(161 days)
Not Found
No
The document describes standard signal processing and does not mention AI, ML, or related concepts. The performance studies are based on traditional clinical validation methods.
No
The device is described as a non-invasive device for spot-checking SpO2 and pulse rate. It is for measurement and monitoring, not for treating or rehabilitating a condition.
Yes
Explanation: The device is intended for "spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate," and its description states it "is used to measure the patient's blood oxygen saturation (SpO2) and pulse rate (PR)." Measuring physiological parameters like oxygen saturation and pulse rate is a diagnostic function, as it provides information about a patient's health status.
No
The device description explicitly lists hardware components such as "main board PCB, lamp panel PCB, sensor, OLED screen, button, silicone gel pad and enclosure." This indicates it is a physical device with integrated hardware, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The Fingertip pulse oximeter is a non-invasive device that measures oxygen saturation and pulse rate directly from the patient's fingertip. It does not involve the collection or analysis of specimens outside the body.
- Intended Use: The intended use clearly states "spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients". This is a direct measurement on the patient, not an analysis of a sample.
Therefore, based on the provided information, the Fingertip pulse oximeter is a non-invasive medical device used for physiological monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DQA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip
Indicated Patient Age Range
Adult, adolescent and child patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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 (
§ 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).
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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
1
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
2
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)
| 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
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
Finger pulse oximeter | Predicate Device
K161560
Fingertip Pulse Oximeter | Remark |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Name | Finger Pulse Oximeter | Fingertip Pulse Oximeter | SE |
| Product Code | DQA | DQA | |
| Regulation
Number | 21 CFR 870.2700 | 21 CFR 870.2700 | |
| Classification
Name(s) | Oximeter | Oximeter | |
| Classification | II | II | |
| Indications for
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 hospitals, hospital-type
facilities, and homecare. | The Fingertip Pulse
Oximeter MD300CN310 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 hospitals, hospital-type
facilities, and homecare | SE |
Table 5-1 Feature Comparison with Predicate Devices
5
| Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. | Fingertip pulse oximeter | ||
|---|---|---|---|
| Item | Subject Device | ||
| Finger pulse oximeter | Predicate Device | ||
| K161560 | |||
| Fingertip Pulse Oximeter | Remark | ||
| Intended patient | |||
| population | Adult, adolescent and child | ||
| patients | Adult, adolescent and child | ||
| patients | SE | ||
| Intended | |||
| application site | Fingertip | Fingertip | SE |
| Basic functions | Spot-checking of oxygen | ||
| saturation of arterial | |||
| hemoglobin (SpO2) and Pulse | |||
| Rate | Spot-checking of oxygen | ||
| saturation of arterial | |||
| hemoglobin (SpO2) and | |||
| Pulse Rate | SE | ||
| Components | Detector and emitter LED, | ||
| Analog front-end IC, MCU, | |||
| data display unit and power | |||
| unit | Detector and emitter LED, | ||
| signal amplify unit, CPU, | |||
| data display unit and power | |||
| 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
Finger pulse oximeter | Predicate Device
K161560
Fingertip Pulse Oximeter | Remark |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Software Level
of concern | Moderate | Moderate | SE |
| Working
principle | The measuring principles of
pulse oximeter is based on
Lambert-Beer law. The
emitter LED of oximeter
contains a dual wavelength
light source. One wavelength
of light source is 660nm,
which is red light source. The
other is 905nm, which is near
infrared light source. The dual
wavelength light source
alternately irradiates the
surface of the finger, and the
photo diode detector at the
other end of the finger will
detect the red light and near-
infrared signal. In the process
of pulse beating, with the
increase and decrease of blood
volume, different amplitude of
light will be absorbed at the
end of the detector. According
to the absorption ratio of two
kinds of wavelength light, DC
signal and AC signal are
extracted, and the oxygen
saturation value and pulse rate
value are obtained by the
above signals. | The pulse oximeter works by
applying a sensor to a
pulsating arteriolar vascular
bed. The sensor contains a
dual light source and photo
detector. The one
wavelength of light source is
660nm, which is red light;
the other is 905nm, which is
infrared-red light. 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
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 and diastole is
translated into an oxygen
saturation measurement.
This measurement is referred
to as SpO2. | Discussion 3 |
| Measurement
wavelength-Red
light | 660±3nm | 660±3nm | |
| Measurement
wavelength-
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 | ||
| Finger pulse oximeter | Predicate Device | ||
| K161560 | |||
| Fingertip Pulse Oximeter | Remark | ||
| Display Type | OLED | OLED | SE |
| Power supply | 2*AAA batteries | 2*AAA batteries | SE |
| Working Time | Approximately 25 hours of | ||
| continuous operation | Approximately 24 hours of | ||
| continuous operation | Discussion 4 | ||
| Discussion 4: | |||
| The working time of the subject device and the predicate device are slightly different. The | |||
| working time of the predicate device is covered by the working time of the subject device. In | |||
| addition, the working hours of the two devices are sufficient to meet the needs of 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. | |||
| 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 the | |||
| subject device, which form 3 display modes when combined with bar-graph and | |||
| plethysmography. There are 4 display directions for the predicate device, which form 6 display | |||
| modes when combined with bar-graph and plethysmography. The difference is only in display | |||
| directions, and the display content on the screen is the same. 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. | |||
| Oxygen saturation | |||
| SpO2 | |||
| Measurement | |||
| Range | 70%~100% | 70%~100% | SE |
| Accuracy | 70%~100%· +2% | 70%~100%· +2%· | Discussion 6 |
8
| Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. | Fingertip pulse oximeter | ||
|---|---|---|---|
| Item | Subject Device | ||
| Finger pulse oximeter | Predicate Device | ||
| K161560 | |||
| Fingertip 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.
| | C
C | 466
O |
|--------|--------|----------|
| I
1 | | ) |
| Measuring range | 30bpm~250bpm | 30bpm~250bpm | SE |
|---|---|---|---|
| Accuracy | 30bpm~250bpm | ||
| ±2bpm or ±2% (which is | |||
| larger) | 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 |
|---|---|---|---|
| ------------------ | ---------------- | ------------------ | ------------ |
9
| Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. | Fingertip pulse oximeter | ||
|---|---|---|---|
| Item | Subject Device | ||
| Finger pulse oximeter | Predicate Device | ||
| K161560 | |||
| Fingertip Pulse Oximeter | Remark | ||
| 30bpm~99bpm | $\pm$ 2bpm ( $\pm$ 2bpm is | ||
| larger than $\pm$ 2%) | $\pm$ 2bpm | SE | |
| 100bpm~250bpm | $\pm$ 2% ( $\pm$ 2% is larger | ||
| 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
±2bpm or ±2% (which is larger) | Not mentioned | Discussion
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 | |||
| Temperature | 5°C~40°C | 5°C~40°C | Discussion |
| 11 | |||
| Storage/Transport | |||
| temperature | -20°C~55°C | -25°C~70°C | |
| Relative | |||
| Humidity | ≤80%; No condensation in | ||
| working status | |||
| ≤93%; No condensation in | |||
| storage status | 15%~93% no condensation | ||
| in operation; | |||
| ≤93% no condensation in | |||
| storage/transport | |||
| Atmospheric | |||
| pressure | 70kPa-106 kPa | 70kPa-106 kPa | |
| Discussion 11: |
10
| 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 | |||
| relative humidity. LEPU Intelligent Medical has verified the environmental requirements of the | |||
| 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
11
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 (