(14 days)
Not Found
No
The document describes a protocol converter for medical devices, focusing on data format translation (MIB protocol). There is no mention of AI, ML, or any learning or adaptive capabilities.
No
The device is a protocol converter that allows different medical devices to connect to a monitoring system; it does not directly provide therapy.
No
The device is described as a "Protocol Converter" that allows various third-party medical devices (like ventilators, blood gas monitors) to connect to Siemens INFINITY Modular Bedside Monitors. Its purpose is to facilitate the display of data from these devices, not to perform diagnosis itself.
No
The device description explicitly mentions "device specific accessory cables" which are hardware components required for the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to convert data protocols from various medical devices (ventilators, blood gas monitors, anesthesia systems, etc.) so they can be displayed on bedside monitors. This is about data communication and display, not about analyzing biological samples from the body to diagnose or monitor a medical condition.
- Device Description: The description focuses on software modifications and accessory cables for connecting different medical devices. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is purely data conversion and display.
Therefore, the Medical Information Bus (MIB) Protocol Converter falls under the category of a medical device used for data management and display in a clinical setting, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medical Information Bus (MIB) Protocol Converter is indicated for use in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that third party medical devices that do not provide data per the IEEE 1073 Medical Information Protocol Standard should be connected to the Siemens INFINITY Modular Bedside Monitors for display, such as:
Siemens SV 300 ventilator Baxter Vigilance blood gas/continuous cardiac output monitor Siemens SV900 ventilator Draeger Evita II ventilator Draeger Evita IV ventilator Draeger Babylog ventilator Puritan Bennett 7200 ventilator Draeger Narkomed II Anesthesia System Draeger Narkomed IV Anesthesia System Draeger Julian Anesthesia Machine Ohmeda 7900 / Modulus CD Anesthesia Machine Abbott Oximetrix 3 Oximeter AVL Medical Instruments: Opti Critical Care Analyzer, Portable Blood Gas Analyzer Optical Sensors Inc .: OSI - Optical CAM VIA Medical: VIA V-ABG1 Blood Gas Chemistry Monitor
Product codes (comma separated list FDA assigned to the subject device)
73 DQA
Device Description
The Medical Information Bus (MIB) Protocol Converter has received two 510(k) clearances.
- 510(k) K970368 was cleared for interface with Siemens SV300 ventilator and 1. the Baxter Vigilance blood gas/continuous cardiac output monitor.
- 510(k) K973222 was cleared for interface with Puritan Bennett 7200 ventilator, 2. the Draeger Evita II, Draeger Evita IV, and Draeger Babylog ventilators, and Siemens SV900 ventilator.
Minor software modifications have been made to Siemens Medical Information Bus (MIB) Protocol Converter and device specific accessory cables are now available that allow interface connections for the following devices to the INFINITY modular bedside monitors (SC9000/SC9000XL/SC8000). The monitor may alarm for some MIB anesthesia parameters independent of the anesthesia machine's alarms.
Anesthesia Systems
- Dräger Narkomed II
- Dräger Narkomed IV
- · Dräger Julian
- Ohmeda 7900 / Modulus CD Anesthesia Machine
Oximeter
- · Abbott Oximetrix 3
Point of Care Blood Gas Analyzers
AVL Medical Instruments
- · Opti Critical Care Analyzer, Portable Blood Gas Analyzer Optical Sensors Inc. • OSI – Optical CAM
VIA Medical
- VIA V-ABG1 Blood Gas Chemistry Monitor
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
healthcare professionals (Physician, Nurse, Technician)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Assessment of non-clinical performance data for equivalence: Section K
Assessment of clinical performance data for equivalence: Not applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Special 510(k): Device Modification SIEMENS Medical Information Bus (MIB) Protocol Converter
510(k) SUMMARY
as required per 807.92(c)
Submitters Name, Address:
Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: David Simard, Director, QA/RA Contact person for this submission: Penelope H. Greco Date submission was prepared: May 5, 1999
Trade Name, Common Name and Classification Name:
- A. Trade Name:
Siemens Medical Information Bus (MIB) Protocol Converter
B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | Classification
Number | Class | Regulation Number |
|---------------------------------------------|--------------------------|-------|-------------------|
| Transducer Signal amplifier and conditioner | 73 DQA | II | 21 CFR 870.2060 |
Legally Marketed Device Identification:
Siemens Medical Information Bus (MIB) Protocol Converter: 510(k) K970368 and K973222.
Description of Modification:
The Medical Information Bus (MIB) Protocol Converter has received two 510(k) clearances.
- 510(k) K970368 was cleared for interface with Siemens SV300 ventilator and 1. the Baxter Vigilance blood gas/continuous cardiac output monitor.
- 510(k) K973222 was cleared for interface with Puritan Bennett 7200 ventilator, 2. the Draeger Evita II, Draeger Evita IV, and Draeger Babylog ventilators, and Siemens SV900 ventilator.
Minor software modifications have been made to Siemens Medical Information Bus (MIB) Protocol Converter and device specific accessory cables are now available that allow interface connections for the following devices to the INFINITY modular bedside monitors (SC9000/SC9000XL/SC8000). The monitor may alarm for some MIB anesthesia parameters independent of the anesthesia machine's alarms.
Anesthesia Systems
- Dräger Narkomed II
- Dräger Narkomed IV
- · Dräger Julian
- Ohmeda 7900 / Modulus CD Anesthesia Machine
Oximeter
- · Abbott Oximetrix 3
Point of Care Blood Gas Analyzers
AVL Medical Instruments
- · Opti Critical Care Analyzer, Portable Blood Gas Analyzer Optical Sensors Inc. • OSI – Optical CAM
VIA Medical
- VIA V-ABG1 Blood Gas Chemistry Monitor
l
COMPANY CONFIDENTIAL
Siemens Medical Systems, Inc.
Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923 USA
Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD)
1
Intended Use:
Siemens Medical Information Bus (MIB) Protocol Converter is intended to connect third party medical devices that do not provide data per the IEEE1073 Medical Information Protocol Standard to the Siemens INFINITY Modular Bedside Monitors for display, such as:
Siemens SV 300 ventilator Baxter Vigilance blood gas/continuous cardiac output monitor Siemens SV900 ventilator Draeger Evita II ventilator Draeger Evita IV ventilator Draeger Babylog ventilator Puritan Bennett 7200 ventilator Draeger Narkomed II Anesthesia System Draeger Narkomed IV Anesthesia System Draeger Julian Anesthesia Machine Ohmeda 7900 / Modulus CD Anesthesia Machine Abbott Oximetrix 3 Oximeter A VL Medical Instruments: Opti Critical Care Analyzer, Portable Blood Gas Analyzer Optical Sensors Inc .: OSI - Optical CAM VIA Medical: VIA V-ABG1 Blood Gas Chemistry Monitor
Assessment of non-clinical performance data for equivalence: Section K
Assessment of clinical performance data for equivalence: Not applicable
Biocompatability: Not applicable
Sterilization: Not applicable
Standards and Guidances: 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
2
COMPANY CONFIDENTIAL
Siemens Medical Systems, Inc. Electromedical Systems Group. PCS
16 Electronics Avenue Danvers, MA 01923 USA
Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD)
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 1999
Mr. David Simard Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923
K991661 Re: Siemens Medical Information Bus (MIB) Protocol Converter Regulatory Class: II (two) Product Code: 73 DQA May 5, 1999 Dated: Received: May 14, 1999
Dear Mr. Simard:
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 legally marketed predicate 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 regulatory 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 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 regulations.
3
Page 2 - Mr. David Simard
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) 594-4648. 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan Ph.D.
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): _
Device Name: Siemens Medical Information Bus (MIB) Protocol Converter
Indications for Use:
The Medical Information Bus (MIB) Protocol Converter is indicated for use in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that third party medical devices that do not provide data per the IEEE 1073 Medical Information Protocol Standard should be connected to the Siemens INFINITY Modular Bedside Monitors for display, such as:
Siemens SV 300 ventilator Baxter Vigilance blood gas/continuous cardiac output monitor Siemens SV900 ventilator Draeger Evita II ventilator Draeger Evita IV ventilator Draeger Babylog ventilator Puritan Bennett 7200 ventilator Draeger Narkomed II Anesthesia System Draeger Narkomed IV Anesthesia System Draeger Julian Anesthesia Machine Ohmeda 7900 / Modulus CD Anesthesia Machine Abbott Oximetrix 3 Oximeter AVL Medical Instruments: Opti Critical Care Analyzer, Portable Blood Gas Analyzer Optical Sensors Inc .: OSI - Optical CAM VIA Medical: VIA V-ABG1 Blood Gas Chemistry Monitor
At. A. Carlousk.
510k) Num
MRI Compatibility Statement:
The Medical Information Bus (MIB) Protocol Converter is not compatible for use in a MRI magnetic field.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use
(Optional Format 1-2-96)