Medke Oximetry Finger Sensor

K152390 · Shenzhen Medke Technology Co., Ltd. · DQA · Aug 18, 2016 · Cardiovascular

Device Facts

• Record ID: K152390
• Device Name: Medke Oximetry Finger Sensor
• Applicant: Shenzhen Medke Technology Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Aug 18, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Indications for Use

Medke Oximetry Finger Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40kg.

Device Story

Medke Oximetry Finger Sensors (models P9119, P8119) are reusable sensors designed for use with compatible OEM patient monitors (e.g., Nellcor NPB40). The device consists of a connector, cable, two LEDs (red and infrared), and a photodetector housed in either a finger clip or soft tip. The sensor operates by emitting light through the patient's tissue (fingers or toes); the photodetector measures light absorption, which varies with arterial blood saturation and pulse rate. This data is transmitted to the host monitor for processing and display. The device is intended for clinical use by healthcare professionals to provide continuous monitoring, aiding in the assessment of patient oxygenation and heart rate. It benefits patients by enabling non-invasive, real-time physiological tracking.

Clinical Evidence

Bench testing and clinical accuracy trials were performed. Clinical accuracy was evaluated via an invasive 'breathe-down' study on 12 healthy adult volunteers (300 data pairs). SpO2 accuracy (Arms) was 1.37-1.39% in the 70-100% range. Pulse rate accuracy was tested using a simulator (30-250 BPM) with Arms of 1.63-1.67. All results met ISO 80601-2-61 requirements. Biocompatibility testing (ISO 10993-5/10) confirmed safety for patient contact.

Technological Characteristics

Materials: ABS, PVC, TPU, Silicone. Sensing: 2-wavelength optical absorption (Red: 660-666nm, IR: 880-950nm) via photodetector. Form factor: Finger clip or soft tip with DB9 connector. Connectivity: Wired to OEM patient monitor. Standards: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61, ISO 10993-5/10. Sterilization: Non-sterile.

Indications for Use

Indicated for continuous non-invasive monitoring of functional oxygen saturation (SpO2) and pulse rate (PR) in adult patients weighing >40kg.

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

• Solaris Medical Technology, Inc. Reusable & Disposable SPO2 Sensors (K100077)

Reference Devices

• Nellcor patient monitor (NPB40) (K963707)

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

August 18, 2016

Shenzhen Medke Technology Co., Ltd Lao Chengxin General Manager 4/F, Bldg. A1, Anle Ind. Zone, Hangcheng RD., Baoan Dist. Shenzhen , China 518126

Re: K152390

Trade/Device Name: Medke Oximetry Finger Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: July 15, 2016 Received: July 20, 2016

Dear Lao Chengxin:

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 mav 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 yours,

James J.
Lee -S

Digitally signed by James J. Lee -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=James J. Lee -S,
0.9.2342.19200300.100.1.1=2000954859
Date: 2016.08.18 17:22:19 -04'00'

For Tina Kiang, PhD 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)

Device Name

Medke Oximetry Finger Sensor

Indications for Use (Describe)

Medke Oximetry Finger Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40kg,

| <span style="text-align: left;">☒ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
|---------------------------------------------------------------------------------------|------------------------------------------------------------|
|---------------------------------------------------------------------------------------|------------------------------------------------------------|

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

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Image /page/3/Picture/0 description: The image shows the logo for Medke. The logo is blue with an orange accent. The logo is stylized and appears to be in a sans-serif font.

# Section 5

# 510(K) Summary

## 1. Prepared Date: 2016-8-16

## 2. Submitter Information

| Name | Shenzhen Medke Technology Co.,LTD |
|---------|------------------------------------------------------------------------|
| Address | 4/F,Bldg.A1,Anle Ind. Zone,Hangcheng RD.,Baoan<br>Dist.,Shenzhen,China |
| Tel | 0086-755-23463462 |
| Fax | 0086-755-29553084 |

### 3. Contact Person

| Contact person | LAO CHENGXIN |
|----------------|------------------------------------------------------------------------|
| Title | General Manager |
| Address | 4/F,Bldg.A1,Anle Ind. Zone,Hangcheng RD.,Baoan<br>Dist.,Shenzhen,China |
| Tel | 0086-755-23463462 |
| Fax | 0086-755-29553084 |
| E-mail | [e-mail] |

### 4. Proposed Device Information

| Trade Name | Medke Oximetry Finger Sensor |
|-----------------------|------------------------------|
| Model | P9119& P8119 |
| Common name | Oximeter |
| Regulatory class | II |
| Production regulation | 21 CFR §870.2700 |
| Product code | DQA |
| Panel | Cardiovascular |

### 5. Predicate Device Information

| 510(K)No. | Trade Name/model | Submitter |
|-----------|------------------------------------------------------------------------|----------------------------------|
| K100077 | Solaris Medical Technology, Inc.<br>Reusable & Disposable SPO2 Sensors | Solaris Medical Technology, Inc. |

### 6. Device description

The Medke Oximetry Finger Sensors are compatible sensor for use with major types of patient monitors and oximeter devices of Original Equipment Manufacturer (OEM).

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Image /page/4/Picture/0 description: The image shows the word "Medke" in a stylized, modern font. The word is primarily blue, with a small orange rectangle above the "d" and another above the "e". The font is bold and angular, giving the word a strong, technological feel.

The sensors are made up of connector, cable, two specific wavelength LEDs & a photo detector assembled into the sensor housing. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter.

The Medke Oximetry Finger Sensors contain finger clip type and soft tip type. The finger clip sensor is comprised of a plastic shell with silicone pads which position the optical components, and a cable with OEM compatible connector. The soft finger sensor consists of an integrated silicone rubber tip which is installed the optical components, and a cable with OEM compatible connector.

The Medke Oximetry Finger Sensors have unique labeling and specifications designed for compatibility with Nellcor patient monitor(NPB40) cleared in K963707.

## 7. Intended use

Medke Oximetry Finger Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40kg.

## 8. Comparison to predicate device

The Medke Oximetry Finger Sensors utilize the same measurement principles as the listed predicate devices: two wavelengths of light (red, infrared) from light emitting diodes (LED's) illuminate the patients arterial tissue; and the light transmission through the tissue is measured using a photodiode light detector. The transmission properties vary with the patient's arterial blood saturation and pulse rate.This method is fundamental to all pulse oximeter sensors and monitors for the non-invasive measurement of functional oxygen saturation (SpO2). Please see the comparison list:

| Comparison<br>item | Subject Device<br>Medke Oximetry<br>Finger Sensor (Model:<br>P9119& P8119) | Predicate Device<br>Reusable and disposable SPO2 sensor<br>compatibility with Nellcor<br>(model:T100A-090103 soft sensor)<br>K100077 | Note | |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|--|
| Intended use&<br>Indications for<br>Use | Medke Oximetry<br>Finger Sensor are<br>indicated for continuous<br>non-invasive monitoring<br>of functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and<br>pulse rate(PR) for adult | When used with a compatible patient<br>monitor or a pulse oximeter device, Solaris<br>Medical Technology, Inc. reusable &<br>disposable SpO2 sensors are intended to be<br>used for continuous, non-invasive functional<br>arterial oxygen saturation (SpO2)<br>and pulse rate monitoring.<br>Solaris Medical Technology, Inc. reusable | same | |
| | patients weighing<br>greater than40kg,. | multi-patient use SpO2 Soft Sensors,<br>reusable multi-patient use SpO2 Finger<br>Sensors, and disposable single patient use<br>SpO2 Soft-finger Sensors are for use with<br>adult/pedliatric patients weighing greater<br>than 40kg.<br>Solaris Medical Technology, Inc. disposable<br>single patient use SpO2 Adhesive<br>Sensors are for use with adult patients<br>weighing greater than 40kg, pediatric<br>patients weighing 10 - 40 kg, and infant<br>(non-neonatal) patients weighing 3 - 15kg.<br>Prescription device. | | |
| Measurement<br>Method | 2-wavelength Relative<br>Optical Absorption | 2-wavelength Relative Optical Absorption | Same | |
| Light Emitting | Red:660-666nm,<br>Ired:880-950nm | Red:660-666nm,<br>Ired:880-950nm | same | |
| Signal<br>Detection<br>Method | Photodetector | Photodetector | Same | |
| SPO2 Accuracy | $\pm3%(70-100%)$ | $\pm2%(70-100%)$ | Similar | |
| Pulse Rate<br>Accuracy | $\pm3(30-250bpm)$ | $\pm2(30-250bpm)$ | Simiar | |
| Applied<br>population | Adult( $\ge40Kg$ ) | Adult( $\ge40Kg$ ) | same | |
| Measurement<br>part | Fingers or toes | Fingers or toes | Same | |
| compatible<br>monitor | Nellcor(N395) | Nellcor(N395) | Same | |
| Sterility | No | No | Same | |
| Usage | Reusable | Reusable | Same | |
| Material | ABS,PVC,TPU,Silicone | ABS,PVC,Silicone | Similar | |
| Cable Length | 1.0 | 0.9 | Similar | |
| Proximal<br>connector<br>Design | DB9 9pin | DB9 7pin | Similar | |
| Distal<br>connector<br>Design | finger clip , soft tip, | soft tip | Similar | |
| Conformance<br>standard | IEC60601-1,IEC60601-<br>1-2.ISO80601-2-61.ISO | IEC60601-1,IEC60601-1-2,ISO80601-2-61<br>,ISO10993-5/10 | Same | |
| | | 10993-5/10 | | |

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Image /page/5/Picture/0 description: The image shows a logo with the word "Medke" in a stylized font. The letters are primarily blue, with orange accents on the top right of the "e" and the "k". The font is bold and slanted, giving the logo a dynamic and modern appearance.

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Image /page/6/Picture/0 description: The image shows the word "Medke" in a stylized font. The word is written in blue, with the exception of the top part of the letters "e" and "k", which are orange. The font is bold and slanted to the right, giving the word a sense of movement. The background of the image is white.

From the comparison form above, both devices have the same Measurement Method, Light Emitting, Signal Detection Method , Measurement part , compatible monitor , Sterility, Usage & Conformance standard.

Regarding SPO2 & Pulse Rate Accuracy, Material, Distal connector design, both devices have some difference, but the subject devices have passed the ISO80601-2-61, IEC60601-1,IEC60601-1-2,and ISO10993-5/10 testing.

According to contrast and analysis, So, the differences between subject device and predicate device do not raise different questions of safety or effectiveness.

## 9. Non-clinical test data

The subject device meets the following the recognized standards:

- IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety, 2005
- IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility-Requirements and Tests, 2007
- ISO 80601-2-61 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity, 2009
- ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity, 2010

### 10. Clinical data summary

### 1) SP02 Accuracy

According to IEC80601-2-61, Invasive "breathe-down" test refers to compare SpO2 which was measured from subject devices and CO-Oximeter of measured standard arterial blood SaO2, that is, through comparing and observing the SpO2 which was obtained from five oxygen saturation stable stages by inhaling different FiO2 by volunteers and SaO2 which was measured by extract radial artery blood sample periodically through arterial duct on a group of healthy adult volunteers within the scope of the oximeter accuracy specification.

12 healthy adults were selected as subjects for this accuracy trial. One subject can acquired 25 data samples, and 300 data pairs were obtained. Compare and analyze these data pairs (SPO2VSSaO2), the result is as follows:

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Image /page/7/Picture/0 description: The image shows a logo for a company or organization. The logo is composed of stylized text in blue, with a small orange accent on one of the letters. The text appears to be a brand name or acronym, designed with a modern and bold font style. The overall design is clean and professional, suggesting a corporate identity.

| Model | Monitor | Root Mean Square(Arms) | | | | | | | |
|------------|---------|------------------------|--------|--------|--------|-------|-------|-------|--------|
| | | 60-79 | 80-100 | 60-100 | 70-100 | 60-69 | 70-79 | 80-89 | 90-100 |
| P9119 | NPB-40 | 1.57 | 1.31 | 1.39 | 1.37 | 2.6 | 1.52 | 1.38 | 1.26 |
| P8119 | NPB-40 | 1.61 | 1.31 | 1.40 | 1.39 | 1.62 | 1.61 | 1.38 | 1.24 |
| Conclusion | | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass |

#### Table 1 SPO2 Accuracy

#### 2) PR Accuracy

Use the simulator with patient monitor(NPB40) to test the PR Accuracy in the range of 30-250BPM, the testing result is as follows:

| | Table 2 Pulse Rate Accuracy | | | | | | | |
|------------|-----------------------------|------------------|----------------|-------|-------|-------|-------|--------|
| Item | Sensor<br>model | Monitor<br>model | Arms<br>70-100 | 77-70 | 84-78 | 92-85 | 97-92 | 100-97 |
| 1 | P9119 | NBP-40 | 1.63 | 1.17 | 0.67 | 1.83 | 2.00 | 2.50 |
| 2 | P8119 | NBP-40 | 1.67 | 0.67 | 2.00 | 1.83 | 2.00 | 1.83 |
| Conclusion | | | Pass | Pass | Pass | Pass | Pass | Pass |

Table 2 Pulse Rate Accuracy

From the test result above,the SPO2 accuracy of Medke Oximetry Finger Sensor (P9119&P8119) is 1.37~1.39 in range 70-100%, and the PR accuracy is 1.63~1.67 in range 30~250 BPM, which meets the requirements of ISO80601-2-61.

### 11. Substantial Equivalence Statement

Based on the comparison ,analysis, and the submitted performance data, Medke Oximetry Finger Sensors are as safe and effective and are substantially equivalent to the predicate devices.