Caremed Disposable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult, pediatric and infant patient populations.

Device Description

The proposed device, Disposable SpO2 Sensors are accessories to the patient monitors, which are intended for continuous non-invasive monitoring of functional arterial oxygen saturation and pulse rate. The compatible patient monitor is Nihon Kohden BSM-5135A. The sensor shall be connected to its corresponding monitor through Caremed adapter cable model SZ30-36. 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

This document describes the performance data and acceptance criteria for the Disposable SpO2 Sensor (K191279).

1. Table of Acceptance Criteria and Reported Device Performance:

Feature	Acceptance Criteria (Predicate Device K142832)	Reported Device Performance (Subject Device)	Comparison
SpO2 Range	70%-100%	70%-100%	Same
SpO2 Accuracy	±3%	±3%	Same
PR Range	30 bpm - 250 bpm	30 bpm - 250 bpm	Same
PR Accuracy	±3	±3	Same
Electrical Safety	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
Biocompatibility: Skin Irritation	Complied with ISO 10993-10	Complied with ISO 10993-10	Same
Biocompatibility: Sensitization	Complied with ISO 10993-10	Complied with ISO 10993-10	Same

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

The document states that "Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Caremed Disposable SpO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry."
For the expanded indication to include infants (3 kg < weight < 15 kg), the document states, "This specification has been verified and validated according to ISO 80601-2-61: 2017 clause 201.12.1.101 SpO2 accuracy of pulse oximeter equipment."

Sample Size: The exact number of human adult volunteers used for the clinical hypoxia test is not explicitly stated. Similarly, the sample size for the infant validation is not provided.
Data Provenance: The general nature of the clinical hypoxia test in "human adult volunteers" suggests prospective data collection for the purpose of the study. The document does not specify the country of origin, but the submission sponsor is Shenzhen Caremed Medical Technology Co., Ltd. in China.

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

The document mentions that "Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Caremed Disposable SpO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry."

Number of Experts: The document does not specify the number of experts used.
Qualifications of Experts: The document does not specify the qualifications of the experts, other than implying they would be qualified to perform arterial blood gas measurements and co-oximetry.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

The document does not provide information regarding any adjudication method used for the clinical test set data. The ground truth was established by co-oximetry.

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 device is a Disposable SpO2 Sensor, a medical device for physiological monitoring, not an AI-powered diagnostic imaging tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this submission.

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

The device itself is a sensor that generates measurements (SpO2 and pulse rate) which are then processed by an oximeter (patient monitor). The clinical testing assessed the accuracy of these measurements against a gold standard (co-oximetry), which effectively evaluates the "standalone" performance of the sensor's ability to accurately measure physiological parameters. There is no explicit mention of a "human-in-the-loop" component for interpretation of the SpO2 values that would differ from standard clinical practice with such devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The ground truth for the clinical accuracy study was established by arterial oxygen saturation (SaO2) as determined by co-oximetry. This is considered a gold standard for measuring blood oxygen levels.

8. The sample size for the training set:

Pulse oximetry devices typically do not have a "training set" in the context of machine learning algorithms for image interpretation or complex diagnostic tasks. Their performance is primarily based on the physical principles of light absorption by hemoglobin. While there might be internal calibration data or historical performance data used in the development of the device's signal processing algorithms, the document does not specify a training set sample size in the way it would be defined for AI/ML models.

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

As noted above, a distinct "training set" in the AI/ML sense is not applicable to traditional pulse oximetry devices. The ground truth for developing and calibrating the device's underlying principles and algorithms would be based on controlled experiments and physiological models that relate light absorption to blood oxygen saturation, typically validated against gold standard measurements like co-oximetry in a laboratory or controlled clinical setting. The document does not provide details on how this early-stage ground truth was established for the development of the device's core technology. The clinical studies mentioned are for validation of the final product.

Summary

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Shenzhen Caremed 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: K191279

Trade/Device Name: Disposable SpO2 Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: November 8, 2019 Received: November 8, 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.

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

510(k) Number (if known)

Device Name Disposable SpO2 Sensors

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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510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2019/11/25

Submission sponsor 1.

Name: Shenzhen Caremed Medical Technology Co., Ltd. Address: East Side, 3/F, C Building, Kelunte Low-Carbon Industries, Gaofeng Community, Dalang Office, Longhua District, Shenzhen, Guangdong, China Contact person: Alan Xie Title: Quality Manager E-mail: cm003@szcaremed.com Tel: +86-755-36560977-889

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
Model	C543-16, C533-16, C523-16, C503-16
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 Caremed Medical Technology Co., Ltd. is requesting clearance for Disposable SpO2 Sensor. It is comparable to the following legally marketed system:

1. UNIMED MEDICAL SUPPLIES INC. Unimed Disposable and Reusable SpO2Sensors under K142832.

5. Device Description

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The sensor shall be connected to its corresponding monitor through Caremed adapter cable model SZ30-36. 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).

Model	Measurement site	Intended population
C503-16	Fingers	Adult (>40 kg)
C523-16	Fingers	Pediatric (10 kg < weight < 40 kg)
C533-16	Fingers	Infant (3 kg < weight < 15 kg)
C543-16	Finger	Adult (> 40 kg)

6. Intended use & Indication for use

Features	Subject Device	Predicate Device K142832	Comparison
	Caremed Disposable SpO2	Unimed Disposable and
	Sensors	Reusable SpO2 Sensors
Applicant	Shenzhen Caremed MedicalTechnology 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
Features	Subject DeviceCaremed Disposable SpO2Sensors	Predicate Device K142832Unimed Disposable andReusable SpO2 Sensors	Comparison
Intended use	Caremed Disposable SpO2Sensors are indicated forcontinuous non-invasivemonitoring of functional oxygensaturation of arterial hemoglobin(SpO2) and pulse rate (PR) foradult, pediatric and infant patientpopulations.	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 Emitting	Red: 660-666nmInfrared: 880-950nm	Red: 660-666nmInfrared: 880-950nm	Same
SignalDetectionMethod	Photodetector	Photodetector	Same
SpO2 Range	70%-100%	70%-100%	Same
SpO2Accuracy	$\pm$ 3%	$\pm$ 3%	Same
PR Range	30 bmp - 250 bmp	30 bmp - 250 bmp	Same
PR Accuracy	$\pm$ 3	$\pm$ 3	Same
Sterile	No	No	Same
Applicationsite	Finger or toes	Finger or toes	Same
PatientcontactingMaterials	Non-woven	Silica gel, Foam, 3M Textile	Different (2)
Cable length	900 $\pm$ 50 mm	Finger clip: 1100 $\pm$ 100 mm	Different (3)
Patient enddesign	Textile Adhesive	finger clip, soft tip, TextileAdhesive, and Non-Adhesive	Same
Connectordesign	DB9M Connector	DB9M ConnectorMasimo 6p ConnectorHypertronic 7pin Connector	Same
Usage	Disposable	Disposable, reusable	Same
ElectricalSafety	Complied with IEC 60601-1	Complied with IEC 60601-1	Same
Features	Subject DeviceCaremed Disposable SpO2Sensors	Predicate Device K142832Unimed Disposable andReusable SpO2 Sensors	Comparison
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 between proposed device and predicate device is different. The difference is the addition of infant (3 kg < weight < 15 kg). This specification has been verified and validated according to ISO 80601-2-61: 2017 clause 201.12.1.101 SpO2 accuracy of pulse oximeter equipment. Thus, this difference does not raise different questions of safety and effectiveness.

Different (2): The predicate devices have 3 type of patient contacting materials and the proposed devices 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 (3): 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.

8. Performance Data

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

Biocompatibility testing

The biocompatibility evaluation for the Caremed Disposable 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 duration of exceed 24 hours but not 30 days.

Non-clinical data

The Caremed Disposable 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

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. 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.

The test was selected to show substantial equivalence between the subject device and the predicate.

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 Caremed Disposable 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

It has been shown in this 510(k) submission that the difference between the proposed devices and the predicate devices do not raise any questions regarding safety and effectiveness. Performance testing and compliance with voluntary standards demonstrate that the proposed are substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, 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).