The Disposable SPO2 Sensor is indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40 kg at hospital facilities.

Device Description

The proposed device, Disposable SpO2 Sensor is accessory to the oximeter, which is intended for continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive with U.S. legally marketed oximeter. It is only intended for adult. The sensor shall be connected with the corresponding monitor (Nellcor N-600). Oxygenation of blood is measured by detecting the infrared and red-light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin, which consists of a probe attached to the patient's finger. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions. Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. Red and infrared light lit alternately according to certain sequence, when the fingertips of capillary repeatedly with the heart pumps blood congestion, light emitting diode after blood vessels and projected onto a photodiode, photodiode can be induced to change with pulse light intensity, the electrical signals in the form of change. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. By measuring the wave crest of the pulse wave and the absorbance of the trough, SpO2 is calculated to obtain the correct oxygen saturation value. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Disposable SpO2 Sensor and includes information about its performance data. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. While it states that clinical studies were conducted to verify accuracy and that the device complies with ISO 80601-2-61:2017, the specifics of those studies (sample size, ground truth methodology, expert qualifications, etc.) are lacking.

Therefore, I will extract what is available and indicate where information is not provided in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Predicate Device)	Reported Device Performance (Subject Device)
SpO2 Range	70% - 100%	70% - 100%
SpO2 Accuracy	±3%	±3%
PR Range	35 bpm - 240 bpm	30 bpm - 250 bpm
PR Accuracy	±2 bpm	±3 bpm
Sterility	No	No
Usage	Disposable	Disposable
Electrical Safety	Complied with IEC 60601-1	Complied with IEC 60601-1
EMC	Complied with IEC 60601-1-2	Complied with IEC 60601-1-2
Performance	Complied with ISO 80601-2-61	Complied with ISO 80601-2-61
Biocompatibility	Complied with ISO 10993-5	Complied with ISO 10993-5
Skin Irritation	Complied with ISO 10993-10	Complied with ISO 10993-10
Sensitization	Complied with ISO 10993-10	Complied with ISO 10993-10

2. Sample size used for the test set and the data provenance

The document states: "Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of disposable SpO2 Sensor versus arterial oxygen saturation (SaO2) as determined by co-oximetry."

Sample Size (Test Set): Not specified.
Data Provenance: Human adult volunteers, prospective study (clinical hypoxia test). Country of origin is not specified, but the submission sponsor and correspondent are based in Shenzhen, China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method for the test set

Adjudication Method: Not specified. The ground truth was established by "co-oximetry," which is an objective measurement rather than expert consensus on images.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is an accessory device (SpO2 sensor) for an oximeter, not an AI-powered diagnostic system involving human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the performance evaluation of the Disposable SpO2 Sensor for SpO2 accuracy and PR accuracy is a standalone assessment of the device's measurement capabilities. The clinical hypoxia test specifically aims to validate the accuracy of the device against a reference standard (co-oximetry). There is no "human-in-the-loop" component in the performance of the sensor itself, as it is a measurement device.

7. The type of ground truth used

Type of Ground Truth: Arterial oxygen saturation (SaO2) as determined by co-oximetry, which is considered an objective, established medical measurement for blood oxygen levels.

8. The sample size for the training set

The document does not mention a "training set" in the context of machine learning. The device's performance is verified through clinical testing against a reference standard rather than through algorithm training on a dataset.

9. How the ground truth for the training set was established

Not applicable as no training set for a machine learning algorithm is discussed. The device is a direct measurement sensor.

Summary

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Shenzhen SINO-K Medical Technology Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical devices Industrial Park, Nanshan District Shenzhen, 518067 CN

Re: K192608

Trade/Device Name: Disposable SpO2 Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: December 26, 2019 Received: December 26, 2019

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

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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 (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,

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 Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

Device Name Disposable SpO2 Sensor

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)	✓ 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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FORM FDA 3881 (7/17)	Page 1 of 1	PSC Publishing Services (301) 443-6740 EF
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K192608

510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2019/09/17

Submission sponsor 1.

Name: Shenzhen SINO-K Medical Technology Co., Ltd.

Room401, Bldg2, Veteran Ind. City, Gongle Community, Xixiang Street, Baoan District, Shenzhen, Guangdong, China Contact person: Lao Chengxin Title: General Manager E-mail: boss@sino-k.com Tel: +86 137 15333326

2. Submission correspondent

Name: Chonconn Medical Device Consulting Co., Ltd.

Address: No. A415, Block A, NanShan Medical devices Industrial Park Nanshan District, Shenzhen, Guangdong, P.R. China 518067 Contact person: Kevin Wang

E-mail: kevin(@chonconn.com

Tel: +86-755 33941160

Trade/Device Name	Disposable SpO2 Sensor
Common Name	Oximeter (Accessory-sensor)
Regulatory Class	Class II
Classification	21CFR 870.2700 / Oximeter / DQA
Submission type	Traditional 510(K)

3. Subject Device Information

4. Predicate Device

Manufacturer: Orantech Inc. 510 (k) #: K181270 Product Name: Disposable SpO2 Sensors

5. Device Description

The sensor shall be connected with the corresponding monitor (Nellcor N-600). Oxygenation of blood is measured by detecting the infrared and red-light absorption characteristics of deoxygenated hemoglobin

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and oxygenated hemoglobin, which consists of a probe attached to the patient's finger. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions.

Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. Red and infrared light lit alternately according to certain sequence, when the fingertips of capillary repeatedly with the heart pumps blood congestion, light emitting diode after blood vessels and projected onto a photodiode, photodiode can be induced to change with pulse light intensity, the electrical signals in the form of change. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. By measuring the wave crest of the pulse wave and the absorbance of the trough, SpO2 is calculated to obtain the correct oxygen saturation value. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

Intended use & Indication for use 6.

Features	Subject DeviceDisposable SpO2 Sensors	Predicate Device K181270Disposable SpO2 Sensors	Comparison
Applicant	Shenzhen SINO-K MedicalTechnology Co., Ltd.	Orantech Inc.	/
ClassificationRegulation	21CFR 870.2700	21CFR 870.2700	Same
Classificationand Code	Class II, DQA	Class II, DQA	Same
Commonname	Oximeter (Accessory-sensor)	Oximeter (Accessory-sensor)	Same
Intended use	The Disposable SPO2 Sensor isindicated for continuous non-invasive monitoring offunctional oxygen saturation ofarterial hemoglobin (SpO2) andpulse rate (PR) for adultpatients weighing greater than40 kg at hospital facilities.	The Disposable and ReusableSPO2 Sensors are indicated forcontinuous non-invasivemonitoring of functional oxygensaturation of arterial hemoglobin(SpO2) and pulse rate (PR) foradult patients weighing greaterthan 40 kg at hospital facilities.	Same
Principle ofoperation	2-wavelength Relative OpticalAbsorption	2-wavelength Relative OpticalAbsorption	Same

7. Comparison to the Predicate Device

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Features	Subject DeviceDisposable SpO2 Sensors	Predicate Device K181270Disposable SpO2 Sensors	Comparison
LightEmitting	Red: 660-666nmInfrared: 880-950nm	Red: 660, 661 and 663nmInfrared: 890, 904 and 940nm	Different 1)
SignalDetectionMethod	Photodetector	Photodetector	Same
SpO2 Range	70%-100%	70%-100%	Same
SpO2Accuracy	±3%	±3%	Same
PR Range	30 bpm - 250 bpm	35 bpm - 240 bpm	Different 2)
PR Accuracy	±3 bpm	±2 bpm
Sterile	No	No	Same
Usage	Disposable	Disposable	Same
ElectricalSafety	Complied with IEC 60601-1	Complied with IEC 60601-1	Same
EMC	Complied with IEC 60601-1-2	Complied with IEC 60601-1-2	Same
Performance	Complied with ISO 80601-2-61	Complied with ISO 80601-2-61	Same
Biocompatibility
Cytotoxicity	Complied with ISO 10993-5	Complied with ISO 10993-5	Same
Skin Irritation	Complied with ISO 10993-10	Complied with ISO 10993-10	Same
Sensitization	Complied with ISO 10993-10	Complied with ISO 10993-10	Same

Justifications for differences between proposed device and the predicate device are shown as below:

Different (1): The light emitting between proposed device and predicate device is slightly different. The light emitting affects the SpO2 measurement. The SpO2 and PR measurement has been verified and validated according to ISO 80601-2-61: 2017 clause 201.12.1.101 SpO2 accuracy of pulse oximeter equipment. This difference does not raise any different questions of safety or effectiveness.

Different (2): The PR measurement between proposed device and predicate device is different. This specification has been verified and validated according to ISO 80601-2-61: 2017. This difference does not raise any different questions of safety or effectiveness.

8. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:

Cytotoxicity .

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. Sensitization
Irritation .

The subject device is considered surface contacting for a duration of not exceed 24 hours.

Non-clinical data

The disposable SpO2 Sensor has been tested according to the following standards:

IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment-. Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic . safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests
. ISO 80601-2-61: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.

Clinical data

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 testing has been performed under an approved protocol with subject informed consent. Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of disposable SpO2 Sensor versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range.

9. Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the 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).