(81 days)
The Datex-Ohmeda S/5™ Cardiac Output module , E-COP and accessories are intended to be used for monitoring cardiac output (C.O.), right ventricular ejection (REF), and invasive blood pressure of hospitalized patients.
The Datex-Ohmeda S/5TM Cardiac Output module , E-COP and accessories are indicated for monitoring cardiac output (C.O.), right ventricular ejection fraction (REF), and invasive blood pressure of hospitalized patients.
The device is indicated for use by qualified medical personnel only.
The Datex-Ohmeda S/5TM Cardiac Output module, E-COP is a single-width plug-in parameter module for a Datex-Ohmeda S/5 modular monitoring system. E-COP is used for monitoring cardiac output (C.O.) and right ventricular ejection fraction (REF) of hospitalized patients. Invasive pressure measurement is also available. All measurements are invasive. The Datex-Ohmeda Cardiac Output module, E-COP can be used with the following Datex-Ohmeda modular monitors with 510(k) clearances:
- S/5TM Anesthesia Monitor (AM) with main software S-STD96(A) or S ARK96(A) or newer ●
- S/5™ Compact Anesthesia Monitor (CAM) with main software S-STD96(A) or S-ARK96(A) . or newer
- S/5TM Critical Care Monitor (CCM) with main software S-ICU97(A) or newer. .
S/5TM Compact Critical Care Monitor (CCCM) with main software S-ICU97(A) or newer. . The E-COP module can be used both with the legacy S/5 8-module monitor frame F CU8 and with the new 5-module monitor frame F-CU5(P) (submitted separately). The Cardiac Output or invasive pressure signal can be displayed on the monitor screen. The waveform size, color and sweep speed can be adjusted. The E-COP module calculates a number of parameters related to oxygenation or hemodynamics. All the calculated parameters can be selected on the display, and trended. Accessories that are in contact with the patient are CE-marked by Baxter and distributed by GE Healthcare
The provided text details the Premarket Notification 510(k) Summary for the Datex-Ohmeda S/5™ Cardiac Output module, E-COP and accessories, which seeks substantial equivalence to a predicate device, the Datex-Ohmeda M-COP Module (K922876). This document is focused on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving that it meets specific, independently established acceptance criteria through a clinical study with detailed performance metrics.
However, based on the information provided, we can infer the "acceptance criteria" and how the device "meets" them in the context of a 510(k) submission.
1. Table of inferred "Acceptance Criteria" and Reported Device "Performance":
Since this is a 510(k) submission, the "acceptance criteria" are implicitly defined by the characteristics of the predicate device, and the "performance" is the new device's ability to achieve "substantial equivalence."
| Acceptance Criteria (Inferred from Predicate Device Features) | Reported Device Performance (E-COP vs. M-COP) |
|---|---|
| Intended Use and Indications for Use | The same intended use and indications for use, with the addition of REF measurement. |
| Fundamental Scientific Technology | Identical fundamental scientific technology. |
| Operating Principle | Uses the same operating principle. |
| Accessories for Cardiac Output Measurement | Identical accessories for Cardiac Output measurement. |
| User Interface and Alarms | Same user interface at the monitor and alarms (can be used with the same monitor software). |
| Customer and Parameter Specifications | Same customer and parameter specifications. |
| Safety and Effectiveness | Same safety and effectiveness. |
| Manufacturing Processes | Manufactured using the same processes. |
| Compliance with Relevant Standards and Guidance | Assessed against and concluded to meet relevant standards (e.g., IEC 60601-1, AAMI ES1-1993, ISO 14971:2000) and FDA guidance documents. |
| Absence of New Questions of Safety and Effectiveness | "No new questions of safety and effectiveness" compared to the predicate device, despite minor physical and electronic changes, and software modifications. |
2. Sample size used for the test set and the data provenance:
The document does not describe a traditional "study" with a test set in the sense of a clinical trial or performance evaluation with patient data. Instead, it relies on nonclinical testing (validation and verification of specifications against standards) to demonstrate equivalence. Therefore, there is no mention of a "sample size for the test set" or "data provenance" in terms of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. As described above, there is no traditional "test set" with ground truth established by experts in the context of this 510(k) submission for demonstrating clinical performance. The assessment is based on engineering evaluations and compliance with standards.
4. Adjudication method for the test set:
Not applicable. No "test set" requiring adjudication by experts is described.
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:
Not applicable. The device is a cardiac output and invasive pressure monitoring module, not an AI-assisted diagnostic tool for interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document describes nonclinical testing, validation, and verification of the device's specifications and compliance with standards. This implicitly represents "standalone" performance testing of the device's functionality and safety, separate from human interaction, but not in the sense of an "algorithm only" performance study. The device is a monitor, not a pure algorithm.
7. The type of ground truth used:
For the nonclinical testing, the "ground truth" refers to established engineering specifications, published international and national standards (e.g., IEC 60601-1), and FDA guidance documents. The device's performance was compared to these defined requirements, rather than clinical outcomes or pathology.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that would require training data. The document describes a medical device seeking substantial equivalence to a predicate.
9. How the ground truth for the training set was established:
Not applicable. As this is not an AI/machine learning device, there is no training set or ground truth in that context.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).