Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related technologies. The device description focuses on standard pulse oximetry technology and data transmission via Bluetooth. The performance studies describe standard testing for accuracy, safety, and usability, without mentioning any AI/ML-specific validation.

Therapeutic

No.
The core function of this device is to non-invasively measure and display blood oxygen saturation (SpO2) and Pulse Rate. It is a monitoring device, not one that directly treats a condition or provides therapy.

Diagnostic

Yes

The device measures and displays patient blood oxygen saturation (SpO2) and Pulse Rate, which are physiological parameters used to assess a patient's health status. The mobile application also acts as a "live data monitoring" and "data repository to refer back to previous reports ... to present to a physician or caregiver for review," indicating its role in providing data for medical assessment. While it does not include AI, DNN, or ML, the direct measurement of physiological parameters for the purpose of informing clinical decisions, and in comparison to a predicate device, solidifies its diagnostic nature.

SaMD (Software as a Medical Device)

No

The device description explicitly states the system contains both the "OxiWear Wearable" (a hardware component with a battery and sensor) and the "OxiWear Mobile Application" (software). The testing summary also includes hardware-related testing like biocompatibility, electrical safety, and bench testing of the wearable and charging case.

IVD (In Vitro Diagnostic)

Based on the provided information, the OxiWear system is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the living body (in vitro).
OxiWear's Function: The OxiWear system is a pulse oximeter that non-invasively measures blood oxygen saturation (SpO2) and pulse rate by transmitting and reflecting light through the ear. This is a measurement taken directly from the living body (in vivo), not from a sample in a laboratory setting.
Intended Use: The intended use describes the device as being used for "non-invasive, spot-checking and/or continuous data collection of adult and adolescent patients." This reinforces its in vivo nature.
Device Description: The description explicitly states it "non-invasively measures and displays patient blood oxygen saturation (SpO2) and Pulse Rate."
Lack of Sample Handling: There is no mention of collecting or analyzing biological samples.

Therefore, the OxiWear system falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

DQA, DPZ

Device Description

The OxiWear 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 OxiWear System can be used with patients that are in both motion and stationary conditions.

The OxiWear System contains the OxiWear Wearable, and the OxiWear Mobile Application. The OxiWear 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 OxiWear Wearable is intended to be recharged by the OxiWear Charger, which is a rechargeable portable charger,

The OxiWear Wearable is designed to be used with the OxiWear Mobile Application which receives data from the OxiWear Wearable via Bluetooth connection to the user's smart phone. The OxiWear 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

helix of the ear

Indicated Patient Age Range

Adult (22+) and adolescent (12-21) patients

Intended User / Care Setting

hospitals, medical facilities, home healthcare environments, and mobile environments.

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Summary of Non-Clinical Testing
The OxiWear system has been evaluated and verified to comply with recognized standards through verification and validation testing. The following testing was performed:

Biocompatibility evaluation and testing was performed for materials of interest per FDA Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (September, 2023).
Installation / Operational Performance Qualifications for mobile application.
Operational performance Qualifications for OxiWear system.
OxiWear was tested and found to be compliant with the following standards for electrical safety an EMC: IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements For Basic Safety and Essential Performance and IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tasks.
Bench Testing was completed for the OxiWear system to confirm the performance of the Wearable and the Charging Case.
Low perfusion testing was performed wherein low perfusion conditions were simulated using a functional tester. Testing demonstrated that the OxiWear device has a level of SpO2 and Pulse Rate accuracy, under conditions of low perfusion, comparable to an industry standard pulse oximeter.
No motion pulse rate testing was performed utilizing a simulator. Testing demonstrated that the OxiWear device has a level of no motion pulse rate accuracy comparable to an industry standard pulse oximeter.
Human Factors and Usability Testing was performed.
Software verification and validation was performed in accordance with IEC 62304 Medical Device Software - Software Lifecycle Processes
Front end and back end penetration testing was performed by third party testing laboratories.

Summary of Clinical Testing
OxiWear further evaluated the performance of the OxiWear device through clinical testing performed to confirm that the SpO2 measurements read by the device are comparable to an industry standard pulse oximeter. No motion SpO2 validation under normal perfusion conditions was conducted under controlled laboratory conditions evaluating the OxiWear system against a cooximeter. Motion SpO2 testing was conducted in subjects wearing the OxiWear device while on a treadmill and evaluating the OxiWear device against a reference pulse oximeter. Motion testing was also performed for Pulse Rate wherein subjects wore the OxiWear device while on a treadmill and were evaluated against a reference pulse oximeter.
Results from this clinical testing demonstrate that OxiWear has a level of accuracy comparable to an industry standard pulse oximeter.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

SpO2, no motion: ± 3.5% (ARMS)
SpO2, motion: ± 3.5% (ARMS)
SpO2, low perfusion: ± 3.5% (ARMS)
Pulse Rate, no motion: ± 3 BPM (ARMS)
Pulse Rate, motion: ± 5 BPM (ARMS)
Pulse Rate, low perfusion: ± 3 BPM (ARMS)

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.

K160865

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.

K201770

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

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)

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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
(K201770) | Comparison |
| Operating /
Storage Humidity | 0% to 90% RH, non-condensing | 10% to 95% RH, non-condensing | 10% to 95% RH, non-condensing | Different – This difference
does not change the
intended use of the device. |
| Operating
Atmospheric
Pressure | 700 mbar to 1,060 mbar (700 hPa
to 1060 hPa) | ≤ 4053 mbar (4053 hPa) | 540 mbar to 1,060 mbar (540 hPA
to 1060 hPa) | Different – This difference
does not change the
intended use of the device. |
| Mechanical | | | | |
| Instrument
Dimensions | 18.9 mm width x 28.1 mm height x
27.3 mm depth | 219 mm width x 92 mm height x
142 mm depth | 7.8 x 2.9 x 1 inch (198 x 74 x 25
mm) | Different – This difference
does not change the
intended use of the device. |
| Instrument Weight | ~ 50 g (0.05 kg) | 900 g (0.9 kg) | 270 g (0.27 kg) | Different – This difference
does not change the
intended use of the device. |
| Electrical | | | | |
| 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 |
| AC Power | Wearable: N/A
Charger: 100-240 VAC, 50-60 Hz,
0.6A

Bluetooth: 2402MHz-2480MHz

Mobile Application

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Summary of Non-Clinical Testing

The OxiWear system has been evaluated and verified to comply with recognized standards through verification and validation testing. The following testing was performed:

Biocompatibility evaluation and testing was performed for materials of interest per FDA ● Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (September, 2023).
. Installation / Operational Performance Qualifications for mobile application.
Operational performance Qualifications for OxiWear system. .
. OxilVear was tested and found to be compliant with the following standards for electrical safety an EMC: IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements For Basic Safety and Essential Performance and IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tasks.
. Bench Testing was completed for the OxiWear system to confirm the performance of the Wearable and the Charging Case.
. Low perfusion testing was performed wherein low perfusion conditions were simulated using a functional tester. Testing demonstrated that the OxiWear device has a level of SpO2 and Pulse Rate accuracy, under conditions of low perfusion, comparable to an industry standard pulse oximeter.
. No motion pulse rate testing was performed utilizing a simulator. Testing demonstrated that the OxiWear device has a level of no motion pulse rate accuracy comparable to an industry standard pulse oximeter.
. Human Factors and Usability Testing was performed.
. Software verification and validation was performed in accordance with IEC 62304 Medical Device Software - Software Lifecvcle Processes
. Front end and back end penetration testing was performed by third party testing laboratories.

Summary of Clinical Testing

OxilWear further evaluated the performance of the OxiWear device through clinical testing performed to confirm that the SpO2 measurements read by the device are comparable to an industry standard pulse oximeter. No motion SpO2 validation under normal perfusion conditions was conducted under controlled laboratory conditions evaluating the OxiWear system against a cooximeter. Motion SpO2 testing was conducted in subjects wearing the OxiWear device while on a treadmill and evaluating the OxiWear device against a reference pulse oximeter.

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Motion testing was also performed for Pulse Rate wherein subjects wore the OxiWear device while on a treadmill and were evaluated against a reference pulse oximeter.

Results from this clinical testing demonstrate that OxiWear has a level of accuracy comparable to an industry standard pulse oximeter.

Substantial Equivalence Conclusions

The intended use of OxiWear is identical to that of the predicate device (K160865) as it relates to both devices are extravascular devices intended for spot- checking and continuous data collection of patient health information. The technological characteristics demonstrate that OxiWear is equivalent to the predicate device (K160865) and reference device (K201770), and testing has demonstrated that OxiWear is substantially equivalent to the predicate device (K160865) and has confirmed that the OxiWear device will be as safe and effective as the predicate device (K160865).

Conclusion

The 510(k) Pre-market Notification for the OxiWear contains adequate information and data to determine that OxiWear is as safe and effective as the legally marketed predicate device(s).