Who is the manufacturer of OxiWear?

Oxiwear, Inc. filed the 510(k) submission for OxiWear (K233827).

What is the FDA product code for OxiWear?

DQA. It is classified under 21 CFR 870.2700 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for OxiWear?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like OxiWear?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

OxiWear

K233827 · Oxiwear, Inc. · DQA · Aug 28, 2024 · Cardiovascular

Device Facts

Record ID	K233827
Device Name	OxiWear
Applicant	Oxiwear, Inc.
Product Code	DQA · Cardiovascular
Decision Date	Aug 28, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2700
Device Class	Class 2

Indications for Use

The OxiWear system is indicated for non-invasive, spot-checking and/or continuous data collection of adult (22+) and adolescent (12-21) patients who are well or poorly perfused, during motion conditions. It is intended for use in hospitals, medical facilities, home healthcare environments, and mobile environments. The recommended application site is the helix of the ear.

Device Story

OxiWear is a wireless, reusable ear pulse oximeter measuring SpO2 and pulse rate via red and infrared light transmission/reflection through the ear helix. The system comprises a wearable device and a mobile application. The wearable attaches to the ear, powered by an internal rechargeable lithium-ion battery. It transmits data via Bluetooth to a smartphone running the OxiWear Mobile Application. The app provides historical trending, live monitoring, and text alerts, serving as a data repository for physician/caregiver review. Used in clinical, home, and mobile environments by patients or caregivers. Output allows healthcare providers to monitor patient oxygenation and pulse rate, supporting clinical decision-making for well or poorly perfused patients.

Clinical Evidence

Clinical testing included controlled laboratory SpO2 validation against a co-oximeter (no motion, normal perfusion) and treadmill-based motion testing for SpO2 and pulse rate against a reference pulse oximeter. Results demonstrate accuracy comparable to industry-standard pulse oximeters. Bench testing confirmed performance under low perfusion and no-motion conditions.

Technological Characteristics

Materials: Silicone (SH516U, SH0130U, MasterSil 151MED), Polyamide (AKULON CARE K1U). Sensing: Red and Infrared LEDs. Power: Internal rechargeable lithium-ion battery. Form factor: Ear-worn wearable (~50g). Connectivity: Bluetooth (wearable to smartphone), Wi-Fi (via smartphone). Standards: ISO 80601-2-61, IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 10993-1/5/10/21.

Indications for Use

Indicated for non-invasive, spot-checking and/or continuous data collection of adult (22+) and adolescent (12-21) patients, well or poorly perfused, during motion and non-motion conditions. Recommended site: helix of the ear. Intended for hospital, medical facility, home, and mobile environments.

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

Models 8100Q2, 8101Q2, and 8102Q2 Reusable, Ear Clip Pulse Oximeter Sensor (K160865)

Reference Devices

The Rad-G Pulse Oximeter and Accessories (K201770)

Related Devices

K221361 — circul pro Ring · Bodimetrics, LLC · Aug 29, 2023
K213515 — WesperO2 · Wesper, Inc. · Jun 10, 2022
K201468 — Pulse Oximeter · Shenzhen Creative Industry Co., Ltd. · Jan 25, 2021
K181503 — Fingertip Pulse Oximeter · Beijing Choice Electronic Technology Co., Ltd. · Oct 11, 2018
K241090 — Evie Med Ring · Movano Inc. Dba Movano Health · Nov 29, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ 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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 28, 2024 OxiWear, Inc. % Rita King Chief Executive Officer MethodSense. Inc. 1 Copley Parkway, Suite 130 Morrisville, North Carolina 27560 Re: K233827 Trade/Device Name: OxiWear Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, DPZ Dated: July 26, 2024 Received: July 29, 2024 Dear Rita King: 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 (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 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. 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 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K233827 Device Name OxiWear Indications for Use (Describe) The OxiWear system is indicated for non-invasive, spot-checking and/or continuous data collection of adult (22+) and adolescent (12-21) patients who are well or poorly perfused, during motion conditions. It is intended for use in hospitals, medical facilities, home healthcare environments, and mobile environments. The recommended application site is the helix of the ear. 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # Summary of 510(k) # OxiWear, Inc. K233827 This 510(k) Summary is in conformance with 21CFR 807.92 | Submitter: | OxiWear Inc. 1111 Arlington Blvd #305 Arlington, VA 22209 Phone: 571-212-7526 | |--------------------------------|--------------------------------------------------------------------------------------------------------------------| | Primary Contact: | Rita King, CEO MethodSense, Inc. Email: ritaking@methodsense.com Phone: 919-313-3961 Fax: 919-313-3979 | | Company Contact: | Shavini Fernando Chief Executive Officer | | Date Prepared: | July 26, 2024 | | Device Name and Classification | | | Trade Name: | OxiWear | | Common Name: | Oximeter | | Classification: | Class II | | Regulation Number: | 21 CFR Part 870.2700 – Oximeter | | Classification Panel: | Cardiovascular | | Product Code: | DQA | | Subsequent Product Code: | DPZ | Predicate Device: {5}------------------------------------------------ | | Primary Predicate | Reference Device | |---------------------------|----------------------------------------------------------------------------|------------------------------------------| | Trade Name | Models 8100Q2, 8101Q2, and 8102Q2 Reusable, Ear Clip Pulse Oximeter Sensor | The Rad-G Pulse Oximeter and Accessories | | Common Name | Pulse Oximeter Sensor | Oximeter | | 510(k) Submitter / Holder | Nonin Medical, Inc. | Masimo Corporation | | 510(k) Number | K160865 | K201770 | | Regulation Number | 21 CFR 870.2700 | 21 CFR 870.2700 | | Classification Panel | Cardiovascular | Cardiovascular | | Product Code | DQA, DPZ | DQA, DPZ, BZQ | {6}------------------------------------------------ ### Device Description and Intended Use The OxilVear System is an ear pulse oximeter that non-invasively measures and displays patient blood oxygen saturation (SpO2) and Pulse Rate for spot-checking and/or continuous data collection. The OxiWear System is intended to be used with well or poorly perfused patients of all skin types in both motion conditions. The system is intended for use in clinical and home environments for adult (22+) and adolescent (12-21) patients of all skin types who are well or poorly perfused, and can safely wear the oximeter device on the helix of the OxilVear System can be used with patients that are in both motion and stationary conditions. The OxilVear System contains the OxilVear Wearable, and the OxiMear Mobile Application. The OxiMear Wearable is a wireless, reusable, non-invasive ear pulse oximeter that is intended to measure SpO2 and Pulse Rate based on the amount of transmitted, reflected light through the ear. The OxiWear Wearable is powered by an internal rechargeable lithium ion battery, and attaches directly to the ear. The OxilVear Wearable is intended to be recharged by the OxiWear Charger, which is a rechargeable portable charger, The OxiMear Wearable is designed to be used with the OxiMeation which receives data from the OxiMear Wearable via Bluetooth connection to the user's smart phone. The OxiMear Mobile Application acts as a historical trending, live data monitoring, and text alert application is intended to be used alongside the OxiWear Wearable during daily use, as well as a data repository to refer back to previous reports containing information about the patient, pulse rate, patient contacts, and more, to present to a physician or caregiver for review. #### Indications for Use The OxilWear system is indicated for non-invasive, spot-checking and/or continuous data collection of adult (12-21) patients who are well or poorly perfused, during motion conditions. It is intended for use in hospitals, medical facilities, home healthcare environments. The recommended application site is the helix of the ear. # Risk Analysis Method The OxilVear system was assessed to determine risks to health associated with the use of the device. Risks related to safety and performance were considered. A risk analysis was conducted in accordance with ISO 14971:2019. Medical devices – Application of risk management to medical devices. #### Substantial Equivalence The table below provides a detailed comparison of OxiWear to the predicate device. {7}------------------------------------------------ | Characteristic | Subject Device OxiWear | Predicate Device Models 8100Q2, 8101Q2, and 8102Q2 Reusable, Ear Clip Pulse Oximeter Sensor (K160865) | Reference Device Rad-G Pulse Oximeter and Accessories (K201770) | Comparison | |----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | | | | | | Intended Use | OxiWear is intended for non- invasive spot-checking and/or continuous data collection of patients. | Models 8100Q2, 8101Q2, and 8102Q2 Reusable, Ear Clip Pulse Oximeter Sensor is intended for non-invasive, spot-checking and/or continuous monitoring of patients. | The Rad-G Pulse Oximeter and Accessories are intended for the non-invasive spot-checking or continuous monitoring of patients. | Identical as it relates to spot-checking and continuous data collection. | | Indications for Use | | | | | | Indications for Use | OxiWear is indicated for non- invasive spot-checking and/or continuous data collection of adult (22+) and adolescent (12-21) patients who are well or poorly perfused, during motion and non- motion conditions. It is intended for use in hospitals, medical facilities, home healthcare environments, and mobile environments. The recommended application site is the helix of the ear. | Models 8100Q2, 8101Q2, and 8102Q2 Reusable, Ear Clip Pulse Oximeter Sensor is indicated for non-invasive, spot-checking and/or continuous monitoring of adult and pediatric patients (> 40 kg / 88 lb) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments. The recommended application site is the earlobe. | The Rad-G Pulse Oximeter and Accessories are intended for the non-invasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), Pulse Rate (PR), and Pleth Respiration Rate (RRp). The Rad-G Pulse Oximeter and Accessories are indicated for noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and | Different – This difference does not change the intended use of the device as it relates to the spot- checking and continuous data collection. | | Characteristic | Subject Device OxiWear | Predicate Device Models 8100Q2, 8101Q2, and 8102Q2 Reusable, Ear Clip Pulse Oximeter Sensor (K160865) | Reference Device Rad-G Pulse Oximeter and Accessories (K201770) | Comparison | | | | | Pulse Rate (PR) of adult, pediatric, infant, and neonate patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, transport, and home environments. | | | | | | The Rad-G Pulse Oximeter and Accessories are indicated for the spot-checking or continuous monitoring of Respiration Rate from the photoplethysmogram (RRp) of adult and pediatric patients during no motion conditions in hospitals, hospital- type facilities, transport, and home environments. | | | Regulation and Product Code | 21 CFR 870.2700 DQA, DPZ | 21 CFR 870.2700 DQA, DPZ | 21 CFR 870.2700 DQA, DPZ, BZQ | Identical to the predicate device. | | Characteristic | Subject Device OxiWear | Predicate Device Models 8100Q2, 8101Q2, and 8102Q2 Reusable, Ear Clip Pulse Oximeter Sensor (K160865) | Reference Device Rad-G Pulse Oximeter and Accessories (K201770) | Comparison | | Environment of Use | No motion and motion conditions in hospitals, hospital-type facilities, home healthcare environments, and mobile environments. | Non-motion conditions in hospitals, hospital-type facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments. | No motion and motion conditions in hospitals, hospital-type facilities, transport, and home environments. | Equivalent to the combination of the predicate and reference devices. The only difference being that the predicate also includes Emergency Medical Service environments whereas the subject device does not. | | Patient Population | Adult (22+) and adolescent (12-21) patients. | Adult and pediatric patients (> 40 kg / 88 lb) | Adult, pediatric, infant, and neonate patients. | Different – This difference in patient population does not change the intended use of the device. | | Application Site | Helix of the ear | Earlobe | Fingertip | Different – This difference in application site does not change the intended use of the device. | | Display | | | | | | Display Type | LCD Touchscreen | LED | LCD Touchscreen | Identical to the reference device. | | Notifications | | | | | | Characteristic | Subject Device OxiWear | Predicate Device Models 8100Q2, 8101Q2, and 8102Q2 Reusable, Ear Clip Pulse Oximeter Sensor (K160865) | Reference Device Rad-G Pulse Oximeter and Accessories (K201770) | Comparison | | Type of Notification | Haptic Notifications | Visual, Audible Alarms | Visual, Audible Alarms | Different – This difference does not change the intended use of the device as it relates to spot- checking and continuous data collection. Continuous monitoring is a more focused use with a higher risk profile. | | Technological Characteristics | | | | | | Measured Parameters | SpO2, PR | SpO2, PR | SpO2, PR, RRp | Identical to the predicate device. | | Materials | SH516U (SHORE 60A) [Silicone] MasterSil 151MED QUART KIT [Silicone] SH0130U SILICONE (SHORE 30A) AKULON CARE K1U (PA6) [Polyamide] | Specific materials unknown; Biocompatible per ISO 10993-1 | Specific materials unknown; Biocompatible per ISO 10993-1 | Different – This difference does not change the intended use of the device. | | Sensor Type | Red and Infrared LEDs | Red and Infrared LEDs | Red and Infrared LEDs | Identical to the predicate device. | | | | Predicate Device | Reference Device | | | Characteristic | Subject Device OxiWear | Models 8100Q2, 8101Q2, and 8102Q2 Reusable, Ear Clip Pulse Oximeter Sensor (K160865) | Rad-G Pulse Oximeter and Accessories (K201770) | Comparison | | Principle of Operation | The pulse oximeter determines functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption of red and infrared light passing through perfused tissue. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. | The pulse oximeter determines functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption of red and infrared light passing through perfused tissue. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. | The pulse oximeter determines functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption of red and infrared light passing through perfused tissue. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. | Identical to the predicate device. | | Performance Specification | | | | | | SpO2 Measurement Range | 70-100% | 70-100% | 70-100% | Identical to the predicate device. | | SpO2, no motion | ± 3.5% (ARMS) | ± 3% (ARMS) | Adults/Pediatrics/Infants: ± 2% (ARMS) Neonates: ± 3% (ARMS) | Different - This difference does not change the intended use of the device. | | SpO2, motion | ± 3.5% (ARMS) | N/A | ± 3% (ARMS) | Different - This difference does not change the intended use of the device. | | Characteristic | Subject Device OxiWear | Predicate Device Models 8100Q2, 8101Q2, and 8102Q2 Reusable, Ear Clip Pulse Oximeter Sensor (K160865) | Reference Device Rad-G Pulse Oximeter and Accessories (K201770) | Comparison | | SpO2, low perfusion | $\pm 3.5\% (A_{RMS})$ | $\pm 2\% (A_{RMS})$ | Adults/Pediatrics/Infants: $\pm 2\% (A_{RMS})$ Neonates: $\pm 3\% (A_{RMS})$ | Different - This difference does not change the intended use of the device. | | Pulse Rate Measurement Range | 20-240 BPM | 25-240 BPM | 25-240 BPM | Different - This difference does not change the intended use of the device. | | Pulse Rate, no motion | $\pm 3 \text{ BPM } (A_{RMS})$ | $\pm 3 \text{ BPM } (A_{RMS})$ | $\pm 3 \text{ BPM } (A_{RMS})$ | Identical to the predicate device. | | Pulse Rate, motion | $\pm 5 \text{ BPM } (A_{RMS})$ | N/A | $\pm 5 \text{ BPM } (A_{RMS})$ | Identical to the reference device. | | Pulse Rate, low perfusion | $\pm 3 \text{ BPM } (A_{RMS})$ | $\pm 3 \text{ BPM } (A_{RMS})$ | $\pm 3 \text{ BPM } (A_{RMS})$ | Identical to the predicate device. | | Environmental | | | | | | Operating Temperature | 0 to 40 °C (32 to 104 °F) | -20 to 50 °C (-4 to 122 °F) | 0 to 40 °C (32 to 104 °F) | Identical to the reference device. | | Storage Temperature | -20 to 60 °C (-4 to 140 °F) | -40 to 70 °C (-40 to 158 °F) | -20 to 60 °C (-4 to 140 °F) | Equivalent to the reference device. | | Characteristic | Subject Device OxiWear | Predicate Device Models 8100Q2, 8101Q2, and 8102Q2 Reusable, Ear Clip Pulse Oximeter Sensor (K160865) | Reference Device Rad-G Pulse Oximeter and Accessories (K20177…

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Indications for Use

Device Story

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Reference Devices

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