(104 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 a "portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate" monitor. It measures physiological parameters but does not actively treat or intervene in a disease or condition.
Yes
The device, a pulse oximeter, measures oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. These measurements provide information about a patient's physiological state, which can be used by medical professionals to make clinical decisions, hence it is for diagnostic purposes.
No
The device description explicitly details hardware components such as a detector and emitter LED, signal amplify unit, CPU, data display unit, and power unit, indicating it is not software-only.
Based on the provided information, 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 Pulse Oximeter MD3001 measures oxygen saturation and pulse rate by applying a sensor to a pulsating arteriolar vascular bed (specifically, the finger). This is a non-invasive measurement taken directly from the body, not from a specimen in vitro (in a lab setting).
- Intended Use: The intended use describes measuring physiological parameters directly from the patient.
Therefore, the function and intended use of the Pulse Oximeter MD3001 clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Pulse Oximeter MD3001 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.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The applicant device of Pulse Oximeter MD3001 is a device, which can display % SpO2, pulse rate value and vertical bar graph pulse amplitude. The applicant device consists of detector and emitter LED, signal amplify unit, CPU, data display unit and power unit. The Pulse oximetry works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 940 nm, which is ultra red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in fingersensor 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 applicant device has low battery voltage alarm function, automatically power of function and data storage function. The power source of the applicant device is 2 AAA alkaline or rechargeable batteries. The applicant device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable and does not need sterilization or re-sterilization. The device is for prescription. The device does contain drug or biological products.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pulsating arteriolar vascular bed
Indicated Patient Age Range
adult and pediatric patient
Intended User / Care Setting
at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care and etc)
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)
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Study Type: Clinical Test
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Sample Size: Not Specified
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Data Source: Lab of Beijing Military General Hospital
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Key Results: The accuracy of MD300I pulse oximeter equipment is compliance to the requirement, and the product is safe during the use. It can be used in the clinical environment. It is substantially equivalent to other pulse oximeter product with the same effectiveness and safety.
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Study Type: Performance Bench Test
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Sample Size: Not Specified
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Key Results: Low-Voltage Alarm System (Report No. MD300I -01-003) reports are presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
510(k) Summary JAN 1 4 2008
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.
The Assigned 510(k) Number is:
1. Statement
This is a special 510(k) report for Pulse Oximeter MD3001, which is a modification device to Fingertip Pulse Oximeter MD300C(K070371). The modification does not change intended use. And the new device has different trade name to predicate device.
The main modifications between applicant device and Fingertip Pulse Oximeter MD300C (K070371) are listed below:
| Item | MD300I | MD300C |
|---|---|---|
| Storage Disk | EEPROM (AT24C256) | None Storage Disk |
| Data Transfer | Data can be transferred to PC | No Transfer Function |
| Sensor | Three separate sensors | One Fixed Sensor |
2. Applicant Device Information
Trade/Proprietary Name: Pulse Oximeter MD300I Common Name: Oximeter Classification Name: Oximeter Device Class: II Product Code: DQA Regulation Number: 870.2700 Review Panel: Anesthesiology Intended Use:
Pulse Oximeter MD3001 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.
1
3. Submitter Information
Manufacturer Name:
Beijing Choice Electronic Technology Co., Ltd. Bailangyuan Building B 1126-1127, Fuxing Road A36, Beijing , P.R.China, 100039
Contact Person of the Submission:
Ms. Diana Hong Mr. Eric Chen Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, Zhongxin Zhongshan Mansion, No.19, Lane 999, Zhong Shan Nan Er Road Shanghai, China 20020 Phone: +86-21-64264467 x 152 Fax: +86-21-64264468 x 809 Email: Diana.hong@mid-link.net
4. Predicate Device
Fingertip Oximeter MD300C K-number: K070371 Product Code: DQA 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.
Manufactured bv:
Beijing Choice Electronic Technology Co., Ltd. Bailangyuan Building B 1126-1127, Fuxing Road A36, Beijing , P.R.China, 100039
5. Device Description
The applicant device of Pulse Oximeter MD3001 is a device, which can display % SpO2, pulse rate value and vertical bar graph pulse amplitude.
The applicant device consists of detector and emitter LED, signal amplify unit, CPU, data display unit and power unit.
The Pulse oximetry works by applying a sensor to a pulsating arteriolar vascular bed. The
2
sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 940 nm, which is ultra red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in fingersensor 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 applicant device has low battery voltage alarm function, automatically power of function and data storage function. The power source of the applicant device is 2 AAA alkaline or rechargeable batteries.
The applicant device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable and does not need sterilization or re-sterilization. The device is for prescription. The device does contain drug or biological products.
The device is electrically operated and the Electrical Safety Test and Electromagnetic Compatibility Test following IEC 60601-1 and IEC60601-1-2 were conducted. Please see the Attachment 2 Electrical Safety and EMC Test.
The device is software-driven and the software validation is provided in Chapter VIII Software Validation.
The Performance Test reports Low-Voltage Alarm System (Report No. MD300I -01-003) are presented in Attachment 3 Performance Bench Test.
The Clinical Test reports following ISO 9919:2005, Medical electrical equipment -Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use are conducted in the lab of Beijing Military General Hospital provided in Attachment 4 Clinical Test Reports.
All applicable standards are listed in Chapter II Standards.
The device is not kit.
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6. Effectiveness and Safety Considerations
Effectiveness:
The Clinical Test reports following ISO 9919:2005, Medical electrical equipment -Particular requirements for the safety and essential performance of pulse oximeter
The accuracy of MD300I pulse oximeter equipment is compliance to the requirement, and the product is safe during the use. It can be used in the clinical environment. It is substantially equivalent to other pulse oximeter product with the same effectiveness and safety.
Safety Considerations:
The Performance Test reports Low-Voltage Alarm System (Report No. MD3001 -01-003) are presented in Attachment 3 Performance Bench Test.
The test results of biocompatibility of all the skin-contacting material are presented as Table IV-2 for the consideration of Biological Specifications. Please see Appendix 1 Biocompatibility Reports.
The Biological Evaluation Tests are in compliance with the standards of ISO 10993. "Biological Evaluation of Medical Devices". The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility.
The applicant device is compliance with IEC60601-1, Medical electrical equipment - Part 1: General requirements for safety and IEC60601-1-2, Medical electrical equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility -. Requirements and tests
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.
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7. Substantially Equivalence Determination
Comparison Analysis
The applicant device has same classification information, same indications and intended use, same design principle, similar product design and specifications, same performance effectiveness, performance safety as the predicate device. The only difference is working time and Relative humidity. These differences are slight and do not effluence the effectiveness and safety of the device and don't raise new question of effectiveness and safety.
Conclusion:
The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the applicant device is determined as safe and effectiveness.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
JAN 1 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Beijing Choice Electronic Technology Company, Limited C/O Ms. Diana Hong Report Correspondent Shanghai Midlink Business Consulting Company, Limited Suite 8D, Zhongxin Zhongshan No19, LN999, Zhong Shan Nan ER Shanghai, China 200030
Re: K072825
Trade/Device Name: Pulse Oximeter MD300I Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: December 28, 2007 Received: January 2, 2008
Dear Ms. Hong:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Ms. Hong
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chris Liu, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number:
Device Name: _Pulse Oximeter MD3001
Indications for Use:
Pulse Oximeter MD3001 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office vice Evaluation (ODE)
Mait Threhnt
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- A.J., S.M., and G.M.R.
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