Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 22, 2022 Huizhou Xiaoou Technology Co., Ltd. Xia Wang General Manager 3rd Floor, No.113 (Building D), Xikeng Industrial Zone Zhongkai High-tech Zone Huizhou, Guangdong 516000 China Re: K212665 Trade/Device Name: Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number-SO711), Pulse Oximeter (SO811), Pulse Oximeter (SO911) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: May 15, 2022 Received: May 23, 2022 Dear Xia Wang: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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/cfpmn/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. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (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 Advice (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 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) K212665 Device Name Pulse Oximeter, Models SO611, SO711, SO811 and SO911 Indications for Use (Describe) The Pulse Oximeter is intended for spot-checking oxygen saturation and pulse rate, and the device is a reusable device and intended to be used with the finger of adults in professional healthcare facility or home conditions when physician follow-up and operated by a physician. And it is not intended to be used under motion or low perfusion scenarios. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| | <span style="text-decoration: overline;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;"><b>☐</b></span> Over-The-Counter Use (21 CFR 801 Subpart C) | --- ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary Prepared in accordance with the requirements of 21 CFR Part 807.92 | 1. Submitter:<br>Contact Person: | Huizhou Xiaoou Technology Co., Ltd.<br>3rd Floor, No.113(Building D), Xikeng Industrial Zone, Zhongkai High-tech Zone,<br>Huizhou, Guangdong, Shenzhen, 516000, P.R. China<br>TEL: +86 752-3302188<br>Xia Wang | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Prepare date: | 2022-04-30 | | 2. Device name and<br>classification | Device Name: Pulse Oximeter<br>Models: SO611, SO711, SO811 and SO911<br>Classification Name: 21 CFR 870.2700 Oximeter<br>Product code: DQA<br>Regulatory Class: Class II<br>Class III Summary and Certification: Not applicable<br>IVD Classification: Not applicable | | 3. Reason for<br>Submission | New Application. No prior submission associated with the current submission. | | 4. Predicate<br>Device(s) | Shenzhen Yimi Life Technology Co., Ltd., YM101/YM201/YM301 Pulse Oximeter /<br>K191430. No recall or medical device report have been happened to the predicate<br>device. | | 5. Device Description | The oximeter consists of probe, electronic circuits, and display and plastic<br>enclosures. And one side of probe is designed to locate light emitting diodes and a<br>light detector (called a photo-detector). Red and Infrared lights are shone through<br>the tissues from one side of the probe to the other. Then parts of the light emitted<br>absorbed by blood and tissues. The light absorbed by the blood varies with the<br>oxygen saturation of haemoglobin. After that, the photo-detector detects the light<br>volume transmitted through the tissues which depends on blood pulse, Hereafter,<br>the microprocessor calculates a value for the oxygen saturation (SpO2).<br>The subject device is a reusable device, and need to reprocess as suggested in the<br>user manual after each use. And the device is intended to be used on the finger,<br>and powered by 2*1.5V AAA battery. | | 6. Indications for Use | All the four models included in this submission, which share the same<br>appearance&size, intended use, performance and similar operation. The<br>differences between all the models is the sound beep and displayed font colors.<br>Sound beep is available for SO811 only, not available for other devices. Regarding<br>the displayed font colors, SO611 and SO711 can show fonts in blue or yellow<br>respectively without multiple colors, while SO811 and SO911 can show the fonts in<br>green/yellow/blue three colors. And the sound beep difference is realized by<br>removing the component buzzer, and the font color difference is realized by minor<br>differentiate the software. Therefore, it can be concluded that all the models share<br>the similar hardware and software in this submission.<br>The Pulse Oximeter is intended for spot-checking oxygen saturation and pulse rate<br>and the device is a reusable device and intended to be used with the finger of<br>adults in professional healthcare facility or home conditions when physician<br>follow-up and operated by a physician. And it is not intended to be used under<br>motion or low perfusion scenarios. | {4}------------------------------------------------ ## 7. Predicate Device Comparison Please refer to following table to find differences between the subject device and predicate device. | ITEM | Predicate Device<br>YM 101/YM201/YM301 Pulse<br>Oximeter<br>K191430 | Proposed Device<br>Pulse Oximeter SO611/SO711/<br>SO811/SO911 | Comparison<br>Result | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | Manufacture | Shenzhen Yimi Life Technology<br>Co., Ltd. | Huizhou Xiaoou Technology Co.,<br>Ltd. | --- | | Indications for Use | The pulse oximeter is a reusable<br>device and intended for<br>spot-checking of oxygen<br>saturation and pulse rate for use<br>with the finger of adult patients<br>in healthcare environments. And<br>it is not intended to be used<br>under motion or low perfusion<br>scenarios. | The Pulse Oximeter is intended for<br>spot-checking oxygen saturation<br>and pulse rate, and the device is a<br>reusable device and intended to be<br>used with the finger of adults in<br>professional healthcare facility or<br>home conditions when physician<br>follow-up and operated by a<br>physician. And it is not intended to<br>be used under motion or low<br>perfusion scenarios. | Different | | Intended patient<br>population | Adult | Adult | | | Contraindications | Not intended to be used under<br>motion or low perfusion<br>scenarios. | Not intended to be used under<br>motion or low perfusion scenarios. | Same | | Operational Specifications | | | | | Intended<br>application site | Finger | Finger | Same | | Measurement<br>Principles | 2-wavelength Relative<br>Optical Absorption | 2-wavelength Relative<br>Optical Absorption | Same | | Signal Detection<br>Method | Photodetector | Photodetector | Same | | Display content | SpO2%, PR, battery indicator,<br>Pulse rate<br>bar graph, pulse waveform | SpO2%, PR, battery indicator, Pulse<br>rate<br>bar graph, pulse waveform | Same | | SpO₂ Range | 0%~100%, of which effective<br>measurement range is<br>70%~100% | 0%~100%, of which effective<br>measurement range is 70%~100% | Same | | SpO2 Accuracy | 70~100%: ±2%<br>0% to 69%: unspecified | 70% ~100%:±2%;<br>0% to 69%: unspecified | | | SpO2 Resolution | 1% | 1% | Same | | Pulse Rate Range | 25 bpm ~ 250 bpm | 30 bpm ~ 250 bpm | Different | | Pulse Rate<br>Accuracy | ±2 bpm | ±3 bpm | | | Pulse<br>Rate Resolution | 1 bpm | 1 bpm | Same | | Data Memory | Not available | Not available | Same | | Shipped Sterile | No | No | Same | | Power suppler | 2*1.5V AAA alkaline battery | 2*1.5V AAA alkaline battery | Same | | Safety classification | Class IIa, Internally powered,<br>Type BF applied part, IP22 | Class IIa, Internally powered, Type BF applied part, IP22 | Same | | Storage and<br>Transport<br>Environment | Temperature: -20°C to 60°C<br>Atmospheric Pressure: 50 kPa to<br>I07.4 kPa<br>Relative Humidity: 10%-95% (no<br>condensation) | Temperature: -10°Cto 40°C<br>Atmospheric Pressure: 50 kPa to<br>106 kPa<br>Relative Humidity: <95% (no<br>condensation) | Different | | Operating<br>Environment | Temperature: 15°Cto 40°C<br>Atmospheric Pressure: 70 kPa to<br>106 kPa<br>Relative Humidity: 15%-95% (no<br>condensation) | Temperature: 5°Cto 40°C<br>Atmospheric Pressure: 86kPa to<br>106 kPa<br>Relative Humidity: 15%-80% (no<br>condensation) | | | Compliance Standards | | | | | Bio-compatibility | ISO 10993-1<br>ISO 109903-5<br>ISO 10993-10 | ISO 10993-1<br>ISO 109903-5<br>ISO 10993-10 | Same | | Electrical Safety | IEC 60601-1<br>IEC 60601-1-11 | IEC 60601-1<br>IEC 60601-1-11 | | | EMC | IEC 60601-1-2 | IEC 60601-1-2 | | | Performance | ISO 80601-2-61 | ISO 80601-2-61 | | Table 1 Comparison between the predicate and the subject devices {5}------------------------------------------------ As seen in the comparison tables, the subject and predicate devices have same design principle, similar design features and performance specifications. The different technological characteristics between the subject and predicate devices will not raise different questions of safety or effectiveness. ## 8. Performance Testing Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below. ## Non-Clinical Testing: The following performance data were provided in support of the substantial equivalence determination. #### Biocompatibility testing The biocompatibility evaluation for the Pulse Oximeter was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the testing included the following tests, results of which demonstrate the biocompatibility of the subject device: - Cytotoxicity - Skin Sensitization - Skin Irritation #### Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC testing were conducted, and the results show that the subject device complies with the IEC 60601-1:2005/ A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance and IEC 60601-1-11: 2015 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 for safety and the IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and {6}------------------------------------------------ essential performance - Collateral Standard: Electromagnetic disturbances – Requirements and tests standard for EMC. #### Bench Testing Bench testing was conducted and the results show that the subject device complies with the ISO 80601-2-61: 2017 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of Pulse Oximeter Equipment standard. And Pulse Rate Accuracy meets the requirements defined in ISO 80601-2-61, Clause 201.12.1.104. #### Software Verification and Validation Testing Software documentation including verification & validation was provided in accordance with FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a moderate level of concern. #### Cleaning Validation Cleaning and disinfection validation testing was conducted in accordance with FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued March 17,2015. Moreover, the performance of the subject device shows no degradation after repeated cleaning and disinfection as suggested in the manual. #### Clinical data: Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO₂ACCURACY in human subjects of ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. There are 13 healthy volunteers aged between 18 - 50 years old were selected in this study, of which includes 8 females and 5 males, 3 light skin subjects and 3 dark skin subjects. The demographic statistical indicators of the subjects is show in the table below. And no adverse effects and complications happened during the clinical study. | | N | Average mean, Sd | Minimal | Maximum | |-------------|----|------------------|---------|---------| | Age (year) | 13 | 30.15±11.25 | 18 | 50 | | Height (cm) | 13 | 166±9.61 | 150 | 180 | | Weight (kg) | 13 | 63.04±12.39 | 47 | 89 | The arm, hand or finger moves may affect the accuracy of SpO2 measurement, while the gender, age and finger size have no effect to the accuracy of SpO2 measurement, as the skin pigmentation, in this study, the statistical shows no effect to the safe and effective performance of the oximeter. ## 9. Conclusion Verification and validation testing was conducted on the subject device Pulse Oximeter and all testing passed pre-specified criteria. The subject device and the predicate device have the same intended use, and the difference in technological features do not raise different questions of safety and effectiveness. This premarket notification submission demonstrates that the subject device is substantially equivalent to the predicate device.