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The CURLIN® 8000 ambulatory infusion pump system is indicated for use in home care and clinical settings for the controlled administration of prescribed medical fluids through clinically accepted routes of administration: intravenous, intra-arterial, subcutaneous, epidural, and perineural, to adult and pediatric patients. The pump is intended to deliver a variety of therapies (drugs and fluids) which have been approved for these routes of administration. Examples of the therapies, which may be delivered using the CURLIN® 8000 pump, include hydration, parenteral nutrition, anti-infectives, pain management, inotropes, chemotherapy, immune globulin, and biologics. The CURLIN 8000 is not indicated for the delivery of cellular blood products.

RxManager Enterprise Solution Software allows the user to create and manage pump configurations and therapy-based protocols to be used with the CURLIN 8000 Ambulatory Infusion Pump.

CURLIN Administration Sets are intended to be used with CURLIN infusion pumps to deliver medication from a container to a patient.

The Curlin 8000 Ambulatory Infusion Pump is a small, compact and light weight infusion delivery device that utilizes a curvilinear peristaltic pumping mechanism to allow the pump to be more compact. The user activates the Curlin 8000 pump via a color LCD screen and keypad user interface. Commands are issued to the microprocessor by activating the user interface. Microprocessor actions are controlled by a program, which is contained in the pump's memory.

The Curlin 8000 pump consists of components such as the user interface, sensors, communication ports, power ports, structural (housing) components, electronics, pumping mechanism, watchdog timer, pump battery and circuitry, real time clock, on-board memory, and pump log. Exterior surface components include the pump housing, platen (door assembly), LCD lens, keypad, and labels. Materials used for the construction of these components are widely used within the medical industry.

The Curlin 8000 pump is designed to deliver measured drug therapy to patients in homecare, infusion suites, oncology and other alternate site locations as appropriate. The pump also has applicability in the acute care market specifically in small hospitals (300 beds or less), Labor and Delivery Units, and other areas of the hospital where pain management is required.

The Curlin 8000 pump is designed to be used with Curlin 380-series administration sets, which provide a sterile pathway for the delivery of the infusate fluid from the infusion container (e.g., IV reservoir bag) to the distal connection, which connects to the patient's catheter / delivery site.

The Rx Manager Enterprise Solution (ES) pharmacy application, which consists of the Rx Manager, Admin Manager and Service Manager, incorporates a Dose Error Reduction System (DERS) software and intuitive workflows to support error prevention. The ES software subsystems are used by Pharmacy Staff, Biomed Staff, IT Staff and Moog Field Service Staff to achieve their specific needs. ES is architected to be scalable, i.e. it can be installed on one to many desktops in a campus-based server network. The applications utilize a common database manager software library along with secure connectivity to the database.

The provided text describes a 510(k) submission for the Curlin 8000 Ambulatory Infusion System, specifically focusing on the addition of a pediatric population to its intended use. The core of the study revolves around evaluating the levels of Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residuals after sterilization, to ensure they are safe for pediatric patients.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state a sample size in terms of a specific number of individual devices tested. Instead, it refers to a "Full EO sterilization Cycle with extended aeration time" being "conducted for Validation of EO/ECH residuals under simulated use extraction method." This suggests a test was performed on one or more representative samples of the administration sets to measure the residuals.

• Sample Size: Not explicitly stated as a number of distinct units. The testing involved a "Full EO sterilization Cycle" on the administration sets.
• Data Provenance: The study is a prospective test conducted specifically to evaluate the device changes for the 510(k) submission. The country of origin of the data is not specified, but the submission is to the U.S. FDA, implying adherence to international and U.S. standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This type of study does not involve human experts establishing ground truth in the traditional sense. The "ground truth" here is based on established international standards (ANSI/AAMI/ISO 10993-7) for acceptable levels of sterilization residuals in medical devices, particularly for vulnerable populations like neonates. These standards are developed by multidisciplinary expert panels in the fields of biocompatibility and toxicology, but no specific number or qualification of experts establishing the ground truth for this particular test is mentioned because it refers back to the existing standard.

4. Adjudication Method for the Test Set:

Not applicable. This is a laboratory-based chemical analysis comparing measured values against predefined acceptable limits from an international standard, not a subjective assessment requiring 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:

Not applicable. This study is not an MRMC comparative effectiveness study, nor does it involve AI. It is a biological evaluation of material safety.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This study does not involve an algorithm.

7. The Type of Ground Truth Used:

The ground truth used is based on established international biological evaluation standards (ANSI/AAMI/ISO 10993-7) which define the maximum tolerable exposure limits for Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residuals, especially for sensitive populations like neonates.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not a machine learning or AI study.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set.

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