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The 740 SELECT series of patient monitors is indicated for use as a portable, multi-parameter, variable acuity device for use by health care professionals, clinicians and medically qualified personnel, in a variety of clinical environments and hospital departments, for non-invasive spot checking, and/or continuous monitoring, recording and alarming of multiple physiological parameters for use in adults, and pediatric patients.

The 740 SELECT series monitors come with multiple configurations and optional features. Standard and optional parameters include:

• . Blood pressure and pulse rate:
• Functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate; .
• Carbon Dioxide concentration of the expired and inspired breath and respiration rate including, with the Covidien Microstream MicroPod option, an Integrated Pulmonary Index (IPI);
• . Electronic predictive and temporal artery temperature;
• . ECG and heart rate derived from ECG:
• . Impedance respiration to detect the rate or absence of respiratory effort with the ECG option for adult, adolescent, child and infant;
• . Non-invasive monitoring, with Masimo Rainbow SET technology, of carboxyhemoglobin saturation (SpCO) and/or respiration (RRa). Other information displayed includes: Signal IO Wayeform. Low Signal IO (Low SIO), Perfusion Index (PI), and/or Pleth Variability Index (PVI) for use during both no motion and motion conditions, and for patients who are well or poorly perfused.

The 740 SELECT is a rugged portable non-invasive multi-parameter device used for spot checking or continuous monitoring of blood pressure, pulse rate, functional oxygen saturation (%Sp02), body temperature, etCO2, FiC02 Respiratory rate derived from etC02, ECG and Impedance Respiration in selected modes of operation.

The non-invasive blood pressure (NIBP) parameter automatically inflates an occluding cuff and, using the oscillometric step-deflation measurement technique, determines systolic, diastolic and mean arterial pressure as well as pulse rate. Measurement results along with user prompts and error messages are displayed on the front panel. The frequency of NIBP determination can be elected by the user in times between one and ninety minutes. The auto (timed), STAT and manual NIBP operating modes provide additional clinical utility.

The pulse oximeter parameter (%SpO2) determines arterial oxyhemoglobin saturation by measuring the absorption of red and infrared light passing through the tissue. Changes in absorption caused by pulsations of blood in the vascular bed are used to determine arterial saturation and pulse rate. The oximeter requires no routine calibration or maintenance. Oxygen saturation and heart rate are displayed on a light emitting diode (LED) digital display. On each detected pulse, the perfusion LED indicates patient perfusion signals. This bar graph gives the user a pulse-by-pulse visual indication of waveform signal quality. An audio "beep" can be enabled that is generated each time the SpO2 module detects a pulse. In addition to % SpO2 the 740 SELECT (equipped with the Masimo Rainbow® Pulse CO-Oximetry™ and Masimo SET ® oximetry) can monitor Pulse Rate (PR), Carboxyhemoglobin (SpC0®), Acoustic Respiration Rate (RRa™) and Pleth Variability Index (PVI®). Alternately, the customer can choose a Nellcor Pulse Oximeter at the of ordering. The Nellcor Oximeter provides Response Mode and Sat Seconds.

The 740 SELECT has (2) options for measuring temperature. The Covidien™ FILAC 3000 predictive temperature parameter has the capability of taking temperature in either normal (predictive) or monitor mode. In the normal mode, the thermometer's microprocessor "predicts" body temperature in about four (4) seconds for oral temperatures, about ten (10) seconds for axillary temperatures and about fifteen (15) seconds for rectal temperatures. The default setting used by the monitor for temperature determinations is the Predictive (normal) mode. Alternately, the customer can choose an Exergen TemporalScanner™ (infrared) Thermometer at the time of ordering. The Exergen TemporalScanner Thermometer, which captures core body temperature, has the capability of taking the Temporal Artery (TA) Temperature in about 3 seconds. The Exergen Temporal scanner has the ability to display the measurement of the patient's core temperature in either °F or °C.

The 740 SELECT offers the optional choice of Sidestream and/or Mainstream etC02 parameter monitoring. The customer choices for Sidestream C02 monitoring are the Masimo - Phasein™ Infrared Sidestream Gas Analyzer (ISA™) or the Covidien Microstream® MicroPod™ which is integrated with the microMediCO2™ board. Customers may also choose Mainstream etCO2 parameter monitoring by using the Masimo Phasein™ infrared Mainstream Gas analyzer (IRMA™). Each of these CO2 options is externally attached to the SELECT.

This clearance adds the parameter ECG and Impedance Respiration.

The provided document is a 510(k) summary for the CAS Medical Systems, Inc. 740 SELECT patient monitor. This document seeks to demonstrate substantial equivalence to previously cleared devices rather than providing a detailed study of the device's performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be fully extracted in the format requested, as the document states that "Clinical performance testing was not performed with the 740 SELECT for this submission. Clinical testing is not necessary to demonstrate safety and effectiveness." The submission relies on demonstrating substantial equivalence to predicate devices, and the performance criteria for those devices are not detailed here.

However, I can extract information about the types of performance testing that were conducted to support the substantial equivalence claim.

Summary of Information from the Document:

The 740 SELECT patient monitor, with the addition of ECG and Impedance Respiration, builds upon a previously cleared device (K140430) and is considered substantially equivalent to it and another predicate device (Zoe Medical Nightingale Monitoring System K130740).

The performance testing mentioned focuses largely on non-clinical aspects and compliance with recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, specific acceptance criteria with numerical targets and the device's reported performance against those targets are not explicitly stated for each physiological parameter in this 510(k) summary. Instead, the document refers to compliance with internal requirements and established safety/performance standards.

2. Sample Size Used for the Test Set and the Data Provenance:

• Sample Size for Test Set: Not applicable or not provided. The document explicitly states, "Clinical performance testing was not performed with the 740 SELECT for this submission." Bench testing is mentioned as complying with internal requirements, but specific sample sizes for this or other non-clinical tests are not detailed.
• Data Provenance: Not applicable, as detailed clinical performance testing was not conducted and no specific data sets are described. The focus is on compliance with standards and substantial equivalence to predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable. No ground truth establishment by experts for a test set is described, as clinical performance testing was not performed.

4. Adjudication Method:

Not applicable. No adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. No MRMC study was conducted or referenced. The submission explicitly states no clinical performance testing was done.

6. Standalone Performance:

Standalone performance (algorithm only) is not relevant for this type of device (a multi-parameter physiological monitor). The device itself is the "algorithm" and performs measurements directly. The document states that the device was tested for electrical safety, EMC, and bench performance according to internal requirements and relevant standards.

7. Type of Ground Truth Used:

Not applicable. Since clinical performance testing was not performed to evaluate the diagnostic or measurement accuracy against a gold standard in a patient population, no "ground truth" (e.g., pathology, outcomes data, or expert consensus) for such clinical performance is mentioned. The ground truth for electrical safety or EMC testing would be the specified limits within the relevant standards.

8. Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI/ML algorithm that undergoes a training phase with a dataset.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As noted above, this is not an AI/ML algorithm that requires a training set.

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The 740 SELECT series of monitors is indicated for use as a portable, multi-parameter, variable aculty device for use by health care professionals, clinicians and medically qualified personnel, in a variety of clinical environments and hospital departments, for non-invasive spot checking, and/or continuous monitoring and recording of:

• Blood pressure and pulse rate of adult, pediatric and neonatal patients; .
• Functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric and . neonatal patients;
• Additionally the Masimo Rainbow SET technology provides noninvasive monitoring of . carboxyhemoglobin saturation (SpCO) and/or respiration (RRa). Other information displayed on the 740 SELECT with the Masimo Rainbow SET option includes: Signal IQ Waveform, Low Signal IQ (Low SIQ), Perfusion Index (PI), and/or Pleth Variability Index (PVI) indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused;
• Carbon Dioxide concentration of the expired and inspired breath and respiration rate of adult, . pediatric, infant or neonatal patient and included, with the Oridion option, an Integrated Pulmonary Index (IPI):
• Intermittent predictive body temperature (oral, axillary, rectal) of adult, pediatric and neonatal ● patients;
• Infrared (over the temporal artery) measurement of body temperature of people of all ages. .

The 740 SELECT is a rugged portable non-invasive multi-parameter device used for spot checking or continuous monitoring of blood pressure, pulse rate, functional oxygen saturation (%Sp02), body temperature and CO2 in various modes of operation.

The CASMED 740 SELECT is a multi-parameter physiological monitor. The provided document does not contain an "acceptance criteria" table with specific performance metrics and acceptance thresholds for the device as a whole. Instead, it states that the device has undergone clinical and non-clinical testing to demonstrate substantial equivalence to predicate devices, and that the OEM's clinical work for the pulse oximeters, CO2, and temperature functions is cited.

Therefore, the acceptance criteria are implicitly tied to demonstrating substantial equivalence, meaning the 740 SELECT performs comparably to the identified predicate devices for each parameter (NIBP, SpO2, Temperature, CO2).

Here's an analysis of the provided information based on your request, with limitations due to the nature of the available document (a 510(k) summary, not a detailed study report):

1. Table of Acceptance Criteria and Reported Device Performance

As noted, a formal table of acceptance criteria and specific reported device performance values is not provided in this 510(k) summary. The summary focuses on demonstrating substantial equivalence. The document indicates that for the NIBP, SpO2, CO2, and Temperature functions, the 740 SELECT incorporates technologies from other manufacturers (OEMs) that have already undergone validation.

The implicit acceptance criteria for each parameter would be that its performance is equivalent to, or within the accepted ranges of, its respective predicate device or the OEM component's validated performance.

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:
  • NIBP: The document states that CAS has "conducted a full program of individual hardware, software and systems verification and validation studies." It also mentions "clinical validation reports for the NIBP." However, specific sample sizes for the NIBP clinical validation are not provided.
  • Pulse Oximeters, CO2, Temperature: The document explicitly states that the 740 SELECT incorporates OEM components (Masimo, Nellcor, Exergen, Phasein, Oridion). For these parameters, the "OEM's clinical work" is cited. This implies that the validation data for these components predates the 740 SELECT and was done by the original equipment manufacturers. No specific sample sizes for these OEM components' clinical work are provided in this document pertaining to the 740 SELECT's submission.
• Data Provenance: The document does not specify the country of origin for any clinical data. Given the submission is to the FDA, it is likely some data would involve studies conducted or accepted in the US, but this is not explicitly stated. It refers to "clinical validation reports for the NIBP" (presumably conducted by CAS Medical Systems) and "the OEM's clinical work" for other parameters. It is retrospective in the sense that the OEM data was already established.

3. Number of Experts and Qualifications for Ground Truth - Test Set

• NIBP: Not specified. "Clinical validation reports" are mentioned, which would typically involve qualified medical professionals, but their number and specific qualifications are not detailed.
• Pulse Oximeters, CO2, Temperature: Not specified. For the OEM components, the ground truth establishment would have been part of their original validation studies, which are not detailed here.

4. Adjudication Method - Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth in the clinical validation studies, either for the NIBP component or for the OEM components.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done as described (human readers improving with AI vs. without AI assistance).
• The device being submitted (740 SELECT) is a physiological monitor, not an AI-assisted diagnostic tool that would typically involve human "readers" interpreting data with and without AI assistance for comparative effectiveness. The focus is on the accuracy and reliability of the physiological measurements themselves.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, in essence, standalone performance was assessed for the measurement algorithms.
• The document implies that the measurement algorithms for NIBP, SpO2, CO2, and Temperature are intended to operate independently to provide accurate physiological readings. The "clinical validation reports for the NIBP" and the "OEM's clinical work for the pulse oximeters, CO2 and the temperature functions" refer to studies evaluating the accuracy of these measurement technologies.
• The 740 SELECT itself is a "device" with algorithms embedded to perform these measurements. The "clinical validation" and "OEM's clinical work" would have primarily focused on the accuracy of these algorithms and sensors in determining physiological parameters against a reference standard.

7. Type of Ground Truth Used

• NIBP: While not explicitly stated, NIBP validation typically uses invasive arterial line measurements as the gold standard ground truth for comparing non-invasive readings.
• Functional Oxygen Saturation (SpO2): For pulse oximeters, the ground truth is often established by co-oximetry of arterial blood samples.
• CO2: For CO2 monitors (Capnography), the ground truth is typically derived from direct measurement of CO2 concentration in exhaled gas using a laboratory reference method.
• Temperature: For thermometry, the ground truth is usually established by highly accurate reference thermometers measuring core body temperature (e.g., rectal, esophageal, or arterial temperature probes).

8. Sample Size for the Training Set

• Not specified. The document does not provide details on training sets for any of the algorithms. Since the device integrates established technologies, the initial development and "training" (if applicable to the algorithm type) would have occurred during the development of these OEM components, not explicitly for the 740 SELECT submission.

9. How the Ground Truth for the Training Set Was Established

• Not specified. As mentioned above, details about training sets and their ground truth establishment are not present in this 510(k) summary. This information would typically be found in detailed design and validation documentation for the individual components by their respective OEM manufacturers.

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The 740 SELECT is indicated for use as a bedside, portable device for use by health care professionals, clinicians and medically qualified personnel for spot checking, continuous monitoring and recording of adult, pediatric and neonatal patients. The Monitor features world class technology to facilitate the monitoring of non-invasive blood pressure, pulse rate, functional arterial oxygen saturation (Sp02) and body temperature in a variety of clinical environments.

The 740 SELECT Series Monitor is a portable and rugged non-invasive multi-parameter device used for spot checking, continuous monitoring, and recording of blood pressure, pulse rate, functional oxygen saturation (%Sp02), and predictive body temperature in a variety of clinical environments. The Monitor includes features that are optional or configurable. The 740 SELECT Series Monitor is compact and lightweight in design, allowing it to be easily carried and or configured for use with a mobile stand, wall mount or on a table top. A Lithium lon (Li-lon) rechargeable battery is provided for automatic switching to back-up power if an untended loss of AC power should occur as well as allow the monitor to be used for clinical applications when portable monitoring is required. The 740 SELECT Series Monitor is equipped with a color touchscreen which is the primary interface for the user to control and configure the Monitor (for patient type, alarms, settings and various clinical workflows). A dedicated message area provides patient alarm and technical messages. Date and time as well as the Monitor ID are displayed. A battery gauge provides approximate battery capacity when the monitor is operating on battery power. The Monitor supports both point-of-care and variable acuity monitoring. Spot vital signs measurements from multiple patients can be saved individually. The monitor can be used for continuous patient monitoring with full alarm support.when increased vigilance in necessary based on patient acuity. The Stand-By Mode provides enhanced bedside patient workflow and alarm management permitting sensor attachment, automatic alarm suspension and switch to active monitoring. The color coded Trends Display allows the user to recall all trended physiologic patient. measurement records. Trends can be recalled for saved snapshots as well as timed intervals. The Monitor provides a screen keyboard for entry of patient data (e.g., age, weight, height, gender, date of birth, patient name, and patient identification number). A serial data output is provided for connectivity to hospital EMR systems and external serial devices. An internal isolated relay switch is provided for nurse call systems. The monitor supports an optional externally connected thermal strip chart recorder which is directly powered from the serial port.

The provided text is a 510(k) Summary for the CASMED 740 SELECT physiological patient monitor. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (CAS 740 Series Monitor, K033048).

However, the document does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested. While it mentions "extensive performance, safety, electromagnetic, and environmental testing" and "clinical validation reports for the NIBP, pulse oximeter and the temperature function," it does not provide the specific metrics, actual performance data against thresholds, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, or other detailed study design elements you asked for.

The 510(k) Summary primarily states that:

• The device "has successfully undergone extensive clinical validation for the indicated use."
• "Clinical evaluation, safety testing, software and systems validation demonstrate the 740 SELECT is substantially equivalent to the predicate device."

It references clinical validation reports for NIBP, pulse oximeter, and temperature but does not provide the content of those reports. Therefore, I cannot extract the specific information requested in your numbered points from the provided text.

To answer your questions, I would need to see the actual clinical validation reports or other detailed performance testing documentation that would typically be submitted as part of a 510(k) application (but is often not included in the publicly available 510(k) Summary).

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