(273 days)
Not Found
No
The description of the device's principle of operation relies on established optical and physiological principles for measuring SpO2 and pulse rate, without mentioning any AI/ML components or algorithms for data processing or interpretation. The performance study focuses on clinical accuracy compared to CO-Oximetry, not on evaluating AI/ML model performance.
No.
The device is described as a non-invasive device intended to measure, display, store, and transfer functional oxygen saturation and pulse rate, which are diagnostic or monitoring functions, not therapeutic.
Yes
Explanation: The device is intended to "measure...functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate (PR)" and is used "for diagnosis" by displaying these measurements. The principle of operation also describes how it measures SpO2, which is a physiological parameter used in diagnosing patient conditions.
No
The device description explicitly lists hardware components such as a power supply module, detector and emitter, signal collection and process module (MCU), OLED display screen, and Bluetooth module. It also describes the physical principle of operation involving a sensor applied to a fingertip with a dual light source and photo detector.
Based on the provided information, 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: The MD300W628 Wrist Pulse Oximeter measures oxygen saturation and pulse rate by applying a sensor to a fingertip and analyzing light absorption through the skin and tissue. This is a non-invasive measurement performed in vivo (on the living body), not on a sample taken from the body.
- Intended Use: The intended use clearly states it's a "portable, non-invasive device intended to measure... functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate (PR)". This aligns with in vivo measurement.
Therefore, the MD300W628 Wrist Pulse Oximeter is a medical device, but it falls under the category of in vivo diagnostic devices rather than in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The MD300W628 Wrist Pulse Oximeter is a portable, non-invasive device intended to measure, display, store and transfer functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate (PR) of adult, adolescent and child in hospitals, clinics, long-term care, and home use.
The device intended for spot-checking and can be reused, not intended for continuous monitoring, use during motion or use with low perfusion.
Product codes
DQA
Device Description
The subject device Pulse Oximeter is an internally powered device. The main functions of the devices include hemoglobin oxygen saturation (SpO2), pulse rate (PR) measurements and Pulse amplitude index (PAI), data storage and transmission.
Place one fingertip into the sensor for diagnosis and the oxygen saturation (SpO2), pulse rate (PR) measurements and pulse amplitude index (PAI) will appear on the display. The device is normally applied to adult and pediatric patients in hospital and home care environment.
The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter, signal collection and process module (MCU), OLED display screen and Bluetooth module.
Principle of the oximeter is as follows: The pulse oximeter works by applying a sensor to a fingertip. The sensor contains a dual light source and photo detector. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector 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 enclosure of the subject device is made of ABS. The contact duration is greater than 30 days.
The Wrist oximeter wristband is made of Silicone Gel. The contact duration is greater than 30 days.
The Probe is made of Silicone Gel. The contact duration is greater than 24 hours and less than 30 days.
The display screen is made of glass. The contact duration is greater than 30 days.
The button is made of Aluminium alloy. The contact duration is greater than 30 days.
The subject device is not for life-supporting or life-sustaining. not for implant.
The device is not sterile, and the transducers are reusable and do not need sterilization and re-sterilization.
The device is for prescription. The device does not contain drug or biological products.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingers
Indicated Patient Age Range
adult, adolescent and child
Intended User / Care Setting
hospitals, clinics, long-term care, and home use.
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
The Clinical Study was conducted at Yue Bei people's Hospital. The study was conducted in accordance to ISO 14155-1, -2, ISO 80601-2-61:2017, and the FDA Guidance Document for Pulse Oximeters. The subject device of this study was to evaluate the SpO2 accuracy performance of the Beijing Choice Electronic Technology Co., Ltd. MD300W628 Wrist Pulse Oximeter and its supporting M-50G Sensor. during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood CO-Oximetry. After Institutional Review Board (IRB) approval, 11 healthy adult volunteer subjects (ages 22-44yr, 53-85kg, 152-179cm, with light to dark pigmentation) were included in the study conducted June. 18, 2022 - Aug. 20, 2022 to evaluate the SpO2 accuracy performance of the Beijing Choice Electronic Technology Co., Ltd. MD300W628 Wrist Pulse Oximeter and its supporting M-50G SpO2 Sensor.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Study
Sample Size: 11 healthy adult volunteer subjects
Key Results: The SpO2 accuracy performance results showed the Beijing Choice Electronic Technology Co., Ltd. MD300W628 Wrist Pulse Oximeter and its supporting M-50G SpO2 Sensor to have an ARMS of 1.68 during steady state conditions over the range of 70-100%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ARMS of 1.68
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of human figures, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue font.
November 30, 2023
Beijing Choice Electronic Technology Co., Ltd. Haiying Zhao Quality director No.9 Shuangyuan road, Badachu Hi-tech Zone, Shijingshan District Beijing, Beijing 100041 China
Re: K230587
Trade/Device Name: Wrist Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: November 1, 2023 Received: November 1, 2023
Dear Haiying Zhao:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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,
Bradley Q. Quinn -S
Bradley Quinn 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
3
Indications for Use
510(k) Number (if known) K230587
Device Name Wrist Pulse Oximeter
Indications for Use (Describe)
The MD300W628 Wrist Pulse Oximeter is a portable, non-invasive device intended to measure, display, store and transfer functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate (PR) of adult, adolescent and child in hospitals, clinics, long-term care, and home use.
The device intended for spot-checking and can be reused, not intended for continuous monitoring, use during motion or use with low perfusion.
| 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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4
510(k) Summary
K230587
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.
There is no prior submission for the device.
2.1 Submitter Information
Manufacturer Name: ●
Establishment Registration Number: 3005569927
Beijing Choice Electronic Technology Co., Ltd.
2nd Floor 3rd Floor and Room 410-412 4th Floor No. 2 Building, No. 9 Shuangyuan Road Shijingshan District 100041 Beijing PEOPLE'S REPUBLIC OF CHINA
● Contact Person:
Haiying Zhao
Beijing Choice Electronic Technology Co., Ltd.
2nd Floor 3rd Floor and Room 410-412 4th Floor No. 2 Building, No. 9 Shuangyuan Road Shijingshan District 100041 Beijing PEOPLE'S REPUBLIC OF CHINA
Phone: +86-10-88204631
Fax: +86-10-88204632
Email: cc@choicemmed.com
Date prepared: February 21, 2023
2.2 Subject Device Information
Regulation Name: Oximeter
5
Device Trade/Proprietary Name: Wrist Pulse Oximeter
Model: MD300W628
Purpose of submission: 510 (k)
Regulation Number: 21 CFR 870.2700
Product Code: DQA
Class: II
Panel: Anesthesiology
Intended use:
The MD300W628 Wrist Pulse Oximeter is a portable, non-invasive device intended to measure, display, store and transfer functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate (PR) of adult, adolescent and child in hospitals, clinics, long-term care, and home use.
The device intended for spot-checking and can be reused, not intended for continuous monitoring, use during motion or use with low perfusion.
2.3 Predicate Device
510(k) Number: K172366
Regulation Name: Oximeter
Device Trade/Proprietarv Name: Wrist Pulse Oximeter
Model: MD300W314
Product Code: DQA
Regulation Number: 21 CFR 870.2700
Device Class: II
Panel: Anesthesiology
Manufacturer: Beijing Choice Electronic Technology Co., Ltd.
6
2.4 Device Description
The subject device Pulse Oximeter is an internally powered device. The main functions of the devices include hemoglobin oxygen saturation (SpO2), pulse rate (PR) measurements and Pulse amplitude index (PAI), data storage and transmission.
Place one fingertip into the sensor for diagnosis and the oxygen saturation (SpO2), pulse rate (PR) measurements and pulse amplitude index (PAI) will appear on the display. The device is normally applied to adult and pediatric patients in hospital and home care environment.
The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter, signal collection and process module (MCU), OLED display screen and Bluetooth module.
Principle of the oximeter is as follows: The pulse oximeter works by applying a sensor to a fingertip. The sensor contains a dual light source and photo detector. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector 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 enclosure of the subject device is made of ABS. The contact duration is greater than 30 days.
The Wrist oximeter wristband is made of Silicone Gel. The contact duration is greater than 30 days.
The Probe is made of Silicone Gel. The contact duration is greater than 24 hours and less than 30 days.
The display screen is made of glass. The contact duration is greater than 30 days.
The button is made of Aluminium alloy. The contact duration is greater than 30 days.
The subject device is not for life-supporting or life-sustaining. not for implant.
The device is not sterile, and the transducers are reusable and do not need sterilization and re-sterilization.
The device is for prescription. The device does not contain drug or biological products.
7
2.5 Comparison list of the technological characteristics
| Comparison Elements | Subject Device | Predicate Device | Similar or
Different | |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Item | Wrist Pulse Oximeter | Wrist Pulse Oximeter | - | |
| Model | MD300W628 | MD300W314 | - | |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | √ | |
| Classification | II | Ⅱ | √ | |
| Regulation Name | Oximeter | Oximeter | √ | |
| Product Code | DQA | DQA | √ | |
| Comparison Elements | Subject Device | Predicate Device | Similar or
Different | |
| Item | Wrist Pulse Oximeter | Wrist Pulse Oximeter | | |
| Model | MD300W628 | MD300W314 | | |
| Indications for Use | The MD300W628 Wrist Pulse Oximeter is
a portable, non-invasive device intended to
measure, display, store and transfer
functional oxygen saturation of arterial
hemoglobin (%SpO2) and pulse rate (PR)
of adult, adolescent and child in hospitals,
clinics, long-term care, and home use.
The device intended for spot-checking and
can be reused, not intended for continuous
monitoring, use during motion or use with
low perfusion. | MD300W314 is a wrist pulse oximeter
indicated for use in measuring,
displaying, storing and transmitting
functional oxygen saturation of arterial
hemoglobin (SpO2) and pulse rate for
adult, adolescent, child and infant
patients. It is intended for spot-check
and / or data collection, recording and
transmitting. It can be used in sleep labs,
long-term care, hospitals and home use. | Difference 1 | |
| Comparison Elements | Subject Device | Predicate Device | Similar or
Different | |
| Item | Wrist Pulse Oximeter | Wrist Pulse Oximeter | - | |
| Model | MD300W628 | MD300W314 | - | |
| Design Principle | The Wrist 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 660nm,
which is red light; the other is 905nm,
which is infrared-red light. Skin, bone,
tissue and venous vessels normally absorb
a constant amount of light over time. The
photo detector 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 | 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
| √ | |
| Comparison Elements | | Subject Device | Predicate Device | Similar or
Different |
| Item | | Wrist Pulse Oximeter | Wrist Pulse Oximeter | |
| Model | | MD300W628 | MD300W314 | |
| | | referred to as SpO2. | referred to as SpO2. | |
| Components | | Power supply module, detector and emitter
LED, signal collection and processor
module, display module, Bluetooth
module. | Power supply module, detector and emitter
LED, signal collection and processor
module, display module, Bluetooth
module. | V |
| The site of application in the
body | | Fingers | Fingers | V |
| Measurement
Wavelength | Red | 660±3nm | 660±3nm | V |
| | Infrared | 905±10nm | 905±10nm | V |
| | Comparison Elements | Subject Device | Predicate Device | Similar or
Different |
| Item | | Wrist Pulse Oximeter | Wrist Pulse Oximeter | - |
| Model | | MD300W628 | MD300W314 | - |
| Performance
Specification | Display Type | OLED | LCD | Difference 2 |
| | Power supply | Lithium-ion rechargeable battery | Lithium-ion rechargeable battery | √ |
| | Display Data | SPO2, PR , PAI | SPO2 , PR | Difference 3 |
| | SPO2 | SpO2 Display Range:
70%~100%
Measurement range: 70%~100%
Accuracy: 70%~100%: ±2%;