FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The CADD-Legacy™ Plus Model 6500 ambulatory infusion pump is similar in design, function, and intended use to Deltec's CADD-PLUS® Ambulatory Infusion Pump and the CADD-Prizm® VIP Model 6100 Ambulatory Infusion System . The Model 6500 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 delivery application. The delivery application resident in the Model 6500 pump and the subject of this 510(k) Notification consists of the continuous/intermittent delivery application.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Results/Conclusion
Functional Safety & Performance	Software Validation	Certified	Test plans associated with software validation, verification of software controlled programming functions, and software related to proper pump operation were certified. This indicates the device's software functions as intended and safely.
Equivalence to Predicate Devices	Substantial equivalence in design, function, and intended use to CADD-PLUS® Ambulatory Infusion Pump and CADD-Prizm® VIP Model 6100 Ambulatory Infusion System.	Achieved	The CADD-Legacy™ Plus Model 6500 was found to be "substantially equivalent to other commercially available ambulatory infusion systems" based on the provided information, which includes its design, function, and intended use as an ambulatory infusion pump.
Risk Mitigation (Potential Adverse Effects)	Minimizing possibility of over-infusion, under-infusion, or no infusion.	Not explicitly detailed but implied by software validation and equivalence to predicate devices.	While specific performance metrics for mitigating these adverse effects are not provided, the certification of software validation and the determination of substantial equivalence to already marketed safe devices suggest that these risks are addressed through design and testing.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: This information is not explicitly provided in the document. The "Functional Testing" section states that "Test plans associated with software validation, verification of software controlled programming functions, and software related to proper pump operation were certified," but it does not specify the number of tests, cases, or data points used in these test plans.
Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. It only mentions general "Test plans" for software validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not mention the use of experts to establish a "ground truth" for the test set. Given that the study primarily involved functional and software validation for a medical device (infusion pump), the "ground truth" would likely be defined by engineering specifications and regulatory standards rather than clinical expert consensus.

4. Adjudication Method for the Test Set:

No adjudication method is described. As mentioned above, the testing appears to be functional and software validation, where the "truth" is determined by engineering compliance and software execution, not human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The device is a medical pump, not an AI diagnostic tool, so such a study would not be applicable. The document explicitly states: "Clinical studies were not deemed necessary regarding the use of the CADD-Legacy™ Plus Model 6500 Ambulatory Infusion System."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This concept is not directly applicable. The device is an infusion pump, which operates autonomously to deliver medication based on programmed settings. Its "performance" would inherently be "standalone" in this context. The functional testing described ("software validation, verification of software controlled programming functions, and software related to proper pump operation") represents the standalone performance evaluation of the device's operational capabilities.

7. Type of Ground Truth Used:

The ground truth for the functional testing and software validation would be engineering specifications, design requirements, and regulatory standards for infusion pump operation and software functionality. This is inferred from the description of "Test plans associated with software validation, verification of software controlled programming functions, and software related to proper pump operation."

8. Sample Size for the Training Set:

This information is not applicable and not provided. The CADD-Legacy™ Plus Model 6500 is an electromechanical infusion pump with software-controlled functions, not a machine learning or AI-driven device that requires a "training set" in the conventional sense of AI models. Its performance is based on its engineering design and validated software.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable, as there is no "training set" for this type of medical device.

Summary

Regulation Number and Section

§ 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).