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510(k) Data Aggregation
(207 days)
The AViTA Pulse Oximeter is intended for spot check monitoring of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adults, adolescents and child in home and professional healthcare facility settings. It is designed for fingers between 0.8cm and 2.3cm (0.3 inches ~0.9 inches) and intended for use during no-motion condition. The device is prescription only
The AViTA Pulse Oximeter is a non-invasive, prescription-use medical device intended for spot-check monitoring measurement of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate in adult, adolescent, and child users in home and professional healthcare environment settings.
The device operates using spectrophotometry by emitting red and infrared light through a pulsatile vascular bed, such as a fingertip, and detecting the light transmitted through the tissue to determine the relative concentrations of oxygenated and deoxygenated hemoglobin.
The device is designed for use on fingers with a thickness range of approximately 0.8 cm to 2.3 cm (0.3 inches to 0.9 inches) and is intended for use under no-motion conditions. The device is intended for spot-check measurements only and is not intended for continuous monitoring.
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(167 days)
YUWELL® Finger Pulse Oximeters are non-invasive, non-sterile, reusable, and spot-checking devices that measure and display SpO₂ and pulse rate (PR) via the patient's finger. They are indicated for use in adults and children (weight > 30 kg) and are intended for professional and home settings. These devices are unsuitable for continuous monitoring, use during motion, or in patients with low perfusion.
YUWELL® Finger Pulse Oximeter (the Oximeter) is a finger pulse oximeter designed to measure functional oxygen saturation (SpO₂) of arterial hemoglobin and pulse rate (PR) in adults and children (weight > 30 kg). The device operates by detecting changes in light absorption caused by blood pulsation in the vascular bed, which are used to determine SpO₂ and PR. It contains light-emitting diodes (LEDs) and a photodetector, with the photodetector positioned on the opposite side of the probe from the LEDs. SpO₂ and PR are displayed on the device's LED/OLED screen, providing a visual pulse indicator that blinks in sync with the detected PR.
The Oximeter is powered by two AAA alkaline batteries and does not feature alarms. The YX310 and YX110 models can transfer data to a mobile device wirelessly whereas the YX105 and YX106 models do not transfer data.
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(105 days)
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(193 days)
YKD SpO2 sensor (Models: CSS032D) is indicated for continuous non-invasive monitoring of arterial hemoglobin oxygen saturation (SpO2) and pulse rate (PR) in adult patients (>40kg) within medical institutions. It is for fingertip use only and prohibited in emergency medical transport, home care, long-term monitoring, mobile patients, motion, and low perfusion conditions.
The SpO2 sensor consist of a probe attached to the patient's finger. The sensor shall be connected to its corresponding pulse oximeter monitor with a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions. Oxygenation of blood is measured by detecting the infrared and red light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).
As an accessory of the legally marketed oximeters or patient monitors in the United States, the proposed device SpO2 Sensor is intended for hospital use and continuous monitoring of functional arterial oxygen saturation and pulse rate.
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(182 days)
Unimed Reusable SpO₂ Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (PR) in adult patients weighing greater than 30 kg who are either well or poorly perfused, when applied to the finger. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only.
The subject devices are Unimed Reusable SpO2 Sensors intended for non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in clinical settings. The sensors are designed for compatibility with Mindray M12, and are supplied non-sterile.
Each sensor consists of a connector, a cable, and a reusable patient-contacting sensor element incorporating a light-emitting diode (LED) and photodetector (PD). The sensors are available in finger clip type.
The subject devices operate on the same principle and share similar design features, materials, and performance characteristics as the predicate device.
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(182 days)
Unimed Reusable SpO₂ Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (PR) in adult patients weighing greater than 30 kg who are either well or poorly perfused, when applied to the finger. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only.
The subject devices are Unimed Reusable SpO2 Sensors intended for non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in clinical settings. The sensors are designed for compatibility with Nonin 9847, and are supplied non-sterile.
Each sensor consists of a connector, a cable, and a reusable patient-contacting sensor element incorporating a light-emitting diode (LED) and photodetector (PD). The sensors are available in multiple configurations, including finger clip, wrap, and soft-tip types, to accommodate various patient needs and anatomical sites.
The subject devices operate on the same principle and share similar design features, materials, and performance characteristics as the predicate device.
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(169 days)
Unimed Reusable SpO2 Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in adult patients weighing greater than 30 kg who are either well or poorly perfused. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only.
The subject device is Unimed Reusable SpO2 Sensors intended for non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in clinical settings. The sensor is designed for compatibility with CSI 8100EP1, and is supplied non-sterile.
The sensor consists of a connector, a cable, and a finger clip housing incorporating a light-emitting diode (LED) and photodetector (PD). The subject device operates on the same principle and share similar design features, materials, and performance characteristics as the predicate device.
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(169 days)
Unimed Reusable SpO2 Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in adult patients weighing greater than 30 kg who are either well or poorly perfused. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only.
The subject device (U403S-06) is Unimed Reusable SpO2 Sensor and are fully compatible for use with BCI SPECTRO2 10. The sensor is supplied non-sterile.
The subject sensor consists of a plug/connector (BCI DB9 sensor connector), a cable (1.1 m), and a patient-contacting sensor (soft tip: U403S-06) where light-emitting diode (LED) and photodetector (PD) are located. The subject sensor shares the same principle of operation as the predicate device for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Also, the subject sensor has identical material composition and performance characteristics to the predicate device.
The purpose of the submission is to receive clearance to market U403S-06 under their own 510k.
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(189 days)
The Pulse Oximeter is intended for spot-checking in measuring and displaying functional arterial hemoglobin (SpO2) and pulse rate. It is intended for adult, adolescent, child users in hospitals, hospital facilities and home healthcare environments.
The Pulse Oximeter model BM20, can display the SpO2 and PR, plethysmogram wave and other indication parameters, such as pulse battery power status and the PI. The model BM20 Pulse Oximeter include the mainboard, display and lithium battery. It has small size, light weight, easy to carry. It adopts low power consumption design, and has the function of battery capacity display.
The pulse oximeter, model BM20, is designed for spot checking of the pulse oxygen saturation and pulse rate for adults, pediatric and adolescent patients in professional healthcare facility or home conditions when physician follow-up and operated by a physician. And it is not intended to be used under motion or low perfusion scenarios. This medical device can be reused. Not for continuously monitoring.
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(138 days)
Unimed Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 30 kg and pediatric patients weighing 10-50 kg. These devices are for prescription use only.
The subject devices are Unimed Reusable SpO2 Sensors intended for non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in clinical settings. The sensors are designed for compatibility with GE B40i, and are supplied non-sterile.
Each sensor consists of a connector, a cable, and a reusable patient-contacting sensor element incorporating a light-emitting diode (LED) and photodetector (PD). The sensors are available in multiple configurations, including finger clip, wrap, and soft-tip types, to accommodate various patient needs and anatomical sites.
The subject devices operate on the same principle and share similar design features, materials, and performance characteristics as the predicate device.
Here's a breakdown of the acceptance criteria and the study details for the Unimed Reusable SpO2 Sensors, based on the provided FDA 510(k) clearance letter:
Acceptance Criteria and Device Performance
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Saturation Accuracy, No Motion (70-100%) | ±3% | ±3% |
| Pulse Rate Accuracy, No Motion | ±2 bpm (30-250 bpm) | ±2 bpm (30-250 bpm) |
| Biocompatibility | Pass ISO 10993 cytotoxicity, skin irritation, and skin sensitivity tests | Pass ISO 10993 cytotoxicity, skin irritation, and skin sensitivity tests |
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size: Twelve human adult volunteers were enrolled for the clinical study. The study contains more than the minimum 200 data points.
- Data Provenance: The study was conducted on human adult volunteers and includes sufficient darkly pigmented subjects (three dark subjects with Fitzpatrick Type 5-6). It is a prospective clinical study. The country of origin is not explicitly stated but implies testing in a controlled clinical environment, likely linked to the manufacturer's location or a designated clinical trial site.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies that arterial oxygen saturation (SaO2) as determined by co-oximetry was used as the ground truth. This is a direct measurement from blood samples. Therefore, typical "experts" in the sense of human readers adjudicating images are not applicable here. The accuracy of co-oximetry itself is the standard.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The ground truth (SaO2 by co-oximetry) is a direct, objective measurement, not subject to human interpretation or adjudication in the same way as an imaging study.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a sensor (hardware) for SpO2 and pulse rate measurement, not an AI-assisted diagnostic tool or an imaging system that would involve human reader interpretation. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a sensor that measures physiological parameters. Its performance is inherent to its design and function, not an algorithm's performance. The "clinical test data" section describes the validation of the sensor's accuracy in vivo.
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The type of ground truth used:
- Arterial oxygen saturation (SaO2) as determined by co-oximetry. This is an objective "gold standard" for blood oxygen measurement.
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The sample size for the training set:
- Not applicable. This device is a hardware sensor, not a machine learning model that requires a training set. The clinical study described is for validation/testing, not training.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
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