circul™ pro Ring

K221361 · Bodimetrics, LLC · DQA · Aug 29, 2023 · Cardiovascular

Device Facts

• Record ID: K221361
• Device Name: circul™ pro Ring
• Applicant: Bodimetrics, LLC
• Product Code: DQA · Cardiovascular
• Decision Date: Aug 29, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The circul™ pro Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot-check and/or continuous data collection of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through the index finger in adult patients. It can be used in hospitals and home environments for up to twelve hours in non-motion and well perfused conditions. It is not intended for single-use and out-of-hospital transport use and does not have alarms.

Device Story

Wearable ring-form pulse oximeter; uses reflective oximetry with red (660nm) and infrared (940nm) LEDs to measure SpO2 and pulse rate. Features spring-fit mechanism for finger stabilization. Data transmitted via Bluetooth (BLE 4.1) to mobile application. Used by adult patients in home or hospital settings for up to 12 hours. Provides spot-check or continuous data collection; no alarms. Healthcare providers review data via mobile app to assess patient oxygenation and pulse status. Benefits include non-invasive, convenient monitoring of SpO2 and PR in non-motion, well-perfused conditions.

Clinical Evidence

Clinical study per ISO 80601-2-61:2017 with 12 subjects (33.3% dark pigmentation). Compared circul™ pro Ring SpO2/PR against blood analyzer and patient monitor. Primary endpoint: SpO2 accuracy (ARMS 1.85%, <3% limit). Secondary endpoint: PR accuracy (mean bias -0.33 bpm, 95% CI [-0.59, -0.07] bpm). No adverse events reported. Bench testing confirmed SpO2 accuracy ±3.5% (70-100%) and PR accuracy ±2% or ±2 bpm (30-240 bpm).

Technological Characteristics

Reflective oximetry; Red (660nm) and IR (940nm) LEDs. Materials: Stainless steel, PC (ISO 10993 compliant). Power: 3.7V Lithium battery. Connectivity: Bluetooth (BLE 4.1). Form factor: Ring with spring-fit mechanism. IP65 ingress protection. Standards: ISO 80601-2-61, IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2.

Indications for Use

Indicated for adult patients for spot-check or continuous collection of SpO2 and pulse rate via index finger. Use limited to non-motion, well-perfused conditions for up to 12 hours in home or hospital settings. Not for single-use, out-of-hospital transport, or patients requiring alarms.

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

• Belun Ring BLR-100X (K211407)

Reference Devices

• Oxiband (Checkme) O2 Pulse Oximeter (K191088)

Submission Summary (Full Text)

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August 29, 2023

BodiMetrics, LLC % Michael Nilo President & Prinicipal Consultant Nilo Medical Consulting Group, LLC 3491 Denny Street Pittsburgh, Pennsylvania 15201

Re: K221361

Trade/Device Name: circul™ pro Ring Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: August 11, 2023 Received: August 14, 2023

Dear Michael Nilo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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. 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

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## Indications for Use

D-2

510(k) Number (if known) K221361

Device Name circul™ pro Ring

### Indications for Use (Describe)

The circul™ pro Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot-check and/ or continuous data collection of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through the index finger in adult patients. It can be used in home environments for up to twelve hours in non-motion and well perfused conditions. It is not intended for single-use and out-of-hospital transport use and does not have alarms.

| 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) |

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This 510(k) Summary was prepared in accordance with 21 CFR 807.92

#### Date Prepared 1.

December 2022

#### Submitter 2.

| Applicant: | BodiMetrics, LLC<br>1601 N. Sepulveda Blvd, Suite 839<br>Manhattan Beach, CA 90266 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Mark Goettling<br>CEO, CFO, and Co-Founder<br>Phone: [phone]<br>Email: [e-mail] |
| Application<br>Correspondent: | Michael Nilo<br>President and Principal Consultant, Nilo Medical Consulting Group<br>Phone: [phone]<br>Email: [e-mail] |

#### 3. Proposed Device Information

| Trade Name: | circul TM pro Ring |
|------------------------|-------------------------------------------------------------------------------------|
| Common Name: | Oximeter |
| Device Classification: | Name: Oximeter<br>Regulation No.: 21 CFR 870.2700<br>Product Code: DQA<br>Class: II |

#### 4. Predicate Device Information

| Trade Name: | Belun Ring BLR-100X |
|------------------------|-------------------------------------------------------------------------------------|
| 510(k) Number: | K211407 |
| Common Name: | Oximeter |
| Device Classification: | Name: Oximeter<br>Regulation No.: 21 CFR 870.2700<br>Product Code: DQA<br>Class: II |

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| Trade Name: | Oxiband (Checkme) O2 Pulse Oximeter |
|------------------------|-------------------------------------------------------------------------------------|
| 510(k) Number: | K191088 |
| Common Name: | Oximeter |
| Device Classification: | Name: Oximeter<br>Regulation No.: 21 CFR 870.2700<br>Product Code: DQA<br>Class: II |

#### Reference Device Information ട്.

#### 6. Device Description

The circul™ pro Ring is a small, wearable, non-invasive, wireless device that the user wears on one finger. The ring features an adjustable fit (by means of multiple ring sizes (S, L, XL) and a spring fit) for comfort and can be worn on any finger on either hand. The circul pro Ring relies on an optical sensor to detect oxygen saturation (SpO2) and pulse rate (PR). The sensor uses two wavelengths of LEDs:

- Red: with a wavelength of 660 nm ± 10 nm
- Infrared: with a wavelength of 940 nm ± 20 nm ●

The wavelength beyond this range has a certain impact on the accuracy of the measurement results. The blood oxygen percentage is calculated based on measuring the passage of the two wavelengths of light (with different absorption rates) through the body, also known as Reflective Oximetry. The integrated sensor technology works to determine the blood oxygen content by determining the light absorption when the skin is illuminated. The circul pro Ring features a spring mechanism, and the elastic structure of the embedded sensor and inner arch of the ring are ergonomically shaped to offer a snug fit, preventing it from slipping off the finger, stabilizing the sensor on the 'belly' of the finger, and minimizing twisting of the ring on the wearer's finger. This also helps to reduce the likelihood of poor SpO2 readings in patients with darker skin pigments.

#### 7. Indications for Use

The circul™ pro Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot-check and/or continuous data collection of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through the index finger in adult patients. It can be used in hospitals and home environments for up to twelve hours in non-motion and well perfused conditions. It is not intended for single-use and out-of-hospital transport use and does not have alarms.

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#### Comparison of Technical Characteristics with the Predicate Device 8.

| Comparison Element | Subject Device<br>circul pro Ring | Predicate Device<br>Belun Ring BLR 100X | Reference Device<br>Oxiband (Checkme) O2<br>Pulse Oximeter | Comments |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Basic Elements | | | | |
| Product Name | Pulse Oximeter | Pulse Oximeter | Pulse Oximeter | Identical |
| Manufacturer | Hangzhou Megasens<br>Technology Company,<br>Ltd. | Belun Technology<br>Company Ltd. | Shenzen Viatom<br>Technology Co., Ltd. | N/A |
| FDA 510(k) Document<br>Number | K221361 | K211407 | K191088 | N/A |
| Regulation Number | 870.2700 | 870.2700 | 870.2700 | Identical |
| Classification | II | II | II | Identical |
| Classification Name | Oximeter | Oximeter | Oximeter | Identical |
| Product Code | DQA | DQA | DQA | Identical |
| Comparison Element | Subject Device | Predicate Device | Reference Device<br>Oxiband (Checkme) O2<br>Pulse Oximeter | Comments |
| | circulTM pro Ring | Belun Ring BLR 100X | | |
| Intended Use | The circulTM pro Ring is a<br>wireless, non-invasive, and<br>stand-alone pulse oximeter<br>intended to be used for<br>spot-check and/or<br>continuous data collection<br>of oxygen saturation of<br>arterial hemoglobin (SpO2)<br>and pulse rate (PR) through<br>the index in adult patients.<br>It can be used in hospitals<br>and home environments for<br>up to twelve hours in non-<br>motion and well perfused<br>conditions. It is not<br>intended for single-use and<br>out-of-hospital transport<br>use and does not have<br>alarms. | Belun Ring BLR-100X is a<br>wireless, non-invasive and<br>stand-alone pulse oximeter<br>intended to be used for<br>continuous data collection<br>and recording of oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and the<br>pulse rate of adult patients<br>through index finger in<br>hospital and home<br>environment for up to ten<br>hours, during no motion<br>and motion conditions, and<br>for patients who are well or<br>poorly perfused. It is not<br>intended for single-use and<br>out-of-hospital transport<br>use and does not have<br>alarms. | The Oxiband Pulse<br>Oximeter is a wrist pulse<br>oximeter indicated for use<br>in measuring, displaying,<br>storing and transmitting<br>functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and<br>pulse rate for adult patients.<br>It is intended for spot-check<br>and/or continuous data<br>collection, and not<br>continuous monitoring. It<br>can be used in sleep labs,<br>long-term care, hospitals<br>and home use. | Substantially Equivalent<br>Both the subject and predicate device share the<br>indication for collection of oxygen saturation or<br>arterial hemoglobin (SpO2) and pulse rate (PR)<br>through the index finger and are therefore considered<br>substantially equivalent.<br>The subject device's indication statement reflects its<br>functionality, in that the subject device is not intended<br>for motion conditions. Use of the subject device for<br>up to twelve hours is supported by testing which<br>demonstrated safe and effective performance under<br>these conditions. Also, the performance of the subject<br>device was not evaluated in poorly perfused subjects<br>and the indication reflects this. The subject device is<br>used for spot-check or continuous data collection, and<br>not continuous monitoring whereas the predicate<br>device is indicated for continuous data collection. The<br>subject device shares the same indication as the<br>legally marketed reference device for use conditions<br>and is therefore considered substantially equivalent.<br>Although the subject device proposes a longer<br>performance window and does not seek indication for<br>motion or poorly perfused conditions relative to the<br>predicate device, the differences in the proposed<br>indication does not raise different questions of safety<br>or effectiveness as the performance of the subject<br>device is adequately supported by test data. |
| Technology | | | | |
| Technology Type | Reflective Light | Reflective Light | Reflective Light | Identical |
| Intended Application Site | Finger | Finger | Finger | Identical |
| Comparison Element | Subject Device<br>circul pro Ring | Predicate Device<br>Belun Ring BLR 100X | Reference Device<br>Oxiband (Checkme) O2<br>Pulse Oximeter | Comments |
| Measurement Wavelength | | | | |
| Red | $660 nm \pm 10 nm$ | $658 nm \pm 2 nm$ | Not Reported | Substantially Equivalent |
| Infrared | $940 nm \pm 20 nm$ | $886 nm \pm 6 nm$ | Not Reported | Although the measurement wavelengths of the subject<br>and predicate device differ slightly, the ability of the<br>subject device to perform accurate measurements was<br>confirmed by meeting the requirements ISO 80601-2-<br>61 as well as a clinical validation which included<br>darkly pigmented subjects. Therefore, the minor<br>differences between the measurement wavelength of<br>the subject and predicate devices do not raise different<br>questions of safety or effectiveness. |
| Performance | | | | |
| Interface | Bluetooth (BLE 4.1) | • USB<br>• Bluetooth | Bluetooth | Substantially Equivalent |
| User Interface | Via mobile application | Via host program interface | Not reported | Substantially Equivalent<br><br>The user interface of the subject and predicate device<br>are similar, and the ability of the subject device to<br>perform and report accurate measurements was<br>confirmed by meeting the requirements ISO 80601-2-<br>61 as well as a clinical validation. Therefore, the<br>minor differences between the subject and predicate<br>device interfaces do not raise different questions of<br>safety or effectiveness. |
| Battery | 3.7 V Lithium Battery…