Fingertip Pulse Oximeter

K161938 · Xuzhou Yongkang Electronic Science Technology Co., Ltd. · DQA · May 8, 2017 · Cardiovascular

Device Facts

• Record ID: K161938
• Device Name: Fingertip Pulse Oximeter
• Applicant: Xuzhou Yongkang Electronic Science Technology Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: May 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The pulse oximeter (YK-81C ) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult and pediatric in clinic environment. This medical device can be reused. Not for continuously monitoring,

Device Story

Fingertip pulse oximeter (YK-81C) performs non-invasive spot-checking of SpO2 and pulse rate. Device uses red (660nm) and infrared (940nm) light-emitting diodes to measure light absorption through fingertip; calculates oxygen saturation and pulse rate; displays SpO2%, pulse rate, and vertical bar graph of pulse amplitude. Used in clinical environments by healthcare providers. Provides real-time physiological data to assist in clinical assessment. Benefits include rapid, non-invasive patient monitoring without continuous tracking requirements.

Clinical Evidence

Clinical trial performed per ISO 80601-2-61:2011 on 12 healthy adult volunteers (ages 21-28) with varying skin pigmentation. Subjects underwent induced hypoxia (70-100% SaO2) under steady-state, non-motion conditions. Reference CO-Oximetry used for comparison. Results showed SpO2 accuracy (Arms) of 2.53% for the YK-81C.

Technological Characteristics

Fingertip clip form factor with built-in sensor. Red (660nm) and IR (940nm) LEDs. Power: 2 AA alkaline batteries. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 80601-2-61 (pulse oximetry), and ISO 10993-5/10 (biocompatibility). Software level of concern: Moderate.

Indications for Use

Indicated for spot-checking pulse oxygen saturation (SpO2) and pulse rate in adult and pediatric patients in clinical environments. Not for continuous monitoring.

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

• Pulse Oximeter (K142687)
• MD300C1 Fingertip pulse oximeter (K093757)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 8, 2017

Xuzhou Yongkang Electronic Science Technology Co., Ltd % Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, Dafangju, No.25 Banbidian Rd. Li Yuan Town, Tongzhou District, Beijing, 101121 CHINA

Re: K161938

Trade/Device Name: Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: March 26, 2017 Received: March 30, 2017

Dear Ray 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. 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.

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Page 2 - Ray Wang

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): medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tina Kiang
-s

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K161938

Device Name Fingertip Pulse Oximeter

Indications for Use (Describe)

The pulse oximeter (YK-81C ) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult and pediatric in clinic environment. This medical device can be reused. Not for continuously monitoring,

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <span style="padding-right: 5px;"> <span style="border: 1px solid black; padding: 0px 2px;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span style="padding-left: 20px;"> <span style="border: 1px solid black; padding: 0px 2px;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |

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### 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K161938

- 1. Date of Preparation
03/27/2017

- Sponsor 2.
## Xuzhou Yongkang Electronic Science Technology Co., Ltd

4F Building C8, 40 Jingshan Road, Econonic and Technolgical Development Zone, Xuzhou, Jiangsu, China Establishment Registration Number: Not yet registered or the Number Contact Person: YanLi Li Position: General Manager Tel: [phone]-631 Fax:[phone] -606 Email: [e-mail]

- Submission Correspondent 3.
Mr. Ray Wang

### Beijing Believe Technology Service Co., Ltd.

5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China Tel: [phone] Fax: [phone] Email: [e-mail]

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#### 4. Identification of Proposed Device

Trade Name: Fingertip Pulse Oximeter Common Name: Pulse Oximeter Model(s): YK-81C

Regulatory Information: Classification Name: Oximeter Classification: II; Product Code: DQA; Regulation Number: 21 CFR 870.2700; Review Panel: Anesthesiology;

Intended Use Statement:

The pulse oximeter, YK-81C, is designed for spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.

- Device Description 5.
The proposed device, fingertip pulse oximeter, YK-81C, can display SpO2%, pulse rate value, and vertical bar graph pulse amplitude;

The pulse oximeter, YK-81C, is designed for spot checking of the pulse oxygen saturation and pulse rate for adults in a clinic environment. This medical device can be reused. Not for continuously monitoring.

The proposed device is NOT for life-supporting or life-sustaining, not for implant. The proposed device is NOT provided sterile and is NOT a reprocessed single-use device.

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#### 6. Identification of Predicate Device

Predicate 1# 510(k) Number: K142687 Product Name: Pulse Oximeter Manufacturer: Shanghai Berry Electronic Tech Co., Ltd.

Predicate 2# 510(k) Number: K093757 Product Name: MD300C1 Fingertip pulse oximeter Manufacturer: Beijing Choice Electronic Technology Co., Ltd

#### 7. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

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

IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

ISO 80601-2-61:2011, Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity.

ISO 10993-10: 2010. Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

IEC 60601-1-8:2012 Medical electrical equipment General requirements for safety - for collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.

Performance Test: SpO2 and PR accuracy/SpO2 and PR accuracy under low perfusion/SpO2 and PR accuracy test after cleaning and low-level disinfection (500 times)

Performance Test: Vertical Pulse Amplitude feature.

Performance Test: Finger Off and Low Battery indicator.

#### 8. Clinical Test Conclusion

The clinical trial was performed according to Clause 201.12.1.101.2 and Annex EE.2 of ISO 80601-2-61:2011 Procedure for invasive laboratory testing on healthy volunteers.

The purpose of the clinical trial was to evaluate the SpO2 accuracy performance of the YK-80C

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Fingertip Pulse Oximeter during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood CO-Oximetry.

After Institutional Review Board (IRB) approval, 12 healthy adult volunteer subjects (ages 21-28yr, 46-74kg, 156-176cm, with light to dark pigmentation) were included in the study conducted Nov. 27-29, 2015 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-Oximetry 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 2.53 (YK-81C) during steady state conditions over the range of 70-100%.

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| ITEM | Proposed Device<br>Fingertip Pulse Oximeter<br>(YK-81C) | Predicate Device<br>Pulse Oximeter (BM1000A &<br>BM2000A) | Predicate Device MD300C1<br>Fingertip pulse oximeter | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DQA | DQA | DQA | |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | 21 CFR 870.2700 | |
| Class | 2 | 2 | 2 | |
| Indications For<br>Use | The pulse oximeter (YK-81C) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring. | The pulse oximeter (BM1000A & BM2000A) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring. | MD300C1 Finger pulse oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/ surgery, anesthesia, intensive care and etc). Not for continuously monitoring. | |
| Application Site | Fingertip | Fingertip | Fingertip | |
| | ITEM | Proposed Device | Predicate Device | Predicate Device |
| | | Fingertip Pulse Oximeter<br>(YK-81C) | Pulse Oximeter (BM1000A &<br>BM2000A) | MD300C1 Fingertip pulse<br>oximeter |
| | Measurement<br>wavelength | Red: 660nm<br>Infrared: 940nm | Red: 660nm<br>Infrared: 940nm | Red: 660nm<br>Infrared: 940nm |
| | LED Radiant<br>Power | 21.8 mW/cm² | N/A | 21.8 mW/cm² |
| | SpO2 Indication<br>Waveform | Yes | Yes | Yes |
| | SpO2measurement<br>range | 0-100% | 0-100% | 0-100% |
| | SpO2accuracy | 70%~100%, ±3% | 70%-100% ±3%; Undefined for<br><70% | 70%~99%, ±3% |
| | SpO2resolution | ±1% | ±1% | 1% |
| | PR measurement<br>range | 30-254 bpm | 25-250 bpm | 30~235bpm |
| | PR accuracy | ±2 bpm | ±2 bpm | ±2 bpm or ±2% |
| | PR resolution | ±1 bpm | ±1 bpm | 1bpm |
| | Vertivcal bar graph<br>pulse amplitude | The Pulse bar graph displays<br>corresponding with the<br>patient's pulse beat. The height<br>of the bar graph shows the<br>patient's pulse strength as<br>defined as below<br>0-15 level 9 block display in<br>horizontal display mode (one<br>block = 3/5 level)<br>15 block display in vertical<br>display mode (one block = 1<br>level) | N/A | The Pulse bar graph<br>displays corresponding<br>with the patient's pulse<br>beat. The height of the bar<br>graph shows the patient's<br>pulse strength. |
| | Data update time | <10s | <15s | <15s |
| Technical Characteristics | Device Form | Finger clip Pulse Oximeter<br>with built-in sensor | Handheld Pulse Oximeter with<br>separate sensor | Finger clip Pulse Oximeter<br>with built-in sensor |
| | Sensor type | Clip type | BM1000A: wrap type<br>BM2000A: Fingertip type | Clip type |
| Display Information | SpO2 measurement data<br>PR measurement data<br>Battery and finger off indicator<br>SpO2/PR alarm setting | SpO2 measurement data<br>PR measurement data<br>Battery and finger off indicator<br>SpO2/PR alarm setting<br>(BM1000A only) | SpO2 measurement data<br>PR measurement data<br>Battery and finger off<br>indicator<br>SpO2/PR alarm setting | |

# 9. Substantially Equivalent (SE) Comparison

Table 1 General Comparison

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Table 2 Performance Comparison

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## Table 3 Testing Comparison

| ITEM | Proposed Device<br>Fingertip Pulse Oximeter<br>(YK-81C) | Predicate Device<br>Pulse Oximeter (BM1000A<br>& BM2000A) | Predicate Device MD300C1<br>Fingertip pulse oximeter |
|-------------------------------------|---------------------------------------------------------|-----------------------------------------------------------|------------------------------------------------------|
| Power Supplier | 2 A AA alkaline batteries | BM1000A: 2AA Batteries<br>BM2000A: Li ion battery | 2 A AA alkaline batteries |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | Comply with IEC 60601-1 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | Comply with ISO 10993-1 |
| Label and<br>Labeling | Conforms to FDA Regulatory<br>Requirements | Conforms to FDA Regulatory<br>Requirements | Conforms to FDA Regulatory<br>Requirements |
| Level of Concern<br>of the Software | Moderate | Moderate | Moderate |

The indications for use of the proposed device is identical to K142687, but varies slightly compared to K093757,However, they have same intended population, same usage environments, same intended use (spot checking and not for continuously monitoring), the only difference is the narrative style. These differences do not affect the safety and effectiveness of the device when used as labeled.

# 10. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices.