(290 days)
PC-1TX, PC-1, PC-2, PC-2TX, PC-4
PC-1, PC-2TX, PC-4
No
The description mentions "state-of-the-art microprocessor circuitry" for monitoring and alarming, which is typical for embedded systems and control logic, not necessarily AI/ML. There are no mentions of AI, ML, deep learning, training data, or performance metrics commonly associated with AI/ML models.
No.
The device administers fluids and medications, but it does not directly treat a disease or condition; it is a delivery mechanism.
No
The device is an infusion pump designed for controlled administration of fluids and medications, not for diagnosing medical conditions.
No
The device description explicitly states it is a "single channel linear peristaltic infusion device" and mentions "microprocessor circuitry," indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "intravascular administration of fluids, of medications, blood, and blood products into a patient in a controlled manner." This describes a device used for delivering substances directly into the body, which is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description details a "single channel linear peristaltic infusion device" with safety features and monitoring capabilities. This aligns with the function of an infusion pump, which is used for administering substances, not for analyzing samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used to perform tests on samples taken from the body to help diagnose diseases or conditions. This device's function is to deliver substances into the body.
N/A
Intended Use / Indications for Use
The Gemini family infusion devices are intended for intravascular administration of fluids, of medications, blood, and blood products into a patient in a controlled manner.
Product codes
Not Found
Device Description
The IMED GEMINI PC-1TX Volumetric Infusion Pump/Controller is a single channel linear peristaltic infusion device. PC-1TX incorporates the same general safety features exhibited in the Models PC-1, PC-2, PC-2TX, and PC-4. The PC-1TX has been designed as a fail-safe device which utilizes state-of-the-art microprocessor circuitry to monitor the operation of the device and to alarm visually and/or audibly whenever assigned parameters have been exceeded, resulting in shutdown until corrective actions, as indicated, have been completed by the user. The PC-1TX displays information relative to operations including advisories, prompts, alarms, and malfunctions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The PC-1TX is designed to operate functionally in the same manner as the PC-1, PC-2TX, and PC-4 with the same level of accuracy, ±5%.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
IMED Corporation Research & Development
NOV 2 1 1996
SAFETY & EFFECTIVENESS SUMMARY
The IMED GEMINI PC-1TX Volumetric Infusion Pump/Controller is a single channel linear peristaltic infusion device. PC-1TX incorporates the same general safety features exhibited in the Models PC-1, PC-2, PC-2TX, and PC-4. The Gemini family infusion devices are intended for intravascular administration of fluids, of medications, blood, and blood products into a patient in a controlled manner. The PC-1TX has been designed as a fail-safe device which utilizes state-of-the-art microprocessor circuitry to monitor the operation of the device and to alarm visually and/or audibly whenever assigned parameters have been exceeded, resulting in shutdown until corrective actions, as indicated, have been completed by the user. The PC-1TX displays information relative to operations including advisories, prompts, alarms, and malfunctions. A full description of each of these types of information is provided in the proposed Operator's Manual (see Labeling Section of this Submission).
The PC-1TX is designed to operate functionally in the same manner as the PC-1, PC-2TX, and PC-4 with the same level of accuracy, ±5%. The PC-1TX design will be reviewed by Underwriter's Laboratories and the Canadian Standards Association for independent assurance of conformance to electrical safety standards.
I hereby certify that, in my capacity as a Compliance Engineer of IMED's Regulatory Affairs Department, I believe that, to the best of my knowledge, all data and information submitted in this Premarket Notification are truthful and accurate and that no material fact has been omitted.
Silina
Signature
Dale Coleman
Name
2 February 1996
Date
K960512
501(k) Number
15 S