(192 days)
Not Found
No
The summary describes a standard pulse oximeter with signal processing capabilities (MCU) but does not mention any AI/ML terms, image processing, or details about training/test data sets typically associated with AI/ML models.
No.
The device is a pulse oximeter used for measuring and displaying physiological parameters (SpO2, pulse rate, PAI), not for treating a disease or condition.
Yes
Explanation: The device is a pulse oximeter intended for measuring, displaying, storing and transmitting functional oxygen saturation and pulse rate, which are used to assess a patient's physiological state. This collection of physiological data for health assessment classifies it as a diagnostic device.
No
The device description explicitly lists hardware components such as a power supply module, detector and emitter, signal collection and process module (MCU), TFT display screen, and Bluetooth module.
Based on the provided information, the WS20A pulse oximeter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- WS20A Function: The WS20A pulse oximeter measures physiological parameters (SpO2 and pulse rate) directly from the patient's finger using non-invasive methods (light absorption). It does not analyze specimens taken from the body.
Therefore, the WS20A falls under the category of a non-invasive medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
WS20A is a pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for patients(≥10 years old, ≥30kg). It is designed for finger circumference more than 33mm. It is intended for spot-check, continuous data collection, recording and transmitting, not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
Pulse Oximeter WS20A is an internally powered pulse oximeter. 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 and the oxygen saturation (SpO2), pulse rate (PR) measurements and pulse amplitude index (PAI) will appear on the display. The device is intended to be applied to adult and pediatric patients in sleep labs, long-term care, hospital and home care environment.
The subject device is composed of the following components to achieve the above detection process: power supply module, detector and emitter, signal collection and process module (MCU), TFT display screen and Bluetooth module.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger
Indicated Patient Age Range
≥10 years old.
Intended User / Care Setting
sleep labs, long-term care, hospitals and home.
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)
Clinical studies were conducted to verify the accuracy of proposed device.
One clinical study is conducted for adult and pediatric patients. The purpose of the clinical trial is to validate accuracy of the pulse oximetry (SpO2) of the WS20A pulse oximeter manufactured by Hunan Accurate Bio-Medical Technology Co. Ltd. during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood CO-Oximetry.
For adult patients, 315 data sets (SpO2 VS SaO2) were obtained from 13 healthy adult subjects under nonmotion, aged 22-30, with skin tones of Fitzpatrick 1-6 and 3 of subjects with Fitzpatrick 5. According to the clinical trial results by all subject, gender and skin tones subgroup, within the blood oxygen range of 70-100%, the ARMS of the pulse oximeter is: 1.81% for all subjects, 1.80% for female subjects, and 1.83% for male subjects, 1.78% for light-skinned subjects.1.91% for dark-skinned subjects.
For pediatric patients, 243 data sets (SpO2 VS SaO2) were obtained from 10 healthy female subjects, aged 22-30, with skin tones of Fitzpatrick 1-6 and 2 of subjects with Fitzpatrick 5. According to the clinical trial results by 10 female subjects and skin tones subgroup, within the blood oxygen range of 70-100%, the ARMS of the pulse oximeter is: 1.80% for 10 female subjects, 1.81% for light-skinned subjects, 1.74% for dark-skinned subjects.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 ARMS: 1.81% for all subjects (adults), 1.80% for female subjects (adults), 1.83% for male subjects (adults), 1.78% for light-skinned subjects (adults), 1.91% for dark-skinned subjects (adults).
SpO2 ARMS: 1.80% for 10 female subjects (pediatric), 1.81% for light-skinned subjects (pediatric), 1.74% for dark-skinned subjects (pediatric).
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
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October 3, 2024
Hunan Accurate Bio-Medical Technology Co., Ltd. % Jie Yang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China
Re: K240808
Trade/Device Name: Pulse Oximeter (WS20A) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: March 25, 2024 Received: March 25, 2024
Dear Jie Yang:
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.
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).
1
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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 Anesthesia, Respiratory, and Sleep 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
Device Name
Pulse Oximeter (WS20A)
- Indications for Use (Describe)
WS20A is a pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for patients(≥10 years old. ≥30kg). It is designed for finger circumference more than 33mm. It is intended for spot-check, continuous data collection, recording and transmitting, not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home.
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
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2024/10/02
1. Submission sponsor
Name: Hunan Accurate Bio-Medical Technology Co., Ltd. Address: Accurate Industrial Park, No.108, Zhixian Road, Xuelian Community, Xueshi Street of Yuelu District, 410208 Changsha, Hunan Province, PEOPLE'S REPUBLIC OF China Contact person: Zhang Li Title: General Manager E-mail: regulation@accbiomed.com Tel: +86 731-8559853
2. Submission correspondent
Name: Chonconn Medical Device Consulting Co., Ltd.
Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China
Contact person: Yang Jie E-mail: yangjie(@chonconn.com
Tel: +86-755 33941160
| Trade/Device Name | Pulse Oximeter |
|---|---|
| Model | WS20A |
| Common Name | Wrist 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: Beijing Choice Electronic Technology Co., Ltd. Device name: Wrist Pulse Oximeter,Model: MD300W314 510(K) Number: K172366
5. Device Description
Pulse Oximeter WS20A is an internally powered pulse oximeter. The main functions of the devices include hemoglobin oxygen saturation (SpO2), pulse rate (PR) measurements and Pulse amplitude index (PAI), data storage and transmission.
5
Place one fingertip into the sensor and the oxygen saturation (SpO2), pulse rate (PR) measurements and pulse amplitude index (PAI) will appear on the display. The device is intended to be applied to adult and pediatric patients in sleep labs, long-term care, hospital and home care environment.
The subject device is composed of the following components to achieve the above detection process: power supply module, detector and emitter, signal collection and process module (MCU), TFT display screen and Bluetooth module.
6. Intended use & Indication for use
WS20A is a pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for patients(≥10 years old, ≥30kg). It is designed for finger circumference more than 33mm. It is intended for spot-check, continuous data collection, recording and transmitting, not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home.
| ITEM | Proposed Device | Predicate Device | Comparison Result |
|---|---|---|---|
| Pulse Oximeter | |||
| WS20A | |||
| K240808 | Wrist Pulse Oximeter, | ||
| Model: MD300W314 | |||
| K172366 | |||
| Manufacture | Hunan Accurate Bio- | ||
| Medical Technology Co., | |||
| Ltd. | Beijing Choice Electronic | ||
| Technology Co., Ltd. | Same | ||
| Indications for | |||
| Use | WS20A is a pulse | ||
| oximeter indicated for use | |||
| in measuring, displaying, | |||
| storing and transmitting | |||
| functional oxygen | |||
| saturation of arterial | |||
| hemoglobin (SpO2) and | |||
| pulse rate for patients(≥10 | |||
| years old, ≥30kg). It is | |||
| designed for finger | |||
| circumference more than | |||
| 33mm. It is intended for | |||
| spot-check, continuous | |||
| data collection, recording | |||
| and transmitting, not | |||
| continuous monitoring. It | |||
| can be used in sleep labs | 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. | Similar | ||
| long-term care, hospitals | |||
| and home. | |||
| Population | adult, adolescent and child | ||
| patients | adult, adolescent, child and | ||
| infant patients | Similar | ||
| 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. | Same | ||
| Type of SpO2 | |||
| Sensor | Transmittance Optical | ||
| Sensor | Transmittance Optical | ||
| Sensor | Same | ||
| Application | |||
| Site | Finger | Finger | Same |
| Measurement | |||
| Wavelength | Red (660 nm) | ||
| Infrared (905 nm) | Red (660 nm) | ||
| Infrared (905 nm) | Same | ||
| Display Type | TFT | LCD | Difference |
| Power Supply | Lithium-ion rechargeable | ||
| battery | Lithium-ion rechargeable | ||
| battery | Same | ||
| Display Data | SPO2 , PR , PAI | SPO2 , PR | Similar |
| SPO2 | SpO2 Display Range: | ||
| 0%~100% | |||
| Measurement range: | |||
| 70~100% | |||
| Accuracy: 70%~100%: | |||
| ±2%; | SpO2 Display Range: | ||
| 0%~100% | |||
| Measurement range: | |||
| 70%~100% | |||
| Accuracy: 70%~100%: | |||
| ±2%; | Same | ||
| PR | PR Display Range | ||
| 25~250bpm | |||
| Measurement range: | |||
| 25~250bpm | |||
| Resolution: 1bpm | |||
| Accuracy: $\pm$ 3bpm; | PR Display Range | ||
| 30~255bpm | |||
| Measurement range: | |||
| 30~250bpm | |||
| Resolution: 1bpm | |||
| Accuracy: 30 | Similar | ||
| Pulse | |||
| amplitude | |||
| index | |||
| (PAI) | Display range: 0.1~20.0% | ||
| Measurement range: | |||
| 0.3~20.0% | |||
| Resolution: 0.1% | |||
| Accuracy: 0.3~1.0% ( $\pm$ 0.2 | |||
| digits); 1.1~20.0% ( $\pm$ 20%) | N/A | Difference | |
| Network | Bluetooth | Bluetooth | Same |
| Environment | |||
| Requirements | Operating Temperature: | ||
| 5~40 $^{\circ}$ C | |||
| Ambient Humidity: | |||
| 10%~90%, no | |||
| condensation | |||
| Storage/Transportation: - | |||
| 20 $^{\circ}$ C~60 $^{\circ}$ C Ambient | |||
| Humidity: 10%~90% no | |||
| condensation | Operating Temperature: | ||
| 5~40 $^{\circ}$ C | |||
| Ambient Humidity: | |||
| 15%~93%, no condensation | |||
| Storage/Transportation: - | |||
| 25 $^{\circ}$ C~70 $^{\circ}$ C Ambient | |||
| Humidity: $\leq$ 93% no | |||
| condensation | Similar | ||
| Contacting | |||
| Material | Enclosure: ABS | ||
| Watchband: Silicone | |||
| Fingertip sensor: Silicone | Enclosure: ABS | ||
| Wrist oximeter wrist belt: | |||
| Nylon brand | |||
| Fingertip sensor: Silicone | Similar | ||
| Electrical | Conformed to IEC60601- | Conformed to IEC60601-1, | Same |
- Comparison to the Predicate Device
6
7
Non-clinical Data 8.
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".
8
Bench testing
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
- 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 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
One clinical study is conducted for adult and pediatric patients. The purpose of the clinical trial is to validate accuracy of the pulse oximetry (SpO2) of the WS20A pulse oximeter manufactured by Hunan Accurate Bio-Medical Technology Co. Ltd. during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood CO-Oximetry.
-
For adult patients, 315 data sets (SpO2 VS SaO2) were obtained from 13 healthy adult subjects under nonmotion, aged 22-30, with skin tones of Fitzpatrick 1-6 and 3 of subjects with Fitzpatrick 5. According to the clinical trial results by all subject, gender and skin tones subgroup, within the blood oxygen range of 70-100%, the ARMS of the pulse oximeter is: 1.81% for all subjects, 1.80% for female subjects, and 1.83% for male subjects, 1.78% for light-skinned subjects.1.91% for dark-skinned subjects.
-
For pediatric patients, 243 data sets (SpO2 VS SaO2) were obtained from 10 healthy female subjects, aged 22-30, with skin tones of Fitzpatrick 1-6 and 2 of subjects with Fitzpatrick 5. According to the clinical trial results by 10 female subjects and skin tones subgroup, within the blood oxygen range of 70-100%, the ARMS of the pulse oximeter is: 1.80% for 10 female subjects, 1.81% for light-skinned subjects, 1.74% for dark-skinned subjects.
Conclusion 9.
Based on the non-clinical and clinical data as documented in the device development, the subject devices were found to be as safe, as effective, and perform as well as the predicate device.