(92 days)
The Infinity Medical Information Bus (MIB) Protocol Converters (MIB, II & MIB Duo) are 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 provide data should be connected to a Draeger INFENTTY Modular Monitor for display. Such devices include:
Maquet SV 300 ventilator Maquet Servoi Ventilator Maquet SV900 ventilator Draeger Evita 2 ventilator Draeger Evita 4 ventilator Draeger EvitaXL ventilator Draeger Savina ventilator Draeger Babylog ventilator Draeger FabiusGS Anesthesia System Draeger Narkomed 2 Anesthesia System Draeger Narkomed 4 Anesthesia System Draeger Narkomed 6000 / 6400 Anesthesia Systems Draeger Julian Anesthesia Machine Puritan Bennett 7200 ventilator Puritan Bennett 840 ventilator Hamilton Galileo ventilator Ohmeda 7900 Anesthesia Machine Abbott Oximetrix 3 Blood Gas Analyzer Abbott Q2 CCO monitor AVL Medical Instruments: Opti Critical Care Analyzer, Portable Blood Gas Analyzer Baxter Vigilance blood gas/continuous cardiac output monitor Optical Sensors Inc .: OSI - Optical CAM VIA Medical: VIA V-ABGI Blood Gas Chemistry Monitor Aspect A-2000 BIS Monitor* Sensormedics Micro Gas 7650
Note: * The SC 9000 does nor support communication with the Aspect BIS Monitor
Draeger's Infinity Medical Information Bus (MIB/MIBII and MIB Duo) Protocol Converters have received numerous 510(k) clearances for connectivity to third party devices. The release of MIB/MIBII VF4 software enables MIB connectivity of the following Draeger devices to the INFINITY modular monitors:
Narkomed 6000 & 6400 Fabius GS Savina Evita XL
These connections enable the display of device specific data on an INFINITY modular monitor. Data from the devices can also be displayed on the VentCentral application (K003246) of the MultiView WorkStation and alarms received from the Evita XL and Savina ventilators annunciated.
This submission, K033807, describes a modification to the Draeger Medical Information Bus (MIB/MIBII and MIB Duo) Protocol Converters. The primary change is the enablement of MIB connectivity for new Draeger devices (Narkomed 6000 & 6400, Fabius GS, Savina, Evita XL) to the INFINITY modular monitors through VF4 software. The key takeaway from the document is that no new clinical or non-clinical performance data was deemed necessary to establish substantial equivalence for this modification.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, and expert adjudication and ground truth establishment is not applicable to this specific 510(k) submission, as it relies on the predicate device's established performance without introducing new performance claims that would require new and extensive testing.
Here's a breakdown of the applicable information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
Since this is a modification to an already cleared device and the submission states "Assessment of non-clinical performance data for equivalence: Section J" and "Assessment of clinical performance data for equivalence: Not applicable," specific acceptance criteria and detailed reported performance for the modified aspects are not explicitly defined in this document. The implicit acceptance criterion is that the modified device maintains the fundamental technology, intended use, and safety/effectiveness of the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintenance of fundamental technology and intended use of predicate device | The modifications have not altered the fundamental technology of the MIB/MIBII Protocol Converters. The intended use and indications are the same as for the unmodified predicate devices. |
| Successful connectivity and display of data from new Draeger devices to INFINITY monitors | MIB connectivity of new Draeger devices to INFINITY modular monitors is enabled, allowing display of device-specific data and annunciation of alarms. |
| Compliance with relevant standards (e.g., medical device communications) | Adherence to 1073.3.1 and 1073.3.2 IEEE Standards for Medical Communications Transport Profile is implied by their listing. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size for test set: Not applicable (no new testing for this modification was deemed necessary beyond demonstrating functionality of the new connections).
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of experts: Not applicable.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC study: Not applicable. The device is a protocol converter, not an AI-driven diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone performance study: Not applicable. The device is a hardware/software protocol converter for data display, not an algorithm with standalone performance metrics in the typical sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of ground truth: Not applicable for new testing specific to this modification. The "ground truth" for the predicate device would have been the accurate transmission and display of physiological data, which, for a protocol converter, relies on functional verification rather than clinical outcomes or expert consensus in the same way a diagnostic imaging device would.
8. The sample size for the training set:
- Sample size for training set: Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Ground truth establishment: Not applicable.
In summary, this 510(k) submission is for a device modification that extends connectivity, and it leverages the substantial equivalence of its predicate devices without requiring new, extensive performance studies for clearance.
§ 870.2060 Transducer signal amplifier and conditioner.
(a)
Identification. A transducer signal amplifier and conditioner is a device used to provide the excitation energy for the transducer and to amplify or condition the signal emitted by the transducer.(b)
Classification. Class II (performance standards).