← Product Code [FRN](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN) · K960957 # EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK (K960957) _Sims Deltec, Inc. · FRN · Jun 4, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K960957 ## Device Facts - **Applicant:** Sims Deltec, Inc. - **Product Code:** [FRN](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN.md) - **Decision Date:** Jun 4, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5725 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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 (612)628-7214 ## 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. Page 1 of 3 {1} 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. Page 2 of 3 {2} 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. Page 3 of 3 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K960957](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K960957) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com