Coreray Reusable SPO2 Sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel. The Reusable SPO2 Sensor is intended for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40kg.

Device Description

The Reusable SPO2 Sensor is comprised of a connector and a cable which terminates into sensor housing. The sensor contains two specific wavelength LEDs and a photo detector assembled into the sensor housing which separate by one housing half and the other half. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. One type of sensor housing is described in this submission: Reusable finger clip sensor. The sensor has a labeling and specifications designed for compatibility with a specific monitor.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a Reusable SpO2 Sensor. It outlines the device's characteristics, intended use, and a comparison to predicate devices to demonstrate substantial equivalence. The document includes information on the non-clinical and clinical tests performed.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from predicate/standards)	Reported Device Performance (Subject Device)
SpO2 Accuracy (70-100%)	±3% (70-100%)
Pulse Rate Accuracy (30-250bpm)	±3 (30-250bpm)

Study Details:

Table of Acceptance Criteria and Reported Device Performance: See table above. The acceptance criteria for SpO2 and Pulse Rate accuracy are directly compared to the predicate device's performance, specifically K153184 for SpO2 accuracy. The document states "compliance with the ISO80601-2-61" standard, which the SpO2 accuracy of ±3% (70-100%) meets.
Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document states, "Clinical testing is conducted for validation of SoO2 the Coreray Reusable & Disposable SpO2 Sensor." However, the exact number of subjects or data points for the clinical test is NOT explicitly stated in the provided text.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. It only mentions "Clinical testing is conducted for validation."
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical testing.
Adjudication Method for the Test Set:
- The document does not describe any adjudication method used for the clinical test set.
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?
- No. The device in question is a SpO2 sensor, which provides direct physiological measurements, not an AI-based diagnostic tool requiring human reader interpretation or MRMC studies. Therefore, this type of study is not applicable and was not performed.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done?
- Yes, effectively. For a device like an SpO2 sensor, the "standalone performance" refers to its ability to accurately measure SpO2 and pulse rate. The clinical testing mentioned ("Clinical testing is conducted for validation of SoO2 the Coreray Reusable & Disposable SpO2 Sensor") serves as the standalone performance evaluation, confirming the device's accuracy without requiring human interpretation of its output beyond standard clinical use. The reported accuracies (±3% for SpO2) are the standalone performance metrics.
The Type of Ground Truth Used:
- For SpO2 sensors, the gold standard (or "ground truth") for SaO2 (arterial oxygen saturation) measurement in clinical studies is typically arterial blood gas (ABG) analysis (Co-oximetry). While the document doesn't explicitly state "ABG," the mention of "Clinical testing is conducted for validation of SoO2" implies comparison against such a reference method as per ISO 80601-2-61, which requires induced hypoxia studies with arterial blood sampling.
The Sample Size for the Training Set:
- This question applies to machine learning models. The device in question is a physiological sensor, not an AI/ML model that requires a "training set" in the computational sense. Therefore, N/A.
How the Ground Truth for the Training Set was Established:
- As this is not an AI/ML device, the concept of "ground truth for the training set" does not apply. N/A.

In summary, the document primarily focuses on demonstrating substantial equivalence through comparison of technical characteristics and adherence to relevant standards for a medical device. While it mentions clinical testing for validation of SpO2, it lacks detailed specifics regarding sample size, expert involvement, or adjudication methods for this clinical study, which are more commonly detailed for AI/ML device submissions.

Summary

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Shenzhen Coreray Technology, Ltd. % Field Fu Consultant Shenzhen Joyantech Consulting Co., Ltd. Room 1122, International Mayor Communication Center No. 55 Shi Zhou Zhong Road Nanshan, Shenzhen 518100 CHINA

Re: K173368

Trade/Device Name: Reusable SpO2 Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: July 24, 2018 Received: August 2, 2018

Dear Field Fu:

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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the name "Todd D. Courtney -S" in black text. The text is positioned in front of a light blue FDA logo. The text is clear and easy to read, and the logo is a simple and recognizable design. The image is likely a nameplate or a document header.

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

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Indications for Use

510(k) Number (if known) K173368

Device Name Reusable 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)

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Version: A/0

SECTION 05 510(k) Summary

5.1 Administrative Information

Date of Summaryprepared	Aug. 24, 2017
Manufacturerinformation	Company title: Shenzhen Coreray TechnologyCo., LtdCompany address:ChuangYe Technology Park, 1th Dong HuanRoad, Longhua New District, Shenzhen, 510000P.R China. P.C.:518109Contact person: Simon FanPhone: +86-755-28839229Fax: +86-755-28839229E-mail: manager@core-ray.com
SubmissionCorrespondentImage: Logo卓远天成	Shenzhen Joyantech Consulting Co., Ltd.Address: Room 1122, International MayorsCommunication Centre, NO. 55 Shizhou middleroad , Nanshan District, ShenzhenContact person: Mr. Field FuE-Mail: cefda13485@163.com

5.2 Device Information

Type of 510(k)submission:	Traditional
Trade Name:	Reusable SpO2 Sensor
Model:	CR001-3106A
Classification name:	Pulse Oximeter Sensor
Review Panel:	Cardiovascular
Product Code:	DQA
Device Class:	II

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Regulation Number: | 870.2700

5.3 Predicate Device Information

Sponsor:	Shenzhen Caremed Medical Technology Co., Ltd.
Device:	Caremed Reusable & Disposable SpO2 Sensors
510(K) Number:	K153184
Sponsor:	Solaris Medical Technology Inc

Medical Technology, Inc. Sponsor: Solaris Reusable & Disposable SPO2 Sensors Device: K100077 510(K) Number: |

5.4 Device Description

The Reusable SPO2 Sensor is comprised of a connector and a cable which terminates into sensor housing.

The sensor contains two specific wavelength LEDs and a photo detector assembled into the sensor housing which separate by one housing half and the other half. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter.

One type of sensor housing is described in this submission:

Reusable finger clip sensor

The sensor has a labeling and specifications designed for compatibility with a specific monitor.

5.5 Intended Use/ Indications for Use

Coreray Reusable SPO2 Sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel. The Reusable SPO2 Sensor is intended for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40kg.

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5.6 Technological characteristics of the subject device compared to the predicate device

Predicate Device Information:

510(K) No.:	K153184
Common name:	Oximeter
Classification name:	Oximeter
Production regulation:	21 CFR § 870.2700
Product code:	DQA
Panel:	Cardiovascular

510(K) No.:	K100077
Common name:	Pulse Oximeter Sensor
Classification name:	Oximeter
Production regulation:	21 CFR § 870.2700
Product code:	DQA
Panel:	Cardiovascular

Comparison to predicate device:

Comparisonitem	Subject DeviceReusable anddisposableSPO2 sensor	Predicate DeviceK153184	Predicate DeviceK100077	Remarks
Product Code	DQA	DQA	DQA	same
RegulationNumber	870.2700	870.2700	870.2700	same
Classification	II	II	II
Intendeduse&Indications for Use	CorerayReusableSPO2 Sensor isintended to be	CaremedReusable &Disposable SPO2Sensors are	When used with acompatiblepatient monitoror a pulse	SE asK100077
	used in hospitalsettings wherepatient care isoffered byqualifiedhealthcarepersonnel. TheReusable SPO2Sensor isintended forcontinuous non-invasive	indicated forcontinuousnon-invasivemonitoring offunctional oxygensaturation ofarterialhemoglobin(SpO2) andpulse rate(PR) foradultpatients weighing	oximeter device,Solaris MedicalTechnology,Inc. reusable &disposableSpO2 sensorsare intendedto be used forcontinuous,non-invasivefunctionalarterial oxygen
	monitoring offunctionaloxygensaturation ofarterialhemoglobin(SpO2) andpulse rate (PR)for adultpatientsweighinggreater than40kg.Prescriptiondevice.	greaterthan40kg andpediatricpatients weighing10 -50 kg.	saturation(SpO2)and pulse ratemonitoring.Solaris MedicalTechnology,Inc. reusablemulti-patientuse SpO2 SoftSensors,reusable multi-patient useSpO2 FingerSensors, anddisposable singlepatientuse SpO2 Soft-fingerSensors are foruse withadult/pediatricpatientsweighing greaterthan 40kg.Solaris MedicalTechnology,Inc. disposablesinglepatient use SpO2AdhesiveSensors are foruse withadult patients
			adult patients
			greater than40kg, pediatricpatients weighing10 - 40kg, and infant(non-neonatal)patientsweighing 3 -15kg.Prescriptiondevice.
MeasurementMethod	2-wavelengthRelativeOpticalAbsorption	2-wavelengthRelativeOpticalAbsorption	2-wavelengthRelativeOpticalAbsorption	same
LightEmitting	Red:660nm±10nmInfrared:905nm±10nm	Red:660-666nm,Ired:880-950nm	Red:660-666nm,Ired:880-950nm	similarWithinthe rangeof thefrequencyof thepredicatedevices.
SignalDetectionMethod	Photodetector	Photodetector	Photodetector	same
SPO2Accuracy	±3% (70-100%)	±3% (70-100%)	±2% (70-100%)	same asK153184,andcompliance withtheISO806011-2-61.
PulseRateAccuracy	±3(30-250bpm)	±3(30-250bpm)	±3(30-250bpm)	same
Appliedpopulation	Adult (≥40Kg)	Adult(≥40Kg)Pediatric(10-50Kg)	Adult(≥40Kg)Pediatric(10-50Kg)Neonatal ( 3-	SE asK100077
				10Kg )
Measurementpart	Fingers	Fingers or toes	Fingers or toes	Fingers or toes	SE
Sterile	No	No	No	No	same
Material	ABS, TPU,Silicone,	ABS, PVC, TPU,Silicone,sponge	ABS, PVC, TPU,Silicone, sponge	ABS, PVC,Silicone and 3M	similarPassedthebiocompatibilitytest.
Biocompatibility	CytotoxicityIrritationSensitization	CytotoxicityIrritationSensitization	CytotoxicityIrritationSensitization	CytotoxicityIrritationSensitization	same
DistalconnectorDesign	clip	finger clip andspongeadhesive	finger clip andspongeadhesive	soft tip and textileadhesive	clipdesignsame asK153184
ElectricalPerformanceand Safety	IEC60601-1,IEC60601-1-2,ISO80601-2-61,ISO10993-5/10	IEC60601-1,IEC60601-1-2,ISO80601-2-61,ISO10993-5/10	IEC60601-1,IEC60601-1-2,ISO80601-2-61,ISO10993-5/10	IEC60601-1,IEC60601-1-2,ISO80601-2-61,ISO10993-5/10	same

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Version: A/0

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Version: A/0

The subject device and the predicate device have the same intended use and similar technological characteristics; they both measure SpO2 values for the patients. Thus the subject device is substantially equivalent to the predicate devices.

5.7 Brief discussion of the nonclinical tests

Reusable SpO2 Sensor conforms to the following standards:

60601-1:2005+CORR.1:2006+CORR.2007+A1:2012 Medical IEC Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential

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Performance.

IEC 60601-1-2: 2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - 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

ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.

ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization.

5.8 Brief discussion of clinical tests

Clinical testing is conducted for validation of SoO2 the Coreray Reusable & Disposable SpO2 Sensor.

The Reusable SpO₂ Sensor was satisfied the requirements of FDA quidance and ISO 80601-2-61:2011 in the range of 70%-100%SaO2.

5.9 Other information (such as required by FDA guidance/Test)

Animal performance testing is not required and was not performed to demonstrate substantial equivalence of the Coreray Reusable SpO2 Sensor.

5.10 Conclusions

Based on the above information, we conclude the subject device, Reusable SpO2 Sensor, is substantially equivalent to the predicate device.

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).