(130 days)
Not Found
No
The description details a standard pulse oximetry technology based on light absorption ratios and does not mention any AI/ML components or algorithms.
No.
The device is for spot-checking oxygen saturation and pulse rate, which are diagnostic measurements, not therapeutic interventions.
Yes
Explanation: The device measures and displays functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, which are physiological parameters used to assess a patient's health status. This falls under the definition of a diagnostic device as it provides information about the state of the body.
No
The device description explicitly states it is a "fingertip device" with "small light-emitting diodes (LEDs) facing a photodiode through a fingertip" and is powered by "2 × AAA batteries," indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the APO-8284 Fingertip Pulse Oximeter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to measure functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate non-invasively through a fingertip. This is a measurement taken directly from the patient's body, not from a sample of biological material in vitro (outside the body).
- Device Description: The device works by emitting light through the fingertip and measuring the absorption. This is a physical measurement technique applied to the living tissue.
- Lack of mention of biological samples: The description does not mention the use of blood, urine, tissue, or any other biological sample that would be tested in vitro.
In Vitro Diagnostic devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The APO-8284 does not perform this function.
N/A
Intended Use / Indications for Use
The APO-8284 Fingertip Pulse Oximeter is a non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The portable fingertip device is indicated for adult patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care, etc). The APO-8284 Fingertip Pulse oximeter is not intended for continuous monitoring.
Product codes
DQA
Device Description
Our device APO-8284 Fingertip Pulse Oximeter is a fingertip device, which can measure the arterial SpO2 and pulse rate value and can display the results to the user.
It is a noninvasive measurement instrument with a pair of small light-emitting diodes (LEDs) facing a photodiode through a fingertip. One LED is red, with wavelength of 660 nm, and the other is infrared, 880 nm. The MCU calculates the ratio of these two wavelengths and get the results of the SPO2. At the same time, by examining only the varying part of the absorption spectrum, a monitor can ignore other tissues or nail, and discern only the absorption caused by arterial blood to detect the pulse rate.
More over, the APO-8284 also has the function of low battery voltage alarm and automatically power off. The power source is 2 × AAA batteries.
The device is for prescription. It is neither for life-supporting nor for implanting. lt does not contain any drug or biological product and it does not need to be sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
fingertip
Indicated Patient Age Range
adult patients
Intended User / Care Setting
The APO-8284 Fingertip Pulse Oximeter is a non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The portable fingertip device is indicated for adult patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care, etc).
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
APO-8284 Fingertip Pulse Oximeter conforms to the following standards:
- · IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
- · EN 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, 2007.
- · ISO 9919:2005: Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.
- · ISO 10993: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
- · ISO 10993: Biological evaluation of medical devices Part 5: Test for in vitro cytotoxicity.
- · ISO 10993: Biological evaluation of medical devices Part 10: Test for irritation and skin sensitization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 measuring range: 70%-99%
SpO2 Accuracy: ±2%
Pulse Rate Measuring Range: 30-250bpm
Pulse Rate Accuracy: ± 2 bpm during the pulse rate range of 30-99 bpm and 2% during the pulse rate range of 100-235 bpm
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) Summary
1 5 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.
1.0 submitter's information
| Name: | Andon Health Co., Ltd. |
|---|---|
| Address: | No 3, Jinping Street Ya An Road, Nankai District, Tianjin, |
| P.R. China | |
| Phone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: | 05/25/2012 |
2.0 Device name
Device name: APO-8284 Fingertip Pulse Oximeter
3.0 Classification
DQA - Oximeter Production code: Regulation number: 870.2700 Classification: II Panel: Cardiovascular
4.0 Predicate device information
Manufacturer: Beijing Choice Electronic Technology Co., Ltd.
MD300C1 Fingertip Pulse Oximeter Device:
510(k) number: K093757
5- I
1
5.0 Intended use
The APO-8284 Fingertip Pulse Oximeter is a non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The portable fingertip device is indicated for adult patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care, etc). The APO-8284 Fingertip Pulse oximeter is not intended for continuous monitoring.
6.0 Device description
Our device APO-8284 Fingertip Pulse Oximeter is a fingertip device, which can measure the arterial SpO2 and pulse rate value and can display the results to the user.
It is a noninvasive measurement instrument with a pair of small light-emitting diodes (LEDs) facing a photodiode through a fingertip. One LED is red, with wavelength of 660 nm, and the other is infrared, 880 nm. The MCU calculates the ratio of these two wavelengths and get the results of the SPO2. At the same time, by examining only the varying part of the absorption spectrum, a monitor can ignore other tissues or nail, and discern only the absorption caused by arterial blood to detect the pulse rate.
More over, the APO-8284 also has the function of low battery voltage alarm and automatically power off. The power source is 2 × AAA batteries.
The device is for prescription. It is neither for life-supporting nor for implanting. lt does not contain any drug or biological product and it does not need to be sterile.
The intended use and the indication for use of APO-8284 Fingertip Pulse Oximeter, as described in the labeling are the same as their predicated device MD300C1 Fingertip Pulse Oximeter (K093757)
2
7.0 Summary comparing technological characteristics with predicate
| device | |
|---|---|
| Technological Characteristics | Comparison result |
| Design principle | Identical |
| Appearance | Similar |
| Patients contact Materials | Identical |
| Performance | Similar |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Energy source | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| EMC | Identical |
| Function | Similar |
8.0 Performance summary
APO-8284 Fingertip Pulse Oximeter conforms to the following standards:
- · IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
- · EN 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, 2007.
- · ISO 9919:2005: Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.
- · ISO 10993: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
- · ISO 10993: Biological evaluation of medical devices Part 5: Test for in vitro cytotoxicity.
- · ISO 10993: Biological evaluation of medical devices Part 10: Test for irritation and skin sensitization.
3
9.0 Comparison to the predicate device and the conclusion
The applicant device APO-8284 Fingertip Pulse Oximeter is substantially equivalent to MD300C1 Fingertip Pulse Oximeter whose 510(k) number is K093757.
| Similarities and differences comparision | ||
|---|---|---|
| Characteristics | Subject device APO-8284 | Predicate device |
| (K093757) | ||
| Intended use | blood oxygen aturation | |
| (SpO2), and pulse | ||
| rate(bpm) measurement | blood oxygen | |
| aturation(SpO2), and pulse | ||
| rate(bpm) measurement | ||
| Design priciple | ||
| Presentation or OTC | Presentation | Presentation |
| Contact material | Silica gel | Silica gel |
| SpO2 measuring | ||
| range | 70%-99% | 70%--99% |
| SpO2 Accuracy | ±2% | 80-99%: ±2% |
| 70-79%: ±3% | ||
| Pulse Rate | ||
| Measuring Range | 30-250bpm | 30-235bpm |
| Pulse Rate Accuracy | ± 2 bpm during the pulse | |
| rate range of 30-99 bpm | ||
| and 2% during the pulse | ||
| rate range of 100-235 bpm | ± 2 bpm during the pulse | |
| rate range of 30-99 bpm | ||
| and 2% during the pulse | ||
| rate range of 100-235 bpm | ||
| Operation | ||
| Temperature | 5°C-40°C | 5°C-40°C |
| Power Source | 2*AAA batteries | 2*AAA or rechargeable |
| batteries | ||
| Operation Humidity |