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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Fingertip pulse oximeter:

Device: Fingertip pulse oximeter (Model LOX100A, LOX100B, LOX100C, LOX100D) by Shenzhen LEPU Intelligent Medical Equipment Co., Ltd.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details the comparison of the subject device against a predicate device (K161560) and adherence to relevant standards. The "Acceptance Criteria" are implied by the requirements of these standards and the equivalence to the predicate, with "Reported Device Performance" reflecting the subject device's demonstrated capabilities.

Acceptance Criterion (Implied by Standard/Predicate)	Reported Device Performance (Subject Device)	Pass/Fail	Comment
SpO2 Measurement Range: 70%~100%	70%~100%	Pass	Same as predicate.
SpO2 Accuracy (70%~100%): <= +/-2%	+/-2% (70%~100%)	Pass	Meets ISO 80601-2-61 requirements.
SpO2 Accuracy (70%~80%): <= +/-2%	+/-2%	Pass	Meets ISO 80601-2-61 requirements.
SpO2 Accuracy (80%~90%): <= +/-2%	+/-2%	Pass	Meets ISO 80601-2-61 requirements.
SpO2 Accuracy (90%~100%): <= +/-2%	+/-2%	Pass	Meets ISO 80601-2-61 requirements.
SpO2 Accuracy (Low Perfusion): <= +/-2% (70-100%)	+/-2% (70%~100%)	Pass	Verified to meet ISO 80601-2-61; predicate does not mention.
SpO2 Resolution: 1%	1%	Pass	Same as predicate.
Pulse Rate Measurement Range: 30bpm~250bpm	30bpm~250bpm	Pass	Same as predicate.
Pulse Rate Accuracy (30bpm~250bpm): +/-2bpm or +/-2% (whichever is larger)	+/-2bpm or +/-2% (whichever is larger)	Pass	Confirmed to be the same as predicate when detailed.
Pulse Rate Accuracy (30-99bpm): +/-2bpm	+/-2bpm	Pass	Same as predicate.
Pulse Rate Accuracy (100-250bpm): +/-2%	+/-2%	Pass	Same as predicate.
Pulse Rate Accuracy (Low Perfusion): +/-2bpm or +/-2% (whichever is larger)	+/-2bpm or +/-2% (whichever is larger)	Pass	Verified to meet ISO 80601-2-61; predicate does not mention.
Pulse Rate Resolution: 1bpm	1bpm	Pass	Meets ISO 80601-2-61 and actual use requirements.
Biocompatibility: ISO 10993 Series Requirements	Cytotoxicity, Skin Sensitization, Skin Irritation tests meet ISO 10993 requirements	Pass	Test results met requirements.
Electrical Safety: IEC 60601-1 and IEC 60601-1-11	Meets requirements	Pass	Same as predicate.
Electromagnetic Compatibility: IEC 60601-1-2	Meets requirements	Pass	Same as predicate.
Software Level of Concern: Moderate	Moderate	Pass	Same as predicate.
Working Temperature: 5°C~40°C	5°C~40°C	Pass	Same as predicate.
Storage/Transport Temperature: -20°C~~55°C (Subject device) vs. -25°C~~70°C (Predicate) vs ISO 80601-2-61	Verified to meet ISO 80601-2-61 requirements	Pass	Different from predicate but verified to meet standards.
Relative Humidity: <=80% working, <=93% storage (Subject device) vs. 15%~93% operating, <=93% storage/transport (Predicate) vs ISO 80601-2-61	Verified to meet ISO 80601-2-61 requirements	Pass	Different from predicate but verified to meet standards.
Atmospheric Pressure: 70kPa-106kPa	70kPa-106kPa	Pass	Same as predicate.
Clinical Study for SpO2 Accuracy: Adherence to Annex EE of ISO 80601-2-61	SpO2 accuracy of 1.52% Arms during steady state conditions over 70-100% range	Pass	Meets requirements.
Cleaning and Disinfection Validation: Compliance with FDA Guidance for Reprocessing Medical Devices	Validated cleaning and disinfection process, compliant with FDA guidance	Pass	Confirmed.

2. Sample Size Used for the Test Set and the Data Provenance

Test Set Sample Size: 12 healthy adult volunteer subjects.
Data Provenance: Retrospective (implied, as the study results are presented as completed data for review), conducted on healthy adult volunteers. The document does not explicitly state the country of origin, but given the company's location (Shenzhen, China) and common regulatory practices, it's likely the study was conducted there or in a region with compatible regulatory/ethical standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document states that arterial blood samples were analyzed on a "reference co-oximeter" to provide the functional SaO2 for comparison. This implies an objective, instrumental ground truth, not one established by human experts. Therefore, the "number of experts" for ground truth establishment is not applicable in this context. The co-oximeter itself serves as the gold standard.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for SpO2 accuracy was established objectively by a co-oximeter, not through human expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study was not described. The study focused on the device's standalone accuracy against a measured physiological ground truth (co-oximetry), not on evaluating human reader performance with or without AI assistance. This device (a pulse oximeter) is a direct measurement device, not an AI diagnostic aid that assists human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes. The clinical study described is a standalone performance test of the device, where the Fingertip pulse oximeter's SpO2 readings were directly compared to arterial blood co-oximeter readings. There's no human "in the loop" for interpreting the device's output influencing the accuracy validation.

7. The Type of Ground Truth Used

The ground truth used for SpO2 accuracy was outcomes data in the form of arterial blood co-oximetry readings (functional SaO2). This is considered a highly objective, gold-standard method for determining true arterial oxygen saturation.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For a pulse oximeter, the core measurement principle is based on pre-established physiological principles (Lambert-Beer law, absorption characteristics of oxygenated/deoxygenated hemoglobin), not on machine learning models that require distinct training and test sets in the same way. The device's calibration and algorithm development would have utilized extensive physiological data, but this is distinct from a "training set" for a new AI algorithm.

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

Given that this is a pulse oximeter and not an AI-driven diagnostic image analysis tool, the concept of a "training set" with ground truth in the typical machine learning sense is not applicable here. The device's underlying algorithm relies on the physical properties of light absorption by blood components, which were established through fundamental scientific research over many decades. The device is calibrated and validated against established standards (like ISO 80601-2-61) and objective physiological measurements (like CO-oximetry) rather than "training" an AI model.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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: aaron.lin@lepu-medica1.com

5.3. Submission Correspondent

Mr. Arthur Goddard 31853 Cedar Road, Ohio, 44124-4445, U.S.A. Tel: (216) 233-5722 Email: asigoddard@aol.com

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

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 DeviceFinger pulse oximeter	Predicate DeviceK161560Fingertip Pulse Oximeter	Remark
Product Name	Finger Pulse Oximeter	Fingertip Pulse Oximeter	SE
Product Code	DQA	DQA
RegulationNumber	21 CFR 870.2700	21 CFR 870.2700
ClassificationName(s)	Oximeter	Oximeter
Classification	II	II
Indications foruse	The Fingertip Pulse Oximeteris a handheld non-invasivedevice intended for spot-checking of oxygen saturationof arterial hemoglobin (SpO2)and Pulse Rate of adult,adolescent and child patientsin hospitals, hospital-typefacilities, and homecare.	The Fingertip PulseOximeter MD300CN310 is ahandheld non-invasivedevice intended for spot-checking of oxygensaturation of arterialhemoglobin (SpO2) andPulse Rate of adult,adolescent and child patientsin hospitals, hospital-typefacilities, 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 DeviceFinger pulse oximeter	Predicate DeviceK161560Fingertip Pulse Oximeter	Remark
Intended patientpopulation	Adult, adolescent and childpatients	Adult, adolescent and childpatients	SE
Intendedapplication site	Fingertip	Fingertip	SE
Basic functions	Spot-checking of oxygensaturation of arterialhemoglobin (SpO2) and PulseRate	Spot-checking of oxygensaturation of arterialhemoglobin (SpO2) andPulse Rate	SE
Components	Detector and emitter LED,Analog front-end IC, MCU,data display unit and powerunit	Detector and emitter LED,signal amplify unit, CPU,data display unit and powerunit	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 DeviceFinger pulse oximeter	Predicate DeviceK161560Fingertip Pulse Oximeter	Remark
Software Levelof concern	Moderate	Moderate	SE
Workingprinciple	The measuring principles ofpulse oximeter is based onLambert-Beer law. Theemitter LED of oximetercontains a dual wavelengthlight source. One wavelengthof light source is 660nm,which is red light source. Theother is 905nm, which is nearinfrared light source. The dualwavelength light sourcealternately irradiates thesurface of the finger, and thephoto diode detector at theother end of the finger willdetect the red light and near-infrared signal. In the processof pulse beating, with theincrease and decrease of bloodvolume, different amplitude oflight will be absorbed at theend of the detector. Accordingto the absorption ratio of twokinds of wavelength light, DCsignal and AC signal areextracted, and the oxygensaturation value and pulse ratevalue are obtained by theabove signals.	The pulse oximeter works byapplying a sensor to apulsating arteriolar vascularbed. The sensor contains adual light source and photodetector. The onewavelength of light source is660nm, which is red light;the other is 905nm, which isinfrared-red light. Skin,bone, tissue, and venousvessels normally absorb aconstant amount of light overtime. The photo detector infinger sensor collects andconverts the light intoelectronic signal which isproportional to the lightintensity. The arteriolar bednormally pulsates andabsorbs variable amounts oflight during systole anddiastole, as blood volumeincreases and decreases. Theratio of light absorbed atsystole and diastole istranslated into an oxygensaturation measurement.This measurement is referredto as SpO2.	Discussion 3
Measurementwavelength-Redlight	660±3nm	660±3nm
Measurementwavelength-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 DeviceFinger pulse oximeter	Predicate DeviceK161560Fingertip Pulse Oximeter	Remark
Display Type	OLED	OLED	SE
Power supply	2*AAA batteries	2*AAA batteries	SE
Working Time	Approximately 25 hours ofcontinuous operation	Approximately 24 hours ofcontinuous operation	Discussion 4
Discussion 4:
The working time of the subject device and the predicate device are slightly different. Theworking time of the predicate device is covered by the working time of the subject device. Inaddition, the working hours of the two devices are sufficient to meet the needs of use. So, thedifference does not raise any new issues of safety or efficacy. The subject device can beconsidered 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.The difference between them is the display direction. There are 2 display directions for thesubject device, which form 3 display modes when combined with bar-graph andplethysmography. There are 4 display directions for the predicate device, which form 6 displaymodes when combined with bar-graph and plethysmography. The difference is only in displaydirections, and the display content on the screen is the same. So, the difference does not raiseany new issues of safety or efficacy. The subject device can be considered to be substantiallyequivalent to that of the predicate device.
Oxygen saturation
SpO2MeasurementRange	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 DeviceFinger pulse oximeter	Predicate DeviceK161560Fingertip Pulse Oximeter	Remark
	70%~80%: $\pm$ 2%	0~69% no definition
	80%~90%: $\pm$ 2%
	90%~100%: $\pm$ 2%
	No requirement for 70%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% $70%~80%: $ \u00b12% $80%~90%: $ \u00b12% $90%~100%: $ \u00b12% $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.

	CC	466O
I1		)

Measuring range	30bpm~250bpm	30bpm~250bpm	SE
Accuracy	30bpm~250bpm±2bpm or ±2% (which islarger)	30bpm~~99bpm, ±2bpm;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 DeviceFinger pulse oximeter	Predicate DeviceK161560Fingertip Pulse Oximeter	Remark
30bpm~99bpm	$\pm$ 2bpm ( $\pm$ 2bpm islarger than $\pm$ 2%)	$\pm$ 2bpm	SE
100bpm~250bpm	$\pm$ 2% ( $\pm$ 2% is largerthan $\pm$ 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±2bpm or ±2% (which is larger)	Not mentioned	Discussion10
---------------	------------------------------------------------	---------------	------------------

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
OperatingTemperature	5°C~40°C	5°C~40°C	Discussion11
Storage/Transporttemperature	-20°C~55°C	-25°C~70°C
RelativeHumidity	≤80%; No condensation inworking status≤93%; No condensation instorage status	15%~93% no condensationin operation;≤93% no condensation instorage/transport
Atmosphericpressure	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 andrelative humidity. LEPU Intelligent Medical has verified the environmental requirements of thedevice 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 usingMTT Method	ISO 10993-5	Under the conditions of this study, the MEMextracts of test article would be considered nocytotoxicity potential. The negative controls,blank controls, and the positive controlsperformed as anticipated.
Skin Sensitization StudyGuinea Pig MaximizationTest	ISO 10993-10	Under the condition of this study, the testarticle extracts showed no evidence ofcausing delayed dermal contact sensitizationin the guinea pig. The test article was notconsidered a sensitizer in the guinea pigmaximization test.
Skin Irritation Study	ISO 10993-10	Under the conditions of this study, theirritation response category of the test articleis classified as Negligible for polar extract andNegligible 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.

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).