(86 days)
Not Found
Not Found
No
The description focuses on communication and remote control via modem and image display, with no mention of AI or ML technologies.
No
The device facilitates communication with an infusion pump but does not directly provide therapy. It is described as substantially equivalent to communication software and modems, not therapeutic devices themselves.
No
The device is described as a communication system for an infusion pump, facilitating data transfer and allowing the user to monitor and control the pump. It does not perform any diagnostic functions or analyze patient data to determine a medical condition.
No
The device description explicitly mentions "two products," the "PC System" and the "Pump System," which are used with the infusion pump. While software is a key component for communication, the description of "Pump Communications System" and its comparison to a "current Modem" suggests hardware components are involved in facilitating the communication, making it more than just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is solely for communication between a personal computer and an infusion pump, or between two pumps. This is a functional communication system for controlling and monitoring a medical device (the infusion pump).
- Device Description: The description reinforces the communication function and mentions its use with an ambulatory infusion pump.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any biological specimens.
- No Mention of Biological Samples or Analysis: The entire description focuses on data transfer and control of the pump, not on analyzing any biological material.
The mention of "image processing" in the context of displaying an image of the pump on the screen is for user interface and control, not for analyzing biological images or data derived from biological samples.
N/A
Intended Use / 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."
Product codes
FRN
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Functional Testing: 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.
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.
Conclusions: 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.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Road
St. Paul, MN 55112 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Edward W. Numainville
Vice President, Regulatory Affairs and
Quality Systems |
| Common/Usual Name: | PC-Communications System and Pump
Communications System |
| Proprietary Name: | CADD-Diplomat™ PC Communications
System and the CADD-Ambassador™ Pump
Communications System |
| Equivalence Device Comparison: | Sabratek's Homerun™ Model 6060 with
MediVIEW™ Software Package and
Deltec's CADD-Prizm™ Model 6100
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.
32
97
1
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
System with
CADD
Prizm™
Pump | Sabratek
MediVIEW™ with
6060 Pump | Deltec
Current
Modem | Deltec
New ASVD
Modem |
|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-----------------------------------------|----------------------------|-----------------------------|
| IBM compatible PC software program. | Yes | Yes | | |
| Allows direct PC to pump cable
connection. | Yes | Yes | | |
| Allows connection to pump via modem
and telephone lines. | Yes | Yes | | |
| Program uses modem with
simultaneous voice and data feature. | Yes | Yes | | |
| User reviews and controls pump via
image of pump on the PC screen. | Yes | Yes | | |
| User can monitor pump via image of
pump on the PC screen. | Yes | Yes | | |
| User can retrieve reports from pump. | Yes | Yes | | |
| User can view, print and save reports to
disk. | Yes | Yes | | |
| User can retrieve, view, print reports
previously saved to disk. | Yes | Yes | | |
| User can capture patient data to
formulate outcomes management
database. | Yes | No | | |
| Program documents "before and after"
snapshot of the pump's program in a
communications log. | Yes | No | | |
| Program can retrieve information on
what 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 voice
data modem that plugs directly into
clinician's and patient's own phone | | | No | Yes |
| Patient and clinician can voice
communicate during communication
setting | | | No | Yes |
2
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.
3h
3
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
4
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
5
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
3S