(305 days)
No
The description details standard pulse oximetry technology and mentions a microprocessor and operating software, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is indicated for measuring and displaying physiological parameters (SpO2 and pulse rate), not for treating or preventing a medical condition.
Yes
The device measures and displays functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate, which are physiological parameters used to assess a patient's condition. While it doesn't make a definitive diagnosis itself, it provides objective data that healthcare professionals can use as part of a diagnostic process to identify potential health issues or monitor existing ones.
No
The device description explicitly states it is a "small, wrist-worn device" that includes hardware components such as a reflectance pulse oximetry sensor with LEDs and a photodiode, a display, a battery, and a microprocessor. It is not solely software.
Based on the provided text, the VYVO Life Watch is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to obtain information for diagnostic or monitoring purposes.
- VYVO Life Watch Function: The VYVO Life Watch measures physiological parameters (%SpO2 and pulse rate) directly from the body using non-invasive pulse oximetry technology. It does not involve the collection or analysis of specimens taken from the body.
The device description clearly states it measures these parameters by emitting light through the skin and detecting reflected light, which is a direct measurement from the living tissue, not an analysis of a sample taken from the body.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
DOA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The expected measuring location of the device is the finger.
Indicated Patient Age Range
Adult
Intended User / Care Setting
hospitals, clinics, long-term care, and home use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Tests:
The subject device was tested to demonstrate substantial equivalence in accordance with the following standards and quidances:
- IEC 60601-1:2005+A1:2012+A2+2020 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance;
- 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;
- ISO 80601-2-61:2017 Medical Electrical Equipment - Part 2-61: Particular Requirements For Basic Safety And Essential Performance Of Pulse Oximeter Equipment
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity;
- ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization;
- ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation:
- Software Validation in compliance with the FDA's Guidance "Content of Premarket Submissions for Device Software Functions".
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- SpO2 Measuring Accuracy: ±3% for 70% ~ 80%; ±3% for 80% ~ 90%; ±3% for 90% ~ 100%;
- Pulse Rate Measuring Accuracy: ±2bpm or ±2% (whichever is greater)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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"
1
(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.
2
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
3
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
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 | |
| information | Submitter's Name: Vyvo Technology Corp.(VT) |
| Address: 123 NW 23 RD Street City Miami, FL | |
| Contact person: Alfonso Cioffi | |
| TEL: +1 2016470536 | |
| E-Mail: a.cioffi@helohealth.com | |
| Submission | |
| Correspondent | Contact person: Fu Ailing |
| Tel: +86-13538216349 | |
| Email: Aileenfu@coctd.com | |
| Company: Shenzhen Global Medical Technology Services Co., Ltd | |
| Address: Room 1702, Shenxintaifeng Building, No. 86, Qianjin 1st | |
| Road, Bao'an District, Shenzhen, 518101, Guangdong, China | |
| Establishment | |
| 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 |
| 510(k) Review Panel: Anesthesiology | |
| Classification name: Oximeter | |
| Regulation Number: 21 CFR 870.2700 | |
| Device Class: II | |
| 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 |
5
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
6
Version: 2.0
| Table 1 Substantial Equivalence Comparison | |||||
|---|---|---|---|---|---|
| Item | Subject Device | ||||
| (K231288) | Primary Predicate Device | ||||
| (K181006) | Reference Device | ||||
| (K122046) | Explanation of | ||||
| Differences Between | |||||
| Predicate and | |||||
| 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 | ||
| Technology 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 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. | The BB-613 Watch | ||||
| Oximeter 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. | The MD300W4 wrist pulse | ||||
| oximeter is a portable non- | |||||
| invasive device intended | |||||
| for spot checking, data | |||||
| collection and recording of | |||||
| arterial oxygen saturation | |||||
| (SpO2) and pulse rate of | |||||
| adult and pediatric patient | |||||
| at home and hospital | |||||
| (including clinical use In | |||||
| internist/surgery, | |||||
| Anesthesia, intensive care | |||||
| 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 | |||||
| Operation | Pulse reflectance | ||||
| technology, Two LED | |||||
| (red + IR) and photo | |||||
| diode absorbs | |||||
| reflected light | Pulse reflectance | ||||
| technology, Four LED | |||||
| (red + IR) and photo | |||||
| diode absorbs | |||||
| reflected light | Pulse reflectance | ||||
| technology, Two | |||||
| (red + IR) and photo | |||||
| diode absorbs | |||||
| reflected light | Same as the | ||||
| reference device | |||||
| K122046. | |||||
| Intended Application Site | Finger | Wrist | Finger | Same as the | |
| reference device | |||||
| K122046 | |||||
| Measurement type | Spot | Spot | Spot | Same | |
| Emitted light peak wavelength | 940nm (IR), 660nm | ||||
| (Red) | 880nm (IR), 650nm | ||||
| (Red) | 940nm (IR), 660nm | ||||
| (Red) | Same as the | ||||
| reference device | |||||
| K122046. | |||||
| Display Parameter | SpO2, pulse rate | SpO2, pulse rate | SpO2, pulse rate | Same | |
| Sensor | MAX30101 | Unspecified | M-50G | Due to different | |
| design scheme, the | |||||
| difference does not | |||||
| raise any new issue of | |||||
| substantial | |||||
| equivalence according | |||||
| to performance test | |||||
| reports. | |||||
| SpO2 module | Integrated into main unit | Integrated into main unit | M-50G, Insertion into main | ||
| 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%; | ||||
| ±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 ±3
digits
Display: 2 characters | 1% | Same as the
reference device
K122046. | |
| Pulse Rate Measuring Range | 40 to 200 bpm | 40 to 240 bpm | 30 to 235 bpm | Difference but is
within the PR
measuring range of
the predicate device
or the reference
device. | |
| Pulse Rate Measuring Accuracy | ±2bpm or ±2% (whichever
is greater) | ±3bpm | ±2bpm or 2% ( the greater) | Same as the
reference device
K122046. | |
| PR Resolution | 1bpm | ±3% or ±3 digits | 1bpm | Same as the | |
| | | | Display: 3 characters | | reference device
K122046. |
| Patient-Contacting Components/
Materials | | Case/Polycarbonate;
Photodiode window;
Watchband/silicone | Case/Polycarbonate;
Photodiode window;
Watchband/Silicone | Belt/Medical silica gel and
Nylon | 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 the
device as a watch
and powers it on | User wears the
device as a watch
and powers it on | User wears the device on
finger | Same |
| Sterility | | Supplied and used
non-sterile | Supplied and used
non-sterile | Supplied and used
non-sterile | Same |
| Display | | OLED | LCD on device | OLED | Same as the
reference device
K122046. |
| Data storage | | No | No | 72-Hour | Same |
| Transmission mode | | No | Bluetooth | USB or GPRS | N/A |
| Working Time | | About 5-7 days of
continuous use | 5 days of continuous use | Work for 10h continuously | Same or better |
| Power supply | | 3.8V
Lithium-ion rechargeable
battery | 5V
Lithium-ion rechargeable
battery | 4.2V
Lithium-ion rechargeable
battery | Due to different
design scheme, the
difference does not
raise any new issue of
substantial
equivalence according
to test reports on
battery and device. |
| Type of protection against Electrical
shock | | Type BF | Type BF | Type BF | Same |
| Operating
Environment | Temperature | 0°C35°C | 4°C to 39°C40°C | The slightly different
(39°F to 103°F) | 5°C
operating temperature
does not raise any
new issue of
substantial
equivalence according |
| | | | | | |
| | Relative
Humidity | 10%95%, non-condensing | Up to 95%, non-106kPa | 700 to 1060hPa
condensing | ≤80%, non-condensing | to IEC 60601-1 test
report.
Difference but is
within the range of the
predicate device. |
| | Atmospheric
pressure | 70kPa
(70kPa106kPa) | 86kPa106kPa | Same |
| Storage and
Transportation
Environment | Temperature | 5°C28°C | -20°C to 70°C106kPa | Difference but is
(-4°F to 158° F) | -20℃55℃ | Difference but is106kPa) | 50kPa
within the range of the
predicate device or
the reference device. |
| | Relative
Humidity | 20%75%, non-condensing | Up to 95%, non-106kPa | 465 hpa to 1060hPa
condensing | ≤93%, non-condensation | Difference but is
within the range of the
predicate device or
the reference device. |
| | Atmospheric
pressure | 70kPa
(46.5kPa
within the range of the
predicate device or
the reference device. |
| Enclosure | | 49x37x137mm | 48X38X16mm | 133mmx63mmx33mm | Difference but does
not raise any new
issue of substantial
equivalence |
| SpO2 Sensor | | Built in main unit | Built in main unit | Accessory of main unit | Same |
| EMC and
Electrical Safety | Electrical Safety | Compliance with IEC
60601-1 | Compliance with IEC
60601-1 | Compliance with IEC
60601-1 | Same |
| | | Compliance with IEC
60601-1-11 | Compliance with IEC
60601-1-11 | Compliance with IEC
60601-1-11 | Same |
| | Electromagnetic
Compatibility | Compliance with IEC
60601-1-2 | Compliance with IEC
60601-1-2 | Compliance with IEC
60601-1-2 | Same |
| Performance
Testing | Laboratory
Testing | Compliance with ISO
80601-2-61 | Compliance with ISO
80601-2-61 | Compliance with ISO 9919 | Same |
| | Clinical Testing | Compliance with ISO
80601-2-61 | Compliance with ISO
80601-2-61 | Compliance with ISO 9919 | Same |
| Biocompatibility | Biocompatibility | Compliance with ISO | Compliance with ISO | Compliance with ISO | Same |
| | Statement | 10993 | 10993 | 10993 | |
| | Biocompatibility
Tests
conducted | Cytotoxicity,
Delayed Contact
Sensitization,
Skin Irritation | Cytotoxicity,
Delayed Contact
Sensitization,
Skin Irritation | Cytotoxicity,
Delayed Contact
Sensitization,
Skin Irritation | Same |
| | Summary of the
biocompatibility
tests | No toxicity to cells,
No delayed contact
sensitization,
No irritation to skin | No toxicity to cells,
No delayed contact
sensitization,
No irritation to skin | No toxicity to cells,
No delayed contact
sensitization,
No irritation to skin | Same |
| | Software | Software Level
of concern | Moderate | Moderate | Moderate |
| | | Brief description
of software
testing | Software Validation in
compliance with the
FDA's Guidance "Content
of Premarket Submissions
for Device Software
Functions". | Software validation per
FDA guidance including
cybersecurity | The Software Validation is
in compliance with FDA
Guidance for the Content
of Premarket
Submissions for Software
Contained in Medical
Devices. |
| | | Cybersecurity
testing | Not applicable | Validated | Validated |
Table 1 Substantial Equivalence Comparison
7
Product: Vyvo Life Watch
Version: 2.0
8
Product: Vyvo Life Watch
Version: 2.0
9
Product: Vyvo Life Watch
Version: 2.0
10
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.
11
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.