Avoset Infusion Pump System

K213744 · Eitan Medical , Ltd. · FRN · Mar 10, 2023 · General Hospital

Device Facts

• Record ID: K213744
• Device Name: Avoset Infusion Pump System
• Applicant: Eitan Medical , Ltd.
• Product Code: FRN · General Hospital
• Decision Date: Mar 10, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Avoset Infusion Pump is a single-channel, volumetric infusion pump. Medication is delivered at continuous rate, and/or with an intermittent bolus, and/or with a patient bolus and/or with taper.

Device Story

Ambulatory, single-channel, volumetric infusion pump; delivers fluids via continuous, intermittent bolus, patient-controlled bolus, or taper modes. Inputs: treatment protocols created via external PC-based Programming Tool; pump accepts bags, syringes, or non-collapsible reservoirs. Operation: microprocessor-controlled linear peristaltic mechanism; DC motor; battery-powered. Output: controlled fluid delivery; status data for fleet management/monitoring via optional Insight Tool (no pump control). Used in clinical, home, and transport settings by clinicians or lay users. Healthcare providers use pump interface to monitor delivery; Insight Tool provides fleet/treatment oversight. Benefits: portable, precise medication delivery across diverse clinical and ambulatory settings.

Clinical Evidence

Bench testing only. Includes software verification/validation (Major Level of Concern), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), home use (IEC 60601-1-11), alarm testing (IEC 60601-1-8), infusion accuracy (FDA Infusion Pump TPLC guidance), biocompatibility (ISO 10993-1), sterility (ISO 11135), human factors/usability engineering, cybersecurity, and shipping validation (ASTM D4169-16).

Technological Characteristics

Microprocessor-controlled linear peristaltic pump; 365g weight; 0.1-300 mL/h flow rate. Materials: PVC, ABS, Acrylic, Polyethylene, Polyethersulfone, PTFE, Silicone, Polypropylene, Polyamide, Polycarbonate, Polyurethane, TPE. Energy: Battery (rechargeable/alkaline). Connectivity: BLE and NFC. Sterilization: EtO (SAL 10^-6). Software: Major level of concern.

Indications for Use

Indicated for parenteral (intra-arterial, intra-venous, subcutaneous, perineural, epidural) and enteral infusions of IV medication, TPN, enteral nutrition, lipids, and epidural medication. Used for pediatric (infants, children, adolescents) and adult patients in clinical and ambulatory environments, including home, plane, and ground transport. Operated by licensed healthcare professionals or lay users.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• CADD-Solis system (K170982)
• Sapphire administration sets (K192860)

Submission Summary (Full Text)

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March 10, 2023

Eitan Medical Ltd. % Rhona Shanker President Z & B Enterprises, Inc. 12154 Darnestown Road, #236 Gaithersburg. Maryland 20878

Re: K213744

Trade/Device Name: Avoset Infusion Pump System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, MRZ, FPA Dated: February 14, 2023 Received: February 14, 2023

Dear Rhona Shanker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerelv.

# Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K213744

Device Name Avoset Infusion Pump

#### Indications for Use (Describe)

Intended use:

The Avoset Infusion Pump is a single-channel, volumetric infusion is delivered at continuous rate, and/or with an intermittent bolus, and/or with a patient bolus and/or with taper.

Indication of use:

Routes: Parenteral (intra-arterial, intra-venous, subcutaneous, perineural, epidural)

and enteral infusions

Fluids: IV medication (including fluids), Total Parenteral Nutrition (TPN), enteral medication and nutrition, lipids, epidural medication.

Program Types (specific uses): The pump delivers in one of four program types: a continuous rate of infusion, and/or an intermittent bolus, and/or with patient-controlled intermittent doses, and/or with tapering.

Patient Population: Pediatric: infants, children, and adolescents and adult patients.

Intended Environments. Intended to be used in clinical environment including, home, plane and ground transportation.

Users: licensed health care professional and lay users

The dedicated Administration Sets for the Avoset Infusion Pump are intended for single-patient use and single-use only. Set configurations are: (i) Enteral; (ii) Epidural and (iii) General purpose for the routes: intra-arterial, intravenous, subcutaneous, perineural.

The Avoset Programming Tool is intended to be used with a computer to create a treatment-based protocol that is boaded onto the pump. The programming tool is intended for use by professional users.

Type of Use (Select one or both, as applicable)

| <span></span> | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|------------------------------------------------------------|
| <span></span> | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### K213744 510(k) Summary

| Owner/Submitter | Eitan Medical Ltd.<br>29 Yad Haruzim St.<br>Netanya 4250529<br>ISRAEL<br>Ph: [phone]<br>Fax: [phone] |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Rhona Shanker<br>FDA Regulatory Consultant to Eitan Medical Ltd<br>Ph: 301-251-9570<br>Email: [e-mail] |
| Trade Name | Avoset Infusion Pump |
| Common Name | Infusion Pump |
| Classification Name | Infusion Pump 21 CFR 880.5725<br>Product Codes:<br>FRN - Infusion pump<br>MRZ - Infusion pump accessories<br>FPA - Administration Sets (21 CFR 880.5440)<br>Class II |
| Predicate Device<br>For Infusion pump | CADD-Solis system (pump and PC Tool) cleared under K170982 |
| Predicate Device for<br>Administration sets | (K192860) Sapphire administration sets |
| Date of Preparation | 8 March 2023 |

#### Device Description

The Avoset Infusion system (pump and accessories) covered by this submission is the Avoset infusion pump, an ambulatory pump intended for controlled infusion at rates between 0.1-300 mL/h at a continuous rate, and/or with an intermittent bolus, and/or with a patient bolus and/or with taper, in the hospital and home environments for pediatric and adult patients.

The Avoset infusion pump weighs 365 grams, has 89 parts, and allows infusion from (i) bags; (ii) syringes; and (iii) non collapsible medication reservoirs.

The device also contains an optional module (referred to as "Insight Tool"). The module receives data from the pump and uses it for (i) fleet management and (ii) treatment monitoring applications to ensure patient has completed the treatment. This module does not impact or pass data into the pump.

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The dedicated Avoset Administration Sets are sterile (apart of the Enteral sets) and intended for singlepatient use and single-use only.

## Intended and Indications for Use

Intended Use

The Avoset Infusion Pump is a single-channel, volumetric infusion pump. Medication is delivered at continuous rate, and/or with an intermittent bolus, and/or with a patient bolus and/or with taper. Indication for use

Routes: Parenteral (intra-arterial, intra-venous, subcutaneous, perineural, epidural) and enteral infusions Fluids: IV medication (including fluids), Total Parenteral Nutrition (TPN), enteral medication and nutrition, lipids, epidural medication.

Program Types (specific users): The pump delivers in one of four program types: a continuous rate of infusion, and/or an intermittent bolus, and/or with patient-controlled intermittent doses, and/or with tapering

Patient Population: Pediatric: infants, children, adolescents and adult patients

Intended Environments: Intended to be used in clinical environment and ambulatory environment including, home, plane and ground transportation.

Users: licensed health care professional and lay users

The dedicated Administration Sets for the Avoset Infusion Pump are intended for single-patient use and single-use only.

Set configurations are: (i) Enteral; (ii) Epidural and (iii) General purpose for the balance of the routes: intra-arterial, intra-venous, subcutaneous, perineural.

The Avoset Programming Tool: is intended to be used with a computer to create a treatment-based protocol that is loaded onto the pump. The programming tool is intended for use by professional users.

# Pump Substantial Equivalence Discussion summary

The table below includes a comparison of the indications for use between the new device and that of the predicate:

| Characteristic | Subject Device - Avoset Infusion Pump | CADD®-Solis Infusion Pump, Model<br>2110 (K170982) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Intended Use<br>The Avoset Infusion Pump is a single-channel, volumetric infusion pump. Medication is delivered at continuous rate, and/or with an intermittent bolus, and/or with a patient bolus and/or with taper.<br>Indication for use<br>Routes: Parenteral (intra-arterial, intra-venous, subcutaneous, perineural, epidural) and enteral infusions | Intended use<br>Intended to be used for patient care for adult and pediatric patients in multiple clinical care areas, including but not limited to post-operative, trauma, critical care, oncology, and labor and delivery. The pump can be programmed with a protocol configuration consisting of a therapy, qualifier, and drug. Medication is delivered at a constant rate, and/or with an |
| Fluids: IV medication (including fluids),<br>Total Parenteral Nutrition (TPN), enteral<br>medication and nutrition, lipids, epidural<br>medication.<br>Program Types (specific users): The pump<br>delivers in one of four program types: a<br>continuous rate of infusion, and/or an<br>intermittent bolus, and/or with patient-<br>controlled intermittent doses, and/or with<br>tapering<br>Patient Population: Pediatric: infants,<br>children, adolescents and adult patients<br>Intended Environments: Intended to be used<br>in clinical environment and ambulatory<br>environment including, home, plane and<br>ground transportation.<br>Users: licensed health care professional and<br>lay users<br>The dedicated Administration Sets for the<br>Avoset Infusion Pump are intended for<br>single-patient use and single-use only.<br>Set configurations are: (i) Enteral; (ii)<br>Epidural and (iii) General purpose for the<br>balance of the routes: intra-arterial, intra-<br>venous, subcutaneous, perineural.<br>The Avoset Programming Tool: is intended<br>to be used with a computer to create a<br>treatment-based protocol that is loaded onto<br>the pump. The programming tool is intended<br>for use by professional users. | intermittent bolus, and/or with a patient<br>dose.<br>Indication for use<br>Indicated for intravenous, intra-arterial,<br>subcutaneous, intraperitoneal, in close<br>proximity to nerves, into an intraoperative<br>site (soft tissue, body cavity/surgical wound<br>site), epidural space or subarachnoid space.<br>The pump is intended for therapies that<br>require a continuous rate of infusion, and/or<br>an intermittent bolus, and/or with patient-<br>controlled demand doses | |
| Prescription or<br>over the counter | Prescription | Prescription |
| Intended<br>population | Pediatric (infants, children, and adolescents)<br>and adult patients. | Pediatric and adult patients. |
| Environment of<br>Use | Clinical environment and ambulatory<br>environment including home, plane and<br>ground transportation | Multiple clinical care areas, including but<br>not limited to post-operative, trauma, critical<br>care, oncology and labor and delivery |

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## Discussions of differences in Indications for Use statement

The Avoset pump has two additions to the Indications for Use statement:

- . Enteral Route: The enteral delivery route was added.
- Taper Delivery profile: This delivery mode was added to allow for infusion that require this ● mode.

## Discussion of differences in the intended population

The target population includes adults and pediatrics excluding neonates. The predicate device does not exclude neonates.

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# Discussion of differences in the Environment of Use

The Avoset pump includes use in ambulatory environments: The predicate device is limited to use in clinical environments.

Conclusion: The CADD is the appropriate predicate device with respect to the indications/ intended use, despite of the differences identified above.

# Pump system Technological Characteristics

The table below includes a comparison of the technological characteristics between the new pump system and those of the predicate pump:

| | Description | Subject Device - Avoset<br>Infusion Pump | CADD®-Solis Infusion<br>Pump, Model 2110<br>(K170982) | Comments |
|-------------------------------|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| | Pump | | | |
| Design | Pumping<br>mechanism | Microprocessor controlled<br>linear peristaltic pumping<br>mechanism (Single channel<br>volumetric) | Microprocessor controlled<br>linear peristaltic pumping<br>mechanism (Single channel<br>volumetric) | Identical |
| | Dimensions | Approximately 424 cm3 (96 mm x 96 mm x 46 mm);<br>Approximately 400 grams | Approximately 500 cm3<br>(40mm x 101mm X 127mm);<br>Approximately 600 grams | Similar<br>dimensions<br>and weight |
| | Motor | DC motor operated by internal<br>batteries and controlled by SW | DC motor operated by<br>internal batteries and<br>controlled by SW | Identical |
| | Accuracy | $ \pm $ 5% (including boluses) under<br>most conditions. Additional<br>details provided in the labeling. | 6% | Supported<br>through<br>performance<br>testing |
| | Flow rate | 0.1-300 mL/h | 0.1-500 mL/h | Within<br>predicate<br>range |
| | VTBI capacity<br>range | 0- 9,999mL | 0- 9,999mL | Identical |
| | Occlusion<br>detection<br>pressure | Upstream: fixed (pre-set in the<br>pump; no option for user to<br>modify) threshold<br>Downstream: 0.5 - 1.6 Bar | Upstream: fixed (pre-set in<br>the pump; no option for user<br>to modify) threshold<br>0.62 - 1.68 bar | Tighter range<br>than the<br>predicate |
| | Description | Subject Device - Avoset Infusion Pump | CADD®-Solis Infusion Pump, Model 2110 (K170982) | Comments |
| | Air detection | 100 µL minimal detection level | 150 µL | Tighter spec than predicate |
| | Air off | Optional mode | Optional mode | Identical |
| | Alarms | Low Battery, battery depletion, battery extraction, pump unattended, action incomplete, cassette misplaced, key stuck, upstream occlusion, downstream occlusion, infusion complete, add bag, air in line, HW/mechanical/SW failures. Alarms comply with IEC 60601-1-8 | Low Battery, battery depletion, battery extraction, pump unattended, action incomplete, cassette misplaced, key stuck, upstream occlusion, downstream occlusion, infusion complete, add bag, air in line, HW/mechanical/SW failures. Alarms comply with IEC 60601-1-8 | Identical |
| Material | Administration sets | The fluid path of the administration sets is biocompatible | The fluid path of the administration sets is biocompatible | Identical |
| Energy source | Powered by | Rechargeable: Duracell DX1500<br>Alkaline: Duracell MN1500 (a.k.a. coppertop) | Rechargeable battery pack or AC adaptor | Within predicate power options |
| Other device features | UI | LCD screen, keypad user interface | LCD screen, keypad user interface | Identical |
| | Reservoir | Syringe (5-60mL) (in addition to infusion bag and a dedicated cartridge) | Infusion bag, dedicated cartridge, no syringe | See comment 2 |
| | Connectivity | BLE and NFC | Wi-Fi | See comment 3 |
| Pump Service life | Service life | 7 years | 5 years | Difference supported through performance testing |
| Pump Altitude operation range | Altitude operation range | 50 kPa to 106 kPa [equivalent to altitude of -381 m to 6096 m (-1210 ft to 20000 ft)] | 70 kPa to 106 kPa | Difference supported through performance testing |
| Use environment | Ambulatory | Ambulatory (home, plane, and ground transportation) | Ambulatory | Difference supported through performance testing. See comment 1 |
| | Description | Subject Device - Avoset<br>Infusion Pump | CADD®-Solis Infusion<br>Pump, Model 2110<br>(K170982) | Comments |
| | | PC Tool | | |
| Intended<br>Use | Intended Use | The Avoset Programming Tool<br>is intended to be used with a<br>computer to create a treatment-<br>based protocol that is loaded<br>onto the pump. The<br>programming tool is intended<br>for use by professional users. | Allows the use of a computer<br>to create therapy-based<br>protocol libraries to be used<br>with the CADD®-Solis<br>Infusion Pump. | See comment<br>4 |
| Design | Treatment data<br>transfer | Allow the transfer of treatment<br>data to the pump: Delivery<br>profile, Drug, rate, VTBI, PCA<br>dose, dose lockout, maximum<br>dose, hard limits for VTBI, rate<br>and KVO, weight-based units,<br>concentration, air detection<br>threshold, occlusion threshold,<br>alarm volume, delayed start. | Allow the transfer of<br>treatment data to the pump:<br>Delivery profile, Drug, rate,<br>VTBI, PCA dose, dose<br>lockout, maximum dose,<br>hard limits for VTBI, rate<br>and KVO, weight-based<br>units, concentration, air<br>detection threshold,<br>occlusion threshold, alarm<br>volume, delayed start. | Identical |
| | Number of<br>treatments | Only one treatment is sent to<br>the pump at a time | Several treatments are sent<br>( | |

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Discussions of differences in technological characteristics

#### Comment 1

These uses are supported by compliance with:

- RTCA DO-160 section 20 (category R): for plane environment
- IEC 60601-1-11: for ground environment .

demonstrating safe and effective operation also under plane environment

## Comment 2

The Avoset pump has the ability to draw from a syringe. This capability does not raise new questions of safety and/or effectiveness since the Avoset's pumping mechanism is such that accuracy is not impacted by the source from which medication is drawn.

## Comment 3

The Avoset pump wireless communication technology is BLE and NFC (opposed to Wi-Fi in the predicate). Avoset wireless complies with FCC, EMC (IEC 60601-1-2) and coexistence (as required) according to FDA guidance. Respective technologies are well established and

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comparable. The connection does not allow for remote programming or control of the connected pump.

Comment 4

Avoset's PC (software) tool is within the scope of the predicate's software tool Intended and Indication for use.

Both tools allow the programing and transferring of treatment information from the tool to the pump. The Avoset tool sends a single treatment ("a treatment") while the predicate can send more than one treatment to the pump.

Conclusion: The technological differences do not raise new questions of safety and effectiveness

#### Administration Sets Substantial Equivalence Discussion summary

#### Set configurations are: (i) Enteral; (ii) Epidural and (iii) General purpose for the balance of the routes: intra-arterial, intra-venous, subcutaneous, perineural.

Avoset has identified as the predicate the Sapphire's Administrations sets (K192860). Below is a discussion of how the two compare with respect to the Intended use/Indications for use and the technological characteristics.

| Characteristic | Subject Device - Avoset Infusion Pump | Sapphire's Administrations sets<br>(K192860) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Intended Use<br>The Avoset Infusion Pump is a single-<br>channel, volumetric infusion pump.<br>Medication is delivered at continuous rate,<br>and/or with an intermittent bolus, and/or with<br>a patient bolus and/or with taper.<br>Indication for use<br>Routes: Parenteral (intra-arterial, intra-<br>venous, subcutaneous, perineural, epidural)<br>and enteral infusions<br>Fluids: IV medication (including fluids),<br>Total Parenteral Nutrition (TPN), enteral<br>medication and nutrition, lipids, epidural<br>medication.<br>Program Types (specific users): The pump<br>delivers in one of four program types: a<br>continuous rate of infusion, and/or an<br>intermittent bolus, and/or with patient-<br>controlled intermittent doses, and/or with<br>tapering<br>Patient Population: Pediatric: infants,<br>children, adolescents and adult patients<br>Intended Environments: Intended to be used<br>in clinical environment and ambulatory | The Sapphire Infusion pump is intended for<br>controlled delivery through intravascular,<br>subcutaneous, intra-arterial, perineural and<br>epidural routes.<br><br>The pump is designed to deliver saline, Total<br>Parenteral Nutrition (TPN),lipids, IV<br>medication, perineural medication, epidural<br>medication, blood and blood products.<br><br>The Sapphire Infusion pump includes the<br>following infusion modes for all intended<br>uses: Continuous, Intermittent, TPN, PCA,<br>Multi-step, and Epidural.<br><br>It is intended to be used in the following<br>environments of use: clinical, ambulatory,<br>pre-hospital medical air and ground<br>transportation and home. The pump is<br>intended to be used by both licensed health<br>care professionals and by lay users.<br><br>The Sapphire and the administration sets are<br>indicated for use by both adult and pediatric |

# Intended use & Indication for use:

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| environment including, home, plane and<br>ground transportation.<br>Users: licensed health care professional and<br>lay users<br>The dedicated Administration Sets for the<br>Avoset Infusion Pump are intended for<br>single-patient use and single-use only.<br>Set configurations are: (i) Enteral; (ii)<br>Epidural and (iii) General purpose for the<br>balance of the routes: intra-arterial, intra-<br>venous, subcutaneous, perineural.<br>The Avoset Programming Tool: is intended<br>to be used with a computer to create a<br>treatment-based protocol that is loaded onto<br>the pump. The programming tool is intended<br>for use by professional users. | populations.<br><br>The dedicated Q Core administration sets for<br>the Sapphire pump are intended for single-<br>patient use and single-use only. |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|

Discussions of differences in Indications for Use statement

The indications for use statement for the subject device is identical to the predicate device.

# Technology characteristics:

As shown in the table below, all technological characteristics listed in the table below are the same except for the design of Avoset's dedicated cartridge. (V&V demonstrates that this difference does not have an impact on safety or effectiveness):

| | Description | Subject Device - Avoset<br>Infusion Pump | Sapphire's Administrations<br>sets (K192860) | Comments |
|-----------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Used with | Sets intended for use with only<br>the specified infusion pump to<br>allow peristaltic flow (by the<br>pump pressing on the cassette<br>tube) | Sets intended for use with<br>only the specified infusion<br>pump to allow peristaltic flow<br>(by the pump pressing on the<br>cassette tube) | Identical |
| | Interaction<br>with the<br>pump | Each administration sets<br>includes a dedicated<br>administration cassette<br>responsible for pump<br>interaction | Each administration sets<br>includes a dedicated<br>administration cassette<br>responsible for pump<br>interaction | Identical |
| | Free flow<br>prevention | Anti-Free Flow Valve in the<br>administration cassette | Anti-Free Flow Valve in the<br>administration cassette | Identical |
| | Length | 1.7-3.2m | 2.1-3m | Difference<br>supported through<br>performance testing<br>(Slightly wider) |
| | Description | Subject Device - Avoset<br>Infusion Pump | Sapphire's Administrations<br>sets (K192860) | Comments |
| | Priming<br>volume | 1-28mL | 3-30mL | range than<br>predicate)<br>Within predicates<br>range |
| | Components<br>on the<br>infusion line | Filters, Drip chamber Slide clamps Roller clamp Spike Needless y site Connectors | Filters, Drip chamber Slide clamps Roller clamp Spike Needless y site Connectors | Identical |
| | Different<br>configurations<br>of the Sets<br>are available,<br>depending<br>upon the<br>required use | Different configurations are available with the different component options as above <b>Optional Cartridge (for 100mL bag)</b> | Different configurations are available with the different component options as above <b>Optional Cartridge (for 100mL bag)</b> | Difference supported through performance testing<br>(The last set component (bolded) has the same administration cassette & functionality and has no additional materials). |
| Sterility | Method<br>SAL<br>Use<br>frequency<br>Shelf life | EtO<br>$10^{-6}$<br>Single use<br>2.3 years | EtO<br>$10^{-6}$<br>Single use<br>5 | Identical |
| Material | Not<br>containing<br>Pyrogenicity<br>Materials | Non-DEHP, latex free and non-pyrogenic<br>Non-pyrogenic PVC ABS Acrylic Polyethylene Polyethersulfone Polytetrafluoroethylene Silicone Polypropylene Polyamide <b>Polycarbonate Polyurethane Rigid PVC</b> TPE | Non-DEHP, latex free and non-pyrogenic<br>Non-pyrogenic PVC ABS Acrylic Polyethylene Polyethersulfone Polytetrafluoroethylene Silicone Polypropylene Polyamide | Identical<br>Difference supported through performance testing<br>(last additional 4 bolded materials) |

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Conclusion: The respective administration sets have the same intended & indication for use and technological characteristics and thus the Sapphire sets are appropriate predicates.

# Performance Testing

The following bench testing was performed and reviewed to support the substantial equivalence of the subject device:

| Software | Software verification and validation per the FDA Guidance for the Content of<br>Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)<br>for a Major Level of Concern and IEC62304:2006/AMD 2015 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical safety | Electrical Safety per IEC 60601-1; 2012 |
| EMC | EMC testing per IEC 60601-1-2; 2014 |
| Home use | Per IEC 60601-1-11; 2015 |
| Alarms | Alarms per IEC 60601-1-8; 2012 |
| Device Performance | FDA Guidance "Infusion Pumps Total Product Life Cycle" Accuracy testing under anticipated environments of use and routes Performance per ISO 8536-4, -8, -9, -10, -11 Administration sets performance testing per ISO 80369-6:2016 |
| Biocompatibility | ISO 10993-1 (Administration sets) |
| Sterility | Validation per ISO 11135 |
| Human Factors | Human factors studies per the FDA Guidance Applying Human Factors and<br>Usability Engineering to Medical Devices (February 3, 2016). The human factors<br>studies were conducted with the intended user population, use environment, and use<br>scenarios to simulate clinical conditions. Results of the human factors testing<br>demonstrate validation of the device per the intended use. |
| Cybersecurity | Cybersecurity was evaluated per the FDA Guidance Content of Premarket<br>Submissions for Management of Cybersecurity in Medical Devices Guidance for<br>Industry and Food and Drug Administration Staff, (Draft guidance, October, 2018).<br>Postmarket Management of Cybersecurity in Medical Devices – Guidance for<br>Industry and FDA Staff (2016) and AAMI TIR57 – Principles for Medical Device<br>Security (2016) Specifically, addressing the following areas: Identify and Protect,<br>Detect, Response and Recovery |
| Reprocessing/Cleaning | Validation per the FDA Guidance for Reprocessing Medical Devices in Health Care<br>Settings: Validation Methods and Labeling (March 17, 2015) confirmed cleaning<br>and disinfection instruction provided in instructions for use |
| Shipping | Per ASTM D4169-16 |

The testing conducted demonstrates that the Avoset Infusion pump system meets its design requirements and is substantially equivalent to the cleared CADD Solis system. Therefore, the Avoset Infusion Pump system that is the subject of this submission is substantially equivalent to the identified predicates.

# Conclusion

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The Avoset Infusion system (pump, sets and accessories) is substantially equivalent to the CADD-Solis system (pump and PC Tool) cleared under K170982¹ with respect to the indications for use, target populations, the basic infusion pump hardware and software used to control delivery of the infusion, technological characteristics, the delivery modes, and safety features.

¹ And K192860 for the administration sets