(379 days)
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No
The document describes a standard pulse oximeter and does not mention any AI or ML components or capabilities.
No
The device is described as a "non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate," indicating it is a diagnostic or monitoring device, not one that provides therapy.
Yes
Explanation: The device measures and displays SpO2 and pulse rate, which are physiological parameters used to assess a patient's condition. While it is a spot-checking device and not for continuous monitoring, obtaining these measurements can contribute to a diagnostic process by providing objective data about a patient's oxygenation and heart rate.
No
The device description explicitly states that the device consists of electronic circuits, plastic housing, OLED/LED display, and a button, powered by batteries. These are hardware components, indicating it is not a software-only 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 provide information for diagnosis, monitoring, or screening.
- Device Function: The YUWELL® Finger Pulse Oximeter measures SpO2 (blood oxygen saturation) and pulse rate non-invasively through the finger. It does not analyze samples taken from the body.
- Intended Use: The intended use is for "spot checking" and "inspection" of SpO2 and pulse rate, not for performing laboratory tests on biological samples.
The device is a non-invasive medical device that measures physiological parameters directly from the body.
N/A
Intended Use / Indications for Use
The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring,use during motion or for patients with low perfusion.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring, use during motion or for patients with low perfusion.
The YUWELL® Finger Pulse Oximeter features in small volume, low power consumption, convenient operation and portable. It is only necessary for patient to put one of his fingers into a fingertip photoelectric sensor for measurement, and then the screen will display the measured value of Pulse Oxygen Saturation (SpO2) and pulse rate(PR). The device consists of electronic circuits, plastic housing. OLED/LED display(differentiated by models) and button (YX301,YX306 equipped, YX102,YX103 not equipped) which powered by two alkaline AAA batteries. The device does not include alarms.
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 and children (weight > 30kg)
Intended User / Care Setting
home and hospital inspection.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The purpose of the clinical trial was to evaluate the SpO2 accuracy performance of the required cleared Pulse Oximeter during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood CO-Oximetry. 12 healthy adult volunteer subjects (ages 18-50yr, with light to dark pigmentation) were included in the study conducted to evaluate the SpO2 accuracy performance of proposed devices. Each system was evaluated during steady state/non-motion conditions with various levels of induced hypoxia resulting in stable oxygen saturation levels between 100% SaO2. Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Pulse Oximeter has been tested according to the following standards: IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, IEC 60601-1-2:2014, IEC 60601-1-11: 2015, ISO 80601-2-61: 2017. Software verification and validation were provided in compliance with FDA Guidance for the Content of the Premarket Submission for Software Contained in Medical Devices. Biocompatibility evaluation was conducted in accordance with ISO 10993-1, including Cytotoxicity, Irritation, and Sensitization tests. Cleaning and disinfection validation testing was conducted. Clinical studies were conducted per ISO 80601-2-61: 2017 and FDA Guidance for Pulse Oximeters - Premarket Notification Submissions. The clinical study involved 12 healthy adult volunteer subjects (ages 18-50yr, with light to dark pigmentation) to evaluate SpO2 accuracy performance during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels compared to arterial blood CO-Oximetry. The SpO2 accuracy performance results showed the fingertip pulse oximeter to have an Arms less than 3% during steady state conditions over the range of 70-100%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The SpO2 accuracy performance results showed the fingertip pulse oximeter to have an Arms less than 3% 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).
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Image /page/0/Picture/0 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 16, 2022
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. Yuzhuo Wang Medical Device Registered Engineer Yunyang Industrial Park Danyang, Jiangsu 212300 China
Re: K212385
Trade/Device Name: YUWELL Finger Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: July 12, 2022 Received: July 18, 2022
Dear Yuzhuo 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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,
for 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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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K212385
Device Name
YUWELL® Finger Pulse Oximeter: YX102, YX103, YX301, YX306
Indications for Use (Describe)
The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring,use during motion or for patients 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(K) SUMMARY
1. OWNER/SUBMITTER'S INFORMATION
| Company Name: | JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY
CO.,LTD. |
|------------------|------------------------------------------------------------------------------|
| Company Address: | Yunyang Industrial Park 212300 Danyang Jiangsu PEOPLE'S
REPUBLIC OF CHINA |
| Contact: | Wang, Yuzhuo |
| Phone: | 0511-86900827 |
| Fax: | 0511-86900991 |
| Email: | wang.yz@yuyue.com.cn |
| Date prepared: | July 12, 2022 |
2. TRADE NAME, COMMON NAME, CLASSIFICATION
| Trade Name: | YUWELL® Finger Pulse Oximeter |
|---|---|
| Common Name: | Finger Pulse Oximeter |
| Model: | YX102, YX103, YX301, YX306 |
| Product Code : | DQA |
| Regulation Number: | 21 CFR 870.2700 |
| Classification Name: | Oximeter |
| Device Classification: | Class II |
| FDA 510 (k) #: | K212385 |
3. DENTIFICATION OF PREDICATE DEVICE(S)
The identification of predicates within this submission is as follow:
| Manufacturer: | Beijing Choice Electronic Technology Co., Ltd. |
|---|---|
| Trade Name: | Fingertip Pulse Oximeter |
| Common Name: | Pulse Oximeter |
| Product Code: | DQA |
| Regulation Number: | 21 CFR 870.2700 |
| Classification Name: | Oximeter |
| Device Classification: | Class II |
| FDA 510 (k) #: | K101577 |
4、DESCRIPTION OF THE DEVICE
The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring, use during motion or for patients with low perfusion.
The YUWELL® Finger Pulse Oximeter features in small volume, low power consumption, convenient operation and portable. It is only necessary for patient to put one of his fingers into a fingertip photoelectric sensor for measurement, and then the screen will display the measured
4
value of Pulse Oxygen Saturation (SpO2) and pulse rate(PR) . The device consists of electronic circuits, plastic housing. OLED/LED display(differentiated by models) and button
(YX301,YX306 equipped, YX102,YX103 not equipped) which powered by two alkaline AAA batteries. The device does not include alarms.
5、INTENDED USE
The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, reusable, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight > 30kg) and is expected for home and hospital inspection. The device is not for continuous monitoring, use during motion or for patients with low perfusion.
6、TECHNOLOGICAL CHARACTERISTIC
Principle of the Oximeter is as follows: An experience formula of data process is established taking use of Lambert Beer law according to Spectrum Absorption Characteristics of deoxyhaemoglobin (HHb) and Oxyhemoglobin (O2Hb ) in glow and near-infrared zones. Operation principle of the instrument is Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of light (red light and infrared light) can be focused onto human nail tip through perspective clamp finger-type sensor. Then measured signal can be obtained by a photosensitive element, information acquired through which will be shown display through process in electronic circuits and microprocessor.
| Description | Subject Device
(K212385) | Predicate Device
(K101577) | Remark |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Manufacturer | JIANGSU YUYUE MEDICAL
EQUIPMENT & SUPPLY
CO.,LTD. | Beijing Choice Electronic
Technology Co., Ltd. | - |
| Product Name | Finger Pulse Oximeter | Fingertip Pulse Oximeter | - |
| Model | YX102,YX103,YX301,YX306 | MD300C63 | - |
| Intended Use | The YUWELL® Finger Pulse
Oximeter is a non-invasive, non-
sterile, reusable, spot checking
device which can measure and
display SpO2 and pulse rate
through finger. It is intended for
adults and children (weight >
30kg) and is expected for home
and hospital inspection. The
device is not for continuous
monitoring, use during motion or
for patients with low perfusion. | Fingertip pulse oximeter is a
portable, non-invasive devices
intended for spot- checking of
arterial hemoglobin oxygen
saturation (SpO2) and pulse
rate of adult and pediatric
patient at home, and hospital
(including clinical use in
internist/surgery, Anesthesia,
and intensive care units). Not
for continuous monitoring. | Note 1 |
| | | | |
| Patient populations | adults and children (weight >30
kg) | adult and pediatric patient | Note 1 |
| Measuring
characteristics | Spot-checking
Not for continuous monitoring,
use during motion or for patients
with low perfusion. | Spot-checking
Not for continuous
monitoring, using during
motion or using with low
perfusion. | Same |
| Application sites | Finger | Finger | Same |
| Components | Power supply module, detector
and emitter LED, signal collection
and processor module, display
module. | Detector and emitter LED,
signal amplify unit, CPU, data
display unit and power unit. | Same |
| Product principle | An experience formula of data
process is established taking use
of Lambert Beer law according to
Spectrum Absorption
Characteristics of
deoxyhaemoglobin(HHb) and
Oxyhemoglobin(O2Hb) in glow
and near-infrared zones. Operation
principle of the instrument is
Photoelectric Oxyhemoglobin
Inspection Technology is adopted
in accordance with Capacity Pulse
Scanning and Recording
Technology, so that two beams of
different wavelength of light (red
light and infrared light) can be
focused onto human nail tip
through perspective clamp finger-
type sensor. Then measured signal
can be obtained by a
photosensitive element,
information acquired through
which will be shown display
through process in electronic
circuits and microprocessor. | An mathematical formula is
established making use of
Lambert Beer Law according
to Spectrum Absorption
Characteristics of Reductive
hemoglobin (RHb) and
Oxyhemoglobin (HbO2 ) in
glow and near-infrared zones.
Operation principle of the
instrument: Photoelectric
Oxyhemoglobin Inspection
Technology is adopted in
accordance with Capacity
Pulse Scanning and Recording
Technology, so that two beams
of different wavelength of
light (660nm glow and 940nm
near infrared light) can be
focused onto a human nail tip
through a clamping finger-
type sensor. A measured signal
obtained by a photosensitive
element, will be shown on the
oximerer's display through
process in electronic circuits
and microprocessor. | Same |
| Measurement
wavelength Red | YX102, YX103, YX306:
660 ±8nm | 660± 2nm | Note 2 |
| light | YX301: 660 ± 20nm | | |
| Measurement
wavelength-Infrared
light | YX102, YX103, YX306: 905 ± 25nm | 940± 10nm | |
| | YX301: 940 ± 25nm | | |
| Display Type | YX102, YX103: LED | | Note 3 |
| | YX301, YX306: OLED | OLED | Same |
| Power Supply | 2AAA alkaline batteries | 2AAA alkaline batteries | Same |
| Battery Working
Time | YX102, YX103, YX306: Two AAA batteries can be operated continuously for 17 hours | Two AAA alkaline batteries can be operated continuously for 30 hours. | Note 4 |
| | YX301: Two AAA batteries can be operated continuously for 45 hours | | |
| Display Content | YX102, YX103: SpO2, PR, Pulse bar, Low battery | SpO2, PR, Power low indicator, Pulse bar graph, Waveform | Note 5 |
| | YX301, YX306: SpO2, PR, Pulse volume wave, Pulse bar, Battery level, Symbol of gravity sensing mode | | |
| User Interface | YX102, YX103: 1 display direction | 4 display directions | Note 6 |
| | YX301, YX306: 4 display directions | | Same |
| SpO2 Display Range | 0%100% | 0100% | |
| SpO2 Measurement
Range | 70%~100% | 70%~100% | Same |
| SpO2
Accuracy | 70%~80%, 80%~90%,
90%~100%, ± 2%;