K Number

Device Name

Med-Link Temp-pulse Oximeter

Manufacturer

Shenzhen Med-link Electronics Tech Co., Ltd

Date Cleared

2021-03-01

(164 days)

Product Code

DQA

Regulation Number

870.2700

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K191403

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on standard pulse oximetry technology and do not mention any AI or ML components or methodologies.

Therapeutic

No
The device is described as a diagnostic tool for measuring and displaying arterial oxygen saturation and pulse rate, not for providing therapy.

Diagnostic

Yes
The device is described as measuring and displaying functional arterial oxygen saturation (SpO2) and pulse rate, and it is used for "spot checking" of these vital signs, which are indicators used in the diagnosis and monitoring of health conditions.

SaMD (Software as a Medical Device)

The device description explicitly lists hardware components such as a power supply module, detector and emitter LED, signal collection and processor module, user interface, and button control. It also mentions a dual light source and a photo detector, which are physical components.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
Pulse Oximeter Function: A pulse oximeter measures oxygen saturation and pulse rate by shining light through the skin (typically on a finger) and detecting the amount of light absorbed. This is a non-invasive measurement performed on the living body.
Intended Use: The intended use clearly states it's for "spot checking in measuring and displaying functional arterial oxygen saturation (SpO2) and pulse rate of patients." This is a physiological measurement, not a diagnostic test performed on a sample.
Device Description: The description details the components involved in light emission and detection through the finger, consistent with a non-invasive physiological monitoring device.

Therefore, based on the provided information, the Med-link Pulse Oximeter is a non-invasive physiological monitoring device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DQA

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Finger

Indicated Patient Age Range

Adult and pediatric

Intended User / Care Setting

hospitals, physician's office, clinical settings and home care environment.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

The clinical study was conducted in the Yue Bei People's Hospital in accordance to ISO 14155-2, BS EN ISO 80601-2-61, and the FDA Guidance Document for Pulse Oximeters.
Subjects: After Institutional Review Board (IRB) approval, 12 healthy adult volunteer subjects (ages 19-34yr, 45-102kg, 160-192cm, with light to dark pigmentation) were included in the study to evaluate the SpO2 accuracy performance of the Shenzhen Med-link Pulse oximeter.
Methods: Each system was evaluated during steady state / non-motions 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 companson. Accuracy data was calculated using the root-mean-squared (ARMS value) for all subjects.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical Performance Data: The purpose of this study was to evaluate the SpO2 accuracy performance of Shenzhen Med-link Pulse oximeter, during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood CO-Oximetry.
Sample Size: 12 healthy adult volunteer subjects.
Key Results: The results show the Shenzhen Med-link Pulse oximeter to pass a SpO2 accuracy specification of 3 during steady state conditions over the range of 70-100%.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

SpO2 accuracy specification of 3

Predicate Device(s)

K191403

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

Indications for Use

510(k) Number (if known) K202743

Device Name Med-link Pulse Oximeter

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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: 0086-755-61568825 Fax: 0086-755-6112005 5 Establishment Registration Number: 3006636961

2. Corres pondent

Jialing Zhang (Regulatory Affairs Specialist, Primary Contact) E-mail: user60@med-linket.com

Yi Liu E-mail: user22@med-linket.com

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

K202743

Shenzhen Med-link Electronics Tech Co., Ltd.

5. Identification of the Predicate Device

Table 1 Predicate Device Information

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

8. Comparison to the Predicate Device

Item	Proposed Device	Predicate Device	Verdict
Trade name	Med-link Pulse Oximeter	Nonin Onyx 3, Model9591 Finger
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
Regulation	21 CFR 870.2700	21 CFR 870.2700	Same
Classification and
Code	Class II,
DQA	Class II,
DQA	Same
Common name	Pulse Oximeter	Finger Pulse Oximeter	Same
Type of Use	Prescription	Prescription	Same
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.	The Nonin® Model 9591 Onyx® 3
Finger Pulse Oximeter is a small,
lightweight, portable and reusable
spot-check device indicated for use
in measuring and displaying
functional oxygen saturation of
aterial hemoglobin(%SpO2) and
pulse rate of patients who are well
or poorly perfused. The Respiration
Rate parameter provides a
non-invasive measurement of
respiration rate, in breaths per
minute.
For %SpO2, and pulse rate, the 9591
is intended for use in hospitals,
clinics, long-term care facilities,
skilled nursing facilities, and home
healthcare services. It is intended for
adult and pediatric patients who are
well or poorly perfused, with digits
that are between 0.3~1.0
inch(0.8~2.5cm) thick, under
non-motion conditions.
For Respiration rate, the 9591 is
intended for use in hospitals, clinics,	Different note
1
Item	Proposed Device	Predicate Device	Verdict
		long-term care facilities, skilled
nursing facilities, and home
healthcare services. It it intended for
adult who are well perfused, with
digits that are between 0.3~1.0
inch (0.8~2.5cm) thick, under non
-motion conditions. It is not
intended for use in high-acuity
environments, such as ICU or
operating rooms where continuous
monitoring is expected.
Operating
Principle	The measurement of PULSE
OXIMETER uses a multi-functional
oxyhemoglobinometer to transmit
some narrow spectrum light bands
through blood samples, and to
measure attenuation of spectrum
with different wavelengths
according to the characteristic that
RHb, O2Hb, Met Hb and COHb
absorb the light of different
wavelength, thereby determining
O2Hb saturation of different
fractions. O2Hb saturation is called
"fractional" O2Hb saturation.
Present SpO2 oximeter transmits
light of two wavelengths only, red
light and infrared, to differentiate
HbO2 from HbR. One side of the
sensor contains two LEDs, and the
other side contains a photoelectric
detector. SpO2 oximeter measures
HbO2 saturation in the blood by the
light plethysmograph when the pulse	Pulse oximetry is a non-invasive
method that passes red and infrared
light through perfused tissue and
detects the fluctuating signals
caused by arterial pulses.
Well-oxygenated blood is bright red,
while poorly
oxygenated blood is dark red. The
pulse oximeter determines
functional oxygen saturation of
arterial hemoglobin (SpO2) from
this color difference by measuring
the ratio of absorbed red and
infrared light as volume fluctuates
with each pulse. Additionally, the
pulse oximeter uses variations in the
pulse volume fluctuation's
amplitude, baseline shift, and timing
to determine the respiratory rate.	Different note
1
Item	Proposed Device	Predicate Device	Verdict
	beats. The result is quite precise
when HbO2 saturation is between
70% to 100%.
Application site	Finger	Finger	Same
Usage	Reusable	Reusable	Same
SpO2 range	70% to 100%	0% to 100% SpO2	Different note
2
SpO2 resolution	1%	Not provided	Different note
2
SpO2 accuracy under
good perfusion	90% to 100% range: ±2%;
70% to 89% range: ±3%;