Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)

K210032 · Leadtek Research, Inc. · DQA · Sep 1, 2021 · Cardiovascular

Device Facts

• Record ID: K210032
• Device Name: Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)
• Applicant: Leadtek Research, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 1, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The Fingertip Pulse Oximeter (Wireless) 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.

Device Story

Fingertip pulse oximeter measures arterial hemoglobin oxygen saturation (SpO2) and pulse rate via red and infrared light absorption through perfused tissue. Device is a stand-alone, battery-powered unit with an OLED display and visual/audio alarms for abnormal readings. Subject device adds Bluetooth Low Energy (BLE) for data transmission to mobile devices or tablets via the 'VIEW TRACKER' app. Used in home or professional settings by patients or clinicians for spot-checking; not for continuous monitoring. Output includes real-time SpO2, pulse rate, and IR waveform display. Data transmission facilitates recording and daily review. Benefits include non-invasive, portable monitoring of oxygenation status.

Clinical Evidence

No new clinical data provided. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), biocompatibility (ISO 10993-1), and wireless coexistence (IEEE/ANSI C63.27). Performance testing confirmed SpO2 accuracy (Arms < 2% in 70-100% range) remains unchanged from the predicate. Clinical performance was previously established for the predicate device (K193350).

Technological Characteristics

Stand-alone fingertip oximeter; Type BF applied part; IP22 water resistance. Dual wavelength LED (660nm/940nm). Powered by 1x AAA alkaline battery. Connectivity: BLE 4.0. Materials evaluated per ISO 10993-1. Software level of concern: Moderate. Dimensions: 67.5mm x 38mm x 25mm; Weight: 26g (without battery).

Indications for Use

Indicated for adults and adolescents requiring non-invasive spot-check monitoring of SpO2 and pulse rate in home or professional settings. Designed for finger sizes 0.8cm-2.3cm; for use only during 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

• Fingertip Pulse Oximeter (K193350)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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 in blue. Underneath the FDA logo is the word "ADMINISTRATION".

September 1, 2021

Leadtek Research Inc. Sharon Peng Regulatory Affairs Specialist 18F, No. 166, Jian-Yi Rd., Chung Ho Dist. New Taipei City, 23511 Taiwan

Re: K210032

Trade/Device Name: Leadtek Fingertip Pulse Oximeter (Wireless) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: July 26, 2021 Received: August 2, 2021

Dear Sharon Peng:

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.

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

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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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K210032

Device Name Fingertip Pulse Oximeter (Wireless)

#### Indications for Use (Describe)

The Fingertip Pulse Oximeter (Wireless) are intended for measuring function 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) and for patients during nomotion condition.

| Type of Use (Select one or both, as applicable) |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-size:12px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

This summary of 510(K) information is being submitted in accordance with the requirements of 21 CFR 807.92

# 1. General Information

| Applicant: | Leadtek Research Incorporation |
|-----------------|------------------------------------------|
| | 18F, No.166, Jian-Yi Rd., Chung Ho Dist. |
| | 23511 New Taipei City, Taiwan |
| | Phone: [phone] |
| | Fax: [phone] |
| Contact Person: | Sharon Peng |
| | Regulatory Affairs Specialist |
| | 18F, No.166, Jian-Yi Rd., Chung Ho Dist. |
| | 23511 New Taipei City, Taiwan |
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Date Prepared: | December 21, 2020 |

# 2. Device Information

| Proprietary Name: | Fingertip Pulse Oximeter (Wireless) |
|----------------------|-------------------------------------|
| Common Name: | Pulse Oximeter |
| Classification Name: | Oximeter |
| Regulatory Class: | Class II |
| Regulation Number: | 21CFR 870.2700 |
| Product Code: | DQA |
| Review Panel: | Anesthesiology |

# 3. Predicate Device

| Proprietary Name: | Fingertip Pulse Oximeter |
|-------------------|--------------------------|
| 510(K) Number: | K193350 |
| Manufacturer: | Leadtek Research Inc. |

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#### 4. Intended Use

The Fingertip Pulse Oximeter (Wireless) 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.

# 5. Device Description

The main function of the Fingertip Pulse Oximeter (Wireless) is to measure the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate as non-invasive spot checking monitoring. The subject determines the functional oxygen saturation of arterial hemoglobin (SpO2) 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. The characteristic of the device is a stand-alone device with 1 AAA Alkaline battery. It includes an OLED display screen and a warning or indicator function for abnormal readings.

The Fingertip Pulse Oximeter (Wireless) is also built in with a Bluetooth low energy (BLE) function to perform data transmission.

# 6. Substantial Equivalence Information:

The intended use and test principle of Fingertip Pulse Oximeter (Wireless) is the same that used in the predicate devices, Fingertip Pulse Oximeter cleared under k193350. The main function of Fingertip Pulse Oximeter (Wireless) is to measure the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate as non-invasive spot checking by measuring the absorption of red and infrared light passing through perfused tissue. No changes of intended use and technological characteristics support the substantial equivalence of the subject device to the predicate.

As compared to the predicate device, the main modification of the subject device is that Fingertip Pulse Oximeter (Wireless) uses Bluetooth Low Energy (BLE) technology to transfer the measurement results from the oximeter to a mobile device or PC tablet enabled Bluetooth function. The Bluetooth icon will light up on the oximeter display when a connection is established successfully. The data of the oximeter will be synchronized with the enable device since the successful connection. The verification and validation tests were found to support that wireless transmission function will not raise different questions of safety and effectiveness.

TEL: [phone] FAX: [phone]

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| Item | Subject Device | Predicate Device |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Name | Fingertip Pulse Oximeter (Wireless) | Fingertip Pulse Oximeter |
| Model No. | 8D01H and 8D01I | 8D01B and 8D01C |
| 510(k) Information | | |
| Regulation<br>Number | 870.2700 | 870.2700 |
| Classification | Class II | Class II |
| Product Code | DQA | DQA |
| Comparison | Unchanged as previous submission | |
| Indication for Use | | |
| Intended Use | Fingertip Pulse Oximeter (Wireless) 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. | Fingertip Pulse Oximeter 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 and adolescent patients | adults and adolescent patients |
| Application<br>site | Finger | Finger |
| Performance | normal condition | normal condition |
| Stand-alone<br>or module | stand-alone | stand-alone |
| Single use or<br>not | multiple use | multiple use |
| Use<br>environment | home and professional caring environment | home and professional caring environment |
| Comparison | Unchanged as previous submission | |
| Test Principle | | |
| Principle | Determine the functional oxygen | Determine the functional oxygen |
| Item | Subject Device | Predicate Device |
| Product<br>Name | Fingertip Pulse Oximeter (Wireless) | Fingertip Pulse Oximeter |
| Model No. | 8D01H and 8D01I | 8D01B and 8D01C |
| | saturation of arterial hemoglobin<br>(SpO2) and pulse rate by measuring the<br>absorption of red and infrared light<br>passing through perfused tissue.<br>Changes in absorption caused by the<br>pulsation of blood in the vascular bed<br>are used to determine SpO2 reading<br>and pulse rate. | saturation of arterial hemoglobin (SpO2)<br>and pulse rate by measuring the<br>absorption of red and infrared light<br>passing through perfused tissue.<br>Changes in absorption caused by the<br>pulsation of blood in the vascular bed<br>are used to determine SpO2 reading and<br>pulse rate. |
| Wavelength | Dual wavelength LED<br>(660 nanometers @ 0.8mW and 940<br>nanometers @ 1.2mW; both as max<br>average) | Dual wavelength LED<br>(660 nanometers @ 0.8mW and 880<br>nanometers @ 1.2mW; both as max<br>average) |
| Comparison | Unchanged as previous submission | |
| Energy | | |
| Type | Battery | Battery |
| Battery | AAA Alkaline battery x 1 | AAA Alkaline battery x 1 |
| Comparison | Unchanged as previous submission | |
| Operation Features | | |
| On/Off | Automatic turn on and off | Automatic turn on and off |
| Display | Full color OLED | Full color OLED |
| Input Key | A 5-directional key (8D01H) or a single<br>push-down (8D01I) key | A 5-directional key (8D01B) or a single<br>push-down (8D01C) key |
| Warning /<br>Indicator | 8D01H: Audio and visual warning<br>8D01I: Visual indicator | 8D01B: Audio and visual warning<br>8D01C: Visual indicator |
| | 8D01H:<br>Appear red color with beep sounds<br>when SpO2 and pulse rate out of the<br>setting range. | 8D01B:<br>Appear red color with beep sounds<br>when SpO2 and pulse rate out of the<br>setting range. |
| Warning /<br>Indicator<br>Function | - Low SpO2 warning:<br>default 87%; setting range: 50% to<br>95% | - Low SpO2 warning:<br>default 87%; setting range: 50% to<br>95% |
| Item | Subject Device | Predicate Device |
| Product<br>Name | Fingertip Pulse Oximeter (Wireless) | Fingertip Pulse Oximeter |
| Model No. | 8D01H and 8D01I | 8D01B and 8D01C |
| | High SpO2 warning:<br>default off; setting range: 80% to 100% Low HR warning:<br>default off; setting range: 30 to 110 bpm High HR warning:<br>default off; setting range: 75 to 250 bpm 8D01I:<br>Appear red color when SpO2 is lower than 87%. | High SpO2 warning:<br>default off; setting range: 80% to 100% Low HR warning:<br>default off; setting range: 30 to 110 bpm High HR warning:<br>default off; setting range: 75 to 250 bpm 8D01C:<br>Appear red color when SpO2 is lower than 87%. |
| Display<br>Rotation | Yes | Yes |
| Wireless<br>Connection | BLE BT 4.0 | None |
| Comparison | The differences of operation features is an additional Bluetooth module with<br>data transmission. With the VIEW TRACKER app, "8D01" Leadtek Fingertip Pulse<br>Oximeter (Wireless) can transmit the real-time heart rate, SpO2, and IR<br>waveform to the compatible mobile device for the sole purpose of data<br>recording, daily review, and IR waveform display, not for continuous monitoring.<br>The software is validated according to FDA's Guidance for Content of Premarket<br>Submissions for Management of Cybersecurity in Medical Devices. The wireless<br>testing is conducted according to FDA's Guidance Radio Frequency Wireless<br>Technology in Medical Devices. The difference does not raise different questions<br>of safety and effectiveness.<br>General Specification | |
| | Usage Life | > 18 hrs typical operation under default<br>setting |
| Operating<br>Temp. | 5 ºC to 40 ºC ( 41 ºF to 104 ºF) | 5 ºC to 40 ºC ( 41 ºF to 104 ºF) |
| Storage<br>Temp. | -30ºC to 70 ºC (-22 ºF to 158 ºF) | -30ºC to 70 ºC (-22 ºF to 158 ºF) |
| Item | Subject Device | Predicate Device |
| Product<br>Name | Fingertip Pulse Oximeter (Wireless) | Fingertip Pulse Oximeter |
| Model No. | 8D01H and 8D01I | 8D01B and 8D01C |
| Humidity | 10% to 90%, non-condensing for both<br>operating and storage | 10% to 90%, non-condensing for both<br>operating and storage |
| Atmospheric<br>Pressure | 700 hPa - 1013 hPa for both operating<br>and storage | 700 hPa - 1013 hPa for both operating<br>and storage |
| Water<br>Resistance | IP22 | IP22 |
| Comparison | The differences of operation features is the usage life for supporting wireless<br>communication and it will not be considered as a NSE between the subject and<br>predicate device. The Fingertip Pulse Oximeter (Wireless) is substantially<br>equivalent to the predicate device (K193350) concerning the general<br>specification. | |
| Classification | | |
| Applied Part | Type BF | Type BF |
| Safety | IEC 60601-1 | IEC 60601-1 |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 |
| Harmonized<br>Standard | ISO 80601-2-61…