(239 days)
The Fingertip Pulse Oximeter (Wireless) are intended for measuring function of arterial hemoglobin (SpO2) and pulse rate for both adults and adolescent as non-invasive spot checking in home and professional caring environment. It is designed for fingers between 0.8cm and 2.3cm (0.3 inches) and for patients during nomotion condition.
The main function of the Fingertip Pulse Oximeter (Wireless) is to measure the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate as non-invasive spot checking monitoring. The subject determines the functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption of red and infrared light passing through perfused tissue. Changes in absorption caused by the pulsation of blood in the vascular bed are used to determine SpO2 reading and pulse rate. The characteristic of the device is a stand-alone device with 1 AAA Alkaline battery. It includes an OLED display screen and a warning or indicator function for abnormal readings. The Fingertip Pulse Oximeter (Wireless) is also built in with a Bluetooth low energy (BLE) function to perform data transmission.
The provided documentation is for a 510(k) premarket notification for the Leadtek Fingertip Pulse Oximeter (Wireless). It establishes substantial equivalence to a predicate device (K193350) and does not present detailed new clinical study data for the subject device beyond referencing the predicate. Therefore, some of the requested information cannot be fully provided from the given document as it refers to the predicate device's clinical testing.
Here's a breakdown of the requested information based on the provided text, focusing on the subject device's demonstrated performance and criteria where available, and referencing the predicate device's clinical study for SpO2 accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| SpO2 Accuracy | Accuracy: 70% to 100% range ± 2% (as per predicate device, implying compliance with ISO 80601-2-61 requirements for pulse oximeters) | Algorithm accuracy for SpO2 is considered unchanged from the predicate device. The document states: "The laboratory evaluations for the performance of the subject device was conducted to ensure the modification do not change the performance that root-mean-square (Arms) value is less than 2% within the range 70% - 100%..." and "Accuracy: 70% to 100% range ± 2%, less than 70% unspecified." |
| Pulse Rate Accuracy | Accuracy: ± 1 bpm or ± 1%, whichever is greater (as per predicate device) | Unchanged from predicate device: "Accuracy: ± 1 bpm or ± 1%, whichever is greater" |
| Electrical Safety | Compliance with IEC 60601-1:2012, IEC 60601-1-11:2015, and ISO 80601-2-61:2011 | Complied with IEC 60601-1:2012, IEC 60601-1-11:2015, and ISO 80601-2-61:2011 (Laboratory tests performed) |
| EMC Testing | Compliance with IEC 60601-1-2:2014 | Complied with IEC 60601-1-2:2014 (Laboratory tests performed) |
| Biocompatibility | Compliance with ISO 10993-1:2009 (cytotoxicity, skin sensitization, skin irritation studies showing no potential risks) | Skin contacting materials are the same as the predicate (K193350) and passed cytotoxicity, skin sensitization, and skin irritation studies per ISO 10993-1:2009. |
| Software Verification & Validation | Compliance with FDA Guidance for the Content of the Premarket Submission for Software Contained in Medical Devices (Moderate level of concern) | Software verification and validation provided in compliance with FDA Guidance; deemed "moderate" level of concern. Tests support substantial equivalence. |
| Wireless Coexistence | Compliance with IEEE/ANSI C63.27:2009, AAM TIR69:2017, and FDA Guidance for Radio Frequency Wireless Technology in Medical Device. | Coexistence testing performed according to IEEE/ANSI C63.27:2009, AAM TIR69:2017, and FDA Guidance. Demonstrated ability to coexist with interfering networks (2.4 GHz ISM band) and BLE. |
| Non-clinical Performance | Root-mean-square (Arms) value less than 2% within the 70%-100% SpO2 range. | Confirmed that modifications did not change performance, with Arms value less than 2% within the 70%-100% range. |
2. Sample Size Used for the Test Set and the Data Provenance (e.g., country of origin of the data, retrospective or prospective)
For the SpO2 accuracy, the document explicitly states that no new clinical testing was performed for the subject device because its pulse oximetry algorithm and measuring technology are the same as the predicate device (K193350). Therefore, the clinical data refers to the predicate device's clearance.
The document does not provide the specific sample size, country of origin, or whether the study was retrospective or prospective for the predicate device's clinical test. It only states that "A clinical study was conducted on the predicate device for K193350 clearance to demonstrate the safety and performance."
For non-clinical performance and wireless coexistence, these were laboratory-based tests and not human clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. As the clinical study was for the predicate device and the details are not elaborated here, the specifics of ground truth establishment and expert qualifications are absent. Typically, for pulse oximeter accuracy studies, arterial blood gas measurements (co-oximetry) performed by trained medical personnel serve as the reference standard (ground truth).
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not provided in the document.
5. 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
This is not applicable. The device is a Fingertip Pulse Oximeter, which directly measures physiological parameters (SpO2 and pulse rate). It does not involve "human readers" interpreting images or data that would be enhanced by AI assistance in the way an MRMC study would assess. The "Wireless" aspect refers to data transmission, not AI-driven interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the core SpO2 and pulse rate measurement algorithm performs in a standalone manner. The device outputs direct measurements based on light absorption. The "Wireless" functionality is for data transmission, not for an AI algorithm interpreting the results for a human. The non-clinical performance testing validated the algorithm's accuracy (Arms value
§ 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).