PULSE OXIMETER

K141105 · Hunan Accurate Bio-Medical Technology Co., Ltd. · DQA · Dec 4, 2014 · Cardiovascular

Device Facts

• Record ID: K141105
• Device Name: PULSE OXIMETER
• Applicant: Hunan Accurate Bio-Medical Technology Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Dec 4, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Indications for Use

The Pulse Oximeter FS10A and FS20A are portable, non-invasive devices intended for spot check monitoring of arterial hemoglobin oxygen saturation (SpO2) and pulse rate of adult patients (weighing ≥ 30 kg) in hospitals.

Device Story

Fingertip pulse oximeter; uses dual-wavelength LED (660nm red, 906nm infrared) and photodetector to measure light absorption in pulsating arteriolar vascular bed; calculates SpO2 and pulse rate based on light intensity ratios during systole/diastole; powered by 2 AAA batteries; features auto-power-off after 8 seconds of no signal; used by clinicians for spot checks in hospitals; provides real-time SpO2 and pulse rate values on LED/OLED display; aids in non-invasive patient assessment.

Clinical Evidence

Clinical testing conducted on model FS20A per ISO 80601-2-61:2011 Annex EE.2 (invasive laboratory testing). Results demonstrated SpO2 accuracy (Arms) < 2%. Testing covered both models due to shared sensor, algorithm, and module.

Technological Characteristics

Materials: ABS+PC/PMMA enclosure, medical silicone gel fingertip cushion. Sensing: Dual-wavelength LED (660nm/906nm) and photodetector. Power: 2 AAA batteries. Connectivity: Standalone. Standards: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61, ISO 10993-1/5/10.

Indications for Use

Indicated for spot check monitoring of SpO2 and pulse rate in adult patients (≥ 30 kg) in hospital settings.

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

• MD300C1, MD300C2 Fingertip pulse Oximeter (K130947)

Submission Summary (Full Text)

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

December 4, 2014

Hunan Accurate Bio-Medical Technology Company Limited Mr. Li Zhang Quality Manager M8-613, No. 8, Lutian Road Changsha National Hi-Tech Industrial Development Zone Changsha, Hunan 410205 CHINA

Re: K141105 Trade/Device Name: Pulse Oximeter, Model FS10A and FS20A Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: November 5, 2014 Received: November 5, 2014

Dear Mr. Zhang:

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. Zhang

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/Industry/default.htm. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K141105

Device Name

Pulse Oximeter

Indications for Use (Describe)

The Pulse Oximeter FS10A and FS20A are portable, non-invasive devices intended for spot check monitoring of arterial hemoglobin oxygen saturation (SpO2) and pulse rate of adult patients (weighing ≥ 30 kg) in hospitals.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## Section 6 - 510(k) Summary

Date of Summary Preparation: 12/04/2014

#### 1. Submitter's Identifications

Submitter's Name: Hunan Accurate Bio-Medical Technology Co., Ltd. Address: M8-613, No.8, Lutian Road, Changsha National Hi-Tech Industrial Development Zone, Changsha, Hunan Province, P.R. China Contact Person: Li Zhang Contact Email Address: Email: [e-mail] Telephone: [phone] Fax: [phone]

#### 2. Correspondent's Identifications

Submitter's Name: Hunan Accurate Bio-Medical Technology Co., Ltd. Address: M8-613, No.8, Lutian Road, Changsha National Hi-Tech Industrial Development Zone, Changsha, Hunan Province, P.R. China Contact Person: Li Zhang Contact Email Address: [e-mail] Telephone: [phone] Fax: [phone]. Name of the Device Device Classification Name: Oximeter

Product Name: Pulse Oximeter Trade Name: Pulse Oximeter Model: FS10A,FS20A Classification Panel: Cardiovascular Product Code: DQA Device Classification: Class II

#### 4. The Predicate Devices

K139047. MD300C1,MD300C2 Fingertip pulse Oximeter 21 CFR 870.2700

#### 5. Device Description

The proposed devices of Pulse Oximeter FS10A, FS20A are fingertip devices, which can display SpO2 and pulse rate value. The proposed devices consist of detector and emitter LED, CPU, display unit and power unit.

The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a

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dual light source and photo detector. The wavelength of one light source is 660 nm, which is red light; the other is 906nm, which is infrared light.

Skin, bone, tissue, and venous vessels normally absorb a constant amount of light overtime. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.

The power sources of the proposed devices are 2 AAA alkaline batteries. All of the proposed devices have low battery voltage indicator function and all of the proposed devices will automatically power off when there is no signal for longer than 8 seconds.

The proposed devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization. The devices are for prescription. The devices do not contain drug or biological products.

The Pulse Oximeters FS10A,FS20A share the same measurement principle and oximeter sensor and oxygen saturation module and power supply. The indented target population and use environment of the Pulse Oximeters FS10A, FS20A are the same.

The devices are software-driven and the software validation is provided in Section of Software.

## 6. Intended Use of Device

The Pulse Oximeter FS10A and FS20A are portable, non-invasive devices intended for spot check monitoring of arterial hemoglobin oxygen saturation (SpO2) and pulse rate of adult patients (weighing ≥ 30 kg) in hospitals.

#### 7. Summary of Substantial Equivalence

| | | FS10A | FS20A |
|----------------------|------|--------------------------------------|---------------------------------------|
| Display Range | Spo2 | 0~99% | 0~100% |
| | PR | 0~250 bpm | 0~250 bpm |
| Measurement<br>Range | Spo2 | 70~99% | 70~100% |
| | PR | 25~250 | 25~250 |
| Accuracy | Spo2 | 70~99%: ±2%<br>0%~69%: no definition | 70~100%: ±2%<br>0%~69%: no definition |
| | PR | ±3 bpm | ±3 bpm |
| Resolution | Spo2 | 1% | 1% |

#### Table 1: The difference between FS10A and FS20A.

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| | PR | 1 bpm | 1 bpm |
|-----------------------------|-----------------------------------------------------------|-------|-------|
| Display Screen | LED | OLED | |
| Pulse Beep | N | Y | |
| Pulse beat sound | N | Y | |
| Pulse sound On/Off function | N | Y | |
| Pulse waveform display | N | Y | |
| Four direction display | N | Y | |
| The shape and size of shell | The proposed devices have the same appearances and sizes. | | |

## Table 2 : The difference between FS10A,FS20A and Predicate

| Compariosn Elements | Proposed Device | | Predicate Device | Comparison |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Device Name | Pulse oximeter | | Fingertip pulse Oximeter (K130947) | Similar |
| Model | FS10A, FS20A | | MD300C1,MD300C2 | ------- |
| Regulation No. | 21 CFR 870.2700 | | 21 CFR 870.2700 | Same |
| Classification | II | | II | Same |
| Classification Name | Oximeter | | Oximeter | Same |
| Product Code | DQA | | DQA | Same |
| Indications for Use | The Pulse Oximeter FS10A and FS20A are portable, non-invasive devices intended for spot check monitoring of arterial hemoglobin oxygen saturation (SpO2) and pulse rate of adult patients (weighing ≥ 30 kg) in hospitals. | | The Fingertip Pulse Oximeter MD300C series, are portable, non-invasive devices intended for spot checking of arterial hemoglobin oxygen saturation(SPO2) and pulse rate of adult and pediatric patient at hospital(including clinical use in internist/surgery, Anesthesia, and intensive care units). | Similar |
| Comparison Statement | The proposed devices have the same indications for use and classification. | | | |
| Components | The applicant device consists of photo detector and emitter LED, CPU, data display unit and power unit. | | detector and emitter LED, signal amplify unit, CPU, data display unit and power unit. | Similar |
| Design Principle | Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed | | Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the | Similar |
| | | | | |
| | | normally pulsates and absorbs<br>variable amount of light during<br>systole and diastole, as blood<br>volume increases and decreases.<br>The ratio of light absorbed at<br>systole and diastole is translated<br>into an oxygen saturation<br>measurement. This measurement<br>is referred to as SPO2. | light intensity. The arteriolar<br>bed normally pulsates and<br>absorbs variable amount of<br>light during systole and<br>diastole, as blood volume<br>increases and decreases. The<br>ratio of light absorbed at<br>systole and diastole is<br>translated into an oxygen<br>saturation measurement. This<br>measurement is referred to as<br>SPO2. | |
| Measurement | Red | 660nm | 660nm | Same |
| Wavelength | Infrared | 906nm | 940nm | The<br>wavelength of<br>IR led is<br>different. |
| Comparision Statement | The proposed devices have the same design principle and similar components. | | | |
| Display Type | | LED: FS10A<br>OLED:FS20A | LED:MD300C1<br>OLED:MD300C2 | Same |
| Working time | | Work about 18 hours continuously. | Work for 30 hours continuously | Same |
| Power Supply | | 2 * AAA | 2 * AAA | Same |
| Display Data | | SPO2, PR | SPO2, PR | Same |
| Spo2 Display Range | | 0~99%: FS10A<br>0~100%: FS20A | 0~99%: MD300C1<br>0~100%: MD300C2 | Same |
| Spo2 Accuracy | | FS10A: 70~99% is ± 2%,<br>0~69% is no definition<br>FS20A: 70~100% is ± 2%,<br>0~69% is no definition | MD300C1: 70~99% is ± 2%, 0~69% is no definition<br>MD300C2: 70~100% is ± 2%, 0~69% is no definition | Same |
| Spo2 resolution | | 1% | 1% | Same |
| PR display range | | 0~250 bpm | 0~254 bpm | The PR range<br>of the<br>predicate<br>device is<br>bigger. |
| PR Accuracy | | ±3bpm | ± 2bpm(30~99bpm) and 2%(100~235bpm) | The PR<br>accuracy of<br>the predicate<br>device is<br>higher. |
| PR resolution | | 1 bpm | 1 bpm | Same |
| Operating temperature | | +5°~+40° C | +5°~+40°C | Same |
| Relative humidity | 10%~95%(Operating and storage) | ≤80%(Operating)<br>≤93%(storage) | Similar | |
| Atmosphere pressure | 70~106kPa (Operating)<br>50~107.4kPa(Storage ) | 86~106 kPa | Similar | |
| Pulse Beep | Available: FS20A<br>Not Available: FS10A | Not Available | The predicate<br>device<br>doesn't have<br>the Beep<br>function. | |
| Comparison Statement | The applicant device has similar device specifications as the predicate device. | | | |
| Contacting<br>Material | Battery<br>cover | ABS + PC | ABS | Similar |
| | Fingertip<br>Cushion | Medical Silicon gel | Medical Silicon gel | Same |
| | Enclosure | ABS + PC /PMMA | ABS | Similar |
| Comparsion Statement | The contacting materials of applicant device are similar to that of the predicate device. | | | |
| Performance<br>Testing | Bench Test | The bench test include SpO2<br>accuracy test , pulse rate test, FFC<br>bending test, drop test, function test<br>and test according to<br>ISO80601-2-61.All the bench test<br>results are provide in performance<br>Testing-Bench | Meet the requirements of<br>FDA Guidance. | Similar |
| | Clinical Test | Conformed to ISO80601-2-61<br>Clinical test for device accuracy is<br>conducted by the Guangzhou<br>Huangpu Traditional Chinese<br>Medicine Hospital. The clinical test<br>report and protocol are provide in<br>performance Testing-clinical | Conformed to ISO 9919 | Similar |
| Electromagnetic<br>Compatibility<br>Safety | Electrical<br>Safety | Conformed to IEC60601-1.<br>The test results are provided in<br>Electromagnetic Compatibility and<br>Electrical Safety. | Conformed to IEC60601-1 | Same |
| | Electromagn<br>etic<br>Compatibility | Conformed to IEC60601-1-2.<br>The test results are provided in<br>Electromagnetic Compatibility and<br>Electrical Safety. | Conformed to IEC60601-1-2 | Same |
| Software | | Moderate level of Concern | Moderate level of<br>Concern | Same |
| | | Compliance with FDA Guidance for<br>the content of Premarket Submissions<br>for Software Contained in Medical<br>Devices. | Compliance with FDA<br>Guidance for the content<br>of<br>Premarket<br>Submissions for Software<br>Contained in Medical<br>Devices. | Same |
| Biocompatibility | Medical<br>Silicone gel | In Vitro No cytotoxic<br>Cytotoxicity potential<br><br>Skin Irritation Test No evidence of<br>causing<br>sensitization<br><br>Skin Sensitization No evidence of<br>Test significant<br>irritation from<br>the test extract<br>to rabbits | In Vitro No cytotoxic<br>Cytotoxici potential<br>ty<br>Skin Irritation No evidence<br>Test of causing<br>sensitization<br>Skin No evidence<br>Sensitizati of<br>on Test significant<br>irritation<br>from the<br>test extract<br>to rabbits | Same |
| | ABS + PC<br>/PMMA<br>plastic | In Vitro No cytotoxic<br>Cytotoxicity potential<br><br>Skin Irritation Test No evidence of<br>causing<br>sensitization<br><br>Skin Sensitization No evidence of<br>Test significant<br>irritation from<br>the test extract<br>to rabbits | In Vitro No cytotoxic<br>Cytotoxici potential<br>ty<br>Skin Irritation No evidence<br>Test of causing<br>sensitization<br>Skin No evidence<br>Sensitizati of<br>on Test significant<br>irritation<br>from the<br>test extract<br>to rabbits | Same |
| | | Label and Labeling | | Compliance with FDA guidance |

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## 8. Substantial Equivalence:

The proposed devices of Pulse Oximeter FS10A, FS20A have the same classification information, same indications and intended use, same design principle, similar product design and specifications, same performance effectiveness, performance safety as the predicate device.

The differences only exist in such contents: Infrared wave length, PR display range and accuracy and Pulse

Beep function. These differences are slight and do not influence the effectiveness and safety of the device.

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According to the non-clinical and clinical test results, the proposed devices are as safe, as effective and perform as well as the predicate device. So the proposed devices are Substantially Equivalent(SE) to the predicate device which is US legally market device.

## 9. Non-Clinical Tests Performed:

The following testing was performed on the Pulse Oximeter FS10A,FS20A in accordance with the requirements of the design control regulations and established quality assurance procedures.

IEC60601-1:2005+CORR.1(2006)+CORR.2(2007),Medical electrical equipment-Part 1:General requirements for basic safety, and essential performance.

IEC60601-1-2:2007, Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility-Requirements and tests.

ISO80601-2-61:2011, Medical electrical equipment-Part 2-6 1: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

ISO10993-1: 2009, Biological evaluation of medical devices -Part 1:Evaluation and testing within a risk management process

ISO10993-5:2009, Biological evaluation of medical devices - PartS5: Tests for In Vitro cytotoxicity.

ISO10993-10:2010, Biological evaluation of medical devices-Part10: Tests for irritation and skin sensitization

In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

## 10. Clinical Trial Conclusion

The Pulse Oximeters FS10A and FS20A share the same pulse oximeter sensor, algorithm and oxygen saturation module. So we considered a clinical test of one of the proposed devices could cover that of other devices. The clinical test of other proposed devices can be exempted. And we conducted clinical test for one of the proposed devices, and the model is FS20A.

The clinical trial was performed according to Annex EE.2 Procedure for invasive laboratory testing of ISO80601-2-61:2011, Medical electrical equipment-Part 2-6 1: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

It can be determined from the result of the clinical study that the accuracy Arms of the proposed device is smaller than 2%.

## 11. Substantially Equivalent Conclusion

The proposed device Pulse Oximeter FS10A,FS20A are determined to be Substantially Equivalent (SE) to the predicate device, Fingertip Pulse Oximeter (K130947) MD300C1,MD300C2 in respect of safety and effectiveness.

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