(130 days)
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Not Found
No
The summary describes a standard pulse oximeter that uses light absorption principles to measure SpO2 and pulse rate. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
No
The device is strictly for monitoring vital signs (SpO2 and pulse rate) and does not provide any form of treatment or therapy.
Yes
The device is described as a "vital sign monitor" that measures and displays functional oxygen saturation (SpO2) and pulse rate. The "Intended Use" section states it's for "non-invasively measuring and displaying" these vital signs. This process of measuring and displaying physiological parameters to provide information about the patient's condition for clinical assessment is a diagnostic function.
No
The device description explicitly mentions a sensor with a dual light source and photo detector, indicating a hardware component is essential for its function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the living body (in vitro).
- Device Function: The MD2000A vital sign monitor measures SpO2 and pulse rate non-invasively by applying a sensor to the finger. It measures light absorption through the skin and tissue to determine these values. This is a measurement taken on the living body (in vivo).
Therefore, because the device measures physiological parameters directly from the patient's body without requiring a sample to be taken and tested externally, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MD2000A vital sign monitor is portable device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial haemoglobin (SpO2), and pulse rate of adult, pediatric and neonate patients via finger in hospitals, medical facilities, and subacute environments. The vital sign monitor is intended for spot-checking and/or continuous monitoring of patients, the sensor of device is reusable.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The device 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 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 of MD2000A Vital Sign Monitor is the Desktop Pulse Oximeter Monitor, which mainly function are measurement, display, alarm, data storage.
Measurement function: That's the mainly function of the device, which use the method describe above to measure the SpO2 value and Pulse Rate value of lay user.
Display function: The display function of the device have two display area dividually, the one display area use the LCD display mode, which displays the date & time, battery capacity indicator, SpO2 and PR alarm limit value, ID number, auditory alarm state indication, pulse beep state indication and pulse plethysmogram. The another display area use the LED display mode, which displays the SpO2 value, PR value and blip bar.
Alarm function: The applicant device has there-level priorities alarm, they are High priority, Medium priority and Low priority. Each alarm of device contains VISUAL and AUDIBLE alarm.
Data storage function: The measured record is stored automatically every four seconds. The monitor can store 72 hours records. The new record will be stored with the initial records being erased when the stored records are full. The device also has the function as "record review", "SpO2 Trend Review" and "PR Trend review", the user can use those function to review stored data easily.
Power: The applicant device has two kinds of power supply as AC power supply and Battery power supply. The AC power supply complies with following specification: 100-230 (VAC), 50/60 (Hz). The battery used in the applicant device is a Ni-MH battery with 7.2V d.c. output, the battery be able to recharged by AC power supply. The battery be able to provide the power to make the device run in normal, when the AC power supply connected, the battery will turn into charge state from power supply state automatically.
The applicant device have 2 models detachable sensor as the accessory, they are listed below: M-50A (for Adult), M-50C (for Pediatric and Neonate).
The applicant device is not for life-supporting or life-sustaining, not for implant. The device is not sterile and does not need sterilization or re-sterilization. The device is for prescription. The device does contain drug or biological product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
finger
Indicated Patient Age Range
adult, pediatric and neonate
Intended User / Care Setting
hospitals, medical facilities, and subacute environments
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device is electrically operated and the electrical safety and electromagnetic compatibility following IEC 60601-1 and IEC60601-1-2 were conducted. The Clinical Test Report 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 Clinical Laboratory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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
Chapter III 510(k) Summary
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. Device Information
Device Common Name: Oximeter Device Trade/Proprietary Name: MD 2000A Vital Sign Monitor
Classification Information:
(1) Classification Name: Oximeter
- (2)Regulation Number:870.2700
- (3)Product Code:DQA
(4) Class: II
- (5)Review Panel: Anesthesiology
2. Submitter Information
Manufacturer:
Beijing Choice Electronic Technology Co., Ltd. Room 1127-1128 Building B, Bailangyuan Fuxing Road , No. A36,Beijing, China 100039
Contact Person of the Submission
Ms. Diana Hong Mr. Tarzan Wang Suite 8D, Zhongxin Zhongshan Mansion, No.19, Lane 999, Zhong Shan Nan Er Road Shanghai, China 20020 Phone: +86-21-64264467 Fax: (240) 238-7587 Email: Diana.hong@mid-link.net
3. Device Description
The device 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
APR - 3 2009
1
・・
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 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 of MD2000A Vital Sign Monitor is the Desktop Pulse Oximeter Monitor, which mainly function are measurement, display, alarm, data storage.
Measurement function
That's the mainly function of the device, which use the method describe above to measure the SpO2 value and Pulse Rate value of lay user.
Display function
The display function of the device have two display area dividually, the one display area use the LCD display mode, which displays the date & time, battery capacity indicator, SpO2 and PR alarm limit value, ID number, auditory alarm state indication, pulse beep state indication and pulse plethysmogram.
The another display area use the LED display mode, which displays the SpO2 value, PR value and blip bar.
Alarm function
The applicant device has there-level priorities alarm, they are High priority, Medium priority and Low priority.
Each alarm of device contains VISUAL and AUDIBLE alarm.
Data storage function
The measured record is stored automatically every four seconds. The monitor can store 72 hours records.
The new record will be stored with the initial records being erased when the stored records are full.
The device also has the function as "record review", "SpO2 Trend Review" and "PR Trend review", the user can use those function to review stored data easily.
Power
The applicant device has two kinds of power supply as AC power supply and Battery power supply.
The AC power supply complies with following specification: 100-230 (VAC),
2
50/60 (Hz).
The battery used in the applicant device is a Ni-MH battery with 7.2V d.c. output, the battery be able to recharged by AC power supply.
The battery be able to provide the power to make the device run in normal, when the AC power supply connected, the battery will turn into charge state from power supply state automatically.
The applicant device have 2 models detachable sensor as the accessory, they are listed below:
M-50A (for Adult)
M-50C (for Pediatric and Neonate)
- . The applicant device is not for life-supporting or life-sustaining, not for implant. The device is not sterile and does not need sterilization or re-sterilization. The device is for prescription. The device does contain drug or biological product.
4. Intended Use
The MD2000A vital sign monitor is portable device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial haemoglobin (SpO2), and pulse rate of adult, pediatric and neonate patients via finger in hospitals, medical facilities, and subacute environments. The vital sign monitor is intended for spot-checking and/or continuous monitoring of patients, the sensor of device is reusable
5. Substantially Equivalence Determination
The applicant devices Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the applicant devices are determined as safe and effectiveness.
6. Test Summary
The device is electrically operated and the electrical safety and electromagnetic compatibility following IEC 60601-1 and IEC60601-1-2 were conducted.
The Clinical Test Report 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 Clinical Laboratory.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Beijing Choice Electronic Technology Company, Limited C/o Ms. Diana Hong General Manager Shanghai Midlink Business Consulting Company, Limited Suite 8D, Zhongxin Zhongshan Mansion Number 19, Lane 999, Zhong Shan Nan Er Road Shanghai, CHINA 20020
APR - 3 2009
Re: K083466
Trade/Device Name: MD 2000A Vital Sign Monitor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: February 27, 2009 Received: March 3, 2009
Dear Ms. Kong:
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.
4
Page 2 - Ms. Kong
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 (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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Susan Loar
Ginette Y. Michaud, M.D.
Ginette Y. Michaud, M.D. Acting 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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Premarket Notification 510(k) Chapter II Indication for Use Statement Report No .: TE20080902
Indication For Use
510(k) Number (if known): _ Pending __________________________________________________________________________________________________________________________________________
Device Name: MD 2000A Vital Sign Monitor
Indications for Use:
The MD2000A vital sign monitor is portable device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial haemoglobin (SpO2), and pulse rate of adult, pediatric and neonate patients via finger in hospitals, medical facilities, and subacute environments. The vital sign monitor is intended for spot-checking and/or continuous monitoring of patients, the sensor of device is reusable ..
Prescription Use (Part 21 CFR 801 Subpart D)
510(k) Number:
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 of Device Evaluation (ODE)
Susankunnes
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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