This SpO2 Sensor is intended for the continuous nonitoring and spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR, measured by an SpO2 sensor) for use with the finger of adult and pediatric patients. It acts as re-usable accessory of a Patient Monitor.

Device Description

The SpO2 Sensor consists of compatible connectors, cable, patient side sensor. And one side of sensor is designed to locate light emitting diodes (LEDs) and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2).

The U401 series SpO2 Sensor acts as re-usable accessory of Mindray PM-8000 Express Patient Monitor, which has been cleared by K070791. And the function alarms and interface accessories are controlled by the monitor, and such information is not available in this submission.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SpO2 Sensor U401-A, U401-B, U401-C, U401-D, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
SpO2 Accuracy	+/- 2%
Pulse Rate Range	20 bpm - 250 bpm
Pulse Rate Accuracy	+/- 2 bpm
SpO2 Range	70% - 100%

Note: The document explicitly states the SpO2 accuracy of the subject device is ±2%, which is better than the predicate's ±3%. This suggests the acceptance criterion for SpO2 accuracy would have been ≤ ±3% (or a target of ±2% as achieved). The Pulse Rate Accuracy is also better than the predicate's ±3 bpm.

Study Details

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

Sample Size: The document states "The volunteer population in the studies composed of local healthy men and women from age 18 to 55, with variations of skin pigmentations." It also specifies that "darkly pigmented subjects are included in the desaturation study is three." However, the exact total number of human subjects (the sample size) is not explicitly stated in the provided text, beyond mentioning the composition of the volunteer population.
Data Provenance: The study was conducted with "local healthy men and women," implying it was conducted domestically where the manufacturer is located (Shenzhen, P.R. China), or where the clinical study site was. The study involved human subjects undergoing desaturation, which is a prospective clinical study methodology.

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

Number of Experts: This information is not provided in the text.
Qualifications of Experts: This information is not provided in the text.

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

The document references the "Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment." This guideline details methods for determining accuracy against a reference, but it does not specify an adjudication method in the context of expert review for a test set. The ground truth method described (CO-oximeter) is a direct physiological measurement, not an interpretative expert adjudication.

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

Not applicable. This device is an SpO2 sensor, which provides direct physiological measurements (SpO2 and pulse rate). It is not an AI-assisted diagnostic imaging or interpretation device that would involve human readers or an MRMC study.

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

Yes, a standalone performance study was done. The clinical data section describes the device's accuracy being validated against arterial blood samples measured with a CO-oximeter. This directly assesses the algorithm's (or the device's) performance in determining SpO2 and pulse rate without human interpretation as part of the measurement process. The device's specified SpO2 Accuracy of +/- 2% and Pulse Rate Accuracy of +/- 2 bpm are results of this standalone testing.

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

Ground Truth Type: For the clinical study, the ground truth for SpO2 accuracy was established using arterial blood sample reference measured with a CO-oximeter.

8. The sample size for the training set

Not applicable. This device is a sensor that directly measures physiological parameters. The provided documentation does not describe a machine learning algorithm that requires a separate "training set" in the context of AI. The "clinical data" section pertains to the validation of the device's accuracy.

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

Not applicable for the reasons stated in point 8.

Summary

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Shenzhen Upnmed Equipment Co., Ltd. Fu Jian Management Representative 4th Floor, Building #1 East, Huihuang Industrial Area Xitian Community, Gongming Town. Guangming District Shenzhen, 518107 Cn

Re: K183277

Trade/Device Name: SpO2 Sensor U401-A, U401-B, U401-C, U401-D Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: April 8, 2019 Received: April 16, 2019

Dear Fu Jian:

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

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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 (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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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,

for Michael Ryan 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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Indications for Use

510(k) Number (if known) K183277

Device Name

SpO2 Sensor, models U401-A, U401-B, U401-C, U401-D

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

K183277

Prepared in accordance with the requirements of 21 CFR Part 807.92

1. Submitter:	Shenzhen Upnmed Equipment Co., Ltd.4th Floor, Building #1 East, Huihuang Industrial Area, Xitian Community,Gongming Town, Guangming District, 518107, Shenzhen, P.R. ChinaTel.: +86 -755-29728789Fax: +86 -755-29423789
Contact Person:	Fu Jian
Prepare date:	2019-04-08
2. Device nameand classification:	Device Name: SpO2 SensorModels: U401-A, U401-B, U401-C, U401-DClassification Name: 21 CFR 870.2700 OximeterProduct code: DQARegulatory Class: Class II
3. Reason forSubmission	New Application.
4. PredicateDevice(s):	Shenzhen Med-link Electronics Tech Co., Ltd., Shenzhen Med-Link Pulse OximeterProbe, model S0136J-L/ K113727
5. DeviceDescription:	The SpO2 Sensor consists of compatible connectors, cable, patient side sensor. Andone side of sensor is designed to locate light emitting diodes (LEDs) and a lightdetector (called a photo-detector). Red and Infrared lights are shone through thetissues from one side of the probe to the other. Then parts of the light emittedabsorbed by blood and tissues. The light absorbed by the blood varies with theoxygen saturation of haemoglobin. After that, the photo-detector detects the lightvolume transmitted through the tissues which depends on blood pulse, Hereafter, themicroprocessor calculates a value for the oxygen saturation (SpO2).The U401 series SpO2 Sensor acts as re-usable accessory of Mindray PM-8000Express Patient Monitor, which has been cleared by K070791. And the functionalarms and interface accessories are controlled by the monitor, and such informationis not available in this submission.

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This SpO2 Sensor is intended for the continuous noninvasive monitoring and 6. Indications for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and Use: pulse rate (PR, measured by an SpO2 sensor) for use with the finger of adult and pediatric patients. It acts as re-usable accessory of a Patient Monitor.

7. Predicate Device Comparison

Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness as the predicate device.

Please refer to following table to find differences between the subject device and predicate device. All the differences do not affect the basic design principle, usage, effectiveness of the subject device. And the differences do not raise different questions of safety of effectiveness.

ITEM	Proposed DeviceU401 Series SpO2 Sensor	Predicate DeviceS0136J-L/K113727	ComparisonResult
Manufacture	Shenzhen Upnmed EquipmentCo., Ltd.	Shenzhen Med-link ElectronicsTech Co., Ltd.	---
Indications for Use	This SpO2 Sensor is intendedfor the continuous noninvasivemonitoring and spot-checkingof functional oxygen saturationof arterial hemoglobin (SpO2)and pulse rate (PR, measuredby an SpO2 sensor) for usewith adult and pediatricpatients.	Shenzhen Med-link disposableprobe, model S0136J-L, isindicated for single patient usewhen continuous, non-invasivearterial oxygen saturation andpulse rate monitoring arerequired for adult patients orpediatric patients weighing morethan 30 kg. The S0136J-L iscontraindicated for use withpatients during motioncondition.	Different 1
Intended patientpopulation	Pediatric, Adult	Pediatric, Adult	Same
Intendedapplication site	Finger	Finger	Same
use under motionand low perfusionconditions	No	No	Same
MeasurementPrinciples	2-wavelength RelativeOptical Absorption	2-wavelength RelativeOptical Absorption	Same
Light EmittingDiodes (LEDs)wavelengths	RED: 660 nm, nominalIRED: 905nm, nominal	RED: 660 nm, nominalIRED: 905 nm, nominal	Same
Signal DetectionMethod	Photodetector	Photodetector	Same
SpO2 Range	70% -100%	70%-100%	Same
SpO2 Accuracy	±2%	±3%	Different 2
Pulse Rate Range	20 bpm - 250 bpm	20 bpm – 250 bpm	Same
Pulse RateAccuracy	±2 bpm	±3 bpm	Different
Measuring Mode	spot-checking or continuousmonitoring	spot-checking or continuousmonitoring	Same
Shipped Sterile	No	No	Same
Storage andTransport	Temperature: -10℃to 50°CAtmospheric Pressure: 50 kPato 106 kPaRelative Humidity: ≤93% (nocondensation)	Temperature: -10℃to 40°CAtmospheric Pressure: 86 kPa to106 kPaRelative Humidity: 0%-80% (nocondensation)	Different 3
OperatingTemperature	Temperature: 5°C to 40°CAtmospheric Pressure: 50 kPato 106 kPaRelative Humidity: ≤85% (nocondensation)	Temperature: -10℃to 40°CAtmospheric Pressure: 86 kPa to106 kPaRelative Humidity: 0%-80% (nocondensation)
Physical Specifications
Cable Length	1.0 m	0.9 m	Different 4

Table 1 Comparison between main predicate S0136J-L and the subject device

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Justification for the differences:

1. Different Indications for Use
  As indicated in the comparison table, the difference of indications for Use is caused by different language, so the difference do not raise different questions of safety and effectiveness.
1. Different SpO2 Accuracy
  The accuracy of the subject device is ±2%, which of the predicate is ±3%, which means the performance of the subject is better, and such specification is verified per the international standard ISO 80601-2-61, so the different accuracy will be acceptable for the subject probe.
1. Different Storage and Transport
  Minor difference to Storage & Transport and operation environments (including Temperature, Atmospheric Pressure and Relative Humidity) for the subject device, but the system has been proved to be safe and effective since the testing was conducted under the suggested environment; Moreover, environment testing data shows the device can work as declared under the suggested conditions. So those changes do not raise different questions of safety and effectiveness.
1. Different Physical Specifications
  The subject and the predicate are of different size but proximity. Moreover, such engineering design has been verified during the international standards, so such minor differences do not raise different questions of safety and effectiveness.

As seen in the comparison tables, the subject and predicate devices have same design principle, similar design features and performance specifications. The main differences between the subject and predicate devices are minor, including only the operating/storage environment, cable length which do not raise different questions of safety or effectiveness. Moreover, as demonstrated in the non-clinical, the different technological characteristics do not raise different questions of safety and effectiveness.

8. Performance Testing:

Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.

Non-Clinical Data:

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

Biocompatibility testing

The biocompatibility evaluation for the SpO2 Sensor was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the battery of testing included the following tests:

Cytotoxicity
Skin Sensitization
Skin Irritation

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted, and the results show that the subject device complies with the IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007)+AM1 (2012) Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2007 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests standard for EMC.

Bench Testing

Bench testing was conducted and the results show that the subject device complies with the ISO 80601-2-61: 2011 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of Pulse Oximeter Equipment standard for performance effectiveness.

Software Verification and Validation Testing

Not applicable, no software is embedded.

Clinical data:

Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-6:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. The SpQ2 accuracy has been validated in human studies against arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed, only about two-thirds of the measurements can be expected to fall within the specified accuracy compared to CO-oximeter measurements. The volunteer population in the studies composed of local healthy men and women from age 18 to 55, with variations of skin pigmentations and per FDA's guidance for Pulse Oximeters, darkly pigmented subjects are included in the desaturation study is three.

Summary

Based on the non-clinical performance and clinical data as documented in the device development, the subject devices were found to be as safe and as effective as the predicate device.

9. Conclusion:

Verification and validation testing was conducted on the subject device and all testing passed pre-specified criteria. This premarket notification submission demonstrates that the subject device 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).