The VYVO Life Watch is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. It is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use.

Device Description

The Life Watch, Model WL is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate (PR). The expected measuring location of the device is the finger, which actively presses onto the sensor on the side of the watch for measurement. The Life Watch is a watch-like device with a reflectance pulse oximetry sensor located at the side of the reflectance pulse oximetry sensor includes two light emitting diodes (LEDs) of red wavelength (660 nm) and infrared wavelength (940 nm), 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 Life Watch 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 Life Watch 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, an analog and digital unit, a microprocessor and an operating software. The functions of the life watch include the following: (1) Measurement and display of the functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate; (2) Spot-checking of specific physiological parameters of adult patients; (3) Easy to read OLED graphic display; (4) Peripheral micro-USB connector used as the battery charging base; (5) Built-in rechargeable lithium ion polymer battery (3.8V, 250mAh) (6) Low battery power indicator in OLED graphic display.

The device consists of the watch case, band, charging case, USB cable.

The proposed device is not used for life-supporting or life-sustaining, and not for implant. The device does not contain drug or biological products.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the VYVO Life Watch, an oximeter, and its claim of substantial equivalence to a predicate device (Bio-Beat Technologies Ltd. BB-613 Watch Oximeter) and a reference device (Beijing Choice Electronic Technology Company, Limited Wrist Pulse Oximeter).

However, the document does not provide specific acceptance criteria or detailed results of a study proving the device meets those criteria in the format requested. It states that "nonclinical and clinical test results have demonstrated that the VYVO Life Watch is the same as safe and effective as the BB-613 Watch Oximeter," and indicates that the clinical test was "conducted in accordance with the FDA's guidance 'Pulse Oximeters - Premarket Notification Submission [510(k)s]' and the standard ISO 80601-2-61:2017."

Based on the provided information, I can extract the following:

1. A table of acceptance criteria and the reported device performance:

The document lists performance specifications and compares them to the predicate and reference devices, but it does not explicitly state specific acceptance criteria (e.g., a mean difference of X with Y confidence interval) that the device aims to meet. Instead, it implies that the device's performance is "same" or "substantially equivalent" to the predicate.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (VYVO Life Watch)
SpO2 Measuring Range	70% to 100% (Same as predicate/reference)	70% to 100%
SpO2 Measuring Accuracy	±3% for 70% ~ 80%; ±3% for 80% ~ 90%; ±3% for 90% ~ 100% (Same as predicate)	±3% for 70% ~ 80%; ±3% for 80% ~ 90%; ±3% for 90% ~ 100%
SpO2 Resolution	1% (Same as reference device)	1%
Pulse Rate Measuring Range	Within the range of predicate or reference device (e.g., 40 to 240 bpm for predicate, 30 to 235 bpm for reference)	40 to 200 bpm (Difference noted but considered within acceptable range)
Pulse Rate Measuring Accuracy	±2bpm or ±2% (whichever is greater) (Same as reference device)	±2bpm or ±2% (whichever is greater)
PR Resolution	1bpm (Same as reference device)	1bpm

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

Sample Size: 12 subjects
Data Provenance: The document states "12 subjects with Fitzpatrick skin types. In addition, the 12 subjects include 6 healthy adult males and 6 healthy adult females, and their age range is from 19 to 42 years old." It does not specify the country of origin or whether the data was retrospective or prospective, though "clinical test has been conducted" implies prospective.

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

This information is not provided in the document. The study compares the device measurements to "simultaneous measurements from the predicate device," implying the predicate device itself served as a reference or a comparative standard, rather than explicit expert ground truth derivation.

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

This information is not provided in the document.

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:

No, this was not an MRMC study. The device is an oximeter, not an AI-assisted diagnostic tool that would involve human readers.

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

Yes, the performance evaluation described (comparison to simultaneous measurements from the predicate device) appears to be a standalone assessment of the device's accuracy.

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

The "ground truth" or reference standard for the clinical test appears to be simultaneous measurements from the predicate device. The document states, "Testing shows equivalence to simultaneous measurements from the predicate device." For pulse oximeters, the typical gold standard for SpO2 accuracy is direct arterial blood gas analysis (CO-oximetry). While the document states adherence to ISO 80601-2-61:2017, which dictates such testing, it explicitly states comparison to the predicate device in this summary.

8. The sample size for the training set:

This information is not provided. The device is an oximeter, not an AI/ML device that typically requires a large training set in the same way. The software mentioned is likely for device operation and data processing, not a deep learning model.

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

This information is not applicable/not provided as a "training set" in the context of an AI/ML model for diagnostic tasks is not described. The software validation is mentioned as "in compliance with the FDA's Guidance 'Content of Premarket Submissions for Device Software Functions'," indicating a robust software development lifecycle and testing, but not a data-driven training process.

Summary

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Vyvo Technology Corp.(VT) Aileen Fu Official Correspondent Shenzhen Global Medical Technology Services Co., Ltd Room 1702 17th Floor, Shenzhen Taifeng Building, B0. 86, Qianjin 1st Road, Bao An Shenzhen, Guangdong 8100 China

Re: K231288

March 4, 2024

Trade/Device Name: Vyvo Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: December 15, 2023 Received: February 2, 2024

Dear Aileen 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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,

Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of 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) K231288

Device Name VYVO Life Watch

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

This summary of 510(k) information is submitted as specified in SMDA and 21 CFR §807.92.

Submission Date	December 15, 2023
Manufacturerinformation	Submitter's Name: Vyvo Technology Corp.(VT)Address: 123 NW 23 RD Street City Miami, FLContact person: Alfonso CioffiTEL: +1 2016470536E-Mail: a.cioffi@helohealth.com
SubmissionCorrespondent	Contact person: Fu AilingTel: +86-13538216349Email: Aileenfu@coctd.comCompany: Shenzhen Global Medical Technology Services Co., LtdAddress: Room 1702, Shenxintaifeng Building, No. 86, Qianjin 1stRoad, Bao'an District, Shenzhen, 518101, Guangdong, China
Establishmentregistration number	NA

1 Administrative Information

2 Proposed Device Information

Common name of the device	WL Watch Oximeter
Trade name of the device	VYVO Life Watch
Type/Model of the device	WL
Classification information	Regulation Medical Specialty: Cardiovascular510(k) Review Panel: AnesthesiologyClassification name: OximeterRegulation Number: 21 CFR 870.2700Device Class: IIProduct Code: DQA
Type of 510(k) submission	Traditional

3 Predicate and Reference Devices

Predicate Device:

Sponsor:	Bio-Beat Technologies Ltd.
Device:	BB-613 Watch Oximeter
510(K) Number:	K181006

Reference Device:

Sponsor:	Beijing Choice Electronic Technology Company, Limited
Device:	Wrist Pulse Oximeter
510(K) Number:	K122046

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VOL 005:001 510(k) Summary Version: 2.0

Product: Vyvo Life Watch

4 Device Description

The device consists of the watch case, band, charging case, USB cable.

The proposed device is not used for life-supporting or life-sustaining, and not for implant. The device does not contain drug or biological products.

5 Intended Use/ Indications for Use

6 Comparison

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Version: 2.0

Table 1 Substantial Equivalence Comparison
Item	Subject Device(K231288)	Primary Predicate Device(K181006)	Reference Device(K122046)	Explanation ofDifferences BetweenPredicate andSubject Devices
Device Name	VYVO Life Watch	BB-613 Watch Oximeter	Wrist Pulse Oximeter	N/A
Device Model	WL	BB-613	MD300W4	N/A
Manufacturer	Vyvo Technology Co., Ltd.	Bio-Beat Technologies Ltd.	Beijing Choice ElectronicTechnology Company,Limited	N/A
Product Code	DQA	DQA	DQA	Same
Regulation Number	21 CFR870.2700	21 CFR870.2700	21 CFR870.2700	Same
Indication for Use	The VYVO Life Watch is asmall, wrist-worn deviceindicated for use inmeasuring and displayingfunctional oxygensaturation of arterialhemoglobin (%SpO2) andpulse rate. It is intended forspot-checking of adultpatients in hospitals,clinics, long-term care, andhome use.	The BB-613 WatchOximeter is a small, wrist-worn device indicated foruse in measuring anddisplaying functionaloxygen saturation ofarterial hemoglobin(%SpO2) and pulse rate. Itis intended for spot-checking of adult patientsin hospitals, clinics, long-term care, and home use.	The MD300W4 wrist pulseoximeter is a portable non-invasive device intendedfor spot checking, datacollection and recording ofarterial oxygen saturation(SpO2) and pulse rate ofadult and pediatric patientat home and hospital(including clinical use Ininternist/surgery,Anesthesia, intensive careand etc).	Same
Intended Population	Adult	Adult	Adult, pediatric	Same
Composition	A main unit	A main unit	A main unit, SpO2 sensor	Same
Principle ofOperation	Pulse reflectancetechnology, Two LED(red + IR) and photodiode absorbsreflected light	Pulse reflectancetechnology, Four LED(red + IR) and photodiode absorbsreflected light	Pulse reflectancetechnology, Two(red + IR) and photodiode absorbsreflected light	Same as thereference deviceK122046.
Intended Application Site	Finger	Wrist	Finger	Same as thereference deviceK122046

Measurement type	Spot	Spot	Spot	Same
Emitted light peak wavelength	940nm (IR), 660nm(Red)	880nm (IR), 650nm(Red)	940nm (IR), 660nm(Red)	Same as thereference deviceK122046.
Display Parameter	SpO2, pulse rate	SpO2, pulse rate	SpO2, pulse rate	Same
Sensor	MAX30101	Unspecified	M-50G	Due to differentdesign scheme, thedifference does notraise any new issue ofsubstantialequivalence accordingto performance testreports.
SpO2 module	Integrated into main unit	Integrated into main unit	M-50G, Insertion into mainunit as an accessory	Same
SpO2 Display Range	70%-100%	70%-100%	0%-100%	Same
SpO2 Measuring Range	70% to 100%	70% to 100%	70% to 100%	Same
SpO2 Measuring Accuracy	±3% for 70% ~ 80%;±3% for 80% ~ 90%;±3% for 90% ~ 100%;	70%-80%±3%80%-90%±3%90%-100%±3%	70%-100%±3%90%-100%±2%80%-90%±3%70%-80%±3%>70% unspecified	Same
SpO2 Resolution	1%	70%-100%, ±3% or ±3digitsDisplay: 2 characters	1%	Same as thereference deviceK122046.
Pulse Rate Measuring Range	40 to 200 bpm	40 to 240 bpm	30 to 235 bpm	Difference but iswithin the PRmeasuring range ofthe predicate deviceor the referencedevice.
Pulse Rate Measuring Accuracy	±2bpm or ±2% (whicheveris greater)	±3bpm	±2bpm or 2% ( the greater)	Same as thereference deviceK122046.
PR Resolution	1bpm	±3% or ±3 digits	1bpm	Same as the
			Display: 3 characters		reference deviceK122046.
Patient-Contacting Components/Materials		Case/Polycarbonate;Photodiode window;Watchband/silicone	Case/Polycarbonate;Photodiode window;Watchband/Silicone	Belt/Medical silica gel andNylon	Same
Contact Duration		Prolonged contact duration>24h to 30d	Prolonged contact duration>24h to 30d	Prolonged contact duration>24h to 30d	Same
Application Method		User wears thedevice as a watchand powers it on	User wears thedevice as a watchand powers it on	User wears the device onfinger	Same
Sterility		Supplied and usednon-sterile	Supplied and usednon-sterile	Supplied and usednon-sterile	Same
Display		OLED	LCD on device	OLED	Same as thereference deviceK122046.
Data storage		No	No	72-Hour	Same
Transmission mode		No	Bluetooth	USB or GPRS	N/A
Working Time		About 5-7 days ofcontinuous use	5 days of continuous use	Work for 10h continuously	Same or better
Power supply		3.8VLithium-ion rechargeablebattery	5VLithium-ion rechargeablebattery	4.2VLithium-ion rechargeablebattery	Due to differentdesign scheme, thedifference does notraise any new issue ofsubstantialequivalence accordingto test reports onbattery and device.
Type of protection against Electricalshock		Type BF	Type BF	Type BF	Same
OperatingEnvironment	Temperature	0°C ~35°C	4°C to 39°C(39°F to 103°F)	5°C~ 40°C	The slightly differentoperating temperaturedoes not raise anynew issue ofsubstantialequivalence according

	RelativeHumidity	10%~95%, non-condensing	Up to 95%, non-condensing	≤80%, non-condensing	to IEC 60601-1 testreport.Difference but iswithin the range of thepredicate device.
	Atmosphericpressure	70kPa~106kPa	700 to 1060hPa(70kPa~106kPa)	86kPa~106kPa	Same
Storage andTransportationEnvironment	Temperature	5°C ~28°C	-20°C to 70°C(-4°F to 158° F)	-20℃~55℃	Difference but iswithin the range of thepredicate device orthe reference device.
	RelativeHumidity	20%~75%, non-condensing	Up to 95%, non-condensing	≤93%, non-condensation	Difference but iswithin the range of thepredicate device orthe reference device.
	Atmosphericpressure	70kPa~106kPa	465 hpa to 1060hPa(46.5kPa~106kPa)	50kPa~106kPa	Difference but iswithin the range of thepredicate device orthe reference device.
Enclosure		49x37x137mm	48X38X16mm	133mmx63mmx33mm	Difference but doesnot raise any newissue of substantialequivalence
SpO2 Sensor		Built in main unit	Built in main unit	Accessory of main unit	Same
EMC andElectrical Safety	Electrical Safety	Compliance with IEC60601-1	Compliance with IEC60601-1	Compliance with IEC60601-1	Same
		Compliance with IEC60601-1-11	Compliance with IEC60601-1-11	Compliance with IEC60601-1-11	Same
	ElectromagneticCompatibility	Compliance with IEC60601-1-2	Compliance with IEC60601-1-2	Compliance with IEC60601-1-2	Same
PerformanceTesting	LaboratoryTesting	Compliance with ISO80601-2-61	Compliance with ISO80601-2-61	Compliance with ISO 9919	Same
	Clinical Testing	Compliance with ISO80601-2-61	Compliance with ISO80601-2-61	Compliance with ISO 9919	Same
Biocompatibility	Biocompatibility	Compliance with ISO	Compliance with ISO	Compliance with ISO	Same
	Statement	10993	10993	10993
	BiocompatibilityTestsconducted	Cytotoxicity,Delayed ContactSensitization,Skin Irritation	Cytotoxicity,Delayed ContactSensitization,Skin Irritation	Cytotoxicity,Delayed ContactSensitization,Skin Irritation	Same
	Summary of thebiocompatibilitytests	No toxicity to cells,No delayed contactsensitization,No irritation to skin	No toxicity to cells,No delayed contactsensitization,No irritation to skin	No toxicity to cells,No delayed contactsensitization,No irritation to skin	Same
	Software	Software Levelof concern	Moderate	Moderate	Moderate
		Brief descriptionof softwaretesting	Software Validation incompliance with theFDA's Guidance "Contentof Premarket Submissionsfor Device SoftwareFunctions".	Software validation perFDA guidance includingcybersecurity	The Software Validation isin compliance with FDAGuidance for the Contentof PremarketSubmissions for SoftwareContained in MedicalDevices.
		Cybersecuritytesting	Not applicable	Validated	Validated

Table 1 Substantial Equivalence Comparison

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Product: Vyvo Life Watch

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Product: Vyvo Life Watch

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Product: Vyvo Life Watch

Version: 2.0

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Version: 2.0

According to above table, VYVO Life Watch Oximeter have the same intended use. Although the subject device have sightly different technological characteristics, but the differences do not effectiveness and affect substantial equivalence.

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7 Non-clinical Tests

The subject device was tested to demonstrate substantial equivalence in accordance with the following standards and quidances.

ゃ IEC 60601-1:2005+A1:2012+A2+2020 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance;
ゃ 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;
� IEC 60601-1-11: 2015 Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in The Home Healthcare Environment;
ゃ ISO 80601-2-61:2017 Medical Electrical Equipment - Part 2-61: Particular Requirements For Basic Safety And Essential Performance Of Pulse Oximeter Equipment
ゃ ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity;
ゃ ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization;
ゃ ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation:
や Software Validation in compliance with the FDA's Guidance "Content of Premarket Submissions for Device Software Functions".

8 Clinical test

The clinical test of the subject device has been conducted in accordance with the FDA's guidance "Pulse Oximeters - Premarket Notification Submission [510(k)s]" and the standard ISO 80601-2-61:2017.

The functional oxygen saturation (SpO2) measurement has been validated on a total of 12 subjects with Fitzpatrick skin types. In addition, the 12 subjects include 6 healthy adult males and 6 healthy adult females, and their age range is from 19 to 42 vears old. Testing shows equivalence to simultaneous measurements from the predicate device. No adverse event is found and the safety and effectiveness of the subject device is identical with that of the predicate device.

9 Conclusion

Totally, the subject device VYVO Life Watch has the same intended use, indications for use, and technological characteristics as the predicate device BB-613 Watch Oximeter. Additionally, nonclinical and clinical test results have demonstrated that the VYVO Life Watch is the same as safe and effective as the BB-613 Watch Oximeter, and the slight technological differences do not raise any issue of safety and effectiveness. As a result, the VYVO Life Watch is substantially equivalent to the BB-613 Watch Oximeter.

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).