(95 days)
Not Found
No
The device description focuses on protocol conversion and data formatting, with no mention of AI/ML terms or functionalities like learning, prediction, or image analysis.
No.
The device's purpose is to convert data from third-party medical devices into a common format for display on a bedside monitor; it does not directly apply therapy to a patient.
No
The device is a protocol converter that transforms data from third-party medical devices for display on a bedside monitor. It does not perform any diagnostic functions itself; it facilitates data communication.
No
The device description explicitly mentions "Attachment cables specific to third party device are offered as accessories," indicating the presence of hardware components beyond 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 to connect third-party medical devices to a bedside monitor for data display. This involves data conversion and transmission, not the examination of specimens derived from the human body.
- Device Description: The device description confirms its function is to transform and transmit data from other medical devices. It doesn't mention any interaction with biological samples or diagnostic testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on biological samples.
The device is a protocol converter, facilitating communication between different medical devices. This falls under the category of medical device accessories or interfaces, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Medical Information Bus (MIB) Protocol Converter is intended to connect third party medical devices that do not provide data per the IEEE 1073 Medical Information Protocol Standard to the Siemens SC9000/SC9015 Bedside Monitor for display.
Product codes
73 DQA
Device Description
The Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter transforms data generated by third party devices (e.g. ventilators, SvO2 devices and infusion pumps) into a common format per the IEEE 1073 Medical Information Protocol and transmits this data to the Siemens SC9000/SC9015 Bedside Monitor. Attachment cables specific to third party device are offered as accessories.
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
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
Not Applicable
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
510 (K) Notification Siemens SC9000/SC9015 Medical Information Bus (MIB) Protocol Converter
MAY
-6 1997
510(k) SUMMARY
as required per 807.92(c)
2: Submitters Name, Address:
Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers. MA 01923 Tel: (508) 750-7500 Fax: (508) 777-3398 Official Correspondent: David Simard, Director Quality Assurance and Regulatory Affairs Contact person for this submission: Jacqueline E. M. Emery ー Date submission was prepared: January 7, 1997
3: Trade Name, Common Name and Classification Name:
A. Trade Name: Siemens SC9000/ SC9015 Series Medical Information Bus (MIB) Protocol Converter
B. Common Name, Classification Number, Class and Regulation Number:
| Common Name | Classification Number | Class | Regulation Number |
|---|---|---|---|
| Transducer Signal amplifier and | |||
| conditioner | 73 DQA | II | 21CFR870.2060 |
4: Predicate Device Identification: Hewlett-Packard Model M1032A Vuelink Interface Plug In Module cleared under 510(K) number: K923682
-
Device Description: The Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter transforms data generated by third party devices (e.g. ventilators, SvO2 devices and infusion pumps) into a common format per the IEEE 1073 Medical Information Protocol and transmits this data to the Siemens SC9000/SC9015 Bedside Monitor. Attachment cables specific to third party device are offered as accessories.
-
Intended Use: The Medical Information Bus (MIB) Protocol Converter is intended to connect third party medical devices that do not provide data per the IEEE 1073 Medical Information Protocol Standard to the Siemens SC9000/SC9015 Bedside Monitor for display.
Siemens Medical Systems, Inc.
Electromedical Group
16 Electronics Avenue Danvers, MA 01923 USA
Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD)
1
7. Table of device similarities and differences to predicate device
| | Substantial Equivalent Device
Hewlett Packard Co
Model M1032A VueLink Module | Applicant
Siemens Medical Systems
SC 9000/9015 Series Medical Information Bus (MIB)
Protocol Converter |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hewlett Packard | Siemens Medical Systems -
Electromedical Group |
| 510K Number | K923682 | To be assigned |
| Intended Use | Provides an external device interface
capability to third party devices that
have a serial RS-232 and/or analog
output | Same |
| Intended Population | NA
Not connected to patients | Same |
| Intended Environment | OR or ICU | Same |
| Input port | RS-232, Analog, Analog/Digital
combination | Same |
| Output Port | HP specific | IEEE 1073 (MIB Connector) |
- Assesment of non-clinical performance data for equivalence:
Substantial equivalence is claimed to the Hewlett Packard M1032A Vuelink Interface Plug-In Module cleared under 510(K) number K923682.
- Assesment of clinical performance data for equivalence: Not applicable
-
- Biocompatability. Not applicable
-
- Sterilization Not applicable
12. Standards and Guidances:
Currently there are no FDA standards for this device. However, the Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter complies with:
- 1073.3.1-1994 IEEE Standard for Medical Device Communications - Transport Profile- Connector Mode
- 1073.4.1-1994 IEEE Standard for Medical Device Communications - Physical Layer Interface - Cable Connected
Siemens Medical Systems, Inc.
Electromedical Group
16 Electronics Avenue Danvers, MA 01923 USA
Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD)