(390 days)
The 740 SafeSAT 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 of adult and pediatric patients, excluding neonates. The Monitor features technology to facilitate the monitoring of non-invasive blood pressure, pulse rate and functional arterial oxygen saturation (SpO2) in a variety of clinical environments.
The 740 SafeSAT physiological patient monitor is a portable and rugged non-invasive multiparameter device used for spot checking, continuous monitoring, and recording of blood pressure, pulse rate, and functional arterial oxygen saturation (SpO2) in a variety of clinical environments. The 740 SafeSAT monitor employs SafeSAT SpO2 technology which includes components from OSI Optoelectronics. The monitor is compact and lightweight, with a color touch screen for user interface. It supports point-of-care and variable acuity monitoring, including saving spot vital signs and continuous monitoring with alarms. Features include a Standby Mode, Trends Display, screen keyboard for patient data entry, serial data output for EMR connectivity, an internal isolated relay switch for nurse call systems, and support for an optional external thermal strip chart recorder. It measures non-invasive blood pressure (NIBP) using the oscillometric technique and pulse oximetry (SpO2) by measuring the absorption of red and infrared light. Alarm conditions are displayed visually and audibly.
Here's a breakdown of the acceptance criteria and study information for the 740 SafeSAT device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly state the quantitative acceptance criteria for SpO2 accuracy. Instead, it refers to the performance requirements of a standard and global claim of "exceeds its performance claims." Based on the clinical testing section, the core acceptance criteria for SpO2 accuracy are derived from ISO 80601-2-61.
| Metric (Source Standard) | Acceptance Criteria (Implied by adherence to standard and "exceeds claims") | Reported Device Performance (Summary from text) |
|---|---|---|
| SpO2 measurement accuracy (ISO 80601-2-61) | Performance standards defined by ISO 80601-2-61 for pulse oximetry accuracy | Device "exceeds its performance claims for SpO2 measurement accuracy under motion and non-motion conditions." (Specific values not provided in this summary) |
| Safety & Essential Performance (ISO 80601-2-61) | Adherence to the standard's requirements | All requirements and performance specifications were met. |
Note: The document states "The clinical data demonstrates that the device exceeds its performance claims for SpO2 measurement accuracy under motion and non-motion conditions," but it does not provide the specific numerical performance claims (e.g., Accuracy Root Mean Square (ARMS) values).
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: "healthy male and female adults in the range of 20 to 40 years of age and with a range of skin tone." The exact number of participants is not specified in the provided text.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective clinical studies conducted specifically for this device's submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the text. For SpO2 accuracy studies, arterial blood gas measurements (which serve as the ground truth) are typically verified by trained medical personnel, but details on the number or specific qualifications of such personnel are not present.
4. Adjudication Method for the Test Set
This information is not explicitly stated. Given that the ground truth for SpO2 accuracy is typically established through arterial blood gas measurements, an adjudication method in the traditional sense (e.g., for image interpretation) would not be directly applicable. The accuracy of the blood gas measurements themselves would follow established laboratory protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not performed. This type of study is more common for diagnostic imaging AI, where human readers interpret medical images. The 740 SafeSAT is a physiological monitor, and its primary clinical validation focuses on the accuracy of its physiological measurements against a reference standard.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes. The clinical studies performed were standalone, meaning they evaluated the device's SpO2 measurement accuracy directly against blood testing (ground truth), not in conjunction with human interpretation or assistance. The device itself performs the measurement.
7. Type of Ground Truth Used
The ground truth used for the SpO2 accuracy studies was blood testing (specifically, arterial blood gas measurements are the de facto standard for this), as stated: "clinical studies were performed... to determine accuracy with respect to blood testing."
8. Sample Size for the Training Set
This information is not provided within the 510(k) summary. The summary focuses on the validation of the device, including its embedded SafeSAT SpO2 OEM technology. The training set would pertain to the development of the SafeSAT SpO2 OEM module's algorithms, which is manufactured by OSI Optoelectronics, not the final 740 SafeSAT device itself. Details on that development are outside the scope of this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. Similar to the training set sample size, the establishment of ground truth for training the SpO2 algorithms embedded within the SafeSAT OEM module would be part of the OEM's development process and is not detailed in this 510(k) summary for the integrating device.
§ 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).