The Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult (> 40 kg) and pediatric (10-50 kg) patients.

Device Description

The proposed device, Reusable SpO2 Sensors are accessories to patient monitors, which are intended for continuous non-invasive monitoring of functional arterial oxygen saturation and pulse rate. The compatible patient monitor is EDAN iM50 with Nellcor SpO2 module (K113623).

The sensor shall be connected with its corresponding monitor. 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 pulse rate conditions.

Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. The light is emitted through human finger and received by a photodiode. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Reusable SpO2 Sensor, based on the provided FDA 510(k) summary:

This device is a Reusable SpO2 Sensor, an accessory to patient monitors used for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult (> 40 kg) and pediatric (10-50 kg) patients.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document specifically details performance criteria and claims for SpO2 and PR accuracy compared to a legally marketed predicate device.

Criteria	Acceptance Criteria (Predicate Device K142832)	Reported Device Performance (Reusable SpO2 Sensor)	Meets Criteria?
SpO2 Range	70% - 100%	70% - 100%	Yes
SpO2 Accuracy	±3%	±3%	Yes
PR Range	30 bpm - 250 bpm	30 bpm - 250 bpm	Yes
PR Accuracy	±3	±3	Yes
Electrical Safety	Complied with IEC 60601-1	Complied with IEC 60601-1	Yes
EMC	Complied with IEC 60601-1-2	Complied with IEC 60601-1-2	Yes
Performance (general)	Complied with ISO 80601-2-61	Complied with ISO 80601-2-61	Yes
Biocompatibility - Cytotoxicity	Complied with ISO 10993-5	Complied with ISO 10993-5	Yes
Biocompatibility - Skin Irritation	Complied with ISO 10993-10	Complied with ISO 10993-10	Yes
Biocompatibility - Sensitization	Complied with ISO 10993-10	Complied with ISO 10993-10	Yes

Note: The document emphasizes substantial equivalence to the predicate device, meaning the new device's performance is demonstrated to be equivalent to a device already cleared by the FDA. The performance data presented are in direct comparison to the predicate's stated specifications.

Study Details Proving Device Meets Acceptance Criteria:

The information provided is typical for a 510(k) submission, focusing on demonstrating substantial equivalence rather than a detailed standalone clinical study report.

2. Sample Sizes Used for the Test Set and Data Provenance:

Test Set Sample Size: The document states that "Clinical hypoxia test results were obtained in human adult volunteers." However, the specific number of adult volunteers (sample size) used for the clinical accuracy testing is not provided in this summary.
Data Provenance: The data appears to be prospective clinical data gathered specifically for this submission, as indicated by "Clinical testing has been performed under an approved protocol with subject informed consent." The country of origin for the data is not explicitly stated, but the submitting company and correspondent are based in Shenzhen, China.

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

This information is not provided in the document. For pulse oximetry clinical studies, ground truth is typically established by arterial blood gas analysis (co-oximetry), not by expert consensus on visual assessment or interpretation.

4. Adjudication Method for the Test Set:

Adjudication methods (like 2+1, 3+1) are typically relevant for studies involving human interpretation of medical images or data where subjective decisions are made. For a pulse oximetry study where ground truth is established by a quantitative measurement (co-oximetry), traditional adjudication methods as described are not applicable.

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

No, an MRMC study was not done. MRMC studies are designed to compare the performance of human readers, often with and without AI assistance, especially in diagnostic imaging. This device is a sensor, and its accuracy is assessed quantitatively against a gold standard (co-oximetry), not through human reader interpretation. Therefore, questions about an effect size of human readers improving with AI assistance are not applicable to this type of device and study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

Yes, in essence. The clinical accuracy study ("Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Changke Reusable SpO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry") assesses the performance of the device (including its internal algorithm for calculating SpO2 and PR) against a gold standard. While the device outputs data for human use, the accuracy assessment itself is effectively a standalone performance evaluation of the sensor and its processing capabilities.

7. The Type of Ground Truth Used:

The ground truth used for the clinical accuracy testing was arterial oxygen saturation (SaO2) as determined by co-oximetry. Co-oximetry is considered the gold standard for measuring arterial oxygen saturation.

8. The Sample Size for the Training Set:

This information is not provided in the 510(k) summary. For medical devices, particularly sensors, "training set" is often interpreted as the data used during the development and calibration of the device's algorithms. The summary focuses on the validation data (clinical studies) rather than internal R&D or algorithm training data.

9. How the Ground Truth for the Training Set Was Established:

As the sample size and specific details of a "training set" (in an AI/ML context) are not explicitly mentioned for this device's development, the method for establishing ground truth for any such internal data is not provided. However, it is inferred that similar, highly accurate methods (like co-oximetry) would have been used during the sensor's design and calibration phases to ensure its foundational accuracy.

Summary

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October 11, 2019

Shenzhen Changke Connect Electronics 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: K191420

Trade/Device Name: Reusable SpO2 Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: September 9, 2019 Received: September 9, 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.

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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-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.

for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K191420

Device Name Reusable SpO2 Sensor

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)
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510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2019/10/10

1. Submission sponsor

Name: Shenzhen Changke Connect Electronics Co., Ltd. Address: A2-4th floor of Xiang dali Technology Park, No.87 of HengPing Road, Henggang, Longgang District, Shenzhen, P.R. China Contact person: Yahui Zhou Title: General Manager E-mail: zhouyahui(@szcklt.com Tel: +86 136 1301 2560

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

3. Subiect Device Information

4. Predicate Device

By submission of the Traditional 510(k), Shenzhen Changke Connect Electronics Co., Ltd. is requesting clearance for Reusable SpO2 Sensor. It is comparable to the following legally marketed system:

UNIMED MEDICAL SUPPLIES INC. Unimed Reusable SpO2Sensors under K142832.

ട്. Device Description

The sensor shall be connected with its corresponding monitor. Oxygenation of blood is measured by

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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 pulse rate conditions.

6. Intended use & Indication for use

Features	Subject DeviceReusable SpO2 Sensors	Predicate Device K142832Unimed Reusable SpO2Sensors	Comparison
Applicant	Shenzhen Changke ConnectElectronics Co., Ltd.	Unimed Medical Supplies Inc.	/
ClassificationRegulation	21CRF 870.2700	21CRF 870.2700	Same
Classificationand Code	Class II, DQA	Class II, DQA	Same
Commonname	Oximeter (Accessory-sensor)	Oximeter (Accessory-sensor)	Same
Intended use	The Reusable SpO2 Sensors areindicated for continuousnon-invasive monitoring offunctional oxygen saturation ofarterial hemoglobin (SpO2) andpulse rate (PR) for adult (> 40kg) and pediatric (10-50 kg)patients.	Unimed Disposable and ReusableSPO2 Sensors are indicated forcontinuous non-invasivemonitoring of functional oxygensaturation of arterial hemoglobin(SpO2) and pulse rate (PR) foradult patients weighing greaterthan40kg, pediatric patientsweighing 10 -50 kg, and neonatalpatients weighing no less than 3Kg.	Different (1)
Principle ofoperation	2-wavelength Relative OpticalAbsorption	2-wavelength Relative OpticalAbsorption	Same
Light	Red: 660-666nm	Red: 660-666nm	Same
Features	Subject DeviceReusable SpO2 Sensors	Predicate Device K142832Unimed Reusable SpO2Sensors	Comparison
EmittingSignalDetectionMethod	Infrared: 880-950nm	Infrared: 880-950nm	Same
SpO2 Range	70%-100%	70%-100%	Same
SpO2Accuracy	±3%	±3%	Same
PR Range	30 bmp - 250 bmp	30 bmp - 250 bmp	Same
PR Accuracy	±3	±3	Same
Sterile	No	No	Same
Usage	Reusable	Disposable, reusable	Same
Supplicationsite	Finger	Finger or toes	Different (2)
PatientcontactingMaterials	Silica gel	Silica gel, Foam, 3M Textile	Different (3)
Cable length	3000 mm	Finger clip: 1100 ± 100 mm	Different (4)
Patient enddesign	finger clip,	finger clip, soft tip, TextileAdhesive, and Non-Adhesive	Different (5)
Connectordesign	6 pin LEMO Connector	DB9M ConnectorMasimo 6p ConnectorHypertronic 7pin Connector	Different (6)
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

7. Comparison to the Predicate Device

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

Different (1): The intended population of proposed devices is within the range of predicate devices. This specification has been verified and validated according to ISO 80601-2-61: 2017 clause 201.12.1.101 clinical accuracy of pulse oximeter equipment. Thus, this difference does not raise different questions of safety and effectiveness.

Different (2): The proposed devices are intended used on finger. This clinical use has been verified and validated according to ISO 80601-2-61: 2017 clause 201.12.1.101 clinical accuracy of pulse oximeter equipment. Thus, this difference does not raise different questions of safety and effectiveness.

Different (3): The predicate devices have 3 type of patient contacting materials and the proposed devices

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have 1 type. The proposed devices can meet the requirement of ISO 10993-5/-10, so this difference does not raise different questions of safety and effectiveness.

Different (4): The cable length is different. However, the proposed devices can meet the requirement of IEC 60601-1, IEC 60601-1-2 and ISO 80601-2-61, so this difference does not raise different questions of safety and effectiveness.

Different (5): The predicate devices have 4 type of patient end design (finger clip, soft tip, Textile Adhesive, and Non-Adhesive). The proposed devices have 1 type of patient end which is finger clip. The proposed devices can meet the requirement of IEC 60601-1-2 and ISO 80601-2-61, so this difference does not raise different questions of safety and effectiveness.

Different (6): The connector design depends on the socket of the compatible patient monitor. The proposed devices can meet the requirement of IEC 60601-1-2 and ISO 80601-2-61 with the compatible patient monitor, so this difference does not raise different questions of safety and effectiveness.

Performance Data 8.

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

Biocompatibility testing

The biocompatibility evaluation for the Changke Reusable SpO2 Sensors 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
. Sensitization
Irritation ●

The subject devices are considered surface contacting for a prolonged duration exceeding 24 hours but not 30 days.

Non-clinical data

The Changke Reusable SpO2 Sensors have 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: 2011 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.

The tests accordance with IEC 60601-1. IEC 60601-1-2. ISO 80601-2-61 and ISO 10993 series are selected to show substantial equivalence between the subject device and the predicate.

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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 Changke Reusable SpO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range.

9. Conclusion

Performance testing and compliance with voluntary standards demonstrate that the proposed devices are substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use.

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).