Pulse Oximeter

K191430 · Shenzhen Yimi Life-Technology Co., Ltd. · DQA · Oct 18, 2019 · Cardiovascular

Device Facts

• Record ID: K191430
• Device Name: Pulse Oximeter
• Applicant: Shenzhen Yimi Life-Technology Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Oct 18, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.

Device Story

Reusable fingertip pulse oximeter; uses red and infrared light-emitting diodes and photodetector to measure light absorption through finger tissue; microprocessor calculates SpO2 and pulse rate based on optical absorption variations; powered by 2x1.5V AAA batteries; displays results on LED or OLED screen; used by clinicians for spot-checks in healthcare settings; provides real-time SpO2 and pulse rate data to assist in patient monitoring; benefits include non-invasive, portable assessment of oxygenation status.

Clinical Evidence

Clinical testing conducted per Annex EE of ISO 80601-2-61:2011 to evaluate SpO2 accuracy in human subjects. Results demonstrated compliance with accuracy requirements for pulse oximeter equipment.

Technological Characteristics

Reusable fingertip pulse oximeter; 2-wavelength optical absorption sensing; LED/OLED display; powered by 2x1.5V AAA batteries. Biocompatibility per ISO 10993-1, -5, -10. Electrical safety per IEC 60601-1, IEC 60601-1-11. EMC per IEC 60601-1-2. Performance per ISO 80601-2-61.

Indications for Use

Indicated for spot-checking oxygen saturation (SpO2) and pulse rate in adult patients in healthcare environments. Not indicated for use under motion or low perfusion conditions.

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

• Shenzhen IMDK Medical Technology Co., Ltd., C101H1 Pulse Oximeter (K173123)

Submission Summary (Full Text)

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October 18, 2019

Shenzhen Yimi Life Technology Co.,Ltd. Shande Peng General Manager 305 Tengbo Industrial Park, Changshangjiang Street, Longbei Village, Pingshan District Shenzhen, 518118 CN

Re: K191430

Trade/Device Name: Pulse Oximeter, models YM101, YM201, YM301 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: September 10, 2019 Received: September 20, 2019

Dear Shande Peng:

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.

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

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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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for 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) K191430

Device Name Pulse Oximeter, models YM101, YM201, YM201, YM301

#### Indications for Use (Describe)

The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

# K191430

# Prepared in accordance with the requirements of 21 CFR Part 807.92

| 1. Submitter: | Shenzhen Yimi Life Technology Co., Ltd.<br>305 Tengbo Industrial Park, Changshangjiang Street, Longbei Village,<br>Pingshan District, 518118, Shenzhen, P.R. China<br>Tel.: [phone] |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Shande Peng |
| Prepare date: | 2019-10-17 |
| 2. Device name<br>and classification | Device Name: Pulse Oximeter<br>Models: YM101, YM201, YM301<br>Classification Name: 21 CFR 870.2700 Oximeter<br>Product code: DQA<br>Regulatory Class: Class II |
| 3. Reason for<br>Submission | New Application. No prior submission associated with the current<br>submission. |
| 4. Predicate<br>Device(s) | Shenzhen IMDK Medical Technology Co., Ltd., C101H1 Pulse Oximeter /<br>K173123 |
| 5. Device<br>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<br>and a light detector (called a photo-detector). Red and Infrared lights are<br>shone through the tissues from one side of the probe to the other. Then parts<br>of the light emitted absorbed by blood and tissues. The light absorbed by the<br>blood varies with the oxygen saturation of haemoglobin. After that, the<br>photo-detector detects the light volume transmitted through the tissues which<br>depends on blood pulse, Hereafter, the microprocessor calculates a value for<br>the oxygen saturation (SpO2).<br>The subject device is a reusable device, and need to reprocess as<br>suggested in the user manual after each use. And the device is intended to<br>be used on the finger, and powered by 2*1.5V AAA battery.<br>YM101 display the measuring results on 1.5' LED screen, and the backlight<br>of the three models are red, white and green respectively. And the screen of<br>YM201 and YM301 are 0.96' OLED and 1.3' OLED. Additionally, battery<br>indicator and pulse waveform can be displayed on YM201 and YM301. |
| 6. Indications for<br>Use | The pulse oximeter is a reusable device and intended for spot-checking of<br>oxygen saturation and pulse rate for use with the finger of adult patients in<br>healthcare environments. And it is not intended to be used under motion or<br>low perfusion scenarios. |

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## 7. Predicate Device Comparison

Please refer to following table to find differences between the subject device and predicate device.

| ITEM | Proposed Device<br>YM series Pulse Oximeter | Predicate Device<br>C101H1/K173123 | Compariso<br>n Result |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Manufacture | Shenzhen Yimi<br>Life Technology Co., Ltd. | Shenzhen Med-link<br>Electronics Tech Co., Ltd. | Different |
| Indications for<br>Use | The pulse oximeter is<br>intended for measure<br>oxygen saturation and pulse<br>rate of adult patients in<br>healthcare environments. | Fingertip Pulse Oximeter<br>C101H1 is a non-invasive<br>device intended for spot<br>checking of functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and pulse<br>rate (PR). This portable<br>device is indicated for use<br>in adult patients in hospitals. | Different |
| Operational Specifications | | | |
| Intended patient<br>population | Adult | Adult | Same |
| Intended<br>application site | Finger | Finger | Same |
| use under motion<br>and low perfusion<br>conditions | No | No | Same |
| Measurement<br>Principles | 2-wavelength Relative<br>Optical Absorption | 2-wavelength Relative<br>Optical Absorption | Same |
| Signal Detection<br>Method | Photodetector | Photodetector | Same |
| SpO2 Range | 0~100% | 0~100% | Same |
| SpO2 Resolution | 1% | 1% | Same |
| SpO2 Accuracy | 70~100%: ±2%<br>0% to 69%: unspecified | 70~100%: ±3%<br>0% to 69%: unspecified | Different |
| Pulse Rate<br>Range | 25 bpm ~ 250 bpm | 30 bpm ~ 240 bpm | Different |
| Pulse Rate<br>Accuracy | ±2 bpm | ±1 bpm or ±1%, whichever is<br>greater | |
| Pulse<br>Rate Resolution | 1 bpm | 1 bpm | Same |
| Shipped Sterile | No | No | Same |
| Power suppler | 2*1.5V AAA alkaline battery | 2*1.5V AAA alkaline battery | Same |
| Storage and<br>Transport<br>Environment | Temperature: -20°C to 60°C<br>Atmospheric Pressure: 50<br>kPa to 107.4 kPa<br>Relative Humidity:<br>10%-95% (no<br>condensation) | Temperature: -10°C to 40°C<br>Atmospheric Pressure: 70<br>kPa to 106 kPa<br>Relative Humidity: 10%-80%<br>(no condensation) | Different |

| | | Table 1 Comparison between main predicate C101H1 and the subject device |
|--|--|-------------------------------------------------------------------------|
| | | |

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| Operating<br>Environment | Temperature: 15℃to 40℃<br>Atmospheric Pressure: 70 kPa to 106 kPa<br>Relative Humidity:<br>15%-95% (no<br>condensation) | Temperature: 5℃to 40℃<br>Atmospheric Pressure: 70 kPa to 106 kPa<br>Relative Humidity: 15%-80%<br>(no 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 | |
| Physical Specifications | | | |
| Dimension<br>(Width*Height*De<br>pth) | 57mm×30mm×30 mm | 60mm×35mm×35 mm | Different |

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+CORR. 1 (2006)+CORR. 2 (2007)+AM1 (2012) Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2007 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC.

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#### Bench Testing

Bench testing was conducted, and the results show that the subject device complies with the ISO 80601-2-61: 2011 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 quidance "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 SpO2 ACCURACY 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.

#### 9. Conclusion

Verification and validation testing was conducted on the subject device Pulse Oximeter and all testing passed pre-specified criteria. This premarket notification submission demonstrates that the subject device is substantially equivalent to the predicate device.