Leadtek Fingertip Pulse Oximeter

K193350 · Leadtek Research, Inc. · DQA · Apr 27, 2020 · Cardiovascular

Device Facts

• Record ID: K193350
• Device Name: Leadtek Fingertip Pulse Oximeter
• Applicant: Leadtek Research, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Apr 27, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The Leadtek 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.

Device Story

Leadtek Fingertip Pulse Oximeter is a stand-alone, battery-powered device for non-invasive spot-checking of SpO2 and pulse rate. It uses dual-wavelength LED (660nm/940nm) to measure light absorption through perfused tissue; changes in absorption due to blood pulsation are processed to calculate SpO2 and pulse rate. Operated by patients or clinicians in home or professional settings. Features include an OLED display, 5-directional or push-down input keys, and audio/visual alarms for out-of-range readings. Output is displayed numerically on the device screen, allowing providers to assess patient oxygenation status. Benefits include portable, rapid assessment of arterial hemoglobin saturation.

Clinical Evidence

Clinical evaluation conducted per ISO 80601-2-61 on 10 healthy subjects (diverse skin tones). Primary endpoint was SpO2 accuracy (Arms) during steady-state conditions. Results demonstrated an Arms of 1.72% over the 70-100% SpO2 range, meeting the <2% requirement.

Technological Characteristics

Stand-alone fingertip pulse oximeter; powered by 1 AAA alkaline battery. Dual-wavelength LED (660nm @ 0.8mW; 940nm @ 1.2mW). OLED display. Dimensions: 67.5mm x 38mm x 25mm. Weight: 26g. IP22 water resistance. Applied part: Type BF. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and ISO 80601-2-61. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for adults and adolescents for non-invasive spot-checking of functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate in home and professional environments. Designed for fingers 0.8cm to 2.3cm thick; for use 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

• Onyx Vantage 9590 (K112843)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.

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

Re: K193350

Trade/Device Name: Leadtek Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: March 23, 2020 Received: April 8, 2020

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([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 Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K193350

Device Name Leadtek Fingertip Pulse Oximeter

#### Indications for Use (Describe)

The Leadtek 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 nomotion condition.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------|
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# 510(k) Summary K193350

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

## 1. Applicant Information

| Applicant: | Leadtek Research Incorporation |
|-----------------|--------------------------------------------------------------------------|
| Address: | 18F, No.166, Jian-Yi Rd., Chung Ho Dist<br>23511 New Taipei City, Taiwan |
| Phone: | [phone] |
| Fax Number: | [phone] |
| Contact Person: | Sharon Peng<br>Regulatory Affairs Specialist |
| Date Prepared: | March 26, 2020 |

## 2. Device Information

| Proprietary Name: | Leadtek Fingertip Pulse Oximeter |
|----------------------|----------------------------------|
| 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: | Onyx Vantage 9590 |
|-------------------|--------------------|
| 510(K) Number: | K112843 |
| Manufacturer: | Nonin Medical Inc. |

## 4. Intended Use

The Leadtek 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.

18F.,No.166, Jian-Yi Rd., Chung Ho Dist., New Taipei City, 23511, Taiwan

TEL: [phone] FAX: [phone]

510(k) No. K193350

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## 5. Device Description

The main function of the Leadtek Fingertip Pulse Oximeter is to measure the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate as non-invasive spot checking. The Fingertip Pulse Oximeter 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.

## 6. Substantial Equivalence Information:

The intended use and test principle of Leadtek Fingertip Pulse Oximeter is similar to that of the predicates, Onyx Vantage 9590. The main function of Leadtek Fingertip Pulse Oximeter 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.

The main differences between the proposed device and predicated device is that Leadtek Fingertip Pulse Oximeter has an input key for the operation and a warning/ indicator function which will show RED and make beep sounds when the value of SpO2 or pulse rate is out of the setting range. The power supply source is same as the predicates with only one battery. A comparison table between the proposed device and the predicated device is in the following below.

| Item | Proposed Device | Predicate Device |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Name | Leadtek Fingertip Pulse Oximeter | Onyx Vantage 9590 |
| Model No. | 8D01B and 8D01C | Onyx 9590 |
| 510(k) Information | | |
| Regulation<br>Number | 870.2700 | 870.2700 |
| Classification | Class II | Class II |
| Product Code | DQA | DQA |
| Indication for Use | | |
| Statement | The 8D01B and 8D01C are intended | The Nonin® Onyx Vantage 9590 Finger |
| Item | Proposed Device | Predicate Device |
| Product<br>Name | Leadtek Fingertip Pulse Oximeter | Onyx Vantage 9590 |
| Model No. | 8D01B and 8D01C | Onyx 9590 |
| | for measuring functional oxygen<br>saturation of arterial hemoglobin<br>(SpO2) and pulse rate for both adults<br>and adolescent as non-invasive spot<br>checking in home and professional<br>caring environment. It is designed for<br>fingers between 0.8cm and 2.3cm (0.3<br>inches to 0.9 inches) and for patients<br>during no-motion condition. | Pulse Oximeter is a small, lightweight,<br>portable device indicated for use in<br>measuring and displaying functional<br>oxygen saturation of arterial hemoglobin<br>(%SpO2) and pulse rate of patients who<br>are well or poorly perfused. It is intended<br>for spot-checking of adult and pediatric<br>patients on digits, including the thumb<br>and toes, that are between 0.3 - 1.0 inch<br>(0.8 -2.5 cm) thick. The device's intended<br>use environments include hospitals,<br>clinics, long-term care facilities, skilled<br>nursing facilities, emergency medical<br>services, and home healthcare services. |
| Population | adults and adolescent patients | adult and pediatric patients |
| Application<br>site | Finger | Finger, thumb, and toes |
| Performance | normal condition | normal and low perfusion conditions |
| 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<br>environment | home and professional caring<br>environment |
| Comparison | The proposed device and the predicated device have the same intended use and<br>classification. All changes in indications for use would not affect the safety and<br>effectiveness. The Leadtek Fingertip Pulse Oximeter is substantially equivalent to<br>the predicate device (K112843) concerning the same intended use. | |
| Test Principle | | |
| Principle | Determine the functional oxygen<br>saturation of arterial hemoglobin | Displays numerical values for functional<br>oxygen saturation of arterial hemoglobin |
| Item | Proposed Device | Predicate Device |
| Product<br>Name | Leadtek Fingertip Pulse Oximeter | Onyx Vantage 9590 |
| Model No. | 8D01B and 8D01C | Onyx 9590 |
| | (SpO2) and pulse rate by measuring<br>the absorption of red and infrared<br>light 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. | (SpO2) and pulse rate by measuring the<br>absorption of red and infrared (IR) light<br>passing through perfused tissue.<br>Changes in absorption caused by the<br>pulsation of blood in the vascular bed are<br>used to determine SpO₂ and 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 910<br>nanometers @ 1.2mW; both as max<br>average |
| Comparison | The difference between the proposed device and the predicate device is the<br>infrared wavelength. There is no additional question of safety and effectiveness as<br>compared to the predicate device. The Leadtek Fingertip Pulse Oximeter is<br>substantially equivalent to the predicated device (K112843) concerning the test<br>principle. | |
| Energy | | |
| Type | Battery | Battery |
| Battery | AAA Alkaline battery x 1 | AAA Alkaline battery x 2 |
| Comparison | There is no additional question of safety and effectiveness as compared to the<br>predicate device raised by the battery. The Leadtek Fingertip Pulse Oximeter is<br>substantially equivalent to the predicate device (K112843) concerning the energy<br>source. | |
| Operation Features | | |
| On/Off | Automatic turn on and off | Automatic turn on and off |
| Display | Full color OLED | LED |
| Input Key | A 5-directional key (8D01B) or a single<br>push-down (8D01C) key | None |
| Warning /<br>Indicator | 8D01B: Audio and visual warning<br>8D01C: Visual indicator | Visual indicator |
| Warning / | 8D01B: | 3 color pulse quality indicator to provide |
| Item | Proposed Device | Predicate Device |
| Product<br>Name | Leadtek Fingertip Pulse Oximeter | Onyx Vantage 9590 |
| Model No. | 8D01B and 8D01C | Onyx 9590 |
| Indicator<br>Function | Appear red color with beep sounds<br>when SpO2 and pulse rate out of the<br>setting range. | assurance of reading quality<br>■ Green Light: Good Reading<br>■ Yellow Light: Fair Reading<br>■ Red Light: Poor Reading. |
| | ■ Low SpO2 warning:<br>default 87%; setting range: 50% to<br>95% | |
| | ■ High SpO2 warning:<br>default off; setting range: 80% to<br>100% | |
| | ■ Low HR warning:<br>default off; setting range: 30 to 110<br>bpm | |
| | ■ High HR warning:<br>default off; setting range: 75 to 250<br>bpm | |
| Display<br>Rotation | Yes | None |
| Comparison | The differences of operation features will not be considered as a NSE between the<br>proposed device and the predicate device. The Leadtek Fingertip Pulse Oximeter<br>is substantially equivalent to the predicate device (K112843) concerning the<br>technological characteristics. | |
| | General Specification | |
| Usage Life | > 24 hrs typical operation under<br>default setting | 6,000 spot checks or 36 hours of<br>operation |
| Operating<br>Temp. | 5 ºC to 40 ºC ( 41 ºF to 104 ºF) | -5 ºC to 40 ºC ( 23 ºF to 104 ºF) |
| Storage<br>Temp. | -30ºC to 70 ºC (-22 ºF to 158 ºF) | -40ºC to 70 ºC (-40 ºF to 158 ºF) |
| Humidity | 10% to 90%, non-condensing for both<br>operating and storage | 10% to 90%, non-condensing for<br>operating<br>10% to 95%, non-condensing for storage |
| | Atmospheric | 700 hPa - 1013 hPa for both operating |
| Item | Proposed Device | Predicate Device |
| Product<br>Name | Leadtek Fingertip Pulse Oximeter | Onyx Vantage 9590 |
| Model No. | 8D01B and 8D01C | Onyx 9590 |
| Pressure<br>and storage | | |
| Water<br>Resistance | IP22 | IP32 |
| 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 | ISO 80601-2-61 |
| Mode of<br>Operation | Spot checking | continuous monitoring |
| Appearance | | |
| Weight | weight without battery: 26g (0,92 ounces) | less than 60g (2 ounces) |
| Size | L67.5 mm (2.63") x W38 mm (1.48") x<br>H25 mm (0.98") | L55.9 mm (2.2") x W33 mm (1.3") x<br>H32.3 mm (1.27") |
| Comparison | The differences of general specification and appearance will not be considered as a NSE between the proposed device and the predicate device. The Leadtek<br>Fingertip Pulse Oximeter is substantially equivalent to the predicate device (K112843) concerning the general specification and appearance. | |
| | Pulse Oximetry and Heat Rate Specification | |
| Range | 0% to 100%…