(104 days)
Not Found
No
The description details a standard pulse oximetry technology based on light absorption and signal processing, with no mention of AI or ML. The software is described as "software-driven" but the validation section is not provided, and there are no mentions of AI, DNN, or ML in the summary.
No
The device is described as a non-invasive device intended for "spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which is a diagnostic or monitoring function, not a therapeutic one. The "Intended Use" section explicitly states its purpose for measurement, and the "Device Description" section confirms it "can detect, display the measured %SpO2 and pulse rate value." Furthermore, it is stated that "The proposed device is not for life-supporting or life-sustaining," which further differentiates it from therapeutic devices.
No.
The device is described as being for "spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which are measurements of physiological parameters but not for diagnosing a specific disease or condition. While the information it provides can be used by a healthcare professional as part of a diagnostic process, the device itself simply measures and displays data.
No
The device description explicitly states it is a "battery powered fingertip device" and lists hardware components such as a power supply module, detector and emitter LED, signal collection and process module, and display module. While it is software-driven, it is not software-only.
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 detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Function: The Fingertip Pulse Oximeter MD300CL37 is a non-invasive device that measures oxygen saturation and pulse rate by applying a sensor to the fingertip. It works by analyzing light absorption through the skin and tissue, not by testing a sample taken from the body.
The description clearly states it's a "portable, non-invasive device intended for spot checking of oxygen saturation... and pulse rate... applied to adult, adolescent, child and infant patients". This is a direct measurement on the patient's body, not a test performed on a sample in a lab setting.
N/A
Intended Use / Indications for Use
The Fingertip Pulse Oximeter MD300CL37 is a portable, 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 home environments.
Product codes
DQA
Device Description
The proposed device of Fingertip Pulse Oximeter MD300CL37 is a battery powered fingertip device, which can detect, display the measured %SpO2 and pulse rate value. The device is normally applied to adult, adolescent, child and infant patient in hospitals, hospital-type facilities, and home environments.
The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module and user interface.
The 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 940nm, which is ultra red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector 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 power sources of the proposed device are 2 AAA alkaline batteries. The proposed device have low battery voltage indicator function and the proposed device will automatically power off when there is no signal for longer than 8 seconds. When the finger is placed into the device, the device will be powered on automatically.
The proposed device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable and does not need sterilization or re-sterilization. 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 Section of Software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip (for applying sensor)
Indicated Patient Age Range
Adult, adolescent, child and infant patients.
Intended User / Care Setting
Used by trained users or patients/caregivers in hospitals, hospital-type facilities, and home environments.
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
Subjects: After Institutional Review Board (IRB) approval, 12 healthy adult volunteer subjects (ages 21-33yr, 46-75kg, 158-183cm, with light to dark pigmentation) where included in the study conducted July.5-6, 2013 to evaluate the SpO2 accuracy performance of the MD300CL37 Finger Pulse Oximeter.
Methods: Each system was evaluated during steady state/non-motion conditions with various levels of 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.
Adverse events and complications: There are no adverse events during the clinical test.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Test:
Study Type: Clinical test for device accuracy.
Sample Size: 12 healthy adult volunteer subjects.
Key Results: The results show the MD300CL37 Finger Pulse Oximeter to pass a SpO2 accuracy specification of 3 which Beijing Choice Electronic Tech Co., Ltd. claims during steady state conditions over the range of 70-100%.
Non-clinical Test:
The Fingertip Pulse Oximeter MD300CL37 is designed and tested and will be manufactured in accordance with both mandatory and voluntary standards, including:
IEC 60601-1:2005 Medical Electrical Equipment-Part 1: General requirements for safety.
IEC60601-1-2:2007 Medical Electrical Equipment-Part 1-2:General requirements for safety, Collateral standard: Electromagnetic compatibility -Requirements and tests.
IEC60601-1-11:2010 Medical electrical equipment-Part1-11: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-Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.
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 ISO 10993, "Biological Evaluation of Medical Devices".
List of non-clinical tests performed:
- Broad-band Vibration Test (The test result is presented in the test report of ISO80601-2-61)
- Pulse rate and SpO2 Accuracy Test after 3000 cycles' disinfection
- System Performance Test
- Shelf Life Test
- Performance Test according to ISO 80601-2-61
- Electromagnetic Compatibility Test According to IEC 60601-1-2
- Electrical Safety Test According to IEC 60601-1
- Irritation, Sensitization and Cytotoxicity Test according to ISO 10993
- Used in the Home Healthcare Environment Test According to IEC60601-1-11
The test results indicate that the safety and effectiveness of the proposed devices is identical to that of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Accuracy: 70%99%: ±3%; 0%235bpm, ±2%69% no definition99bpm, ±2bpm; 100
PR Accuracy: 30
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three profiles facing right, suggesting a sense of forward movement and progress. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 13, 2014
Beijing Choice Electronic Technology Co., Ltd. Mr. Lei Chen North Building 3F, No.9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District, Beijing, P.R. China, 100041
Re: K141128
Trade/Device Name: Fingertip Pulse Oximeter MD300CL37 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 13, 2014 Received: May 15, 2014
Dear Mr. 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, 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
Page 2 - Mr. Chen
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section II Indications for Use Statement
Indications for Use
510(k) Number (if known): Device Name: Fingertip Pulse Oximeter MD300CL37
Indications for Use:
The Fingertip Pulse Oximeter MD300CL37 is a portable, 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 home environments.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
3
Section III 510(k) Summary
This 510(k) summary 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 320,West Building 4, No.83 FuXing Road Beijing 100039, 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: Mar.25, 2014
3.2Proposed Device Information
Device Common Name: Pulse Oximeter Device Trade/Proprietary Name: Fingertip Pulse Oximeter Model: MD300CL37 Classification Name: Oximeter Regulation Number: 870.2700 Product Code: DQA Class: II Panel: Anesthesiology
3.3Predicate Device
510(k) Number: K123871 Common Name: Pulse Oximeter
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Premarket Notification 510(k) Submission—Section III 510(k) Summary Device Trade/Proprietary Name: Fingertip Pulse Oximeter Model: MD300CF315 Classification Name: Oximeter Product Code: DQA Regulation Number: 870.2700 Device Class: II Panel: Anesthesiology Manufacturer: Beijing Choice Electronic Technology Co., Ltd.
3.4Device Description
The proposed device of Fingertip Pulse Oximeter MD300CL37 is a battery powered fingertip device, which can detect, display the measured %SpO2 and pulse rate value. The device is normally applied to adult, adolescent, child and infant patient in hospitals, hospital-type facilities, and home environments.
The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module and user interface.
The 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 940nm, which is ultra red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector 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 power sources of the proposed device are 2 AAA alkaline batteries. The proposed device have low battery voltage indicator function and the proposed device will automatically power off when there is no signal for longer than 8 seconds. When the finger is placed into the device, the device will be powered on automatically.
The proposed device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable and does not need sterilization or re-sterilization. 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 Section of Software.
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3.5 Comparison list of the technological characteristics
| Comparison Elements | Proposed Device | Predicate Device | |
|---|---|---|---|
| Product Name | Fingertip Pulse Oximeter | Fingertip Pulse Oximeter(K123871) | |
| Model | MD300CL37 | MD300CF315 | |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | |
| Classification | II | II | |
| Classification Name | Oximeter | Oximeter | |
| Product Code | DQA | DQA | |
| Indications for Use | The fingertip pulse oximeter is a portable non-invasive device intended for spot-checking of arterial hemoglobin oxygen saturation(SpO2) and pulse rate of adult, adolescent, child and infant patient in hospitals, hospital-type facilities, and home environments. | The Fingertip Pulse Oximeter is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care etc). | |
| Comparison Statement | The proposed device has the same indications for use and classification as the predicate device. | ||
| device. | |||
| Components | The proposed device consists of detector and emitter LED, signal amplify unit, CPU, data display unit and power unit | power supply module, detector and emitter LED, signal collection and process module, display module, user interface, voice module and button control circuit. | |
| Design Principle | The pulse oximeter works by applying a | The 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 660 nm, which is red light; the other | |||
| is 940 nm, which is ultra 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. | sensor to a pulsating arteriolar vascular bed. | ||
| The sensor contains a dual light source and | |||
| photo detector. The one wavelength of light | |||
| source is 660 nm, which is red light; the | |||
| other is 940 nm, which is ultra 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. | |||
| Measurement | |||
| Wavelength | Red | 660nm | 660nm |
| Infrared | 940nm | 940nm | |
| Comparison Statement | The proposed device has the same design and similar components as the predicate | ||
| device. | |||
| Device | |||
| specification | Display Type | OLED | |
| Power Supply | 2 AAA-size alkaline batteries | ||
| Display Data | SpO2 , PR | ||
| SpO2 | |||
| display | 0~99% | ||
| range | |||
| Measurement | |||
| range | 70-99% | 70~99% | |
| Accuracy | 70%~99%: ±3%; | ||
| 0%~69% no definition | 70%~99%: ±3%; | ||
| 0%~69% no definition | |||
| Resolution | 1% | 1% | |
| PR display range | 0~235BPM | 0~254BPM | |
| PR measurement | |||
| range | 30-235 BPM | 30-235 BPM | |
| PR Accuracy | 30 | 30 | |
| ±2% | |||
| Resolution | 1bpm | 1bpm | |
| Operating | |||
| Temperature | 5~40°C | 5~40°C | |
| Storage | |||
| Temperature | -25~+70°C | -20~55°C | |
| Relative | |||
| Humidity | 15%~93% in operation | ||
| ≤93% in storage | ≤80% in operation | ||
| ≤93% in storage | |||
| Atmosphere | |||
| pressure | 86kPa~106kPa | 86kPa~106kPa | |
| Low Power | |||
| Beep Tip | |||
| Function | No | Yes | |
| Automatically | |||
| powered on | Yes | No | |
| Comparison Statement | The applicant device has similar device specifications as the predicate device | ||
| Construction | Battery Cover | ABS | ABS |
| Materials | Fingertip | ||
| Cushion | Laser etching medical silicone gel | Black Medical Silicon gel | |
| Enclose | ABS | ABS | |
| Comparison Statement | The materials used in the applicant device are similar as the predicated device except for | ||
| the material used in the fingertip cushion. The test report was presented in | |||
| Biocompatibility. | |||
| Performance Testing | Bench Test | The bench tests include Pulse Rate and SpO2 | |
| accuracy test after 3000 cycles disinfection, | |||
| Weak Perfusion Test, High and Low | |||
| Temperature & Humidity Test and | |||
| ISO80601-2-61. | Meet the requirements of FDA Guidance | ||
| Clinical Test | Conformed to ISO 80601-2-61 | ||
| Clinical test for device accuracy is conducted | |||
| by the Yue Bei People's hospital. The clinical | |||
| test report and protocol are provided in | |||
| Performance Testing-Clinical | Conformed to ISO 80601-2-61 | ||
| Electrical Safety | Conformed to IEC60601-1 | Conformed to IEC60601-1 | |
| Electromagnetic compatibility | |||
| and safety | Electromagnetic Compatibility | Conformed to IEC60601-1-2 | Conformed to IEC60601-1-2 |
| Software | Moderate Level of Concern | Moderate Level of Concern |
Table 3-1 Performance Specification Comparison
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Premarket Notification 510(k) Submission—Section III 510(k) Summary
7
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Premarket Notification 510(k) Submission—Section III 510(k) Summary
8
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Premarket Notification 510(k) Submission—Section III 510(k) Summary
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Premarket Notification 510(k) Submission—Section III 510(k) Summary
| | 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. | | |
|--------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------|----------------------------------------------------------------------------|
| | Risk Management in Compliance with
ISO:14971:2007 | | Risk Management in Compliance with
ISO:14971:2007 | | |
| Biocompatibility | Medical Silicon gel | In Vitro Cytotoxicity | No cytotoxic potential. | In Vitro Cytotoxicity | No cytotoxic potential. |
| | | Skin Irritation Test | No evidence of causing sensitization. | Skin Irritation Test | No evidence of causing sensitization. |
| | | Animal Skin Sensitization Test | No evidence of significant sensitization from the test extract to rabbits. | Animal Skin Sensitization Test | No evidence of significant sensitization from the test extract to rabbits. |
| | ABS plastic Enclosure | In Vitro Cytotoxicity | No cytotoxic potential. | In Vitro Cytotoxicity | No cytotoxic potential. |
| | | Skin Irritation Test | No evidence of causing sensitization. | Skin Irritation Test | No evidence of causing sensitization. |
| | | Animal Skin Sensitization Test | No evidence of significant sensitization from the test extract to rabbits. | Animal Skin Sensitization Test | No evidence of significant sensitization from the test extract to rabbits. |
| Label and Labeling | | Compliance with FDA guidance | | Compliance with FDA guidance | |
10
Premarket Notification 510(k) Submission—Section III 510(k) Summary
3.6Intended use
The MD300CL37 Fingertip pulse oximeter is a portable 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 home environments.
3.7 Test
Non-clinical Test
The Fingertip Pulse Oximeter MD300CL37 is designed and tested and will be manufactured in accordance with both mandatory and voluntary standards, including:
IEC 60601-1:2005 Medical Electrical Equipment-Part 1: General requirements for safety.
IEC60601-1-2:2007 Medical Electrical Equipment-Part 1-2:General requirements for safety, Collateral standard: Electromagnetic compatibility -Requirements and tests.
IEC60601-1-11:2010 Medical electrical equipment-Part1-11: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-Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.
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 ISO 10993, "Biological Evaluation of Medical Devices".
| No. | Test Name |
|---|---|
| 1 | Broad-band Vibration Test( The test result is presented in the test report of |
| ISO80601-2-61) | |
| 2 | Pulse rate and SpO2 Accuracy Test after 3000 cycles' disinfection |
| 3 | System Performance Test |
| 4 | Shelf Life Test |
The list of non-clinical test performed on the proposed device.
11
| 5 | Performance Test according to ISO 80601-2-61 |
|---|---|
| 6 | Electromagnetic Compatibility Test According to IEC 60601-1-2 |
| 7 | Electrical Safety Test According to IEC 60601-1 |
| 8 | Irritation ,Sensitization and Cytotoxicity Test according to ISO 10993 |
| 9 | Used in the Home Healthcare Environment Test According to IEC60601-1-11 |
Premarket Notification 510(k) Submission--Section III 510(k) Summary
The test results indicate that the safety and effectiveness of the proposed devices is identical to that of the predicate device.
Clinical Test
The Clinical Test reports was conducted in accordance to EN ISO 14155-1:2009, EN ISO 14155-2:2009, ISO 9919:2005, EN ISO 9919:2009, BS EN 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 21-33yr, 46-75kg, 158-183cm, with light to dark pigmentation) where included in the study conducted July.5-6, 2013 to evaluate the SpO2 accuracy performance of the MD300CL37 Finger Pulse Oximeter.
Methods:
Each system was evaluated during steady state/non-motion conditions with various levels of 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.
Adverse events and complications:
There are no adverse events during the clinical test.
Conclusions:
The results show the MD300CL37 Finger Pulse Oximeter to pass a SpO2 accuracy specification of 3 which Beijing Choice Electronic Tech Co., Ltd. claims during steady state conditions over the range of 70-100%.
3.8Determination of substantial equivalence
The proposed device of Fingertip Pulse Oximeter MD300CL37 has the same classification information, same indications and intended use, same design principle, similar product design and specifications, same performance performance effectiveness, performance
12
Premarket Notification 510(k) Submission—Section III 510(k) Summary
safety as the predicated device. The differences only exist audible indicator and low power beep tip function. These differences are slight and do not influence the effectiveness and safety of the device. According to the non-clinical test results, the proposed device is as safe as effective and perform as well as the predicate device. So the proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device.