The oCare Wrist Pulse Oximeter, Model Pro 100, is a wrist-worn device indicated for use in noninvasive measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate (PR). The intended measuring site of this device is the wrist skin surface. It is intended for spot-checking or continuous monitoring of adult patients during no motion conditions, in hospital-type facilities, and home environments.

Device Description

The oCare™ Wrist Pulse Oximeter, Model Pro 100 is a wrist-worn device for noninvasive measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate. The intended measuring site of this device is the lateral side of wrist and slightly above the wrist bone (ulnar styloid processus).

The oCare™ Wrist Pulse Oximeter, Model Pro 100 is a watch-like device with a reflectance pulse oximetry sensor located at the bottom of the watch case and on top of the wrist. The reflectance pulse oximetry sensor includes three light emitting diodes (LEDs) of red, infrared and green wavelength and one photodiode light detector placed next to each other. Light beams are emitted from LEDs through the skin to the arteriolar bed of the tissue. Changes in light absorption during the pulsing cycle are measured by the photodiode light detector as scattered lights are reflected back from the pulsating arteriolar bed. The functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate are measured by the well-established non-invasive pulse oximetry technology where the red and infrared light is absorbed in different amounts depending on the oxygenation of the blood during the arterial pulsing. The maximum optical output power is less than 2 mW.

The oCare™ Wrist Pulse Oximeter, Model Pro 100 is a single-patient use, non-sterile pulse oximeter. It is available in one configuration as a standalone device with a wrist pulse oximeter and a detachable watchband for wearing the pulse oximeter on the wrist.

The oCare™ Wrist Pulse Oximeter, Model Pro 100 is a compact and light weight device which consists of a reflectance pulse oximetry sensor, a color graphic OLED display, a lithium ion polymer rechargeable battery, a memory, an analog and digital unit, a microprocessor and an operating software.

AI/ML Overview

The provided text describes the performance data for the oCare™ Wrist Pulse Oximeter, Model Pro 100, focusing on its accuracy in measuring functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate (PR).

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 Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Specification)	Reported Device Performance (Test Results)
SpO2 Accuracy	±3% SpO2 (over 70-100% SaO2 range), non-motion	Within ±3% SpO2 (over 70-100% SaO2 range), non-motion
Pulse Rate	±3 bpm (from 40-240 bpm)	±3 bpm (from 40-240 bpm)

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The exact number of human subjects is not explicitly stated. The text mentions "human subjects screened for this testing" and "each human subject," implying multiple individuals, but a specific number (e.g., n=X) is not provided.
Data Provenance: The study was conducted at an "independent research university hospital." The subjects were "health, male, female, no-smoking and light to dark-skinned adult subjects of 20-40 years of age."
- Country of Origin: Not explicitly stated, but the submission is from Taiwan Biophotonic Corporation, suggesting the study might have been conducted in Taiwan or an affiliated institution.
- Retrospective or Prospective: Prospective. The study "was designed in accordance with ISO 80601-2-61" to "verify the SpO2 accuracy" where hypoxia was induced in a "stair-stepped manner" and arterial blood samples were taken simultaneously. This indicates a pre-planned, forward-looking study.

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

The text does not indicate that human experts were used to establish ground truth for the device's performance. The ground truth for SpO2 was established invasively using co-oximetry with arterial blood samples. Therefore, this section is not applicable in the context of expert review for ground truth.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for SpO2 accuracy was established through direct
invasive measurement (co-oximetry) of arterial blood samples, not through human
adjudication of medical images or observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted. This study focused on the standalone accuracy of the pulse oximeter device against an invasive gold standard (co-oximetry), not on evaluating how human readers (e.g., clinicians) perform with or without AI assistance. The device is a diagnostic tool, not an AI-assisted diagnostic aid for clinicians.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone study was performed. The "Clinical Studies" section describes a study testing the oCare™ Wrist Pulse Oximeter's accuracy in measuring SpO2 directly against a gold standard (co-oximetry with arterial blood samples). This is a purely algorithmic/device performance evaluation without any human interpretation of the device's output being part of the primary performance metric.

7. The Type of Ground Truth Used

The ground truth used for SpO2 accuracy was invasive functional oxygen saturation of arterial hemoglobin (% SaO2) analyzed by the co-oximetry method with arterial blood samples taken simultaneously.

8. The Sample Size for the Training Set

Not applicable. The device is a pulse oximeter that uses well-established non-invasive pulse oximetry technology (based on light absorption by hemoglobin) and does not appear to employ machine learning that would require a "training set" in the conventional sense (e.g., for AI model development). Its operation is based on physiological principles and signal processing, not a data-driven learning algorithm.

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

Not applicable, as there is no mention or indication of a "training set" for this
device's underlying technology.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Taiwan Biophotonic Corporation JC Chen President 4F-1, No. 6-1, Sec.2, Shengyi Rd. Zhubei, 30261 Tw

Re: K183556

Trade/Device Name: oCare Wrist Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: December 18, 2018 Received: December 20, 2018

Dear JC Chen:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (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,

Todd D. Courtney -S

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) K183556

Device Name

oCare Wrist Pulse Oximeter, Model Pro 100

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

K183556

This 510(k) summary is being submitted in accordance with the requirements of 21CFR 807.92.

Submitter:	Taiwan Biophotonic Corporation
Submitter's Address andTelephone Number	4F-1, No. 6-1, Section 2, Shengyi Road, Zhubei City,Hsinchu County 30261, Taiwan, R.O.C.Phone: +886-3-667-0888; Fax: +886-3-667-0222
Contact Person:	JC Chen, PresidentPhone: +886-3-667-0888 ext.201e-mail: jc.chen@tbpchc.com
Date Prepared:	November 9, 2018

1. Submitter Information

2. Device Information

Trade Name:	oCare™ Wrist Pulse Oximeter, Model Pro 100
Common Name:	Oximeter
Classification Name	Oximeter
Regulation Number:	21 CFR 870.2700
Regulatory Class:	Class II
Product Code:	DQA

3. Legally Marketed Predicate Devices

The predicates (legally marketed devices) for the subject device (oCare™ Wrist Pulse Oximeter, Model Pro 100) are identified as below:

Primary Predicate: Oxitone 1000, Wrist Pulse Oximeter (K163382)

Reference Device: Nellcor Bedside SpO2 Patient Monitoring System (K142865).

Device Description 4.

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The functions of oCare™ Wrist Pulse Oximeter, Model Pro 100 include the following:

(1) Measurement, display and storage of the functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate,
(2) Spot-checking or continuous monitoring of specific physiological parameters,
(3) Built-in memory for up to 72 hours of data storage,
(4) Interface to other health data collection system through the embedded Bluetooth module,
(5) Easy to read 128 x 128 (RGB) color OLED graphic display.
(6) Peripheral micro-USB connector used as the battery charging port,

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(7) Built-in rechargeable lithium ion polymer battery,

(8) Pulsing quality indicator and battery power indicator in OLED graphic display,

The proposed device is not for life-supporting or life-sustaining, not for implant.

The device does not contain drug or biological products.

5. Indications for Use

The oCare™ Wrist Pulse Oximeter, Model Pro 100, is a wrist-worn device indicated for use in noninvasive measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate (PR). The intended measuring site of this device is the wrist skin surface. It is intended for spot-checking or continuous monitoring of adult patients during no motion conditions, in hospitals, hospital-type facilities, and home environments.

The subject device has the same intended uses as the predicate Oxitone 1000, Wrist Pulse Oximeter. However, the indications for use of the subject device include additional features as storing and continuous monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate. Although these features are not present in the predicate Oxitone 1000, Wrist Pulse Oximeter, they are present in the reference predicate Nellcor Bedside SpO2 Patient Monitoring System. Thus, it does not constitute a new intended use for the wrist pulse oximeter nor do they different questions of safety and effectiveness for the subject device relative to the predicates.

6. Comparison of Technological Characteristics with the Predicate Devices

The subject device and predicates all use the well-established non-invasive pulse oximetry method to measure the functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate. It is based on two basic principles: (1) oxygenated hemoglobin (HbO2) and deoxygenated hemoglobin (Hb) have different absorption characteristic to red and infrared light; (2) the light absorption by the blood (Hb and HbO2) is cyclic changing by the periodic pulsations of the arterial blood volume during each heartbeat. This periodic changing of light absorption signal is commonly known as the photoplethysmography (PPG).

At a high level, the subject device and predicates are based on the following similar technological elements:

(1) Use of a reflectance pulse oximetry sensor which includes LEDs for emitting light beams through the skin to the arteriolar bed of the tissue, and the photodiode for detecting the PPG signals reflected back from the pulsating arteriolar bed. It has
Image /page/5/Picture/12 description: The image contains the logo for Taiwan Biophotonic Co. The logo consists of a colorful graphic to the left of the company name. The graphic is made up of three interlocking shapes in yellow, pink, and teal. The company name is written in a simple, sans-serif font.

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identical radiant output wavelength of red and infrared and radiant output power of less than 15 mW.

(2) Use of patient contact materials which have been tested to compile with the same standard of ISO 10993 for the category of surface device, intact skin contact and limited contact duration (< 24 hours).
(3) Use of an OLED or LCD display for displaying % SpO2, pulse rate, battery level indicator and system status.
(4) Use of rechargeable lithium ion polymer battery for the power supply of devices.
(5) The display range, measuring range and accuracy of %SpO2 provided by the subject device and the predicates are similar.
(6) The display range and measuring accuracy of pulse rate provided by the subject device and the predicates are similar.

The following technological differences exist between the subject device and predicate devices:

(1) The oximetry sensor used by the subject device is configured with three LEDs of red, infrared and green wavelength and one photodiode light detector, but the oximetry sensor used by the predicates is configured with two LEDs of red and infrared wavelength and one photodiode light detector.
(2) The lower limit of measuring rage of pulse rate provided by the predicates is slightly lower than the subject device.
(3) The subject device has an enclosure degree of ingress protection of IPX65, which is better than the enclosure degree of ingress protection of predicates.
(4) The outline dimensions and weight of the subject device is different from the outline dimensions and weight of the predicates.

These different technological characteristics of the subject devices do not raise different questions of safety and effectiveness.

Image /page/6/Picture/13 description: The image contains the logo for Taiwan Biophotonic Co. The logo consists of a colorful, abstract heart-shaped design to the left of the text "tBPC Healthcare". To the right of this is the company name, "Taiwan Biophotonic Co.", written in a simple, sans-serif font. The overall design is clean and professional, suggesting a company involved in healthcare or medical technology.

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Items	Subject DeviceoCare Wrist PulseOximeter, Model Pro100	Primary PredicateOxitone 1000Wrist Pulse Oximeter	Reference DeviceNellcor Bedside SpO2Patient MonitoringSystem
Type of SpO2Sensor	ReflectanceOptical Sensor	ReflectanceOptical Sensor	Reflectance orTransmissionOptical Sensor
Application Site	Wrist	Wrist	Finger, Forehead
Output Wavelengthand Radiant Powerof SpO2 Sensor	Red (655 nm) @3.8 mW maximumInfrared (940 nm) @1.7 mW maximumGreen (530nm) @6.9 mW maximum	Red (640 nm) @1.05 mWInfrared (940 nm) @0.95 mWNot Available	Red (660 nm) @<15 mWInfrared (900 nm) @<15 mWNot Available
Sterility	Non-sterility	Non-sterility	Non-sterility
Display	OLED(128x128 RGB)	LCD,Multi-pixel 3 digits	TFT LCD(480 x 272 pixel )
Display Parameters	SpO2, Pulse Rate,Battery Level Indicator,Pulse Quality Indicator,Alarm Indicator, Time,Date, System Status	SpO2, Pulse Rate,Battery Level Indicator,System Status	SpO2, Pulse Rate,Battery Level Indicator,Signal Quality Indicator,Alarm Indicator, Time,Date, System Status
Mode of Operation	Spot-checking,Continuous MonitoringData-recording, andWatch Mode	Spot-checking	Spot-checking,Continuous MonitoringData-recording
Display Range	0-100 % SpO240-240 bpm	0-100 % SpO230-250 bpm	0-100 % SpO220-250 bpm
Display Resolution	1%1 bpm	1%1 bpm	1%1 bpm
Measuring Range
SpO2	70-100 % SpO2	70-100 % SpO2	70-100 % SpO2
Pulse Rate	40-240 bpm	30-250 bpm	20-250 bpm
Measuring Accuracy
SpO2	+3 % SpO2	+3 % SpO2	+2 % SpO2
Pulse Rate	+3 bpm	+3 bpm	+3 bpm
Pulse AmplitudeIndicator	Not Available.(Readings or dashesgive pulse qualityindication)	Not Available.(Readings or dashesgive pulse qualityindication)	Pulse AmplitudeIndicator (8-segments)
Data Memory
Type	Non-volatile	Not Available	Non-volatile
Capacity	Up to 72 hours	Not Available	Up to 88000 data event
Data StorageRate	One-second interval	Not Available
Alarm
	Visual Alarm Indicator	Not Available	Visual and Audio Alarm
Alarm Type	Low BatteryMalfunctionPoor Signal ConditionHigh/Low SpO2 /PR	Not Available	Low BatteryTechnical System ErrorSpO2 Sensor OffHigh/Low SpO2 /PR
SpO2 High/LowAlarm Range	High Limit:86-100 %SpO2Low Limit:85-95 %SpO2	Not Available	High Limit: 100 %SpO2Low Limit: 90 % SpO2
PR High/LowAlarm Range	High Limit: 75-240 bpmLow Limit: 40-110 bpm	Not Available	High Limit: 170 bpmLow Limit: 50 bpm
High Priority	Not Available	Not Available	Alarm Indicator: RedFast Flashing Numeric
Medium Priority	Alarm Indicator: YellowAlarm FlashingFrequency: 0.4 Hz	Not Available	Alarm Indicator: YellowSlow Flashing Numeric
Low Priority	Alarm Indicator: BlueAlarm FlashingFrequency: Constant ON	Not Available	Alarm Indicator: YellowSteady Numeric
Power Supply	Rechargeable Lithium	Rechargeable Lithium	Rechargeable Lithium
	Ion Polymer Battery	Ion Battery	Ion Battery
Battery Charger	Micro USB AB Type	5V AC/DC Adaptor	AC/DC Adaptor
AC Power forBattery Charger	100-240VAC, 50-60Hz,10VA max	100-240VAC, 50-60Hz,10VA max	100-240VAC, 50-60Hz,45VA max
Type of Protection	Internal Powered	Internal Powered	Internal Powered
Degree ofProtection -sensor	Type BF – applied part	Type BF - applied part	Type BF – applied part
Enclosure Degree ofIngress Protection	IPX65	Not Available	IP22
Dimension(LxWxH)	Watch Case:48 x 42 x 14 [mm]	Watch Case57 x 36 x 18 [mm]	Main Body:255 x 82 x 155 [mm]
Weight	Watch Case: 25gWatch Band: 33g	Watch Case & WatchBand: 55 g	Main Body: 1600 gincluding battery
	Patient ContactMaterials	Patient contact materialshave been tested tocompile with ISO10993-1, 10993-3 and10993-5.	Patient contact materialshave been tested tocompile with ISO10993-1, 10993-3 and10993-5.
Interface	Bluetooth	Bluetooth	Not Available
Operating
TemperatureHumidity	10 °C to 40 °C10 % to 93 %,non-condensing;	0 °C to 36 °C5 % to 95 %,non-condensing;	5 °C to 40 °C15 % to 93 %,non-condensing;
AtmospherePressure	760 hPa to 1,060 hPa.(Altitude: 0 ~3,000m)	Not Provided	58 kPa to 103kPa
Storage
Temperature	-40 °C to 70 °C	-20 °C to 60 °C	-20 °C to 70 °C
Humidity	5 % to 95 %,non-condensing;	Not Provided	5 % to 93 %,non-condensing;

Table 5A - Comparison of Technological Characteristics

Image /page/7/Picture/3 description: The image contains the logo for Taiwan Biophotonic Co. The logo consists of a colorful, abstract heart-shaped graphic on the left, followed by the text "tBPC" in bold, black letters. Below "tBPC" is the word "HEALTHCare" in smaller, gray letters. To the right of the logo is the company name, "Taiwan Biophotonic Co.", in black text.

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Image /page/8/Picture/2 description: The image shows the logo for Taiwan Biophotonic Co. The logo consists of a colorful, abstract heart shape on the left, followed by the text "tBPC" in bold black letters. Below "tBPC" is the word "HEALTHCARE" in smaller, lighter font. To the right of the logo is the company name, "Taiwan Biophotonic Co.", in a simple, sans-serif font.

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7. Performance Data

Accuracy of pulse oximeter, electrical, mechanical, electromagnetic compatibility, software and biocompatibility testing have been performed on the oCare™ Wrist Pulse Oximeter, Model Pro 100. The results of the testing demonstrate that the subject device is as safe and effective, as the legally marketed predicate devices. The following performance data were provided in support of the substantial equivalence determination.

Non-clinical Testing

Non clinical tests were conducted on the oCare™ Wrist Pulse Oximeter, Model Pro 100 to verify that the subject device met design specifications was substantially equivalent to the predicates.

The test results demonstrated that the subject device complies with electrical safety, electromagnetic compatibility, biocompatibility, software verification and validation, alarm system, usability engineering, battery safety, particulate and water ingress testing, home used medical devices safety and photobiological safety standards.

Test results show that the subject device meets the product specifications including: SpO2 accuracy without motion of ±3% from 70-100%, and pulse rate of ±3% from 40-240 bpm.

The subject device is considered as skin contacting for duration less than 24 hours. The patient contact materials used by the subject device have been tested to compile with the ISO 10993, and is substantially equivalent to the predicates.

The software for this subject device was considered as a "moderate" level of concern, which is the same as the predicates. Software verification and validation testing were conducted and documentation was provided.

Basic Safety andEssential Performanceof Pulse Oximeter	ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particularrequirements for basic safety and essential performance of pulse oximeterequipment.
Electrical EquipmentSafety and Performance	AAMI/ ANSI ES 60601-1: 2012 Medical electrical equipment - Part 1:General requirements for basic safety and essential performance
ElectromagneticCompatibility (EMC)	IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: generalrequirements for basic safety and essential performance - collateralstandard: electromagnetic disturbances - requirements and tests.
EMC for Radio	EN 301 489-1: 2017 Electromagnetic compatibility and radio spectrum
Equipment	matters (ERM) - Electromagnetic compatibility (EMC) Standard for radioequipment and services - Part 1: Common technical requirementsEN 301 489-17: 2017 Electromagnetic compatibility and radio spectrummatters (ERM); Electromagnetic compatibility (EMC) standard for radioequipment; Part 17: Specific conditions for broadband data transmissionsystemsIEC 62479:2010 Assessment of the compliance of low-power electronicand electrical equipment with the basic restrictions related to humanexposure to electromagnetic fields. (10 MHz to 300 GHz)
Biocompatibility	ISO 10993-1: 2009 Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management processISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: testsfor in vitro cytotoxicityISO 10993-10:2010 Biological evaluation of medical devices - Part 10:tests for irritation and skin sensitization
Usability	IEC 60601-1-6: 2013 Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance - collateralstandard: UsabilityIEC 62366: 2014 Consolidated version medical devices - Application ofusability engineering to medical devices
Alarm System	IEC 60601-1-8: 2012 Medical electrical equipment - Part 1-8: Generalrequirements for basic safety and essential performance - collateralstandard: general requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems.
Safety and Performanceof Medical Device Usedin Home	IEC 60601-1-11: 2015 Medical electrical equipment - Part 1-11: Generalrequirements for basic safety and essential performance - collateralstandard: requirements for medical electrical equipment and medicalelectrical systems used in the home healthcare environment
Lithium Ion BatterySafety	ISO 62133:2012 Secondary cells and batteries containing alkaline or othernon-acid electrolytes – Safety requirements for portable sealed secondarycells, and for batteries made from them, for use in portable applications
Medical DeviceSoftware	US FDA Guidance, No. 337, 2015, Guidance for the Content of PremarketSubmissions for Software Contained in Medical Devices"

	IEC 62304:2006 Medical device software-Software life cycle processes
Photobiological Safety	IEC 62471: 2006 Photobiological safety of lamps and lamp systems
Wideband TransmissionSystem	EN 300328:2016 Data transmission equipment operating in the 2,4 GHzISM band and using wide band modulation techniques
WirelessTelecommunicationRequirements	FCC Part 15, Subpart B - Unintentional RadiatorsFCC Part 15, Subpart C - Intentional Radiators
Package	ISTA 2A:2011 Partial Simulation Performance Tests, Packaged-Productsweighing 150 lb (68 kg) or Less

These standards include:

Image /page/10/Picture/11 description: The image contains the logo for Taiwan Biophotonic Co. The logo consists of a colorful, abstract heart-shaped symbol on the left, followed by the text "tBPC" in bold black letters, with "HEALTHCare" in smaller letters underneath. To the right of the logo is the company name, "Taiwan Biophotonic Co.", in a simple, sans-serif font.

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Clinical Studies

The SpO2 accuracy testing of the subject device, oCare™ Wrist Pulse Oximeter, Model Pro 100 has been conducted at an independent research university hospital. The human subjects screened for this testing are health, male, female, no-smoking and light to dark-skinned adult subjects of 20-40 years of age. The non-invasive functional oxygen saturation of arterial hemoglobin (% SpO2) measured by the subject device were compared to the invasive functional oxygen saturation of arterial hemoglobin (% SaO2) analyzed by the co-oximetry method with arterial blood samples taken simultaneously. The accuracy of SpO2 measured by the subject device is evaluated over the SaO2 range of 70-100% under non-motion condition. Accuracy data was calculated using the root-mean-squared (ARMS value) for all human subjects, per ISO 80601-2-61, Standard Specification for Pulse Oximeters for Accuracy in a non-motion environment. It demonstrated that the SpO2 accuracy of the subject device is within ± 3%. There were no reported adverse effects during these investigations.

Objectives: The purpose of this study was to verify the SpO2 accuracy of the oCare™ Wrist Pulse Oximeter, Model Pro 100 on adult subjects under stationary (non-motion) condition. The measuring site is the wrist. These aims were achieved by comparing SpQ2 measurements with those of arterial blood samples assessed by CO-oximetry. The study was designed in accordance with ISO 80601-2-61. The goal, in its entirety, was to show the SpO2 accuracy performance for the devices. It was expected that the Accuracy Root Mean Square (Arms) performance of the above pulse oximetry systems will meet a specification of ± 3% for the range of 70-100% SaO2.
Human subjects were connected to a breathing circuit, in which the gas flow Methods:

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delivery was adjusted for the best comfort of human subject. This gas circuit provided a gas mixture of medical grade nitrogen and air. The program was run in manual mode, in which the gas mixture was changed by the controller. The program was used to induce hypoxia in a stair-stepped manner which allowed each human subject to settle at his or her SpO2 level (e.g. plateau). At each plateau, arterial blood sampling was performed. After drawing a waste sample to clear the arterial line, an arterial sample was drawn. The beginning and end of each draw was noted on the data collection system. This series of waste draw, and arterial draws was repeated multiple times for each plateau. At the end of each plateau, the arterial line was flushed with sterile saline. Subsequently, the program was adjusted to allow the human subject to reach a new level of SpO2 and the process was repeated.

Conclusions: This subject device, oCare™ Wrist Pulse Oximeter, Model Pro 100 demonstrated a specified accuracy of ± 3% SpO2 in non-motion conditions on the wrist for all data points with an arterial oxygen saturation (SaO2) range over 70 - 100 %. Test results show that the subject device meets the product specifications, is substantially equivalent to the predicate Oxitone 1000 Wrist Pulse Oximeter.

8. Conclusions

Based on the clinical data and non-clinical testing summarized in this 510(k) submission, the result demonstrates that the oCare™ Wrist Pulse Oximeter. Model Pro 100 is in compliance with design specifications, applicable standards, and the intended use. The oCare™ Wrist Pulse Oximeter, Model Pro 100 is substantial equivalence to the predicates. The differences do not raise different questions of safety or effectiveness when compared to the predicates.

Image /page/13/Picture/5 description: The image contains the logo for Taiwan Biophotonic Co. The logo consists of a colorful, abstract symbol resembling interconnected hearts or loops, followed by the text "tBPC" in bold, black font, with "HEALTHCare" in a smaller font size underneath. To the right of this is the full company name, "Taiwan Biophotonic Co.", in a larger, clear font.

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).