(72 days)
The Horizon® Lite is an electrical, external volumetric infusion pump that provides infusions of parenteral fluids. The pump may be used to infuse all intravenous medications, blood, and blood components. Adjustable occlusion pressure settings allow arterial, epidural and intrathecal infusions. The system created by using dedicated cassettes is intended to provide accurate and continuous flow of these fluids to the patient. The pump is software controlled and operates using volumetric displacement with a stepper-motor mechanism.
The new incorporation of a Barcode Reading System is intended to decrease the incidence of medication errors. The Barcode Reader provides a method to automate the implementation of an infusion by verifying nurse and patient identifications and transferring infusion parameters to the pump.
The Horizon® Lite is intended for but not limited to use in the hospital, home care and/or nursing home (extended care) settings. The Horizon® Lite is intended for use by trained healthcare providers in accordance with the instructions provided in the Operation Manual. All data entry and validation of the Horizon® Lite is performed by the trained healthcare provider per a physician's order.
The predicate device has been modified to create the Horizon® Lite. The case top and bottom have been modified to produce a newer, smaller profile and thereby decreasing the total weight. The material composition will not change. The main board and power supply board have been upgraded from through-hole to surface mounted technology. Modifications will be made to support a hardwire RS232 instead of the optical RS232 currently in the predicate device. The RAM has been increased to 512K. An LCD will replace the existing seven segment LED. LCD technology has been updated for increased visibility. The Air-in-Line has been upgraded to an ultrasonic detector.
The subject pump is also different from the predicate in that it incorporates the use of a Barcode Reading and Labeling System. The new incorporation of the B. Braun Medical Barcode Reading and Label Generating System is intended to decrease the incidence of medication errors by reducing the amount of steps necessary to program the pump. The Barcode Reader provides a method to automate the implementation of an infusion by verifying nurse and patient identifications and transferring infusion parameters to the pump.
The Barcode Reading and Label Generating System allows a pharmacist or authorized user to enter patient identification, medication and infusion parameters into a computer format. This information is printed in a barcode format and placed on the medication container. Infusion parameters are then transferred into the pump by scanning the barcode. The patient data on the container must match the patients' personal identification label. The nurse must also scan his/her personal identification barcode. Access is denied if all patient and nurse identifiers are not verified. The user must then manually enter infusion data.
The Barcode Reader in the Horizon® Lite can only read barcode labels produced by the B. Braun Barcode Generating System software, that is provided with the pump.
The infusion pump contains the following hardware assemblies: swivel-drive pumping mechanism assembly, power supply assembly, pole clamp assembly, display assembly, and electronics assembly. The display subassembly contains an LCD display and a keypad used to input data into the pump as well as to present pump status and information to the user.
The electronics subassembly contains all of the electronics in the pump, including the microprocessors that run the software. The electronics subassembly also contains communications electronics that will allow the pump to transmit and receive messages to and from external devices, including personal computers and hospital monitoring systems.
The software provides communication capabilities from the pump to external communication devices. This includes transmission of the following information: Operation / Alarm Log, pump status and pump configuration / calibration data. The software also provides communication abilities from external devices to the pump. These features are only accessible by a trained Biomedical Technician. Programming of the pump is to be performed by trained biomedical professionals. The pump's software does not allow for the capability to control rate, volume or therapy information from external devices.
The provided text is a 510(k) summary for the Horizon® Lite Infusion Pump. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not include detailed information regarding specific acceptance criteria, studies that prove the device meets those criteria, or quantitative performance data like sensitivity, specificity, or accuracy.
The document focuses on:
- Substantial Equivalence: Arguing that the Horizon® Lite is similar in design, material, components, manufacturing, intended use, and labeling to a previously cleared device (Horizon® Modular Infusion System).
- Technological Differences: Highlighting modifications such as a smaller profile, surface-mounted technology for boards, upgraded RS232, increased RAM, LCD display, and an ultrasonic air-in-line detector.
- New Feature - Barcode Reading System: Introducing a barcode reader intended to reduce medication errors by verifying nurse and patient identifications and transferring infusion parameters.
Therefore, based on the provided text, I cannot complete a table of acceptance criteria and reported device performance or answer most of the specific questions about the study design and results. The document explicitly states: "The substantial equivalence claim between the subject and predicate device is supported by the information and data provided in this 510(k) submission. This includes the following information: ... Subject device system and software test plans. ... Subject device system and software test matrix." However, these detailed plans and matrix are not included in the provided 510(k) summary.
Here's an attempt to answer what can be gleaned from the text, with clear indications of where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred/Missing) | Reported Device Performance (Missing/Implied) |
|---|---|
| Accuracy and continuous flow of parenteral fluids (Implied from "accurate and continuous flow") | Not provided in the summary. |
| Occlusion Pressure Settings Functionality (Implied from "Adjustable occlusion pressure settings") | Not provided in the summary. |
| Reduced incidence of medication errors via Barcode Reading System (Key intended benefit) | Not provided in the summary. |
| Verification of nurse and patient IDs by Barcode Reader (Specific function of barcode system) | Not provided in the summary. |
| Transfer of infusion parameters via Barcode Reader (Specific function of barcode system) | Not provided in the summary. |
| Hardware Functionality (e.g., swivel-drive, power supply, display, electronics) | Not provided in the summary. |
| Software Functionality (e.g., communication capabilities, data transmission, programming by trained personnel) | Not provided in the summary. |
| Safety and Effectiveness (General regulatory requirement for substantial equivalence) | Not provided in the summary. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not provided in the 510(k) summary.
- Data provenance (country of origin, retrospective/prospective): Not provided in the 510(k) summary. The document mentions "Subject device system and software test plans" and "Subject device system and software test matrix" as part of the submission, but the details of these tests are not included here.
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 510(k) summary. The nature of the device (infusion pump, not an imaging or diagnostic device requiring expert interpretation for ground truth) makes this type of expert review less directly applicable to its primary function, though clinical validation might involve healthcare professionals.
4. Adjudication method
- Not applicable/Not mentioned. The device is an infusion pump, and the evaluation for its primary functions (flow, pressure, etc.) would typically involve engineering and performance testing, not expert adjudication in the traditional sense for diagnostic tools. The barcode system's function would be evaluated on its ability to correctly read and transfer data, likely against predefined correct inputs.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, an MRMC comparative effectiveness study was not mentioned and is not applicable. MRMC studies are typically used for imaging and diagnostic devices to assess how AI affects human reader performance. This device is an infusion pump with a barcode reader for automating data entry, not a diagnostic tool requiring image interpretation or similar expert judgment.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, implicitly. The "Subject device system and software test plans" and "Subject device system and software test matrix" would undoubtedly include standalone performance testing of the pump's core functions (e.g., accuracy of infusion, occlusion detection, air-in-line detection) and the barcode reader's ability to accurately scan and transfer data. However, the details of these tests and their results are not provided in this summary.
7. The type of ground truth used
- For the pump's core functions (flow rate, occlusion pressure, air-in-line detection): Engineering specifications and validated measurement techniques would serve as the ground truth.
- For the barcode reader: The correct predefined patient, nurse, and infusion parameters encoded in the barcodes, as generated by the "B. Braun Barcode Generating System software," would be the ground truth against which the reader's performance is measured.
- Clinical outcomes data or pathology: Not directly applicable for ground truth in this device's performance evaluation, although overall safety and effectiveness would contribute to regulatory approval.
8. The sample size for the training set
- Training set sample size: Not applicable and not provided. This device is mechanical/electronic with software for control and data input. It does not employ machine learning or AI that would require a "training set" in the typical sense for image recognition or predictive analytics. The software is programmed based on defined rules and algorithms, not trained on a dataset.
9. How the ground truth for the training set was established
- Not applicable. As mentioned above, there is no "training set" for this device in the context of machine learning. The software's "ground truth" is its design specifications and algorithms, which are established through engineering principles and compliance with medical device standards.
§ 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).