intended. Throughout the infusion, the measured flow rate may vary ±36% from the flow rate labeled on the dial.
| OneSett™
Subcutaneous
| Administration Set | Dial Setting - Nominal Flowrate per Infusion Site (mL/hr/site) | ||
|---|---|---|---|
| 10 | 15* | 20 - 60 | |
| 1 Needle | 6.45 - 13.6 | ||
| (±36%) | 9.68 - 20.4 | ||
| (±36%) | Do not set the | ||
| flowrate dial | |||
| above 15 | |||
| mL/hr/site. | |||
| 2 Needles | 6.45 - 13.6 | ||
| (±36%) | 9.68 - 20.4 | ||
| (±36%) | |||
| 3 Needles | 6.45 - 13.6 | ||
| (±36%) | 9.68 - 20.4 | ||
| (±36%) | |||
| 4 Needles | 6.45 - 13.6 | ||
| (±36%) | 9.68 - 20.4 | ||
| (±36%) |
*Subsequent infusion after initial infusion.
= Outside of drug's prescribing information recommended minimum - maximum flowrate.
Hizentra® for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Flowrates
The table below presents the measured flowrates for the OneSett™ Subcutaneous Administration Set when used with Hizentra® for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Flowrates presented were measured by visually assessing the change in volume in a graduated cylinder every 30 seconds, when using the InsignisTM Syringe Infusion System as intended. Throughout the infusion, the measured flow rate may vary ±36% from the flow rate labeled on the dial.
| OneSett™
Subcutaneous
Administration
| Set | Dial Setting - Nominal Flowrate per Infusion Site (mL/hr/site) | ||||||
|---|---|---|---|---|---|---|---|
| 1 Needle | 10 | 15 | 20* | 25* | 30* | 35* | 40 - 60 |
| 6.45 – 13.6 | 9.68 – 20.4 | 12.9 – 27.1 | 16.1 – 33.9 | 19.3 – 40.7 | 22.5 – 47.5 |
19
| | (±36%) | (±36%) | (±36%) | (±36%) | (±36%) | (±36%) | Do not set the
flowrate dial
above 35
mL/hr/site. |
|-----------|-----------------------|-----------------------|-----------------------|-----------------------|-----------------------|-----------------------|------------------------------------------------------------|
| 2 Needles | 6.45 - 13.6
(±36%) | 9.68 - 20.4
(±36%) | 12.9 - 27.1
(±36%) | 16.1 - 33.9
(±36%) | 19.3 - 40.7
(±36%) | 22.5 - 47.5
(±36%) | |
| 3 Needles | 6.45 - 13.6
(±36%) | 9.68 - 20.4
(±36%) | 12.9 - 27.1
(±36%) | 16.1 - 33.9
(±36%) | 19.3 - 40.7
(±36%) | 22.5 - 47.5
(±36%) | |
| 4 Needles | 6.45 - 13.6
(±36%) | 9.68 - 20.4
(±36%) | 12.9 - 27.1
(±36%) | 16.1 - 33.9
(±36%) | 19.3 - 40.7
(±36%) | 22.5 - 47.5
(±36%) | |
*Subsequent infusion after initial infusion.
= Outside of drug's prescribing information recommended minimum - maximum flowrate.
Xembify® for Primary Immunodeficiency (PI) Flowrates
The table below presents the measured flowrates for the OneSett™ Subcutaneous Administration Set when used with Xembify® for Primary Immunodeficiency (PI). Flowrates presented were measured by visually assessing the change in volume in a graduated cylinder every 30 seconds, when using the Insignis™ Syringe Infusion System as intended. Throughout the infusion, the measured flow rate may vary -48.4%, +9% from the flow rate labeled on the dial.
| OneSett™
Subcutaneous
Administration
| Set | Dial Setting - Nominal Flowrate per Infusion Site (mL/hr/site) | 10 | 15 | 20 | 25 - 60 |
|---|---|---|---|---|---|
| 1 Needle | 5.16 - 10.9 | ||||
| (-48.4%, +9%) | 7.74 - 16.3 | ||||
| (-48.4%, +9%) | 10.3 - 21.7 | ||||
| (-48.4%, +9%) | |||||
| 2 Needles | 5.16 - 10.9 | ||||
| (-48.4%, +9%) | 7.74 - 16.3 | ||||
| (-48.4%, +9%) | 10.3 - 21.7 | ||||
| (-48.4%, +9%) | Do not set the | ||||
| flowrate dial | |||||
| above 20 | |||||
| mL/hr/site. | |||||
| 3 Needles | 5.16 - 10.9 | ||||
| (-48.4%, +9%) | 7.74 - 16.3 | ||||
| (-48.4%, +9%) | 10.3 - 21.7 | ||||
| (-48.4%, +9%) | |||||
| 4 Needles | 5.16 - 10.9 | ||||
| (-48.4%, +9%) | 7.74 - 16.3 | ||||
| (-48.4%, +9%) | 10.3 - 21.7 | ||||
| (-48.4%, +9%) |
= Outside of drug's prescribing information recommended minimum - maximum flowrate.
Cuvitru® for Primary Immunodeficiency (PI) Flowrates
The table below presents the measured flowrates for the OneSett™ Subcutaneous Administration Set when used with Cuvitru® for Primary Immunodeficiency (PI). Flowrates presented were measured by visually assessing the change in volume in a graduated cylinder every 30 seconds, when using the Insigmis™ Syringe Infusion System as intended. Throughout the infusion, the measured flow rate may vary from the flow rate labeled on the dial.
| OneSett™
Subcutaneous
Administration
| Set | Dial Setting - Nominal Flowrate per Infusion Site (mL/hr/site) | ||||||
|---|---|---|---|---|---|---|---|
| 10 - 15 | 20* | 25* | 30* | 35* | 40* | 45 - 60 | |
| 1 Needle | Do not set | ||||||
| the flowrate | |||||||
| dial below | 11.7 - 24.7 | ||||||
| (-41.5%, | |||||||
| +23.5%) | 14.6 - 30.8 | ||||||
| (-41.6%, | |||||||
| +23.2%) | 17.5 - 37.0 | ||||||
| (-41.7%, | |||||||
| +23.3%) | 20.5 - 43.1 | ||||||
| (-41.4%, | |||||||
| +23.1%) | 23.4 - 49.2 | ||||||
| (-41.5%, | |||||||
| +23%) | Do not set | ||||||
| the flowrate | |||||||
| dial above |
20
| | 20
mL/hr/site. | 11.7 – 24.7
(-41.5%,
+23.5%) | 14.6 – 30.8
(-41.6%,
+23.2%) | 17.5 – 37.0
(-41.7%,
+23.3%) | 20.5 – 43.1
(-41.4%,
+23.1%) | 23.4 – 49.2
(-41.5%,
+23%) | 40
mL/hr/site. |
|-----------|-------------------|------------------------------------|------------------------------------|------------------------------------|------------------------------------|----------------------------------|-------------------|
| 2 Needles | | 11.7 – 24.7
(-41.5%,
+23.5%) | 14.6 – 30.8
(-41.6%,
+23.2%) | 17.5 – 37.0
(-41.7%,
+23.3%) | 20.5 – 43.1
(-41.4%,
+23.1%) | 23.4 – 49.2
(-41.5%,
+23%) | |
| 3 Needles | | 11.7 – 24.7
(-41.5%,
+23.5%) | 14.6 – 30.8
(-41.6%,
+23.2%) | 17.5 – 37.0
(-41.7%,
+23.3%) | 20.5 – 43.1
(-41.4%,
+23.1%) | 23.4 – 49.2
(-41.5%,
+23%) | |
| 4 Needles | | 11.7 – 24.7
(-41.5%,
+23.5%) | 14.6 – 30.8
(-41.6%,
+23.2%) | 17.5 – 37.0
(-41.7%,
+23.3%) | 20.5 – 43.1
(-41.4%,
+23.1%) | 23.4 – 49.2
(-41.5%,
+23%) | |
*Subsequent infusion after first two infusions.
*Subsquent influsion after first two information recommended minimum - maximum flowrate.
14. Substantial Equivalence Conclusion
The subject device demonstrates substantial equivalence to the predicate device and does not raise any new questions regarding safety or effectiveness.