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The Trip® Tonometry Catheter, 16 F (with stopcock) is used for the determination of regional PCO2 (PrCO>) and intramucosal pH (pHi) of the gastric mucosal tissue. This catheter is also used as a gastrointestinal tract access device for connecting the Tonocap™ monitor. The sampling line and biofilter (which are separate from the device) serve as a means of connecting the catheter to the Tonocap™ monitor and as a transducer protector to prevent patient cross-contamination and to prevent monitor damage, respectively. Since it incorporates a vented gastric sump, the catheter is also used for feeding and/or decompression or aspiration of the contents of the stomach.

The device is indicated for use in surgical/operating room patients, intensive care unit patients, emergency/trauma patients and hospital patients with suspected mesenteric ischemia

The Trip® Tonometry Catheter, 16 F (with biofilter and sampling line) is used for the determination of regional PCO2 (PrCO2) and intramucosal pH (pHi) of the gastric mucosal tissue when used as a gastrointestinal tract access device for connecting the Tonocap™ monitor. The sampling line and biofilter serve as a means of connecting the catheter to the Tonocap™ monitor and as a transducer profector to prevent patient cross-contamination and to prevent monitor damage, respectively. Since it incorporates a vented gastric sump, the catheter is also used for feeding and/or decompression or aspiration of the contents of the stomach.

The device is indicated for use in surgical/operating room patients, intensive care unit patients, emergency/trauma patients and hospital patients with suspected mesenteric ischemia

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This document is a 510(k) clearance letter from the FDA for a medical device (TRIP Tonometry Catheter). It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and thus can be marketed.

Therefore, I cannot provide the requested information based on the given text.

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For monitoring hospital patient's respiration (CO2, O2, N2O and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption VO2, Carbon (an way production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). The system is intended for use by qualified medical personnel only.

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The provided text is a Fragment of a 510(k) summary letter from the FDA to Datex Engstrom, Inc. regarding their CS/3™ Compact Airway Module, M-COVX. This document primarily focuses on the FDA's decision of substantial equivalence and does not contain detailed information about acceptance criteria or specific study results to prove a device meets those criteria.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them based on the text provided. The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication methods.
5. Information about MRMC comparative effectiveness studies.
6. Results of standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document is a regulatory approval letter, not a technical study report.

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The Datex-Engstrom Light Monitor, F-LM1, F-LMP1 is for stationary and mobile monitoring of patient's ECG, SpO2, body temperature, invasive and non-invasive blood pressures as well as respiration and CO2 in hospitals and ambulances. When used outdoors, the monitor must be in the protective case.

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The provided text is a 510(k) premarket notification approval letter for the Datex-Engstrom Light Monitor, F-LM1, F-LMP1. This document confirms the device is substantially equivalent to legally marketed predicate devices. However, it does not contain information about acceptance criteria, device performance, or any studies used to prove the device meets specific criteria.

The letter focuses on the regulatory approval process and states the device's intended use and general controls provisions of the Act. It does not include the detailed technical or clinical study data that would be necessary to answer the questions about acceptance criteria and study design.

Therefore, I cannot provide the requested information based on the given input.

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The AS/3™ Anaesthesia Delivery Unit (AS/3™ ADU) is an Anesthesia Gas Machine for The A.J. > Anaesthetic breathing gas and manual or mechanical ventilation for patients undergoing anesthesia.

The AS/3™ ADU is indicated for all persons that require inhalation anesthesia.

The AS/3™ ADU shall be operated by qualified anesthesia personnel.

AS/3™ Anaesthesia Delivery Unit (AS/3TM ADU) is an Anesthesia Gas Machine.

This appears to be a 510(k) clearance letter for a medical device (AS/3™ Anaesthesia Delivery Unit), not a study report. Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted directly from the provided text.

The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on a comparison to existing devices, not necessarily on a novel clinical study with explicit acceptance criteria as would be presented in a performance study report.

The letter explicitly mentions:

• Device Name: AS/3™ Anaesthesia Delivery Unit (AS/3™ ADU)
• Indications For Use: Anaesthetic breathing gas and manual or mechanical ventilation for patients undergoing anesthesia. Indicated for all persons requiring inhalation anesthesia and to be operated by qualified anesthesia personnel.
• Regulatory Class: II

Since the provided text is an FDA clearance letter and not a study report, I cannot provide the specific details requested concerning acceptance criteria and study data.

To answer your questions accurately, you would typically need a separate document, such as a "Summary of Safety and Effectiveness" or a clinical/device performance study report, which would outline the testing performed to demonstrate performance.

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The Datex-Engstrom MRI Patient Monitor and accessories is indicated for monitoring of ECG waveform for Heart Rate and Asystole detection, SpO22, Non-invasive blood pressure (NIBP), airway gases, anesthetic agents, airway flow, airway pressure and airway volume on patients during MR imaging. It is indicated for use inside the MRI room mounted outside the 20 Gauss line and with magnets of field strength 1.5 Tesla or less.

SpO2monitoring is indicated only with the use of Datex-Engstrom sensors specifically designed for use in the MRI environment. ECG monitoring is indicated only with use of the MRI ECG lead set.

MRI Patient Monitor and Accessories

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (MRI Patient Monitor and Accessories). It does not contain any information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement in a study to prove the device meets acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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The CS/3™ Monitors are indicated for multiparameter patient monitoring in all hospital patients.

CS/3™ Monitors* * Includes CS/3™ Critical Care Monitor and CS/3™ Compact Monitor.

This document is a 510(k) clearance letter from the FDA for the Datex Engstrom, Inc. CS/3™ Monitors. It indicates the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information. The document primarily focuses on regulatory approval and indications for use.

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The TRIP Tonometry Catheter, 18F is used for the determination of regional PCO2 (PrCO2) and intramucosal pH (pHi) of the gastric mucosal tissue when used as a gastrointestinal tract access device for connecting the Tonocap™ monitor. The sampling line and biofilter built into the device serve as a means of connecting the catheter to the TONOCAP™ monitor and as transducer protector to prevent patient cross-contamination and monitor damage, respectively. Since it incorporates a vented gastric sump it is also used for feeding and/or decompression or aspiration of the contents of the stomach. It is indicated for use in surgical/operating room patients, intensive care unit patients , emergency / trauma patients and hospital patients with suspected mesenteric ischemia.

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The provided document is a 510(k) clearance letter from the FDA for the TRIP Tonometry Catheter, 18F. This type of letter confirms the substantial equivalence of a new medical device to a legally marketed predicate device. It does not typically contain detailed information about acceptance criteria or specific study results that prove a device meets those criteria.

Therefore, based solely on the provided text, I cannot extract the information required to populate the table and answer the study-related questions. The letter simply states that the device is substantially equivalent to pre-amendments devices for the indications for use stated in the enclosure.

To answer your questions, I would need to review the actual 510(k) submission document (K980384) which would contain the performance data and testing details.

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The CS/3™ Arrythmia Workstation (ARRWS) is indicated for centralized monitoring, arrhythmia analysis and detection, waveform data storage and patient data storage in hospitalized patients connected to Datex-Engstrom monitors.

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I apologize, but the provided text is a 510(k) clearance letter from the FDA regarding the "CS/3™ Arrhythmia Workstation." This document confirms the device's substantial equivalence to a predicate device and outlines regulatory information.

However, this document does not contain any information about:

• Acceptance criteria
• Reported device performance
• Details of a study proving the device meets acceptance criteria
• Sample sizes (test or training set)
• Data provenance
• Number or qualifications of experts for ground truth
• Adjudication methods
• MRMC comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used
• How ground truth for training was established

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely a regulatory clearance communication, not a performance study report.

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The Datex-Engstrom Network transfers information between networked Datex-Engstrom devices. It allows a networked device to display, store, print and otherwise process information received from other networked devices.

The Datex-Engstrom Information Centre maintains the network connections between the Datex-Engstrom bedside monitors and other networked devices in Datex-Engstrom Network. Furthermore, it coordinates the transfer of information between devices in the Datex-Engstrom Network as well as between the Datex-Engstrom Network and Hospital Information Systems (HIS).

The Datex-Engstrom Information Centre can be used for storing, printing, viewing or otherwise processing of information from several bedside monitors or other networked devices.

The Datex-Engstrom Network will be used for patients in the hospital and it is meant for continuous use.

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Unfortunately, the provided document is a 510(k) clearance letter for the Datex-Engstrom Network, a device for transferring information between networked medical devices. This document does not contain any information about acceptance criteria, device performance studies, or clinical trial data.

The letter primarily focuses on the FDA's determination of substantial equivalence for the device based on its intended use as described by the manufacturer. It confirms that the device can be legally marketed, subject to general controls and potentially special controls for its regulatory class.

Therefore, I cannot answer your specific questions related to acceptance criteria and performance studies because that information is not present in the provided text. To answer those questions, you would need access to the actual 510(k) submission or related technical documentation, which would detail the performance testing and validation results for the Datex-Engstrom Network.

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