(184 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not mention any AI/ML components or methodologies.
No
The device is intended for measuring and displaying SpO2 and pulse rate, which are diagnostic functions, not therapeutic. It does not treat or alleviate a medical condition.
Yes
This device measures SpO2 and pulse rate, which are physiological parameters used to assess a patient's health status in a "professional caring environment." The device's function is to provide quantifiable data that can be used to inform a diagnosis or monitor a patient's condition, even though it's "not for lifesustaining" or "not for implant." It is also a "prescription only" device, further indicating its role in a clinical context.
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, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The description clearly states that the Fingertip Pulse Oximeter is a non-invasive device that measures SpO2 and pulse rate through the finger. It does not analyze samples taken from the body.
- Intended Use: The intended use is for "measuring function of atterial hemoglobin (SpO2) and pulse rate for adults as non-invasive spot checking". This is a physiological measurement, not a diagnostic test performed on a biological sample.
Therefore, the device falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Fingertip Pulse Oximeter are intended for measuring function of atterial hemoglobin (SpO2) and pulse rate for adults as non-invasive spot checking in 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. The device is prescription only.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The subject device AVITA Pulse Oximeter with Bluetooth 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 lifesustaining, not for implant and does not contain drug or biological products. The device is for prescription use. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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 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, which 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.
February 19, 2025
AVITA Corporation Maggie Chao Adm. Manager 9F, No.78, Sec.1, Kwang Fu Road, Sanchong Dist., New Taipei City, 24158 Taiwan
Re: K242455
Trade/Device Name: AViTA Pulse Oximeter (SP62B) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: January 22, 2025 Received: January 22, 2025
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 (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 (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242455
Device Name AVITA Pulse Oximeter (SP62B)
Indications for Use (Describe)
The Fingertip Pulse Oximeter are intended for measuring function of atterial hemoglobin (SpO2) and pulse rate for adults as non-invasive spot checking in 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. The device is prescription only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/0 description: The image shows the logo for AViTA. The logo features the word "AViTA" in blue, with a stylized heart shape surrounding it. The top of the heart is yellow, the bottom is red, and the right side is green. There is a registered trademark symbol to the bottom right of the heart.
AVITA CORPORATION
510(K) Submission for AViTA Pulse Oximeter
510(K) Summary
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Image /page/5/Picture/0 description: The image shows the logo for AViTA. The logo features the word "AViTA" in blue, with a stylized heart shape behind it. The heart is composed of three colored segments: yellow at the top, red at the bottom, and green on the right side. A registered trademark symbol is present near the bottom right of the heart.
APPLICANT INFORMATION 1
| Applicant: | AVITA Corporation |
|---|---|
| Address: | 9F, No.78, Sec.1, Kwang-Fu Rd., San-Chung District, New Taipei |
| City 24158, Taiwan | |
| Applicant Establishment Number: | 9617543 |
| Applicant Contact: | Maggie Chao |
| Email: | Maggie_chao@avita.com.tw |
| Phone Number: | +886-2-8512-1568 |
| Fax Number: | +886-2-8512-1347 |
| Date of Submission: | August 19, 2024 |
SUBJECT DEVICE 2
| Trade/Proprietary Name: | AViTA Pulse Oximeter |
|---|---|
| Common Name: | Pulse Oximeter |
| Review Panel: | Anesthesiology |
| Classification Product Code: | DQA |
| Regulation Number: | 870.2700 |
| Device Class: | II |
3 PREDICATE DEVICE
| 510(k) Number: | K223399 |
|---|---|
| Manufacturer: | AViTA Corporation |
DEVICE DESCRIPTION 4
The subject device AVITA Pulse Oximeter with Bluetooth 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 lifesustaining, not for implant and does not contain drug or biological products. The device is for prescription use. 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
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Image /page/6/Picture/0 description: The image shows the AViTA logo, which is a stylized heart shape with the letters "AViTA" to the left of the heart. The heart is made up of three different colors: yellow at the top, red on the left side, and green on the right side. Below the logo, the text "include alarms." is written in a simple, sans-serif font.
5 INDICATIONS FOR USE
The Fingertip Pulse Oximeter are intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adults as non-invasive spot checking in professional caring environment. It is designed for fingers between 0.8cm and 2.3cm (0.3 inches) and for patients during no-motion condition. The device is prescription only.
TECHNOLOGICAL CHARACTERISTICS 6
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 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.
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Image /page/7/Picture/0 description: The image shows the logo for AViTA. The logo features the word "AViTA" in blue, with a stylized heart shape surrounding it. The heart is composed of three colored sections: a yellow arc at the top, a green curve forming the right side, and a red curve at the bottom left. A registered trademark symbol is visible near the bottom right of the heart.
DEVICE COMPARISON TABLE 7
| Item | Proposed Device | Predicate Device | Predicate Device |
|---|---|---|---|
| Product | |||
| Name | AViTA Pulse Oximeter | AViTA Pulse Oximeter | Beijing Choice Pulse |
| Oximeter | |||
| Model No. | SP62B | SP61 | MD300C228 |
| 510(k) Information | |||
| Regulation | |||
| Number | 870.2700 | 870.2700 | 870.2700 |
| Classification | Class II | Class II | Class II |
| Product Code | DQA | DQA | DQA |
| K. No. | - | K223399 | K232975 |
| Indication for Use | |||
| Statement | The Fingertip Pulse Oximeter | ||
| are intended for measuring | |||
| functional oxygen saturation of | |||
| arterial hemoglobin (SpO2) and | |||
| pulse rate for adults as non- | |||
| invasive spot checking in | |||
| 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. | The Fingertip Pulse Oximeter | ||
| are intended for measuring | |||
| functional oxygen saturation | |||
| of arterial hemoglobin (SpO2) | |||
| and pulse rate for adults as | |||
| non-invasive spot checking in | |||
| 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. | The Pulse Oximeter is a | ||
| handheld non-invasive device | |||
| intended for | |||
| spot-checking of oxygen | |||
| saturation of arterial | |||
| hemoglobin (SpO2) and | |||
| Pulse Rate of adult, | |||
| adolescent child and infant | |||
| patients in hospitals, | |||
| hospital-type facilities and | |||
| homecare. The device can be | |||
| used by the people whose | |||
| finger thickness is between | |||
| 8mm and 22mm (0.3 inches | |||
| to 0.9 inches). | |||
| Population | adults | adults | adult, adolescent, child |
| and infant patients | |||
| Application site | finger | finger | finger |
| Performance | normal condition | normal condition | normal condition |
| Stand-alone or | |||
| module | stand-alone | stand-alone | stand-alone |
| Single use or | |||
| not | multiple use | multiple use | multiple use |
| Use | |||
| environment | professional | ||
| caring environment | professional | ||
| caring environment | hospitals, hospital-type | ||
| facilities and homecare | |||
| Comparison | The proposed device and the predicated device have the same intended use and classification. All | ||
| changes in indications for use would not affect the safety and | |||
| effectiveness. The AViTA Pulse Oximeter SP62B is substantially equivalent to the predicate | |||
| device (K223399) concerning the same intended use. | |||
| Test Principle | Traditional 510(k) | ||
| AViTA pulse oximeters | AViTA pulse oximeters | The pulse oximeter works by | |
| work by the principles of | work by the principles of | applying a sensor | |
| spectrophotometry, emitting | spectrophotometry, emitting | to a pulsating arteriolar | |
| two different wavelengths of | two different wavelengths | vascular bed. The sensor | |
| light, typically red and | of light, typically red and | contains a dual light | |
| infrared, through a pulsating | infrared, through a pulsating | source and photo detector. | |
| capillary bed, such as a | capillary bed, such as a | The one | |
| fingertip. The sensor on the | fingertip. The sensor on the | wavelength of light source is | |
| other side of the tissue | other side of the tissue | 660nm, which is red light; | |
| detects the light that | detects the light that | the other is 905nm, which is | |
| emerges from the tissues. | emerges from the tissues. | infrared-red light. | |
| The device then measures | The device then measures | Skin, bone, tissue and | |
| the intensity of red and | the intensity of red and | venous vessels | |
| infrared light that is | infrared light that is | normally absorb a | |
| transmitted through the | transmitted through the | constant | |
| capillary bed. | capillary bed. | amount of light over time. | |
| The photo detector | |||
| Based on the differences in | Based on the differences in | in finger sensor collects | |
| absorption between | absorption between | and converts the light into | |
| Principle | oxygenated and | oxygenated and | electronic signal which is |
| deoxygenated blood at | deoxygenated blood at | proportional to the light | |
| specific wavelengths, the | specific wavelengths, the | intensity. The arteriolar | |
| device can calculate the ratio | device can calculate the | bed normally pulsates and | |
| of oxygenated hemoglobin | ratio of oxygenated | absorbs variable amounts | |
| (HbO) to total hemoglobin in | hemoglobin (HbO) to total | of light during systole and | |
| the blood, which is known as | hemoglobin in the blood, | diastole, as blood volume | |
| oxygen saturation (SpO2). | which is known as oxygen | increases and decreases. | |
| saturation (SpO2). | The ratio of light absorbed | ||
| It's important to keep the | at systole and diastole is | ||
| finger or the measurement | It's important to keep the | translated | |
| site stationary during the | finger or the measurement | into an oxygen saturation | |
| reading to avoid introducing | site stationary during the | measurement. This | |
| motion artifacts that could | reading to avoid introducing | measurement is referred to | |
| affect the accuracy of the | motion artifacts that could | as SpO2. | |
| measurement. | affect the accuracy of the | ||
| Additionally, it is | measurement. | ||
| Page 6 of 11 | |||
| Additionally, it is | |||
| Image: AVITA logo | recommended to use the | ||
| pulse oximeter before or | |||
| after engaging in sports | |||
| activities rather than during | |||
| physical exercise. Do not | |||
| use for continuous | |||
| monitoring. | |||
| The proposed devices of this | |||
| submission do not differ | |||
| from the predicate device. | recommended to use the | ||
| pulse oximeter before or | |||
| after engaging in sports | |||
| activities rather than during | |||
| physical exercise. Do not | |||
| use for continuous | |||
| monitoring. | |||
| The proposed devices of this | |||
| submission do not differ | |||
| from the predicate device. | Traditional 510(k) | ||
| Measurement | |||
| Method | Wavelength | Wavelength | Wavelength |
| Comparison | The proposed device and the predicated device have the same principle. There is no | ||
| additional question of safety and effectiveness as compared to the predicate device. | |||
| AVITA Pulse Oximeter SP62B is substantially equivalent to the predicated | |||
| device K223399) concerning the test principle. | |||
| Energy | |||
| Type | Battery | Battery | Battery |
| Battery | AAA Alkaline battery x 1 | AAA Alkaline battery x 1 | AAA Alkaline battery x 2 |
| Comparison | There is no additional question of safety and effectiveness as compared to the predicate | ||
| device raised by the battery. The AVITA Pulse Oximeter SP62B is substantially | |||
| equivalent to the predicate device (K223399) concerning the energy | |||
| source. | |||
| Operation Features | |||
| On/Off | Automatic turn on and off | Automatic turn on and off | Automatic turn on and off |
| Display | Two color OLED | Two color OLED | LCD |
| Input Key | A 4-directional key | A 4-directional key | A 2-directional key |
| Warning | |||
| /Indicator | Visual indicator | Visual indicator | Visual indicator |
| Warning / | |||
| Indicator | |||
| Function | Reading starts to flash when | ||
| detects user SpO2 and Pulse | |||
| rate. | |||
| Display shows "Finger Out" | |||
| when no | |||
| measurement detects. | Reading starts to flash when | ||
| detects user SpO2 and Pulse | |||
| rate. | |||
| Display shows “Finger | |||
| Out” when no | |||
| measurement detects. | the device will power off | ||
| automatically in 8 seconds | |||
| when "Finger out" is | |||
| displayed | |||
| Display | |||
| Rotation | Yes | Yes | Yes |
| Bluetooth | BLE 4.2 | N/A | BLE 5.0 |
| Comparison | The proposed device is configured the Bluetooth 4.2 module which predicate |
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Image /page/8/Picture/0 description: The image shows the logo for AViTA. The logo has the word "AViTA" in blue font. To the right of the word is a heart shape, with the top of the heart in green, the top left in yellow, and the bottom left in red.
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Image /page/9/Picture/0 description: The image shows the logo for AVITA. The word "AVITA" is in blue, and there is a heart-shaped design to the right of the word. The heart is colored in yellow, red, and green.
10
11
| | device is configured the Bluetooth 5.0 module. The Bluetooth is the independent function
module, it would not affect other function module of the device. In additional 510(k)
embedded software could meet the requirements of Submissions for Software Contained
in Medical Devices, the related document of software could refer to Software Document
section of this submission. Therefore, this difference does not affect substantially
equivalence between proposed device and predicate
device on safety and effectiveness. | | | | | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|------------------------------------------------------------------|--|--|--|
| General Specification | | | | | | |
| Operating
Temp | 5 °C to 40 °C ( 41 °F to
104 °F) | 5 °C to 40 °C ( 41 °F to
104 °F) | 0 °C to 40 °C ( 32 °F to
104 °F) | | | |
| Storage
Temp. | -30°C to 70 °C (-22 °F to
158 °F) | -30°C to 70 °C (-22 °F to
158 °F) | -2570°C (-13158 °F ) | | | |
| Humidity | 10% - 90%
(non-condensing) | 10% - 90%
(non-condensing) | 15% to 93%, non-
condensing for both
operating and storage | | | |
| Atmospheric
Pressure | 700 hPa - 1060 hPa for both
operating and
storage | 700 hPa - 1060 hPa for both
operating and
storage | 70kPa~106kpa for both
operating and storage | | | |
| Water
Resistance | IP22 | IP22 | IEC 60601-1-11 | | | |
| Comparison | There's no difference in usage life and atmospheric pressure. The AVITA Pulse Oximeter
SP62B is substantially equivalent to the predicate device (K223399)
concerning the technological characteristics. | | | | | |
| | | Classification | | | | |
| Applied Part | Type BF | Type BF | Type BF | | | |
| Safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | | | |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | | | |
| Harmonized
Standard | ISO 80601-2-61 | ISO 80601-2-61 | ISO 80601-2-61 | | | |
| Mode of
Operation | Spot checking | Spot checking | Spot checking | | | |
| | | Appearance | | | | |
| Weight | weight without battery:
26.5g | weight without battery:
25g | weight without battery:
50g | | | |
| Size | L68 mm x W37.8 mm
xH28.5 mm | L68 mm x W37.8 mm
xH27.7 mm | L58 mm x W32mm x H34
mm | | | |
| Comparison | The differences of general specification and appearance will not be considered as a NSE
between the proposed device and the predicate device. The AVITA Pulse Oximeter
SP62B is substantially equivalent to the predicate device (K223399)
concerning the general specification and appearance.
Pulse Oximetry Specification | | | | | |
| | | | | | | |
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Image /page/12/Picture/0 description: The image shows a logo for AViTA. The logo features the word "AViTA" in blue, sans-serif font. Above the "A" is a curved yellow shape, and below the "A" is a curved red shape. To the right of the word is a green heart shape, with the "R" symbol inside a circle in the bottom right corner of the heart.
| Traditional 510(k | |||
|---|---|---|---|
| Range | 0% to 100% | 0% to 100% | 0% to 100% |
| Resolution unit | 1% | 1% | 1% |
| Accuracy | 70% to 100% range ± 2%, | ||
| less than 70% are | |||
| unspecified | 70% to 100% range ± 2%, | ||
| less than | |||
| 70% are unspecified | 70% to 100% range ± 2%, | ||
| less than | |||
| 0~69% no definition | |||
| Comparison | The AVITA Pulse OximeterSP62B is substantially equivalent to the predicate | ||
| device (K223399) concerning the general specification and appearance. | |||
| Biocompatibility Testing | |||
| cytotoxicity | In accordance with ISO | ||
| 10993-1 | 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 | In accordance with ISO | ||
| 10993-1 | |||
| skin irritation | In accordance with ISO | ||
| 10993-1 | In accordance with ISO | ||
| 10993-1 | In accordance with ISO | ||
| 10993-1 | |||
| Material used | Enclosure material: ABS | ||
| Lens: PMMA | |||
| Mylar: PET | Enclosure material: ABS | ||
| Lens: PMMA | |||
| Mylar: PET | Battery Cover: ABS | ||
| Enclosure: ABS | |||
| Screen protect Film: | |||
| PMMA | |||
| Power Button: ABS | |||
| Comparison | The AVITA Pulse Oximeter SP62B is substantially equivalent to the predicate | ||
| device (K223399) concerning the general specification and appearance. | |||
| Pulse Rate Specification | |||
| Range | 30 to 250 bpm | 30 to 250 bpm | 30 to 250 bpm |
| Resolution unit | 1 bpm (no decimal) | 1 bpm (no decimal) | 1 bpm (no decimal) |
| Accuracy | ±2 bpm or ±2%, | ||
| whichever is greater | ±2 bpm or ±2%, | ||
| whichever is greater | 30 bpm~99 bpm, ± 2 bpm; | ||
| 100 bpm~250 bpm, ± 2% | |||
| Comparison | The AVITA Pulse Oximeter SP62B is substantially equivalent to the predicate | ||
| device (K223399) concerning the performance specification |
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Image /page/13/Picture/1 description: The image shows the logo for AViTA. The logo features the text "AViTA" in a bold, sans-serif font, with the "A" and "V" in blue and the "iTA" in black. Above the text is a stylized heart shape, with the top portion in yellow, the bottom left portion in red, and the right side in green. A registered trademark symbol is located to the bottom right of the heart.
8 PERFORMANCE TESTING
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.
8.1 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.
8.2 Electrical Safety and EMC Testing
The laboratory tests of electroal safety, electromagnetic compatibility, 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 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.
Biocompatibility testing 8.3
The biocompatibility evaluation for the subject device with surface contact and prolonged duration 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)
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Image /page/14/Picture/1 description: The image shows the logo for AViTA. The logo consists of the word "AViTA" in blue, with a stylized heart shape surrounding it. The top of the heart is yellow, the left side is red, and the right side is green. There is a registered trademark symbol in the bottom right corner of the heart.
8.4 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 software for the subject device is 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.
Cleaning Validation 8.5
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.
Clinical Performance 8.6
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.
9 SUBSTANTIAL EQUIVALENCE
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.