CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP

K955180 · Sims Deltec, Inc. · FRN · May 23, 1996 · General Hospital

Device Facts

• Record ID: K955180
• Device Name: CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP
• Applicant: Sims Deltec, Inc.
• Product Code: FRN · General Hospital
• Decision Date: May 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CADD-PCA® Model 5800 or 5800R Pump: The CADD-PCA pump is indicated for intravenous, subcutaneous, epidural space or subarachnoid space infusions. CADD-Micro® Model 5900 Pump: The CADD-Micro pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space microinfusions. CADD-Prizm™ Model 6100 Pump: The CADD-Prizm pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space infusions.

Device Story

Microcomputer-controlled ambulatory infusion pumps deliver medication via parenteral routes (intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural, subarachnoid). Devices operate via programmed infusion parameters to deliver medication through compatible catheters. Used in clinical or ambulatory settings by healthcare providers or patients. Output consists of controlled fluid delivery; informs clinical pain management or therapeutic infusion regimens. Benefit includes expanded site-specific delivery options for existing pump platforms.

Clinical Evidence

No clinical studies or functional testing were performed. The submission relies on the existing clearance of the pump hardware and the established clinical indication for subarachnoid use associated with compatible catheter systems.

Technological Characteristics

Microcomputer-controlled ambulatory infusion pumps. No hardware or software modifications were made for this labeling expansion. Connectivity and materials are consistent with previously cleared versions of the CADD-PCA, CADD-Micro, and CADD-Prizm pump lines.

Indications for Use

Indicated for patients requiring medication delivery via intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural, or subarachnoid routes using microcomputer-controlled ambulatory infusion pumps.

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.

Reference Devices

• IPI AlgoLine™ Catheter Kits (PS Medical Corporation)

Submission Summary (Full Text)

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K955180

510(k) Summary
Date Prepared: November 8, 1995

## I. GENERAL INFORMATION

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

Contact:
David H. Short
Manager, Regulatory Affairs
[phone]

## II. PRODUCT INFORMATION

Common/Usual Name:
Ambulatory Infusion Pumps

Classification Name:
Infusion Pump

Proprietary Name:
CADD-PCA® Model 5800 Pump
CADD-PCA® Model 5800R Pump
CADD-Micro® Model 5900 Pump
CADD-Prizm™ Model 6100 Pump

## III. EQUIVALENCE DEVICE COMPARISON

IPI AlgoLine™ Catheter Kits manufactured by PS Medical Coporation, Goleta, CA.

## IV. DEVICE DESCRIPTION

The subject devices are microcomputer controlled ambulatory infusion pumps intended for the delivery of medication via various parenteral routes, i.e., intravenous, intra-arterial, subcutaneous, intraperitoneal, or epidural space infusion. The purpose of this 510(k) Notification is to add subarachnoid space infusion to the labeling and thereby expanding the intended use of each pump. The subject devices, as a matter of course, will be used for the delivery of medication through catheters that have this indication.

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510(k) Summary
Date Prepared: November 8, 1995

## IV. DEVICE COMPARISON

Provided in Table 1 is a comparison of devices and their respective indications for use.

Table 1. Comparison of indications for use of various devices.

| | CADD-Prizm™ Pump | CADD-PCA® Pump
(Model 5800 & 5800R) | CADD-Micro® Pump | AngoLine™ Catheter Kits |
| --- | --- | --- | --- | --- |
| Manufacturer | SIMS Deltec, Inc. | SIMS Deltec, Inc. | SIMS Deltec, Inc. | IPI PS Medical Corporation |
| SYSTEM | | | | |
| Microcomputer controlled pump | YES | YES | YES | n/a |
| INDICATIONS FOR USE | | | | |
| Intravenous | YES | YES | YES | n/a |
| Intra-arterial | YES | NO | YES | n/a |
| Subcutaneous | YES | YES | YES | n/a |
| Intraperitoneal | YES | NO | YES | n/a |
| Epidural space | YES | YES | YES | YES |
| Subarachnoid space | NO | NO | NO | YES |

## V. INTENDED USE

CADD-PCA® Model 5800 or 5800R Pump:

The CADD-PCA pump is indicated for intravenous, subcutaneous, epidural space or subarachnoid space infusions.

CADD-Micro® Model 5900 Pump:

The CADD-Micro pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space microinfusions.

CADD-Prizm™ Model 6100 Pump:

The CADD-Prizm pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space infusions.

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510(k) Summary
Date Prepared: November 8, 1995

## VI. SUMMARY OF STUDIES

### A. Functional Testing

No software and/or functional modifications were required as it relates to the addition of the subarachnoid space infusion indication to the labeling of each subject device, therefore, no functional testing was deemed necessary.

### B. Clinical Studies

Clinical studies were not deemed necessary.

## VII. CONCLUSION

Based upon the information provided above, the addition of subarachnoid space infusion to the labeling of each subject device is substantially equivalent to the labeling of commercially available catheters, such as the IPI AlgoLine™ Catheter Kits manufactured by PS Medical Coporation, with this indication.

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