Vyvo

K231288 · Vyvo Technology Corp.(Vt) · DQA · Mar 4, 2024 · Cardiovascular

Device Facts

• Record ID: K231288
• Device Name: Vyvo
• Applicant: Vyvo Technology Corp.(Vt)
• Product Code: DQA · Cardiovascular
• Decision Date: Mar 4, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Indications for Use

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 Story

The Vyvo Life Watch is a wrist-worn, non-sterile, single-patient use pulse oximeter. It utilizes reflectance pulse oximetry to measure SpO2 and pulse rate. The device features a sensor with two LEDs (660 nm red, 940 nm infrared) and a photodiode. The user initiates measurement by pressing a finger onto the sensor located on the side of the watch. The device processes light absorption changes in the arteriolar bed to calculate physiological parameters, which are displayed on an integrated OLED screen. It is powered by a rechargeable lithium-ion polymer battery and includes a micro-USB connector for charging. The device is intended for spot-checking by adult patients or healthcare providers in clinical and home environments. It does not provide life-supporting or life-sustaining functions. The output allows for immediate assessment of oxygenation and pulse rate, aiding in clinical decision-making for spot-check monitoring.

Clinical Evidence

Clinical validation conducted per ISO 80601-2-61:2017 on 12 healthy adult subjects (6 male, 6 female, ages 19-42) with varying Fitzpatrick skin types. Results showed equivalence to simultaneous measurements from the predicate device. No adverse events were reported.

Technological Characteristics

Wrist-worn reflectance pulse oximeter. Materials: Polycarbonate case, silicone watchband. Sensing: MAX30101 sensor (660nm red, 940nm IR LEDs, photodiode). Power: 3.8V 250mAh rechargeable lithium-ion polymer battery. Display: OLED. Connectivity: Peripheral micro-USB for charging. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-61, ISO 10993 (biocompatibility).

Indications for Use

Indicated for spot-checking functional oxygen saturation (%SpO2) and pulse rate in adult patients in hospitals, clinics, long-term care, and home settings.

Regulatory Classification

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.

Predicate Devices

• BB-613 Watch Oximeter (K181006)

Reference Devices

• Wrist Pulse Oximeter (K122046)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer<br>information | Submitter's Name: Vyvo Technology Corp.(VT)<br>Address: 123 NW 23 RD Street City Miami, FL<br>Contact person: Alfonso Cioffi<br>TEL: [phone]<br>E-Mail: [e-mail] |
| Submission<br>Correspondent | Contact person: Fu Ailing<br>Tel: [phone]<br>Email: [e-mail]<br>Company: Shenzhen Global Medical Technology Services Co., Ltd<br>Address: Room 1702, Shenxintaifeng Building, No. 86, Qianjin 1st<br>Road, Bao'an District, Shenzhen, 518101, Guangdong, China |
| Establishment<br>registration 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: Cardiovascular<br>510(k) Review Panel: Anesthesiology<br>Classification name: Oximeter<br>Regulation Number: 21 CFR 870.2700<br>Device Class: II<br>Product 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 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.

# 5 Intended Use/ Indications for Use

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.

# 6 Comparison

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Version: 2.0

| Table 1 Substantial Equivalence Comparison | | | | | |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Subject Device<br>(K231288) | Primary Predicate Device<br>(K181006) | Reference Device<br>(K122046) | Explanation of<br>Differences Between<br>Predicate and<br>Subject 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 Electronic<br>Technology Company,<br>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 a<br>small, wrist-worn device<br>indicated for use in<br>measuring and displaying<br>functional oxygen<br>saturation of arterial<br>hemoglobin (%SpO2) and<br>pulse rate. It is intended for<br>spot-checking of adult<br>patients in hospitals,<br>clinics, long-term care, and<br>home use. | The BB-613 Watch<br>Oximeter is a small, wrist-<br>worn device indicated for<br>use in measuring and<br>displaying functional<br>oxygen saturation of<br>arterial hemoglobin<br>(%SpO2) and pulse rate. It<br>is intended for spot-<br>checking of adult patients<br>in hospitals, clinics, long-<br>term care, and home use. | The MD300W4 wrist pulse<br>oximeter is a portable non-<br>invasive device intended<br>for spot checking, data<br>collection and recording of<br>arterial oxygen saturation<br>(SpO2) and pulse rate of<br>adult and pediatric patient<br>at home and hospital<br>(including clinical use In<br>internist/surgery,<br>Anesthesia, intensive care<br>and etc). | Same | |
| Intended Population | Adult | Adult | Adult, pediatric | Same | |
| Composition | A main unit | A main unit | A main unit, SpO2 sensor | Same | |
| Principle of<br>Operation | Pulse reflectance<br>technology, Two LED<br>(red + IR) and photo<br>diode absorbs<br>reflected light | Pulse reflectance<br>technology, Four LED<br>(red + IR) and photo<br>diode absorbs<br>reflected light | Pulse reflectance<br>technology, Two<br>(red + IR) and photo<br>diode absorbs<br>reflected light | Same as the<br>reference device<br>K122046. | |
| Intended Application Site | Finger | Wrist | Finger | Same as the<br>reference device<br>K122046 | |
| | | | | | |
| Measurement type | Spot | Spot | Spot | Same | |
| Emitted light peak wavelength | 940nm (IR), 660nm<br>(Red) | 880nm (IR), 650nm<br>(Red) | 940nm (IR), 660nm<br>(Red) | Same as the<br>reference device<br>K122046. | |
| Display Parameter | SpO2, pulse rate | SpO2, pulse rate | SpO2, pulse rate | Same | |
| Sensor | MAX30101 | Unspecified | M-50G | Due to different<br>design scheme, the<br>difference does not<br>raise any new issue of<br>substantial<br>equivalence according<br>to performance test<br>reports. | |
| SpO2 module | Integrated into main unit | Integrated into main unit | M-50G, Insertion into main<br>unit 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%;<br>±3% for 80% ~ 90%;<br>±3% for 90% ~ 100%; | 70%-80%±3%<br>80%-90%±3%<br>90%-100%±3% | 70%-100%±3%<br>90%-100%±2%<br>80%-90%±3%<br>70%-80%±3%<br>>70% unspecified | Same | |
| SpO2 Resolution | 1% | 70%-100%, ±3% or ±3<br>digits<br>Display: 2 characters | 1% | Same as the<br>reference device<br>K122046. | |
| Pulse Rate Measuring Range | 40 to 200 bpm | 40 to 240 bpm | 30 to 235 bpm | Difference but is<br>within the PR<br>measuring range of<br>the predicate device<br>or the reference<br>device. | |
| Pulse Rate Measuring Accuracy | ±2bpm or ±2% (whichever<br>is greater) | ±3bpm | ±2bpm or 2% ( the greater) | Same as the<br>reference device<br>K122046. | |
| PR Resolution | 1bpm | ±3% or ±3 digits | 1bpm | Same as the | |
| | | | Display: 3 characters | | reference device<br>K122046. |
| Patient-Contacting Components/<br>Materials | | Case/Polycarbonate;<br>Photodiode window;<br>Watchband/silicone | Case/Polycarbonate;<br>Photodiode window;<br>Watchband/Silicone | Belt/Medical silica gel and<br>Nylon | Same |
| Contact Duration | | Prolonged contact duration<br>>24h to 30d | Prolonged contact duration<br>>24h to 30d | Prolonged contact duration<br>>24h to 30d | Same |
| Application Method | | User wears the<br>device as a watch<br>and powers it on | User wears the<br>device as a watch<br>and powers it on | User wears the device on<br>finger | Same |
| Sterility | | Supplied and used<br>non-sterile | Supplied and used<br>non-sterile | Supplied and used<br>non-sterile | Same |
| Display | | OLED | LCD on device | OLED | Same as the<br>reference device<br>K122046. |
| Data storage | | No | No | 72-Hour | Same |
| Transmission mode | | No | Bluetooth | USB or GPRS | N/A |
| Working Time | | About 5-7 days of<br>continuous use | 5 days of continuous use | Work for 10h continuously | Same or better |
| Power supply | | 3.8V<br>Lithium-ion rechargeable<br>battery | 5V<br>Lithium-ion rechargeable<br>battery | 4.2V<br>Lithium-ion rechargeable<br>battery | Due to different<br>design scheme, the<br>difference does not<br>raise any new issue of<br>substantial<br>equivalence according<br>to test reports on<br>battery and device. |
| Type of protection against Electrical<br>shock | | Type BF | Type BF | Type BF | Same |
| Operating<br>Environment | Temperature | 0°C ~35°C | 4°C to 39°C<br>(39°F to 103°F) | 5°C~ 40°C | The slightly different<br>operating temperature<br>does not raise any<br>new issue of<br>substantial<br>equivalence according |
| | | | | | |
| | Relative<br>Humidity | 10%~95%, non-condensing | Up to 95%, non-<br>condensing | ≤80%, non-condensing | to IEC 60601-1 test<br>report.<br>Difference but is<br>within the range of the<br>predicate device. |
| | Atmospheric<br>pressure | 70kPa~106kPa | 700 to 1060hPa<br>(70kPa~106kPa) | 86kPa~106kPa | Same |
| Storage and<br>Transportation<br>Environment | Temperature | 5°C ~28°C | -20°C to 70°C<br>(-4°F to 158° F) | -20℃~55℃ | Difference but is<br>within the range of the<br>predicate device or<br>the reference device. |
| | Relative<br>Humidity | 20%~75%, non-condensing | Up to 95%, non-<br>condensing | ≤93%, non-condensation | Difference but is<br>within the range of the<br>predicate device or<br>the reference device. |
| | Atmospheric<br>pressure | 70kPa~106kPa | 465 hpa to 1060hPa<br>(46.5kPa~106kPa) | 50kPa~106kPa | Difference but is<br>within the range of the<br>predicate device or<br>the reference device. |
| Enclosure | | 49x37x137mm | 48X38X16mm | 133mmx63mmx33mm | Difference but does<br>not raise any new<br>issue of substantial<br>equivalence |
| SpO2 Sensor | | Built in main unit | Built in main unit | Accessory of main unit | Same |
| EMC and<br>Electrical Safety | Electrical Safety | Compliance with IEC<br>60601-1 | Compliance with IEC<br>60601-1 | Compliance with IEC<br>60601-1 | Same |
| | | Compliance with IEC<br>60601-1-11 | Compliance with IEC<br>60601-1-11…