(224 days)
MD300W512 / MD300W314/ MD300W314B4 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.
The proposed devices Wrist Pulse Oximeter MD300W512 /MD300W314/MD300W314B4 are internally powered devices. The main functions of the devices include hemoglobin oxygen saturation (SpO2) and pulse rate (PR) measurements, visual and audible indication, data storage and transmission. The proposed device MD300W512/MD300W314/MD300W314B4 consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface, button control circuit, data storage and transmission module.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria & Reported Device Performance
| Acceptance Criteria (Stated) | Reported Device Performance (Proposed Device) |
|---|---|
| SpO2 measurement range: 70%~100% | 70%~100% |
| SpO2 accuracy: | 70%~100%, ±2%; <70%: unspecified |
| PR display range: 30-255bpm | 30-255bpm |
| PR measurement range: 30-250bpm | 30-250bpm |
| PR accuracy: | 30-99bpm, ±2bpm; 100~250bpm, ±2% |
| PR Resolution: 1bpm | 1bpm |
| Operating temperature: 5-40°C | 5~40°C |
| Storage and transportation: -25~70°C | -25~70°C |
| Relative humidity: ≤93%, no condensation | ≤93%, no condensation |
| Atmosphere pressure: 70kPa~106kPa | 70kPa~106kPa |
| SpO2 ARMS (root mean square error) | 1.71 (during steady state conditions over 70-100%) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 12 healthy adult volunteer subjects.
- Data Provenance: The study was conducted in a hospital setting (Yue Bei people's Hospital) to evaluate the SpO2 accuracy performance of the MD300W512 Wrist Pulse Oximeter and its supporting M-50G010CS03 Oximeter probe. The text does not specify the country of origin but implies China, as the manufacturer is based in Beijing, China, and the hospital name is in Chinese. The study was prospective in nature, involving induced hypoxia and simultaneous blood sample collection.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. It mentions that "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." This implies that the reference CO-Oximetry results serve as the ground truth, which would typically be operated by trained medical professionals in a laboratory setting.
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The ground truth was established by direct measurement using Reference CO-Oximetry, which is a quantitative and objective method, rendering adjudication for this specific ground truth less relevant than for subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The study focuses on the standalone performance of the device against a reference standard.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was conducted. The Wrist Pulse Oximeter directly measures and displays SpO2 and pulse rate. The clinical test evaluated the device's accuracy directly against a reference CO-Oximetry, without human interpretation as part of the primary measurement.
7. Type of Ground Truth Used
The ground truth for SpO2 accuracy was established using Reference CO-Oximetry analysis of arterial blood samples. This is an objective, gold-standard method for determining arterial oxygen saturation (SaO2).
8. Sample Size for the Training Set
The document provided does not specify a separate training set or its sample size. The description pertains to the clinical test set used for validation of the device's performance.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned or detailed in the provided text, the method for establishing its ground truth is not available from this document. The document describes the ground truth for validation (test set) as being established by Reference CO-Oximetry.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 16, 2018
Beijing Choice Electronic Technology Co., Ltd. Lei Chen Quality Director No.9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan Dist, Beijing, 100041 CHINA
Re: K172366
Trade/Device Name: Wrist Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: February 12, 2018 Received: February 14, 2018
Dear Lei Chen:
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. The general controls provisions of the Act include requirements for annual registration. Iisting 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.
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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Tina Kiang -2
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section II Indications for Use Statement
Indications for Use
510(k) Number (if known):_K172366
Device Name: Wrist Pulse Oximeter
Indications for Use:
MD300W512 / MD300W314/ MD300W314B4 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.
| Prescription Use | √ |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Section III 510(k) Summary
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.
3.1Submitter Information
- Manufacturer Name:
Establishment Registration Number: 3005569927 Beijing Choice Electronic Technology Co., Ltd. Room 4104,No.A12 Yuquan Road Haidian District 100143 Beijing, P.R.China
● Contact Person:
Mr. Lei Chen Beijing Choice Electronic Technology Co., Ltd. North Building 3F, No. 9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District Beijing China 100041 Phone: +86-10-88798300 Ext 6020 Fax:215-4052545 Email: cc@choicemmed.com
- Date prepared: February 12, 2018
3.2Proposed Device Information
Device Common Name: Wrist Pulse Oximeter Device Trade/Proprietary Name: Pulse Oximeter Model: MD300W512/MD300W314/MD300W314B4 Classification Name: Oximeter Regulation Number: 870.2700 Product Code: DQA
Class: II
Panel: Anesthesiology
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3.3Predicate Device
510(k) Number: K081125 Common Name: Wrist Pulse Oximeter Device Trade/Proprietary Name: Pulse Oximeter Model: MD300W Classification Name: Oximeter Product Code: DQA Regulation Number: 870.2700
Device Class: II
Panel: Anesthesiology
Manufacturer: Beijing Choice Electronic Technology Co., Ltd.
Intended Use: The MD300W wrist oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate adult and pediatric patient at home, and hospital (including clinical use in internist/ surgery, Anesthesia, intensive care and etc). Not for continuously monitoring.
3.4Device Description
Pulse The proposed devices Wrist Oximeter MD300W512 /MD300W314/MD300W314B4 are internally powered devices. The main functions of the devices include hemoglobin oxygen saturation (SpO2) and pulse rate (PR) measurements, visual and audible indication, data storage and transmission.
The proposed device MD300W512/MD300W314/MD300W314B4 consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface, button control circuit, data storage and transmission module.
The proposed devices Wrist Pulse Oximeter MD300W512/MD300W314/MD300W314B4 share the same measurement principle, appearance, structure design, electro-optical components, SpO2 module and equivalent sensor characteristics. The differences among each model of the proposed devices are shown in the table 3-1.
| MD300W512 | MD300W314 | MD300W314B4 | |
|---|---|---|---|
| DisplayScreen Type | OLED | LCD | OLED |
| Power Supply | 2 AAA alkalinebatteries | Lithium-ionrechargeable battery | Lithium-ionrechargeable battery |
Table 3-1
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| Datatransmission | By USB cable | By Bluetooth or USBcable | By Bluetooth |
|---|---|---|---|
| Bluetoothmodule | No | 2.0 | 4.0 |
Premarket Notification 510(k) Submission-Section III 510(k) Summary
The device is not for life-supporting or life-sustaining, not for implant. The device or sensor is not sterile and the sensor does not need sterilization and the sensor is reusable but does not need re-sterilization since it is not sterile. The device is for prescription. The device does not contain drug or biological products.
The device is software-driven and the software validation is provided in software.
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3.5 Comparison list of the technological characteristics
| Parameter | Proposed Device | Predicate Device | |||
|---|---|---|---|---|---|
| Product Name | Wrist Pulse Oximeter | Wrist Pulse Oximeter | |||
| Model | MD300W512/MD300W314/MD300W314B4 | MD300W | |||
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | |||
| Classification | II | II | |||
| Classification Name | Oximeter | Oximeter | |||
| Product Code | DQA | DQA | |||
| Indications for use | MD300W512 / MD300W314/ MD300W314B4 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. | The MD300W wrist oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate adult and pediatric patient at home, and hospital (including clinical use in internist/ surgery, Anesthesia, intensive care and etc). Not for continuously monitoring. | |||
| Comparison Statement | The proposed device and the predicate device have the same intended use and classification. The minor | ||||
| differences in the indication statements do not raise different questions of safety or effectiveness. | |||||
| Components | The proposed devices consist of power supplymodule, detector and emitter LED, signal collectionand process module, display module, user interface,button control circuit, data storage and transmissionmodule. | The predicate device consists of sensor, signalamplify unit, CPU, data display unit, data transmitunit, storage and power unit. | |||
| Design Principle | The pulse oximeter works by applying a sensor to apulsating arteriolar vascular bed. The sensor containsa dual light source and photo detector. The onewavelength of light source is 660nm, which is redlight; the other is 905nm, which is infrared-red light.Skin, bone, tissue and venous vessels normallyabsorb a constant amount of light over time. Thephoto detector in finger sensor collects and convertsthe light into electronic signal which is proportionalto the light intensity. The arteriolar bed normallypulsates and absorbs variable amounts of light duringsystole and diastole, as blood volume increases anddecreases. The ratio of light absorbed at systole anddiastole is translated into an oxygen saturationmeasurement. This measurement is referred to asSpO2. | The wrist oximeter works by applying a sensor toa pulsating arterial vascular bed. The sensorcontains a dual light source and photo detector.The one wavelength of light source is 660nm,which is red light; the other is 940nm, which isultra red light. Skin, bone, tissue and venousvessels normally absorb a constant amount oflight during systole and diastole, as blood volumeincreases and decreases. The ratio of lightabsorbed at systole and diastole is translated intoan oxygen saturation measurement. Thismeasurement is referred to as SpO2. | |||
| MeasurementWavelength | Red | 660±3nm | 660±2nm | ||
| Infrared | 905 ± 10nm | 940±10nm | |||
| Comparison Statement | The proposed device and the predicate device have the same design principle and similar measurement wavelength. | ||||
| Performance Specification | Display Type | MD300W512/MD300W314B4 | OLED | LCD | |
| MD300W314 | LCD | ||||
| Power Supply | MD300W512 | 2 AAA alkaline batteries | One AAA alkaline battery | ||
| MD300W314/MD300W314B4 | Lithium rechargeable batteries | ||||
| SpO2 measurement range | 70%~100% | 70%~100% | |||
| SpO2 accuracy | 70%~100%, ±2%; <70%: unspecified | 70%~100%, ±3%; <70%: unspecified | |||
| PR display range | 30-255bpm | 0~254bpm | |||
| PR measurement range | 30-250bpm | 30~235bpm | |||
| PR accuracy | 30-99bpm, ±2bpm; 100~250bpm, ±2% | 30-99bpm, ±2bpm; 100~250bpm, ±2% | |||
| PR Resolution | 1bpm | 1bpm | |||
| Operating temperature | 5~40°C | 5~40°C | |||
| Storage and transportation environment | -25~70°C | -20~70°C | |||
| Relative humidity | ≤93%, no condensation | ≤93%, no condensation | |||
| Atmosphere pressure | 70kPa~106kPa | 86kPa~106kPa | |||
| Dimensions ( L x W xH) | MD300W512 | 70mm x 67mm x 30mm | 50mm x 60mm x20mm | ||
| MD300W314 | 67mm x 66mm x 28mm | ||||
| MD300W314B4 | 67mm x 66mm x 28mm | ||||
| Bluetooth Technology | MD300W512 | Not apply | Not apply | ||
| MD300W314 | Bluetooth 2.0 Module | ||||
| MD300W314B4 | Bluetooth 4.0 Module | ||||
| Comparison Statement | The proposed device has similar product specification as the predicate device. | ||||
| Contacting | Fingertip Cushion | Medical Silicone (Oximeter probe M-50G010CS03) | Medical Silicone | ||
| components | Wrist Belt | Nylon brand | Nylon brand | ||
| Plastic Case Cover | ABS | ABS | |||
| Contacting | Fingertip Cushion | Less than 24h | Less than 24h | ||
| Duration | Wrist Belt | ||||
| Plastic Case Cover | Patient rarely contacted | Patient rarely contacted | |||
| Typeofcontact | Fingertip Cushion | Skin surface-contacting | Skin surface-contacting | ||
| Wrist Belt | |||||
| Plastic Case Cover | |||||
| Comparison Statement | The contacting materials of the proposed device are similar to those of the predicate device. | ||||
| Performance Testing | Laboratory Testing | The laboratory tests include SpO2 and PR accuracyTest, Weak Perfusion Test, High and LowTemperature and Humidity Test, Performance TestAfter Cleaning and ISO80601-2-61 | The laboratory tests include SpO2 and PRaccuracy Test, Weak Perfusion Test, High and LowTemperature and Humidity Test, Performance TestAfter Cleaning and ISO9919 | ||
| Clinical Testing | Conformed to ISO 80601-2-61. Clinical Test for thedevice accuracy is conducted in Yue Bei people'sHospital. The clinical test report and protocol areprovided in Performance Testing-Clinical Test Report | Conformed to ISO9919 | |||
| EMC andElectricalSafety | Electrical Safety | Conformed to IEC60601-1, IEC60601-1-11 | Conformed to IEC60601-1 | ||
| ElectromagneticCompatibility | Conformed to IEC60601-1-2 | Conformed to IEC60601-1-2 | |||
| Biocompatibility | BiocompatibilityReport | In Vitro Cytotoxicity | No cytotoxic potential | In Vitro Cytotoxicity | Grade I |
| Animal skin irritation test | No evidence ofsignificant irritationfrom the test extractto rabbits | Skin Irritation Test | Primary IrritationIndex(PII)was 0.0 | ||
| Skin Sensitization Test | No evidence ofsensitization wasobserved. | Skin Sensitization Test | No Evidence of delayeddermal contactsensitization | ||
| Comparison Statement | Compliance with ISO10993 |
Table 3-1 Performance Specification Comparison Table between the Proposed Device (MD300W512) and Predicate Device
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| Premarket Notification 510(k) Submission—Section III 510(k) Summary | ||
|---|---|---|
| Label and Labeling | Compliance with the Guidance of pulseoximeter-premarket notification issued onMarch 4, 2013 | Compliance with FDA guidance |
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3.6Intended use
MD300W512 / MD300W314/ MD300W314B4 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.
3.7 Functional and Electrical Safety Testing:
Non-clinical Test:
The Wrist pulse oximeter is designed and tested and will be manufactured in accordance with both mandatory and voluntary standards, including:
IEC 60601-1:2005/AC: 2012 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2007 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-2:2014 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-11:2010 Medical 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 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
The Software Validation is in compliance with FDA Guidance to Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards of ISO10993. "Biological Evaluation of Medical Devices"
The list of non-clinical test performed on the proposed device is shown as following:
| No. | Test Name |
|---|---|
| 1 | System Performance Test |
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| 2 | Shelf Life Test |
|---|---|
| 3 | Performance Test after Cleaning |
| 4 | Performance Test according to ISO 80601-2-61 |
| 5 | Electromagnetic Compatibility Test According to IEC 60601-1-2 |
| 6 | Electrical Safety Test According to IEC 60601-1 |
| 7 | Medical electrical equipment and medical electrical system used in thehome healthcare environment according to IEC 60601-1-11 |
| 8 | Irritation ,Sensitization and Cytotoxicity Test according to ISO 10993 |
Premarket Notification 510(k) Submission-Section III 510(k) Summary
Clinical Test
The Clinical study of MD300W512 Wrist Pulse Oximeter and its supporting M-50G010CS03 Oximeter probe was conducted in accordance to ISO 14155-1, -2, ISO 80601-2-61:2011 and the FDA Guidance Document for Pulse Oximeters.
Subjects:
After Institutional Review Board (IRB) approval, 12 healthy adult volunteer subjects (ages 21-43yr, 47-82kg, 155-185cm, with light to dark pigmentation) were included in the study conducted Sep. 20-22, 2014 to evaluate the SpO2 accuracy performance of the MD300W512 Wrist Pulse Oximeter and its supporting M-50G010CS03 Oximeter probe.
Method:
Each system was evaluated during steady state/ non-motion conditions with various levels induced hypoxia resulting in stable oxygen saturation levels between 100% and 70% 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.
Conclusion:
The SpO2 accuracy performance results showed the MD300W512 Wrist Pulse Oximeter and its supporting M-50G010CS03 Oximeter probe to have an ARMS of 1.71 during steady state conditions over the range of 70-100%. The results show the MD300W512 Wrist Pulse Oximeter and its supporting M-50G010CS03 Oximeter probe is compliance to the accuracy specification claimed by the manufacturer.
The proposed device MD300W314/MD300W314B4 and the device MD300W512 have the same electro-optical component, SpO2 module and have equivalent sensor characteristics. So we think the predicate device clinical study results can be as the clinical study results of the proposed device.
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3.8 Determination of substantial equivalence
The proposed device has the same classification information, similar intended use, same design principle, similar product design and specifications and similar performance effectiveness as the predicate device. So the proposed devices are Substantially Equivalent (SE) to the predicate device which is US legally market device.
§ 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).