EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK

K960957 · Sims Deltec, Inc. · FRN · Jun 4, 1996 · General Hospital

Device Facts

• Record ID: K960957
• Device Name: EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK
• Applicant: Sims Deltec, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Jun 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2

Indications for Use

The External Power Source (EPS) System is designed to provide an alternative source of power for the following Deltec Pumps: CADD-1*, CADD-PCA*, CADD-PLUS*, CADD-TPN*, and CADD-Prizm™ ambulatory infusion pumps.

Device Story

External Power Source (EPS) System provides rechargeable power for CADD ambulatory infusion pumps; replaces standard 9V batteries. System includes rechargeable power pack, AC adaptor, battery adaptor, notched battery door, and nickel-metal hydride (NiMH) battery pack. Operates within 2°C to 40°C; weight approximately 570g. Includes low battery alarm and ready indicator lights. Used in clinical or home settings by patients or clinicians to ensure continuous pump operation during infusion therapy.

Clinical Evidence

No clinical data. Functional testing conducted per 'Rechargeable Battery Preliminary Guidance for Data to be Submitted to the Food and Drug Administration in Support of Premarket Notification Applications' (January 1994). Device performed as intended and within specifications.

Technological Characteristics

Rechargeable power pack using nickel-metal hydride (NiMH) battery chemistry. Includes AC adaptor, battery adaptor, and notched battery door. Weight: ~570g. Operating temperature: 2°C to 40°C. Features low battery alarm and ready indicator lights. System is an external power accessory for ambulatory infusion pumps.

Indications for Use

Indicated for use as an alternative power source for Deltec CADD-1, CADD-PCA, CADD-PLUS, CADD-TPN, and CADD-Prizm 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.

Predicate Devices

• External Power Source (EPS) System, Power Pack (nickel cadmium, NiCad)

Submission Summary (Full Text)

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K960957

510(k) Summary of Safety and Effectiveness
Date Prepared: March 4, 1996

JUN - 4 1996

## 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: Battery Pack
Classification Name: Unknown
Proprietary Name: External Power Source (EPS) System, Alternate Power Pack (nickel-metal hydride)

## III. EQUIVALENCE DEVICE COMPARISON

SIMS Deltec's External Power Source (EPS) System, Power Pack (nickel cadmium, NiCad)

## IV. DEVICE DESCRIPTION

The External Power Source (EPS) System is comprised of a rechargeable power pack, AC adaptor, battery adaptor, notched battery door, and replacement battery pack for the power pack. The EPS System was developed as an alternate power source to 9 volt batteries for various CADD* pumps Deltec manufactures. The EPS System is designed for use with CADD-1* pump, CADD-PLUS* pump, CADD-PCA* (Models 5800 and 5800R) pumps, and the CADD-Prizm™ pump. An alternate rechargeable power pack with replaceable nickel-metal hydride (NiNH) batteries has been developed and the subject of this 510(k) Notification.

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510(k) Summary of Safety and Effectiveness
Date Prepared: March 4, 1996

## IV. DEVICE COMPARISON

Provided in Table 1 is a feature comparison of the EPS System Power Pack with NiMH batteries and the EPS System Power Pack with NiCad batteries.

Table 1. Comparison Chart

| | External Power Source (EPS) System
Alternate Power Pack | External Power Source (EPS) System
Power Pack |
| --- | --- | --- |
| Manufacturer | SIMS Deltec, Inc. | SIMS Deltec, Inc. |
| Power Pack Feature |
| Battery Chemistry | nickel-metal hydride | nickel cadmium |
| Rechargeable Power Pack | YES | YES |
| Replaceable Battery Pack | YES | YES |
| Low Battery Alarm | YES | YES |
| Ready Indicator Lights | YES | NO |
| Operating Temperature | 2°C to 40°C | 2°C to 40°C |
| Weight | ≈570 g | ≈570 g |

## V. INTENDED USE

The External Power Source (EPS) System is designed to provide an alternative source of power for the following Deltec Pumps: CADD-1*, CADD-PCA*, CADD-PLUS*, CADD-TPN*, and CADD-Prizm™ ambulatory infusion pumps.

## VI. SUMMARY OF STUDIES

### A. Functional Testing

Function testing was conducted using the alternate power pack of the External Power Source (EPS) System in accordance with the Rechargeable Battery Preliminary Guidance for Data to be Submitted to the Food and Drug Administration in Support of Premarket Notification Applications (January 1994). Based upon the testing that was conducted, the power pack with NiMH batteries performed as intended and within specification.

### B. Clinical Studies

Clinical studies were not deemed necessary.

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510(k) Summary of Safety and Effectiveness
Date Prepared: March 4, 1996

## VII. CONCLUSION

Based upon the information provided above, the alternate power pack developed for use in the External Power Source (EPS) System is suitable for its intended use, i.e., as an alternative source of power for the following Deltec Pumps: CADD-1*, CADD-PCA*, CADD-PLUS*, CADD-TPN*, and CADD-Prizm™ ambulatory infusion pumps.

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