The CADD-Legacy™ 1 Model 6400 ambulatory infusion pump is similar in design, function, and intended use to Deltec's CADD-1 " Ambulatory Infusion Pump and the CADD-Prizm® VIP Model 6100 Ambulatory Infusion System . The Model 6400 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 6400 pump and the subject of this 510(k) Notification is the continuous delivery application.

AI/ML Overview

The provided text describes the 510(k) submission for the CADD-Legacy™ 1 Model 6400 Ambulatory Infusion System. However, it does not include detailed acceptance criteria or a study designed to explicitly prove the device meets specific performance criteria in the way modern AI/ML device submissions typically do (e.g., using metrics like sensitivity, specificity, AUC).

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices (CADD-1® Ambulatory Infusion Pump and CADD-Prizm® VIP Model 6100 Ambulatory Infusion System) as per FDA 510(k) requirements from 1998. The "study" for this type of device at that time primarily involved functional testing and a comparison to already approved devices.

Here's an analysis based on the provided text, highlighting where information is absent due to the nature of the submission:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence: Device performs as intended for infusion delivery (intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space, or subarachnoid space).	Substantially Equivalent: The CADD-Legacy™ 1 Model 6400 is similar in design, function, and intended use to predicate devices (CADD-1® and CADD-Prizm® VIP Model 6100).
Safety: Does not introduce new risks or adverse effects compared to predicate devices.	Similar Potential Adverse Effects: Potential for overinfusion, under-infusion, or no infusion, similar to other commercially available non-implantable ambulatory infusion pumps.
Software Validation: Software controls programming and proper pump operation.	Certified Test Plans: Test plans associated with software validation, verification of software controlled programming functions, and software related to proper pump operation were certified.

Missing specific quantitative acceptance criteria: The document does not provide specific numerical acceptance criteria (e.g., "infusion accuracy within X%," "flow rate deviation within Y ml/hr") that would typically be found in detailed engineering specifications or test reports. The assessment relies on a broader "functional equivalence" and the successful completion of internal functional testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not explicitly stated for performance testing. The "Functional Testing" section mentions "test plans associated with software validation, verification of software controlled programming functions, and software related to proper pump operation were certified." This implies internal testing was conducted, but details on the number of units tested or specific test cases are not provided.
Data Provenance: Not applicable in the context of this 510(k) as the "studies" primarily consisted of functional/software testing and comparison to predicate devices, not clinical data collection from patient populations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is an ambulatory infusion pump, not an AI/ML-based diagnostic or prognostic tool that would require expert-established ground truth from medical images or patient records. The "ground truth" for functional testing would be the engineering specifications and expected operational behavior of the pump.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, this kind of adjudication is relevant for expert-driven ground truth establishment in clinical studies, which were not conducted for this 510(k) due to it being a functional device rather than a diagnostic AI/ML system.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. An MRMC study is not relevant for this device. This is a standalone medical device (an infusion pump), not an AI-assisted diagnostic tool that would be used by human "readers" (e.g., radiologists interpreting images).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in a sense. The "Functional Testing" described the testing of the pump's software-controlled functions and proper operation. This is inherently a standalone performance assessment of the device's functionality. The clinical studies were "not deemed necessary," further indicating the focus was on the device's inherent functional performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the "Functional Testing" would have been the device's design specifications, engineering requirements, and pre-established expected performance parameters for infusion delivery (e.g., flow rates, volumes, alarm conditions). This is based on engineering standards and the known behavior of similar predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set. The device is a hardware-based infusion pump with embedded software, not a machine learning algorithm trained on data.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 4 1998 NOY for the CADD-Legacy™ 1 MODEL 6400 AMBULATORY INFUSION SYSTEM

GENERAL INFORMATION I.

Common/Usual Name:	Ambulatory Infusion Pump
Proprietary Name:	CADD-Legacy™ 1 Model 6400Ambulatory Infusion System
Applicant's name and address:	SIMS Deltec, Inc.1265 Grey Fox RoadSt. Paul, MN 55112
Equivalence device comparison:	CADD-1® Ambulatory Infusion Pump andCADD-Prizm® VIP Model 6100 AmbulatoryInfusion System

DEVICE DESCRIPTION II.

Ш. ALTERNATIVES

Alternatives to the CADD-Legacy™ 1 Model 6400 pump include the use of other commercially available ambulatory infusion pumps, such as Deltec's CADD-1® and CADD-Prizm® VIP Ambulatory Infusion Pumps.

POTENTIAL ADVERSE EFFECTS IV.

The potential direct adverse effects that may occur when using the CADD-Legacy™ 1 Model 6400 pump, as well as other commercially available non-implantable ambulatory infusion pumps, include the possibility of overinfusion, under-infusion, or no infusion.

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K982838

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS for the CADD-Legacy™ 1 MODEL 6400 AMBULATORY INFUSION SYSTEM

SUMMARY OF STUDIES V.

Functional Testing A.

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™ 1 Model 6400 Ambulatory Infusion System.

B. Clinical Studies

Clinical studies were not deemed necessary regarding the use of the CADD-Legacy™ 1 Model 6400 Ambulatory Infusion System.

CONCLUSIONS DRAWN FROM THESE STUDIES VI.

Based upon the information provided above, the CADD-Legacy™ 1 Model 6400 Ambulatory Infusion System is substantially equivalent to other commercially available ambulatory infusion systems.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird or eagle with three lines forming the wings and head. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 1998 NOV

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

K982838 Re : CADD-Legacy™ 1 Ambulatory Infusion Trade Name: System, Model 6400 Requlatory Class: II Product Code: FRN Dated: August 12, 1998 August 12, 1998 Received:

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst 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 regulations 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 Reqister. 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 regulations.

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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 requlation 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

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INDICATIONS FOR USE

510(k) Number (if known):

CADD-Legacy™ 1 Model 6400 Ambulatory Infusion Pump Device Name:

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 BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use L (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1/2/96)

Palace Crescenta
(Division Sign-On)

Division of Denal, Infection Control, and General Hospital Devices

510(k) Number 4982858

M:\510(k)ISDSubmissions1998\CADD-LegacyNIndicationsLegacy1

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).