(247 days)
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No
The document explicitly states that the device is identical to its predicate with the exception of a microprocessor/memory chip replacement and associated software modifications to accommodate the hardware change. There is no mention of AI, ML, or related concepts.
No.
The device injects therapeutic fluid but is not the therapeutic fluid itself, nor does it provide a therapeutic effect. It is a pump.
No
Explanation: The device is a syringe pump designed to inject therapeutic fluid, which is a treatment delivery function, not a diagnostic one.
No
The device description explicitly states that the device is a syringe pump with physical components (plastics, microprocessor/memory chip, daughter board) and is a modification of a predicate hardware device. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject a set amount of therapeutic fluid into a patient." This describes a device used in vivo (within the living body) for direct patient treatment.
- Device Description: The description focuses on the mechanical function of moving a syringe plunger and mentions "no fluid or drug contacting surfaces." This further supports its role in delivering substances to the patient, not analyzing samples from the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This syringe pump does not fit that description.
N/A
Intended Use / Indications for Use
The intended medical application of Medex Medfusion 2000 Series syringe pumps is to produce controlled movement of the plunger of a syringe to inject a set amount of therapeutic fluid into a patient within a hospital setting at a set rate and at set times.
Product codes
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Device Description
The new model Medex Medfusion Series 2000 pumps are identical to their predicate models with the exception that the microprocessor/memory chip is replaced by a drop-in replacement microprocessor-EPROM daughter board and that associated memory addresses in the software are modified to accommodate the hardware change.
The exterior surfaces are made of plastics. There are no fluid or drug contacting surfaces.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
hospital setting
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
The legally marketed devices to which these new devices are equivalent are the previous products marketed by Medex under the same trade names
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/0 description: The image shows the text "K955231" on the top line. Below that is the logo for "medexinc". The date "JUL 1 8 1996" is on the bottom right of the image. The text and logo are all in black and white.
510(k) SUMMARY FOR MEDEX MEDFUSION 2001, 2010, & 2010i WITH NEW MICROPROCESSOR/MEMORY SYSTEM
The following summary of safety and effectiveness information is provided as required by Section 807.92(c) of the Safe Medical Devices Act of 1990.
| Submitter | Medex, Inc. |
|---|---|
| Contact person | James W. Lewis |
| Summary prepared | 22 April 1996 |
| Trade names | Medfusion 2001, 2010, & 2010i |
| Common name | Syringe pump |
| Classification name | Infusion pump (per 21 CFR 880.5725) |
| Predicate devices | The legally marketed devices to which these new devices are equivalent are the previous products marketed by Medex under the same trade names |
| Device description | The new model Medex Medfusion Series 2000 pumps are identical to their predicate models with the exception that the microprocessor/memory chip is replaced by a drop-in replacement microprocessor-EPROM daughter board and that associated memory addresses in the software are modified to accommodate the hardware change. |
The exterior surfaces are made of plastics. There are no fluid or drug contacting surfaces. |
| Intended use | The intended medical application of Medex Medfusion 2000 Series syringe pumps is to produce controlled movement of the plunger of a syringe to inject a set amount of therapeutic fluid into a patient within a hospital setting at a set rate and at set times. |
| Technological characteristics | The basic design, material, chemical composition, and energy sources are the same as for the current corresponding Medex Medfusion model pumps. They are identical in operation, function, features, and form as their predicate devices and represent no technological differences. |
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