(176 days)
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No
The summary describes a standard infusion pump with different delivery applications and mentions software validation, but there is no mention of AI, ML, or related concepts.
Yes
The device is a pump that delivers measured drug therapy, which inherently provides a therapeutic effect to patients.
No
The device is described as an ambulatory infusion pump that provides measured drug therapy, indicating it is a therapeutic device for delivering medication, not for diagnosing conditions.
No
The device description explicitly states it is an "ambulatory infusion pump," which is a hardware device. The summary also mentions "software validation, verification of software controlled programming functions, and software related to proper pump operation," indicating software is a component of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide "measured drug therapy for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space delivery to patients". This describes a device that administers substances into the body for therapeutic purposes.
- Device Description: The description reinforces the intended use as an "ambulatory infusion pump" for delivering drug therapy.
- Lack of IVD Characteristics: An IVD device is used to examine specimens from the human body (like blood, urine, tissue) to provide information about a person's health. The provided text does not mention any analysis of biological samples.
Therefore, the CADD-Prizm™ Model 6100 ambulatory infusion pump is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes
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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.
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
patients in hospital or outpatient settings
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
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.
Key Metrics
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Predicate Device(s)
Abbott Laboratories AIM™ System and Deltec's CADD-Prizm™ Model 6100 PCS (Pain Control System).
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
AUG 23
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.
1
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 nonimplantable 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.