(558 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard pulse oximetry components and functionality.
No.
The primary purpose of this device, a pulse oximeter, is to measure and display physiological parameters (SpO2 and pulse rate), not to treat or alleviate a medical condition. It is a diagnostic/monitoring device.
Yes
The device measures physiological parameters (oxygen saturation and pulse rate) to assess a patient's health status, which is a diagnostic function.
No
The device description explicitly states that the device consists of "sensor, electronic circuits, display and plastic enclosures," indicating it is a hardware device with embedded software.
Based on the provided information, the AVITA Pulse Oximeter 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 body (in vitro).
- AVITA Pulse Oximeter Function: The AVITA Pulse Oximeter measures oxygen saturation and pulse rate non-invasively by placing the device on a finger. It does not involve taking samples from the body or performing tests on those samples.
Therefore, the AVITA Pulse Oximeter falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The AVITA Pulse Oximeter is intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adults as non-invasive spot checking in professional caring environment. It is designed for fingers between 0.8cm and 2.5cm (0.3 inches to 1 inches) and for patients during no-motion condition. The device is prescription only.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The AVITA Pulse Oximeter SPO2 is non-invasive spot checking, not provided sterile, multi-use device, which can measure and display user's oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through finger during no-motion condition. The subject device is not for life-sustaining, not for implant and does not contain drug or biological products. The device is for prescription use only.
The subject device consists of sensor, electronic circuits, display and plastic enclosures. It is a battery powered device and is adopted with two color OLED screen to display SpO2 and PR. It is software-driven and does not include alarms.
AViTA pulse oximeters work by the principles of spectrophotometry, emitting two different wavelengths of light, typically red and infrared, through a pulsating capillary bed, such as a fingertip. The sensor on the other side of the tissue detects the light that emerges from the tissues. The device the intensity of red and infrared light that is transmitted through the capillary bed.
Based on the differences in absorption between oxygenated and deoxygenated blood at specific wavelengths, the device can calculate the ratio of oxygenated hemoglobin (HbO) to total hemoglobin in the blood, which is known as oxygen saturation (SpO2).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Spectrophotometry (red and infrared light)
Anatomical Site
Fingers
Indicated Patient Age Range
adults
Intended User / Care Setting
professional caring environment
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)
Performance Data: All necessary performance testing was conducted oxygenated hemoglobin characterization testing on the subject device to support a determination of substantial equivalence to the predicate device in accordance with ISO 80601-2-61.
Electrical Safety and EMC Testing: The laboratory tests of electrical safety, electromagnetic compatibility, and reliability testing were conducted and showed that the subject device complied with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and ISO 80601-2-61.
Biocompatibility testing: The biocompatibility evaluation for the subject device was in accordance with the FDA Biocompatibility guidance. The standards tested and met the acceptance criteria included Biological evaluation (ISO10993-1), Cytotoxicity (ISO10993-5), Sensitization (ISO10993-10), and Irritation (ISO10993-23).
Software Verification and Validation: Software verification and validation were provided in compliance with FDA Guidance "The Content of the Premarket Submission for Software Contained in Medical Devices." The verifications and validations demonstrate that the subject device work functionally. The subject device is considered as a "moderate" level of concern, identical to the predicate device.
Cleaning Validation: Cleaning validation was executed in accordance with FDA Guidance "Reprocessing Medical Device in Health Care Setting: Validation Methods and Labeling." The performance of the subject device will not be affected after multiple cleaning procedures.
Clinical Performance: Clinical performance was conducted per ISO 80601-2-61. The clinical validation testing of the SpO2 performance under no motion was on healthy, adult volunteers in the range of 70% to 100%. The ARMS for SpO2 under no motion was found to be 1.89%. No adverse effects and complications happened during the clinical study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Accuracy: Range 70% to 100% range ± 2%, less than 70% are unspecified.
Pulse Rate Accuracy: ±2 bpm or ±2%, whichever is greater.
ARMS for SpO2 under no motion was found to be 1.89%.
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.
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION".
May 20, 2024
AViTA Corporation Maggie Chao 9F, No.78, Sec.1, Kwang-Fu Rd. New Taipei City, San-Chung District 24158 Taiwan
Re: K223399
Trade/Device Name: AViTA Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: February 1, 2024 Received: February 1, 2024
Dear Maggie Chao:
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 Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
AVITA Pulse Oximeter (SP61)
Indications for Use (Describe)
The AVITA Pulse Oximeter is intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adults as non-invasive spot checking in professional caring environment. It is designed for fingers between 0.8cm and 2.5cm (0.3 inches to 1 inches) and for patients during no-motion condition. The device is prescription only.
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
510(k) Summary
This summary of 510(k) information is being submitted in accordance with the requirement of 21 CFR 807.92.
Submitter's Name: AViTA Corporation 1 Address: 9F, No.78, Sec.1, Kwang-Fu Rd., San-Chung District, New Taipei City 24158, Taiwan Telephone number: +886-2-8512-1568 ext.2010 Fax Number: +886-2-8512-1347 Applicant Contact: Meggie Chao The Date of the Summary: May 2, 2024
- 2 Trade/Proprietary Name: AViTA Pulse Oximeter Common Name: Pulse Oximeter Model numbers: SP61 Review Panel: Anesthesiology Classification Product Code: DQA Classification name: Oximeter Regulation Number: 870.2700 Device Class: II
PREDICATE DEVICE 3
| 510(k) Number: | K193350 |
|---|---|
| Trade Name: | Leadtek Fingertip Pulse Oximeter |
| Manufacturer: | Leadtek Research Incorporation |
4 DEVICE DESCRIPTION
The AViTA Pulse Oximeter SPO2 is non-invasive spot checking, not provided sterile, multi-use device, which can measure and display user's oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through finger during no-motion condition. The subject device is not for life-sustaining, not for implant and does not contain drug or biological products. The device is for prescription use only.
The subject device consists of sensor, electronic circuits, display and plastic enclosures. It is a battery powered
5
device and is adopted with two color OLED screen to display SpO2 and PR. It is software-driven and does not include alarms. Table 1 shows the specifications for the subject device.
A ViT A pulse oximeters work by the principles of spectrophotometry, emitting two different wavelengths of light, typically red and infrared, through a pulsating capillary bed, such as a fingertip. The sensor on the other side of the tissue detects the light that emerges from the tissues. The device the intensity of red and infrared light that is transmitted through the capillary bed.
Based on the differences in absorption between oxygenated and deoxygenated blood at specific wavelengths, the device can calculate the ratio of oxygenated hemoglobin (HbO) to total hemoglobin in the blood, which is known as oxygen saturation (SpO2).
It's important to keep the finger or the measurement site stationary during the reading to avoid introducing motion artifacts that could affect the accuracy of the measurement. Additionally, it is recommended to use the pulse oximeter before or after engaging in sports activities rather than during physical exercise. Do not use for continuous monitoring. Table 1 shows the specifications for the subject device.
| Property | Specification |
|---|---|
| Dimension | L68mm (2.68") x W37.8mm (1.49") x H28mm (1.1") |
| Weight | |
| (without battery) | 26g (0,92 ounces) |
| Display | Two color OLED |
| Auto on/off | Whenever user inserts a finger, the device will turn on |
| automatically. Vice versa, the device will turn off automatically | |
| when the finger is removed from it. | |
| Input key | © key for screen rotate |
| Measurement | |
| Method | wavelength |
| SpO2 Range & | |
| Resolution | Range: 0% to 100% |
| resolution: 1% | |
| SpO2 Accuracy | Range 70% to 100% range ± 2%, |
| less than 70% are unspecified | |
| Pulse Rate | |
| Range & | |
| Resolution | Range: 30 to 250 bpm; |
| resolution: 1 bpm | |
| Pulse Rate | |
| Accuracy | ±2 bpm or ±2%, whichever is greater |
| Water-resistance | Against water splash (IP22 Approved) |
| Battery Type | 1 AAA-size Alkaline battery |
| Usage Life | > 18 hrs typical operation under default setting |
| Shelf Life | 3 years |
Table 1 Technical Specification
6
| Ambient
Temperature | Operation: 5 °C - 40 °C (41 °F - 104 °F);
Storage: -30°C ~ 70 °C (-22 °F ~ 158 °F) |
|-------------------------|---------------------------------------------------------------------------------------|
| Atmospheric
Pressure | Operation & storage are both 700 hPa - 1060 hPa |
| Humidity | Operation & storage are both 10% - 90%, non-condensing |
INDICATIONS FOR USE 5
The A ViTA Pulse Oximeter is intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adults as non-invasive spot checking in professional caring environment. It is designed for fingers between 0.8cm and 2.5cm (0.3 inches to 1 inches) and for patients during no-motion condition. The device is prescription only.
The Indications for Use statement for the AVITA Pulse Oximeter is not identical to the predicate device; however, the differences do not alter the intended diagnostic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have intended use for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adults as noninvasive spot checking in professional caring environment.
| Item | Subject Device | Predicate Device |
|---|---|---|
| Product Name | AVITA Pulse Oximeter | Leadtek Fingertip Pulse Oximeter |
| Model No. | SP61 | 8D01B and 8D01C |
| 510(k) Information | ||
| Regulation | ||
| Number | 870.2700 | 870.2700 |
| Classification | Class II | Class II |
| Product Code | DQA | DQA |
| Indication for Use | ||
| Statement | The AVITA Pulse Oximeter is intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adults as non-invasive spot checking in professional caring environment. It is designed for fingers between 0.8cm and 2.5cm (0.3 inches to 1 inches) and for patients during no-motion condition. The device is prescription only. | The 8D01B and 8D01C are intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for both adults and adolescent as non-invasive spot checking in home and professional caring environment. It is designed for fingers between 0.8cm and 2.3cm (0.3 inches to 0.9 inches) and for patients during no-motion condition. |
| Population | adults | adults and adolescent |
| Application site | Finger | Finger |
| Performance | normal condition | normal condition |
| Stand-alone or | ||
| module | stand-alone | stand-alone |
| Single use or not | multiple use | multiple use |
| Use environment | professional caring environment | home and professional caring environment |
| Test Principle | ||
| Principle | The LED contains a red light and an infrared | |
| light that are differentially absorbed by | ||
| oxygenated and oxygenated hemoglobin. Based | ||
| on the relative absorption of the two | ||
| wavelengths that is determined by the sensor, | ||
| the POX determines the relative amount of | ||
| oxygenated and deoxygenated hemoglobin, | ||
| which is calculated as SpO2. In order to make | ||
| the SpO2 | ||
| calculation independent of skin color, finger | ||
| size, etc., the pulse oximeter sensor uses only | ||
| the time varying light absorption component | ||
| generated by the patient's pulse. | Determine the functional oxygen | |
| saturation of arterial hemoglobin (SpO2) | ||
| and pulse rate by measuring the absorption | ||
| of red and infrared light passing through | ||
| perfused tissue. | ||
| Changes in absorption caused by the | ||
| pulsation of blood in the vascular bed are | ||
| used to determine SpO2 reading and pulse | ||
| rate. | ||
| Wavelength | Dual wavelength LED | |
| (660 nanometers @ 3.2mW and 905 nanometers | ||
| @2.4mW; both as max average | Dual wavelength LED | |
| (660 nanometers @ 0.8mW and 940 | ||
| nanometers @ 1.2mW; both as max | ||
| average | ||
| Energy | ||
| Type | Battery | Battery |
| Battery | AAA Alkaline battery x 1 | AAA Alkaline battery x 1 |
| Operation Features | ||
| On/Off | Automatic turn on and off | Automatic turn on and off |
| Display | Two color OLED | Full color OLED |
| Input Key | A 4-directional key | A 5-directional key (8D01B) or a single |
| push-down (8D01C) key | ||
| Warning | ||
| /Indicator | Visual indicator | 8D01B: Audio and visual warning |
| 8D01C: Visual indicator | ||
| Warning / | ||
| Indicator | ||
| Function | Reading starts to flash as an indicator to user | |
| when SpO2 and Pulse rate drop out of the | ||
| setting range. | 8D01B: Appear red color with beep | |
| sounds when SpO2 and pulse rate out of | ||
| the setting range. | ||
| Low SpO2 warning: | ||
| default 87%; setting range: 50% to 95% | ||
| High SpO2 warning: | ||
| default off; setting range: 80% to 100% | ||
| Low HR warning: | ||
| default off; setting range: 30 to 110 bpm | ||
| High HR warning:default off; setting | ||
| range: 75 to 250 bpm | ||
| Display Rotation | Yes | Yes |
| General Specification | ||
| Usage Life | > 24 hrs typical operation under default setting | > 24 hrs typical operation under default |
| setting | ||
| Operating | ||
| Temperature | 5 °C to 40 °C (41 °F to 104 °F) | 5 °C to 40 °C (41 °F to 104 °F) |
| Storage | ||
| Temperature | -30 | -30°C to 70 °C (-22 °F to 158 °F) |
| Humidity | 10% - 90% (non-condensing) | 10% to 90%, non-condensing for both |
| operating and storage | ||
| Atmospheric | ||
| Pressure | 700 hPa – 1060 hPa for both operating and | |
| storage | 700 hPa - 1013 hPa for both operating and | |
| storage | ||
| Water | ||
| Resistance | IP22 | IP22 |
| Classification | ||
| Applied Part | Type BF | Type BF |
| Safety | IEC 60601-1 | IEC 60601-1 |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 |
| Harmonized | ||
| Standard | ISO 80601-2-61 | ISO 80601-2-61 |
| Mode of | ||
| Operation | Spot checking | Spot checking |
| Appearance | ||
| Weight | weight without battery: 26g (0,92 ounces) | weight without battery: 26g (0,92 ounces) |
| Size | L68mm (2.68") x W37.8mm (1.49") x H28mm | |
| (1.1") | L67.5 mm (2.63”) x W38 mm (1.48”) x | |
| H25 mm (0.98") | ||
| Pulse Oximetry | ||
| Range | 70%-100% | 0% to 100% |
| Resolution | Resolution | Resolution |
| Accuracy | 70% to 100% range ± 2%, less than 70% are | |
| unspecified | 70% to 100% range ± 2%, less than 70% | |
| are unspecified | ||
| Biocompatibility Testing | ||
| Cytotoxicity | In accordance with ISO 10993-1 | In accordance with ISO 10993-1 |
| Skin | ||
| sensitization | In accordance with ISO 10993-1 | In accordance with ISO 10993-1 |
| Skin irritation | In accordance with ISO 10993-1 | In accordance with ISO 10993-1 |
| Heart Rate Specification | ||
| Range | 30 to 250 bpm | 30 to 250 bpm |
| Resolution | 1 bpm | 1 bpm |
DEVICE COMPARISON TABLE 6
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7 PERFORMANCE SUMMARY
The following tests were conducted to evaluate the safety and effectiveness of the subject device, and the test results indicated that the subject device is safe and effective.
Performance Data【807.92(b)】 7.1
All necessary performance testing was conducted oxygenated hemoglobin characterization testing on the subject device to support a determination of substantial equivalence to the predicate device in accordance with ISO 80601-2-61.
7.2 Electrical Safety and EMC Testing
The laboratory tests of electrical safety, electromagnetic compatibility, and reliability testing were conducted and showed that the subject device complied with IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, IEC 60601-1-11 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in home healthcare environment, and ISO 80601-2-61 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
7.3 Biocompatibility testing
The biocompatibility evaluation for the subject device was in accordance with the FDA Biocompatibility guidance (Use of International Standard ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"). The standards below are tested and met the acceptance criteria.
- Biological evaluation (ISO10993-1)
- Cytotoxicity (ISO10993-5)
- Sensitization (ISO10993-10)
- Irritation (ISO10993-23)
7.4 Software Verification and Validation
Software verification and validation were provided in compliance with FDA Guidance "The Content of the Premarket Submission for Software Contained in Medical Devices". The verifications and validations demonstrate that the subject device work functionally. The subject device is considered as a "moderate" level of concern, which is identical to the predicate device. A failure or latent flaw in the software could not directly cause serious injury or death to the patient or operator, but a non-serious injury could occur. According to FDA Guidance document, the software validation documentation summarized the required for a Moderate level of concern device.
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7.5 Cleaning Validation
Cleaning validation was executed in accordance with FDA Guidance "Reprocessing Medical Device in Health Care Setting: Validation Methods and Labeling" The performance of the subject device will not be affected after multiple cleaning procedures as illustrated in user manual.
7.6 Clinical Performance
Clinical performance was conducted per ISO 80601-2-61. The clinical validation testing of the SpO2 performance under no motion on healthy, adult volunteers in the range of 70% to 100%. The ARMS for SpO2 under no motion was found to be 1.89%. No adverse effects and complications happened during the clinical study.
SUBSTANTIAL EQUIVALENCE 8
Based upon equivalences in: intended use, patient population, conditions of use, operating principles, and the non-clinical performance data, the subject device have been shown to be safe and effective and to perform equivalently as compared to the legally marketed predicate device. Therefore, the subject devices are substantially equivalent to the legally marketed predicate device.