GEMINI PC-ITX

K960512 · Imed Corp. · FRN · Nov 21, 1996 · General Hospital

Device Facts

• Record ID: K960512
• Device Name: GEMINI PC-ITX
• Applicant: Imed Corp.
• Product Code: FRN · General Hospital
• Decision Date: Nov 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gemini family of infusion devices are intended for intravascular administration of fluids, medications, blood, and blood products into a patient in a controlled manner.

Device Story

Single-channel linear peristaltic infusion pump/controller; microprocessor-controlled; monitors infusion parameters; provides visual/audible alarms for parameter deviations or malfunctions; triggers automatic shutdown upon alarm; displays operational status, advisories, and prompts. Used in clinical settings by healthcare professionals for controlled fluid/medication delivery. Benefits include precise, fail-safe administration of intravenous therapies.

Clinical Evidence

Bench testing only. Device performance validated against established safety standards, including electrical safety review by Underwriter's Laboratories and Canadian Standards Association. Accuracy confirmed at ±5%.

Technological Characteristics

Linear peristaltic infusion mechanism; microprocessor-based control circuitry; single-channel configuration; ±5% accuracy; electrical safety conformance per UL and CSA standards.

Indications for Use

Indicated for patients requiring controlled intravascular administration of fluids, medications, blood, and blood products.

Regulatory Classification

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.

Predicate Devices

• IMED Model PC-1
• IMED Model PC-2
• IMED Model PC-2TX
• IMED Model PC-4

Submission Summary (Full Text)

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IMED Corporation
Research & Development
NOV 21 1996
K960512

# imed 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 of infusion devices are intended for intravascular administration of fluids, 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, $\pm 5\%$. 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.


Signature

Dale Coleman

Name

2 February 1996

Date

K960512

501(k) Number

150