(14 days)
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
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 the Baxter Vigilance blood gas/continuous cardiac output monitor. 510(k) K973222 was cleared for interface with Puritan Bennett 7200 ventilator, 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.
This describes an acceptance criterion for the Siemens Medical Information Bus (MIB) Protocol Converter.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not contain a specific table of acceptance criteria with numerical targets and reported performance metrics in the way one might expect for a diagnostic or efficacy study. Instead, the document describes a modification to an existing device (the Siemens MIB Protocol Converter) that expands its compatibility with additional third-party medical devices.
The "acceptance criteria" in this context are implicitly related to the successful interfacing and display of data from these new devices via the MIB Protocol Converter to the Siemens INFINITY Modular Bedside Monitors. The "reported device performance" is the successful clearance of the 510(k), indicating that the FDA assessed the modifications and deemed the device substantially equivalent to its predicate.
Given the nature of the device (a protocol converter), the performance would relate to accurate and timely data transmission, not diagnostic accuracy. The document states: "Assessment of non-clinical performance data for equivalence: Section K." This section would typically contain details of the testing performed to demonstrate that the new interfaces function as intended and that the device still meets safety and performance requirements. However, the details of "Section K" are not included in the provided text.
Therefore, a table cannot be constructed with specific numerical acceptance criteria and performance metrics for this type of device based solely on the provided text. The "performance" is primarily functional: does it connect and display data from the listed devices? The FDA's clearance implies that this functional performance was demonstrated to be acceptable.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide any information regarding a "test set" in the context of patient data or clinical samples. This device is a protocol converter, not a diagnostic or therapeutic device that would typically involve patient data for performance evaluation.
The "modifications" were related to adding compatibility with more medical devices (e.g., specific ventilators, anesthesia machines, oximeters, blood gas analyzers). The "test set" for this type of device would likely involve testing with each of the newly supported third-party devices to ensure proper data transmission and display. However, the sample size (e.g., number of test runs, amount of data processed) for these tests is not specified.
Data provenance (country of origin, retrospective/prospective) is not applicable as there is no mention of a test set involving patient or clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. Establishing "ground truth" and using experts for that purpose is typically associated with devices that perform diagnostic interpretations or make clinical decisions. The MIB Protocol Converter's function is to convert and display data. Its "ground truth" would be the accurate transmission of the original data, which is verified through technical testing, not expert interpretation of patient cases.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among experts or readers when establishing ground truth for diagnostic studies. Since this device does not involve such an assessment, no adjudication method is relevant or mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not mentioned. MRMC studies evaluate the performance of human readers, sometimes with and without AI assistance, for diagnostic tasks. This device is a protocol converter and does not involve human interpretation for diagnosis or AI assistance for clinical tasks.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not directly applicable in the traditional sense of an "algorithm" for diagnostic purposes. The device itself (the MIB Protocol Converter) is the "standalone" component in its function of converting and transmitting data. Its performance is evaluated purely on its technical ability to correctly convert data from one protocol to another and present it for display. There isn't an "algorithm only" performance being contrasted with "human-in-the-loop" because the device's role is foundational data integration, not interpretive.
The document implicitly describes the standalone performance of the modified device by demonstrating its capability to interface with the new list of third-party devices and send data to the INFINITY monitors. The success of the 510(k) indicates this standalone functional performance was deemed acceptable.
7. The Type of Ground Truth Used
The "ground truth" for this device is the accurate and complete transmission of physiological data from the third-party medical devices through the MIB Protocol Converter to the Siemens INFINITY monitors. This "ground truth" is established through technical validation and functional testing. For example, by comparing the data displayed on the INFINITY monitor with the data output directly from the source third-party device. It is not based on expert consensus, pathology, or outcomes data, as those are relevant for diagnostic or therapeutic devices.
8. The Sample Size for the Training Set
The document does not mention a "training set." This type of device (a hardware/software protocol converter) does not typically involve machine learning or AI models that require a training set in the conventional sense. The "knowledge" or "rules" for protocol conversion are programmed, not learned from data.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set mentioned or implied for this device, the question of how its ground truth was established is not applicable.
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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 | ClassificationNumber | 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
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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)
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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)
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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.
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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
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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)
§ 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).