(255 days)
No
The description focuses on hardware modifications for communication and does not mention any AI or ML algorithms or functionalities.
No
The device is described as a modem intended to facilitate telephonic communication between a PC and infusion pumps. Its function is to transmit signals, not to provide therapy directly.
No
The device description indicates it's a modem for facilitating telephonic communication between a PC and infusion pumps. It does not mention any function related to diagnosing medical conditions.
No
The device description explicitly states the addition of an "alternative serial communication outlet that uses Infra red light" and describes the conversion of light impulses to electrical signals, indicating the presence of hardware components beyond just software.
Based on the provided information, the D-MODEM is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to facilitate telephonic communication between a PC and infusion pumps. This is a communication and data transfer function, not a diagnostic test performed on biological samples.
- Device Description: The device description focuses on the communication technology (serial port, infrared light) and its function in transmitting electrical signals over telephone lines. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases or conditions based on biological sample analysis.
The D-MODEM is a communication interface designed to transfer data from medical devices (infusion pumps) to a computer, likely for monitoring, programming, or data logging purposes. This falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The D-MODEM is Intended to facilitate telephonic communication between a Personal Computer (PC) and the Disetronic Infusion Pumps. The modified device adds the Disetronic Multifuse Infusion Pump to the list of compatible pumps.
Product codes
Not Found
Device Description
The D-MODEM has been modified by adding an alternative serial communication outlet that uses Infra red light as the means of communication. The current serial port requires a direct electrical connection to allow the signals to be transmitted. The infra red port sends and receives light impulses that are converted to the same electrical signals before transmission over the telephone lines. This modification was implemented to take advantage of the ability of the infra red port to achieve communication without any direct electrical connections. The absence of a direct electrical connection eliminates the potential for leakage or transmission of unwanted electrical current.. This allows the user, via a modem connected through a telephone line, to electronically link the pump to the computer in a doctor's office for communication purposes without having to interrupt his therapy. The original D-Modem (K943952) was designed and manufactured with the all of the circuits and components necessary for the IR interface. The IR components and circuits specific to the use of the IR interface are detailed in Appendix II, A and B. In principal, this infrared (IR) interface works the same way as any IR interface that allows a personal computer to be "connected" to an accessory such as a printer. The D-MODEM and the Pump have a very small infrared light range and must be placed in very close proximity to each other (see Instructions for Use). The positioning pin on the D-MODEM, which mates to the Pump in only one way, ensures proper positioning. The transmission between the D-MODEM and the Pump utilizes amplitude modulation while other IR devices, such as TV remotes, utilize pulse modulation. In addition to the necessary distance, the D-MODEM and Pump transmission accuracy is verified by the communication protocol via a CRC-16 checksum (See Appendix II, D).
Mentions image processing
Not Found
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
user, via a modem connected through a telephone line, to electronically link the pump to the computer in a doctor's office
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
New
§ 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
Image /page/0/Picture/0 description: The image shows a handwritten number sequence enclosed in a box. The numbers are "961975". The handwriting is somewhat stylized, with distinct strokes forming each digit.
JAN 30 1997 9.0 SUMMARY OF SAFETY AND EFFECTIVENESS
"510(k) SUMMARY"
| 9.1 Trade/Proprietary Name: | Disetronic D-MODEM |
|---|---|
| 9.2 Common/Usual Name: | Telephonic Communication Modem |
| 9.3 Classification Name: | Infusion Pump - Accessory |
9.4 Comparison to Currently Marketed Devices
The modified D-MODEM is substantially equivalent to the currently marketed D-MODEM (K943952). The design, materials and construction of the modified D-MODEM are identical to the currently marketed D-MODEM with the exception of the additional serial communications port capability. The use of an infra red serial communications port as an alternative to a direct serial communications port does not raise any significant new questions of safety or effectiveness.
9.5 Device Description
9.5.1 Discussion
The D-MODEM has been modified by adding an alternative serial communication outlet that uses Infra red light as the means of communication. The current serial port requires a direct electrical connection to allow the signals to be transmitted. The infra red port sends and receives light impulses that are converted to the same electrical signals before transmission over the telephone lines.
This modification was implemented to take advantage of the ability of the infra red port to achieve communication without any direct electrical connections. The absence of a direct electrical connection eliminates the potential for leakage or transmission of unwanted electrical current.. This allows the user, via a modem connected through a telephone line, to electronically link the pump to the computer in a doctor's office for communication purposes without having to interrupt his therapy.
9.5.2 Physical Specifications
9.5.2.1 'Modified' components
The original D-Modem (K943952) was designed and manufactured with the all of the circuits and components necessary for the IR interface. These were not discussed in the original submission as they were not capable of functioning with any device available in the U.S. at that time. The IR components and circuits specific to the use of the IR interface are detailed in Appendix II, A and B.
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In principal, this infrared (IR) interface works the same way as any IR interface that allows a personal computer to be "connected" to an accessory such as a printer. Although the operation is similar in principal to a computer and printer connected via an IR interface. the big difference is the distance involved. The D-MODEM and the Pump have a very small infrared light range and must be placed in very close proximity to each other (see Instructions for Use). The positioning pin on the D-MODEM, which mates to the Pump in only one way, ensures proper positioning.
The transmission between the D-MODEM and the Pump utilizes amplitude modulation while other IR devices, such as TV remotes, utilize pulse modulation. In addition to the necessary distance, the D-MODEM and Pump transmission accuracy is verified by the communication protocol via a CRC-16 checksum (See Appendix II, D).
The original D-Modem was designed and manufactured with the all of the circuits and components necessary for the IR interface. These were not discussed in the original submission as they were not capable of functioning with any device available in the U.S. at that time. The IR components and circuits specific to the use of the IR interface are detailed in Appendix II, A and B.
A schematic diagram of the IR circuitry is also attached as Appendix II, B.
9.5.2.2 Operational Specifications
9.5.2.2.1 Serial Port Communication
The modified device is capable of infra red communication as well as direct connection to the serial port. In principal, this infrared interface works the same way as the IR interface that allows a personal computer to be "connected" to an accessory such as a printer. Although the operation is similar in principal to a computer and printer connected via an IR interface, the big difference is the distance involved. The D-MODEM and the Pump have a very small infrared light range and must be placed in close proximity to each other (see Instructions for Use). The positioning pin on the D-MODEM, which mates to the Pump in only one way, ensures proper positioning.
The transmission between the D-MODEM and the Pump utilizes amplitude modulation while other IR devices, such as TV remote control devices, utilize pulse modulation. In addition to the necessary distance, the D-MODEM and Pump transmission accuracy is verified by the communication protocol via a CRC-16 checksum (See Appendix II, D).
9.5.2.2.2 Environmental Susceptibility
The modifications do not have any effect on the susceptibility of the unit to withstand environmental influences. The ability of the unit to perform within specifications under normal temperature and pressure variations and its ability to withstand electrostatic discharge (ESD) and Electromagnetic interference (EMI) has not changed. As stated above, the difference in the type of IR modulation, as well as the very small
2
range of the IR sensor shields the device from interference by other IR sources. Additionally, the safety systems in the pump described in the pump submission, preclude other IR sources from interfering with pump operation.
9.5.3 Intended Use
The D-MODEM is Intended to facilitate telephonic communication between a Personal Computer (PC) and the Disetronic Infusion Pumps. The modified device adds the Disetronic Multifuse Infusion Pump to the list of compatible pumps.
9.6 Conclusion
Disetronic Medical Systems has concluded that the minor modification to the D-MODEM has not significantly changed the safety or effectiveness of the device. The modified D-MODEM, with the addition of the Disetronic Multifuse Infusion Pump as a compatible pump for which the device is intended to be used, is substantially equivalent to the currently marketed device.