(466 days)
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.
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.
The dedicated Avoset Administration Sets are sterile (apart of the Enteral sets) and intended for singlepatient use and single-use only.
This document is a 510(k) Summary for the Avoset Infusion Pump system, which is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed device (predicate device). It is not a study report per se, but it summarizes the performance testing conducted to support substantial equivalence.
Here's an breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Performance - CADD®-Solis Infusion Pump, Model 2110 (K170982)) | Reported Device Performance (Avoset Infusion Pump) | Comments |
|---|---|---|---|
| Pump | |||
| Pumping mechanism | Microprocessor controlled linear peristaltic pumping mechanism (Single channel volumetric) | Microprocessor controlled linear peristaltic pumping mechanism (Single channel volumetric) | Identical |
| Dimensions | Approximately 500 cm3 (40mm x 101mm X 127mm); Approximately 600 grams | Approximately 424 cm3 (96 mm x 96 mm x 46 mm); Approximately 400 grams | Similar dimensions and weight |
| Motor | DC motor operated by internal batteries and controlled by SW | DC motor operated by internal batteries and controlled by SW | Identical |
| Accuracy | 6% | ± 5% (including boluses) under most conditions. Additional details provided in the labeling. | Supported through performance testing (Avoset has tighter accuracy spec) |
| Flow rate | 0.1-500 mL/h | 0.1-300 mL/h | Within predicate range |
| VTBI capacity range | 0- 9,999mL | 0- 9,999mL | Identical |
| Occlusion detection pressure | Upstream: fixed (pre-set in the pump; no option for user to modify) threshold 0.62 - 1.68 bar | Upstream: fixed (pre-set in the pump; no option for user to modify) threshold Downstream: 0.5 - 1.6 Bar | Tighter range than the predicate |
| Air detection | 150 µL | 100 µL minimal detection level | Tighter spec than predicate |
| Air off | Optional mode | Optional mode | Identical |
| Alarms | Low Battery, battery depletion, battery extraction, pump unattended, etc. (Comply with IEC 60601-1-8) | Same list of alarms (Comply with IEC 60601-1-8) | Identical |
| Material (Fluid path) | Biocompatible | Biocompatible | Identical |
| Energy source | Rechargeable battery pack or AC adaptor | Rechargeable: Duracell DX1500 Alkaline: Duracell MN1500 (a.k.a. coppertop) | Within predicate power options |
| UI | LCD screen, keypad user interface | LCD screen, keypad user interface | Identical |
| Reservoir | Infusion bag, dedicated cartridge, no syringe | Syringe (5-60mL) (in addition to infusion bag and a dedicated cartridge) | Additional capability, supported through safety/effectiveness assessment |
| Connectivity | Wi-Fi | BLE and NFC | Different technologies, compliance with FCC, EMC, coexistence demonstrated |
| Service life | 5 years | 7 years | Difference supported through performance testing |
| Altitude operation range | 70 kPa to 106 kPa | 50 kPa to 106 kPa [equivalent to altitude of -381 m to 6096 m (-1210 ft to 20000 ft)] | Difference supported through performance testing |
| Use environment | Clinical environments (multiple clinical care areas) | Clinical environment and ambulatory environment including home, plane and ground transportation. | Difference supported by compliance with RTCA DO-160 section 20 and IEC 60601-1-11 |
| Administration Sets | (Predicate: Sapphire's Administrations sets (K192860)) | ||
| Design (Used with) | Sets intended for use with only the specified infusion pump to allow peristaltic flow (by the pump pressing on the cassette tube) | Same description | Identical |
| Interaction with pump | Each administration sets includes a dedicated administration cassette responsible for pump interaction | Same description | Identical |
| Free flow prevention | Anti-Free Flow Valve in the administration cassette | Same description | Identical |
| Length | 2.1-3m | 1.7-3.2m | Difference supported through performance testing (Slightly wider) |
| Priming volume | 3-30mL | 1-28mL | Within predicates range |
| Components on 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 configurations | Available with different component options, Optional Cartridge (for 100mL bag) | Same, Optional Cartridge (for 100mL bag) | Difference supported through performance testing |
| Sterility | EtO, 10^-6 SAL, Single use, 5 years shelf life | EtO, 10^-6 SAL, Single use, 2.3 years shelf life | Shelf life difference not directly addressed as acceptance criteria but acknowledged. |
| Material (Not Pyrogenic) | Non-DEHP, latex free, non-pyrogenic (PVC ABS Acrylic Polyethylene Polyethersulfone Polytetrafluoroethylene Silicone Polypropylene Polyamide) | Same, plus Polycarbonate Polyurethane Rigid PVC TPE (bolded materials) | Difference supported through performance testing |
2. Sample size used for the test set and the data provenance
The document does not specify general "test set" sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for the overall device performance. It only lists various performance tests conducted. For example, for Human Factors studies, it mentions "conducted with the intended user population, use environment, and use scenarios," but no specific numbers are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The performance tests mentioned (e.g., accuracy, electrical safety, EMC, biocompatibility) typically rely on engineering specifications, standardized testing, and validated methods rather than expert consensus on a "ground truth" in the way that, for example, a diagnostic AI might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided as the regulatory filing details engineering and performance testing rather than human-expert derived ground truth adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study is not mentioned and is not relevant for an infusion pump's substantial equivalence demonstration. The device is an infusion pump, which is a physical medical device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Insight Tool" is mentioned as an "optional module" that "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." This suggests it operates in a standalone manner for data analysis after the pump's operation, but its performance is not detailed in the context of specific acceptance criteria. The primary device performance testing focuses on the infusion pump itself, not this module's data analysis capabilities. The document does not describe "algorithm only" performance in the context of AI without human intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing of an infusion pump would be defined by engineering specifications, international standards (e.g., IEC, ISO), and regulatory guidance. For example:
- Accuracy: Measured flow rate compared to programmed flow rate, against a defined tolerance range (e.g., ± 5%).
- Occlusion detection: Pressure measurements against specified thresholds.
- Air detection: Detection of air volumes against specified thresholds.
- Electrical Safety, EMC, Alarms, Biocompatibility: Compliance with the requirements of relevant IEC and ISO standards.
These are not "expert consensus" or "pathology" in the typical sense for AI/diagnostic devices but rather objective, measurable parameters against established norms.
8. The sample size for the training set
This information is not provided and is not applicable in the context of the regulatory submission for this type of device. The Avoset Infusion Pump is a hardware device with embedded software, not an AI/ML system that undergoes explicit "training" on a dataset for a specific task like image classification. The software verification and validation (V&V) mentioned refers to standard software development lifecycle testing, not machine learning model training.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of machine learning for this device, this question is not applicable. Software validation typically involves testing against requirements derived from device specifications and established standards, rather than a machine learning "ground truth."
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.
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 (1-800-638-2041 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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K213744 510(k) Summary
| Owner/Submitter | Eitan Medical Ltd.29 Yad Haruzim St.Netanya 4250529ISRAELPh: +972-73-2388888Fax: +972-73-2388800 |
|---|---|
| Contact Person | Rhona ShankerFDA Regulatory Consultant to Eitan Medical LtdPh: 301-251-9570Email: rhonashanker07@verizon.net |
| Trade Name | Avoset Infusion Pump |
| Common Name | Infusion Pump |
| Classification Name | Infusion Pump 21 CFR 880.5725Product Codes:FRN - Infusion pumpMRZ - Infusion pump accessoriesFPA - Administration Sets (21 CFR 880.5440)Class II |
| Predicate DeviceFor Infusion pump | CADD-Solis system (pump and PC Tool) cleared under K170982 |
| Predicate Device forAdministration 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, Model2110 (K170982) |
|---|---|---|
| Indications forUse | Intended UseThe 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 useRoutes: Parenteral (intra-arterial, intra-venous, subcutaneous, perineural, epidural) and enteral infusions | Intended useIntended 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),Total Parenteral Nutrition (TPN), enteralmedication and nutrition, lipids, epiduralmedication.Program Types (specific users): The pumpdelivers in one of four program types: acontinuous rate of infusion, and/or anintermittent bolus, and/or with patient-controlled intermittent doses, and/or withtaperingPatient Population: Pediatric: infants,children, adolescents and adult patientsIntended Environments: Intended to be usedin clinical environment and ambulatoryenvironment including, home, plane andground transportation.Users: licensed health care professional andlay usersThe dedicated Administration Sets for theAvoset Infusion Pump are intended forsingle-patient use and single-use only.Set configurations are: (i) Enteral; (ii)Epidural and (iii) General purpose for thebalance of the routes: intra-arterial, intra-venous, subcutaneous, perineural.The Avoset Programming Tool: is intendedto be used with a computer to create atreatment-based protocol that is loaded ontothe pump. The programming tool is intendedfor use by professional users. | intermittent bolus, and/or with a patientdose.Indication for useIndicated for intravenous, intra-arterial,subcutaneous, intraperitoneal, in closeproximity to nerves, into an intraoperativesite (soft tissue, body cavity/surgical woundsite), epidural space or subarachnoid space.The pump is intended for therapies thatrequire a continuous rate of infusion, and/oran intermittent bolus, and/or with patient-controlled demand doses | |
| Prescription orover the counter | Prescription | Prescription |
| Intendedpopulation | Pediatric (infants, children, and adolescents)and adult patients. | Pediatric and adult patients. |
| Environment ofUse | Clinical environment and ambulatoryenvironment including home, plane andground transportation | Multiple clinical care areas, including butnot limited to post-operative, trauma, criticalcare, 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 - AvosetInfusion Pump | CADD®-Solis InfusionPump, Model 2110(K170982) | Comments | |
|---|---|---|---|---|
| Pump | ||||
| Design | Pumpingmechanism | Microprocessor controlledlinear peristaltic pumpingmechanism (Single channelvolumetric) | Microprocessor controlledlinear peristaltic pumpingmechanism (Single channelvolumetric) | Identical |
| Dimensions | Approximately 424 cm3 (96 mm x 96 mm x 46 mm);Approximately 400 grams | Approximately 500 cm3(40mm x 101mm X 127mm);Approximately 600 grams | Similardimensionsand weight | |
| Motor | DC motor operated by internalbatteries and controlled by SW | DC motor operated byinternal batteries andcontrolled by SW | Identical | |
| Accuracy | $ \pm $ 5% (including boluses) undermost conditions. Additionaldetails provided in the labeling. | 6% | Supportedthroughperformancetesting | |
| Flow rate | 0.1-300 mL/h | 0.1-500 mL/h | Withinpredicaterange | |
| VTBI capacityrange | 0- 9,999mL | 0- 9,999mL | Identical | |
| Occlusiondetectionpressure | Upstream: fixed (pre-set in thepump; no option for user tomodify) thresholdDownstream: 0.5 - 1.6 Bar | Upstream: fixed (pre-set inthe pump; no option for userto modify) threshold0.62 - 1.68 bar | Tighter rangethan thepredicate | |
| 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 DX1500Alkaline: 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 - AvosetInfusion Pump | CADD®-Solis InfusionPump, Model 2110(K170982) | Comments | |
| PC Tool | ||||
| IntendedUse | Intended Use | The Avoset Programming Toolis intended to be used with acomputer to create a treatment-based protocol that is loadedonto the pump. Theprogramming tool is intendedfor use by professional users. | Allows the use of a computerto create therapy-basedprotocol libraries to be usedwith the CADD®-SolisInfusion Pump. | See comment4 |
| Design | Treatment datatransfer | Allow the transfer of treatmentdata to the pump: Deliveryprofile, Drug, rate, VTBI, PCAdose, dose lockout, maximumdose, hard limits for VTBI, rateand KVO, weight-based units,concentration, air detectionthreshold, occlusion threshold,alarm volume, delayed start. | Allow the transfer oftreatment data to the pump:Delivery profile, Drug, rate,VTBI, PCA dose, doselockout, maximum dose,hard limits for VTBI, rateand KVO, weight-basedunits, concentration, airdetection threshold,occlusion threshold, alarmvolume, delayed start. | Identical |
| Number oftreatments | Only one treatment is sent tothe pump at a time | Several treatments are sent( |
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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(K192860) |
|---|---|---|
| Indications forUse | Intended UseThe Avoset Infusion Pump is a single-channel, volumetric infusion pump.Medication is delivered at continuous rate,and/or with an intermittent bolus, and/or witha patient bolus and/or with taper.Indication for useRoutes: Parenteral (intra-arterial, intra-venous, subcutaneous, perineural, epidural)and enteral infusionsFluids: IV medication (including fluids),Total Parenteral Nutrition (TPN), enteralmedication and nutrition, lipids, epiduralmedication.Program Types (specific users): The pumpdelivers in one of four program types: acontinuous rate of infusion, and/or anintermittent bolus, and/or with patient-controlled intermittent doses, and/or withtaperingPatient Population: Pediatric: infants,children, adolescents and adult patientsIntended Environments: Intended to be usedin clinical environment and ambulatory | The Sapphire Infusion pump is intended forcontrolled delivery through intravascular,subcutaneous, intra-arterial, perineural andepidural routes.The pump is designed to deliver saline, TotalParenteral Nutrition (TPN),lipids, IVmedication, perineural medication, epiduralmedication, blood and blood products.The Sapphire Infusion pump includes thefollowing infusion modes for all intendeduses: Continuous, Intermittent, TPN, PCA,Multi-step, and Epidural.It is intended to be used in the followingenvironments of use: clinical, ambulatory,pre-hospital medical air and groundtransportation and home. The pump isintended to be used by both licensed healthcare professionals and by lay users.The Sapphire and the administration sets areindicated for use by both adult and pediatric |
Intended use & Indication for use:
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| environment including, home, plane andground transportation.Users: licensed health care professional andlay usersThe dedicated Administration Sets for theAvoset Infusion Pump are intended forsingle-patient use and single-use only.Set configurations are: (i) Enteral; (ii)Epidural and (iii) General purpose for thebalance of the routes: intra-arterial, intra-venous, subcutaneous, perineural.The Avoset Programming Tool: is intendedto be used with a computer to create atreatment-based protocol that is loaded ontothe pump. The programming tool is intendedfor use by professional users. | populations.The dedicated Q Core administration sets forthe Sapphire pump are intended for single-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 - AvosetInfusion Pump | Sapphire's Administrationssets (K192860) | Comments | |
|---|---|---|---|---|
| Design | Used with | Sets intended for use with onlythe specified infusion pump toallow peristaltic flow (by thepump pressing on the cassettetube) | Sets intended for use withonly the specified infusionpump to allow peristaltic flow(by the pump pressing on thecassette tube) | Identical |
| Interactionwith thepump | Each administration setsincludes a dedicatedadministration cassetteresponsible for pumpinteraction | Each administration setsincludes a dedicatedadministration cassetteresponsible for pumpinteraction | Identical | |
| Free flowprevention | Anti-Free Flow Valve in theadministration cassette | Anti-Free Flow Valve in theadministration cassette | Identical | |
| Length | 1.7-3.2m | 2.1-3m | Differencesupported throughperformance testing(Slightly wider) | |
| Description | Subject Device - AvosetInfusion Pump | Sapphire's Administrationssets (K192860) | Comments | |
| Primingvolume | 1-28mL | 3-30mL | range thanpredicate)Within predicatesrange | |
| Componentson theinfusion 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 | |
| Differentconfigurationsof the Setsare available,dependingupon therequired use | Different configurations are available with the different component options as above Optional Cartridge (for 100mL bag) | Different configurations are available with the different component options as above Optional Cartridge (for 100mL bag) | Difference supported through performance testing(The last set component (bolded) has the same administration cassette & functionality and has no additional materials). | |
| Sterility | MethodSALUsefrequencyShelf life | EtO$10^{-6}$Single use2.3 years | EtO$10^{-6}$Single use5 | Identical |
| Material | NotcontainingPyrogenicityMaterials | Non-DEHP, latex free and non-pyrogenicNon-pyrogenic PVC ABS Acrylic Polyethylene Polyethersulfone Polytetrafluoroethylene Silicone Polypropylene Polyamide Polycarbonate Polyurethane Rigid PVC TPE | Non-DEHP, latex free and non-pyrogenicNon-pyrogenic PVC ABS Acrylic Polyethylene Polyethersulfone Polytetrafluoroethylene Silicone Polypropylene Polyamide | IdenticalDifference supported through performance testing(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 ofPremarket Submissions for Software Contained in Medical Devices (May 11, 2005)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 andUsability Engineering to Medical Devices (February 3, 2016). The human factorsstudies were conducted with the intended user population, use environment, and usescenarios to simulate clinical conditions. Results of the human factors testingdemonstrate validation of the device per the intended use. |
| Cybersecurity | Cybersecurity was evaluated per the FDA Guidance Content of PremarketSubmissions for Management of Cybersecurity in Medical Devices Guidance forIndustry and Food and Drug Administration Staff, (Draft guidance, October, 2018).Postmarket Management of Cybersecurity in Medical Devices – Guidance forIndustry and FDA Staff (2016) and AAMI TIR57 – Principles for Medical DeviceSecurity (2016) Specifically, addressing the following areas: Identify and Protect,Detect, Response and Recovery |
| Reprocessing/Cleaning | Validation per the FDA Guidance for Reprocessing Medical Devices in Health CareSettings: Validation Methods and Labeling (March 17, 2015) confirmed cleaningand 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
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).