(255 days)
MD300CB3
MD300CB3
No
The device description and performance studies focus on traditional signal processing and light absorption principles for SpO2 and pulse rate measurement, with no mention of AI or ML.
No
The device is described as a "spot checking" tool for measuring oxygen saturation and pulse rate, which are diagnostic or monitoring functions, not therapeutic interventions.
Yes
The device is described as "intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which are measurements used in diagnosing a patient's condition.
No
The device description explicitly states it is a battery-powered device with hardware components including a detector and emitter LED, signal collection and process module, display module, and user interface and button control circuit.
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 Fingertip Pulse Oximeter MD300CG11/MD300CG51 is a non-invasive device that measures oxygen saturation and pulse rate by applying a sensor to the finger. It does not analyze samples taken from the body.
- Intended Use: The intended use is for "spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which is a physiological measurement taken directly from the patient.
Therefore, this device falls under the category of a non-invasive medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Fingertip Pulse Oximeter MD300CG11/MD300CG51 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 patient with the fingers between 0.9 - 2.2 cm (0.4 - 0.9 inch) thick in hospital.
Product codes
DQA
Device Description
The proposed devices Fingertip Pulse Oximeter MD300CG11/MD300CG51 are battery powered devices, which can detect and display the measured %SpO2 and pulse rate working 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 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 devices are normally applied to adult, adolescent, child and infant in hospital and home environments.
The Proposed devices MD300CG11 and MD300CG51 consist of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit.
The proposed devices Fingertip Pulse Oximeter MD300CG11/MD300CG51 share the same measurement principle, structure design, electro-optical components, SpO2 module and equivalent sensor characteristics. The differences among each model of the proposed devices are shown in the table 3-1.
The proposed devices are not for life-supporting or life-sustaining, not for implant and not sterile. They are reusable and do not need sterilization or re-sterilization.
The devices are for prescription.
The devices do 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
Fingers
Indicated Patient Age Range
Adult, Adolescent, Child and Infant
Intended User / Care Setting
Hospital
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 Fingertip Pulse Oximeter MD300CG11/MD300CG51 is designed and tested and will be manufactured in accordance with the following standards, including:
- IEC 60601-1:2005 Medical Electrical Equipment - Part1: General requirements for safety.
- IEC 60601-1-2:2007 Medical Electrical Equipment – Part 1: General requirements for safety-2, Collateral Standard: Electromagnetic compatibility - Requirements and tests.
- ISO 80601-2-61:2011 Medical electrical equipment – part2-61: Particular requirements for the basic safety and essential performance of pulse oximeter equipment
- IEC 60601-1-11 : 2010 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
We have conducted performance test for the proposed device in accordance with ISO 80601-2-61. We have also conducted other performance tests for proposed device, including SpO2 and PR range & accuracy Test, Weak Perfusion Test, High and Low Temperature & Humidity Test. Performance Test after Disinfection, Shelf-life Test per Guidance for Industry and FDA Staff: Pulse Oximeters - Premarket Notification Submissions [510(k)s]. The test reports are presented in Performance Testing.
The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. We have conducted the cytotoxicity, sensitization, and irritation tests which are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices".
The Software Validation is in compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Clinical Test:
The proposed device MD300CG11/MD300CG51 and the predicate device MD300CB3 have the same electro-optical component, SpO2 module and have equivalent sensor characteristics. We state that clinical testing is not necessary because the differences between the subject and predicate devices do not affect calculation of SpO2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2:
Display Range: 0-99%
Measurement Range: 70-99%
Accuracy: 70%-99%: ±2%; 0%-69% no definition
Resolution: 1%
PR:
Display Range: 0-254BPM
Measurement Range: 30-235BPM
Accuracy: 30-99bpm, ±2bpm; 100-235bpm, ±2%
Resolution: 1bpm
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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 14, 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, 100041 CHINA
Re: K160268
Trade/Device Name: Fingertip Pulse Oximeter MD300CG11/MD300CG51 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: September 13, 2016 Received: September 16, 2016
Dear Lei Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, 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
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section II Indication for Use Statement
Indication for Use
510(k) Number (if known): K160268
Device Name: Fingertip Pulse Oximeter MD300CG11/MD300CG51
Indications for Use:
The Fingertip Pulse Oximeter MD300CG11/MD300CG51 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 patient with the fingers between 0.9 - 2.2 cm (0.4 - 0.9 inch) thick in hospital.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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.
The assigned 510(K) number is _ K160268
3.1 Date of Submission: Sep. 13, 2016
3.2 Sponsor Information
Establishment Registration Number: 3005569927 Beijing Choice Electronic Technology Co., Ltd. Room 4104, No.A12 Yuquan Road, Haidian District, Beijing 100143, 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, P.R. China, 100041 Phone: +86-10-88798300 Ext 6020 Fax: 215-4052545
3.3 Proposed Device Information
Device Common or Usual Name: Pulse Oximeter Device Trade or Proprietary Name: Fingertip Pulse Oximeter Model: MD300CG11/MD300CG51 Classification Name: Oximeter Product Code: DQA Regulation Number: 870.2700 Panel: Anesthesiology Class: II
3.4 Predicate Device
510(k) Number: K131047 Common Name: Oximeter Device Trade or Proprietary Name: Fingertip Pulse Oximeter Model: MD300CB3 Classification Name: Oximeter
4
Device Class: II Product Code: DQA Regulation Number: 870.2700 Review Panel: Anesthesiology
3.5 Device Description
The proposed devices Fingertip Pulse Oximeter MD300CG11/MD300CG51 are battery powered devices, which can detect and display the measured %SpO2 and pulse rate working 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 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 devices are normally applied to adult, adolescent, child and infant in hospital and home environments.
The Proposed devices MD300CG11 and MD300CG51 consist of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit.
The proposed devices Fingertip Pulse Oximeter MD300CG11/MD300CG51 share the same measurement principle, structure design, electro-optical components, SpO2 module and equivalent sensor characteristics. The differences among each model of the proposed devices are shown in the table 3-1.
| Table 3-1 | ||
|---|---|---|
| MD300CG11 | MD300CG51 | |
| Display Screen Type | LED | LCD |
| Display Mode | 1 direction for display | 2 direction for display |
| Appearance | Blue top shell | Blue top shell |
Table 3-1
The proposed devices are not for life-supporting or life-sustaining, not for implant and not sterile. They are reusable and do not need sterilization or re-sterilization.
The devices are for prescription.
The devices do not contain drug or biological products.
5
3.6 Intended Use
The Fingertip Pulse Oximeter MD300CG11/MD300CG51 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 patient with the fingers between 0.9 - 2.2 cm (0.4 - 0.9 inch) thick in hospital.
6
| Characteristic | Proposed Device | Predicate Device | |
|---|---|---|---|
| Product Name | Fingertip Pulse Oximeter | Fingertip Pulse Oximeter(K131047) | |
| Model | MD300CG11/MD300CG51 | MD300CB3 | |
| Intended Use | The Fingertip Pulse Oximeter MD300CG11/ | ||
| MD300CG51 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 patient with the fingers | |||
| between 0.9 - 2.2 cm (0.4 - 0.9 inch) thick in hospital. | The Fingertip Pulse Oximeter MD300CB3 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 patient in hospital. | |||
| Design Principle | 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. | 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. | |||
| Components | The Proposed devices MD300CG11 and | ||
| MD300CG51 consist of power supply module, | |||
| detector and emitter LED, signal collection and | |||
| process module, display module, user interface and | |||
| button control circuit. | Power supply module, detector and emitter LED, | ||
| signal collection and process module, display | |||
| module, user interface and button control circuit | |||
| Power | Internal powered equipment | Internal powered equipment | |
| 1 AAA-size alkaline battery | 1 AAA-size alkaline battery | ||
| Display Screen Type | MD300CG11: LED | ||
| MD300CG51: LCD | OLED | ||
| Display Mode | MD300CG11: 1 direction for display | ||
| MD300CG51: 2 directions for display | 6 directions for display | ||
| Interface Display | MD300CG11: SpO2, PR, Pulse bar graph, Low | ||
| power indicator | |||
| MD300CG51: SpO2, PR, Pulse bar graph, Low | |||
| power indicator | SpO2, PR, SpO2 Waveform, Pulse bar graph, Low | ||
| power indicator | |||
| LED | |||
| Specification | RED | 660±2nm | 660±2nm |
| IR | 940±10nm | 940±10nm | |
| Display Range | 0-99% | 0-100% | |
| SpO2 | Measurement | ||
| Range | 70-99% | 70-100% | |
| Accuracy | 70%-99%: ±2%; | ||
| 0%-69% no definition | 70%-100%: ±2%; | ||
| 0%-69% no definition | |||
| Resolution | 1% | 1% | |
| PR | Display Range | 0-254BPM | 0-254BPM |
| Measurement | |||
| Range | 30-235BPM | 30-235BPM | |
| Accuracy | 30-99bpm, ±2bpm; 100-235bpm, ±2% | 30-99bpm, ±2bpm; 100-235bpm, ±2% | |
| Resolution | 1bpm | 1bpm | |
| Patient Contacting Material | Medical silicone gel | Medical silicone gel | |
| ABS plastic | |||
| Material of Shell | Medical silicone gel | ||
| ABS plastic | Medical silicone gel |
3.7 Technological Characteristics Comparison:
7
Fingertip Pulse Oximeter
8
Fingertip Pulse Oximeter
9
3.8 Test Conclusion
Non-clinical Test
The Fingertip Pulse Oximeter MD300CG11/MD300CG51 is designed and tested and will be manufactured in accordance with the following standards, including:
- IEC 60601-1:2005 Medical Electrical Equipment - Part1: General requirements for safety.
- IEC 60601-1-2:2007 Medical Electrical Equipment – Part 1: General requirements for safety-2, Collateral Standard: Electromagnetic compatibility - Requirements and tests.
- ISO 80601-2-61:2011 Medical electrical equipment – part2-61: Particular requirements for the basic safety and essential performance of pulse oximeter equipment
- IEC 60601-1-11 : 2010 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
We have conducted performance test for the proposed device in accordance with ISO 80601-2-61. We have also conducted other performance tests for proposed device, including SpO2 and PR range & accuracy Test, Weak Perfusion Test, High and Low Temperature & Humidity Test. Performance Test after Disinfection, Shelf-life Test per Guidance for Industry and FDA Staff: Pulse Oximeters - Premarket Notification Submissions [510(k)s]. The test reports are presented in Performance Testing.
The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. We have conducted the cytotoxicity, sensitization, and irritation tests which are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices".
The Software Validation is in compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Clinical Test
The proposed device MD300CG11/MD300CG51 and the predicate device MD300CB3 have the same electro-optical component, SpO2 module and have equivalent sensor characteristics. We state that clinical testing is not necessary because the differences between the subject and predicate devices do not affect calculation of SpO2.
3.9 Determination of substantial equivalence
The proposed device has the same classification information, similar intended use, same design principle, similar product design and specifications, same performance effectiveness as the predicate device. So the proposed devices are Substantially Equivalent (SE) to the
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predicate device which is US legally market device.