To allow communication between a personal computer and the CADD-Prizm™ Ambulatory Infusion Pump, Model 6100, or pump-to-pump, either remotely or locally via a modem over telephone lines.

Device Description

The PC-Communications System ("PC System") and Pump Communications System ("Pump System") are two products that will be used with CADD-Prizm™ Model 6100 Ambulatory Infusion Pumps. The PC System and the Pump System products are substantially equivalent to Sabratek's MediVIEW™ Software Package used with their Homerun™ Model 6060 Ambulatory Infusion Pump and the current Modem used with SIMS Deltec's CADD-Prizm™ Model 6100 Ambulatory Infusion Pump. The products allow communications between a personal computer and an ambulatory infusion pump, either locally or remotely via modem over telephone lines and allow the clinician and patient to converse during PC to pump, or pump-to-pump communications, respectively.

AI/ML Overview

This document describes a 510(k) submission for the PC-Communication and Pump Communications System used with the CADD-Prizm™ Model 6100 Ambulatory Infusion System. The submission aims to demonstrate substantial equivalence to existing devices rather than prove clinical efficacy against specific acceptance criteria. Therefore, many of the requested details about acceptance criteria for device performance, ground truth, and clinical study specifics are not applicable or detailed in this type of submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for device performance in terms of accuracy, sensitivity, specificity, or other typical performance metrics for AI/CAD devices. Instead, it relies on feature-by-feature comparison for substantial equivalence.

Feature/Function	Acceptance Criteria (Implied)	Reported Device Performance (Deltec PC System with CADD Prizm™ Pump)
IBM compatible PC software program.	Must have this capability.	Yes
Allows direct PC to pump cableconnection.	Must have this capability.	Yes
Allows connection to pump via modemand telephone lines.	Must have this capability.	Yes
Program uses modem withsimultaneous voice and data feature.	Must have this capability.	Yes
User reviews and controls pump viaimage of pump on the PC screen.	Must have this capability.	Yes
User can monitor pump via image ofpump on the PC screen.	Must have this capability.	Yes
User can retrieve reports from pump.	Must have this capability.	Yes
User can view, print and save reports todisk.	Must have this capability.	Yes
User can retrieve, view, print reportspreviously saved to disk.	Must have this capability.	Yes
User can capture patient data toformulate outcomes managementdatabase.	Must have this capability (for the new device).	Yes
Program documents "before and after"snapshot of the pump's program in acommunications log.	Must have this capability (for the new device).	Yes
Program can retrieve information onwhat accessories are attached to pump,e.g. AC adapter, air detector, cassette,etc.	Must have this capability (for the new device).	Yes
Kit contains separate analog phone	Not applicable to the new device; predicate's feature.	(Does not apply to Deltec PC System)
Kit contains analog simultaneous voicedata modem that plugs directly intoclinician's and patient's own phone	Must have this capability (for the new device).	(Does not apply to Deltec PC System, but to new ASVD Modem)
Patient and clinician can voicecommunicate during communicationsetting	Must have this capability (for the new device's modem component).	(Does not apply to Deltec PC System, but to new ASVD Modem)

Note: The "acceptance criteria" here are implied by the substantial equivalence comparison table. The new device is considered to "meet" these criteria if it possesses the enumerated features, especially those present in the predicate devices. For features specific to the new device (e.g., "capture patient data to formulate outcomes management database"), the implication is that these are additional positive features that do not negatively impact safety or effectiveness.

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

The document explicitly states: "Clinical studies were not deemed necessary regarding the use of the PC -Communications System and Pump Communications System with the CADD-Prizm™ Ambulatory Infusion System, Model 6100."
Therefore, there is no test set in the context of clinical performance evaluation, and thus no sample size or data provenance information available for such a test set. The evaluation was based on functional testing (see point A in "SUMMARY OF STUDIES V.")

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

As clinical studies were not performed, there was no test set requiring expert-established ground truth.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technical features and functional testing, not on comparative effectiveness for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The device is a communication system, not an AI or algorithm-based diagnostic tool. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in the typical sense of AI/CAD devices. The "standalone" evaluation would be the functional testing of the communication system itself, ensuring it performs its intended communication tasks. The provided document mentions "Functional Testing A. Test plans associated with the validation of software controlled interface functions," which serves this purpose.

7. The Type of Ground Truth Used:

For the functional testing, the "ground truth" would be the expected behavior and output of the communication system, verified against its design specifications and industry standards for data transmission and software functionality. This is not "expert consensus," "pathology," or "outcomes data" in the typical clinical sense, but rather engineering and software validation.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

for the

PC-Communication and Pump Communications System used with the CADD-Prizm™ Model 6100 Ambulatory Infusion System

GENERAL INFORMATION I.

Applicant's Name and Address:	SIMS Deltec, Inc.1265 Grey Fox RoadSt. Paul, MN 55112
Contact Person:	Edward W. NumainvilleVice President, Regulatory Affairs andQuality Systems
Common/Usual Name:	PC-Communications System and PumpCommunications System
Proprietary Name:	CADD-Diplomat™ PC CommunicationsSystem and the CADD-Ambassador™ PumpCommunications System
Equivalence Device Comparison:	Sabratek's Homerun™ Model 6060 withMediVIEW™ Software Package andDeltec's CADD-Prizm™ Model 6100Ambulatory Infusion System

II. DEVICE DESCRIPTION

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III. INTENDED USE OF DEVICE

To allow communication between a personal computer and the CADD-Prizm™ Ambulatory Infusion Pump, Model 6100, or pump-to-pump, either remotely or locally via a modem over telephone lines.

IV. DEVICE COMPARISONS

Feature/Function	Deltec PCSystem withCADDPrizm™Pump	SabratekMediVIEW™ with6060 Pump	DeltecCurrentModem	DeltecNew ASVDModem
IBM compatible PC software program.	Yes	Yes
Allows direct PC to pump cableconnection.	Yes	Yes
Allows connection to pump via modemand telephone lines.	Yes	Yes
Program uses modem withsimultaneous voice and data feature.	Yes	Yes
User reviews and controls pump viaimage of pump on the PC screen.	Yes	Yes
User can monitor pump via image ofpump on the PC screen.	Yes	Yes
User can retrieve reports from pump.	Yes	Yes
User can view, print and save reports todisk.	Yes	Yes
User can retrieve, view, print reportspreviously saved to disk.	Yes	Yes
User can capture patient data toformulate outcomes managementdatabase.	Yes	No
Program documents "before and after"snapshot of the pump's program in acommunications log.	Yes	No
Program can retrieve information onwhat accessories are attached to pump,e.g. AC adapter, air detector, cassette,etc.	Yes	No
Kit contains separate analog phone			Yes	No
Kit contains analog simultaneous voicedata modem that plugs directly intoclinician's and patient's own phone			No	Yes
Patient and clinician can voicecommunicate during communicationsetting			No	Yes

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SUMMARY OF STUDIES V.

Functional Testing A.

Test plans associated with the validation of software controlled interface functions with respect PC - Communications System and Pump Communications System for use with CADD-Prizm™ Ambulatory Infusion Systems, Model 6100.

B. Clinical Studies

Clinical studies were not deemed necessary regarding the use of the PC -Communications System and Pump Communications System with the CADD-Prizm™ Ambulatory Infusion System, Model 6100.

C. Conclusions Drawn from Studies

Based upon the information provided above, the use of the PC - Communications System and Pump Communications System with the CADD-Prizm™ Ambulatory Infusion System, Model 6100 is substantially equivalent to Sabratek's MediVIEW™ Software Package used with their Homerun™ Model 6060 Ambulatory Infusion Pump and the current Modem used with SIMS Deltec's CADD-Prizm™ Model 6100 Ambulatory Infusion Pump.

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Image /page/3/Picture/2 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the seal is a stylized symbol that resembles three overlapping human figures or abstract shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JAN - 9 1998

Re: K973917 CADD-Diplomat™ PC Communications System Trade Name: and the CADD-Ambassador™ Pump Communications System Requlatory Class: II Product Code: FRN Dated: October 14, 1997 Received: October 15, 1997

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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, 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 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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

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Page 2 - Mr. Numainville

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.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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

Time r A ulato 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):

Unknown
月973917

Device Name:

PC- Communications System and Pump Communications System for use with CADD-Prizm™ Ambulatory Infusion System, Model 6100.

Indications For Use:

" To allow communication between a personal computer and the CADD-Prizm™ Ambulatory Infusion Pump, Model 6100, or pump-to-pump, either remotely or locally via a modem over telephone lines."

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1/2/96)

DS\INDICATIONS4USE.DOC

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).