Med-Link Temp-pulse Oximeter

K202743 · Shenzhen Med-Link Electronics Tech Co., Ltd. · DQA · Mar 1, 2021 · Cardiovascular

Device Facts

• Record ID: K202743
• Device Name: Med-Link Temp-pulse Oximeter
• Applicant: Shenzhen Med-Link Electronics Tech Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Mar 1, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Med-link Pulse Oximeter is intended for spot checking in measuring and displaying functional arterial oxygen saturation (SpO2) and pulse rate of patients in hospitals, physician's office, clinical settings and home care environment. It's a reusable device intended for adults and pediatrics who are well or poorly perfused.

Device Story

Device is a reusable, non-sterile, finger-worn pulse oximeter for spot-checking SpO2 and pulse rate. Input: dual-wavelength light (660nm red, 905nm infrared) transmitted through finger tissue; photo detector measures light attenuation. Principle: photoplethysmography; calculates SpO2 based on differential absorption of light by oxygenated vs. deoxygenated hemoglobin in pulsating arterial bed. Output: SpO2, pulse rate, pulse waveform, bar graph, and battery status displayed on device screen. Used by clinicians or patients in hospitals, clinics, or home environments. Healthcare providers use output for spot-check assessment of patient oxygenation status; aids in clinical decision-making regarding patient respiratory health. Benefits: non-invasive, portable, rapid assessment of oxygen saturation.

Clinical Evidence

Clinical study conducted on 12 healthy adult volunteers (ages 19-34) with varying skin pigmentation. Subjects underwent induced hypoxia (70-100% SaO2) under stationary conditions. Device SpO2 accuracy compared against arterial blood CO-Oximetry. Results demonstrated an ARMS value of 3% over the 70-100% range. No adverse events reported.

Technological Characteristics

Materials: ABS enclosure, PC lens, silica gel finger pad. Sensing: dual-wavelength (660nm/905nm) LED emitter and photo detector. Power: 2x 1.5V AAA alkaline batteries. Form factor: finger-worn. Connectivity: standalone. Software: moderate level of concern. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-61, ISO 10993-5/10.

Indications for Use

Indicated for spot-check measurement of SpO2 and pulse rate in adult and pediatric patients, including those who are well or poorly perfused, in hospitals, clinics, physician offices, and home care settings.

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

• Nonin Onyx 3, Model 9591 (K191403)

Submission Summary (Full Text)

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Shenzhen Med-link Electronics Tech Co., Ltd Jialing Zhang Regulatory Affairs Specialist 4th and 5th Floor, Building Two, Hualian Industrial Zone Xinshi Community, Dalang Street Shenzhen, Guangdong 518109 China

Re: K202743

Trade/Device Name: Med-Link Temp-pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: January 22, 2021 Received: January 25, 2021

Dear Jialing Zhang:

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 Actinclude 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 (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-devices/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 ([e-mail]) or phone [phone] 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 Ouality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K202743

Device Name Med-link Pulse Oximeter

Indications for Use (Describe)

Med-link Pulse Oximeter is intended for spot checking in measuring and displaying functional arterial oxygen saturation (SpO2) and pulse rate of patients in hospitals, physician's office, clinical settings and home care environment. It's a reusable device intended for adults and pediatrics who are well or poorly perfused.

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

| <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------|
| <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/2 description: The image shows the logo for MedLinket. The logo is composed of the letter 'M' in orange and the rest of the word 'MedLinket' in blue. The logo is simple and modern.

## 510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

Type of submission:Traditional

The assigned 510(k) number is: K202743

### 1. Submitter information

Manufacturer Name: Shenzhen Med-link Electronics Tech Co., Ltd. Address: 4th and 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community, Dalang Street, Longhua District, 518109 Shenzhen, PEOPLE'S REPUBLIC OF CHINA Tel: [phone] Fax: [phone] Establishment Registration Number: 3006636961

### 2. Corres pondent

Jialing Zhang (Regulatory Affairs Specialist, Primary Contact) E-mail: [e-mail]

Yi Liu E-mail: [e-mail]

### 3. Data of Preparation

22nd, Jan. 2021

#### 4. Identification of the Device

Trade Name: Med-link Pulse Oximeter Common Name: pulse oximeter Classification Regulation: 21 CFR 870.2700 Product Code: DQA Class: II Review Panel: Anesthesiology

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K202743

### Shenzhen Med-link Electronics Tech Co., Ltd.

### 5. Identification of the Predicate Device

### Table 1 Predicate Device Information

| No. | Device Name | Common<br>Name | Manufacturer | Classification<br>and Code | Classification<br>regulation | 510(k)<br>number |
|-----|-------------------------|--------------------------|------------------------|----------------------------|------------------------------|------------------|
| 1 | Nonin Onyx 3, Model9591 | Finger Pulse<br>Oximeter | Nonin<br>Medical, Inc. | Class II,<br>DQA | 21 CFR<br>870.2700 | K191403 |

#### Intended Use and Indications for Use of the Subject Device 6.

Med-link Pulse Oximeter is intended for spot checking in measuring functional arterial oxygen saturation (SpO2) and pulse rate of patients in hospitals, physician's office, clinical settings and home care environment. It's a reusable device intended for adults and pediatrics who are well or poorly perfused.

### 7. Device Description

Med-Link Pulse Oximeter is to spot-check oxygen saturation in blood (SpO2) and pulse oximeter is used on adults and pediatrics at hospital, clinics, and/or home. The device mainly consists of power supply module, detector and emitter LED, signal collection and processor module, user interface and button control. There is no visual or audio alarm. The device is reusable and non-sterile. The device has AM801. The device contains a dual light source (Red LED and Infrared red LED) and a photo detector. Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over time. The arteriolar bed normally pulsates and absorbs variable amounts of light during the pulsations. The ratio of light absorbed in an oxygen saturation measurement (SpO2). Because a measurement of SpO2 is dependent on light from the device, excessive ambient light can interfere with this measurement. The wavelength of red LED is 660mm and infrated LED is 905nm with maximum optical output power of 15mW.

### 8. Comparison to the Predicate Device

| Item | Proposed Device | Predicate Device | Verdict |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Trade name | Med-link Pulse Oximeter | Nonin Onyx 3, Model9591 Finger<br>Pulse Oximeter | / |
| 510(K) Submitter | Shenzhen Med-link Electronics | Nonin Medical, Inc. | / |
| Item | Proposed Device | Predicate Device | Verdict |
| | Tech Co., Ltd. | | |
| 510(K) Number | K202743 | K191403 | / |
| Classification<br>Regulation | 21 CFR 870.2700 | 21 CFR 870.2700 | Same |
| Classification and<br>Code | Class II,<br>DQA | Class II,<br>DQA | Same |
| Common name | Pulse Oximeter | Finger Pulse Oximeter | Same |
| Type of Use | Prescription | Prescription | Same |
| Intended use | Med-link Pulse Oximeter is intended<br>for spot checking in measuring and<br>displaying functional arterial oxygen<br>saturation (SpO2) and pulse rate of<br>patients in hospitals, physician's<br>office, clinical settings and home<br>care environment. It's a reusable<br>device intended for adults and<br>pediatrics who are well or poorly<br>perfused. | The Nonin® Model 9591 Onyx® 3<br>Finger Pulse Oximeter is a small,<br>lightweight, portable and reusable<br>spot-check device indicated for use<br>in measuring and displaying<br>functional oxygen saturation of<br>aterial hemoglobin(%SpO2) and<br>pulse rate of patients who are well<br>or poorly perfused. The Respiration<br>Rate parameter provides a<br>non-invasive measurement of<br>respiration rate, in breaths per<br>minute.<br>For %SpO2, and pulse rate, the 9591<br>is intended for use in hospitals,<br>clinics, long-term care facilities,<br>skilled nursing facilities, and home<br>healthcare services. It is intended for<br>adult and pediatric patients who are<br>well or poorly perfused, with digits<br>that are between 0.3~1.0<br>inch(0.8~2.5cm) thick, under<br>non-motion conditions.<br>For Respiration rate, the 9591 is<br>intended for use in hospitals, clinics, | Different note<br>1 |
| Item | Proposed Device | Predicate Device | Verdict |
| | | long-term care facilities, skilled<br>nursing facilities, and home<br>healthcare services. It it intended for<br>adult who are well perfused, with<br>digits that are between 0.3~1.0<br>inch (0.8~2.5cm) thick, under non<br>-motion conditions. It is not<br>intended for use in high-acuity<br>environments, such as ICU or<br>operating rooms where continuous<br>monitoring is expected. | |
| Operating<br>Principle | The measurement of PULSE<br>OXIMETER uses a multi-functional<br>oxyhemoglobinometer to transmit<br>some narrow spectrum light bands<br>through blood samples, and to<br>measure attenuation of spectrum<br>with different wavelengths<br>according to the characteristic that<br>RHb, O2Hb, Met Hb and COHb<br>absorb the light of different<br>wavelength, thereby determining<br>O2Hb saturation of different<br>fractions. O2Hb saturation is called<br>"fractional" O2Hb saturation.<br>Present SpO2 oximeter transmits<br>light of two wavelengths only, red<br>light and infrared, to differentiate<br>HbO2 from HbR. One side of the<br>sensor contains two LEDs, and the<br>other side contains a photoelectric<br>detector. SpO2 oximeter measures<br>HbO2 saturation in the blood by the<br>light plethysmograph when the pulse | Pulse oximetry is a non-invasive<br>method that passes red and infrared<br>light through perfused tissue and<br>detects the fluctuating signals<br>caused by arterial pulses.<br>Well-oxygenated blood is bright red,<br>while poorly<br>oxygenated blood is dark red. The<br>pulse oximeter determines<br>functional oxygen saturation of<br>arterial hemoglobin (SpO2) from<br>this color difference by measuring<br>the ratio of absorbed red and<br>infrared light as volume fluctuates<br>with each pulse. Additionally, the<br>pulse oximeter uses variations in the<br>pulse volume fluctuation's<br>amplitude, baseline shift, and timing<br>to determine the respiratory rate. | Different note<br>1 |
| Item | Proposed Device | Predicate Device | Verdict |
| | beats. The result is quite precise<br>when HbO2 saturation is between<br>70% to 100%. | | |
| Application site | Finger | Finger | Same |
| Usage | Reusable | Reusable | Same |
| SpO2 range | 70% to 100% | 0% to 100% SpO2 | Different note<br>2 |
| SpO2 resolution | 1% | Not provided | Different note<br>2 |
| SpO2 accuracy under<br>good perfusion | 90% to 100% range: ±2%;<br>70% to 89% range: ±3%;<br><70%: unspecified. | ±2 digits | Different note<br>2 |
| SpO2 accuracy under<br>low perfusion | 90% to 100% range: ±2%;<br>70% to 89% range: ±3%;<br><70%: unspecified. | ±2 digits | Different note<br>2 |
| Pulse rate range | 30 to 245 bpm | 18~321 BPM | Different note<br>2 |
| Pulse rate resolution | 1 bpm | Not provided | Different note<br>2 |
| Pulse rate accuracy<br>under good perfusion | ±3 bpm | 20 to 250 BPM±3 digits | Different note<br>2 |
| Pulse rate accuracy<br>underlow perfusion | ±3 bpm | 40 to 240 BPM±3 digits | Different note<br>2 |
| Applicable population | Adult and pediatric | Adult and pediatric | Same |
| Measurement<br>wavelength | Red: approximately 660nm;<br>Infrared: approximately 905nm | 660 and 910 nanometers | Different note<br>3 |
| Operation<br>Environment | Temperature:<br>41°F~104°F(5°C~40°C);<br>Humidity: ≤80%; atmospheric<br>pressure: 86kPa~106kPa | Temperature: -5°C~40°C; humidity:<br>10~95% non-condensing; | Different note<br>4 |
| Storage Environment | Temperature<br>14°F~104°F(-10°C~40°C); humidity<br>≤80%; atmospheric pressure:<br>86kPa~106kPa | Temperature: -40°C~70°C;<br>humidity: 10~95% non-condensing; | Different note<br>4 |
| Item | Proposed Device | Predicate Device | Verdict |
| Power requirements | 1.5V (AAA)alkaline batteryX2<br>(IEC Type<br>LR03) | 3V DC | Same |
| Battery life(operating) | 2400 spot checks<br>20 hours continuous | 2000 spot checks<br>25 hours continuous | Different note<br>5 |
| Battery life(storage) | 6 months, with batteries installed | 1 month, with batteries installed | Different note<br>5 |
| User interface | 8 directions for display | Not provided | Different note<br>5 |
| Display parameter | SpO2, Pulse Rate, Pulse Waveform<br>Display, Bar Graph(Pulse<br>Amplitude Indicator) and Battery<br>Indicator | SpO2, Pulse Rate and Respiration<br>Rate | Different note<br>5 |
| Electrical-type and<br>degree of protection | Type BF internally powered | Type BF internally powered | Same |
| Enclosure-degree<br>of<br>ingress<br>protection<br>against liquids | IPX2 | IP32 | Same |
| Measuring Mode | Spot-check…