CADD-PRIZM MODEL 6100 PUMP

K960826 · Sims Deltec, Inc. · FRN · Aug 23, 1996 · General Hospital

Device Facts

• Record ID: K960826
• Device Name: CADD-PRIZM MODEL 6100 PUMP
• Applicant: Sims Deltec, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Aug 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Ambulatory infusion pump; delivers measured drug therapy via intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural, or subarachnoid routes. Used in hospital or outpatient settings. Stores 1-4 delivery applications (TPN, continuous, intermittent). Operated by clinicians or patients. Provides controlled drug delivery; mitigates risks of over/under-infusion common to ambulatory pumps.

Clinical Evidence

No clinical studies performed. Evidence based on functional testing, software validation, and verification of software-controlled programming functions.

Technological Characteristics

Ambulatory infusion pump; software-controlled programming for TPN, continuous, and intermittent delivery. Supports multiple delivery routes. No specific materials or connectivity standards provided.

Indications for Use

Indicated for patients requiring measured drug therapy via intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural, or subarachnoid routes in hospital or outpatient settings.

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

• Abbott Laboratories AIM™ System
• Deltec's CADD-Prizm™ Model 6100 PCS (Pain Control System)

Submission Summary (Full Text)

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K960826

AUG 23 1988

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 6100 Ambulatory Infusion System

Applicant's name and address: SIMS Deltec, Inc.
1265 Grey Fox Road
St. Paul, MN 55112

Equivalence device comparison: Abbott Laboratories AIM™ System and Deltec'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 non-implantable 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.