← Product Code [FRN](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN) · K960512 # GEMINI PC-ITX (K960512) _Imed Corp. · FRN · Nov 21, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K960512 ## Device Facts - **Applicant:** Imed Corp. - **Product Code:** [FRN](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN.md) - **Decision Date:** Nov 21, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5725 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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. ![img-0.jpeg](img-0.jpeg) Signature Dale Coleman Name 2 February 1996 Date K960512 501(k) Number 150 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K960512](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K960512) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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