Insignis™ Syringe Infusion System

K232328 · Innovative Health Sciences, LLC · FPA · Mar 1, 2024 · General Hospital

Device Facts

• Record ID: K232328
• Device Name: Insignis™ Syringe Infusion System
• Applicant: Innovative Health Sciences, LLC
• Product Code: FPA · General Hospital
• Decision Date: Mar 1, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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)

Device Story

Portable, non-electric mechanical infusion system; uses constant force spring-loaded driver to apply 13.5 psi pressure to 50 mL BD syringe. Input: user-filled syringe. Transformation: constant pressure drives fluid through selectable-rate flow controller (in-line) and administration set (subcutaneous needle sets or IV tubing). Output: controlled fluid delivery to patient. Used in home, hospital, or ambulatory settings by clinicians or lay users. Healthcare providers use flow rate dials to set infusion parameters; system compensates for resistance (viscosity, back pressure). Benefits: enables portable, controlled delivery of immunoglobulins and antibiotics without electricity; reduces complexity and inventory management compared to fixed-rate systems.

Clinical Evidence

Bench testing only. Performance verified via infusion system testing (flow rate accuracy, structural integrity, safety), biocompatibility (ISO 10993-1), sterilization validation, and drug compatibility (immunoglobulins and antibiotics). Usability/human factors testing confirmed safe operation by intended users. No clinical trials performed.

Technological Characteristics

Mechanical, non-electric constant pressure infusion system. Materials: ABS, polycarbonate, polyurethane, stainless steel, polyethylene, polypropylene. Sensing/Actuation: Constant force spring mechanism. Dimensions: 8.5" x 4" x 2.5". Connectivity: None (standalone). Sterilization: Electron beam radiation. Flow control: Selectable-rate flow controller (in-line).

Indications for Use

Indicated for subcutaneous infusion of specific human plasma-derived immunoglobulins (Cuvitru, Hizentra, Xembify) and intravenous infusion of saline, dextrose, and specific antibiotics (vancomycin, ertapenem, meropenem, oxacillin, tobramycin). Intended for adults and adolescents (13-21 years) in home, hospital, or ambulatory settings. Adolescent use requires adult supervision after clinician instruction.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• FREEDOM Integrated Syringe Infusion System (K200176)

Reference Devices

• SCIg60 Infusion System (K222087)
• Insignis Subcutaneous Needle Sets (K202279)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="padding-right: 20px;"> <span style="padding-right: 5px;">☑</span>Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="padding-right: 5px;">☐</span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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#### K232328 510(k) Summary

#### 1. 510(k) Number

K232328

#### 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

- . K222087 SCIg60 Infusion System
- K202279 Insignis Subcutaneous Needle Sets ●

#### 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

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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.

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## 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<br>or Feature | Insignis™ Syringe Infusion<br>System (K232328) | FREEDOM Integrated<br>Syringe Infusion System<br>(K200176) | Explanation of Technological<br>Comparisons / Rationale for<br>Safety / Contrary to the<br>Predicate |
|-----|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Indications for<br>Use | Infusion of intravenous or<br>subcutaneous infusion of<br>medications in the home,<br>hospital, or ambulatory<br>settings. | Infusion of intravenous or<br>subcutaneous infusion of<br>medications in the home,<br>hospital, or ambulatory<br>settings. | Equivalent |
| 2. | Fluid Reservoir<br>Type | Syringe | Syringe | Equivalent |
| 3. | Fluid Reservoir<br>Volume | BD Syringe 0 - 50 mL | BD Syringe 0 - 50 mL | Equivalent |
| 4. | Vertical<br>Sensitivity | ~ 2.4% per foot | ~ 2.4% per foot | Equivalent |
| 5. | Operating<br>Mechanism | 2-Constant force springs | Constant force spring | Different<br>The designs differ in spring<br>configuration for fitment within<br>the devices. |
| 6. | Principle of<br>Action | Constant pressure acting on<br>calibrated variable flowrate<br>restrictions. | Constant pressure acting on<br>fixed flow rate restrictions. | Equivalent<br>Both designs share the same<br>PoA; however, the Insignis<br>system provides (selectable)<br>variable flowrate infusion sets.<br>See "Intravenous Administration<br>System Design" and<br>"Subcutaneous Administration<br>System Design". |
| 7. | Syringe<br>Mechanism | Plunger inserted into<br>mechanism.<br>• Positive syringe<br>flange lock | Plunger inserted into<br>mechanism. | Equivalent<br>The Insignis system is designed<br>so that it cannot be operated if<br>the syringe is not properly<br>secured, and thus eliminates<br>(violent) ejection that could<br>damage the mechanism or injure<br>the user. The Insignis system<br>leaves the syringe luer tip free<br>without applying the operating<br>force of the mechanism onto the |
| | | | | |
| | | | | syringe tip, which may break the<br>tip and cause syringe ejection or<br>drug leakage. |
| 8. | Spring Loading<br>Mechanism | Forward gradual force loading<br>Enables partial dosing Reduces complexity Reduces parts Reduces noise/impulses Scalability | Spring loaded mechanism | Different<br>The Insignis system gradually<br>loads force to prepare the<br>infusion without the use of<br>complex or error-prone<br>mechanisms and does create<br>noise when loading. The design<br>consists of less parts allowing for<br>scalability and reduced<br>complexity. Upon deactivation<br>the pressure is immediately<br>released, and the infusion stops<br>instantly without causing<br>damage to the mechanism or<br>alarming the user. The Insignis<br>system has the ability to deliver<br>up to 10 mL for each lever strok<br>allowing users to review infusion<br>status before proceeding. |
| 9. | System<br>Accuracy | Reference flowrate tables<br>within the IFU. Flowrates, per<br>device and infused fluid will<br>perform within a specified<br>range. | Flowrates will fall between the<br>minimum and maximum<br>predicted values as specified in<br>the IFU. | Equivalent |
| 10. | Operating<br>Pressure | 13.5 psi | 15.0 psi | Different<br>Both designs provide safe<br>infusion pressures, the Insignis<br>system has a lower operating<br>pressure. |
| 11. | Maximum<br>Pressure | 14.2 psi | 15.0 psi | Different<br>Both designs provide safe<br>maximum infusion pressures, the<br>Insignis system has a lower<br>maximum pressure. |
| 12. | Pressure Profile | Linear, no slope | Linear, no slope | Equivalent |
| 13. | Time to Reach<br>Steady State<br>Flowrate | < 1s | < 1s | Equivalent |
| 14. | Pressure<br>Accuracy<br>(During<br>infusion<br>accuracy) | 3% | 3% | Equivalent |
| 15. | Infusion Pump<br>Weight | 1.6 lbs | 1 lb | Different<br>Both devices are different<br>weights. |
| 16. | Infusion Pump<br>Dimensions | 8.5" x 4" x 2.5" | 9" x 3.25x 1.5' | Different |
| 17. | Infusion Pump<br>Materials | Acrylonitrile butadiene styrene<br>(ABS) and polycarbonate<br>(PC) | Acrylonitrile butadiene styrene<br>(ABS) | Both devices are different sizes.<br>Different<br><br>The devices use different pump<br>materials. |
| 18. | Subcutaneous<br>Needle Gauge<br>Size | 26G (for OneSett) | 26G, 24G | Equivalent<br><br>IHS offers 26G needles that can<br>obtain equivalent flow<br>performance of 24G needles<br>within a smaller less painful<br>needle, providing a smaller<br>needle with equivalent flow rate<br>performances. Predicate contain<br>additional offering(s). |
| 19. | Subcutaneous<br>Needle Safety<br>Closure<br>Mechanism | Butterfly safety closure<br>• Guide-assisted<br>closure<br>• Tactile/audible<br>closure confirmation<br>(for OneSett) | Butterfly safety closure | Equivalent<br><br>Both designs offer subcutaneous<br>butterfly safety closure features.<br>The Insignis system contains a<br>guide-assisted closure that<br>provides both audible and tactile<br>feedback upon closure providing<br>a more secure butterfly safety<br>closure which may reduce needle<br>stick injury occurrences. |
| 20. | Subcutaneous<br>Needle<br>Alignment | 90° from butterfly safety<br>closure plane<br>• Pre-use needle<br>securement feature<br>(for OneSett) | 90° from butterfly safety<br>closure plane | Equivalent<br><br>The Insignis system<br>subcutaneous butterfly safety<br>contains a needle alignment<br>design feature to maintain the<br>needle at 90° prior to use. |
| 21. | Subcutaneous<br>Needle Lengths<br>Available | 6, 9, 12 and 14mm<br>(for OneSett) | 4, 6, 9, 12 and 14mm | Equivalent<br><br>Predicate contains additional<br>offering(s). |
| 22. | Number of<br>Subcutaneous<br>Needle Sites | 1 - 4<br>(for OneSett) | 1 - 6, - 8 with Y-connector | Equivalent<br><br>Predicate contains additional<br>offering(s). |
| 23. | Tubing Length | 24" for OneSett Subcutaneous<br>Administration Set<br><br>62" for Intravenous Controller | 20" for 26G needle set<br>configurations<br>24" for 24G needle set<br>configurations<br><br>6 - 72" for Precision Flow<br>Rate Tubing | Equivalent<br><br>See "Subcutaneous Needle<br>Gauge Size". Predicate contains<br>additional offering(s). |
| 24. | Multi Needle<br>Site Flowrate<br>Performance | Equal flowrate to each infusion<br>site (for OneSett) | Equal flowrate to each infusion<br>site. | Equivalent |
| 25. | Residual<br>Volumes | 0.342 – 2.428 mL per infusion<br>set | 0.1 - 1.4 mL per infusion set | Different<br><br>The Insignis system offers the |
| 26. | Sterilization<br>Method | Radiation (electron beam) | Radiation (gamma) | selectable rate flow controller as<br>one device, contrary the<br>predicate requires a fixed rate<br>tubing and needle set to achieve<br>the same functioning, requiring<br>summing at least two residual<br>volumes.<br>Equivalent<br><br>Both methods are industry<br>recognized and standardized<br>sterilization methods for medical<br>devices. |
| 27. | Intravenous<br>Administration<br>System Design | Selectable rate flow controller<br>for IV applications w/ syringe<br>driver<br><br>Real time response<br>adjustments of flowrate (i.e.,<br>anaphylaxis adjustment)<br>Selectable to precise<br>flow rate.<br>● | Fixed flow rate tubing sets. | Different<br><br>The Insignis system offers the<br>ability to change the flow rate in<br>real time. The desired flowrate<br>can be accurately and precisely<br>set, contrary to fixed rate tubing<br>systems. |
| 28. | Subcutaneous<br>Administration<br>System Design | OneSett™ Subcutaneous<br>Administration Set<br><br>Combines selectable<br>flowrate controller and needle<br>set in a single device<br><br>Minimum 1<br>packaging to track in inventory<br>to achieve intended use.<br><br>Direct indication of<br>delivered flowrate per infusion<br>site<br><br>No calculators<br>required<br><br>Real time response<br>adjustments of flowrate (i.e.,<br>responding to dynamic<br>equilibrium)<br><br>Reduced material and<br>packaging<br>●<br>●<br>●<br>●<br>●<br>● | Multiple needle set offerings<br>Different gauges<br>Different fixed rate<br>tubing<br>Calculators<br>Lookup charts<br>●<br>●<br>● | Different<br><br>The Insignis system offers a<br>single device combining<br>subcutaneous needle sets and a<br>selectable rate flow controller<br>offering the ability to change the<br>flow rate in real time. The<br>Insignis system is packaged as a<br>single device and does not<br>require multiple connections,<br>multiple SKU management, or<br>calculators, contrary to fixed rate<br>tubing. Provides clear indication<br>of flow rate delivered per<br>infusion site. |
| 29. | Application of<br>Dynamic<br>Equilibrium to<br>Selectable Flow<br>Rate Controller | Real time site patency<br>determination with adjustable<br>flowrate to respond to adverse<br>reactions. | Real time site patency. | Equivalent |
| 30. | Intravenous<br>Viscosity<br>Considerations | IV calibration adjustment for<br>flowrate resistances caused<br>from drug viscosity, PICC line<br>resistance, and venous<br>pressure. | IV calibration adjustment for<br>flowrate resistances caused<br>from drug viscosity, PICC line<br>resistance, and venous<br>pressure. | Equivalent |
| 31. | Subcutaneous<br>Viscosity<br>Considerations | Dedicated selectable flow rate<br>controller infusion sets for<br>specific immunoglobulin (IgG)<br>concentrations.<br>Current 20% IgG<br>offering16x SKU IgG<br>offerings<br>Dedicated Subcutaneous<br>Needle Sets for specific<br>immunoglobulin (IgG)<br>concentrations. | Fixed Rate Tubing<br>Tables / calculators<br>for determining flowrate and<br>infusion set combinations for<br>different drug viscosities.<br>>460 infusion set<br>combinations | Different<br>See "Subcutaneous<br>Administration System Design" |
| 32. | Temperature<br>Compensation | OneSett: Selectable rate flow<br>controller with ability to<br>compensate for temperature<br>adjustments.<br>3% mL/hr per °C<br>temperature adjustment | Fixed Rate Tubing<br>Fixed flow rate | Different<br>The Insignis system offers the<br>ability to adjust the flowrate in<br>response to ambient temperature<br>conditions. |
| 33. | Infusion Set<br>Tubing<br>Material | Polyurethane (TPU) | Polyvinyl chloride (PVC) | Different<br>The devices use different tubing<br>materials. |
| 34. | Infusion Set<br>Luer Fitting and<br>Connector<br>Material | Polycarbonate (PC)<br>OneSett contain: female Luer<br>lock<br>Intravenous Controller contain:<br>female and male Luer locks. | Polyvinyl chloride (PVC)<br>HIgH Flo Needle Sets contain:<br>female Luer lock<br>Precision Flow Rate Tubing<br>contain: female and male Luer<br>locks. | Different<br>The devices use different<br>connector materials. Both<br>materials are commonly used in<br>medical devices. |
| 35. | Infusion Set<br>Luer Cap<br>Materials | High density polyethylene<br>(HDPE) and Polypropylene<br>(PP) | Polypropylene (PP) | Different<br>The devices use different luer<br>cap materials. |
| 36. | Infusion Set<br>Adhesive<br>Material | Ultraviolet (UV) adhesives and<br>cyclohexanone | Ultraviolet (UV) adhesives | Different<br>The devices use different<br>adhesive materials. |
| 37. | Infusion Set<br>Slide Clamp<br>Material | Polypropylene (PP) | Polyethylene (PE) | Different<br>The devices use different slide<br>clamp materials. |
| 38. | Infusion Set<br>Packaging<br>Material | Polyethylene (PE) bag…