(271 days)
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.
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 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.
The document describes the OxiWear system, an ear pulse oximeter, and its claim of substantial equivalence to predicate devices (Nonin Medical, Inc. Models 8100Q2, 8101Q2, and 8102Q2; and Masimo Corporation's Rad-G Pulse Oximeter). The acceptance criteria are primarily defined by the performance specifications for SpO2 and Pulse Rate accuracy, and the studies conducted to prove these metrics are largely non-clinical bench and simulator tests, complemented by clinical testing for SpO2 and Pulse Rate accuracy under no motion and motion conditions.
Here's a breakdown based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as a separate table but compares the subject device's (OxiWear) performance specifications against those of the predicate and reference devices. These comparisons implicitly define the performance targets for acceptance.
| Characteristic | Acceptance Criteria (Predicate/Reference) | Reported Device Performance (OxiWear) |
|---|---|---|
| SpO2 Measurement Range | 70-100% | 70-100% |
| SpO2 Accuracy, no motion | Predicate: ± 3% (ARMS); Reference: Adults/Pediatrics/Infants: ± 2% (ARMS) | ± 3.5% (ARMS) |
| SpO2 Accuracy, motion | Reference: ± 3% (ARMS) | ± 3.5% (ARMS) |
| SpO2 Accuracy, low perfusion | Predicate: ± 2% (ARMS); Reference: Adults/Pediatrics/Infants: ± 2% (ARMS) | ± 3.5% (ARMS) |
| Pulse Rate Measurement Range | Predicate & Reference: 25-240 BPM | 20-240 BPM |
| Pulse Rate Accuracy, no motion | Predicate & Reference: ± 3 BPM (ARMS) | ± 3 BPM (ARMS) |
| Pulse Rate Accuracy, motion | Reference: ± 5 BPM (ARMS) | ± 5 BPM (ARMS) |
| Pulse Rate Accuracy, low perfusion | Predicate & Reference: ± 3 BPM (ARMS) | ± 3 BPM (ARMS) |
Note: For SpO2 accuracy, OxiWear's reported accuracy (± 3.5% ARMS) is slightly less precise than either predicate's specified accuracy (± 3% or ± 2% ARMS). However, the document concludes that "OxiWear has a level of accuracy comparable to an industry standard pulse oximeter," implying this difference was deemed acceptable within the context of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document specifies "clinical testing" but does not provide specific sample sizes for the SpO2 and Pulse Rate accuracy studies.
- Test Set Sample Size: Not explicitly stated in the provided text.
- Data Provenance: The document states that "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."
- It doesn't specify the country of origin.
- The studies appear to be prospective clinical testing (as subjects wore the device and were evaluated).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For pulse oximetry, the ground truth for SpO2 accuracy is typically established using a co-oximeter in a controlled desaturation study, not necessarily by human experts.
4. Adjudication Method for the Test Set
Not applicable/not provided. For technical performance metrics like SpO2 and Pulse Rate accuracy, ground truth is typically established by reference devices (e.g., co-oximeters) or a simulator, not through human adjudication of subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not conducted. This type of study is more common for diagnostic imaging AI where human readers interpret cases with and without AI assistance. The OxiWear is a sensor device measuring vital signs directly.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes. The described clinical testing for SpO2 and Pulse Rate accuracy, where the OxiWear device's measurements are compared against a reference (co-oximeter or reference pulse oximeter), represents a standalone performance evaluation of the device's algorithmic and sensor capabilities.
7. The Type of Ground Truth Used
- Objective Measurement from Reference Devices:
- For SpO2 accuracy (no motion): A co-oximeter was used as the ground truth reference in controlled laboratory conditions.
- For SpO2 and Pulse Rate accuracy (motion): A reference pulse oximeter was used as the ground truth.
- For Low Perfusion Testing and No Motion Pulse Rate Testing: Simulators were used to establish controlled conditions, and comparisons were made against "an industry standard pulse oximeter."
8. The Sample Size for the Training Set
The document does not mention any "training set" in the context of machine learning or AI model development. The OxiWear device appears to be a traditional pulse oximeter, not an AI-driven diagnostic device that would require such training sets. If there are internal signal processing algorithms that might have been "trained," this information is not disclosed in the provided FDA submission summary.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set for an AI/ML model is explicitly mentioned or relevant based on the description of the device as a traditional oximeter.
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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, 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.
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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.
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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
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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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Summary of 510(k)
OxiWear, Inc. K233827
This 510(k) Summary is in conformance with 21CFR 807.92
| Submitter: | OxiWear Inc.1111 Arlington Blvd#305Arlington, VA 22209Phone: 571-212-7526 |
|---|---|
| Primary Contact: | Rita King, CEOMethodSense, Inc.Email: ritaking@methodsense.comPhone: 919-313-3961Fax: 919-313-3979 |
| Company Contact: | Shavini FernandoChief 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:
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| 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 |
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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.
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| Characteristic | Subject DeviceOxiWear | Predicate DeviceModels 8100Q2, 8101Q2, and8102Q2 Reusable, Ear Clip PulseOximeter Sensor(K160865) | Reference DeviceRad-G Pulse Oximeter andAccessories(K201770) | Comparison |
|---|---|---|---|---|
| Intended Use | ||||
| Intended Use | OxiWear is intended for non-invasive spot-checking and/orcontinuous data collection ofpatients. | Models 8100Q2, 8101Q2, and8102Q2 Reusable, Ear Clip PulseOximeter Sensor is intended fornon-invasive, spot-checking and/orcontinuous monitoring of patients. | The Rad-G Pulse Oximeter andAccessories are intended for thenon-invasive spot-checking orcontinuous monitoring of patients. | Identical as it relates tospot-checking andcontinuous data collection. |
| Indications for Use | ||||
| Indications for Use | OxiWear is indicated for non-invasive spot-checking and/orcontinuous data collection of adult(22+) and adolescent (12-21)patients who are well or poorlyperfused, during motion and non-motion conditions. It is intendedfor use in hospitals, medicalfacilities, home healthcareenvironments, and mobileenvironments. The recommendedapplication site is the helix of theear. | Models 8100Q2, 8101Q2, and8102Q2 Reusable, Ear Clip PulseOximeter Sensor is indicated fornon-invasive, spot-checking and/orcontinuous monitoring of adultand pediatric patients (> 40 kg / 88lb) who are well or poorlyperfused, during non-motionconditions. It is intended for use inhospitals, medical facilities,Emergency Medical Service (EMS)environments, home healthcareenvironments, and mobileenvironments. The recommendedapplication site is the earlobe. | The Rad-G Pulse Oximeter andAccessories are intended for thenon-invasive spot-checking orcontinuous monitoring offunctional oxygen saturation ofarterial hemoglobin (SpO2), PulseRate (PR), and Pleth RespirationRate (RRp).The Rad-G Pulse Oximeter andAccessories are indicated fornoninvasive spot-checking orcontinuous monitoring offunctional oxygen saturation ofarterial hemoglobin (SpO₂) and | Different – This differencedoes not change theintended use of the deviceas it relates to the spot-checking and continuousdata collection. |
| Characteristic | Subject DeviceOxiWear | Predicate DeviceModels 8100Q2, 8101Q2, and8102Q2 Reusable, Ear Clip PulseOximeter Sensor(K160865) | Reference DeviceRad-G Pulse Oximeter andAccessories(K201770) | Comparison |
| Pulse Rate (PR) of adult, pediatric,infant, and neonate patientsduring both no motion and motionconditions, and for patients whoare well or poorly perfused inhospitals, hospital-type facilities,transport, and homeenvironments. | ||||
| The Rad-G Pulse Oximeter andAccessories are indicated for thespot-checking or continuousmonitoring of Respiration Ratefrom the photoplethysmogram(RRp) of adult and pediatricpatients during no motionconditions in hospitals, hospital-type facilities, transport, and homeenvironments. | ||||
| Regulation andProduct Code | 21 CFR 870.2700DQA, DPZ | 21 CFR 870.2700DQA, DPZ | 21 CFR 870.2700DQA, DPZ, BZQ | Identical to the predicatedevice. |
| Characteristic | Subject DeviceOxiWear | Predicate DeviceModels 8100Q2, 8101Q2, and8102Q2 Reusable, Ear Clip PulseOximeter Sensor(K160865) | Reference DeviceRad-G Pulse Oximeter andAccessories(K201770) | Comparison |
| Environment ofUse | No motion and motion conditionsin hospitals, hospital-type facilities,home healthcare environments,and mobile environments. | Non-motion conditions inhospitals, hospital-type facilities,Emergency Medical Service (EMS)environments, home healthcareenvironments, and mobileenvironments. | No motion and motion conditionsin hospitals, hospital-type facilities,transport, and homeenvironments. | Equivalent to thecombination of thepredicate and referencedevices. The onlydifference being that thepredicate also includesEmergency Medical Serviceenvironments whereas thesubject device does not. |
| Patient Population | Adult (22+) and adolescent (12-21)patients. | Adult and pediatric patients (> 40kg / 88 lb) | Adult, pediatric, infant, andneonate patients. | Different – This differencein patient population doesnot change the intendeduse of the device. |
| Application Site | Helix of the ear | Earlobe | Fingertip | Different – This differencein application site does notchange the intended use ofthe device. |
| Display | ||||
| Display Type | LCD Touchscreen | LED | LCD Touchscreen | Identical to the referencedevice. |
| Notifications | ||||
| Characteristic | Subject DeviceOxiWear | Predicate DeviceModels 8100Q2, 8101Q2, and8102Q2 Reusable, Ear Clip PulseOximeter Sensor(K160865) | Reference DeviceRad-G Pulse Oximeter andAccessories(K201770) | Comparison |
| Type ofNotification | HapticNotifications | Visual, Audible Alarms | Visual, Audible Alarms | Different – This differencedoes not change theintended use of the deviceas it relates to spot-checking and continuousdata collection. Continuousmonitoring is a morefocused use with a higherrisk profile. |
| Technological Characteristics | ||||
| MeasuredParameters | SpO2, PR | SpO2, PR | SpO2, PR, RRp | Identical to the predicatedevice. |
| 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 differencedoes not change theintended use of the device. |
| Sensor Type | Red and Infrared LEDs | Red and Infrared LEDs | Red and Infrared LEDs | Identical to the predicatedevice. |
| Predicate Device | Reference Device | |||
| Characteristic | Subject DeviceOxiWear | Models 8100Q2, 8101Q2, and8102Q2 Reusable, Ear Clip PulseOximeter Sensor(K160865) | Rad-G Pulse Oximeter andAccessories(K201770) | Comparison |
| Principle ofOperation | The pulse oximeter determinesfunctional oxygen saturation ofarterial hemoglobin (SpO2) bymeasuring the absorption of redand infrared light passing throughperfused tissue. Changes in theabsorption caused by the pulsationof blood in the vascular bed areused to determine oxygensaturation and pulse rate. | The pulse oximeter determinesfunctional oxygen saturation ofarterial hemoglobin (SpO2) bymeasuring the absorption of redand infrared light passing throughperfused tissue. Changes in theabsorption caused by the pulsationof blood in the vascular bed areused to determine oxygensaturation and pulse rate. | The pulse oximeter determinesfunctional oxygen saturation ofarterial hemoglobin (SpO2) bymeasuring the absorption of redand infrared light passing throughperfused tissue. Changes in theabsorption caused by the pulsationof blood in the vascular bed areused to determine oxygensaturation and pulse rate. | Identical to the predicatedevice. |
| Performance Specification | ||||
| SpO2MeasurementRange | 70-100% | 70-100% | 70-100% | Identical to the predicatedevice. |
| SpO2, no motion | ± 3.5% (ARMS) | ± 3% (ARMS) | Adults/Pediatrics/Infants: ± 2%(ARMS)Neonates: ± 3% (ARMS) | Different - This differencedoes not change theintended use of the device. |
| SpO2, motion | ± 3.5% (ARMS) | N/A | ± 3% (ARMS) | Different - This differencedoes not change theintended use of the device. |
| Characteristic | Subject DeviceOxiWear | Predicate DeviceModels 8100Q2, 8101Q2, and8102Q2 Reusable, Ear Clip PulseOximeter Sensor(K160865) | Reference DeviceRad-G Pulse Oximeter andAccessories(K201770) | Comparison |
| SpO2, lowperfusion | $\pm 3.5% (A_{RMS})$ | $\pm 2% (A_{RMS})$ | Adults/Pediatrics/Infants: $\pm 2% (A_{RMS})$Neonates: $\pm 3% (A_{RMS})$ | Different - This differencedoes not change theintended use of the device. |
| Pulse RateMeasurementRange | 20-240 BPM | 25-240 BPM | 25-240 BPM | Different - This differencedoes not change theintended use of thedevice. |
| Pulse Rate, nomotion | $\pm 3 \text{ BPM } (A_{RMS})$ | $\pm 3 \text{ BPM } (A_{RMS})$ | $\pm 3 \text{ BPM } (A_{RMS})$ | Identical to the predicatedevice. |
| Pulse Rate, motion | $\pm 5 \text{ BPM } (A_{RMS})$ | N/A | $\pm 5 \text{ BPM } (A_{RMS})$ | Identical to the referencedevice. |
| Pulse Rate, lowperfusion | $\pm 3 \text{ BPM } (A_{RMS})$ | $\pm 3 \text{ BPM } (A_{RMS})$ | $\pm 3 \text{ BPM } (A_{RMS})$ | Identical to the predicatedevice. |
| Environmental | ||||
| OperatingTemperature | 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 referencedevice. |
| StorageTemperature | -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 referencedevice. |
| Characteristic | Subject DeviceOxiWear | Predicate DeviceModels 8100Q2, 8101Q2, and8102Q2 Reusable, Ear Clip PulseOximeter Sensor(K160865) | Reference DeviceRad-G Pulse Oximeter andAccessories(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 differencedoes not change theintended use of the device. |
| OperatingAtmosphericPressure | 700 mbar to 1,060 mbar (700 hPato 1060 hPa) | ≤ 4053 mbar (4053 hPa) | 540 mbar to 1,060 mbar (540 hPAto 1060 hPa) | Different – This differencedoes not change theintended use of the device. |
| Mechanical | ||||
| InstrumentDimensions | 18.9 mm width x 28.1 mm height x27.3 mm depth | 219 mm width x 92 mm height x142 mm depth | 7.8 x 2.9 x 1 inch (198 x 74 x 25mm) | Different – This differencedoes not change theintended use of the device. |
| Instrument Weight | ~ 50 g (0.05 kg) | 900 g (0.9 kg) | 270 g (0.27 kg) | Different – This differencedoes not change theintended use of the device. |
| Electrical | ||||
| Characteristic | Subject DeviceOxiWear | Predicate DeviceModels 8100Q2, 8101Q2, and8102Q2 Reusable, Ear Clip PulseOximeter Sensor(K160865) | Reference DeviceRad-G Pulse Oximeter andAccessories(K201770) | Comparison |
| AC Power | Wearable: N/ACharger: 100-240 VAC, 50-60 Hz,0.6ANote: Input voltage is onlyapplicable while charging. Thedevice is not operational whilecharging. | 100-240 VAC, 50-60 Hz | 100-240 VAC, 50-60 Hz, 0.6A | Different – This differencedoes not change theintended use of the device. |
| Battery Power | Internally rechargeable lithium ionbattery | Internally rechargeable NiMHbattery | Internally rechargeable lithium ionbattery | Identical to the referencedevice. |
| I/O Interface | WearableBluetooth: 2402MHz-2480MHzMobile ApplicationWi-Fi via smart device | Hirose connector | Wi-Fi, Bluetooth | Equivalent to the referencedevice. |
| Mode of Operation | ||||
| Mode of Operation | Spot-Checking and ContinuousData collection | Spot-Checking and ContinuousData collection | Spot-Checking and ContinuousData collection | Identical to the predicatedevice. |
| Characteristic | Subject DeviceOxiWear | Predicate DeviceModels 8100Q2, 8101Q2, and8102Q2 Reusable, Ear Clip PulseOximeter Sensor(K160865) | Reference DeviceRad-G Pulse Oximeter andAccessories(K201770) | Comparison |
| Testing | ||||
| Electrical Safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | Identical to the referencedevice. |
| Temperature andHumidity | IEC 60601-1 | IEC 60601-1EN 1789 | IEC 60601-1 | Identical to the referencedevice. |
| AtmosphericPressure (Altitude) | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | Identical to the referencedevice. |
| ElectromagneticImmunity andEmissions | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Identical to the referencedevice. |
| Performance | ISO 80601-2-61IEC 60601-1IEC 60601-1-6IEC 62304 | ISO 80601-2-61IEC 60601-1IEC 60601-1-6IEC 60601-1-12IEC 62304 | ISO 80601-2-61IEC 60601-1IEC 60601-1-6IEC 62304 | Equivalent to the referencedevice. |
| Characteristic | Subject DeviceOxiWear | Predicate DeviceModels 8100Q2, 8101Q2, and8102Q2 Reusable, Ear Clip PulseOximeter Sensor(K160865) | Reference DeviceRad-G Pulse Oximeter andAccessories(K201770) | Comparison |
| Ingress Protection | IEC 60601-1-11ISO 80601-2-61 | ISO 80601-2-61 | Ingress Protection Testing wasperformed. | Equivalent to the predicatedevice. |
| MechanicalDurability | IEC 60601-1ISO 80601-2-61 | IEC 60601-1ISO 80601-2-61 | Mechanical Durability Testing wasperformed. | Equivalent to the predicatedevice. |
| Usability | Human Factors / Usability Testingwas performed. | Human Factors / Usability Testingwas performed. | Human Factors / Usability Testingwas performed. | Equivalent to the predicatedevice. |
| Biocompatibility | ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-21 | ISO 10993-1ISO 10993-5ISO 10993-10 | ISO 10993-1ISO 10993-5ISO 10993-10 | Equivalent to the predicatedevice.Note that since theclearance of the predicateand reference devices, ISO10993-10 (sensitivity andirritation) was split into ISO10993-10 sensitization andISO 10993-21 irritation. |
| Characteristic | Subject DeviceOxiWear | Predicate DeviceModels 8100Q2, 8101Q2, and8102Q2 Reusable, Ear Clip PulseOximeter Sensor(K160865) | Reference DeviceRad-G Pulse Oximeter andAccessories(K201770) | Comparison |
| Clinical Testing | SpO2 Accuracy - ISO 80601-2-61SpO2 and Pulse Rate LowPerfusion - ISO 80601-2-61 | SpO2 Accuracy - ISO 80601-2-61SpO2 and Pulse Rate LowPerfusion - ISO 80601-2-61 | SpO2 Accuracy - ISO 80601-2-61SpO2 and Pulse Rate LowPerfusion - ISO 80601-2-61 | Equivalent to the predicatedevice. |
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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).
§ 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).