(146 days)
Not Found
No
The description details a standard pulse oximetry technology based on light absorption and pulsation, with no mention of AI or ML terms or methodologies.
No.
The device is used for measuring health parameters (SpO2 and pulse rate) for monitoring purposes, and its intended use does not involve treating or alleviating a disease or condition.
Yes
The device is described as "measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which are physiological parameters used in the assessment and monitoring of a patient's health status, enabling healthcare professionals to make informed decisions about diagnosis and treatment.
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.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living organism (in vitro).
- Device Function: The Leadtek Fingertip Pulse Oximeter measures oxygen saturation and pulse rate by shining light through the finger and analyzing the light absorption. This is a non-invasive measurement performed on the living organism (in vivo).
- Intended Use: The intended use clearly states it's for "measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate... as non-invasive spot checking." This aligns with in vivo measurement, not in vitro testing of samples.
Therefore, based on its function and intended use, the Leadtek Fingertip Pulse Oximeter is a non-invasive medical device used for physiological monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DQA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingers, 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)
Functional and Safety Testing:
The Leadtek Fingertip Pulse Oximeter is designed and conducted in accordance with the related standards. The following tests were performed to verify and validate that Leadtek Fingertip Pulse Oximeter 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, and reliability testing were conducted and show that the proposed 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 biocompatibility testing for Leadtek Fingertip Pulse Oximeter was 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.
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 Leadtek Fingertip Pulse Oximeter work functionally. The software for the device is considered as a "moderate" level of concern, which 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, 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:
Cleaning and disinfection validations were executed in accordance with FDA Guidance "Reprocessing Medical Device in Health Care Setting: Validation Methods and Labeling" The performance of Leadtek Fingertip Pulse Oximeter will not be affected after multiple cleaning and disinfection procedures as illustrated in user manual.
Performance Testing:
The laboratory and clinical evaluations for the performance of Leadtek Fingertip Pulse Oximeter demonstrate that the modifications do not raise different questions of safety and effectiveness. The root-mean-square (Arms) was used to analyze the accuracy of Leadtek Fingertip Pulse Oximeter, per ISO 80601-2-61:2011, the SpO2 accuracy results demonstrate that the root-mean-square (Arms) value of Leadtek Fingertip Pulse Oximeter is less than 2% within the range 70% - 100%.
Clinical Evaluation:
The functional oxygen saturation (SpO2) measurements were validated in accordance with ISO 80601-2-61. The clinical evaluation for SpO2 accuracy was conducted on healthy male and female, light to dark skinned subjects, and total 10 subjects were enrolled. The SpO2 accuracy data was calculated using the root-mean-square (Arms); the performance results showed the Leadtek Fingertip Pulse Oximeter has an Arms of 1.72 during steady state conditions over the range of 70-100% and it is also in compliance with the specified performance claimed by the manufacturer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 accuracy results demonstrate that the root-mean-square (Arms) value of Leadtek Fingertip Pulse Oximeter is less than 2% within the range 70% - 100%.
The SpO2 accuracy data was calculated using the root-mean-square (Arms); the performance results showed the Leadtek Fingertip Pulse Oximeter has an Arms of 1.72 during steady state conditions over the range of 70-100%
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).
0
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
1
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 (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 Quality Center for Devices and Radiological Health
Enclosure
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 |
| 23511 New Taipei City, Taiwan | |
| Phone: | +886-2-8226-5800 |
| Fax Number: | +886-2-8226-5801 |
| Contact Person: | Sharon Peng |
| 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: 886-2-8226-5800 FAX: 886-2-8226-5801
510(k) No. K193350
4
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 | ||
| Name | Leadtek Fingertip Pulse Oximeter | Onyx Vantage 9590 |
| Model No. | 8D01B and 8D01C | Onyx 9590 |
| 510(k) Information | ||
| Regulation | ||
| 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 | ||
| Name | Leadtek Fingertip Pulse Oximeter | Onyx Vantage 9590 |
| Model No. | 8D01B and 8D01C | Onyx 9590 |
| 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. | Pulse Oximeter is a small, lightweight, | |
| portable device indicated for use in | ||
| measuring and displaying functional | ||
| oxygen saturation of arterial hemoglobin | ||
| (%SpO2) and pulse rate of patients who | ||
| are well or poorly perfused. It is intended | ||
| for spot-checking of adult and pediatric | ||
| patients on digits, including the thumb | ||
| and toes, that are between 0.3 - 1.0 inch | ||
| (0.8 -2.5 cm) thick. The device's intended | ||
| use environments include hospitals, | ||
| clinics, long-term care facilities, skilled | ||
| nursing facilities, emergency medical | ||
| services, and home healthcare services. | ||
| Population | adults and adolescent patients | adult and pediatric patients |
| Application | ||
| site | Finger | Finger, thumb, and toes |
| Performance | normal condition | normal and low perfusion conditions |
| 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 | 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 Leadtek Fingertip Pulse Oximeter is substantially equivalent to | ||
| the predicate device (K112843) concerning the same intended use. | ||
| Test Principle | ||
| Principle | Determine the functional oxygen | |
| saturation of arterial hemoglobin | Displays numerical values for functional | |
| oxygen saturation of arterial hemoglobin | ||
| Item | Proposed Device | Predicate Device |
| Product | ||
| Name | Leadtek Fingertip Pulse Oximeter | Onyx Vantage 9590 |
| Model No. | 8D01B and 8D01C | Onyx 9590 |
| (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. | (SpO2) and pulse rate by measuring the | |
| absorption of red and infrared (IR) light | ||
| passing through perfused tissue. | ||
| Changes in absorption caused by the | ||
| pulsation of blood in the vascular bed are | ||
| used to determine SpO₂ 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 910 | ||
| nanometers @ 1.2mW; both as max | ||
| average | ||
| Comparison | The difference between the proposed device and the predicate device is the | |
| infrared wavelength. There is no additional question of safety and effectiveness as | ||
| compared to the predicate device. The Leadtek Fingertip Pulse Oximeter is | ||
| substantially equivalent to the predicated device (K112843) concerning the test | ||
| 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 | |
| predicate device raised by the battery. The Leadtek Fingertip Pulse Oximeter is | ||
| substantially equivalent to the predicate device (K112843) concerning the energy | ||
| 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 | |
| push-down (8D01C) key | None | |
| Warning / | ||
| Indicator | 8D01B: Audio and visual warning | |
| 8D01C: Visual indicator | Visual indicator | |
| Warning / | 8D01B: | 3 color pulse quality indicator to provide |
| Item | Proposed Device | Predicate Device |
| Product | ||
| Name | Leadtek Fingertip Pulse Oximeter | Onyx Vantage 9590 |
| Model No. | 8D01B and 8D01C | Onyx 9590 |
| Indicator | ||
| Function | Appear red color with beep sounds | |
| when SpO2 and pulse rate out of the | ||
| setting range. | assurance of reading quality | |
| ■ Green Light: Good Reading | ||
| ■ Yellow Light: Fair Reading | ||
| ■ Red Light: Poor Reading. | ||
| ■ Low SpO2 warning: | ||
| default 87%; setting range: 50% to | ||
| 95% | ||
| ■ 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 | ||
| Display | ||
| Rotation | Yes | None |
| Comparison | The differences of operation features will not be considered as a NSE between the | |
| proposed device and the predicate device. The Leadtek Fingertip Pulse Oximeter | ||
| is substantially equivalent to the predicate device (K112843) concerning the | ||
| technological characteristics. | ||
| General Specification | ||
| Usage Life | > 24 hrs typical operation under | |
| default setting | 6,000 spot checks or 36 hours of | |
| operation | ||
| Operating | ||
| Temp. | 5 ºC to 40 ºC ( 41 ºF to 104 ºF) | -5 ºC to 40 ºC ( 23 ºF to 104 ºF) |
| Storage | ||
| 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 | |
| operating and storage | 10% to 90%, non-condensing for | |
| operating | ||
| 10% to 95%, non-condensing for storage | ||
| Atmospheric | 700 hPa - 1013 hPa for both operating | |
| Item | Proposed Device | Predicate Device |
| Product | ||
| Name | Leadtek Fingertip Pulse Oximeter | Onyx Vantage 9590 |
| Model No. | 8D01B and 8D01C | Onyx 9590 |
| Pressure | ||
| and storage | ||
| Water | ||
| 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 | ||
| Standard | ISO 80601-2-61 | ISO 80601-2-61 |
| Mode of | ||
| 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 | |
| H25 mm (0.98") | L55.9 mm (2.2") x W33 mm (1.3") x | |
| 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 | |
| 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% | 0% to 100% |
| Resolution | 1% | 1% |
| Accuracy | 70% to 100% range ± 2%, less than | |
| 70% are unspecified | 70% to 100% range ± 2%, less than 70% | |
| are unspecified | ||
| Heat Rate Specification | ||
| Range | 30 to 250 bpm | 18 to 321 bpm |
| Resolution | 1 bpm | 1 bpm |
| Accuracy | ±1 bpm or ±1%, whichever is greater | 20 to 250 bpm ±3 digits |
| Item | Proposed Device | Predicate Device |
| Product | ||
| Name | Leadtek Fingertip Pulse Oximeter | Onyx Vantage 9590 |
| Model No. | 8D01B and 8D01C | Onyx 9590 |
| Comparison | The difference of Heart Rate Specification will not be considered as a NSE | |
| between the proposed device and the predicate device. The Leadtek Fingertip | ||
| Pulse Oximeter is substantially equivalent to the predicate device (K112843) | ||
| concerning the performance specification. |
18F.,No.166, Jian-Yi Rd., Chung Ho Dist., New Taipei City, 23511, Taiwan
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TEL: 886-2-8226-5800 FAX: 886-2-8226-5801
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TEL: 886-2-8226-5800
FAX: 886-2-8226-5801
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TEL: 886-2-8226-5800 FAX: 886-2-8226-5801
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TEL: 886-2-8226-5800
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7. Functional and Safety Testing:
The Leadtek Fingertip Pulse Oximeter is designed and conducted in accordance with the related standards. The following tests were performed to verify and validate that Leadtek Fingertip Pulse Oximeter 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, and reliability testing were conducted and show that the proposed 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 biocompatibility testing for Leadtek Fingertip Pulse Oximeter was 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.
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
18F.,No.166, Jian-Yi Rd., Chung Ho Dist., New Taipei City, 23511, Taiwan
TEL: 886-2-8226-5800 FAX: 886-2-8226-5801
10
verifications and validations demonstrate that Leadtek Fingertip Pulse Oximeter work functionally. The software for the device is considered as a "moderate" level of concern, which 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, 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
Cleaning and disinfection validations were executed in accordance with FDA Guidance "Reprocessing Medical Device in Health Care Setting: Validation Methods and Labeling" The performance of Leadtek Fingertip Pulse Oximeter will not be affected after multiple cleaning and disinfection procedures as illustrated in user manual.
Performance Testing
The laboratory and clinical evaluations for the performance of Leadtek Fingertip Pulse Oximeter demonstrate that the modifications do not raise different questions of safety and effectiveness. The root-mean-square (Arms) was used to analyze the accuracy of Leadtek Fingertip Pulse Oximeter, per ISO 80601-2-61:2011, the SpO2 accuracy results demonstrate that the root-mean-square (Arms) value of Leadtek Fingertip Pulse Oximeter is less than 2% within the range 70% - 100%.
Clinical Evaluation
The functional oxygen saturation (SpO2) measurements were validated in accordance with ISO 80601-2-61. The clinical evaluation for SpO2 accuracy was conducted on healthy male and female, light to dark skinned subjects, and total 10 subjects were enrolled. The SpO2 accuracy data was calculated using the root-mean-square (Arms); the performance results showed the Leadtek Fingertip Pulse Oximeter has an Arms of 1.72 during steady state conditions over the range of 70-100% and it is also in compliance with the specified performance claimed by the manufacturer.
8. Conclusion
The Leadtek Fingertip Pulse Oximeter has the same intended use and similar characteristics as that of the predicate device manufactured by Nonin Medical Inc. and cleared by FDA under K112843. Based on the information contained in this submission demonstrate that any different characteristics do not raise different questions of safety and effectiveness.
18F.,No.166, Jian-Yi Rd., Chung Ho Dist., New Taipei City, 23511, Taiwan
TEL: 886-2-8226-5800 FAX: 886-2-8226-5801
510(k) No. K193350