(16 days)
Not Found
No
The device description focuses on protocol conversion and data communication standards (IEEE 1073), with no mention of AI or ML technologies.
No.
The device is a protocol converter designed to display data from third-party medical devices on a Siemens INFINITY Modular Monitor; it does not directly administer therapy or address a medical condition.
No
The device is a protocol converter that enables third-party medical devices to connect to a Siemens INFINITY Modular Monitor for the display of data. It facilitates data communication rather than performing diagnostic analysis itself.
No
The device description explicitly states it is a "Protocol Converter" and mentions physical components like "SDL style connectors" and "RJ45 connectors," indicating it is a hardware device with embedded software.
Based on the provided text, the Siemens INFINITY MIB II Duo Protocol Converter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to connect third-party medical devices (like ventilators, blood gas monitors, and anesthesia systems) to a Siemens INFINITY Modular Monitor for the display of data. This is about data communication and display, not about performing tests on biological samples in vitro.
- Device Description: The device is described as a "Protocol Converter" that facilitates communication between different medical devices using specific communication standards (IEEE 1073). This aligns with a data interface or communication device, not an IVD.
- Lack of IVD Characteristics: The description 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 diagnostic information based on laboratory tests
- Reagents, calibrators, or controls used in laboratory testing
The device's function is to translate and transmit data from other medical devices to a patient monitor, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The INFINITY MIB II Duo Protocol Converter is intended for use in an environment where patient of experience is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines is provided by healthcare professionals (1 a Siemens INFINITY Modular Monitors (SC 7000 / SC 8000 / SC 9000 / SC 9000XL) for display of data from devices 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 Anesthesia Machine .
- Abbott Oximetrix 3 Blood Gas Analyzer .
- A VL Medical Instruments: Opti Critical Care Analyzer Portable Blood Gas Analyzer .
- Optical Sensors Inc .: OSI Optical CAM .
- VIA Medical: VIA V-ABGI Blood Gas Chemistry Monitor .
- Aspect A-2000 BIS Monitor* .
*The SC 9000 does not support communication with the Aspect BIS Monitor
Siemens INFINITY MIB II Duo 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 devices that do not provide data per the IEEE 1073 Medical Information Protocol Standard should be connected to a Siemens INFINITY Modular Monitor (SC 9000 / SC 8000 / SC 9000XL) for the display of data. MIB connectivity to third party medical devices 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 Anesthesia Machine Abbott Oximetrix 3 Blood Gas Analyzer 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 * Aspect A-2000 BIS Monitor
- The SC 9000 does not support communication with the Aspect BIS Monitor
The INFINITY MIB II Duo Protocol Converter is not compatible for use in a MRI magnetic field.
Product codes (comma separated list FDA assigned to the subject device)
74 DSI
Device Description
The new INFINITY MIB II Duo Protocol Converter employs the same fundamental scientific technology and has the same intended use as that of the predicate device. The INFINITY MIB II Duo Protocol and no all band internets and device specific cables as that of the predicate device, 510(k) Converter Supperts original MIB Protocol Converter (K970368, K973222, K991661, K003248) uses SDL style connectors. The MIB II (K010640) uses RJ45 connectors. Modifications have been implemented to enable use of both connector types. The INFINITY MIB II Duo Protocol Converter supports IEEE Standards 1073.3.1 (Medical Device Communications-Transport Profile-Connection Mode) and 1073.3.2-2000 (Medical Communications - Transport Profile - IrDA Based - Cable Connected).
The only difference between the INFINITY MIB II and INFINITY MIB II Duo Protocol Converter is that the "Duo" has an additional interface and is compatible with the IEEE Standard 1073.3.1. No other modifications were required to implement this change. Testing has been performed to validate the overall performance of the modified MIB II Duo Protocol Converter and to verify proper communication with the INFINITY modular bedside monitors and the MIB supported devices.
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
Environment where patient care is provided by 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)
Electromagnetic compatibility testing has been performed by Chomerics Test Services in accordance with EN 60601-1-2, Part 2, Medical Electrical Equipment Collateral Standard: Electromagnetic compatibility, and in accordance with FDA suggestions.
Testing has been performed to validate the overall performance of the modified MIB II Duo Protocol Converter and to verify proper communication with the INFINITY modular bedside monitors and the MIB supported devices.
Assessment of non-clinical performance data for equivalence:_Section J
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.
K010640, K970368, K973222, K991661, K003248
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
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
K012461 p. 1/3
AUG 1 7 2001
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: Connie Hertel, Director, QA/RA Contact person for this submission: Penelope H. Greco May 25, 2001 Date submission was prepared:
Trade Name, Common Name and Classification Name:
- A. Trade Name:
Siemens INFINITY MIB II Duo Protocol Converter
B. Common Name, Classification Name, Class and Regulation Number:
| A ST ST M S M S C . C
ommon Name | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Product
COOP | - 1855 | Number
Regulation I |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|-------------------------|
| Transducer Signal amplifier and conditioner
Complete of the contract and the program of the propertion of the status and the status and the contribution of the comments of | | | 870,2066
A 1977 1977 |
Legally Marketed Device Identification:
Siemens INFINITY MIB II Protocol Converter: 510(k) K010640 Siemens Medical Information Bus (MIB) Protocol Converter: 510(k) K970368, K973222, K991661, K003248
Description of Modification:
The new INFINITY MIB II Duo Protocol Converter employs the same fundamental scientific technology and has the same intended use as that of the predicate device. The INFINITY MIB II Duo Protocol and no all band internets and device specific cables as that of the predicate device, 510(k) Converter Supperts original MIB Protocol Converter (K970368, K973222, K991661, K003248) uses SDL style connectors. The MIB II (K010640) uses RJ45 connectors. Modifications have been implemented to enable use of both connector types. The INFINITY MIB II Duo Protocol Converter supports IEEE Standards 1073.3.1 (Medical Device Communications-Transport Profile-Connection Mode) and 1073.3.2-2000 (Medical Communications - Transport Profile - IrDA Based - Cable Connected).
The only difference between the INFINITY MIB II and INFINITY MIB II Duo Protocol Converter is that the "Duo" has an additional interface and is compatible with the IEEE Standard 1073.3.1. No other modifications were required to implement this change. Testing has been performed to validate the overall performance of the modified MIB II Duo Protocol Converter and to verify proper communication with the INFINITY modular bedside monitors and the MIB supported devices.
Electromagnetic compatibility testing has been performed by Chomerics Test Services in accordance with EN 60601-1-2, Part 2, Medical Electrical Equipment Collateral Standard: Electromagnetic compatibility, and in accordance with FDA suggestions.
1/2
COMPANY CONFIDENTIAL
Siemens Medical Systems, Inc.
Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
1
K012461 p. 2/3
Intended Use:
The INFINITY MIB II Duo Protocol Converter is intended for use in an environment where patient of experience is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines
is provided by healthcare professionals (Physician, Nurse, March Marke Is provided by nealtheare professionals (1 a Siemens INFINITY Modular Monitors (SC 7000 / SC 8000 / SC 9000 / SC 9000XL) for display of data from devices 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 Anesthesia Machine .
- Abbott Oximetrix 3 Blood Gas Analyzer .
- A VL Medical Instruments: Opti Critical Care Analyzer Portable Blood Gas Analyzer .
- Optical Sensors Inc .: OSI Optical CAM .
- VIA Medical: VIA V-ABGI Blood Gas Chemistry Monitor .
- Aspect A-2000 BIS Monitor* .
*The SC 9000 does not support communication with the Aspect BIS Monitor
Assessment of non-clinical performance data for equivalence:_Section J
Assessment of clinical performance data for equivalence: Not applicable
Biocompatability: Not applicable
Sterilization: Not applicable
Standards and Guidances:
1073.3.1 Medical Device Communications-Transport Profile-Connection Mode 1073.3.2 - 2000 IEEE Standard for Medical Communications Transport Profile - IrDA Based - Cable Connected
2/2
COMPANY CONFIDENTIAL
Siemens Medical Systems, Inc.
Electromedical Systems Group, PCS
16 Electronics Avenue Danvers. MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
2
K012461 p.3/3
Premarket Notification Truthful and Accurate Statement
(As required per 21 CFR 807.87[j])
I certify, in my capacity as Director of Quality Assurance and Regulatory Affairs of Siemens Medical Systems, Inc., Electromedical Systems Group, PCS, that I believe, to the best of my knowledge, that all data and information submitted in this premarket notification to be truthful and accurate and that no material fact has been omitted.
Lisete Coleman perty for Connie Hertel 7/31/01
Connie Hertel, Director Date
Connie Hertel, Director Quality Assurance & Regulatory Affairs Official Correspondent
Date
[Premarket Notification 510(k) Number]
COMPANY CONFIDENTIAL
Siemens Medical Systems, Inc. Electromedical Systems Group, PCS
16 Electronics Avenue Danvers. MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
3
Image /page/3/Picture/2 description: The image shows the 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" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three wavy lines representing the body and a head-like shape at the top.
AUG 1 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Penelope H. Greco Siemens Medical Systems, inc. Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923
Re: K012461
Trade Name: INFINITY MIB II Duo Converter Regulation Number: 21 CFR 870.1025 Regulatory Class: III (three) Product Code: 74 DSI Dated: July 31, 2001 Received: August 1, 2001
Dear Ms. Greco:
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 control provisions of the Act. The general control 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
4
Page 2 - Ms. Penelope H. Greco
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.
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) 594-4645. 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" (21CFR 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,
Dale Tella
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
510(k) Number (if known): KO1Z46 /
Device Name: Siemens INFINITY MIB II Duo Protocol Converter
Indications for Use:
Siemens INFINITY MIB II Duo 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 devices that do not provide data per the IEEE 1073 Medical Information Protocol Standard should be connected to a Siemens INFINITY Modular Monitor (SC 9000 / SC 8000 / SC 9000XL) for the display of data. MIB connectivity to third party medical devices 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 Anesthesia Machine Abbott Oximetrix 3 Blood Gas Analyzer 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 * Aspect A-2000 BIS Monitor
- The SC 9000 does not support communication with the Aspect BIS Monitor
MRI Compatibility Statement:
The INFINITY MIB II Duo 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) |