The Wrist Pulse Oximeter is intended for spot checking in measuring and displaying oxygen saturation of functional arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in hospital facilities and home healthcare environments.

Device Description

This device is a small, lightweight, portable device intended for use in measuring and displaying oxygen saturation of functional arterial haemoglobin (%SpO2) and pulse rate (PR).The device measures SpO2 and PR with a SpO2 senror and displays on the OLED after certain further processing. The device is mainly composed of the motherboard, SpO2 transducer and built-in battery. The power supply is 4.2V Li-battery and also the subject device can be powered by adapter. The subject device has a detachable sensor as an accessory to measure the SpO2 and pulse rate (PR). The subject device is not for life-supporting or life-sustaining and it is not an implantable device. The subject device owns software which has been validated by the manufacturer.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study findings for the Wrist Pulse Oximeter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The relevant acceptance criteria and performance data for the Wrist Pulse Oximeter primarily come from the "Substantial Equivalence" section and the "Clinical Test" section.

Feature	Acceptance Criteria (Predicate or Standard)	Reported Device Performance (SONOSAT-W01T)
SpO2 Accuracy	70 to 100% ±3% (Predicate MD300W4)	±2% in the range of 70% to 100%
SpO2 Measurement Range	70%-100% (Predicate MD300W4)	0%-100% (Subject Device)
Pulse Rate Accuracy	25bpm~250bpm, ±3bpm (Predicate MD300W4)	25bpm~250bpm, ±3bpm (Subject Device)
SpO2 Resolution	1% (Predicate MD300W4)	1% (Subject Device)
Pulse Rate Resolution	1 bpm (Predicate MD300W4)	1 bpm (Subject Device)
General Requirement	Compliance with IEC60601-1 (Predicate & Subject)	Compliance with IEC60601-1
Special Requirement	Compliance with ISO 80601-2-61, IEC 60601-1-11	Compliance with ISO 80601-2-61, IEC 60601-1-11
EMC	Compliance with IEC60601-1-2 (Predicate & Subject)	Compliance with IEC60601-1-2
Biocompatibility	Compliance with ISO10993-1 (Predicate & Subject)	Compliance with ISO10993-1
Biocompatibility Test Results	No toxicity, no delayed contact sensitization, no irritation to skin (Predicate)	No toxicity to cells, No delayed contact sensitization, No irritation to skin (Subject Device)
Software Validation	Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices	In compliance with FDA Guidance
Clinical Study Compliance	Compliance with ISO 80601-2-61:2011 and FDA guidance - "Pulse Oximeter Premarket Notification Submissions"	In compliance with standards and guidance

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The clinical evaluation was conducted on a total of 24 healthy adult male and female volunteers.
Data Provenance: The document does not explicitly state the country of origin for the clinical study participants beyond mentioning "2 white people, and 15 yellow-skin people." It is implied to be a prospective study as it describes a clinical evaluation conducted to generate data for the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical study. For pulse oximetry, the ground truth is typically established by arterial blood gas (ABG) analysis, which is a laboratory measurement, not directly by "experts" in the sense of human readers. The clinical study compares the device's readings against these reference measurements.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method in the context of human expert review for the test set. For a pulse oximeter, the "ground truth" is typically objective physiological measurements (ABG), not subjective expert interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. A MRMC study is typically performed for image-based diagnostic aids where the AI assists human readers. This document describes a medical device (pulse oximeter) that provides a direct physiological measurement, and its accuracy is validated against a gold standard (ABG), not via a comparative effectiveness study with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes. The primary study detailed is a standalone performance validation of the Wrist Pulse Oximeter where its measurements (SpO2 and pulse rate) are compared directly against a reference method (likely arterial blood gas measurements, though not explicitly stated for SpO2, it's the standard for oximeter validation). The reported SpO2 accuracy of ±2% is an algorithm-only performance metric.

7. The Type of Ground Truth Used

The ground truth for the SpO2 accuracy validation was established using a physiological reference standard. While not explicitly named for SpO2 in the clinical test section, the widely accepted and regulatory-mandated method for validating pulse oximeter accuracy (specifically the Arms value) involves inducing various levels of hypoxemia and comparing the oximeter readings to co-oximeter measurements of arterial blood samples (Arterial Blood Gas - ABG).

8. The Sample Size for the Training Set

The document does not provide information regarding a separate training set or its sample size. The description of validation usually pertains to the final, locked algorithm or device. For devices like pulse oximeters, the core algorithm is often developed based on photometric principles and extensive internal testing, rather than a "training set" in the machine learning sense. The clinical test described is a validation test, not a training activity.

9. How the Ground Truth for the Training Set was Established

As no training set is described in the document, there is no information provided on how ground truth for such a set (if it existed) was established. Device development often involves internal calibration and verification, but these details are not typically part of a 510(k) summary focused on regulatory validation.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other, representing the department's focus on people and health.

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

August 17, 2016

Jiangsu Konsung Bio-Medical Science and Technology Co. Ltd Mr. Yu Defeng No. 8, Shengchang West Road Danyang Economy Development Zone Jiang Su. China

Re: K152089

Trade/Device Name: Wrist Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: July 12, 2016 Received: July 19, 2016

Dear Mr. Defeng:

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.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

forth in the quality systems (QS) 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K152089

Device Name Wrist Pulse Oximeter

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR807.92 (a) (1)]

August 5th, 2016

2. Submitter's Information [21 CFR807.92 (a) (1)]

Name of Sponsor: Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd Address: NO.8,Shengchang West Road,Danyang Economy Development Zone China Contact Name: Li xu Telephone No.:+86-511-86378639 Fax No.: +86-511-86381308

3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]

Trade Name:	Wrist Pulse Oximeter
Model Name:	SONOSAT-W01T
Common Name:	Pulse Oximeter
Regulatory Classification:	21 CFR 870.2700
Product Code:	DQA
Classification Panel:	Anesthesiology
Device Class:	II

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicates within this submission are as follows:

K122046 Wrist Pulse Oximeter model MD300W4

5. Description of the Device [21 CFR 807.92(a)(4)]

The device is mainly composed of the motherboard, SpO2 transducer and built-in battery.

{4}------------------------------------------------

The power supply is 4.2V Li-battery and also the subject device can be powered by adapter.

The subject device has a detachable sensor as an accessory to measure the SpO2 and pulse rate (PR). The subject device is not for life-supporting or life-sustaining and it is not an implantable device.

The subject device owns software which has been validated by the manufacturer.

6. Indications for Use [21 CFR 807.92(a)(5)]

7. Technological Characteristics [21 CFR 807.92(a)(6)]

The Wrist 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 662±3 nm, which is red light; the other is 890±5 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 and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.This equipment mainly composed of the motherboard, SpO2 transducer and built-in battery.

8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]

The subject device wrist pulse oximeter has taken the Electricity safety, EMC, performance and biocompatibility testing into concern in accordance with Food and Drug Administration related guidance and recognized international standards.

Items	Predicate device	Subject device
	MD300W4	SONOSAT-W01T
Indications foruse	The MD300W4 wrist pulseoximeter is a portable non-invasive device intended for spotchecking, data collection andrecording of arterial oxygensaturation (SpO2) and pulse rateof adult and pediatric patient athome and hospital( includingclinical use in internist/ surgery,Anesthesia, intensive care andetc).	The Wrist Pulse Oximeter isintended for spot checking inmeasuring and displaying oxygensaturation of functional arterialhemoglobin (SpO2) and pulse rateof adult and pediatric patients inhospitals, hospital facilities andhome healthcare environments.
Intendedpatientpopulation	Adult, pediatric	Adult, pediatric
Intendapplication site	Finger	Finger
MeasurementRange	SpO270%-100%	SpO20%-100%
AccuracyTolerance	Saturation70 to 100% ±3%Less than 70%, unspecified	Saturation70 to 100% ±2%Less than 70%, unspecified
	Pulse Rate25bpm~250bpm,±3bpm	Pulse Rate25bpm~250bpm,±3bpm
Resolution	SpO2 1%Pulse Rate 1 bpm	SpO2 1%Pulse Rate 1 bpm
	Generalrequirement	Compliance with IEC60601-1
Specialrequirement	Compliance with ISO 80601-2-61Compliance with IEC 60601-1-11	Compliance with ISO 80601-2-61Compliance with IEC 60601-1-11
EMC	Compliance with IEC60601-1-2	Compliance with IEC60601-1-2
Biocompatibility	Compliance with ISO10993-1	Compliance with ISO10993-1
Regulation No.	CFR 870.2700	CFR 870.2700
Product code	DQA	DQA
Classification	II	II
Type ofprotection	Internally powered	Internally powered
Power Type	battery	battery
Degree ofprotection	Type BF - Applied part	Type BF - Applied part
Principles ofSensor	pulse oximetry sensors adopts	pulse oximetry sensors adopts
	non-invasive double wavelengthto measure SpO2 and PR	non-invasive double wavelength tomeasure SpO2 and PR
Testsconducted	Cytotoxicity,	Cytotoxicity,
	Delayed Contact Sensitization,	Delayed Contact Sensitization,
	Skin Irritation	Skin Irritation
Result of tests	No toxicity to cells,	No toxicity to cells,
	No delayed contact sensitization,	No delayed contact sensitization,
	No irritation to skin	No irritation to skin
Description	OLED	OLED
Pleth waveform	YES	YES
Lagre Numeric	YES	YES
SpO2	YES	YES
PR	YES	YES
Level ofconcern	Moderate	Moderate

The following is comparison table between subject device and predicate device.

{5}------------------------------------------------

Based on the comparison mentioned above, Test data and report information included in this submission, we demonstrate that the subject device is substantially equivalent to the predicate device.

{6}------------------------------------------------

9. Functional and safety testing

Non-Clinical Test

The SONOSAT-W01T Wrist Pulse Oximeter is tested in accordance with both mandatory and voluntary standards, including:

IEC 60601-1:2005+Corr.1 (2006)+Corr.2(2007) Medical equipment-Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2007/AC:2010 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility

IEC 60601-1-11:2010 medical electrical equipment - part 1-11: general requirements for basic safety and essential performance - collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

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

The Software Validation is in compliance with FDA Guidance to Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards of ISO10993. "Biological Evaluation of Medical Devices".

Clinical Test

The clinical evaluation was conducted and the result of SONOSAT-W01T Wrist Pulse Oximeter is in compliance with the criteria of ISO 80601-2-61:2011 standard and FDA guidance - "Pulse Oximeter Premarket Notification Submissions". The functional oxygen saturation (SpO2) measurement has been validated on a total of 24 healthy adult male and female volunteers with2 white people, and 15 yellow-skin people in the range of 70% to 100%.

The SpO2 accuracy result showed that the root-mean-square (Arms) value of SONOSAT-W01T Wrist Pulse Oximeter is ±2% with the saturations from 70% to 100%.

10. Conclusion [21 CFR 807.92(b) (3)]

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd concludes that SONOSAT-W01T Wrist Pulse Oximeter is substantially equivalent to predicate devices.

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).