(20 days)
The Spectrum and Spectrum with Master Drug Library is intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically acceptable routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. The spectrum is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user.
The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services.
The Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to physician's directive.
The Spectrum with Master Drug Library (device) is an infusion pump having a basic The Spectrum with Master Brag Libra, P(2018) Section 5725. The Spectrum infusion desomplon as loonimou nicuitry and mechanical mechanisms that are integrated into pump consists of clouronio sirounly and mechanical operations are software a lightweight plastic ontroller and processor technology. The motor control / controlled dolly disorte merces in the linear peristaltic design using inlet and exit recoback partiping moontrol. Infusion therapy fluids and selected intravenous (IV) sets The Spectrum infusion pump is specifically are supplied by the device user. are Supplied by the cated for the application of standard gravity infusion sets of a manufacturer's brand, as indicated by the Spectrum's labeling. The IV set is loaded into the Spectrum infusion pump. After acceptance of program parameters, the pump is the Upontain 'infactor' palled by the rhythmic action of the pumping mechanism against started and is properies a fine in tubing. The pump is controlled to create smooth fluid the outbide carace on volumetric accuracy, and uniformity of flow rate profile. The Spectrum infusion pump is small in comparison to the traditional "Large Volume" infusions pumps currently on the market. However, it is designed to be used in a infosions pampe carren IV pole mounted configuration or carried by the user in an ambulatory manner.
The Master Drug Library (MDL) capability is a software package that allows the rno nation and management of a patented downloadable drug library into to a target infusion pump. The library may be loaded directly into the infusion pump or uploaded into another computer, Personal Assistants (PDA's), or other transfer apparatus (I.e. "smart" C-pen) for wired or wireless communication to the infusion pump. The MDL software reduces the risk of medication errors by providing programmed delivery profiles and limits for a corresponding drug that is intend for a specific use classification. The MDL software will operate on a popular software systems platform (I.e. Windows) and have the capability (using external peripherals) of printing text / barcode labels that may be used to label and identify drug therapy bags and or patient identification labels. Through the application of the C-pen equipment, scanned patient and IV prescription information can be downloaded into the Spectrum infusion pump. The Spectrum infusion pump has the capability of communicating with a hospital information management system. The Spectrum infusion pump uses coded passwords and redundancy checks to mitigate the acceptance of improper information.
This document is a 510(k) summary for the SIGMA International General Medical Apparatus, LLC Spectrum with or without Master Drug Library infusion pump, submitted in 2004. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed performance studies with acceptance criteria, sample sizes, expert involvement, or comparison to human readers.
Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance or other detailed study descriptions.
Explanation for missing information:
- Acceptance Criteria & Reported Performance: The document states that "non-clinical testing based on the validation of design requirements has been conducted and is provided as support data for this 510(k) submission. The performance data indicate that the Spectrum and Spectrum with Master Drug Library meets specification requirements and is substantially equivalent to the predicate devices." However, the specific acceptance criteria (e.g., volumetric accuracy thresholds, flow rate uniformity) and the numerical results against these criteria are not included in this summary.
- Study Details (Sample Size, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone): This summary focuses on establishing substantial equivalence through a comparison of technological characteristics and intended use to predicate devices, rather than presenting a standalone performance study with detailed methodologies as would be standard for AI/imaging device submissions. The "non-clinical performance data" mentioned refers to engineering tests to ensure the device meets its own specifications, not clinical performance studies comparing it to humans or a gold standard.
- Training Set Information: This is an infusion pump, not an AI/ML device that requires a training set in the typical sense (i.e., for model training with labeled data). The "Master Drug Library" is a software package with programmed delivery profiles and limits, not a machine learning model developed through training data.
§ 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).