(218 days)
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 strictly for measuring and displaying physiological parameters (SpO2 and pulse rate) and is explicitly stated as "not intended for continuous monitoring," "not intended for life-supporting or life-sustaining," and lacking alarms, which are functions typically associated with therapeutic devices. Its purpose is diagnostic/monitoring, not treatment.
Yes
The device measures functional oxygen saturation (SpO2) and pulse rate (PR), which are physiological parameters used to assess a patient's condition.
No
The device description explicitly details hardware components such as a PCB board, buttons, screen, battery compartment, and plastic shell, indicating it is a physical device, not software-only.
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.
- Device Function: This pulse oximeter measures functional oxygen saturation (SpO2) and pulse rate (PR) by applying a sensor to the finger. This is a non-invasive measurement taken directly from the body, not from a sample in vitro (in glass or outside the body).
- Intended Use: The intended use clearly states it's for measuring SpO2 and PR, which are physiological parameters measured in vivo (in the living body).
Therefore, based on the provided information, this pulse oximeter falls under the category of a medical device, but specifically a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This Pulse Oximeter is intended for measuring the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check of SpO2, PR of adult or pediatric patients (weight >=40kg) in home. This device is not intended for continuous monitoring. It is intended to be used by both lay person or healthcare professional in the home environment.
Product codes
DQA
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 2 AAA alkaline batteries.
The device mainly composed of PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, and plastic shell. The device is a spot-check pulse oximeter and does not include alarms. The device is not intended for life-supporting 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
adult or pediatric patients (weight >=40kg)
Intended User / Care Setting
lay person or healthcare professional in the home 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
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.
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 biocompatibility testing included the following tests: Cytotoxicity, Sensitization, Irritation.
The Pulse Oximeter has been tested according to the following standards: ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD); 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 Edition 2.0 2015-01Medical 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 the home healthcare environment; ISO 80601-2-61: 2017 Medical Electrical Equipment Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
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 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 Metrics
SpO2 Measuring Range: 35%-100%
SpO2 Resolution: 1%
SpO2 Accuracy: 70~100%, ARMS±3%.
§ 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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February 25, 2022
Shenzhen Mericonn 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: K212300
Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: February 25, 2022 Received: February 23, 2022
Dear Kevin Wang:
We have reviewed vour 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 and Part 809); medical device reporting (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 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 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K212300
Device Name
Pulse Oximeter (Model: PO101, PO102, PO103)
Indications for Use (Describe)
This Pulse Oximeter is intended for measuring the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check of SpO2, PR of adult or pediatric patients (weight >=40kg) in home. This device is not intended for continuous monitoring. It is intended to be used by both lay person or healthcare professional in the home environment.
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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5 510(k) Summary
4
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2022/2/7
1. Submission sponsor
Name: Shenzhen Mericonn Technology Co., Ltd. Address: Room 20203, Building 6, Donglongxing Kejiyuan, Huaning Road, Xinshishequ, Dalang Street, Longhua district, Shenzhen City, Guangdong, 518109 P.R. China Contact person: Jiang Chuanyuan Title: General manager E-mail: info@digitalems.net Tel: 0086 13928416535
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 | PO101, PO102, PO103 |
| Common Name | Fingertip Pulse Oximeter |
| Regulatory Class | Class II |
| Classification | 21CFR 870.2700 / Oximeter / DQA |
| Submission type | Traditional 510(K) |
3. Subject Device Information
4. Predicate Device
Manufacturer: Shenzhen Creative Industry Co., Ltd. Device name: Pulse Oximeter, AP-10 510(K) Number: K201468
ട്. 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
5
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 2 AAA alkaline batteries.
The device mainly composed of PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, and plastic shell. The device is a spot-check pulse oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.
6. Intended use & Indication for use
This Pulse Oximeter is intended for measuring and recording the functional oxygen saturation (SpO2) and pulse rate (PR).
It is intended for spot check of SpO2, PR of adult or pediatric patients (weight >=40kg) in hospitals, clinics, or home. This device is not intended for continuous monitoring. It is intended to be used by both lay person or healthcare professional in the home environment.
| Features | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Pulse Oximeter, | |||
| PO101/PO102/PO103 | K201468 | ||
| Pulse Oximeter, AP-10 | |||
| Applicant | Shenzhen Mericonn | ||
| Technology Co., Ltd. | Shenzhen Creative | ||
| Industry Co., Ltd. | / | ||
| Classification | |||
| Regulation | 21CRF 870.2700 | 21CRF 870.2700 | Same |
| Classification | |||
| and Code | Class II, DQA | Class II, DQA | Same |
| Common | |||
| name | Pulse Oximeter | Pulse Oximeter | Same |
| Intended use | This Pulse Oximeter is | ||
| intended for | |||
| measuring and | |||
| recording the | |||
| functional oxygen | |||
| saturation (SpO2) and | |||
| pulse rate (PR). | |||
| It is intended for spot | |||
| check of SpO2, PR of | |||
| adult or pediatric | This Pulse Oximeter is | ||
| intended for measuring | |||
| and recording the | |||
| functional oxygen | |||
| saturation (SpO2) and | |||
| pulse rate (PR). It is | |||
| intended for spot check | |||
| and continuous recording | |||
| of SpO2, PR of adult or | |||
| pediatric patients in | The subject devices | ||
| do not support | |||
| continuous recording | |||
| compared with the | |||
| predicate, but the rest | |||
| is the same. The | |||
| difference does not | |||
| raise any safety and | |||
| effectiveness | |||
| questions. | |||
| Features | Subject Device | Predicate Device | |
| K201468 | Comparison | ||
| Pulse Oximeter, | |||
| PO101/PO102/PO103 | |||
| patients in hospitals, | |||
| clinics, or home. This | |||
| device is not intended | |||
| for continuous | |||
| monitoring. It is | |||
| intended to be used by | |||
| both lay person or | |||
| healthcare | |||
| professional in the | |||
| home environment. | Pulse Oximeter, AP-10 | ||
| hospitals, clinics, or | |||
| home. | |||
| This device is not | |||
| intended for continuous | |||
| monitoring. | |||
| Patient | |||
| populations | adult or pediatric | adult or pediatric | Same |
| Type of | |||
| SpO2 Sensor | Transmittance Optical | ||
| Sensor | Transmittance Optical | ||
| Sensor | Same | ||
| Application | |||
| Site | Finger | Finger | Same |
| Light | |||
| Emitting | Red: 660 nm | ||
| Infrared: 905nm | Red: 660 nm | ||
| Infrared: 905nm | Same | ||
| Measuring | |||
| Mode | Spot-check | Spot-check and | |
| Continuous recording | Different | ||
| SpO2 | |||
| Measuring | |||
| Range | 35%-100% | 0%-100% | Different |
| SpO2 | |||
| Resolution | 1% | 1% | Same |
| SpO2 | |||
| Accuracy | 70~100%, | ||
| ARMS±3%. |