(222 days)
No
The description details standard pulse oximetry technology based on light absorption and signal processing, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is described as a Pulse Oximeter, which is intended for monitoring physiological parameters (SpO2 and pulse rate), not for providing therapy.
Yes
The device is intended for continuous monitoring and spot-checking of physiological parameters (SpO2 and pulse rate), which are measurements used to assess a patient's health status. The intended use in hospitals and clinics further supports its role in aiding medical diagnosis and patient management.
No
The device description explicitly states it consists of hardware components such as a photo detector, display screen, signal amplify unit, CPU, display unit, and power supply unit, and describes the physical principle of operation involving light transmission and detection. While it is software-driven, it is not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the living body (in vitro).
- Device Function: The description clearly states that the Pulse Oximeter measures functional pulse oxygen saturation (SpO2) and pulse rate (PR) by focusing light on a human nail tip through a clamping finger-type sensor. This is a non-invasive measurement taken on the living body.
- Lack of Sample Analysis: There is no mention of collecting or analyzing any biological samples from the patient.
Therefore, the device's method of operation and intended use fall outside the scope of In Vitro Diagnostics. It is a medical device used for physiological monitoring in vivo.
N/A
Intended Use / Indications for Use
The Pulse Oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult, adolescent, child and infant patients in hospitals and clinics.
Product codes
DQA
Device Description
The Pulse Oximeter MD300M/MD300K2 can display the SpO2%, pulse rate, Pulse Amplitude Index and other indication parameters, such as time, ID number, pulse amplitude bar and battery power status, alarm limits and the connections of sensors. It is used for adult, adolescent, child and infant patients. The device has physiological alarm and technology alarm function. There are two-level alarm priorities in oximeter. High priority: "Di-Di-Di-----------Di-Di" indicates the patient is in the very dangerous situation. Low priority: "Di" indicates the technical alarm caused by the device itself. The device also has visual alarm function to indicate users by lamp and information on the device. The power supply of the applicant device is 3 AA alkaline batteries, rechargeable batteries or adapter.
The proposed device consists of photo detector, display screen, signal amplify unit, CPU, display unit and power supply unit.
Principle of the oximeter is as follows: A mathematic formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in red and near-infrared zones. Operation principle of the instrument: Photoeletric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm red and 905nm near infrared light) can be focused on a human nail tip through a clamping finger-type sensor. A measured signal obtained by a photosensitive element, will be shown on the oximeter's display through process in electronic circuits and microprocessor.
The proposed 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.
The device is software-driven and the software validation is provided in software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human nail tip
Indicated Patient Age Range
adult, adolescent, child and infant patients
Intended User / Care Setting
hospitals and clinics.
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
Clinical Test:
The Clinical Test was conducted following the testing described in clause 201.12.1 of ISO 80601-2-61:2011 Medical electrical equipment- Part 2-61 Particular requirements for basic safety and essential performance of pulse oximeter equipment.
The supporting Oximeter probes of Pulse Oximeter MD300M are adult finger probe M-50E012CS09, pediatric finger probe M-50B008CS09, single use probe M-50J033CS045. The clinical study of MD300M was conducted with its supporting finger probe respectively.
The Clinical Test of MD300M was conducted in Yue Bei people's Hospital.
Subjects information:
12 healthy adult volunteer subjects (6 females and 6 males ages 21-43yr, 47-82kg, 155-185cm, among which 6 with light pigmentation from Asian, 3 with light (white) pigmentation from Caucasian, 3 with dark pigmentation from African) were included in the study connected Sep. 20-22, 2014 to evaluate the SpO2 accuracy performance of the MD300M Pulse Oximeter and its supporting M-50E012CS09/M-50B008CS09/ M-50J033CS045 Oximeter Probe.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Test:
Study Type: Clinical Test
Sample Size: 12 healthy adult volunteer subjects (6 females and 6 males)
Key Results:
The SpO2 accuracy performance results showed the MD300M Pulse Oximeter and its supporting M-50E012CS09 Oximeter probe to have an Arms of 1.75 during steady state conditions over the range of 70-100%.
The SpO2 accuracy performance results showed the MD300M Pulse Oximeter and its supporting M-50B008CS09 Oximeter probe to have an Arms of 1.48 during steady state conditions over the range of 70-100%.
The SpO2 accuracy performance results showed the MD300M Pulse Oximeter and its supporting M-50J033CS045 Oximeter probe to have an Arms of 1.75 during steady state conditions over the range of 70-100%.
Conclusion:
The results of the study provide supporting evidence that the pulse oximeter MD300M with its supporting finger probes was compliance to the accuracy specification claimed by the manufacturer.
The proposed device MD300K2 and MD300M have similar hardware and software design. They have same contain identical materials, electro-optical component, SpO2 module, same supporting finger probes and have equivalent sensor characteristics. The main difference between them is the appearance design (enclosure). So we think MD300M clinical study results can be to support clearance of the proposed device of MD300K2.
Non-Clinical Test:
The Pulse Oximeter MD300M/MD300K2 is designed 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 60601-1-8:2012 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
- 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".
List of non-clinical test performed:
- System Performance Test
- Shelf Life Test
- Performance Test after Cleaning
- 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
- Alarm System Tests According to IEC60601-1-8
- Irritation, Sensitization and Cytotoxicity Test according to ISO 10993
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- SpO2 accuracy:
- 70%~100%, ± 2%
- 0~69% no definition
- PR accuracy:
- 30bpm~99bpm, ± 2bpm
- 100bpm~250bpm, ± 2%
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 and Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 18, 2016
Beijing Choice Electronic Technology Co., Ltd. Lei Chen Quality Director North Building 3F, No.9 Shuangyuan Road Badachu Hi-tech Zone, Shijingshan District Beijing, China 100041
Re: K152563
Trade/Device Name: Pulse Oximeter (MD300M, MD300K2) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: March 7, 2016 Received: March 11, 2016
Dear Mr. 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. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
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
Indications for Use
510(k) Number (if known) K152563
Device Name Pulse Oximeter
Indications for Use (Describe)
The Pulse Oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult, adolescent, child and infant patients in hospitals and clinics.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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: March 17, 2016
3.2Proposed Device Information
Device Common Name: Pulse Oximeter Device Trade/Proprietary Name: Pulse Oximeter Model: MD300M, MD300K2 Classification Name: Oximeter Regulation Number: 870.2700 Product Code: DQA
Class: II
Panel: Anesthesiology
3.3Predicate Device
510(k) Number: K090599
4
Premarket Notification 510(k) Submission-Section III 510(k) Summary Common Name: Pulse Oximeter Device Trade/Proprietary Name: Pulse Oximeter Model: MD300K1 Classification Name: Oximeter Product Code: DQA Regulation Number: 870.2700
Device Class:
Panel: Anesthesiology
Manufacturer: Beijing Choice Electronic Technology Co., Ltd.
Intended Use: MD300K1 Pulse Oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult and pediatric patients in hospitals and home care.
3.4Device Description
The Pulse Oximeter MD300M/MD300K2 can display the SpO2%, pulse rate, Pulse Amplitude Index and other indication parameters, such as time, ID number, pulse amplitude bar and battery power status, alarm limits and the connections of sensors. It is used for adult, adolescent, child and infant patients. The device has physiological alarm and technology alarm function. There are two-level alarm priorities in oximeter. High priority: "Di-Di-Di-----------Di-Di" indicates the patient is in the very dangerous situation. Low priority: "Di" indicates the technical alarm caused by the device itself. The device also has visual alarm function to indicate users by lamp and information on the device. The power supply of the applicant device is 3 AA alkaline batteries, rechargeable batteries or adapter.
The proposed device consists of photo detector, display screen, signal amplify unit, CPU, display unit and power supply unit.
Principle of the oximeter is as follows: A mathematic formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in red and near-infrared zones. Operation principle of the instrument: Photoeletric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm red and 905nm near infrared light) can be focused on a human nail tip through a clamping finger-type sensor. A measured signal obtained by a photosensitive element, will be shown on the oximeter's display through process in electronic circuits and microprocessor.
The proposed 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.
5
The device does not contain drug or biological products.
The device is software-driven and the software validation is provided in software.
6
3.5 Comparison list of the technological characteristics
| Comparison Elements | Proposed Device | Predicate Device | ||
|---|---|---|---|---|
| Product Name | Pulse Oximeter | Pulse Oximeter | ||
| Model | MD300M | MD300K1 | ||
| 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 MD300M pulse oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult, adolescent, child and infant patients in hospitals and clinics. | MD300K1 Pulse Oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult and pediatric patients in hospitals and home care. | ||
| Comparison Statement | The proposed device and the predicated device have the similar intended use and classification. The only difference is that the proposed device cannot be used in the home care environment while the predicated device can be used in the home care environment. | |||
| Components | Photo detector, display screen, signal amplify unit, CPU, display unit and power unit. | Photo detector, display screen, signal amplify unit, CPU, display unit and power unit. | ||
| Design Principle | Principle of the oximeter is as follows: A mathematic formula is established making use | The MD300K1 Pulse Oximeter works by applying a sensor to a pulsating arteriolan | ||
| of Lambert Beer Law according to Spectrum | vascular bed. The sensor contains a dual light | |||
| Characteristics | ||||
| Absorption | ||||
| of | ||||
| Reductive | source and photo detector. The one wavelength | |||
| (RHb) and | ||||
| Oxyhemoglobin | ||||
| hemoglobin | of light source is 660nm, which is red light; the | |||
| red and near-infrared zones. | ||||
| (HbO2) in | other is 940nm, which is ultra red light. Skin, | |||
| principle | ||||
| Operation | ||||
| of | ||||
| the | ||||
| instrument: | bone, tissue, and venous normally absorb a | |||
| Oxyhemoglobin | ||||
| Photoeletric | ||||
| Inspection | constant amount of light during systole and | |||
| Technology is adopted in accordance with | diastole, as blood volume increases and | |||
| Capacity Pulse Scanning and Recording | decreases. The ratio of light absorbed at systole | |||
| Technology, so that two beams of different | and diastole is translated into an oxygen | |||
| wavelength of lights (660nm red and 905nm | saturation measurement. This measurement is | |||
| near infrared light) can be focused on a human | referred to as SpO2. | |||
| nail tip through a clamping finger-type sensor. | ||||
| signal | ||||
| measured | ||||
| obtained | ||||
| A | ||||
| by | ||||
| ದ | ||||
| photosensitive element, will be shown on the | ||||
| display through process | ||||
| oximeter's | ||||
| in | ||||
| electronic circuits and microprocessor. | ||||
| Measurement | Red | 660±3nm | 660 nanometers | |
| Wavelength | Infrared | 905 ± 8nm | 940 nanometers | |
| Comparison Statement | The proposed device and the predicate device have the same design principle and similar | |||
| measurement wavelength. | ||||
| Display Type | TFT (colorized) | OLED | ||
| Battery | 3*AA alkaline batteries, rechargeable | 2*AA alkaline batteries | ||
| batteries or adapter | ||||
| Power adapter | 5V 2A | Not available | ||
| SpO2 display range | 0%~100% | 0~100% | ||
| SpO2 measurement | ||||
| range | 0~100% | 0~100% | ||
| SpO2 accuracy | 70%~100%, $ \u00b1 $ 2%; | |||
| 0~69% no definition | 70%~100%, $ \u00b1 $ 3%; | |||
| 0~69% no definition | ||||
| PR display range | 0~250bpm | 0~235bpm | ||
| PR measurement | ||||
| range | 30~250bpm | 30~235bpm | ||
| PR accuracy | 30bpm~99bpm, $ \u00b1 $ 2bpm | |||
| 100bpm~250bpm, $ \u00b1 $ 2% | 30bpm~99bpm, $ \u00b1 $ 2bpm | |||
| 100bpm~235bpm, $ \u00b1 $ 2% | ||||
| PR Resolution | 1% | 1% | ||
| Pulse amplitude | ||||
| index measurement | ||||
| range | 0.1%~20% | --- | ||
| Operating | ||||
| temperature | 0°C~40°C | 5°C~40°C | ||
| Relative humidity | $ \le $ 80% no condensation in operation; | |||
| $ \le $ 93% no condensation in storage | $ \le $ 80% no condensation in operation; | |||
| $ \le $ 93% no condensation in storage | ||||
| Atmosphere pressure | 86kPa~106kpa | 86kPa~106kpa | ||
| Alarm type | Audio type, visual alarm and information | Audio type, visual alarm and information | ||
| Alarm limit range | SpO2 70%~100% | |||
| PR 30bpm~250bpm | SpO2 70%~100% | |||
| PR 30bpm~235bpm | ||||
| Default | ||||
| Limit | SpO2 | High 100%, Low 90% | High 99%, Low 90% | |
| PR | High 100bpm, Low 60bpm | High 100bpm, Low 60bpm | ||
| Comparison Statement | The proposed device has similar product specification as predicate device. | |||
| Contacting | ||||
| Material | Battery Cover | ABS | ABS | |
| Plastic Case Cover | ||||
| Fingertip Cushion | Medical Silicone Gel (Finger probe M-50E012CS09, M-50B008CS09) | Medical Silicone Gel (Finger probe M-50 series) | ||
| Fingertip Cushion | Microfoam (Finger probe M-50J033CS045) | N/A | ||
| Comparison Statement | The contacting materials of the proposed device are similar to those of the predicate device. The only difference is that the material of MD300M supporting finger probe M-50J033CS045 is microfoam while which is not available to the predicate device. | |||
| Performance Testing | Laboratory Testing | The laboratory tests include SpO2 and PR accuracy Test, Weak Perfusion Test, High and Low Temperature and Humidity Test, Performance Test After Cleaning and ISO80601-2-61 | Meet the requirements of FDA Guidance | |
| Clinical Testing | Conformed to ISO9919&ISO 80601-2-61 | Conformed to ISO9919 | ||
| Clinical Test for the device accuracy is conducted in Yue Bei people's Hospital. The | ||||
| clinical test report and protocol are provided | ||||
| in Performance Testing-Clinical Test Report | ||||
| Electrical | Electrical Safety | Conformed to IEC60601-1, IEC 60601-1-8 | Conformed to IEC60601-1 | |
| Electromagnetic Compatibility | Conformed to IEC60601-1-2 | Conformed to IEC60601-1-2 | ||
| EMC | ||||
| and | ||||
| Safety | Software | Moderate level of concern | ||
| Compliance with FDA Guidance for the | ||||
| content of Premarket Submissions for | ||||
| Software Contained in Medical Devices | ||||
| Risk Management in Compliance with | ||||
| ISO14971:2007 | ||||
| Biocompati | Microfoam | In Vitro Cytotoxicity | No cytotoxic potential | N/A |
| Animal skin irritation test | No evidence of significant irritation from the test extract to rabbits | |||
| Skin Sensitization Test | No evidence of sensitization was observed. | |||
| Comparison Statement | Compliance with ISO10993 | |||
| Label and Labeling | Compliance with the Guidance of pulse oximeter-premarket notification issued on March 4,2013 | Compliance with FDA guidance |
Table 3-1 Performance Specification Comparison Table between the Proposed Device (MD300M) and Predicate Device
7
8
Performance Specification
9
Premarket Notification 510(k) Submission—Section III 510(k) Summary
10
11
Table 3-2 Performance Specification Comparison Table between the Proposed Device (MD300K2) and Predicate Device
| Comparison Elements | Proposed Device | Predicate Device |
|---|---|---|
| Product Name | Pulse Oximeter | Pulse Oximeter |
| Model | MD300K2 | MD300K1 |
| 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 MD300K2 pulse oximeter is intended for | |
| continuous monitoring, spot-checking of | ||
| functional pulse oxygen saturation (SpO2) and | ||
| pulse rate (PR) of single adult, adolescent, | ||
| child and infant patients in hospitals and | ||
| clinics. | MD300K1 Pulse Oximeter is intended for | |
| continuous monitoring, spot-checking of | ||
| functional pulse oxygen saturation (SpO2) | ||
| and pulse rate (PR) of single adult and | ||
| pediatric patients in hospitals and home care. |
12
| | Comparison Statement | The proposed device and the predicated device have the similar intended use and
classification. The only difference is that the proposed device cannot be used in the home
care environment while the predicated device can be used in the home care environment. | | |
|--|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | Components | Photo detector, display screen, signal amplify
unit, CPU, display unit and power unit. | Photo detector, display screen, signal amplify
unit, CPU, display unit and power unit. | |
| | Design Principle | Principle of the oximeter is as follows: A
mathematic formula is established making use
of Lambert Beer Law according to Spectrum
Absorption Characteristics of Reductive
hemoglobin (RHb) and Oxyhemoglobin
(HbO2) in red and near-infrared zones.
Operation principle of the instrument:
Photoeletric Oxyhemoglobin Inspection
Technology is adopted in accordance with
Capacity Pulse Scanning and Recording
Technology, so that two beams of different
wavelength of lights (660nm red and 905nm
near infrared light) can be focused on a human
nail tip through a clamping finger-type sensor.
A measured signal obtained by a photosensitive
element, will be shown on the oximeter's
display through process in electronic circuits
and microprocessor. | The MD300K1 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
normally absorb a constant amount 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±3nm | 660 nm |
| | | Infrared | 905 ± 10nm | 940 nm |
13
| Comparison Statement | The proposed device and the predicate device have the same design principle and similar measurement wavelength. | ||
|---|---|---|---|
| Performance Specification | Display Type | TFT (colorized) | OLED |
| Battery | 3*AA alkaline batteries, rechargeable batteries or adapter | 2*AA alkaline batteries | |
| Power adapter | 5V 2A | Not available | |
| SpO2 Display Range | 0~100% | 0~100% | |
| SpO2 Measurement Range | 0~100% | 0~100% | |
| SpO2 Accuracy | 70% | 70% | |
| SpO2 resolution | 1% | 1% | |
| PR Display Range | 0~250bpm | 0~235bpm | |
| PR Measurement Range | 30bpm~250bpm | 30bpm~235bpm | |
| PR Accuracy | 30bpm~99bpm, $\pm$ 2bpm; | ||
| 100bpm~250bpm, $\pm$ 2% | 30bpm~99bpm, $\pm$ 2bpm; | ||
| 100bpm~235bpm, $\pm$ 2% | |||
| PR Resolution | 1% | 1% | |
| Pulse amplitude index display range | 0.1%~20% | --- |
14
| | Operating
Temperature | 0°C40°C | 5°C40°C | | |
|------------------------|-------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | Relative Humidity | ≤80% no condensation in operation;
≤93% no condensation in storage | ≤80% no condensation in operation;
≤93% no condensation in storage | | |
| | Atmosphere Pressure | 86kPa106kpa | 86kPa106kpa | | |
| | Alarm type | Audio type, visual alarm and information | Audio type, visual alarm and information | | |
| | Alarm limit range | SpO2 70%100%250bpm | SpO2 70%
PR 30bpm100%235bpm | | |
PR 30bpm
| Default
Limits | SpO2 | High 100%, Low 95% | High 99%, Low 90% | | |
| | PR | High 100bpm, Low 60bpm | High 100bpm, Low 60bpm | | |
| Comparison Statement | | The proposed device has similar product specification as predicate device. | | | |
| Contacting
Material | Battery Cover
Plastic Case Cover | ABS | ABS | | |
| | Fingertip Cushion | Medical Silicone Gel(Finger probe
M-50E012CS09, M-50B008CS09) | Medical Silicone Gel(M-50 series) | | |
| | Fingertip Cushion | Microfoam(Finger probe M-50J033CS045) | N/A | | |
| Comparison Statement | | | The contacting materials of the proposed device are similar to those of the predicate
device. The only difference is that the material of MD300K2 supporting finger probe
M-50J033CS045 is microfoam while which is not available to the predicate device. | | |
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| Performance
Testing | Laboratory Testing | The laboratory tests include SpO2 and PR
accuracy Test, Weak Perfusion Test, High and
Low Temperature and Humidity Test,
Performance Test After Cleaning and
ISO80601-2-61 | Meet the requirements of FDA Guidance | |
|-------------------------------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| EMC and
Electrical
Safe | Electrical Safety | Conformed to IEC60601-1, IEC 60601-1-8 | Conformed to IEC60601-1 | |
| | Electromagnetic
Compatibility | Conformed to IEC60601-1-2 | Conformed to IEC60601-1-2 | |
| | Software | Moderate level of concern
Compliance with FDA Guidance for the content
of Premarket Submissions for Software
Contained in Medical Devices
Risk Management in Compliance with
ISO14971:2007 | Moderate level of concern
Compliance with FDA Guidance for the
content of Premarket Submissions for
Software Contained in Medical Devices
Risk Management in Compliance with
ISO14971:2007 | |
| | | | | |
| | | | | |
| Biocompatibilit
y | Microfoam | In Vitro Cytotoxicity | No cytotoxic
potential | N/A |
| | | Animal skin irritation
test | No evidence of
significant irritation
from the test extract
to rabbits | |
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| | Skin Sensitization Test | No evidence of
sensitization was
observed. |
|----------------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Comparison Statement | Compliance with ISO10993 | |
| Label and Labeling | Compliance with the Guidance of pulse
oximeter-premarket notification issued on
March 4,2013 | Compliance with FDA guidance |
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3.6Intended use
The MD300M/MD300K2 pulse oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult, adolescent, child and infant patients in hospitals and clinics.
3.7 Functional and Safety Testing:
Non-Clinical Test
The Pulse Oximeter MD300M/MD300K2 is designed 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 60601-1-8:2012 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
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".
| No. | Test Name |
|---|---|
| 1 | System Performance Test |
| 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 |
The list of non-clinical test performed on the proposed device is shown as following:
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| Premarket Notification 510(k) Submission-Section III 510(k) Summary | |
|---|---|
| --------------------------------------------------------------------- | -- |
| 7 | Alarm System Tests According to IEC60601-1-8 |
|---|---|
| 8 | Irritation,Sensitization and Cytotoxicity Test according to ISO 10993 |
Clinical Test
The Clinical Test was conducted following the testing described in clause 201.12.1 of ISO 80601-2-61:2011 Medical electrical equipment- Part 2-61 Particular requirements for basic safety and essential performance of pulse oximeter equipment.
The supporting Oximeter probes of Pulse Oximeter MD300M are adult finger probe M-50E012CS09, pediatric finger probe M-50B008CS09, single use probe M-50J033CS045. The clinical study of MD300M was conducted with its supporting finger probe respectively.
The Clinical Test of MD300M was conducted in Yue Bei people's Hospital. The clinical s study report was presented in Performance Testing-Clinical Test Report.
Subjects information:
12 healthy adult volunteer subjects (6 females and 6 males ages 21-43yr, 47-82kg, 155-185cm, among which 6 with light pigmentation from Asian, 3 with light (white) pigmentation from Caucasian, 3 with dark pigmentation from African) were included in the study connected Sep. 20-22, 2014 to evaluate the SpO2 accuracy performance of the MD300M Pulse Oximeter and its supporting M-50E012CS09/M-50B008CS09/ M-50J033CS045 Oximeter Probe.
Results:
The SpO2 accuracy performance results showed the MD300M Pulse Oximeter and its supporting M-50E012CS09 Oximeter probe to have an Arms of 1.75 during steady state conditions over the range of 70-100%.
The SpO2 accuracy performance results showed the MD300M Pulse Oximeter and its supporting M-50B008CS09 Oximeter probe to have an Arms of 1.48 during steady state conditions over the range of 70-100%.
The SpO2 accuracy performance results showed the MD300M Pulse Oximeter and its supporting M-50J033CS045 Oximeter probe to have an Arms of 1.75 during steady state conditions over the range of 70-100%.
Conclusion:
The results of the study provide supporting evidence that the pulse oximeter MD300M with its supporting finger probes was compliance to the accuracy specification claimed by the manufacturer.
The proposed device MD300K2 and MD300M have similar hardware and software design. They have same contain identical materials, electro-optical component, SpO2 module,
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same supporting finger probes and have equivalent sensor characteristics. The main difference between them is the appearance design (enclosure). So we think MD300M clinical study results can be to support clearance of the proposed device of MD300K2.
The clinical statement was presented in Performance Testing-Clinical Statement.
3.8Determination of substantial equivalence
The proposed device of Pulse Oximeter MD300M/MD300K2 has the same classification information, similar intended use, same design principle, similar product design and specifications as the predicated device. The differences exist in display screen, SpO2 accuracy and PR display range. The main difference is that the proposed device cannot be used in the homecare environment while the predicated device can be used in the home care environment. The differences are slight and do not influence the effectiveness and safety of the device. According to the laboratory and clinical test results, the proposed device is as safe and as effective as the predicate device. So the proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device.