Fingertip pulse oximeter

K202776 · Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. · DQA · Mar 1, 2021 · Cardiovascular

Device Facts

• Record ID: K202776
• Device Name: Fingertip pulse oximeter
• Applicant: Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Mar 1, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Fingertip pulse oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospital-type facilities, and homecare.

Device Story

Handheld, non-invasive fingertip pulse oximeter; measures SpO2 and pulse rate via photoplethysmography. Device uses dual-wavelength LED (660nm red, 905nm infrared) and photodiode detector to measure light absorption changes in pulsating arteriolar blood. Signal acquisition module captures data; Analog front-end IC amplifies signals; MCU processes data to calculate SpO2 and pulse rate based on Lambert-Beer law. Output displayed on OLED screen. Used by clinicians or patients for spot-checking in hospitals or homecare. Provides real-time physiological data to assist in monitoring patient oxygenation status.

Clinical Evidence

Clinical study conducted per ISO 80601-2-61 Annex EE. Study included 12 healthy adult volunteers (ages 18-50, diverse pigmentation). Evaluated SpO2 accuracy during steady-state/non-motion conditions across 70-100% SaO2 range compared to arterial blood co-oximeter. Results showed an Arms of 1.52% for SpO2 accuracy.

Technological Characteristics

Materials: Silicone gel pad, PCTG/PMMA enclosure. Sensing: Dual-wavelength LED (660nm, 905nm) and photodiode. Power: 2x AAA batteries. Connectivity: Standalone. Standards: ISO 80601-2-61, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 10993. Software: Moderate level of concern.

Indications for Use

Indicated for spot-checking SpO2 and pulse rate in adult, adolescent, and child patients in hospital and homecare 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

• Fingertip Pulse Oximeter MD300CN310 (K161560)

Submission Summary (Full Text)

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March 1, 2021

Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. % Arthur Goddard President FDA Regulatory and Quality Systems Consultant 31853 Cedar Road Mayfield Heights, Ohio 44124-4445

Re: K202776

Trade/Device Name: Fingertip pulse oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: January 8, 2021 Received: January 25, 2021

Dear Arthur Goddard:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm_identifies_combination product submissions. 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Todd Courtney Assistant Director DHT1C: Division of ENT. Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K202776

Device Name Fingertip pulse oximeter

Indications for Use (Describe)

The Fingertip pulse oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospital-type facilities, and homecare.

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

| <span> <b> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-----------------------------------------------------------------------------|
| <span> <b> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# Section 5: 510(K) Summary

This summary of 510(K) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1900 and 21 CFR 807.92.

The assigned 510(K) Number: K202776

#### 5. 510(K) Summary

### 5.1. Date of Preparation: September 11th, 2020

### 5.2. Sponsor

Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. North side of floor 3, BLD 9 BaiWangxin High-Tech Industrial Park Songbai Road, Xili Street, Nanshan District 518055 Shenzhen, Guangdong, CHINA. Tel: + 86-0755-86952278 Fax: + 86-0755-86952287

Contact Person: Aaron Lin Position: General Manager Email: [e-mail]

### 5.3. Submission Correspondent

Mr. Arthur Goddard 31853 Cedar Road, Ohio, 44124-4445, U.S.A. Tel: [phone] Email: [e-mail]

### 5.4. Subject Device Identification

Subject Device Name: Fingertip pulse oximeter Model: LOX100A, LOX100B, LOX100C, LOX100D Common name: Oximeter Classification Name(s): Oximeter Product Code: DOA Regulation Number: 21 CFR 870.2700 Review Panel: Anesthesiology Classification: II

### 5.5. Predicate Device

510(k) Number: K161560 Device Name: Fingertip Pulse Oximeter MD300CN310 Manufacturer: Beijing Choice Electronic Technology Co., Ltd.

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#### 5.6. Indications for use

The Fingertip pulse oximeter is a handheld non-invasive device intended for spotchecking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospitals, hospital-type facilities, and homecare.

# 5.7. Device Description

Fingertip pulse oximeter, LOX100A, LOX100B, LOX100C, LOX100D, mainly include of signal acquisition module, signal processing module, prompt module, detector, and emitter LED, display and user interface module, power supply module, the device is used to measure the patient's blood oxygen saturation (SpO2) and pulse rate (PR). The device is mainly composed of main board PCB, lamp panel PCB, sensor, OLED screen, button, silicone gel pad and enclosure.

All the models, LOX100A, LOX100B, LOX100C, LOX100D of proposed device, have difference in appearance, but follow the same design principle and technical specification. The device is a stand-alone device is intended only for spot checking, and the device is reusable and do not need sterilization and re-sterilization.

# 5.8. Predicate Devices and Subject Device Comparison

| Item | Subject Device<br>Finger pulse oximeter | Predicate Device<br>K161560<br>Fingertip Pulse Oximeter | Remark |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Name | Finger Pulse Oximeter | Fingertip Pulse Oximeter | SE |
| Product Code | DQA | DQA | |
| Regulation<br>Number | 21 CFR 870.2700 | 21 CFR 870.2700 | |
| Classification<br>Name(s) | Oximeter | Oximeter | |
| Classification | II | II | |
| Indications for<br>use | The Fingertip Pulse Oximeter<br>is a handheld non-invasive<br>device intended for spot-<br>checking of oxygen saturation<br>of arterial hemoglobin (SpO2)<br>and Pulse Rate of adult,<br>adolescent and child patients<br>in hospitals, hospital-type<br>facilities, and homecare. | The Fingertip Pulse<br>Oximeter MD300CN310 is a<br>handheld non-invasive<br>device intended for spot-<br>checking of oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and<br>Pulse Rate of adult,<br>adolescent and child patients<br>in hospitals, hospital-type<br>facilities, and homecare | SE |

Table 5-1 Feature Comparison with Predicate Devices

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| Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. | | Fingertip pulse oximeter | |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------|
| Item | Subject Device<br>Finger pulse oximeter | Predicate Device<br>K161560<br>Fingertip Pulse Oximeter | Remark |
| Intended patient<br>population | Adult, adolescent and child<br>patients | Adult, adolescent and child<br>patients | SE |
| Intended<br>application site | Fingertip | Fingertip | SE |
| Basic functions | Spot-checking of oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and Pulse<br>Rate | Spot-checking of oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and<br>Pulse Rate | SE |
| Components | Detector and emitter LED,<br>Analog front-end IC, MCU,<br>data display unit and power<br>unit | Detector and emitter LED,<br>signal amplify unit, CPU,<br>data display unit and power<br>unit | Discussion 1 |

## Discussion 1:

The device composition of the subject device and the predicate device is different in the signal processing unit, the predicate device is the signal amplify unit, and the target device is the Analog front-end IC. The function of the signal amplify unit is to convert the current signal of the receiving tube into a voltage signal, and then amplify the voltage signal. The voltage signal received by the CPU is the waveform and amplitude recognized after ADC conversion; The function of the Analog front-end IC is to directly amplify the current signal and then convert it into pulse signals of different frequencies. The MCU captures the pulse signal and converts the frequency signal into a waveform and amplitude signal. The essence of the two is the same, they both amplify the signal. In addition, we verify the performance of the subject device through clinical study (See Section 20 for details) and ISO80601-2-61 performance test (See Section 18 for details), and the verification results meet the requirements for device performance. So, the difference does not raise any new issues of safety or efficacy. The subject device can be considered to be substantially equivalent to that of the predicate device.

| Contacting Material | |
|---------------------|--|

| Fingertip pad | Silicone Gel | Silicone Gel | SE |
|---------------|--------------|--------------|--------------|
| Enclosure | PCTG, PMMA | ABS | Discussion 2 |

### Discussion 2:

The Enclosure of the two devices is made of different materials. The materials used in subject device have excellent performance and safety, and can meet the requirements of the device for the material. The biological safety of all materials has been verified, including cytotoxicity, sensitization, and irritation tests. The test results meet the requirements of the ISO10993 series of standards (See Section 15 for details). So, the difference does not raise any new issues of safety or efficacy. The subject device can be considered to be substantially equivalent to that of the predicate device.

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Fingertip pulse oximeter

| Item | Subject Device<br>Finger pulse oximeter | Predicate Device<br>K161560<br>Fingertip Pulse Oximeter | Remark |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Software Level<br>of concern | Moderate | Moderate | SE |
| Working<br>principle | The measuring principles of<br>pulse oximeter is based on<br>Lambert-Beer law. The<br>emitter LED of oximeter<br>contains a dual wavelength<br>light source. One wavelength<br>of light source is 660nm,<br>which is red light source. The<br>other is 905nm, which is near<br>infrared light source. The dual<br>wavelength light source<br>alternately irradiates the<br>surface of the finger, and the<br>photo diode detector at the<br>other end of the finger will<br>detect the red light and near-<br>infrared signal. In the process<br>of pulse beating, with the<br>increase and decrease of blood<br>volume, different amplitude of<br>light will be absorbed at the<br>end of the detector. According<br>to the absorption ratio of two<br>kinds of wavelength light, DC<br>signal and AC signal are<br>extracted, and the oxygen<br>saturation value and pulse rate<br>value are obtained by the<br>above signals. | The pulse oximeter works by<br>applying a sensor to a<br>pulsating arteriolar vascular<br>bed. The sensor contains a<br>dual light source and photo<br>detector. The one<br>wavelength of light source is<br>660nm, which is red light;<br>the other is 905nm, which is<br>infrared-red light. Skin,<br>bone, tissue, and venous<br>vessels normally absorb a<br>constant amount of light over<br>time. The photo detector in<br>finger sensor collects and<br>converts the light into<br>electronic signal which is<br>proportional to the light<br>intensity. The arteriolar bed<br>normally pulsates and<br>absorbs variable amounts 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.<br>This measurement is referred<br>to as SpO2. | Discussion 3 |
| Measurement<br>wavelength-Red<br>light | 660±3nm | 660±3nm | |
| Measurement<br>wavelength-<br>Infrared | 905±10nm | 905±10nm | |

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| Item | Subject Device | Predicate Device | Remark |
|------|-----------------------|--------------------------|--------|
| | Finger pulse oximeter | K161560 | |
| | | Fingertip Pulse Oximeter | |

Fingertip pulse oximeter

# Discussion 3:

Though the working principle expressions of the subject device and predicate device are a little different, the working principle is basically the same. Both the ratio of red light and infrared light of different wavelengths are converted into electronic signals through the sensor, thereby calculating the oxygen saturation measurement value. The wavelength of red light is 660mm and the wavelength of infrared light is 905nm. So, the difference does not raise any new issues of safety or efficacy. The subject device can be considered to be substantially equivalent to that of the predicate device.

| Table 5-2 Specification Comparison | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|---------------------------------------------------------|--------------|
| Item | Subject Device<br>Finger pulse oximeter | Predicate Device<br>K161560<br>Fingertip Pulse Oximeter | Remark |
| Display Type | OLED | OLED | SE |
| Power supply | 2*AAA batteries | 2*AAA batteries | SE |
| Working Time | Approximately 25 hours of<br>continuous operation | Approximately 24 hours of<br>continuous operation | Discussion 4 |
| Discussion 4: | | | |
| The working time of the subject device and the predicate device are slightly different. The<br>working time of the predicate device is covered by the working time of the subject device. In<br>addition, the working hours of the two devices are sufficient to meet the needs of use. So, the<br>difference does not raise any new issues of safety or efficacy. The subject device can be<br>considered to be substantially equivalent to that of the predicate device. | | | |
| User Interface | 3 display modes | 6 display modes | Discussion 5 |
| Discussion 5: | | | |
| There are 3 display modes for the subject device and 6 display modes for the predicate device.<br>The difference between them is the display direction. There are 2 display directions for the<br>subject device, which form 3 display modes when combined with bar-graph and<br>plethysmography. There are 4 display directions for the predicate device, which form 6 display<br>modes when combined with bar-graph and plethysmography. The difference is only in display<br>directions, and the display content on the screen is the same. So, the difference does not raise<br>any new issues of safety or efficacy. The subject device can be considered to be substantially<br>equivalent to that of the predicate device. | | | |
| Oxygen saturation | | | |
| SpO2<br>Measurement<br>Range | 70%~100% | 70%~100% | SE |
| Accuracy | 70%~100%· +2% | 70%~100%· +2%· | Discussion 6 |

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| Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. | | Fingertip pulse oximeter | |
|-------------------------------------------------------|-----------------------------------------|---------------------------------------------------------|--------|
| Item | Subject Device<br>Finger pulse oximeter | Predicate Device<br>K161560<br>Fingertip Pulse Oximeter | Remark |
| | 70%~80%: $\pm$ 2% | 0~69% no definition | |
| | 80%~90%: $\pm$ 2% | | |
| | 90%~100%: $\pm$ 2% | | |
| | No requirement for 70%<br>below | | |

# Discussion 6:

The SpO2 accuracy of the subject device and the predicate device are described in different ways. The accuracy of SpO2 of the subject device is ±2% at different levels (70%~80%, 80%~90%, 90%~100%, 70%~100%), which meets the requirements of ISO 80601-2-61. The accuracy of the predicate device at different levels is not mentioned. The accuracy of SpO2 of the two devices is 2% within the 70%~100% level. So, the difference does not raise any new issues of safety or efficacy. The subject device can be considered to be substantially equivalent to that of the predicate device.

| Resolution | 1% | 1% | SE |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--------------|
| Low Perfusion | 70%~100%: $ \u00b12% $<br>70%~80%: $ \u00b12% $<br>80%~90%: $ \u00b12% $<br>90%~100%: $ \u00b12% $<br>No requirement for 70% below | Not mentioned | Discussion 7 |

# Discussion 7 :

The accuracy of SpO2 at different levels (70%~80%, 80%~90%, 90%~100%, 70%~100%) of the subject device under low perfusion conditions is ± 2%, and the accuracy of SpO2 of the predicate device under low perfusion conditions is not mentioned. LEPU Intelligent Medical has verified the accuracy of SpO2 of the subject device under low perfusion conditions, and the results met the requirements of ISO 80601-2-61. So, the difference does not raise any new issues of safety or efficacy. The subject device can be considered to be substantially equivalent to that of the predicate device.

| | C<br>C | 466<br>O |
|--------|--------|----------|
| I<br>1 | | ) |

| Measuring range | 30bpm~250bpm | 30bpm~250bpm | SE |
|-----------------|---------------------------------------------------|-------------------------------------------|--------------|
| Accuracy | 30bpm~250bpm<br>±2bpm or ±2% (which is<br>larger) | 30bpm~99bpm, ±2bpm;<br>100bpm~250bpm, ±2% | Discussion 8 |

# Discussion 8:

The pulse rate accuracy of the subject device and the predicate device are described in different ways. The detail comparison is shown in the table below:

| Pulse rate range | Subject device | Predicate device | Conclusion |
|------------------|----------------|------------------|------------|
|------------------|----------------|------------------|------------|

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| Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. | | Fingertip pulse oximeter | |
|---------------------------------------------------------------------------------------------|-----------------------------------------------------|---------------------------------------------------------|--------------|
| Item | Subject Device<br>Finger pulse oximeter | Predicate Device<br>K161560<br>Fingertip Pulse Oximeter | Remark |
| 30bpm~99bpm | $\pm$ 2bpm ( $\pm$ 2bpm is<br>larger than $\pm$ 2%) | $\pm$ 2bpm | SE |
| 100bpm~250bpm | $\pm$ 2% ( $\pm$ 2% is larger<br>than $\pm$ 2bpm) | $\pm$ 2% | SE |
| So, the accuracy of pulse rate of the subject device and the predicate device are the same. | | | |
| Resolution | 1bpm | 1% | Discussion 9 |

## Discussion 9:

There is a difference between the resolution of the subject device and the predicate device. The display value of the pulse rate can only be an integer. The minimum resolution setting is 1bpm. According to the requirement of the pulse rate unit in ISO 80601-2-61, it is the number of pulses per minute. The pulse rate resolution of the subject device is set to 1bpm to meet the requirements of ISO 80601-2-61 and actual use. So, the difference does not raise any new issues of safety or efficacy. The subject device can be considered to be substantially equivalent to that of the predicate device.

| Low perfusion | 30bpm~250bpm<br>±2bpm or ±2% (which is larger) | Not mentioned | Discussion<br>10 |
|---------------|------------------------------------------------|---------------|------------------|
|---------------|------------------------------------------------|---------------|------------------|

# Discussion 10:

The accuracy of Pulse rate of the subject device under low perfusion conditions is ±2% (which is larger within 30bpm), and the accuracy of Pulse rate of the predicate device under low perfusion conditions is not mentioned. LEPU Intelligent Medical has verified the accuracy of Pulse rate of the subject device under low perfusion conditions, and the results met the requirements of ISO 80601-2-61. So, the difference does not raise any new issues of safety or efficacy. The subject device can be considered to be substantially equivalent to that of the predicate device.

| Environment requirement | | | |
|----------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------|
| Operating<br>Temperature | 5°C~40°C | 5°C~40°C | Discussion<br>11 |
| Storage/Transport<br>temperature | -20°C~55°C | -25°C~70°C | |
| Relative<br>Humidity | ≤80%; No condensation in<br>working status<br>≤93%; No condensation in<br>storage status | 15%~93% no condensation<br>in operation;<br>≤93% no condensation in<br>storage/transport | |
| Atmospheric<br>pressure | 70kPa-106 kPa | 70kPa-106 kPa | |
| Discussion 11: | | | |

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| Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. | | Fingertip pulse oximeter | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|--------------------------|--------|
| Item | Subject Device | Predicate Device | Remark |
| | Finger pulse oximeter | K161560 | |
| | | Fingertip Pulse Oximeter | |
| The subject device and the predicate device are different in storage/transportation temperature and<br>relative humidity. LEPU Intelligent Medical has verified the environmental requirements of the<br>device in accordance with the requirements in ISO 80601-2-61, and the results meet the | | | |

requirements. So, the difference does not raise any new issues of safety or efficacy. The subject

Item Subject Device Predicate Device Remark Finger pulse oximeter K161560 Fingertip Pulse Oximeter Particular Meeting the requirements of Meeting the requirements SE ISO 80601-2-61 of ISO 80601-2-61 requirements for basic safety and essential performance Electrical Safety Meeting the requirements of Meeting the requirements SE IEC 60601-1 and IEC 60601-1of IEC 60601-1 and IEC 11 60601-1-11 Electromagnetic Meeting the requirements of Meeting the requirements SE Compatibility IEC 60601-1-2 of IEC 60601-1-2 Biocompatibility Meeting the requirements of Not mentioned Discussion ISO 10993-1, ISO 10993-5, 12 ISO 10993-10 Clinical study Meeting the requirements of Meeting the requirements SE Annex EE of ISO 80601-2-61 of Annex EE of ISO 80601-2-61

# Table 5-3 Performance and Safety Comparison

device can be considered to be substantially equivalent to that of the predicate device.

Discussion 12: The fingertip pad and enclose of the subject device are in direct contact with the patient's tissue. According to the requirements of ISO10993 series standard and FDA Guidance: Pulse Oximeters - Premarket Notification Submissions [510(k)s], LEPU Intelligent Medical conducted the cytotoxicity test, irritation test and sensitization test on the device, and the test results met the requirements. So, the difference does not raise any new issues of safety or efficacy. The subject device can be considered to be substantially equivalent to that of the predicate device.

# 5.9. Performance Tests Summary

Bench test were conducted to verify that the subject device met all design specifications, as was Substantially Equivalent (SE) to the predicate device.

#### A Biocompatibility Testing

The Fingertip pulse oximeter was assessed against the International Standard ISO

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Fingertip pulse oximeter

10993-1, "Biological evaluation of medical devices. Part 1. Guidance on selection of tests." The subject device would be classified as a Surface Medical Device in contact with the intact skin for a Limited Duration (<24 hours). The following test were performed for any user contacting material:

| Test | Standard | Results |
|-------------------------------------------------------------|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity Study using<br>MTT Method | ISO 10993-5 | Under the conditions of this study, the MEM<br>extracts of test article would be considered no<br>cytotoxicity potential. The negative controls,<br>blank controls, and the positive controls<br>performed as anticipated. |
| Skin Sensitization Study<br>Guinea Pig Maximization<br>Test | ISO 10993-10 | Under the condition of this study, the test<br>article extracts showed no evidence of<br>causing delayed dermal contact sensitization<br>in the guinea pig. The test article was not<br>considered a sensitizer in the guinea pig<br>maximization test. |
| Skin Irritation Study | ISO 10993-10 | Under the conditions of this study, the<br>irritation response category of the test article<br>is classified as Negligible for polar extract and<br>Negligible for non-polar extract. |

#### Non-clinical Tests A

The Fingertip pulse oximeter is tested per the following standard, to evaluate its performance. The test results demonstrated that the proposed device comply with the standard requirements.

IEC 60601-1: 2005+AMD1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic disturbances - Requirements and tests.

IEC 60601-1-11 Edition 2.0:2015-01 Medical Electrical Equipment Part 1-11: General requirements for basic safety and essential performance-Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

ISO 80601-2-61 Second Edition 2017-12 Medical Electrical Equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

#### A Clinical data

A clinical study was conducted per the requirement of Annex EE of ISO 80601-2-61 to validate the SpO2 accuracy of Fingertip pulse oximeter. The purpose of the clinical

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study was to evaluate the SpO2 accuracy performance of the Fingertip pulse oximeter during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood co-oximeter. 12 healthy adult volunteer subjects (ages 18-50yr, with light to dark pigmentation, include male and female) were included in the study conducted to evaluate the SpO2 accuracy performance of proposed devices. Each system was evaluated during steady state/non-motion conditions with various levels of induced hypoxia resulting in stable oxygen saturation levels between 100% and 70% SaO2. Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on reference co-oximeter providing functional SaO2 for the basis of the SpO2 accuracy comparison. The SpO2 accuracy performance results showed the Fingertip pulse oximeter to have an Arms of 1.52% during steady state conditions over the range of 70-100% .

#### Software A

The software embedded in Fingertip pulse oximeter has been developed, documented, and validated in accordance with industry standards (IEC 62304 - Medical device software - Software life cycle processes) and FDA guidance (GUIDANCE FOR THE CONTENT OF PRE-MARKET SUBMISSIONS FOR SOFTWARE CONTAINED IN DEVICES). The software is of Moderate Level of Concern

#### A Cleaning and disinfection validation

The Fingertip pulse oximeter is reusable, and Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. has verified the cleaning and disinfection process of the device. The Cleaning and disinfection Validation is compliance with FDA Guidance to Compliance with FDA Guidance for the Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.

### 5.10. Substantially Equivalent Conclusion

The subject device and the predicate device have intended use, and the technological differences do not raise different questions of safety and effectiveness. The subject device, Fingertip pulse oximeter, is determined to be Substantially Equivalent (SE) to the predicate device.