Not Found
No
The description details a standard pulse oximetry technology based on light absorption and does not mention any AI or ML components.
No
The device is used for non-invasive spot checking of oxygen saturation and pulse rate, not for providing therapy.
No
The device is intended for "spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR)," which are measurements, not diagnoses. It measures and displays physiological parameters but does not interpret those measurements to make a medical diagnosis.
No
The device description explicitly states it includes a sensor with a dual light source and photo detector, which are hardware components. It also describes the physical mechanism of light absorption and detection, indicating a hardware-based measurement process.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Pulse Oximeter Function: The description clearly states that the Pulse Oximeter is a non-invasive device that measures oxygen saturation and pulse rate by applying a sensor to the finger. It works by analyzing light absorption through the skin and tissue. This is a measurement taken on the body, not on a sample taken from the body.
Therefore, based on the intended use and device description, the Pulse Oximeter described is a non-invasive medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.
Product codes (comma separated list FDA assigned to the subject device)
DOA
Device Description
The Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).
The Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The Pulse Oximeter is powered by smart phone and the measurement result will display on an Apple iPhone and Android phone.
The device is a spot-check pulse oximeter and does not include alarms. The device is not intended for lifesupporting or life-sustaining.
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
Intended User / Care Setting
Clinical institution and home environments.
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)
Biocompatibility testing:
The biocompatibility evaluation for the Pulse Oximeter was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The testing included the following:
- Cytotoxicity
- Sensitization
- Irritation
The subject devices are considered surface contacting for a duration of not exceed 24 hours.
Non-clinical data:
The Pulse Oximeter has been tested according to the following standards:
- IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, 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
- ISO 80601-2-61: 2017 Medical Electrical Equipment Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
Clinical data:
Clinical studies were conducted to verify the accuracy of proposed device. The clinical studies were conducted per following standards:
- ISO 80601-2-61: 2017 Medical Electrical Equipment Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
- Pulse Oximeters-Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff
Clinical testing has been performed under an approved protocol with subject informed consent. Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Pulse Oximeter versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range.
Key results: Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Measuring Range: 50%-100%
SpO2 Resolution: 1%
SpO2 Accuracy: 70~100%, ±3%; 0-69%, unspecified;
PR Range: 30 bmp – 240 bmp
PR Resolution: 1 bpm
PR Accuracy: ± 1
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 and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 27, 2020
Guangdong Long Yao Electronic Technology Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China
Re: K201294
Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: October 28, 2020 Received: October 30, 2020
Dear Kevin Wang:
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
1
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 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 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
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Pulse Oximeter
Indications for Use (Describe)
The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.
| Type of Use (Select one or both, as applicable) | X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
3
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
K201294
Prepared Date: 2020/11/16
1. Submission sponsor
Name: Guangdong Long Yao Electronic Technology Co., Ltd.
Address: Unit A03, 2nd Floor, No. 19, Huali Road, Tianhe District, Guangzhou, Guangdong, P.R. China Contact person: Lei Wang
Title: General Manager
E-mail: 965731439@qq.com
Tel: +86 135 80508450
2. Submission correspondent
Name: Chonconn Medical Device Consulting Co., Ltd.
Address: Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067
Contact person: Kevin Wang
E-mail: kevin@chonconn.com
Tel: +86-755 33941160
| Trade/Device Name | Pulse Oximeter |
|---|---|
| Model | LYOX01 |
| Common Name | Fingertip Pulse Oximeter |
| Regulatory Class | Class II |
| Classification | 21CFR 870.2700 / Oximeter / DQA |
| Submission type | Traditional 510(K) |
Subject Device Information 3.
4. Predicate Device
Manufacturer: Shenzhen Aeon Technology Co., Ltd. Device name: Pulse Oximeter 510(K) Number: K190869
5. Device Description
The Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).
The Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains
4
a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The Pulse Oximeter is powered by smart phone and the measurement result will display on an Apple iPhone and Android phone.
The device is a spot-check pulse oximeter and does not include alarms. The device is not intended for lifesupporting or life-sustaining.
Intended use & Indication for use 6.
The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.
| Features | Subject Device
Pulse Oximeter | Predicate Device K190869
AEON Pulse Oximeter | Compariso
n | |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Applicant | Guangdong Long Yao
Electronic Technology Co.,
Ltd. | Shenzhen Aeon Technology
Co., Ltd. | / | |
| Classification
Regulation | 21CFR 870.2700 | 21CFR 870.2700 | Same | |
| Classification and
Code | Class II, DQA | Class II, DQA | Same | |
| Common name | Fingertip Pulse Oximeter | Fingertip Pulse Oximeter | Same | |
| Intended use | The Pulse Oximeter is a non-
invasive device intended for
spot checking of functional
oxygen saturation of arterial
hemoglobin (SpO2) and pulse
rate (PR). This portable device
is indicated for use in adult
patients in clinical institution
and home environments. | The Pulse Oximeter is a non-
invasive device intended for
spot checking of functional
oxygen saturation of arterial
hemoglobin (SpO2) and pulse
rate (PR). This portable device
is indicated for use in adult
patients in clinical institution
and home environments. | Same | |
| Patient populations | Adults | Adults | Same | |
| Principle | The device displays numerical
values for functional oxygen
saturation of arterial | The device displays numerical
values for functional oxygen
saturation of arterial | Same | |
| Features | | Subject Device | Predicate Device K190869
AEON Pulse Oximeter | Comparison |
| | | Pulse Oximeter | | n |
| | | hemoglobin (SpO2) and pulse
rate by measuring the
absorption of red and infrared
(IR) light passing through
perfused tissue. Changes in the
absorption caused by the
pulsation of blood in the
vascular bed are used to
determine oxygen saturation
and pulse rate. | hemoglobin (SpO2) and pulse
rate by measuring the
absorption of red and infrared
(IR) light passing through
perfused tissue. Changes in the
absorption caused by the
pulsation of blood in the
vascular bed are used to
determine oxygen saturation
and pulse rate. | |
| | Light Emitting | Red: 660
Infrared: 905nm | Red: 660
Infrared: 905nm | Same |
| | Power source | Cell phone | 2 AAA alkaline batteries | Different (1) |
| | Display data | SpO2%, PR | SpO2%, PR | Same |
| | SpO2 Measuring
Range | 50%-100% | 35%-100% | Different (2) |
| | SpO2 Resolution | 1% | 1% | Same |
| | SpO2 Accuracy | 70100%, ±3%;100%, ±3%;
0-69%, unspecified; | 70
0-69%, unspecified; | Same |
| | PR Range | 30 bmp – 240 bmp | 30 bmp – 250 bmp | Different (3) |
| | PR Resolution | 1 bpm | 1 bpm | Same |
| | PR Accuracy | ± 1 | ± 2 | Different (4) |
| | Sterile | No | No | Same |
| | Application site | Finger | Finger | Same |
| | Electrical Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 | Same |
| | EMC | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 | Same |
| | Performance | Complied with ISO 80601-2-
61 | Complied with ISO 80601-2-
61 | Same |
| Biocompatibility | Cytotoxicity | Complied with ISO 10993-5 | Complied with ISO 10993-5 | Same |
| | Skin Irritation | Complied with ISO 10993-10 | Complied with ISO 10993-10 | Same |
| | Sensitization | Complied with ISO 10993-10 | Complied with ISO 10993-10 | Same |
Comparison to the Predicate Device 7.
5
Justifications for differences between proposed device and the predicate device are shown as below: Different (1): The power source is different. The subject device is powered by cell phone through connector cable. The predicate device is powered by internal battery. The electricity safety testing was conducted according to IEC 60601-1: 2012. Thus, this difference does not raise different questions of safety and effectiveness.
6
Different (2): The SpO2 measuring range is different. The SpO2 measurement of the subject device was validated according to ISO 80601-2-61. Thus, this difference does not raise different questions of safety and effectiveness.
Different (3) & (4): The pulse rate measuring range and accuracy is different. The PR measurement of the subject device was validated according to declared range and accuracy. Thus, this difference does not raise different questions of safety and effectiveness.
8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Pulse Oximeter was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The testing included the following:
- . Cytotoxicity
- Sensitization .
- Irritation .
The subject devices are considered surface contacting for a duration of not exceed 24 hours.
Non-clinical data
The Pulse Oximeter has been tested according to the following standards:
- . IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, 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
- ISO 80601-2-61: 2017 Medical Electrical Equipment Part 2-61: Particular Requirements for . Basic Safety and Essential Performance of Pulse Oximeter Equipment.
Clinical data
Clinical studies were conducted to verify the accuracy of proposed device. The clinical studies were conducted per following standards:
- ISO 80601-2-61: 2017 Medical Electrical Equipment Part 2-61: Particular Requirements for . Basic Safety and Essential Performance of Pulse Oximeter Equipment.
- Pulse Oximeters-Premarket Notification Submissions: Guidance for Industry and Food and . Drug Administration Staff
Clinical testing has been performed under an approved protocol with subject informed consent. Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Pulse Oximeter
7
versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range.
9. Conclusion
Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device. The subject device has the same intended use as the predicate device, and the technological differences do not raise different questions of safety and effectiveness.