(244 days)
The Shenzhen Med-Linket™ Adult SpO2 Finger Sensor is indicated for use in continuous, non-invasive arterial oxygen saturation and pulse rate monitoring.
Model S0044D-S (S0012A) is reusable and for patients weighing more than 40 kg.
The Shenzhen Med-Linket™ Adult SpO2 Finger Sensor is contraindicated for use on active patients, or during conditions of motion or low perfusion.
Shenzhen Med-Linket™ Adult SpO2 Finger Sensors (Med-Linket Sensors) are compatible sensors for use with major brands of patient monitors and oximeter devices.
Med-Linket Sensors are electro-optical sensors which function without skin penetration, electrical contact, or heat transfer. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the patient monitor or oximeter device. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The LED and photodiode are contained in silicon rubber pads.
Acceptance Criteria and Study for Shenzhen Med-Linket™ Adult SpO2 Finger Sensors
As per the provided 510(k) summary, the Shenzhen Med-Linket™ Adult SpO2 Finger Sensors (Model S0044D-S) underwent various performance tests to demonstrate substantial equivalence to predicate devices. The primary focus for demonstrating clinical performance was on pulse rate accuracy and SpO2 accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pulse Rate Accuracy | Meets specifications defined in ISO 9919: 2005, Medical electrical equipment — Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use. | "Test results indicated that the sensors meet the published specifications for pulse rate accuracy over the specified range." (Specific numerical criteria of ISO 9919:2005 not provided in the document for direct comparison, but compliance is stated). |
| Clinical (SpO2 Accuracy) | Meets published specifications for accuracy over the specified range (as determined by comparison to co-oximetry under controlled hypoxia). | "Test results indicated that the sensors meet the published specifications for accuracy over the specified range." (Specific numerical accuracy criteria not provided, but compliance is stated). This implies that the bias and precision within the specified SpO2 range met pre-defined limits typical for pulse oximeters, such as an Arms (Accuracy Root Mean Square) value below a certain threshold (e.g., 2-3% SpO2). |
| Biocompatibility | Patient contact materials are non-toxic, non-sensitizing, and non-irritating, in accordance with ISO 10993-1: 2003. | "Test results indicated that the patient contact materials were non-toxic, non-sensitizing and non-irritating." |
| Electrical Safety | Complies with applicable clauses of IEC 60601-1:1988; Am1: 1991; A2: 1995 and ISO 9919: 2005. | "Test results indicated that the sensors comply with the applicable clauses of the Standards." |
| Electromagnetic Compatibility | Complies with applicable clauses of IEC 60601-1-2:2001. | "Test results indicated that the sensors comply with the applicable clauses of the Standard." |
| Cleaning | Cleaning instructions do not damage sensor labeling, degrade materials, and sensors remain functional after cleaning. | "Test results indicated that the cleaning instructions do not damage sensor labeling, degrade materials, and that the sensors remain functional after cleaning." |
| Excessive Temperature | Sensors do not exceed 41°C at the sensor-tissue interface at an ambient temperature of 35°C, in accordance with ISO 9919: 2005. | "Test results indicated that the sensors do not exceed 41°C at the sensor-tissue interface at an ambient temperature of 35°C." |
| Environmental | Operative and storage temperatures, and random vibration do not damage sensor functionality (tested in accordance with internal protocols). | "Test results indicated that the operative and storage temperatures, and random vibration do not damage sensor functionality." |
2. Sample Size for the Test Set and Data Provenance
The document does not specify the exact sample size (number of subjects/patients) used for the clinical performance testing related to SpO2 accuracy. However, it states that "All testing was performed under an institutionally approved protocol with subject informed consent." This indicates a prospective study involving human subjects. The country of origin for the clinical data is not explicitly stated.
For other performance tests like biocompatibility, electrical safety, etc., the "sample size" would refer to the number of devices or material samples tested, which is not detailed in the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The clinical ground truth for oxygen saturation (SpO2) was established using co-oximetry, which is an objective measurement from arterial blood samples, not through expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. The ground truth for clinical SpO2 accuracy was established by co-oximetry, which is an objective measurement and does not require an adjudication method among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a sensor component for a pulse oximeter, which provides direct physiological measurements (SpO2 and pulse rate), rather than an interpretive system requiring human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the performance testing for SpO2 and pulse rate accuracy evaluates the standalone performance of the sensor in conjunction with a patient monitor/oximeter device. The clinical testing conducted under controlled hypoxia directly assesses the sensor's ability to accurately measure physiological parameters without human interpretation in the loop.
7. The Type of Ground Truth Used
For SpO2 accuracy, the ground truth used was arterial oxygen saturation as determined by co-oximetry. This is considered the gold standard for measuring oxygen saturation in blood. The study involved "controlled hypoxia," where subjects' oxygen levels were intentionally lowered to create a range of SpO2 values that the device would be challenged to measure accurately.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware sensor, not a machine learning or AI-driven system that requires a "training set" for algorithm development. Its functionality is based on established electro-optical principles for pulse oximetry.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).