(221 days)
Biobeat Watch K181006
Belun Ring K211407
No
The summary does not mention AI, ML, or any related terms, and the description of the signal processing and performance studies focuses on standard pulse oximetry methods and accuracy metrics.
No.
A therapeutic device is used to treat or cure a condition, while this device is for monitoring purposes only.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "can aid in the diagnosis and treatment of health conditions." While it primarily performs monitoring, this phrase indicates its role in the diagnostic process.
No
The device description explicitly states that the EvieMED Ring is a "rechargeable noninyasive wearable" with an "optical sensor that collects physiological signals." It is supplied with a "wearable, a charger, a USB-C cable," and is designed to be worn on the finger. This indicates the presence of physical hardware components beyond just software.
Based on the provided information, the EvieMED Ring is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves blood, urine, tissue, or other bodily fluids.
- The EvieMED Ring is a pulse oximeter. It measures oxygen saturation and pulse rate non-invasively by shining light through the skin and detecting the absorption of that light. It does not analyze any bodily specimens.
- The intended use explicitly states it's a "wireless, non-invasive, and stand-alone pulse oximeter." This aligns with the definition of a medical device that interacts with the body externally to gather physiological data.
Therefore, the EvieMED Ring falls under the category of a medical device, specifically a pulse oximeter, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
EvieMED Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot checking oxygen saturation of peripheral arterial hemoglobin (SpO2) and pulse rate of adult users with a condition that might benefit from monitoring. Only the Pulse Oximeter function of the EvieMED device provides medical data. The device is designed for use in a healthcare or home environment, during no motion conditions. It is not intended for critical care and out-of-hospital transport use and does not have alarms. It is available with a prescription and can aid in the diagnosis and treatment of health conditions.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The EvieWED Ring is a rechargeable noninyasive wearable is an open arrow design that allows for a snug fit and comfort during fluctuations in fluid retention and/or weight changes. There is an optical sensor that collects physiological signals and an app that processes the signals and provides spot SpO2 and pulse rate (PR) measurements during a spot check on a user's connected iOS phone. The ring is designed to be worn continuously and is waterproof, allowing the user to wear the device during handwashing, showering, and bathing without damaging the ring.
The EvieMED Ring is designed for accurate pulse oximeter readings inside of a clinical setting. The device is for a single user but can be used for many users, with the rechargeable battery in the ring and the charger expected to last 2 years or more. The device is not life-sustaining or life-supporting and does not include alarms. It is not indicated for use in motion or in conditions of low perfusion.
The device is supplied in a labeled box that includes a wearable, a charger, a USB-C cable, and a quick start guide. The ring is provided in common ring sizes (e.g., US 5 through US 12). Operation of the device depends on connection to the user's device running iOS 16.0 and above where the EvieWED Ring Mobile Application has been installed and registered, and a user-supplied AC adaptor is required for recharging the charger.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical sensor
Anatomical Site
finger/fingertip
Indicated Patient Age Range
adult users
Intended User / Care Setting
healthcare or home environment
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
Clinical validation per IEC 60601-2-61 and FDA guidance was completed in an IRB-approved SpO2 accuracy study at an independent lab. Eleven (3 male, 7 female) healthy young adults were enrolled into the study with 4 rings/subject. Subjects were evaluated per the Fitzpatrick scale with 3/11 in group III/V, and 3/11 in group V/V. There were no deviations or adverse events for the 11 subjects. Test devices and reference devices were placed and an arterial line started in one wrist. Subjects were placed into controlled hypoxia from 100% to 70%. SaO2 and test samples were taken at baseline (1) and then four samples at each decile (90's, 80's, and 70's) for two runs for a total of approximately 25 samples/subject. SaO2 data was compared to the test (SpO2) data and the root mean square error calculated. Paired samples were evaluated for each test placement site, by gender, and finally pooled together over the range of 70-100%. By placement site, acceptance criteria of less than 3.5%. By gender, the range varied by placement with all below the 3.5% acceptance criteria. By Fitzpatrick scale, accuracy varied by placement but no trends were identified for Fitzpatrick V/VI and all were under the 3.5% threshold.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests:
- Electrical safety, EMC, and home safety testing per IEC 60601-1, 62133, 60601-1-2, and 60601-1-11
- Usability testing per IEC 62133
- Software validation per FDA guidance including cybersecurity
- Bench study pulse accuracy was completed per IEC 80601-2-61
- Cytotoxicity, sensitization, and irritation testing per ISO 10993-5. and ISO 10993-11 to evaluate the permanent contact of a copolyester and LiquidMetal™ with intact skin was completed.
Clinical Tests:
- Clinical validation per IEC 60601-2-61 and FDA guidance was completed in an IRB-approved SpO2 accuracy study at an independent lab. Eleven (3 male, 7 female) healthy young adults were enrolled into the study with 4 rings/subject. Subjects were evaluated per the Fitzpatrick scale with 3/11 in group III/V, and 3/11 in group V/V. There were no deviations or adverse events for the 11 subjects. Test devices and reference devices were placed and an arterial line started in one wrist. Subjects were placed into controlled hypoxia from 100% to 70%. SaO2 and test samples were taken at baseline (1) and then four samples at each decile (90's, 80's, and 70's) for two runs for a total of approximately 25 samples/subject. SaO2 data was compared to the test (SpO2) data and the root mean square error calculated. Paired samples were evaluated for each test placement site, by gender, and finally pooled together over the range of 70-100%. By placement site, acceptance criteria of less than 3.5%. By gender, the range varied by placement with all below the 3.5% acceptance criteria. By Fitzpatrick scale, accuracy varied by placement but no trends were identified for Fitzpatrick V/VI and all were under the 3.5% threshold. All samples (816) were pooled for an overall accuracy of 2.46%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 accuracy: +/- 3.5% over the range of 70 to 100%.
Pulse rate accuracy: +/- 3 bpm over the range of 40 to 240
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.
Biobeat Watch K181006
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.
Belun Ring K211407
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 29, 2024
Movano Inc. dba Movano Health Kim Tompkins VP, Quality, Regulatory, & Clinical (ORC) 6800 Koll Center Parkway, Suite 160 Pleasanton, California 94566
Re: K241090
Trade/Device Name: Evie Med Ring Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: November 4, 2024 Received: November 4, 2024
Dear Kim Tompkins:
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.
1
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" (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 (OS) 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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/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,
James J. Lee -S
for Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
EvieMED Ring
Indications for Use (Describe)
EvieMED Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot checking oxygen saturation of peripheral arterial hemoglobin (SpO2) and pulse rate of adult users with a condition that might benefit from monitoring. Only the Pulse Oximeter function of the EvieMED device provides medical data. The device is designed for use in a healthcare or home environment, during no motion conditions. It is not intended for critical care and out-of-hospital transport use and does not have alarms. It is available with a prescription and can aid in the diagnosis and treatment of health conditions.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
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Image /page/4/Picture/0 description: The image shows the logo for Movano Health. The logo consists of a stylized "V" shape on the left, which transitions in color from blue to purple. To the right of the "V" is the word "MOVANO" in a bold, sans-serif font. Below "MOVANO" is the word "HEALTH" in a smaller, sans-serif font.
| Submitter
Legal Manufacturer
Specification Developer | Movano Inc. dba Movano Health
6800 Koll Center Parkway, Suite 160
Pleasanton, CA 94566
USA |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | November 27, 2024 |
| Contact | Kim Tompkins
VP, QRC
Movano Inc. dba Movano Health
Email: ktompkins@movano.com
Phone: 408 981 4889
Fax: 925 596 7100 |
| Trade Name | EvieMED Ring |
| Common Name | Pulse Oximeter |
| Classification | 21 CFR 870.2700 Class II |
| Product Code | DQA |
| Establishment Registration Number | NA |
| Predicate Device | Biobeat Watch K181006 |
| Reference Predicate | Belun Ring K211407 |
Device Description
The EvieWED Ring is a rechargeable noninyasive wearable is an open arrow design that allows for a snug fit and comfort during fluctuations in fluid retention and/or weight changes. There is an optical sensor that collects physiological signals and an app that processes the signals and provides spot SpO2 and pulse rate (PR) measurements during a spot check on a user's connected iOS phone. The ring is designed to be worn continuously and is waterproof, allowing the user to wear the device during handwashing, showering, and bathing without damaging the ring.
The EvieMED Ring is designed for accurate pulse oximeter readings inside of a clinical setting. The device is for a single user but can be used for many users, with the rechargeable battery in the ring and the charger expected to last 2 years or more. The device is not life-sustaining or life-supporting and does not include alarms. It is not indicated for use in motion or in conditions of low perfusion.
The device is supplied in a labeled box that includes a wearable, a charger, a USB-C cable, and a quick start guide. The ring is provided in common ring sizes (e.g., US 5 through US 12). Operation of the device depends on connection to the user's device running iOS 16.0 and above where the EvieWED Ring Mobile Application has been installed and registered, and a user-supplied AC adaptor is required for recharging the charger.
Intended Use/Indications for Use
EvieMED Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot checking oxygen saturation of peripheral arterial hemoglobin (SpO2) and pulse rate of adult users with a condition that might benefit from monitoring. Only the Pulse Oximeter function of the EvieMED device provides medical data. The device is designed for use in a healthcare or home environment, during no motion conditions. It is not intended for critical care and out-ofhospital transport use and does not have alarms. It is available with a prescription and can aid in the diagnosis and treatment of health conditions.
Technological Characteristics
Operating Principles
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Image /page/5/Picture/0 description: The image shows the logo for Movano Health. The logo consists of a stylized "V" shape on the left, transitioning from blue to purple. To the right of the "V" is the text "MOVANO" in bold, black letters, with the word "HEALTH" in a smaller font size directly below it.
Pulse oximetry of the EvieMED Ring is based upon the fundamental principle that hemoglobin bound to oxygen (oxyhemoglobin) and hemoglobin unbound to oxygen (deoxyhemoglobin) vary in the absorption of different wavelengths of light and the absorption can be used to estimate SpO2 and PR. Intended Use
The Evie Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot checking oxygen saturation of peripheral arterial hemoglobin (SpO2) and pulse rate of adult users in a healthcare or home environment. during no motion conditions. It is not intended for critical care and out-of-hospital transport use and does not have alarms.
Mechanism of Action
Pulse oximetry using the EvieMED Ring can be performed with the ring worn on the patient's finger or held in place at the fingertip. Optical sensors within the ring transmit to and receive light from the issue using a photodetector that detects the signal variation resulting from differences in the absorption of light. Signals are then passed to the user's connected iOS device where they are processed to provide a spot check SpO2 and pulse rate.
Comparison Summary of Technological Characteristics
Similarities and Differences: Subject and Predicate Devices
| Description | Subject Device:
EvieMED [Movano Health]
Ring Pulse Oximeter | Predicate Device:
Biobeat Pulse Oximeter
K181006 | Reference Predicate Device:
Belun Ring BLR-100X
K211407 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Details | Regulatory Class II DQA | Class II DQA | Class II DQA |
| | Intended Use
EvieMED Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot checking oxygen saturation of peripheral arterial hemoglobin (SpO2) and pulse rate of adult users with a condition that might benefit from monitoring. Only the Pulse Oximeter function of the EvieMED device provides medical data. The device is designed for use in a healthcare or home environment, during no motion conditions. It is not intended for critical care and out-of-hospital transport use and does not have alarms. It is available with a prescription and can aid in the diagnosis and treatment of health conditions. | 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. | Belun Ring BLR-100X is a wireless, non-invasive and stand-alone pulse oximeter intended to be used for continuous data collection and recording of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through index finger in hospital and home environment for up to ten hours, during no motion and motion conditions, and for patients who are well or poorly perfused. It is not intended for single-use and out-of-hospital transport use and does not have alarms. |
| | Availability Rx | Rx | Rx |
Intended Use Comparison Discussion: Similar intent population and pulse oximetry use. Both the subject device and the predicate device are indicated for spot checking SpO2 and pulse during non-motion. All can be used in a home environment. "Not intended for out of hospital transport use" is the same as the reference device. "Not intended for use in critical care" and "a diagnosis and treatment" are prescribing that is important for the safety of the patient. Medical data function (in bold), while not included in the predicate or reference device's intended use was added to the subject device to ensure safety following usability testing.
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Image /page/6/Picture/0 description: The image shows the logo for Movano Health. The logo consists of a stylized checkmark symbol on the left, transitioning from blue to purple. To the right of the symbol is the text "MOVANO" in a bold, sans-serif font, with the word "HEALTH" in a smaller font size directly underneath.
| Subject Device: | Predicate Device: | Reference Predicate Device: | |||
|---|---|---|---|---|---|
| Description | EvieMED [Movano Health] | ||||
| Ring Pulse Oximeter | Biobeat Pulse Oximeter | ||||
| K181006 | Belun Ring BLR-100X | ||||
| K211407 | |||||
| See Attachments 12-1, 12-2, & 12-3 | See Attachments 12-4, 12-5, & 12-6 | ||||
| Technology | Measure- | ||||
| ment site | Finger/fingertip | Wrist | Finger | ||
| Data | |||||
| collection | Spot check | Spot check | Continuous | ||
| Principle of | |||||
| operation | Pulse Reflective: green, red, and | ||||
| IR LEDs | Pulse Reflective: red and IR | ||||
| LEDs | Pulse Reflective: multi- | ||||
| wavelength | |||||
| Users | Single user or multi-user | ||||
| [patients] | Single patient use | Multi-patient use | |||
| User | |||||
| interface | Mobile application software (app) | ||||
| installed on a user-supplied | |||||
| compatible phone. | LCD on device | Not specified | |||
| Form factor | Ring wearable or fingertip | Wrist wearable | Ring wearable | ||
| How | |||||
| supplied | Supplied and used non-sterile | Supplied and used non-sterile | Supplied and used non-sterile | ||
| Data | |||||
| storage | Yes | No | Yes | ||
| Technology Discussion: The form factor for the subject device is a ring and the predicate device is a | |||||
| ring device cleared for continuous pulse oximetry use. All devices are wearable, with the subject | |||||
| device is for a single user or multi-user, while the predicate device is only for single patient use, and the reference device is for multi- | |||||
| patient use. The key difference is the user interface screen display for the subject device and direct display for the predicate device. | |||||
| This difference has been tested in clinical and bench testing for the subject device and found to be safe and effective for its intended | |||||
| Subject Device: | Predicate Device: | Reference Predicate Device: | |||
| Description | EvieMED [Movano Health] | ||||
| Ring Pulse Oximeter | Biobeat Pulse Oximeter | ||||
| K181006 | Belun Ring BLR-100X | ||||
| K211407 | |||||
| See Attachments 12-1, 12-2, & 12-3 | See Attachments 12-4, 12-5, & 12-6 | ||||
| Design and Material Specs | Commun- | ||||
| ication | Communication between the | ||||
| wearable and the App using | |||||
| Bluetooth Low Energy (BLE). | Not specified | Communication between the | |||
| wearable and the App using | |||||
| Bluetooth 4.2 or above; 5.0 or | |||||
| above is preferred. | |||||
| Material, | |||||
| contact | Outer ring: amorphous metal | ||||
| Inner ring: polymer | Polycarbonate, silicone | Ring: thermoplastic elastomers | |||
| and polycarbonates. | |||||
| Power | Rechargeable battery powered | Battery powered | Battery powered | ||
| Operating | |||||
| Temp- | |||||
| erature | 5°C to 40°C (41°F to 104° F) | ||||
| Ambient | 4°C to 39°C (39°F to 103°F) | Keep Belun" Ring away from dust, lint, vibration, corrosive substances, explosive materials, high temperature and moisture When Belun" Ring is carried from cold environment to warm or humid environment, do not use it immediately. | |||
| Design and Material Specifications Discussion: All devices are battery-powered wearables and communication between | |||||
| the wearable and the mobile app depends on Bluetooth for both the subject and the reference device. Materials are all | |||||
| common skin contacting materials. Operating temperature are similar between the primary predicate and the subject | |||||
| device while the reference predicate does not have specified temperatures but has implied ambient room temperature | |||||
| from the information provided. The key difference between the subject device and the predicate device is the form | |||||
| factor, which is the same between the subject and the reference devices. Differences in the form factor and materials | |||||
| have been tested and essential performance demonstrated, | |||||
| Accuracy Validation | SpO2 | ||||
| accuracy | +/- 3.5% over the range of 70 to | ||||
| 100%. | +/- 3% over the range of 70 to | ||||
| 100%. | +/- 2.7% over the range of 70 to | ||||
| 100% | |||||
| Pulse rate | |||||
| accuracy | +/- 3 bpm over the range of 40 to | ||||
| 240 | +/- 3% over the range of 40 to | ||||
| 240 bpm | +/- 2.5 bpm or 2% whichever is | ||||
| larger over the range 30 to 250 | |||||
| bpm. | |||||
| Accuracy: Accuracy specifications are similar for all three devices with the only difference that the reference device has | |||||
| a broader range for pulse. All are within the accuracy for SpO2 specified in the pulse oximeter guidance. |
use. The additional wellness features of the subject device have no impact on the medical device pulse oximeter function—these features are exempt under the wellness policy and/or enforcement discretion as a multi-function device.
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Image /page/7/Picture/0 description: The image shows the logo for Movano Health. The logo consists of a stylized checkmark symbol on the left, with the word "MOVANO" in bold, sans-serif font to the right of the symbol. Below "MOVANO" is the word "HEALTH" in a smaller, sans-serif font. The checkmark symbol is a gradient of blue and purple.
Technological Comparison Summary
The form factor for the subject device is a ring and the predicate device is a watch; the reference device is a ring device cleared for continuous pulse oximetry use. All devices are wearable, with the same principle of operation. The subject device is for a single user or multi-user, while the predicate device is only for single patient use, and the reference device is for multi-patient use. The key difference is the user interface with a screen display for the subject device and direct display for the predicate device. Both the subject device and the reference device include wellness features. Differences
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Image /page/8/Picture/0 description: The image shows the logo for Movano Health. The logo consists of a stylized "V" shape that transitions from blue to purple on the left side. To the right of the "V" is the word "MOVANO" in bold, black letters, with the word "HEALTH" in smaller, thinner, black letters underneath.
have been tested in clinical, usability, biocompatibility, and bench testing for the subject device and effective for its intended use.
Non-Clinical and Clinical Tests Summary & Conclusions
The following performance testing was completed to demonstrate substantial equivalence:
- Electrical safety, EMC, and home safety testing per IEC 60601-1, 62133, 60601-1-2, and 60601-1-11 ●
- Usability testing per IEC 62133
- Software validation per FDA guidance including cybersecurity ●
- Bench study pulse accuracy was completed per IEC 80601-2-61
- Cytotoxicity, sensitization, and irritation testing per ISO 10993-5. and ISO 10993-11 to evaluate the . permanent contact of a copolyester and LiquidMetal™ with intact skin was completed.
Clinical validation per IEC 60601-2-61 and FDA guidance was completed in an IRB-approved SpO2 accuracy study at an independent lab. Eleven (3 male, 7 female) healthy young adults were enrolled into the study with 4 rings/subject. Subjects were evaluated per the Fitzpatrick scale with 3/11 in group III/V, and 3/11 in group V/V. There were no deviations or adverse events for the 11 subjects. Test devices and reference devices were placed and an arterial line started in one wrist. Subjects were placed into controlled hypoxia from 100% to 70%. SaO2 and test samples were taken at baseline (1) and then four samples at each decile (90's, 80's, and 70's) for two runs for a total of approximately 25 samples/subject. SaO2 data was compared to the test (SpO2) data and the root mean square error calculated. Paired samples were evaluated for each test placement site, by gender, and finally pooled together over the range of 70-100%. By placement site, acceptance criteria of less than 3.5%. By gender, the range varied by placement with all below the 3.5% acceptance criteria. By Fitzpatrick scale, accuracy varied by placement but no trends were identified for Fitzpatrick V/VI and all were under the 3.5% threshold. All samples (816) were pooled for an overall accuracy of 2.46%.
Conclusions
The EvieWED Ring is as safe and as effective as the Biobeat BB-613 Watch Oximeter. The EvieWED Ring has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended diagnostic use of the device when used as labeled. In addition, the minor technological differences between the EvieWED Ring and its predicate devices do not raise different questions of safety or effectiveness. Performance data from the nonclinical tests demonstrated that the test device is as safe, as effective, and performs as well or better than the legally marketed predicate devices identified. Thus, the EvieMED Ring pulse oximeter is substantially equivalent.