(85 days)
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No
The device description and performance studies focus solely on the electrical and functional performance of a power source for infusion pumps, with no mention of AI or ML technologies.
No
The device is described as an alternative power source for existing infusion pumps, not a therapeutic device itself.
No
The device is an external power source for infusion pumps and is not designed to diagnose any medical condition.
No
The device description explicitly lists hardware components such as a rechargeable power pack, AC adaptor, battery adaptor, notched battery door, and replacement battery pack.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides an alternative power source for ambulatory infusion pumps. This is a functional role for a medical device, not a diagnostic one.
- Device Description: The description details the components of a power system (power pack, adaptors, etc.), which are consistent with a power supply for medical equipment, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is solely to power other medical devices.
N/A
Intended Use / 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.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Functional 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. Clinical studies were not deemed necessary.
Key Metrics
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Predicate Device(s)
SIMS Deltec's External Power Source (EPS) System, Power Pack (nickel cadmium, NiCad)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
510(k) Summary of Safety and Effectiveness Date Prepared: March 4, 1996
I. GENERAL INFORMATION
| Applicant's name and address: | SIMS Deltec, Inc.
1265 Grey Fox Road
St. Paul, MN 55112 |
| ------------------------------- | --------------------------------------------------------------- |
|---|
David H. Short Manager, Regulatory Affairs (612)628-7214
II. PRODUCT INFORMATION
Contact:
Common/Usual Name:
Battery Pack
Unknown
Classification Name:
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)
DEVICE DESCRIPTION IV.
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.
1
510(k) Summary of Safety and Effectiveness Date Prepared: March 4, 1996
DEVICE COMPARISON IV.
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 | External Power | |
| Source (EPS) System | ||
| Alternate Power Pack | 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 |
: ﺗ
INTENDED USE V.
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.
SUMMARY OF STUDIES VI.
Functional Testing A.
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.
Clinical Studies B.
Clinical studies were not deemed necessary.
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510(k) Summary of Safety and Effectiveness Date Prepared: March 4, 1996
CONCLUSION VII.
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.