(122 days)
K16258
Not Found
No
The summary describes standard pulse oximetry technology and data analysis without mentioning AI or ML.
No.
The device is a diagnostic tool used for measuring and displaying physiological parameters (SpO2 and pulse rate); it does not treat or alleviate a disease or condition.
Yes
This device measures, displays, and stores physiological parameters (functional oxygen saturation of arterial hemoglobin and pulse rate) which are used by healthcare professionals to monitor a patient's health status and aid in diagnosis.
No
The device description explicitly states that the Oxxiom Pulse Oximetry System has two main components: the Oxxiom device (hardware device) and the Oxxiom Rx App. This indicates the system includes a physical hardware component for data acquisition.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Oxxiom's Function: The Oxxiom Pulse Oximetry System measures functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) non-invasively by using light reflectance on the finger. It does not analyze any specimens taken from the body.
- Intended Use: The intended use clearly states it's for measuring, displaying, and storing SpO2 and PR, which are physiological parameters measured directly from the patient's body.
- Device Description: The description reinforces that it's a non-invasive device placed on the finger.
While the performance study uses arterial blood samples (SaO2) as a reference for comparison, the device itself does not analyze these samples. It measures SpO2 non-invasively.
N/A
Intended Use / Indications for Use
The Oxxiom Pulse Oximetry System is a wireless, fully disposable, single-use device indicated for measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It may be used for spot checking, intermittent monitoring, and/or data collection of patients 12 years and older in low acuity settings in facilities such as hospitals, clinics, and doctor's offices. It can also be used in home healthcare settings under prescription use. It is not intended for continuous monitoring.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
Oxxiom Pulse Oximetry System is a wireless, fully disposable, single-use device for measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It also measures Pulse Amplitude (PA). It is a prescription device for spot checking, intermittent monitoring, and data collection.
Oxxiom has two main components, the Oxxiom device (hardware device) and the Oxxiom Rx App. Oxxiom also provides tape to apply the device to the finger. Oxxiom also requires the use of an iOS display device, such as an iPhone, iPad, or iPod, that has iOS version 10.1 or later. The iOS device is not provided with the Oxxiom Pulse Oximetry System.
Oxxiom is small, lightweight, and has a 24-hour battery life. The device simultaneously, and wirelessly transfers all collected data through a Bluetooth connection to the Oxxiom App on the iOS device, which analyzes data, displays information, provides warnings as necessary, and stores the information.
Oxxiom has been tested on a subject population with devices placed on the finger. Monitoring at other sites of the body is not recommended. The principle of operation is based upon the noninvasive reflectance of red and infrared light.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger
Indicated Patient Age Range
12 years and older
Intended User / Care Setting
Low acuity settings in facilities such as hospitals, clinics and doctor's offices. It can also be used in home healthcare settings under prescription use.
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)
Clinical Evaluation:
A comparative, single-center, non-randomized study was conducted to evaluate SpO2 accuracy and performance of the sensor placed on fingers during non-motion conditions over the range of 70-100% SaO2 arterial blood samples assessed by CO-Oximetry. Arterial blood sampling was used as the basis for comparison.
The demographics of subjects in this study included five males and five females. They range by age (21-37 years), weight (134-230 lbs.), height (62-74"), and BMI (20.7 – 35). For race and ethnicity, the subject pool included two Black/African-American, one Asian, and seven White subjects. One of the ten subjects was of Hispanic/Latino ethnicity and the other nine were not.
The skin pigmentation tones ranged from light to dark, meeting the protocol requirements of having at least 2 (15%) of subjects be of dark pigmented skin.
The Accuracy root mean square (Arms) between measured SpO2 and reference SaO2 met the 3.5% specification for the sensor. Arms is based on statistically distributed measurements, therefore, a sensor/oximeter with n Arms specification of 3.5 is expected to have approximately 68% of the data points fall within that range. The SpO2 performance accuracy evaluated over the SaO2 range of 70-100% under non-motion conditions was shown to have an Arms value of 3.4. This study provides supporting evidence that the SpO2 accuracy performance meets an acceptable specification for the sensor passing an Arms specification of 3.5 under steady state/non-motion conditions over the range of 70-100%.
Nonclinical Functional and Safety Testing:
- Electrical Safety (IEC 60601-1, IEC 60601-1-2): Pass
- Clinical Performance Testing (ISO 80601-2-61:2011): Pass
- Biocompatibility Testing (ISO 10993-10:2010, ISO 10993-2, ISO 10993-5, ISO 10993-10, ISO 10993-12): Pass
- EMC Testing (IEC 60601-1-2): Pass
- Alarm Testing (IEC 60601-1-8): Pass
- FCC Testing and Certifications (FCC Part 15 Subpart B Class B, FCC Part 15 Subpart C): Pass
- Wireless Coexistence Testing (FDA Guidance Radio Frequency Wireless Technology in Medical Device (2013)): Pass
- Software Verification and Validation (IEC 62304, FDA Guidance—Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices): Pass
Additional Non-standard testing:
- Battery capacity/life: Test results for energy capacity and voltage limits verification of the Oxxiom's Li-MnO2 Battery.
- Drop testing: Performance/functionality of the Oxxiom pulse oximeter, after being dropped from various heights.
- Shipping conditions: Demonstrate the ability of the Oxxiom pulse oximeter packaging to protect shipped items from foreseeable stresses encountered during shipping.
- Shelf Life: Validate the ability of Oxxiom pulse oximeter to withstand storage conditions for 12 months by using an accelerated shelf life study method.
- Environmental: Environmental temperature and humidity testing performed on the Oxxiom pulse oximeter, in order to verify and validate the ability of Oxxiom to withstand operational conditions from 5°C - 40°C and 5% - 95% RH.
- Water Resistance: Demonstrate the ability of the Oxxiom pulse oximeter to withstand water immersion.
- Skin Surface Temperature: Demonstrate the Oxxiom pulse oximeter meets skin surface temperature requirements.
- Ambient Light Testing: Demonstrate Oxxiom's performance under different ambient light conditions (incandescent and fluorescent lights, and sunlight light).
- Silence, Airplane, Guided Access Modes: Demonstrate Oxxiom operates as intended under the various iOS modes.
- Dimensions: Verify Oxxiom's dimensions, weight, outer edges (no sharp edges), and sterility (No visible particles).
- Display Range and Waveforms: Oxxiom Pulse Oximetry meets specifications in terms if display ranges (i.e., SpO2: 1-100%, PR: 25-250 BPM, PA: 0.03-20%, Waveforms: graph with auto-adjustable scale).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 performance accuracy (Arms): 3.4% (met specification of 3.5%)
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.
K16258
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.
Not Found
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
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
True Wearables, Inc. % Amy Fowler Regulatory Counsel Gardner Law, PLLC 423 Main Street Stillwater, Minnesota 55082
Re: K200537
Trade/Device Name: Oxxiom Pulse Oximetry System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: June 2, 2020 Received: June 4, 2020
Dear Amy Fowler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200537
Device Name Oxxiom Pulse Oximetry System
Indications for Use (Describe)
The Oxxiom Pulse Oximetry System is a wireless, fully disposable, single-use indicated for measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It may be used for spot checking, intermittent monitoring, and/or data collection of patients 12 years and older in low acuity settings in facilities such as hospitals, clinics and doctor's offices. It can also be used in home healthcare settings under prescription use. It is not intended for continuous monitoring.
| 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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Image /page/3/Picture/1 description: The image shows the logo for True Wearables. The logo consists of a black circle with a white lowercase "t" inside, followed by the words "true wearables" in black, bold font. The "TM" symbol is present twice in the logo, once above the "t" in the circle and once after the word "wearables".
510(k) Summary
According to 21 CFR 807.92
Date Prepared: June 2, 2020
Submitter Information
| Submitter: | True Wearables, Incorporated |
|---|---|
| 29826 Avenida de Las Banderas, Suite 300 | |
| Rancho Santa Margarita, CA 92688 |
- Manufacturer: True Wearables, Incorporated 29826 Avenida de Las Banderas, Suite 300 Rancho Santa Margarita, CA 92688
Establishment Registration Number: 3012234356
| Contact: | Amy Fowler, Gardner Law
Regulatory Counsel for True Wearables, Inc.
423 Main Street South
Stillwater, MN 55082 |
|----------|-------------------------------------------------------------------------------------------------------------------------|
| Phone: | 612-356-9653 (Mobile)
949-709-0850 (True Wearables, Inc.) |
| Fax: | NA |
| E-mail: | afowler@gardner.law |
| Alternate Contact: | Marcelo Lamego |
|---|---|
| CEO, True Wearables, Inc | |
| Phone: | 949-709-0850 |
| Fax: | NA |
| E-mail: | mmlamego@truewearables.com |
Name of Device and Classification
| Trade Name: | Oxxiom® Pulse Oximetry System |
|---|---|
| Common Name: | Pulse Oximetry System |
| Device Classification: | Oximeter, CFR §870.2700, Class II |
| Product Code(s): | DQA |
Predicate Device
| Predicate: | Guardian Angel GA1000 Digital Vital Sign Monitoring System; K16258 |
|---|---|
| ------------ | -------------------------------------------------------------------- |
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Image /page/4/Picture/1 description: The image shows the logo for True Wearables. The logo consists of a black circle with a white lowercase "t" inside, followed by the words "true wearables" in black, bold font. The "TM" symbol is present twice in the logo, once above the "t" in the circle and once after the word "wearables".
True Wearables, Inc. 29826 Avenida de Las Banderas Rancho Santa Margarita CA 92688 (949) 709-0850 www.truewearables.com
Intended Use/Indications for Use
The Oxxiom Pulse Oximetry System is a wireless, fully disposable, single-use device indicated for measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It may be used for spot checking, intermittent monitoring, and/or data collection of patients 12 years and older in low acuity settings in facilities such as hospitals, clinics, and doctor's offices. It can also be used in home healthcare settings under prescription use. It is not intended for continuous monitoring.
Device Description
Oxxiom Pulse Oximetry System is a wireless, fully disposable, single-use device for measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). lt also measures Pulse Amplitude (PA). It is a prescription device for spot checking, intermittent monitoring, and data collection.
Oxxiom has two main components, the Oxxiom device (hardware device) and the Oxxiom Rx App. Oxxiom also provides tape to apply the device to the finger. Oxxiom also requires the use of an iOS display device, such as an iPhone, iPad, or iPod, that has iOS version 10.1 or later. The iOS device is not provided with the Oxxiom Pulse Oximetry System.
Oxxiom is small, lightweight, and has a 24-hour battery life. The device simultaneously, and wirelessly transfers all collected data through a Bluetooth connection to the Oxxiom App on the iOS device, which analyzes data, displays information, provides warnings as necessary, and stores the information.
Oxxiom has been tested on a subject population with devices placed on the finger. Monitoring at other sites of the body is not recommended. The principle of operation is based upon the noninvasive reflectance of red and infrared light.
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Image /page/5/Picture/0 description: The image shows the logo for True Wearables. The logo consists of a lowercase "t" inside of a black circle, followed by the words "true wearables" in black font. The trademark symbol is located to the upper right of both the "t" and the word "wearables". The number "K200537" is located in the upper right corner of the image.
True Wearables, Inc. 29826 Avenida de Las Banderas Rancho Santa Margarita CA 92688 (949) 709-0850 www.truewearables.com
Summary of Comparison of Intended Use and Technological Characteristic
Oxxiom Pulse Oximetry System is compared below to the legally marketed predicate device, Guardian Angel GA1000 Digital Vital Sign Monitoring System K162580
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| Product Name | Oxxiom Pulse Oximetry System | Guardian Angel GA1000 Digital |
| Vital Sign Monitoring System | ||
| Manufacturer | True Wearables, Inc | Taiwan Aulisa Medical Devices |
| Technologies, Inc | ||
| Regulation | Oximeter CFR §870.2700 | |
| Pulse Oximeter | Oximeter CFR §870.2700 | |
| Pulse Oximeter | ||
| Product | ||
| Code(s) | DQA | DQA |
| Device Class | Class II | Class II |
| Indications for | ||
| Use | The Oxxiom® Pulse Oximetry System is a | |
| wireless, fully disposable, single-use | ||
| device indicated for measuring, | ||
| displaying, and storing functional | ||
| oxygen saturation of arterial | ||
| hemoglobin (SpO2) and pulse rate (PR). | ||
| It may be used for spot checking, | ||
| intermittent monitoring, and/or data | ||
| collection of patients 12 years and older | ||
| in low acuity settings in facilities such as | ||
| hospitals, clinics, and doctor's offices. It | ||
| can also be used in home healthcare | ||
| settings under prescription use. It is not | ||
| intended for continuous monitoring. | The Guardian Angel GA1000 Digital | |
| Vital Sign Monitoring System is | ||
| indicated for use in measuring and | ||
| displaying functional oxygen | ||
| saturation of arterial hemoglobin | ||
| (SpO2) and pulse rate of adult and | ||
| pediatric patients. It is indicated for | ||
| spot-checking and / or continuous | ||
| monitoring of patients during non- | ||
| motion and under well-perfused | ||
| conditions. The intended | ||
| environment of use is hospital. This | ||
| system is a reusable device. | ||
| Type of Use | Spot checking | |
| Intermittent monitoring | ||
| Data collection | Spot checking | |
| Continuous use | ||
| Motion | Non-motion | Non-motion |
| Patient | ||
| Population | Patients 12 years and older | Adult |
| Pediatric | ||
| Perfusion | Well | Well |
| Environment | ||
| of Use | Hospitals, clinics, doctor's offices. | |
| Home (under prescription use) | Hospitals | |
| Characteristic | Subject Device | Predicate Device |
| Disposable | Yes | No |
| Application Site | Finger | Finger |
| Technology | Red and Infrared reflectance technology | Red and Infrared transmittance technology |
| System Components | Wireless, disposable oximeter device and software App. User to supply iOS device | Sensor Module and Display Unit |
| Wireless Technology / Data Transmission | Bluetooth V4.0 | Bluetooth V4.0 |
| Display | Non-dedicated iOS Device Display | Dedicated Display |
| Software Level of Concern | Moderate | Moderate |
| SpO2 Specifications (No Motion) | Displayed Range: 1-100% | Displayed Range: 1-100% |
| Declared Range: 70-100% | Declared Range: 70-100% | |
| Accuracy: Patients 12 years and older | ||
| ± 3.5% | Accuracy: Adults/Pediatrics ± 3% | |
| Pulse Rate Specifications (No Motion) Controls | Displayed Range: 25-250 bpm | Displayed Range: 30-290 bpm |
| Accuracy: Patients 12 years and older | ||
| ± 3 bpm | Accuracy: Adults/Pediatrics ± 3 bpm | |
| Measurement Wavelengths and Output Power | Red 655 nm | |
| Infrared 940 nm | Red 660 nm @ 1.8 mw nominal | |
| Infrared 905 nm @ 2 mw nominal | ||
| Characteristic | Subject Device | Predicate Device |
| Battery | Wireless Disposable Oximeter: Non | |
| rechargeable Lithium Manganese | ||
| Dioxide (LiMnO2), 150 mAh, 3 V | Sensor Module: 3.7 V Lithium Battery | |
| Display Unit: Lithium Battery, AC | ||
| Adaptor | ||
| Alarm | Audible and visual pulse rate, oxygen | |
| saturation, low battery, out of range, | ||
| and off patient alarms | Audible and visual pulse rate and | |
| oxygen saturation alarms. | ||
| Low battery and critical battery, | ||
| disconnection alarms |
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Image /page/6/Picture/0 description: The image shows the logo for "true wearables™". The logo consists of a lowercase "t" inside of a black circle, followed by the words "true wearables" in black font. The trademark symbol is present next to both the "t" and the word "wearables". The number "K200537" is in the upper right corner of the image.
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Image /page/7/Picture/0 description: The image shows the logo for True Wearables. The logo consists of a black circle with a white lowercase "t" inside, followed by the words "true wearables" in black, with a "TM" symbol in the upper right corner of both the circle and the word "wearables". The letters are bold and sans-serif.
Comparative analysis of the indication statements between the subject and predicate devices show both similarities and differences. The core indications of measuring and displaying SpO2 and PR is the same for both devices. The patient population for both devices is for adult and pediatric patient populations, but Oxxiom provides age 12 as a specific age limit. Both devices are for prescription use and for use in hospitals, but Oxxiom is indicated for additional environments, including clinics, doctor's offices and home use. While the predicate device is for continuous monitoring and spot checking, the subject device is indicated for low acuity setting spot checking/intermittent use. These differences in indications for use are all within the same intended use and support substantial equivalence. These differences do not affect the safety or efficacy of the subject device when used according to its labeling addresses these differences and provide appropriate instructions for use.
There are some differences in technological characteristics, including the feature of disposable versus reusable and iOS nondedicated display versus dedicated display that do not present different questions of safety and efficacy. Comparison of the similarities and differences between the proposed device and the predicate do not raise new or different questions of safety and effectiveness, when compared to the predicated devices and therefore support the proposed device as substantially equivalent to the predicate devices.
Summary of Performance Testing
Oxxiom Pulse Oximetry System is supported by electromagnetic compatibility, software validation, biocompatibility, clinical testing and other device performance tests to ensure appropriate functionality and demonstrate substantial equivalence to the predicate device. FDA Guidance – Pulse Oximeters – Premarket Notification Submissions [510(k)s] was consulted in determining necessary testing. Software verification and validation testing was done according to FDA Guidance – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
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Image /page/8/Picture/1 description: The image shows the logo for True Wearables. The logo consists of a lowercase "t" inside of a black circle, followed by the words "true wearables" in black, sans-serif font. The letters "TM" are written in superscript next to the "t" and "wearables".
Nonclinical and Clinical Functional and Safety Testing
The following functional and safety testing has been conducted for the OXXIOM device, performed according to the OXXIOM device product requirement specification and quality system to illustrate substantial equivalence.
| Test | Reference | Result |
|---|---|---|
| Electrical Safety | IEC 60601-1 | |
| IEC 60601-1-2 | Pass | |
| Clinical Performance Testing | ISO 80601-2-61:2011 | Pass |
| Biocompatibility Testing | ISO 10993-10:2010 | |
| ISO 10993-2 | ||
| ISO 10993-5 | ||
| ISO 10993-10 | ||
| ISO 10993-12 | Pass | |
| EMC Testing | IEC 60601-1-2 | Pass |
| Alarm Testing | IEC 60601-1-8 | Pass |
| FCC Testing and | ||
| Certifications | FCC Part 15 Subpart B Class B | |
| FCC Part 15 Subpart C | Pass | |
| Wireless Coexistence Testing | FDA Guidance Radio Frequency | |
| Wireless Technology in Medical | ||
| Device (2013) | Pass | |
| Software Verification and | ||
| Validation | IEC 62304: | |
| FDA Guidance—Guidance for | ||
| the Content of Premarket | ||
| Submissions for Software | ||
| Contained in Medical Devices | Pass |
Additional tests performed on the Oxxiom Pulse Oximetry System include the following: Non-standard testing:
-
- Battery capacity/life: Test results for energy capacity and voltage limits verification of the Oxxiom's Li-MnO2 Battery.
-
- Drop testing: Performance/functionality of the Oxxiom pulse oximeter, after being dropped from various heights.
9
Image /page/9/Picture/0 description: The image shows the logo for True Wearables. The logo consists of a lowercase "t" inside of a black circle, followed by the words "true wearables" in black font. The "TM" symbol is located to the upper right of both the circle and the word "wearables".
-
- Shipping conditions: Demonstrate the ability of the Oxxiom pulse oximeter packaging to protect shipped items from foreseeable stresses encountered during shipping.
-
- Shelf Life: Validate the ability of Oxxiom pulse oximeter to withstand storage conditions for 12 months by using an accelerated shelf life study method.
-
- Environmental: Environmental temperature and humidity testing performed on the Oxxiom pulse oximeter, in order to verify and validate the ability of Oxxiom to withstand operational conditions from 5°C - 40°C and 5% - 95% RH.
-
- Water Resistance: Demonstrate the ability of the Oxxiom pulse oximeter to withstand water immersion.
-
- Skin Surface Temperature: Demonstrate the Oxxiom pulse oximeter meets skin surface temperature requirements.
-
- Ambient Light Testing: Demonstrate Oxxiom's performance under different ambient light conditions (incandescent and fluorescent lights, and sunlight light).
-
- Silence, Airplane, Guided Access Modes: Demonstrate Oxxiom operates as intended under the various iOS modes.
-
- Dimensions: Verify Oxxiom's dimensions, weight, outer edges (no sharp edges), and sterility (No visible particles).
-
- Display Range and Waveforms: Oxxiom Pulse Oximetry meets specifications in terms if display ranges (i.e., SpO2: 1-100%, PR: 25-250 BPM, PA: 0.03-20%, Waveforms: graph with auto-adjustable scale).
Clinical Evaluation
A comparative, single-center, non-randomized study was conducted to evaluate SpO2 accuracy and performance of the sensor placed on fingers during non-motion conditions over the range of 70-100% SaO2 arterial blood samples assessed by CO-Oximetry. Arterial blood sampling was used as the basis for comparison.
The demographics of subjects in this study included five males and five females. They range by age (21-37 years), weight (134-230 lbs.), height (62-74"), and BMI (20.7 – 35). For race and ethnicity, the subject pool included two Black/African-American, one Asian, and seven White subjects. One of the ten subjects was of Hispanic/Latino ethnicity and the other nine were not.
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Image /page/10/Picture/0 description: The image shows the alphanumeric string "K200537" in a simple, sans-serif font. The text is black against a white background. The characters are evenly spaced and clearly legible.
Image /page/10/Picture/1 description: The image shows the logo for True Wearables. The logo consists of a black circle with a white lowercase "t" inside, followed by the words "true wearables" in black, bold font. The letters "TM" are written in superscript next to the circle and after the word "wearables".
True Wearables, Inc. 29826 Avenida de Las Banderas Rancho Santa Margarita CA 92688 (949) 709-0850 www.truewearables.com
The skin pigmentation tones ranged from light to dark, meeting the protocol requirements of having at least 2 (15%) of subjects be of dark pigmented skin.
The Accuracy root mean square (Arms) between measured SpO2 and reference SaO2 met the 3.5% specification for the sensor. Arms is based on statistically distributed measurements, therefore, a sensor/oximeter with n Arms specification of 3.5 is expected to have approximately 68% of the data points fall within that range. The SpO2 performance accuracy evaluated over the SaO2 range of 70-100% under non-motion conditions was shown to have an Arms value of 3.4. This study provides supporting evidence that the SpO2 accuracy performance meets an acceptable specification for the sensor passing an Arms specification of 3.5 under steady state/non-motion conditions over the range of 70-100%.
Conclusion
In this 510(k), the low-risk intended use/indications for use statement and technological characteristics of the Oxxiom Pulse Oximetry System are demonstrated to be substantially equivalent to the Guardian Angel GA1000 Digital Vital Sign Monitoring System. Substantial equivalence is based upon the comparison of labeling, clinical data, and nonclinical/bench testing data. The difference in technological features of the subject device compared to the predicate does not raise different questions of safety and effectiveness. No animal testing was conducted.