IHEALTH FINGERTIP PULSE OXIMETER

K131111 · Andon Health Co, Ltd. · DQA · Sep 11, 2013 · Cardiovascular

Device Facts

• Record ID: K131111
• Device Name: IHEALTH FINGERTIP PULSE OXIMETER
• Applicant: Andon Health Co, Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended 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).

Device Story

Fingertip pulse oximeter; measures arterial SpO2 and pulse rate via non-invasive optical sensing. Device utilizes two LEDs (660 nm red, 880 nm infrared) and a photodiode; MCU calculates SpO2 ratio and pulse rate by isolating arterial absorption from other tissues. Used in home and hospital environments by clinicians or patients for spot-checking; not for continuous monitoring. Data transmitted wirelessly to mobile devices (iPhone, iPod Touch, iPad). Provides digital display of results to user; assists healthcare providers in assessing patient oxygenation status. Powered by Lithium-ion battery.

Clinical Evidence

Bench testing only. Device performance verified against ISO 80601-2-61:2011. Biocompatibility testing performed per ISO 10993-1, -5, and -10. Electrical safety and electromagnetic compatibility verified per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Non-invasive optical pulse oximeter; red (660 nm) and infrared (880 nm) LEDs; photodiode sensor. Materials: silica gel (patient contact). Power: 330mAh Lithium-ion battery. Connectivity: wireless data transmission to mobile devices. Standards: ISO 80601-2-61, IEC 60601-1, IEC 60601-1-2, ISO 10993. SpO2 range 70-99% (±2% accuracy); pulse rate 30-250 bpm (±2 bpm or 2% accuracy).

Indications for Use

Indicated for adult patients in home and hospital settings for non-invasive spot-checking of functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate.

Regulatory Classification

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.

Predicate Devices

• APO-8284 Fingertip Pulse Oximeter (K121697)

Submission Summary (Full Text)

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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 �

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).

#### 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.

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.

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 device<br>APO-8284 (K121697) |
| Intended use | The PO3M Wireless Pulse<br>Oximeter is a non-invasive<br>device intended for<br>spot-checking of functional<br>oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse<br>rate. The portable fingertip<br>device is indicated for adult<br>patients in home and hospital<br>environments (including | The APO-8284 Fingertip Pulse<br>Oximeter is a non-invasive<br>device intended for<br>spot-checking of functional<br>oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse<br>rate. The portable fingertip<br>device is indicated for adult<br>patients in home and hospital<br>environments (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 measuring<br>range | 70%-99% | 70%-99% |
| | | |
| SpO2 Accuracy | $\pm$ 2% | $\pm$ 2% |
| Pulse Rate<br>Measuring Range | 30-250bpm | 30-250bpm |
| | | |
| Pulse Rate Accuracy | $\pm$ 2 bpm during the pulse<br>rate range of 30-99 bpm<br>and 2% during the pulse<br>rate range of 100-250 bpm | $\pm$ 2 bpm during the pulse<br>rate range of 30-99 bpm<br>and 2% during the pulse<br>rate range of 100-250 bpm |
| Operation<br>Temperature | 5°C-40°C | 5°C-40°C |
| | | |
| Power Source | 330mAh Lithium-ion<br>battery | 2*AAA or rechargeable<br>batteries |
| | | |
| Operation Humidity | <80% | <80% |
| Other function | low battery voltage alarm:<br>automatically power off | low battery voltage alarm:<br>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 [phone] or [phone] 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 [phone] or [phone] 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