(59 days)
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.
| Category | Acceptance Criteria (Implied / Standard) | Reported Device Performance |
|---|---|---|
| Sterilization | Not applicable (device cannot be sterilized) | Not applicable |
| Biocompatibility | Accessories are biocompatible (claimed by manufacturers' premarket notification) | Accessories are claimed biocompatible |
| Software | Designed and developed in accordance with developer's software development processes; Verified and Validated | Software was designed, developed, verified, and validated |
| Electrical Safety | Compliance with IEC 60601-2-27:2011 (due to ECG addition) and other listed standards (AAMI/AAMI ES 60601-1:2005, IEC 60601-1:2005, ANSI/AAMI/ISO 81060-2, IEC 60601-1-6:2006, IEC 60601-1-8:2006, IEC 80601-2-30:2009, IEC 60601-2-49:2011, ISO 80601-2-56:2009, ISO 80601-2-61:2011, ISO 80601-2-55:2011) | Proposed device has been tested to and meets these standards |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2007 | Tested for EMC and complies with its predetermined specification |
| Performance Testing - Bench | Compliance with internal requirements and procedures | Device complies with predetermined requirements |
| Performance Testing - Animal | Not performed | Not performed |
| Performance Testing - Clinical | Not necessary to demonstrate safety and effectiveness (as per submission) | Not performed |
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.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).