K Number
K131111
Device Name
IHEALTH FINGERTIP PULSE OXIMETER
Date Cleared
2013-09-11

(145 days)

Product Code
Regulation Number
870.2700
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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).
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.
More Information

Not Found

No
The description details standard pulse oximetry technology based on light absorption ratios and does not mention any AI or ML components for data processing or interpretation.

No
A therapeutic device is used to treat a disease or condition. This device, a pulse oximeter, is a diagnostic device used for measurement and monitoring, not for treatment.

Yes

This device is a diagnostic device because it measures and displays physiological parameters (functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate) which can be used to assess a patient's health status. The "Intended Use / Indications for Use" section explicitly states its purpose is for "spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which are diagnostic measurements.

No

The device description clearly outlines hardware components like LEDs, a photodiode, an MCU, and a battery, indicating it is a physical device with embedded software, not a software-only medical device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
  • Device Function: The PO3M Fingertip Pulse Oximeter is a non-invasive device that measures oxygen saturation and pulse rate directly from the fingertip. It does not analyze samples taken from the body.
  • Intended Use: The intended use describes a non-invasive measurement of physiological parameters.

Therefore, while it is a medical device, it falls under a different regulatory category than In Vitro Diagnostics.

N/A

Intended Use / Indications for 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).

Product codes (comma separated list FDA assigned to the subject device)

DQA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

fingertip

Indicated Patient Age Range

adult patients

Intended User / Care Setting

Home and hospital environments (clinical use in internist/surgery, anesthesia, intensive care, etc).

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

(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
The device was tested according to IEC 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.

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 100-250 bpm

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K121697

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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

1

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)

2

Technological CharacteristicsComparison result
Design principleIdentical
AppearanceSimilar
Patients contact MaterialsIdentical
PerformanceIdentical
BiocompatibilityIdentical
Mechanical safetyIdentical
Energy sourceIdentical
Standards metIdentical
Electrical safetyIdentical
EMCIdentical
FunctionSimilar

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

3

(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
CharacteristicsSubject device PO3MPredicate device
APO-8284 (K121697)
Intended useThe 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 (includingThe 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

4

clinical use in internist/surgery,clinical use in internist/surgery,
anesthesia, intensive care,anesthesia, intensive care,
etc). The PO3M Wirelessetc). The APO-8284 Fingertip
Pulse oximeter is not intendedPulse oximeter is not intended
for continuous monitoring.for continuous monitoring.
Design principleSee section 6See section 6
Presentation or OTCPresentationPresentation
Contact materialSilica gelSilica gel
SpO2 measuring
range70%-99%70%-99%
SpO2 Accuracy$\pm$ 2%$\pm$ 2%
Pulse Rate
Measuring Range30-250bpm30-250bpm
Pulse Rate Accuracy$\pm$ 2 bpm during the pulse
rate range of 30-99 bpm
and 2% during the pulse
rate range of 100-250 bpm$\pm$ 2 bpm during the pulse
rate range of 30-99 bpm
and 2% during the pulse
rate range of 100-250 bpm
Operation
Temperature5°C-40°C5°C-40°C
Power Source330mAh Lithium-ion
battery2*AAA or rechargeable
batteries
Operation Humidity