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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the APO-8284 Fingertip Pulse Oximeter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (Predicate Device)	Reported Device Performance (APO-8284)
SpO2 Measuring Range	70%-99%	70%-99%
SpO2 Accuracy	80-99%: ±2%70-79%: ±3%	±2%
Pulse Rate Measuring Range	30-235bpm	30-250bpm
Pulse Rate Accuracy	±2 bpm (30-99 bpm)±2% (100-235 bpm)	±2 bpm (30-99 bpm)±2% (100-235 bpm)
Operation Temperature	5°C-40°C	5°C-40°C
Operation Humidity	15%~80%	<80%

Note: The document explicitly states the APO-8284's SpO2 accuracy as "±2%", which appears to imply it meets or exceeds the predicate's accuracy in both ranges. The SpO2 range is identical, and the pulse rate range and accuracy are either identical or slightly improved (wider range) for the APO-8284. The operation humidity range for the APO-8284 is stated as "<80%", which is broader than the predicate's "15%~80%".

Regarding the study proving the device meets acceptance criteria:

The provided document (510(k) Summary) is a submission for substantial equivalence, not a detailed clinical study report. It asserts that the device meets the performance criteria based on comparison to a predicate device and adherence to international standards. However, it does not provide specific details of a clinical study (like the nitty-gritty of participant recruitment, specific methods of SpO2 and pulse rate measurement against a gold standard, or data analysis) that would typically be described in a dedicated clinical trial report.

Instead, the submission relies on the following to support its claims of safety and effectiveness, and thus meeting acceptance criteria:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a sample size for a test set or its data provenance. It implies that "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness to the new devices," but it doesn't describe the test itself. This suggests that the "test" might refer to internal validation against technical specifications and established standards rather than a formal clinical study with a defined test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. No information is provided about experts establishing ground truth for a test set.

4. Adjudication Method:

Not applicable. No information is provided about an adjudication method for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it mention effect sizes of human readers with or without AI assistance. This device is a standalone oximeter, not an AI-assisted diagnostic tool for interpretation by human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, essentially. The device itself is a standalone measurement tool. While the information doesn't detail a specific "algorithm-only" study distinct from typical device performance testing, the validation of its SpO2 and pulse rate accuracy against established standards (ISO 9919:2005) is by definition a standalone performance assessment. The device functions automatically without human input for result generation.

7. Type of Ground Truth Used:

The document implies that the ground truth for performance assessment would be established by reference to a recognized standard for pulse oximeters: ISO 9919:2005: Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use. This standard typically involves comparing oximeter readings against a direct measurement of arterial oxygen saturation (e.g., co-oximetry of arterial blood samples) in carefully controlled studies (often hypoxia studies). However, the document does not explicitly detail how this was done for this specific device in its submitted "test."

8. Sample Size for the Training Set:

Not applicable. The document does not describe a training set because this is a traditional medical device (pulse oximeter) that uses established physical principles (light absorption at different wavelengths) to calculate SpO2 and pulse rate, rather than a machine learning or AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

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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

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5.0 Intended use

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.

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)

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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.

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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 pulserate(bpm) measurement	blood oxygenaturation(SpO2), and pulserate(bpm) measurement
Design priciple
Presentation or OTC	Presentation	Presentation
Contact material	Silica gel	Silica gel
SpO2 measuringrange	70%-99%	70%--99%
SpO2 Accuracy	±2%	80-99%: ±2%70-79%: ±3%
Pulse RateMeasuring Range	30-250bpm	30-235bpm
Pulse Rate Accuracy	± 2 bpm during the pulserate range of 30-99 bpmand 2% during the pulserate range of 100-235 bpm	± 2 bpm during the pulserate range of 30-99 bpmand 2% during the pulserate range of 100-235 bpm
OperationTemperature	5°C-40°C	5°C-40°C
Power Source	2*AAA batteries	2*AAA or rechargeablebatteries
Operation Humidity	<80%	15%~80%
Other function	low battery voltage alarm:automatically power off	low battery voltage alarm:automatically power off

As a result, APO-8284 is very similar with its predicate device in the intended use, the design principle, the material, the performance and the applicable standards. Only their appearance, the power source, the pulse rate range and the operation humidity range are a little bit different. However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness to the new devices.

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Image /page/4/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Andon Health Company, Limited Mr. Liu Yi President Number 3, Jin Ping Street, Ya An Road Nankai District Tianjin, China 300190

Re: K121697

Trade/Device Name: APO-8284 Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 13, 2012 Received: September 13, 2012

Dear Mr. Yi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Mr. Yi

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Antmon D. N.

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

510(k) Number :

Device name: APO-8284 Fingertip Pulse Oximeter

Indications for use:

Prescription use Over-The-Counter Use ア AND/OR Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

y. Adultho

esthesiology, General Hospital

) Number: 1421697

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Regulation Number and Section

§ 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).