(32 days)
The Datex-Ohmeda S/5™ E-MEM module is indicated for storing patient related physiological data, discrete record keeping events, and menu configurations in removable flash memory cards. The device is indicated for use by qualified medical personnel only.
The Datex-Ohmeda Memory module, E-MEM is a single-width plug-in parameter module for a Datex-Ohmeda modular monitoring system. The Datex-Ohmeda S/STM Memory module, E-MEM can be used with the following Datex-Ohmeda S/5™ modular monitors: S/5 Anesthesia Monitor(AM) with main software S-STD95, S-ARK95 or newer version S/5 Critical Care Monitor (CCM) with main software S-ICU97 or newer version. The Datex-Ohmeda S/5™ Memory Module, E-MEM, is an data storage module for the S/5 family anesthesia monitors. It is used for storing patient related physiological data, discrete record keeping events, menu configurations and user defined monitor configurations in removable PCMCIA compatible flash memory cards. The E-MEM has two card slots; one for patient data (MemCard Data) and the other for anesthesia record keeping configurations and monitoring modes. (MemCard Menu).
This document pertains to a 510(k) premarket notification for the Datex-Ohmeda S/5™ E-MEM module. It is a memory module for medical monitors and its acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device (Datex-Ohmeda M-MEM Module, K945234), rather than specific performance metrics evaluated through a clinical study. As such, many of the requested categories related to clinical study design and performance will not be applicable.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Test Performed | Reported Device Performance (Summary) |
|---|---|---|
| Substantial Equivalence to Predicate | Functional Equivalence: | Met: Identical intended use, indications for use, fundamental scientific technology, operating principle, user interface, alarms, customer/parameter specifications, safety/effectiveness, and manufacturing processes compared to the predicate device (M-MEM, K945234). |
| Safety Standards Compliance: | Met: Assessed against and complies with relevant international and national safety standards for medical electrical equipment, including: |
- COUNCIL DIRECTIVE 93/42/EEC
- FDA/DCRND Reviewer Guidance for Premarket Notification Submissions
- IEC 60601-1 (General requirements for safety)
- EN 60601-1
- CAN/CSA C22.2 No. 601.1-M90
- UL 2601-1
- IEC 60601-1-2 (Electromagnetic compatibility)
- FDA/ODE Guidance for Content of Premarket Submission for Software Contained in Medical Devices. |
| | Verification and Validation: | Met: The device has been "thoroughly tested through validation and verification of specifications." (Specific details of these tests are not provided in the summary, but implied to be sufficient for demonstrating compliance with standards and equivalence.) |
| Minor Differences Impact Assessment: | Differences in Aesthetics/Mechanics: | Deemed Non-Impactful: New color, shape, size, front panel/labeling changes. These are mechanical/aesthetic and do not affect functional equivalence. |
| | Minor Improvements to Electronics/Software: | Deemed Non-Impactful: Minor improvements to the electronic board and module software. These are presented as enhancements that do not alter the fundamental safety or effectiveness. |
| | PC Card Software Updating: | Deemed Non-Impactful: Added support for module software updating via PC card in one slot. This is an added feature that improves serviceability. |
| | Changed PCMCIA Card Type: | Deemed Non-Impactful: Changed type of PCMCIA cards used. This is a component change that does not affect the core function or safety. |
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a non-clinical substantial equivalence assessment and verification/validation testing against established medical device standards and the predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable in the context of a 510(k) for a data storage module of this nature. The "test set" here refers to the device itself and its components undergoing engineering verification and validation against specified requirements and standards. It's not a clinical data set in the traditional sense.
- Data Provenance: Not applicable. The "data" evaluated is the device's design, engineering specifications, test results from internal verification and validation, and comparison to the predicate device. There is no mention of patient data being used for the substantial equivalence claim itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not explicitly stated. The "ground truth" for a medical device like this is primarily derived from established engineering principles, international and national medical device standards (e.g., IEC 60601-1), and the performance of the legally marketed predicate device. Experts involved would be internal R&D, quality assurance, regulatory affairs personnel at GE Healthcare, and potentially independent testing labs for specific standard compliance. Their qualifications would be in medical device engineering, safety, and regulatory compliance, but not in clinical specialties like radiology for image interpretation.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This wasn't a study involving human interpretation or subjective assessment that would require an adjudication process. Compliance was assessed against objective standards and technical specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
- MRMC Study: No, an MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic or screening devices where human readers interpret patient data (e.g., medical images) with and without AI assistance. The E-MEM module is a data storage device, not a diagnostic or interpretive tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Standalone Performance Study: No, a standalone performance study in the context of an "algorithm only" was not done. While the device has "module software," its function is data storage and system integration, not complex algorithmic analysis requiring a "standalone" performance evaluation separate from the hardware. Its performance is tied to the reliable storage and retrieval of data according to specifications.
7. The Type of Ground Truth Used:
- Type of Ground Truth: The "ground truth" for this submission is based on:
- Engineering Specifications: The defined requirements for the module's performance, reliability, and functionality.
- Regulatory Standards: Compliance with established international and national medical device safety and performance standards (e.g., IEC 60601-1, EMC standards).
- Predicate Device Performance: The established safety and effectiveness of the legally marketed Datex-Ohmeda M-MEM Module (K945234), which serves as the benchmark for substantial equivalence.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that is "trained" on a dataset in the conventional sense. The "module software" would have been developed and tested using standard software engineering practices.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth for Training Set Was Established: Not applicable. As it's not an AI/ML device, there isn't a "training set" or "ground truth" for training in the traditional sense. Software validation would ensure the software performs according to its design specifications.
§ 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.