AViTA Pulse Oximeter (SP62B)

K242455 · Avita Corporation · DQA · Feb 19, 2025 · Cardiovascular

Device Facts

• Record ID: K242455
• Device Name: AViTA Pulse Oximeter (SP62B)
• Applicant: Avita Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Feb 19, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended 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.

Device Story

Non-invasive, battery-powered fingertip pulse oximeter; measures SpO2 and pulse rate via spectrophotometry (red and infrared light emission/detection through fingertip capillary bed). Operated by clinicians in professional settings for spot-checking; requires stationary finger/no-motion condition. Device features OLED display, 4-directional key, and Bluetooth 4.2 connectivity. Output provides real-time SpO2 and pulse rate values to assist clinicians in patient assessment. Benefits include rapid, non-invasive physiological monitoring without continuous use requirements.

Clinical Evidence

Clinical validation conducted per ISO 80601-2-61 on healthy adult volunteers under no-motion conditions (range 70%-100% SpO2). Primary endpoint ARMS for SpO2 was 1.89%. No adverse effects or complications reported.

Technological Characteristics

Materials: ABS enclosure, PMMA lens, PET Mylar. Principle: Spectrophotometry (red/IR). Energy: 1x AAA alkaline battery. Form factor: Fingertip, 68x37.8x28.5mm, 26.5g. Connectivity: Bluetooth 4.2. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-61, ISO 10993-1. Software: Moderate level of concern.

Indications for Use

Indicated for adult patients requiring non-invasive spot-check measurement of functional oxygen saturation (SpO2) and pulse rate in professional clinical environments. Designed for finger thickness 0.8-2.3cm. Use restricted to no-motion conditions.

Regulatory Classification

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.

Predicate Devices

• AViTA Pulse Oximeter (K223399)

Reference Devices

• Beijing Choice Pulse Oximeter (K232975)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (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

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) 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: | [e-mail] |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| 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<br>Name | AViTA Pulse Oximeter | AViTA Pulse Oximeter | Beijing Choice Pulse<br>Oximeter |
| Model No. | SP62B | SP61 | MD300C228 |
| 510(k) Information | | | |
| Regulation<br>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<br>are intended for measuring<br>functional oxygen saturation of<br>arterial hemoglobin (SpO2) and<br>pulse rate for adults as non-<br>invasive spot checking in<br>professional caring environment.<br>It is designed for fingers<br>between 0.8cm and 2.3cm (0.3<br>inches to 0.9 inches) and for<br>patients during no-motion<br>condition. | The Fingertip Pulse Oximeter<br>are intended for measuring<br>functional oxygen saturation<br>of arterial hemoglobin (SpO2)<br>and pulse rate for adults as<br>non-invasive spot checking in<br>professional caring<br>environment. It is designed for<br>fingers between 0.8cm and<br>2.3cm (0.3 inches to 0.9<br>inches) and for patients during<br>no-motion condition. | The Pulse Oximeter is a<br>handheld non-invasive device<br>intended for<br>spot-checking of oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and<br>Pulse Rate of adult,<br>adolescent child and infant<br>patients in hospitals,<br>hospital-type facilities and<br>homecare. The device can be<br>used by the people whose<br>finger thickness is between<br>8mm and 22mm (0.3 inches<br>to 0.9 inches). |
| Population | adults | adults | adult, adolescent, child<br>and infant patients |
| Application site | finger | finger | finger |
| Performance | normal condition | normal condition | normal condition |
| Stand-alone or<br>module | stand-alone | stand-alone | stand-alone |
| Single use or<br>not | multiple use | multiple use | multiple use |
| Use<br>environment | professional<br>caring environment | professional<br>caring environment | hospitals, hospital-type<br>facilities and homecare |
| Comparison | The proposed device and the predicated device have the same intended use and classification. All<br>changes in indications for use would not affect the safety and<br>effectiveness. The AViTA Pulse Oximeter SP62B is substantially equivalent to the predicate<br>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.<br>Page 6 of 11<br>Additionally, it is | |
| | | | |
| Image: AVITA logo | recommended to use the<br>pulse oximeter before or<br>after engaging in sports<br>activities rather than during<br>physical exercise. Do not<br>use for continuous<br>monitoring.<br>The proposed devices of this<br>submission do n…