(19 days)
Not Found
No
The summary describes a standard vital signs monitor with basic monitoring and alarm functions. There is no mention of AI, ML, or any advanced data processing that would suggest the use of such technologies.
No.
The devices (VSM-300 and VSM-300A Vital Signs Monitors) are described as patient monitoring devices used for non-invasive continuous monitoring of physiological parameters (SpO2, NIBP, TEMP). They do not provide therapy or treatment.
No
The device monitors physiological parameters (SpO2, NIBP, TEMP) but does not interpret this data to provide a diagnosis or identify a specific disease. Its primary function is continuous monitoring.
No
The device description explicitly lists hardware components such as an LCD or LED display, SpO2 module, and a built-in Lithium-ion Battery, indicating it is a physical device, 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Vital Signs Monitors described measure physiological parameters directly from the patient's body (SpO2, NIBP, TEMP) using non-invasive methods. They do not analyze samples taken from the body.
- Intended Use: The intended use clearly states "non-invasive continuous monitoring of SpO2, NIBP and TEMP." This is a direct measurement of vital signs, not an in vitro test.
Therefore, the VSM-300 and VSM-300A Vital Signs Monitors fall under the category of patient monitoring devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Vital Signs Monitors models VSM-300 and VSM-300A (hereinafter called monitor) are intended to be used for non-invasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature).
The monitors are intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in hospitals, hospital type facilities and intra-hospital moves.
The monitors are equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
Product codes (comma separated list FDA assigned to the subject device)
DQA, DXN, FLL
Device Description
VSM-300 & VSM-300A Vital Signs Monitors are patient monitoring devices providing the patient with a continuous vital physiological monitoring of noninvasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature) in a hospital, hospital type facilities environment and intra-hospital moves. The following lists the detailed features of the subject device.
- · LCD or LED display
- · SpO2, Pulse Rate NIBP and TEMP measurement
- · Nellcor or EDAN SpO2 module
- · Display numeric and waveform information simultaneously
- · Nurse call feature
- · Built-in Lithium-ion Battery
- · Suitable for adult, pediatric and neonate patients
- · Visual and audible alarm
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, pediatric, and neonatal
Intended User / Care Setting
clinical personnel in hospitals, hospital type facilities and intra-hospital moves.
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)
Not Found
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
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510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is:
Submitter
Advanced Instrumentations, Inc. 6800 N.W. 77th Court Miami, Fl 33166 Telephone: 305-477-6331 Fax: 305-477-5351
Registration # 1066270
Official correspondent :
Jorge Millan, PhD Email: jmillan@hiatec.org 601 West 20 St Hialeah, FL 33010 Phone : (305) 925-1260
Date Prepared:
September 13, 2011
Device name and classification:
- Device Name: VSM-300 & VSM-300A Vital Signs Monitors .
- . Classification Name: Non-invasive blood pressure system, oximeter, clinical electronic thermometer
- Product code: DQA, DXN, FLL .
- . Regulatory Class: Class II
1
Predicate Device:
M3 & M3A Vital Signs Monitor K102835 Manufacturer: EDAN Instruments
Device Description:
VSM-300 & VSM-300A Vital Signs Monitors are patient monitoring devices providing the patient with a continuous vital physiological monitoring of noninvasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature) in a hospital, hospital type facilities environment and intra-hospital moves. The following lists the detailed features of the subject device.
- · LCD or LED display
- · SpO2, Pulse Rate NIBP and TEMP measurement
- · Nellcor or EDAN SpO2 module
- · Display numeric and waveform information simultaneously
- · Nurse call feature
- · Built-in Lithium-ion Battery
- · Suitable for adult, pediatric and neonate patients
- · Visual and audible alarm
Intended Use:
The Vital Signs Monitor models VSM-300 and VSM-300A (hereinafter called monitor) are intended to be used for non-invasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature).
The monitor is intended to be used only under reqular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in hospitals, hospital type facilities and intra-hospital moves.
The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
Effectiveness and Safety Contraindications:
Non-clinical test:
The following quality assurance measures were applied to the development of the Vital Signs Monitor Models VSM-300 & VSM-300A:
2
- Software testing .
- . Safety testing
- . Performance testing
- . Risk analvsis
- Final validation .
Comparison to the predicate device:
The subject device has similar technology characteristics and has the same intended use as the predicate device. The VSM-300 & VSM-300A Vital Signs Monitor has the same characteristics as the predicate device cleared under K102835. Both models use the same technology and circuitry.
Substantially Equivalent Determination:
Verification and validation testing was done on the VSM-300 & VSM-300A Vital Signs Monitor. This premarket notification submission demonstrates that VSM-300 & VSM-300A Vital Signs Monitor is substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Advanced Instrumentations. Inc. c/o Jorge Millan, Ph.D. Executive Director 601 West 20 St Hialeah, FL 33010
1 4 2011 SEP
Re: K112465
Trade/Device Name: VSM-300 & VSM-300A Vital Signs Monitors Regulation Number: 21 CFR 870,2700 Regulation Name: Oximeter Regulatory Class: Class II (two) Product Code: DQA. DXN. FLL Dated: August 23, 2011 Received: August 26, 2011
Dear Dr. Millan:
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 ffor 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 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 - Jorge Millan, Ph.D.
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Reportal?roblem/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/Resourcesfor You/industry/default.htm.
Sincerely yours,
Bram D. Tuckerman, M.D. Director/ Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
VSM-300 & VSM-300A Vital Signs Monitor
Indications for Use:
The Vital Signs Monitors models VSM-300 and VSM-300A (hereinafter called monitor) are intended to be used for non-invasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature).
The monitors are intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in hospitals, hospital type facilities and intra-hospital moves.
The monitors are equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Wf
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(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K112465