CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM

K973917 · Sims Deltec, Inc. · FRN · Jan 9, 1998 · General Hospital

Device Facts

• Record ID: K973917
• Device Name: CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM
• Applicant: Sims Deltec, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Jan 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

System enables communication between personal computer and CADD-Prizm™ Model 6100 ambulatory infusion pump; facilitates local or remote data transfer via modem over telephone lines. Includes simultaneous voice and data capability allowing clinician-patient conversation during communication sessions. PC software displays pump image for monitoring/control; retrieves pump reports; documents program snapshots in communication logs; captures patient data for outcomes management; identifies attached accessories. Used by clinicians and patients in clinical or home settings. Output allows clinicians to review pump status, manage therapy, and maintain patient records. Benefits include remote monitoring, improved clinical oversight, and efficient data management.

Clinical Evidence

No clinical data. Substantial equivalence supported by functional testing of software-controlled interface functions.

Technological Characteristics

System consists of PC software and modem hardware. Connectivity via direct cable or analog telephone lines. Features simultaneous voice and data transmission. Software provides graphical user interface (GUI) for pump control and report generation. Operates with CADD-Prizm™ Model 6100 pump. No specific materials or standards cited.

Indications for Use

Indicated for clinicians and patients using the CADD-Prizm™ Model 6100 Ambulatory Infusion System to facilitate remote or local communication between a personal computer and the pump, or between two pumps, via modem and telephone lines.

Regulatory Classification

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.

Predicate Devices

• Sabratek's Homerun™ Model 6060 with MediVIEW™ Software Package
• Deltec's CADD-Prizm™ Model 6100 Ambulatory Infusion System (current Modem)

Submission Summary (Full Text)

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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.<br>1265 Grey Fox Road<br>St. Paul, MN 55112 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Edward W. Numainville<br>Vice President, Regulatory Affairs and<br>Quality Systems |
| Common/Usual Name: | PC-Communications System and Pump<br>Communications System |
| Proprietary Name: | CADD-Diplomat™ PC Communications<br>System and the CADD-Ambassador™ Pump<br>Communications System |
| Equivalence Device Comparison: | Sabratek's Homerun™ Model 6060 with<br>MediVIEW™ Software Package and<br>Deltec's CADD-Prizm™ Model 6100<br>Ambulatory Infusion System |

#### II. 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.

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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 PC<br>System with<br>CADD<br>Prizm™<br>Pump | Sabratek<br>MediVIEW™ with<br>6060 Pump | Deltec<br>Current<br>Modem | Deltec<br>New ASVD<br>Modem |
|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-----------------------------------------|----------------------------|-----------------------------|
| IBM compatible PC software program. | Yes | Yes | | |
| Allows direct PC to pump cable<br>connection. | Yes | Yes | | |
| Allows connection to pump via modem<br>and telephone lines. | Yes | Yes | | |
| Program uses modem with<br>simultaneous voice and data feature. | Yes | Yes | | |
| User reviews and controls pump via<br>image of pump on the PC screen. | Yes | Yes | | |
| User can monitor pump via image of<br>pump on the PC screen. | Yes | Yes | | |
| User can retrieve reports from pump. | Yes | Yes | | |
| User can view, print and save reports to<br>disk. | Yes | Yes | | |
| User can retrieve, view, print reports<br>previously saved to disk. | Yes | Yes | | |
| User can capture patient data to<br>formulate outcomes management<br>database. | Yes | No | | |
| Program documents "before and after"<br>snapshot of the pump's program in a<br>communications log. | Yes | No | | |
| Program can retrieve information on<br>what accessories are attached to pump,<br>e.g. AC adapter, air detector, cassette,<br>etc. | Yes | No | | |
| Kit contains separate analog phone | | | Yes | No |
| Kit contains analog simultaneous voice<br>data modem that plugs directly into<br>clinician's and patient's own phone | | | No | Yes |
| Patient and clinician can voice<br>communicate during communication<br>setting | | | 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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