The PO3M 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).

Device Description

Our device PO3M 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.

The power source is Lithium-ion battery.

More over, the PO3M can transmit the measurement data to the iPhone, iPod Touch or iPad by wireless transmission.

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
SpO2 measuring range: 70-99%	SpO2 measuring range: 70-99%
SpO2 Accuracy: ± 2%	SpO2 Accuracy: ± 2%
Pulse Rate Measuring Range: 30-250 bpm	Pulse Rate Measuring Range: 30-250 bpm
Pulse Rate Accuracy: ± 2 bpm (30-99 bpm)	Pulse Rate Accuracy: ± 2 bpm (30-99 bpm)
Pulse Rate Accuracy: ± 2% (100-250 bpm)	Pulse Rate Accuracy: ± 2% (100-250 bpm)

2. Sample Size and Data Provenance

The document does not specify the sample size used for performance testing (e.g., test set for SpO2 and Pulse Rate accuracy). It states that the device was tested according to ISO 80601-2-61:2011, which likely involves human subject testing with controlled hypoxia. However, details of the number of subjects and their characteristics are not provided in this summary.

The provenance of the data (e.g., country of origin, retrospective or prospective) is not explicitly stated.

3. Number and Qualifications of Experts for Ground Truth

This information is not provided in the document. For pulse oximetry, the ground truth for SpO2 accuracy is typically established by arterial blood gas analysis, which does not require expert adjudication in the same way imaging studies might.

4. Adjudication Method

This information is not applicable and therefore not provided, as the ground truth for pulse oximetry accuracy is derived from direct physiological measurements (e.g., arterial blood gas analysis) rather than subjective expert interpretation requiring adjudication.

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

No MRMC comparative effectiveness study was done, as this type of study is typically performed for diagnostic imaging devices where human interpretation is a key component. This device is a direct measurement device (pulse oximeter), not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done for the device's main function. The performance testing section (4. Performance Testing) indicates that the "device was tested according to ISO 80601-2-61: 2011" and found to meet all applicable requirements. This standard specifies requirements for pulse oximeter equipment, including accuracy measurements against a reference standard. The reported accuracy metrics for SpO2 and pulse rate are based on the device's direct measurements.

7. Type of Ground Truth Used

The ground truth used for performance assessment (SpO2 and pulse rate accuracy) is based on direct comparison to a reference method, typically arterial blood gas analysis for oxygen saturation. The ISO 80601-2-61 standard outlines these methods.

8. Sample Size for the Training Set

This information is not provided. Pulse oximeters are typically based on well-established physical principles of light absorption by hemoglobin, and their algorithms are often derived from theoretical models and empirical calibrations rather than extensive machine learning training sets in the modern sense. If any machine learning or adaptive algorithms are used, the training set details are not disclosed in this summary.

9. How the Ground Truth for the Training Set was Established

This information is not provided. As mentioned above, the underlying principles of pulse oximetry are generally not based on "training sets" in the context of supervised machine learning. If any calibration or algorithm development involved data, the method for establishing its ground truth is not detailed here.

Summary

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Attachment 3

510(k) Summary

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:	04/08/2013

SEP 1 1 2013## 2.0 Device name

Device name:

iHealth PO3M Fingertip Pulse Oximeter

3.0 Classification

Production code:	DQA - Oximeter
Regulation number:	870.2700
Classification:	II
Panel:	Cardiovascular

4.0 Predicate device information

Manufacturer: Andon Health Co., Ltd. APO-8284 Fingertip Pulse Oximeter Device: 510(k) number: K121697

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5.0 Intended use �

6.0 Device description

Our device PO3M 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.

The power source is Lithium-ion battery.

More over, the PO3M can transmit the measurement data to the iPhone, iPod Touch or iPad by wireless transmission.

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 PO3M Fingertip Pulse Oximeter, as described in the labeling are the same as their predicated device APO-8284 Fingertip Pulse Oximeter (K121697)

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Technological Characteristics	Comparison result
Design principle	Identical
Appearance	Similar
Patients contact Materials	Identical
Performance	Identical
Biocompatibility	Identical
Mechanical safety	Identical
Energy source	Identical
Standards met	Identical
Electrical safety	Identical
EMC	Identical
Function	Similar

7.0 Summary comparing technological characteristics with predicate device

8.0 Non-clinical Testing Summary

The following testing was performed on the iHealth PO3M Fingertip Pulse Oximeter in accordance with the requirements of the design control regulations and established quality assurance procedures.

(1) Biocompatibility of materials

Materials used on the new device PO3M that contact with the patient is exactly the same as the predicate device APO-8284(K121697). Because the material only contact with the user's intact skin within 24 hours, so according to ISO 10993-1, the cytotoxicity, sensitization, and irritaion testing have been performed on the final finished device material according to the following standards, and found to meet the applicable requirements:

ISO 10993-1: 2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

ISO 10993-5: 2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity

ISO 10993-10: 2002/Amd. 1:2006(E), Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity AMENDMENT 1

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(2) Electromagnetic Compatibilitv

The device was tested according to IEC 60601-1-2, and also conform to the requirements set in ISO 80601-2-61, Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment. The test result show that, the device meet all the applicable requirements.

(3) Electrical Safety Testing

was tested according to to IEC The device 60601-1: 2005+ CORR.1(2006)+CORR.2(2007), and IEC 60601-1-11:2010, and also conform to the requirements set in ISO 80601-2-61, Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment. The test result show that, the device meet all the applicable requirements.

(4) Performance Testing

The device was tested according to ISO 80601-2-61: 2011-Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment. And found the device meet all the applicable requirements.

9.0 Comparison to the predicate device and the conclusion

The applicant device Fingertip Pulse Oximeter is substantially equivalent to PO3M Fingertip Pulse Oximeter whose 510(k) number is K121697.

Similarities and differences comparision
Characteristics	Subject device PO3M	Predicate deviceAPO-8284 (K121697)
Intended use	The PO3M Wireless PulseOximeter is a non-invasivedevice intended forspot-checking of functionaloxygen saturation of arterialhemoglobin (SpO2) and pulserate. The portable fingertipdevice is indicated for adultpatients in home and hospitalenvironments (including	The APO-8284 Fingertip PulseOximeter is a non-invasivedevice intended forspot-checking of functionaloxygen saturation of arterialhemoglobin (SpO2) and pulserate. The portable fingertipdevice is indicated for adultpatients in home and hospitalenvironments (including

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	clinical use in internist/surgery,	clinical use in internist/surgery,
	anesthesia, intensive care,	anesthesia, intensive care,
	etc). The PO3M Wireless	etc). The APO-8284 Fingertip
	Pulse oximeter is not intended	Pulse oximeter is not intended
	for continuous monitoring.	for continuous monitoring.
Design principle	See section 6	See section 6
Presentation or OTC	Presentation	Presentation
Contact material	Silica gel	Silica gel
SpO2 measuringrange	70%-99%	70%-99%

SpO2 Accuracy	$\pm$ 2%	$\pm$ 2%
Pulse RateMeasuring Range	30-250bpm	30-250bpm

Pulse Rate Accuracy	$\pm$ 2 bpm during the pulserate range of 30-99 bpmand 2% during the pulserate range of 100-250 bpm	$\pm$ 2 bpm during the pulserate range of 30-99 bpmand 2% during the pulserate range of 100-250 bpm
OperationTemperature	5°C-40°C	5°C-40°C

Power Source	330mAh Lithium-ionbattery	2*AAA or rechargeablebatteries

Operation Humidity	<80%	<80%
Other function	low battery voltage alarm:automatically power off	low battery voltage alarm:automatically power off

As a result, PO3M 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 and the wireless data transmission function are 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.

ર- 5

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

September 11, 2013

Andon Health Co., Ltd. Liu Yi, President #3, Jin Ping St. Ya An Rd. Nankai District Tianjin, China 300190

Re: K131111

Trade/Device Name: iHealth PO3M Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: August 8, 2013 Received: August 12, 2013

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 - Liu Yu

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.html 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.lda.gov/MedicalDevices/Safety/Reportal/roblem/default.htm for the CDRH's Office of Surveillance and Biometries/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/Resourcesfor You/Industry/default.html.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID

FOR

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, 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

K131111 510(k) Number :

Device name: iHealth PO3M Fingertip Pulse Oximeter

Indications for use:

The PO3M Wireless 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).

Prescription use 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)

Lester W. Schultheis Jr 2013.09.10 15:38:01 -04'00'

(Division Sign-Off) Page I of I l Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices 510(k) Number: _K131111 ______________________________________________________________________________________________________________________________________________________ _4-1

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).