(121 days)
Not Found
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 non-invasive and intended for spot-checking measurements of SpO2 and pulse rate, which are diagnostic/monitoring functions, not therapeutic. It explicitly states that it is not for life-supporting or life-sustaining purposes, which aligns with non-therapeutic use.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device is "intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which are measurements used to assess a patient's physiological state and thus aids in diagnosis.
No
The device description explicitly lists hardware components such as a power supply module, detector and emitter LED, signal collection and process module, display module, and user interface and button control circuit. While it is software-driven, it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Fingertip Pulse Oximeter MD300C29-H works by applying a sensor to the finger to measure oxygen saturation and pulse rate directly from the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent and child patient in hospital." This is a direct measurement on the patient, not an analysis of a sample.
Therefore, based on the provided information, the Fingertip Pulse Oximeter MD300C29-H is a non-invasive medical device that performs measurements on the patient's body, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
DQA
Device Description
The proposed device Fingertip Pulse Oximeter MD300C29-H is a battery powered device, which can detect and display the measured %SpO2 and pulse rate value, pulse bar graph and SpO2 waveform. The device is normally applied to adult, child and adolescent patient in the hospital.
The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit.
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 or re-sterilization.
The device is for prescription.
The device does not contain drug or biological products.
The device is software -driven and the software validation is provided in Software
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, adolescent and child patient
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 MD300C29-H is designed and tested and will be manufactured in accordance with the following standards, including:
- IEC 60601-1:2005 Medical Electrical Equipment - Partl: 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.
- 80601-2-61:2011 Medical electrical equipment - part2-61:Particular ISO requirements for the basic safety and essential performance of pulse oximeter equipment.
The Software Validation is in compliance with FDA Guidance for the Content of PreMarket Submissions for Software Contained in Medical Devices.
The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices".
Clinical Test:
The Clinical Test were conducted following the testing described in clause 201.12.1 of ISO 80601-2-61:2011, Medical electrical equipment- Part 2-61 Particular reguirements for basic safety and essential performance of pulse oximeter equipment.
The results of the study provide supporting evidence that the Fingertip Pulse Oximeter MD300C29-H is compliance to the accuracy specification claimed by the manufacturer. The Fingertip Pulse Oximeter can be used under steady state / non-motion conditions for the range 70-100%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
JUL 1 7 2014
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 _ K140682
3.1 Date of Submission: June 11, 2014
3.2 Sponsor Information
Establishment Registration Number: 3005569927 Beijing Choice Electronic Technology Co., Ltd. Room 320, West Building 4, No.83 Fuxing Road, Beijing 100039, P.R.China
Contact Person:
Mr. Lei Chen Beijing Choice Electronic Technology Co., Ltd. North Building 3F, No.9 Shuangyuan Road, Badachu Hi -tech Zone, Shijingshan District, Beijing, 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: MD300C29-H Classification Name: Oximeter Product Code: DQA Regulation Number: 870.2700 Panel: Anesthesiology Class: II
3.4 Predicate Device
510(k) Number: K070371 Common Name: Oximeter Device Trade or Proprietary Name: Fingertip Pulse Oximeter Model: MD300C Classification Name: Oximeter
1
Device Class: II Product Code: DQA Regulation Number: 870.2700 Review Panel: Anesthesiology
Manufacturer: Beijing Choice Electronic Technology Co., Ltd.
Intended Use : Fingertip Pulse Oximeter MD300C is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care and etc). Not for continuously monitoring.
3.5 Device Description
The proposed device Fingertip Pulse Oximeter MD300C29-H is a battery powered device, which can detect and display the measured %SpO2 and pulse rate value, pulse bar graph and SpO2 waveform. The device is normally applied to adult, child and adolescent patient in the hospital.
The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit.
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 or re-sterilization.
The device is for prescription.
The device does not contain drug or biological products.
The device is software -driven and the software validation is provided in Software
3.6 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.
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Premarket Notification 510(k) Submission - Section III 510(k) Summary
Fingertip Pulse Oximeter MD300C29-H
3.7 Comparison with the Predicate Device
| Comparison with the Predicate Device | |||
|---|---|---|---|
| Comparison Elements | Applicant Device | Predicate Device | |
| Device Name | Fingertip Pulse Oximeter MD300C29-H | MD300C Fingertip Pulse Oximeter (K070371) | |
| Model | MD300C29-H | MD300C | |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 | |
| Classification | II | II | |
| Classification Name | Oximeter | Oximeter | |
| Product Code | DQA | DQA | |
| Indented 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, child and adolescent patient in hospital. | Fingertip Pulse Oximeter MD300C is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care and etc). Not for continuously monitoring. | |
| Comparison Statement | The proposed devices have the similar intended use and classification. | ||
| Components | The applicant device consists of detector and emitter LED, signal amplify unit, CPU, data display unit and power unit | detector and emitter LED, signal amplify unit, CPU, data display unit and power unit | |
| 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. | |
| Measurement | |||
| wavelength | Red | $660\pm3nm$ | $660\pm2nm$ |
| Infrared | $905\pm8nm$ | $940\pm10nm$ | |
| Comparison Statement | The proposed device has the same design principle and similar components. The only difference is the | ||
| wavelength of the infrared LED emitter, and we can verify that which will not effect the basic safety | |||
| and the essential performance of the proposed device. | |||
| Display Type | OLED | OLED | |
| Working time | Approximately 25 hours of continuous operation | Approximately 30 hours of continuous operation | |
| Brightness of backlight | Adjustable | Adjustable | |
| User Interface | 6 directions for display | 6 directions for display | |
| Power supply | 2*AAA alkaline battery | 2*AAA alkaline battery | |
| Display Data | SpO2; PR | SpO2, PR | |
| SpO2 display range | 35%~100% | 0~100% | |
| SpO2 measurement range | 70~100% | 70~100% | |
| Device Specification | SpO2 Accuracy | 70%~100%; $\pm$ 2% | |
| 0%~69% no definition | 70%~100%; $\pm$ 3% | ||
| 0%~69% no definition | |||
| SpO2 resolution | 1% | 1% | |
| PR Display Range | 30-250bpm | 0-254bpm | |
| PR Measurement Range | 30~250bpm | 30~235bpm | |
| PR Accuracy | $\pm$ 2bpm (30-99bpm) and $\pm$ 2%(100-250bpm) | $\pm$ 2bpm (30-99bpm) and $\pm$ 2% (100-235bpm) | |
| PR resolution | 1bpm | 1bpm | |
| Operating temperature | 5℃~40℃ | 5°C~40°C | |
| Relative humidity | ≤80% , no condensation (operating) | ||
| ≤93% no condensation (storage) | ≤80% , no condensation (operating) | ||
| ≤93% no condensation (storage) | |||
| Atmosphere pressure | 86kPa~106kPa | 86kPa~106kPa | |
| Comparison Statement | The proposed device has similar device specifications as the predicate device. |
III-3
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Page 5 of 7 .
Premarket Notification 510(k) Submission - Section III 510(k) Summar
Fingertip Pulse Oximeter MD300C29-H
| | ABS | Laser Etching Medical Silicon gel | | Inks | The contacting materials of Proposed device are same to those of the predicate device except Fingertip Cushion and
Power Button. | The bench tests include SpO2 and PR accuracy Test, Weak
Perfusion Test, High and Low Temperature and Humidity
Test, Performance Test After Disinfection and ISO
80601-2-61. | Meet the requirements of FDA Guidance | Conformed to ISO 9919 | Conformed to ISO 9919 & ISO80601-2-61 | Conformed to IEC60601-1 | Conformed to IEC60601-1 | Conformed to IEC60601-1-2. | Conformed to IEC60601-1-2. | Moderate Level of Concern | Moderate Level of Concern | Compliance with FDA Guidance for the Content of
Premarket Submissions for Software Contained in Medical
Devices. |
|---------------|-----------|-----------------------------------|--------------|---------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|-----------------------|---------------------------------------|-------------------------|----------------------------|----------------------------------|----------------------------|---------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------|
| Battery cover | Enclosure | Fingertip
Cushion | Power button | Coating | Comparison Statement | Bench Test | | Clinical Test | | Electrical Safety | | Electromagnetic
Compatibility | | Software | | |
| | | Contacting
Material | | | | Performance Testing | | Clinical Test | | | EMC and
Electrical Safe | | | | | |
ાત-ર
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Page 6 of 7
Premarket Notification 510(k) Submission - Section III 510(k) Summan
Fingertip Pulse Oximeter MD300C29-H
| Risk Management in Compliance with ISO14971:2007 | Risk Management in Compliance with ISO14971:2007 | |||
|---|---|---|---|---|
| In Vitro Cytotoxicity | No cytotoxic potential | In Vitro Cytotoxicity | No cytotoxic potential | |
| Biocompatibility | Skin Irritation Test | No evidence of causing sensitization | Skin Irritation Test | No evidence of causing sensitization |
| Animal skin irritation test | No evidence of significant irritation from the test extract to rabbits | Animal skin irritation test | No evidence of significant irritation from the test extract to rabbits | |
| Medical silicone gel | ||||
| Comparison Statement | Compliance with the ISO 10993 | |||
| Label and Labeling | Compliance with the Guidance of pulse oximeter-premarket notification submission issued on March 4, 2013 | Compliance with FDA guidance |
:
6
3.8 Test Conclusion
Non-clinical Test
The Fingertip Pulse Oximeter MD300C29-H is designed and tested and will be manufactured in accordance with the following standards, including:
- . IEC 60601-1:2005 Medical Electrical Equipment - Partl: 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.
- � 80601-2-61:2011 Medical electrical equipment - part2-61:Particular ISO requirements for the basic safety and essential performance of pulse oximeter equipment.
The Software Validation is in compliance with FDA Guidance for the Content of PreMarket Submissions for Software Contained in Medical Devices.
The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices".
Clinical Test
The Clinical Test were conducted following the testing described in clause 201.12.1 of ISO 80601-2-61:2011, Medical electrical equipment- Part 2-61 Particular reguirements for basic safety and essential performance of pulse oximeter equipment.
The results of the study provide supporting evidence that the Fingertip Pulse Oximeter MD300C29-H is compliance to the accuracy specification claimed by the manufacturer. The Fingertip Pulse Oximeter can be used under steady state / non-motion conditions for the range 70-100%.
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. performance safety as the predicate device. The main difference is the wavelength of the infrared LED emitter, and we can verify that which will not effect the basic safety and the essential performance of the proposed device. So the proposed devices are Substantially Equivalent (SE) to the predicate device which is US legally market device.
7
Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is smaller than the central symbol.
Public Flealth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 17, 2014
Beijing Choice Electronic Technology Co., Ltd. Mr. Lei Chen Quality Director North Building 3F, No.9 Shuangyuan Road Badachu Hi -tech Zone, Shijingshan District. Beijing, P.R. China, 100041
Re: K140682
Trade/Device Name: Fingertip Pulse Oximeter MD300C29-H Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: June 11, 2014 Received: June 16, 2014
Dear Mr. Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither 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.
8
Page 2 - Mr. Lei Chen
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21) CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
在线视频 | Tejasbri Purobit-Sheth, M.D. Tejashri Purofiit-Sheth, M.D. Clialcal Deputy Director A CORPORATION 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
9
Section II Indication for Use Statement
Indication for Use
510(k) Number (if known):
Device Name: Fingertip Pulse Oximeter MD300C29-H
Indications for 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.
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)