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

{0}------------------------------------------------

K982836

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS for the CADD-Legacy™ Plus MODEL 6500 AMBULATORY INFUSION SYSTEM

2 1998 NOV

GENERAL INFORMATION I.

Common/Usual Name:	Ambulatory Infusion Pump
Proprietary Name:	CADD-Legacy™ Plus Model 6500Ambulatory Infusion System
Applicant's name and address:	SIMS Deltec, Inc.1265 Grey Fox RoadSt. Paul, MN 55112
Equivalence device comparison:	CADD-PLUS® Ambulatory Infusion Pumpand CADD-Prizm® VIP Model 6100Ambulatory Infusion System

II. DEVICE DESCRIPTION

ALTERNATIVES Ш.

Alternatives to the CADD-Legacy™ Plus Model 6500 pump include the use of other commercially available ambulatory infusion pumps, such as Deltec's CADD-PLUS® and CADD-Prizm® VIP Ambulatory Infusion Pumps.

IV. POTENTIAL ADVERSE EFFECTS

The potential direct adverse effects that may occur when using the CADD-Legacy™ Plus Model 6500 pump, as well as other commercially available non-implantable ambulatory infusion pumps, include the possibility of overinfusion, under-infusion, or no infusion.

{1}------------------------------------------------

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS for the CADD-Legacy™ Plus MODEL 6500 AMBULATORY INFUSION SYSTEM

V. 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-Legacy™ Plus Model 6500 Ambulatory Infusion System.

B. Clinical Studies

Clinical studies were not deemed necessary regarding the use of the CADD-Legacy™ Plus Model 6500 Ambulatory Infusion System.

CONCLUSIONS DRAWN FROM THESE STUDIES VI.

Based upon the information provided above, the CADD-Legacy™ Plus Model 6500 Ambulatory Infusion System is substantially equivalent to other commercially available ambulatory infusion systems.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1998 NOV

Mr. Edward W. Numainville Vice President, Requlatory Affairs and Quality Systems SIMS Deltec, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112

K982836 Re : Trade Name: CADD-Legacy™ Plus, Model 6500, Ambulatory Drug Infusion System Regulatory Class: II Product Code: FRN Dated: August 12, 1998 Received: August 12, 1998

Dear Mr. Numainville:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labelinq, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

{3}------------------------------------------------

Page 2 - Mr. Numainville

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known):

1982836

Device Name:

CADD-Legacy™ Plus Model 6500 Ambulatory Infusion Pump

Indications For Use:

"The CADD-Legacy™ pump is suitable for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space, or subarachnoid space infusion."

(PLEASE DO NOT WRITE BELUW THIS LINE - CUNIMAJE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use OR

(Optional Format 1/2/96)

Patrice Cresente

(Division Sign-Off) Division of Demal Infection Control, and General Hospital Devices

510(k) Number K982835

M:\510(k)ISDSubmissions1998\CADD-Legacy\IndicationsLegacyPlus

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).