(239 days)
Not Found
No
The description focuses on standard pulse oximetry technology based on light absorption and blood pulsation, with no mention of AI or ML algorithms for data processing or interpretation. The performance studies also do not indicate the use of AI/ML.
No
The device is intended for measuring vital signs (SpO2 and pulse rate) for monitoring purposes, not for treating or preventing a disease or condition.
Yes
The device measures physiological functions (SpO2 and pulse rate) intended for non-invasive spot checking to provide information about the body's condition, which aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "stand-alone device with 1 AAA Alkaline battery" and includes an "OLED display screen," indicating it is a hardware device with integrated 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 devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- This device measures physiological parameters directly from the patient's body (SpO2 and pulse rate) through non-invasive means (light absorption through the finger). It does not analyze a sample taken from the body.
The description clearly states it's a "non-invasive spot checking" device that measures "functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate" by "measuring the absorption of red and infrared light passing through perfused tissue." This is characteristic of a non-IVD medical device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DQA
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.
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 and adolescent
Intended User / Care Setting
home and 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)
Electrical Safety and EMC Testing: The laboratory tests of electrical safety electromagnetic compatibility testing were conducted and show that the subject device complies with IEC 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-1-11:2015, and ISO 80601-2-61:2011.
Biocompatibility Testing: The skin contacting materials used with the subject device are the same that used for the predicate device under K193350. These materials were evaluated for biocompatibility testing in accordance with ISO 10993-1:2009. The studies of cytotoxicity, skin sensitization, and skin irritation were performed and show that the skin contacting materials do not cause the potential risks.
Software Verification and Validation: Software verification and validation were provided in compliance with FDA Guidance for the Content of the Premarket Submission for Software Contained in Medical Devices. These verifications and validations demonstrate that the subject device work functionally and the software for the device is considered as a "moderate" level of concern.
Coexistence Testing: Coexistence testing was performed according to IEEE/ANSI C63.27:2009, AAM TIR69:2017, and FDA Guidance for Radio Frequency Wireless Technology in Medical Device to demonstrate that the subject device is able to coexist with interfering networks in the 2.4 GHz ISM band and the communication links for the subject device can coexist with BLE.
Non-clinical Performance Testing: The laboratory evaluations for the performance of the subject device was conducted to ensure the modification do not change the performance that root-mean-square (Arms) value is less than 2% within the range 70% - 100%.
Clinical Testing: No additional clinical testing of the subject device performance is required necessary to support the substantial equivalence as there is no change to the subject device in pulse oximetry algorithm, and a clinical study was conducted on the predicate device for K193350 clearance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Pulse Oximetry Accuracy: 70% to 100% range ± 2%, less than 70% (Not Specified for accuracy)
Heat Rate Accuracy: ± 1 bpm or ± 1%, whichever is greater
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ 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: +886-2-8226-5800 | |
| Fax: +886-2-8226-5801 | |
| Contact Person: | Sharon Peng |
| Regulatory Affairs Specialist | |
| 18F, No.166, Jian-Yi Rd., Chung Ho Dist. | |
| 23511 New Taipei City, Taiwan | |
| Phone: +886-2-8226-5800 | |
| Fax: +886-2-8226-5801 | |
| Email: Sharon_peng@leadtek.com.tw | |
| 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: 886-2-8226-5800 FAX: 886-2-8226-5801
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| Item | Subject Device | Predicate Device |
|---|---|---|
| Product | ||
| Name | Fingertip Pulse Oximeter (Wireless) | Fingertip Pulse Oximeter |
| Model No. | 8D01H and 8D01I | 8D01B and 8D01C |
| 510(k) Information | ||
| Regulation | ||
| 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 | ||
| site | Finger | Finger |
| Performance | normal condition | normal condition |
| Stand-alone | ||
| or module | stand-alone | stand-alone |
| Single use or | ||
| not | multiple use | multiple use |
| Use | ||
| environment | 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 | ||
| Name | Fingertip Pulse Oximeter (Wireless) | Fingertip Pulse Oximeter |
| Model No. | 8D01H and 8D01I | 8D01B and 8D01C |
| saturation of arterial hemoglobin | ||
| (SpO2) and pulse rate by measuring the | ||
| absorption of red and infrared light | ||
| passing through perfused tissue. | ||
| Changes in absorption caused by the | ||
| pulsation of blood in the vascular bed | ||
| are used to determine SpO2 reading | ||
| and pulse rate. | saturation of arterial hemoglobin (SpO2) | |
| and pulse rate by measuring the | ||
| absorption of red and infrared light | ||
| passing through perfused tissue. | ||
| Changes in absorption caused by the | ||
| pulsation of blood in the vascular bed | ||
| are used to determine SpO2 reading and | ||
| pulse rate. | ||
| Wavelength | Dual wavelength LED | |
| (660 nanometers @ 0.8mW and 940 | ||
| nanometers @ 1.2mW; both as max | ||
| average) | Dual wavelength LED | |
| (660 nanometers @ 0.8mW and 880 | ||
| nanometers @ 1.2mW; both as max | ||
| 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 | |
| push-down (8D01I) key | A 5-directional key (8D01B) or a single | |
| push-down (8D01C) key | ||
| Warning / | ||
| Indicator | 8D01H: Audio and visual warning | |
| 8D01I: Visual indicator | 8D01B: Audio and visual warning | |
| 8D01C: Visual indicator | ||
| 8D01H: | ||
| Appear red color with beep sounds | ||
| when SpO2 and pulse rate out of the | ||
| setting range. | 8D01B: | |
| Appear red color with beep sounds | ||
| when SpO2 and pulse rate out of the | ||
| setting range. | ||
| Warning / | ||
| Indicator | ||
| Function | - Low SpO2 warning: | |
| default 87%; setting range: 50% to | ||
| 95% | - Low SpO2 warning: | |
| default 87%; setting range: 50% to | ||
| 95% | ||
| Item | Subject Device | Predicate Device |
| Product | ||
| Name | Fingertip Pulse Oximeter (Wireless) | Fingertip Pulse Oximeter |
| Model No. | 8D01H and 8D01I | 8D01B and 8D01C |
| High SpO2 warning: | ||
| default off; setting range: 80% to 100% Low HR warning: | ||
| default off; setting range: 30 to 110 bpm High HR warning: | ||
| default off; setting range: 75 to 250 bpm 8D01I: | ||
| Appear red color when SpO2 is lower than 87%. | High SpO2 warning: | |
| default off; setting range: 80% to 100% Low HR warning: | ||
| default off; setting range: 30 to 110 bpm High HR warning: | ||
| default off; setting range: 75 to 250 bpm 8D01C: | ||
| Appear red color when SpO2 is lower than 87%. | ||
| Display | ||
| Rotation | Yes | Yes |
| Wireless | ||
| Connection | BLE BT 4.0 | None |
| Comparison | The differences of operation features is an additional Bluetooth module with | |
| data transmission. With the VIEW TRACKER app, "8D01" Leadtek Fingertip Pulse | ||
| Oximeter (Wireless) can transmit the real-time heart rate, SpO2, and IR | ||
| waveform to the compatible mobile device for the sole purpose of data | ||
| recording, daily review, and IR waveform display, not for continuous monitoring. | ||
| The software is validated according to FDA's Guidance for Content of Premarket | ||
| Submissions for Management of Cybersecurity in Medical Devices. The wireless | ||
| testing is conducted according to FDA's Guidance Radio Frequency Wireless | ||
| Technology in Medical Devices. The difference does not raise different questions | ||
| of safety and effectiveness. | ||
| General Specification | ||
| Usage Life | > 18 hrs typical operation under default | |
| setting | ||
| Operating | ||
| Temp. | 5 ºC to 40 ºC ( 41 ºF to 104 ºF) | 5 ºC to 40 ºC ( 41 ºF to 104 ºF) |
| Storage | ||
| 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 | ||
| Name | Fingertip Pulse Oximeter (Wireless) | Fingertip Pulse Oximeter |
| Model No. | 8D01H and 8D01I | 8D01B and 8D01C |
| Humidity | 10% to 90%, non-condensing for both | |
| operating and storage | 10% to 90%, non-condensing for both | |
| operating and storage | ||
| Atmospheric | ||
| Pressure | 700 hPa - 1013 hPa for both operating | |
| and storage | 700 hPa - 1013 hPa for both operating | |
| and storage | ||
| Water | ||
| Resistance | IP22 | IP22 |
| Comparison | The differences of operation features is the usage life for supporting wireless | |
| communication and it will not be considered as a NSE between the subject and | ||
| predicate device. The Fingertip Pulse Oximeter (Wireless) is substantially | ||
| equivalent to the predicate device (K193350) concerning the general | ||
| 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 | ||
| Standard | ISO 80601-2-61 | ISO 80601-2-61 |
| Mode of | ||
| Operation | Spot checking | Spot checking |
| Comparison | Unchanged as previous submission | |
| Appearance | ||
| Weight | weight without battery: 26g (0,92 | |
| ounces) | weight without battery: 26g (0,92 | |
| ounces) | ||
| Size | L67.5 mm (2.63") x W38 mm (1.48") x | |
| H25 mm (0.98") | L67.5 mm (2.63") x W38 mm (1.48") x | |
| H25 mm (0.98") | ||
| Comparison | Unchanged as previous submission | |
| Pulse Oximetry and Heat Rate Specification | ||
| Range | 0% to 100% | 0% to 100% |
| Resolution | 1% | 1% |
| Accuracy | 70% to 100% range ± 2%, less than 70% | 70% to 100% range ± 2%, less than 70% |
| Item | Subject Device | Predicate Device |
| Product | ||
| Name | Fingertip Pulse Oximeter (Wireless) | Fingertip Pulse Oximeter |
| Model No. | 8D01H and 8D01I | 8D01B and 8D01C |
| Comparison | Unchanged as previous submission | Unchanged as previous submission |
| Heat Rate Specification | ||
| Range | 30 to 250 bpm | 30 to 250 bpm |
| Resolution | 1 bpm | 1 bpm |
| Accuracy | $\pm$ 1 bpm or $\pm$ 1%, whichever is greater | $\pm$ 1 bpm or $\pm$ 1%, whichever is greater |
| Comparison | Unchanged as previous submission | Unchanged as previous submission |
Table 6-1. A comparison table between subject and predicate device
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7. Functional and Safety Testing:
The Fingertip Pulse Oximeter (Wireless) is designed and conducted in accordance with the related standards. The following tests were performed to verify and validate that Leadtek Fingertip Pulse Oximeter (Wireless) meets all requirements of related standards and demonstrates substantial equivalence to the predicates.
Electrical Safety and EMC Testing
The laboratory tests of electrical safety electromagnetic compatibility testing were conducted and show that the subject device complies with IEC 60601-1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, IEC 60601-1-11:2015 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in home healthcare environment, and ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
Biocompatibility Testing
The skin contacting materials used with the subject device are the same that used for the predicate device under K193350. These materials were evaluated for biocompatibility testing in accordance with ISO 10993-1:2009 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" as recognized by FDA. The studies of cytotoxicity, skin sensitization, and skin irritation were performed and show that the skin contacting materials do not cause the potential risks.
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Software Verification and Validation
Software verification and validation were provided in compliance with FDA Guidance for the Content of the Premarket Submission for Software Contained in Medical Devices. These verifications and validations demonstrate that the subject device work functionally and the software for the device is considered as a "moderate" level of concern, as defined by the FDA guidance, and it is identical to the predicate devices. A failure or latent flaw in the software could not directly cause serious injury or death to the patient or operator. According to FDA Guidance document, the software validation documentation summarized the required for a Moderate level of concern device and the test results are found to support the substantial equivalence of the subject device.
Coexistence Testing
Coexistence testing was performed according to IEEE/ANSI C63.27:2009 American National Standard for Evaluation of Wireless Coexistence, AAM TIR69:2017 Risk Management radio-frequency wireless coexistence for medical devices and systems, and FDA Guidance for Radio Frequency Wireless Technology in Medical Device to demonstrate that the subject device is able to coexist with interfering networks in the 2.4 GHz ISM band and the communication links for the subject device can coexist with BLE as the interfering network operating at maximum throughput and minimum transmit power. The wireless coexistence and the security of wireless data is within the limits declared in accordance with the characteristics of the subject device.
Non-clinical Performance Testing
The laboratory evaluations for the performance of the subject device was conducted to ensure the modification do not change the performance that root-mean-square (Arms) value is less than 2% within the range 70% - 100% and do not raise different questions of safety and effectiveness.
Clinical Testing
There is no change to the subject device in pulse oximetry algorithm since the subject device use the same test principle and measuring technology as the predicate device. A clinical study was conducted on the predicate device for K193350 clearance to demonstrate the safety and performance and additional clinical testing of the subject device performance is not required necessary to support the substantial equivalence.
8. Conclusion
The Fingertip Pulse Oximeter (Wireless) has the same intended use and technology and similar characteristics as that of the predicate device cleared by FDA under K193350 and manufactured
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by Leadtek Research Inc. Based on the information contained in this submission demonstrate that the subject device is substantially equivalent to the predicate device and any different characteristics do not raise different questions of safety and effectiveness.