(114 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 algorithms for data analysis or interpretation.
No.
The device is explicitly stated as "non-invasive" and "intended for spot-checking of oxygen saturation... and pulse rate". It provides diagnostic measurements but does not administer therapy or directly treat a condition.
Yes
Explanation: The device is intended for "spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate" and the description states "Place one fingertip into the photoelectric sensor for diagnosis," which indicates its use in providing diagnostic information.
No
The device description explicitly lists hardware components such as a power supply module, detector and emitter LED, signal collection and processor module, display module, and Bluetooth module. While it is software-driven, it is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Fingertip Pulse Oximeter is a non-invasive device that measures oxygen saturation and pulse rate by applying a sensor to the fingertip. 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 of adult, adolescent and child patients". This is a physiological measurement, not a diagnostic test performed on a sample.
Therefore, the device's function and intended use fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Fingertip Pulse Oximeter MD300C208/MD300C198 is a non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent and child patients in hospitals and hospital facilities.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The Fingertip Pulse Oximeter features low power consumption, convenient operation and portability. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display.
The proposed device consists of power supply module, detector and emitter LED, signal collection and processor module, display module, Bluetooth module, user interface and button control.
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 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.
The 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
Fingertip
Indicated Patient Age Range
adult, adolescent and child patients
Intended User / Care Setting
hospitals and hospital facilities.
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)
The Fingertip Pulse Oximeter MD300C208 and MD300C198 were supported by both laboratory and clinical accuracy testing in order to ensure that they were appropriate performance and functional features to fully comply with recognized standards and is substantially equivalent to the predicate device.
Non-clinical Test:
The Fingertip Pulse Oximeter MD300C208/MD300C198 is designed and tested and will be manufactured in accordance with both mandatory and voluntary standards, including:
IEC60601-1: 2005 Medical Electrical Equipment-Part 1: General Requirements for Safety.
IEC60601-1-2:2007 Medical Electrical Equipment-Part1-2: General requirements for safety, Collateral standard: Electromagnetic compatibility -Requirements and tests.
ISO 80601-2-61:2011 Medical Electrical Equipment- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
All clauses are assessed to comply with the requirement of ISO 80601-2-61:2011(First Edition) for use with IEC60601-1:2005 (Third Edition) +CERR.1(2005)+CORR.2(2007). Excluded the following clauses:
201.7.9.2.14.101c) biocompatibility
201.10 Protection against unwanted and excessive radiation HAZARDS
201.12 ACCURACY of controls and instruments and protection against hazardous outputs
201.15.3.5.101.2 Shock and vibration for professional transport
202 EMC
208 Alarm
Other performance tests conducted include SpO2 and PR Accuracy Test, Device Output Time and Finger Out Time Test, Device Response Time Test, Weak Perfusion Test, High and Low Temperature & Humidity Test Per Guidance for Industry and FDA Staff: Pulse Oximeter-Premarket Notification submission [510(k)s].
Software Validation:
In compliance with FDA Guidance to Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
List of non-clinical tests performed:
- System Performance 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
- Bluetooth Wireless Test according to FCC Part 15B and Part 15C
Key Results:
The test results indicate that the safety and effectiveness of the proposed device is identical to that of the predicate device. The proposed device is as safe as effective and performance as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Accuracy: 70%100%, ±2%; 069% no definition
PR Accuracy: 30bpm99bpm, ±2bpm; 100bpm250bpm, ±2%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2015
Beijing Choice Electronic Technology Co., Ltd. Lei Chen Quality Director No. 9 Shuangyuan Road, Badachu Hi-tech Zone Shijingshan District Beijing, 100041 CHINA
Re: K151206
Trade/Device Name: Fingertip Pulse Oximeter MD300C208/MD300C198 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: July 17, 2015 Received: July 24, 2015
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.
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
1
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 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 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) K151206
Device Name
Fingertip Pulse Oximeter MD300C208/MD300C198
Indications for Use (Describe)
The Fingertip Pulse Oximeter MD300C208/MD300C198 is a non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent and child patients in hospitals and hospital facilities.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Section III 510(k) Summary
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is K151206 .
3.1 Submitter 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: August 28, 2015 .
3.2 Proposed Device Information
Device Common Name: Pulse Oximeter Device Trade/Proprietary Name: Fingertip Pulse Oximeter Model: MD300C208, MD300C198 Classification Name: Oximeter Regulation Number: 870.2700 Product Code: DQA
Class: II
Panel: Anesthesiology
4
3.3 Predicate Device
510(k) Number: K140682 Common Name: Pulse Oximeter Device Trade/Proprietary Name: Fingertip Pulse Oximeter Model: MD300C29-H Classification Name: Oximeter Product Code: DQA Regulation Number: 870.2700
Device Class: II
Panel: Anesthesiology
Manufacturer: Beijing Choice Electronic Technology Co., Ltd.
Intended Use: The Fingertip Pulse Oximeter MD300C29-H is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent and child patient in hospital.
3.4 Device Description
The Fingertip Pulse Oximeter features low power consumption, convenient operation and portability. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display.
The proposed device consists of power supply module, detector and emitter LED, signal collection and processor module, display module, Bluetooth module, user interface and button control.
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 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.
The 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.
5
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 | Fingertip Pulse Oximeter | Fingertip Pulse Oximeter | ||
| Model | MD300C208 | MD300C29-H | ||
| 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 MD300C208 is a | |||
| non-invasive device intended for spot-checking | ||||
| of oxygen saturation of arterial hemoglobin | ||||
| (SpO2) and pulse rate of adult, adolescent and | ||||
| child patients in hospitals and hospital | ||||
| facilities. | The Fingertip Pulse Oximeter MD300C29-H is a | |||
| portable, non-invasive device intended for spot | ||||
| checking of oxygen saturation of arterial | ||||
| hemoglobin (SpO2) and pulse rate of adult, | ||||
| adolescent and child patient in hospital. | ||||
| Comparison Statement | The proposed device and the predicated device have the same intended use and classification | |||
| Components | Power supply module, detector and emitter LED, | |||
| signal collection and processor module, display | ||||
| module, Bluetooth module, user interface and | ||||
| button control. | detector and emitter LED, signal amplify unit, | |||
| CPU, data display unit and power unit | ||||
| Design Principle | 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 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. | The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. | ||
| Measurement | ||||
| Wavelength | Red | $660\pm3nm$ | $660\pm3nm$ | |
| Infrared | $905\pm8nm$ | $905\pm8nm$ | ||
| Comparison Statement | The proposed device and the predicate device have the same design principle and similar measurement wavelength. The only difference is that the proposed device adds the Bluetooth module in the product components, and we can verify which will not affect the basic safety and essential performance of the proposed device. | |||
| Display Type | OLED | OLED | ||
| Performance Specification | Working Time | Approximately 28 hours of continuous monitoring | Approximately 25 hours of continuous monitoring | |
| User Interface | 2 display directions and 2 displayed parameters | 6 directions for display | ||
| Power supply | 2*AAA alkaline batteries | 2*AAA alkaline batteries | ||
| Display Data | SpO2, PR, Pulse Amplitude | SpO2 ,PR | ||
| SpO2 Display Range | 35%~100% | 35%~100% | ||
| SpO2 Measurement Range | 70%~100% | 70%~100% | ||
| SpO2 Accuracy | 70%~100%, ±2%; | |||
| 0~69% no definition | 70%~100%, ±2%; | |||
| 0~69% no definition | ||||
| SpO2 Resolution | 1% | 1% | ||
| PR Display Range | 30bpm~250bpm | 30bpm~250bpm | ||
| PR Measurement Range | 30bpm~250bpm | 30bpm~250bpm | ||
| PR Accuracy | 30bpm~99bpm, ±2bpm; | |||
| 100bpm~250bpm, ±2% | 30bpm~99bpm, ±2bpm; | |||
| 100bpm~250bpm, ±2% | ||||
| PR Resolution | 1% | 1% | ||
| Operating Temperature | 5°C~40°C | 5°C~40°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 | 86kPa~106kpa | 86kPa~106kpa | ||
| Comparison Statement | The proposed device has similar product specification as predicate device. | |||
| Contacting | Battery Cover | ABS | ABS | |
| Material | Enclosure | |||
| Fingertip Cushion | ||||
| Power Button | Laser Etching Medical Silicone Gel | Laser Etching Medical Silicone Gel | ||
| Coating | Inks | Inks | ||
| Comparison Statement | The contacting materials of the proposed device are same to those of the predicate device. | |||
| 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 | |||
| Performance Testing | ||||
| and | ||||
| EMC | ||||
| Electrical Safe | Electromagnetic Compatibility | Conformed to IEC60601-1-2 | ||
| Conformed to FCC certification | 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 | 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 | Risk Management in Compliance with | |||
| ISO14971:2007 | ||||
| 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 (MD300C208) and Predicate Device
7
8
9
10
Table 3-2 Performance Specification Comparison Table between the Proposed Device (MD300C198) and Predicate Device
| Comparison Elements | Proposed Device | Predicate Device | |
|---|---|---|---|
| Product Name | Fingertip Pulse Oximeter | Fingertip Pulse Oximeter | |
| Model | MD300C198 | MD300C29-H | |
| 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 MD300C198 is a | ||
| non-invasive device intended for spot-checking | |||
| of oxygen saturation of arterial hemoglobin | |||
| (SpO2) and pulse rate of adult, adolescent and | |||
| child patients in hospitals and hospital | |||
| facilities. | The Fingertip Pulse Oximeter MD300C29-H | ||
| is a portable, non-invasive device intended for | |||
| spot checking of oxygen saturation of arterial | |||
| hemoglobin (SpO2) and pulse rate of adult, | |||
| adolescent and child patient in hospital. | |||
| Comparison Statement | The proposed device and the predicated device have the same intended use and | ||
| classification | |||
| Components | detector and emitter LED, signal amplify unit, | ||
| CPU, data display unit and power unit, | |||
| Bluetooth module | detector and emitter LED, signal amplify | ||
| unit, CPU, data display unit and power unit | |||
| Design Principle | 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 905nm, which is | |||
| infrared-red light. Skin, bone, tissue and venous | |||
| vessels normally absorb a constant amount of | |||
| light over time. The photo detector in finger | |||
| sensor collects and converts the light into | |||
| electronic signal which is proportional to the | |||
| light intensity. The arteriolar bed normally | |||
| pulsates and absorbs variable amounts of light | |||
| during systole and diastole, as blood volume | |||
| increases and decreases. | The pulse oximeter works by applying a | ||
| sensor to a pulsating arteriolar vascular bed. | |||
| The sensor contains a dual light source and | |||
| photo detector. The one wavelength of light | |||
| source is 660nm, which is red light; the other | |||
| is 905nm, which is infrared-red light. Skin, | |||
| bone, tissue and venous 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 | |||
| absorbed at systole and diastole is translated | |||
| into an oxygen saturation measurement. This | |||
| measurement is referred to as SpO2. | 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 | $660 \pm 3$ nm | $660 \pm 3$ nm |
| Infrared | $905 \pm 8$ nm | $905 \pm 8$ nm | |
| Comparison Statement | The proposed device and the predicate device have the same design principle and similar | ||
| measurement wavelength. The only difference is that the proposed device adds the | |||
| Bluetooth module in the product components, and we can verify which will not affect the | |||
| basic safety and essential performance of the proposed device. | |||
| Performance Specification | Display Type | LED | OLED |
| Working Time | Approximately 24 hours of continuous | ||
| monitoring | Approximately 25 hours of continuous | ||
| monitoring | |||
| User Interface | 2 directions for display | 6 directions for display | |
| Power supply | 2*AAA alkaline batteries | 2*AAA alkaline batteries | |
| Display Data | SpO2, PR | SpO2, PR | |
| SpO2 Display Range | 35%~99% | 35%~100% | |
| SpO2 Measurement | |||
| Range | 70%~99% | 70%~100% | |
| SpO2 Accuracy | 70% | 70% | |
| SpO2 Resolution | 1% | 1% | |
| PR Display Range | 30bpm~250bpm | 30bpm~250bpm | |
| PR Measurement | |||
| Range | 30bpm~250bpm | 30bpm~250bpm | |
| PR Accuracy | 30bpm~99bpm, $\pm$ 2bpm; | ||
| 100bpm~250bpm, $\pm$ 2% | 30bpm~99bpm, $\pm$ 2bpm; | ||
| 100bpm~250bpm, $\pm$ 2% | |||
| PR Resolution | 1% | 1% | |
| Operating | |||
| Temperature | 5°C~40°C | 5°C~40°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 | 86kPa~106kPa | 86kPa~106kPa | |
| Comparison Statement | |||
| The proposed device has similar product specification as predicate device. | |||
| Contacting | |||
| Material | Battery Cover | ||
| Enclosure | ABS | ABS | |
| Fingertip Cushion | |||
| Power Button | Laser Etching Medical Silicone Gel | Laser Etching Medical Silicone Gel | |
| Coating | Inks | Inks | |
| Comparison Statement | |||
| The contacting materials of the proposed device are same to those of 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 | ||
| Electrical Safety | Conformed to IEC60601-1 | Conformed to IEC60601-1 | |
| EMC and | |||
| Electrical Safe | Electromagnetic Compatibility | Conformed to IEC60601-1-2 | |
| Conformed to FCC certification | Conformed to IEC60601-1-2 | ||
| Moderate level of concern | |||
| Software | Compliance with FDA Guidance for the content | ||
| of Premarket Submissions for Software | |||
| Contained in Medical Devices | Compliance with FDA Guidance for the | ||
| content of Premarket Submissions for | |||
| Software Contained in Medical Devices | |||
| Risk Management in Compliance with | |||
| ISO14971:2007 | Risk Management in Compliance with | ||
| ISO14971:2007 |
11
12
13
14
15
| Premarket Notification 510(k) Submission—Section III 510(k) Summary | ||
|---|---|---|
| Label and Labeling | Compliance with the Guidance of pulse | |
| oximeter-premarket notification issued on | ||
| March 4,2013 | Compliance with FDA guidance |
16
3.6 Intended use
The Fingertip Pulse Oximeter MD300C208/MD300C198 is a non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent and child patients in hospitals and hospital facilities.
3.7 Testing
The Fingertip Pulse Oximeter MD300C208 and MD300C198 were supported by both laboratory and clinical accuracy testing in order to ensure that they were appropriate performance and functional features to fully comply with recognized standards and is substantially equivalent to the predicate device.
Non-clinical Test
The Fingertip Pulse Oximeter MD300C208/MD300C198 is designed and tested and will be manufactured in accordance with both mandatory and voluntary standards, including:
IEC60601-1: 2005 Medical Electrical Equipment-Part 1: General Requirements for Safety.
IEC60601-1-2:2007 Medical Electrical Equipment-Part1-2: General requirements for safety, Collateral standard: Electromagnetic compatibility -Requirements and tests.
ISO 80601-2-61:2011 Medical Electrical Equipment- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
All clauses are assessed to comply with the requirement of ISO 80601-2-61:2011(First Edition) for use with IEC60601-1:2005 (Third Edition) +CERR.1(2005)+CORR.2(2007). Excluded the following clauses:
The following clauses/collaterals were excluded from this testing:
201.7.9.2.14.101c) biocompatibility
201.10 Protection against unwanted and excessive radiation HAZARDS
201.12 ACCURACY of controls and instruments and protection against hazardous outputs
201.15.3.5.101.2 Shock and vibration for professional transport
202 EMC
208 Alarm
We have also conducted other performance test including SpO2 and PR Accuracy Test, Device Output Time and Finger Out Time Test, Device Response Time Test, Weak Perfusion Test, High and Low Temperature & Humidity Test Per Guidance for Industry and FDA Staff: Pulse Oximeter-Premarket Notification submission [510(k)s].
17
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.
| No. | Test Name |
|---|---|
| 1 | System Performance Test |
| 2 | Performance Test according to ISO 80601-2-61 |
| 3 | Electromagnetic Compatibility Test According to IEC 60601-1-2 |
| 4 | Electrical Safety Test According to IEC 60601-1 |
| 5 | Bluetooth Wireless Test according to FCC Part 15B and Part 15C |
The list of non-clinical test performed on the proposed devices.
The test results indicate that the safety and effectiveness of the proposed device is identical to that of the predicate device.
3.8 Determination of substantial equivalence
The proposed device of Fingertip Pulse Oximeter MD300C208/MD300C198 has the same classification information, similar intended use, same design principle, similar product design and specifications, and the same performance as the predicated device. The main differences are the proposed devices have function of Bluetooth and MD300C208 can display Pulse Amplitude while the predicate device does not have these function. The differences are slight and do not influence the effectiveness and safety of the device. According to the test results, the proposed device is as safe as effective and performance as well as the predicate device. So the proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device.