(204 days)
Not Found
No
The device description outlines a standard pulse oximetry principle based on light absorption and ratio calculation, with no mention of AI or ML in the signal processing or analysis. The performance studies also focus on standard accuracy metrics for pulse oximeters.
No.
A therapeutic device is used to treat or cure a condition, while this device is intended for non-invasive spot-checking of oxygen saturation and pulse rate, which are diagnostic measurements for monitoring, not therapy.
Yes
The device is described as a non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate. It is also mentioned that it is used for "diagnosis" in the Device Description. These functions involve measuring physiological parameters to assess a patient's health status, which falls under the definition of a diagnostic device.
No
The device description explicitly lists hardware components such as a battery, detector and emitter LED, signal collection and process module (MCU), LED display screen, user interface and button control circuit, and an enclosure made of ABS and silicone gel. This indicates it is a physical device with integrated software, not a software-only medical device.
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 description clearly states that the Pulse Oximeter is a "handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate". It works by applying a sensor to a fingertip and measuring light absorption through the skin and tissue.
- No Sample Collection: The device does not require the collection of any biological samples from the patient. It performs its measurement externally and non-invasively.
Therefore, because the device does not analyze samples taken from the body, it does not fit the definition of an In Vitro Diagnostic. It is a non-invasive physiological monitoring device.
N/A
Intended Use / Indications for Use
The Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent child and infant patients in hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.
Product codes
DQA
Device Description
The subject device Pulse Oximeter is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display. The device has 2 display modes. The device is normally applied to adult, adolescent child and infant patients in hospitals, hospital-type facilities and homecare.
The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter LED, signal collection and process module (MCU), LED display screen, user interface and button control circuit.
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. 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 referred to as SpO2.
The enclosure of the subject device is made of ABS and the fingertip cushion is made of Silicone Gel.
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
fingertips
Indicated Patient Age Range
adult, adolescent child and infant patients
Intended User / Care Setting
hospital-type facilities and homecare
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)
Non-clinical Test: The Pulse Oximeter MD300C19 is designed and tested and will be manufactured in accordance with both mandatory and voluntary standards, including:
- IEC60601-1: 2005, AMD1:2012, AMD2:2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC60601-1-11: 2015, AMD1:2020 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.
- IEC60601-1-2:2014, AMD1:2020 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- ISO80601-2-61:2017 Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Tests performed on the subject device include:
- System Performance Test
- Performance Test according to ISO 80601-2-61: 2017
- Electromagnetic Compatibility Test According to IEC60601-1-2:2014, AMD1:2020
- Electrical Safety Test According to IEC60601-1: 2005, AMD1:2012, AMD2:2020
- Used in the home healthcare environment test according to IEC60601-1-11: 2015, AMD1:2020
- Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process ISO 10993-1:2018
- Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO10993-5:2009
- Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO10993-10:2010
The test results indicate that the safety and effectiveness of the subject device is substantially equivalent to that of the predicate device.
Clinical Test: The clinical study was conducted in accordance to ISO 14155-1, -2, ISO80601-2-61:2017, 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. MD300C19 Pulse Oximeter 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. MD300C19 Pulse Oximeter.
The SpO2 accuracy performance results showed the Beijing Choice Electronic Technology Co., Ltd. MD300C19 Pulse Oximeter to have an ARMS of 1.5 during steady state conditions over the range of 70-100%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ARMS of 1.5 during steady state conditions over the range of 70-100% for SpO2 accuracy.
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
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.
August 12, 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: K230172
Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: July 12, 2023 Received: July 12, 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 (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.
1
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) 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 (QS) 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 medical devices and radiation-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.
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
2
Indications for Use
510(k) Number (if known) K230172
Device Name Pulse Oximeter
Indications for Use (Describe)
The Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent child and infant patients in hospital-type facilities and homecare. The device is not intended for continuous monion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Section II 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.
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 10,2023 ●
2.2 Subject Device Information
Device Trade/Proprietary Name: Pulse Oximeter
Regulation Medical Specialty: Cardiovascular
Device Classification Name: Oximeter
4
Premarket Notification 510(k) Submission—Section II 510(k) Summary
Model: MD300C19
Purpose of submission: 510 (k)
Regulation Number: 21 CFR 870.2700
Product Code: DQA
Class: II
Panel: Anesthesiology
2.3 Predicate Device
510(k) Number: K181503 Device Trade/Proprietary Name: Fingertip Pulse Oximeter Regulation Medical Specialty: Cardiovascular Device Classification Name: Oximeter Model: MD300CI218 Product Code: DQA Regulation Number: 21 CFR 870.2700 Device Class: II Panel: Anesthesiology
Manufacturer: Beijing Choice Electronic Technology Co., Ltd.
2.4 Device Description
The subject device Pulse Oximeter is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display. The device has 2 display modes. The device is normally applied to adult, adolescent child and infant patients in hospitals, hospital-type facilities and homecare.
The subject device is composed of following components to achieve the above detection
5
Premarket Notification 510(k) Submission—Section II 510(k) Summary
process: power supply module, detector and emitter LED, signal collection and process module (MCU), LED display screen, user interface and button control circuit.
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. 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 referred to as SpO2.
The enclosure of the subject device is made of ABS and the fingertip cushion is made of Silicone Gel.
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.
6
2.5 Comparison list of the technological characteristics
Table II-1 Performance Specification Comparison Table between the Subject Device and Predicate Device
| Comparison Elements | Subject Device | Predicate Device | Similar or
Different | |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------|
| Model | MD300C19 | MD300CI218 | - | |
| Item | Pulse Oximeter | Fingertip Pulse Oximeter | - | |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | √ | |
| Classification | II | II | √ | |
| Device Classification Name | Oximeter | Oximeter | √ | |
| Product Code | DQA | DQA | √ | |
| Indications for use | The Pulse Oximeter is a handheld
non-invasive device intended for
spot-checking of oxygen saturation of
arterial hemoglobin (SpO2) and Pulse
Rate of adult, adolescent child and infant
patients in hospitals, hospital-type
facilities and homecare. The device is not | The Fingertip Pulse Oximeter
MD300CI218 is a handheld
non-invasive device intended for
spot-checking of oxygen saturation of
arterial hemoglobin
(SpO2) and Pulse Rate of adult,
adolescent, child and infant patients in | Difference | |
| Comparison Elements | Subject Device | Predicate Device | Similar or
Different | |
| Model | MD300C19 | MD300CI218 | - | |
| | intended for continuous monitoring, use
during motion or use with low perfusion.
The device is intended for reuse. The
device is wearing on fingertips while
using | hospitals, hospital-type facilities and
homecare environment. | | |
| Components | Power supply module, detector and
emitter LED, signal collection and
processor module, display module, user
interface and button control. | Power supply module, detector and
emitter LED, signal collection and
processor module, display module,
Bluetooth module, user interface and
button control. | Difference
2 | |
| Design Principle | The pulse oximeter works by applying a
sensor to a fingertip. 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 | The fingertip 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 | √ | |
| Comparison Elements | Subject Device | Predicate Device | Similar or
Different | |
| Model | MD300C19 | MD300CI218 | - | |
| | 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. | 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. | | |
| Measurement
Wavelength | Red | $660\pm3$ nm | $660\pm3$ nm | √ |
| | Infrared | $905\pm10$ nm | $905\pm10$ nm | √ |
| | Comparison Elements | Subject Device | Predicate Device | Similar or
Different |
| Performance Specification | Model | MD300C19 | MD300CI218 | - |
| | Display Type | LED | OLED | Difference
3 |
| | User Interface | 2 display directions | 2 display directions | √ |
| | Power supply | 2AAA alkaline batteries | 2AAA alkaline batteries | √ |
| | Display Data | SpO2, PR | SpO2, PR | √ |
| | SpO2 Display
Range | 0100% | 0100% | - |
| | SpO2
Measurement
Range | 70%100% | 70%250bpm | Difference100% | √ |255bpm | 30bpm
| | SpO2 Accuracy | 70%100%, ±2%;69% no definition | 70%
0100%, ±2%;69% no definition | √ |
0
| Comparison Elements | Subject Device | Predicate Device | Similar or
Different | |
| Model | MD300C19 | MD300CI218 | - | |
| SpO2
Resolution | 1% | 1% | √ | |
| PR Display
Range | 0bpm
4 | |
| PR
Measurement
Range | 30bpm250bpm | 30bpm250bpm | √ | |
| PR Accuracy | 30bpm99bpm, ±2bpm;250bpm, ±2% | 30bpm
100bpm99bpm, ±2bpm;250bpm, ±2% | √ | |
100bpm
| PR Resolution | 1bpm | 1bpm | √ | |
| Transmitter | NA | Bluetooth Compliance:
Version 4.0 | Difference
5 | |
| Comparison Elements | Subject Device | Predicate Device | Similar or
Different | |
| Model | MD300C19 | MD300CI218 | - | |
| Environment | Operating
Temperature | 0°C40°C | 5°C40°C | |
| | Storage/
Transport
temperature | -25°C~+70°C | -25°C~+70°C | Difference
6 |
| | Relative
Humidity | 15%93% no condensation in operation;106kPa | |
≤93% no condensation in
storage/transport | 15%93% no condensation in106kPa | 70kPa
operation;
≤93% no condensation in
storage/transport | |
| | Atmosphere
Pressure | 70kPa
| Contacting
Material | Battery Cover | ABS | ABS | √ |
| | Enclosure | ABS | ABS | √ |
| | Lens | PMMA | PMMA | √ |
| Comparison Elements | Subject Device | Predicate Device | Similar or
Different | |
| Model | MD300C19 | MD300CI218 | - | |
| Button | Silica gel pad | ABS | Difference 7 | |
| Fingertip
Cushion | Silica gel pad | Silica gel pad | √ | |
| Testing | Laboratory
Testing | ISO 80601-2-61 | ISO 80601-2-61 | √ |
| | Electrical Safety | Conformed to IEC60601-1, IEC
60601-1-11 | Conformed to IEC60601-1, IEC
60601-1-11 | √ |
| | Electromagnetic
Compatibility | Conformed to IEC60601-1-2 | Conformed to IEC60601-1-2 | √ |
| | Software | Compliance with FDA Guidance for the
content of Premarket Submissions for
Software Contained in Medical Devices | Compliance with FDA Guidance for the
content of Premarket Submissions for
Software Contained in Medical Devices | √ |
| Label and Labeling | Compliance with the Guidance of pulse
oximeter-premarket notification issued on
March 4 2013 | Compliance with the Guidance of pulse
oximeter-premarket notification issued
on March 4,2013 | √ | |
7
8
9
10
11
12
13
Premarket Notification 510(k) Submission-Section II 510(k) Summary
Difference 1: Indications for use ●
Compared with the intended use of predicate device, the subject device increases the description of the application location, application conditions and use frequency. The subject device has been verification and validation and the results could meet the requirement of IEC 60601-1, IEC 60601-1-11, IEC60601-1-2 and ISO 80601-2-61. Therefore, this difference does not affect substantially equivalence between subject device and predicate device on safety and effectiveness.
● Difference 2: Components
The components of subject device are similar with predicate device but it does not have the Bluetooth module. The Bluetooth module is the independent module that does not affect other function of device. In addition, the subject device has been verification and validation and the results could meet the requirement of IEC 60601-1, IEC 60601-1-11, IEC60601-1-2 and ISO 80601-2-61. Therefore, this difference does not affect substantially equivalence between subject device and predicate device on safety and effectiveness.
● Difference 3: Display Type
The subject device has the different display type with the predicate device. The subject device is configured with the LED display; the predicate device is using the OLED display. The varies display type is due to different marked strategy. In addition, the subject device has been verification and validation and the result could meet the requirement of IEC 60601-1, IEC 60601-1-11, IEC60601-1-2 and ISO 80601-2-61. Therefore, this difference does not affect substantially equivalence between subject device and predicate device on safety and effectiveness.
● Difference 4: PR Display Range
The subject device has the different pulse rate display range with the predicate device. The subject device pulse rate display range is Obpm255bpm which the predicate device is 30bpm250bpm. The pulse rate display range of the subject device was verified according to IEC 60601-1 and ISO 80601-2-61. All the results can meet the standard requirements. Therefore, this difference does not affect substantially equivalence between subject device and predicate device on safety and effectiveness.
14
Premarket Notification 510(k) Submission-Section II 510(k) Summary
Difference 5: Transmitter ●
The subject device does not have the Bluetooth function which is different from predicate device. The Bluetooth is the independent function module; it will not affect other functions. Therefore, this difference does not affect substantially equivalence between subject device and predicate device on safety and effectiveness.
● Difference 6: Environment
The Operating Temperature of subject device is different with the predicate device and other environment requirements are same. The lower limit operating temperature of subject device is 0℃ which the predicate device is 5℃. However, the operating temperature of subject device has been verification according to standard ISO 80601-2-61. All the results can meet the standard requirements. Therefore, this difference does not affect substantially equivalence between subject device and predicate device on safety and effectiveness.
● Difference 7: Contacting Material
The contact material of subject device is different with the predicate device. All of the contact materials of the proposed device have been done the biocompatibility test per ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and the results can meet the standard requirements. Therefore, this difference does not affect substantially equivalence between proposed device and predicate device on safety and effectiveness.
2.6 Indications for use
The Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent child and infant patients in hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.
15
The Pulse Oximeter MD300C19 was supported by both laboratory and clinical accuracy testing in order to ensure that they were appropriate performance and functional features to fully comply with recognized standards and is substantially equivalent to the predicate device.
Non-clinical Test
The Pulse Oximeter MD300C19 is designed and tested and will be manufactured in accordance with both mandatory and voluntary standards, including:
- IEC60601-1: 2005, AMD1:2012, AMD2:2020 Medical electrical equipment Part 1: ● General requirements for basic safety and essential performance
- IEC60601-1-11: 2015, AMD1:2020 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.
- IEC60601-1-2:2014, AMD1:2020 Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- ISO80601-2-61:2017 Medical electrical equipment Part 2-61: Particular requirements . for basic safety and essential performance of pulse oximeter equipment
- . ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- . ISO10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- . ISO10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
We have performance tests per FDA guidance "Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers".
The Software Validation is in compliance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Compliant to FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".
16
Premarket Notification 510(k) Submission-Section II 510(k) Summary
Table II-2 The list of non-clinical test performed on the subject devices.
| No. | Test Name |
|---|---|
| 1 | System Performance Test |
| 2 | Performance Test according to ISO 80601-2-61: 2017 |
| 3 | Electromagnetic Compatibility Test According to IEC60601-1-2:2014, |
| AMD1:2020 | |
| 4 | Electrical Safety Test According to IEC60601-1: 2005, AMD1:2012, |
| AMD2:2020 | |
| 5 | Used in the home healthcare environment test according to |
| IEC60601-1-11: 2015, AMD1:2020 | |
| 6 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a |
| risk management process ISO 10993-1:2018 | |
| 7 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| ISO10993-5:2009 | |
| 8 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin |
| sensitization ISO10993-10:2010 |
The test results indicate that the safety and effectiveness of the subject device is substantially equivalent to that of the predicate device.
Clinical Test
The clinical study was conducted in accordance to ISO 14155-1, -2, ISO80601-2-61:2017, 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. MD300C19 Pulse Oximeter 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. MD300C19 Pulse Oximeter.
The SpO2 accuracy performance results showed the Beijing Choice Electronic Technology Co., Ltd. MD300C19 Pulse Oximeter to have an ARMS of 1.5 during steady state conditions over the range of 70-100%.
17
Premarket Notification 510(k) Submission—Section II 510(k) Summary 2.8 Determination of substantial equivalence
The subject device of Pulse Oximeter MD300C19 has the same classification information, same intended use, similar components, same performance effectiveness as the predicated device. The subject device is Substantially Equivalent (SE) to the predicate device which is US legally market device.