(22 days)
The Datex-Ohmeda Cardiocap 5 (REV. B) and accessories are indicated for indoor monitoring of hemodynamic (ECG, Impedance respiration, NIBP, Temperature, SPO2 and invasive pressure) , respiratory (CO2, O2, N2O, respiration rate, anesthetic agent and agent identification), ventilatory (airway pressure, volume and flow) and relaxation status (NMT) of all hospital patients.
With the N-XOSAT option, monitoring of arterial oxygen saturation includes monitoring hospital patients under clinical motion conditions.
Impedance Respiration measurement is indicated for patients ages 3 years and older.
Cardiocap/5 is indicated for patients weighing 5 kg (11 lb.) or more.
The monitor is indicated for use by qualified medical personnel only.
The Cardiocap 5 monitor is a multi-parameter monitor that is factory configured. The monitor provides basic hemodynamic monitoring of ECG, SpO2, Temp, NIBP and Invasive provides outs addition to the hemodynamic monitoring it can be configured with Gas monitoring which are: CO2, N2O, O2, Anesthetic Agents with agent identification and Patient Spirometry TM .
The Cardiocap 5 monitor software available is for Anesthesia or Critical Care. The customer upon purchase for optimized use of monitor can select the software for application.
In addition the Cardiocap 5 rev. B will offer other options and enhanced features. These features are the following:
OSAT - Enhanced D-O Oximetry (SpO2) performance NSAT - Nellcor Oximetry XP w/2 temp - Invasive pressure with 2 temp feature Rec. w/2 key - Recorder with 2 direct key function
Because the Cardiocap 5 monitor is factory-configured for cost-effectiveness and compactness, the parameters and optional thermal array recorder cannot be upgraded later. Software is upgradeable.
Cardiocap 5 is based on the same state-of-the-art monitoring and user interface technology, including menu logic and alarm philosophy, as the S/5 monitors. The Cardiocap 5 can also be networked to the Datex-Ohmeda Network.
The hemodynamic frame (F-MX) and hemodynamic with gases frame (F-MXG) both include ECG with ST analysis and impedance respiration, SpO2, 1 temperature, and noninvasive blood pressure. Invasive blood pressures (2 channels) and second temperature is an option for both models. Airway gas options are for hemodynamic with gases frame .
The Cardiocap 5 monitor now extends its feature sets to allow flexibility of customerpreferred oximetry options. These new oximetry features replace the functionality of the original oximetry offering. (Only one oximetry option is available at a time.
The Datex-Ohmeda Cardiocap 5 (Rev B) and its accessories, including the N-XOSAT option, are patient monitoring devices. The provided text outlines the declaration of substantial equivalence to a predicate device (Datex-Ohmeda Cardiocap 5 Rev A, K992323) rather than a direct study demonstrating acceptance criteria met for a novel device. The basis for acceptance is demonstrating that the new device is as safe and effective as the predicate device by showing identical intended use, substantially identical indications for use, and similar technological characteristics, with any differences not raising new questions of safety or effectiveness.
Here's an analysis based on the provided text, focusing on how the new device's equivalence and safety/effectiveness were established:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are primarily established by the predicate device's performance and compliance with relevant standards. The "reported device performance" is implicitly that it meets or maintains these standards.
| Acceptance Criterion (Implicit) | Reported Device Performance (as stated in submission) |
|---|---|
| Intended Use Equivalence: Same intended purpose as the predicate device. | "The Datex-Ohmeda Cardiocap 5 (REV. B) and accessories is substantially equivalent... in legally marketed (predicate) Datex-Ohmeda Cardiocap 5 Rev A (K992323). The intended use of the devices have not changed." |
| Indications for Use Equivalence: Nearly identical indications for use as the predicate, with minor enhancements not raising new concerns. | "The indications for use for Cardiocap 5 REV B. and the predicate is nearly identical. Information about the N-XOSAT monitoring SPO2 during clinical motion conditions was added." (This addition is presented as an enhancement, not a new safety concern). |
| Technological Characteristics Equivalence: Key measurement parameters and core technology are identical or similar. | "The Cardiocap 5 REV. B measurement of ECG, SpO2, Temperature, invasive and non-invasive blood pressures together with respiration, CO2, O2, N2O, Anesthetic Agents and Agent ID, Patient Spirometry™, NMT, recorder and datacard/network functionality are all identical to the predicate Cardiocap/5 Rev A." |
| Safety and Effectiveness: No new questions of safety and effectiveness are raised by the changes. | "The comparisons above as well as supporting data and analysis shows that there are no new questions of safety and effectiveness for the Cardiocap/5 Rev B and accessories described in this submission is substantially equivalent to the predicate device." |
| "The Datex-Ohmeda Cardiocap 5 (REV. B) and accessories complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested including electrical safety, electromagnetic compatibility, mechanical and environmental tolerance, software validation and verification of specifications." | |
| "Conclusion: The summary above shows that there are no new questions of safety and effectiveness for Datex-Ohmeda Cardiocap 5 (REV. B) and accessories as compared to the predicate device." | |
| Compliance with Standards: Adherence to recognized national and international safety and performance standards. | The device "complies with the safety standards below" and lists numerous IEC, EN, CAN/CSA, ISO, and AAMI standards (e.g., IEC 601-1, IEC 601-2-27, ISO 9919, AAMI EC13-1992, AAMI SP10-92). |
| Software Validation: Software changes are validated. | "The software was updated to incorporate those changes noted below but otherwise is the same as the predicate. ...software validation and verification of specifications." (Mention of S-XANE99 rev.01 and S-XCCA99 rev.01 compatibility with S-ARR99). |
| Hardware Changes (if any) do not impact safety/performance or are properly accounted for. | "The hardware is essentially the same with the exception of adding a new quick pushbutton key for simpler access to the recorder trend function." |
| "The only paramater differences are to add a 2nd temperature option (specification is the same as predicate) and to add options for two additional SPO2 measurement options N-XNSAT (Nellcor oximetry) and N-XOSAT (D-O enhanced oximetry)." |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical testing for compliance with standards rather than a clinical study with a "test set" of patients. The evaluations are primarily engineering and bench testing, software validation, and verification against established performance specifications and regulatory standards. There is no mention of a patient-based test set or data provenance (e.g., country of origin, retrospective/prospective). The N-XOSAT option mentions "monitoring hospital patients under clinical motion conditions," implying some level of testing for this specific feature, but no details on sample size or study design are provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This is not a study requiring expert-established ground truth for patient outcomes or diagnoses. The "ground truth" for non-clinical testing refers to compliance with predefined engineering specifications and regulatory standards.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of a human-read test set requiring adjudication in the context of this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was mentioned or performed as described in the provided text. The submission focuses on substantial equivalence to an existing device, not on demonstrating an improvement in human reader performance with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not explicitly detailed as a separate study. The device itself is a patient monitor, which inherently provides information to a human operator. The "software validation and verification of specifications" would constitute an assessment of the algorithm's performance in its specific functions (e.g., ST analysis, gas analysis, NIBP measurement) in a standalone capacity against its own internal specifications and relevant standards.
7. The Type of Ground Truth Used:
For the non-clinical testing, the "ground truth" refers to:
- Engineering Specifications: The device's performance parameters (e.g., accuracy of ECG, SpO2, NIBP measurements) are verified against internal design specifications derived from industry standards and clinical requirements.
- Regulatory Standards: Compliance with the listed mandatory and voluntary standards (e.g., IEC 601-1, AAMI SP10-92) serves as a "ground truth" for safety and basic performance acceptance.
- Predicate Device Performance: The predicate device itself acts as a "ground truth" benchmark for demonstrating substantial equivalence.
8. The Sample Size for the Training Set:
Not applicable. This document does not describe the development or validation of machine learning algorithms that typically require training sets. The "software validation" mentioned would refer to traditional software engineering quality assurance.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a training set for machine learning.
§ 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.