Wrist Pulse Oximeter

{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) | | |-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | <span style="font-family: Arial;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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<br>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<br>Different | | | Item | Wrist Pulse Oximeter | Wrist Pulse Oximeter | | | | Model | MD300W628 | MD300W314 | | | | Indications for Use | The MD300W628 Wrist Pulse Oximeter is<br>a portable, non-invasive device intended to<br>measure, display, store and transfer<br>functional oxygen saturation of arterial<br>hemoglobin (%SpO2) and pulse rate (PR)<br>of adult, adolescent and child in hospitals,<br>clinics, long-term care, and home use.<br>The device intended for spot-checking and<br>can be reused, not intended for continuous<br>monitoring, use during motion or use with<br>low perfusion. | MD300W314 is a wrist pulse oximeter<br>indicated for use in measuring,<br>displaying, storing and transmitting<br>functional oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse rate for<br>adult, adolescent, child and infant<br>patients. It is intended for spot-check<br>and / or data collection, recording and<br>transmitting. It can be used in sleep labs,<br>long-term care, hospitals and home use. | Difference 1 | | | Comparison Elements | Subject Device | Predicate Device | Similar or<br>Different | | | Item | Wrist Pulse Oximeter | Wrist Pulse Oximeter | - | | | Model | MD300W628 | MD300W314 | - | | | Design Principle | The Wrist Pulse Oximeter works by<br>applying a sensor to a pulsating arteriolar<br>vascular bed. The sensor contains a dual<br>light source and photo detector. The one<br>wavelength of light source is 660nm,<br>which is red light; the other is 905nm,<br>which is infrared-red light. Skin, bone,<br>tissue and venous vessels normally absorb<br>a constant amount of light over time. The<br>photo detector in finger sensor collects and<br>converts the light into electronic signal<br>which is proportional to the light intensity.<br>The arteriolar bed normally pulsates and<br>absorbs variable amounts of light during<br>systole and diastole, as blood volume<br>increases and decreases. The ratio of light<br>absorbed at systole and diastole is<br>translated into an oxygen saturation<br>measurement. This measurement is | The pulse oximeter works by applying a<br>sensor to a pulsating arteriolar vascular<br>bed. The sensor contains a dual light<br>source and photo detector. The one<br> | √ | | | Comparison Elements | | Subject Device | Predicate Device | Similar or<br>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<br>LED, signal collection and processor<br>module, display module, Bluetooth<br>module. | Power supply module, detector and emitter<br>LED, signal collection and processor<br>module, display module, Bluetooth<br>module. | V | | The site of application in the<br>body | | Fingers | Fingers | V | | Measurement<br>Wavelength | Red | 660±3nm | 660±3nm | V | | | Infrared | 905±10nm | 905±10nm | V | | | Comparison Elements | Subject Device | Predicate Device | Similar or<br>Different | | Item | | Wrist Pulse Oximeter | Wrist Pulse Oximeter | - | | Model | | MD300W628 | MD300W314 | - | | Performance<br>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:<br>70%~100%<br>Measurement range: 70%~100%<br>Accuracy: 70%~100%: ±2%; <69%:<br>unspecified. | SpO2 Display Range:<br>0%~100%<br>Measurement range: 70%~100%<br>Accuracy: 70%~100%: ±2%; <69%:<br>unspecified. | Difference 4 | | | PR | PR Display Range<br>30~250bpm<br>Measurement range: 30~250bpm<br>Resolution: 1bpm<br>Accuracy:<br>30~99bpm, ±2bpm;<br>100~250bpm, ±2% | PR Display Range<br>30~255bpm<br>Measurement range: 30~250bpm<br>Resolution: 1bpm<br>Accuracy:<br>30~99bpm, ±2bpm;<br>100~250bpm, ±2% | Difference 5 | | Comparison Elements | Subject Device | Predicate Device | Similar or<br>Different | | | Item | Wrist Pulse Oximeter | Wrist Pulse Oximeter | - | | | Model | MD300W628 | MD300W314 | - | | | Pulse amplitude<br>index (PAI) | Display range: 0.1~20.0%<br>Measurement range: 0.3~20.0%<br>Resolution: 0.1%<br>Accuracy:<br>0.3~1.0% (±0.2digits); 1.1~20.0% (±20%) | NA | Difference 6 | | | Network | Bluetooth | Bluetooth | √ | | | Wireless<br>Transmission<br>Range | 0~10m | 0~10m | √ | | | Antenna Type | Internal | Internal | √ | | | Comparison Elements | | Subject Device | Predicate Device | Similar or<br>Different | | Item | | Wrist Pulse Oximeter | Wrist Pulse Oximeter | - | | Model | | MD300W628 | MD300W314 | - | | Environment<br>Requirements |…