(176 days)
The Model 6100 pump provides measured drug therapy for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space delivery to patients in hospital or outpatient settings.
The CADD-Prizm™ Model 6100 ambulatory infusion pump is similar in design, function, and intended use to Abbott Laboratories AIM™ System and Deltec's CADD-Prizm™ Model 6100 PCS (Pain Control System). The Model 6100 pump provides measured drug therapy for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space delivery to patients in hospital or outpatient settings. The pump is capable of storing one to four delivery applications at one time. The delivery applications supplied for use with the Model 6100 pump and the subject of this 510(k) Notification are the TPN delivery application, continuous delivery application and the intermittent delivery application.
This request cannot be fulfilled. The provided text describes an ambulatory infusion pump, not an AI device or a device that has acceptance criteria based on studies involving test sets, expert ground truth, or statistical analysis of performance metrics typically associated with AI/ML device evaluations. All questions refer to aspects of AI/ML device studies, which are not applicable to this document.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS for the CADD-Prizm™ MODEL 6100 AMBULATORY INFUSION SYSTEM
I. GENERAL INFORMATION
| Common/Usual Name: | Ambulatory Infusion Pump |
|---|---|
| Proprietary Name: | CADD-Prizm™ Model 6100Ambulatory Infusion System |
| Applicant's name and address: | SIMS Deltec, Inc.1265 Grey Fox RoadSt. Paul, MN 55112 |
| Equivalence device comparison: | Abbott Laboratories AIM™ System andDeltec's CADD-Prizm™ Model 6100 PCS(Pain Control System). |
II. DEVICE DESCRIPTION
The CADD-Prizm™ Model 6100 ambulatory infusion pump is similar in design, function, and intended use to Abbott Laboratories AIM™ System and Deltec's CADD-Prizm™ Model 6100 PCS (Pain Control System). The Model 6100 pump provides measured drug therapy for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space delivery to patients in hospital or outpatient settings. The pump is capable of storing one to four delivery applications at one time. The delivery applications supplied for use with the Model 6100 pump and the subject of this 510(k) Notification are the TPN delivery application, continuous delivery application and the intermittent delivery application.
III. ALTERNATIVES
Alternatives to the CADD-Prizm™ Model 6100 pump include the use of other commercially available ambulatory drug infusion pumps such as Abbott AIM™ System.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS for the CADD-Prizm™ MODEL 6100 AMBULATORY INFUSION SYSTEM
V. POTENTIAL ADVERSE EFFECTS
The potential direct adverse effects that may occur when using the CADD-Prizm™ Model 6100 pump, as well as other commercially available nonimplantable ambulatory infusion pumps, include the possibility of over-infusion, under-infusion, or no infusion.
VI. SUMMARY OF STUDIES
A. Functional Testing
Test plans associated with software validation, verification of software controlled programming functions, and software related to proper pump operation were certified for the CADD-Prizm™ Model 6100 Ambulatory Infusion System.
B. Clinical Studies
Clinical studies were not deemed necessary regarding the use of the CADD-Prizm™ Model 6100 Ambulatory Infusion System.
VII. CONCLUSIONS DRAWN FROM THESE STUDIES
Based upon the information provided above, the CADD-Prizm™ Model 6100 Ambulatory Infusion Pump is substantially equivalent to other commercially available ambulatory infusion systems.
§ 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).