(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."
§ 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).