Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard pulse oximetry technology based on light absorption and does not mention any AI/ML components or algorithms.

Therapeutic

No
The device is a diagnostic tool for measuring physiological parameters (SpO2 and pulse rate), not for treating conditions. The "Intended Use" explicitly states it's for "spot-checking," not for continuous monitoring or therapy. Furthermore, it explicitly states, "The device is not intended for life-supporting or life-sustaining."

Diagnostic

Yes

The device measures oxygen saturation and pulse rate, which are physiological parameters used to assess a patient's health status. While it's for spot-checking and not continuous monitoring, the information it provides can be used to aid in a diagnosis or to monitor a condition. The "Intended Use / Indications for Use" section states it's for "spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR)," and the "Summary of Performance Studies" indicates clinical studies were conducted to verify accuracy against arterial oxygen saturation, implying a diagnostic context.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is composed of hardware components such as a PCB board, key, OLED&LED screen, battery compartment, and plastic shell, and is powered by batteries.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
This Device's Function: This Fingertip Pulse Oximeter is a non-invasive device that measures oxygen saturation and pulse rate directly from the fingertip. It does not analyze samples taken from the body. It works by shining light through the tissue and measuring the light absorption.

Therefore, based on the provided information, this device clearly falls outside the definition of an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It is indicated for adult patients in home and hospital environment. The device is not intended for continuous monitoring, use during motion or use with low perfusion.

Product codes

DQA

Device Description

The Fingertip Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).

The Fingertip Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The Fingertip Pulse Oximeter is powered by 2 AAA batteries. The device mainly composed of PCB board, one key, OLED&LED screen, battery compartment, and plastic shell. The device is a spot-check Fingertip Pulse Oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Fingertip

Indicated Patient Age Range

adult patients

Intended User / Care Setting

Home and Hospital

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

Not Found

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

Clinical studies were conducted to verify the accuracy of proposed device. The clinical studies were conducted per following standards:

ISO 80601-2-61: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
Pulse Oximeters-Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff

Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Pulse Oximeter versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range.

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

Not Found

Predicate Device(s)

K203854

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

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 30, 2022

Shenzhen Witleaf Medical Electronics Co.,Ltd % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China

Re: K213430

Trade/Device Name: Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: November 18, 2022 Received: November 18, 2022

Dear Kevin 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. 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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

James J. Lee -S

James J. Lee, Ph.D. Director DHT1C: Division of 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

2

Indications for Use

510(k) Number (if known) K213430

Device Name Fingertip Pulse Oximeter

Indications for Use (Describe)

This Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It is indicated for adult patients in home and hospital environment. The device is not intended for continuous monitoring, use during motion or use with low perfusion.

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

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3

510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2021/11/17

1. Submission sponsor

Name: Shenzhen Witleaf Medical Electronics Co., Ltd. Address: 13/F-B2, Block 1, Senyang Science Park, No.7 Road, West District of High-Tech Park, Guangming, Shenzhen City, Guangdong, 518109 P.R. China Contact person: Wu Tao Title: Management Representative E-mail: wutao@szwitleaf.com Tel: +86-755 21384132

2. Submission correspondent

Name: Chonconn Medical Device Consulting Co., Ltd.

Address: Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067

Contact person: Kevin Wang

E-mail: kevin(@chonconn.com

Tel: +86-755 33941160

Trade/Device Name	Fingertip Pulse Oximeter
Model	WIT-S200, WIT-S400
Common Name	Fingertip Pulse Oximeter
Regulatory Class	Class II
Classification	21CFR 870.2700 / Oximeter / DQA
Submission type	Traditional 510(K)

3 Subiect Device Information

4. Predicate Device

Manufacturer: Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd Device name: Pulse Oximeter, A2, A3, A4, A5 510(K) Number: K203854

5. Device Description

The Fingertip Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).

The Fingertip Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red

4

light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The Fingertip Pulse Oximeter is powered by 2 AAA batteries. The device mainly composed of PCB board, one key, OLED&LED screen, battery compartment, and plastic shell. The device is a spot-check Fingertip Pulse Oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.

6. Intended use & Indication for use

This Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It is indicated for adult patients in home and hospital environment. The device is not intended for continuous monitoring, use during motion or use with low perfusion.

Features	Subject Device	Predicate Device K203854	Comparison
	Fingertip Pulse Oximeter
WIT-S200, WIT-S400	Pulse Oximeter, Model: A2, A3, A4, A5
Applicant	Shenzhen Witleaf Medical
Electronics Co., Ltd.	Shenzhen Hexin ZONDAN
Medical Equipment Co., Ltd.	/
Classification
Regulation	21CRF 870.2700	21CRF 870.2700	Same
Classification
and Code	Class II, DQA	Class II, DQA	Same
Prescription or
OTC	Prescription	Prescription	Same
Intended use	This Fingertip Pulse Oximeter
is non-invasive device
intended for spot-checking of
functional oxygen saturation of
arterial hemoglobin (SpO2)
and pulse rate (PR). It is
indicated for adult patients in
home and hospital
environment. The device is not	The Pulse Oximeter is intended
for measuring the functional
oxygen
saturation and pulse rate (PR)
through a
patient's finger. It is applicable for
spot-checking SpO2 and pulse
rate (PR) of adult and pediatric
patients in homes and clinics.	Same
Indication for
use	intended for continuous
monitoring, use during motion
or use with low perfusion.	The Pulse Oximeter is non-
invasive device intended for spot-
checking of functional oxygen	Same
Features	Subject Device	Predicate Device K203854	Comparison
	Fingertip Pulse Oximeter
WIT-S200, WIT-S400	Pulse Oximeter, Model: A2, A3, A4, A5