(359 days)
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No
The document describes standard vital sign monitoring devices and their parameters. There is no mention of AI or ML in the intended use, device description, or any other section.
No
The device is described as measuring and monitoring various physiological parameters, not delivering therapy.
No
The devices are described as measuring and monitoring various physiological parameters, such as ECG, NIBP, SpO2, and temperature, which are typically used to assess a patient's current state. The document does not state that the devices interpret these measurements to make a diagnosis or provide diagnostic output. Therefore, they function as monitoring devices rather than diagnostic devices.
No
The device description explicitly mentions hardware components such as printers, invasive pressure waveforms, temperature channels, and analog outputs, indicating it is not solely software.
Based on the provided text, these devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use clearly states that these devices are for measuring and monitoring physiological parameters directly from a patient (ECG, NIBP, SpO2, Temperature, EtCo2, Respiration rate, etc.).
- Device Description: The device descriptions detail the types of measurements taken and the options available, all related to direct patient monitoring.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD device.
These devices are patient monitoring systems used in a clinical setting to assess a patient's vital signs.
N/A
Intended Use / Indications for Use
The Vitalmax 4000 is intended for use in the hospital/clinical environment to measure and monitor the following parameters: - ECG waveform . - NIBP systolic, diastolic, and mean arterial pressure values (MEAN or MAP) . - Blood oxygen saturation (SpO2 or Pulse oximetry) . - SpO2 waveform . - Pulse (SpO2 and NIBP) signal strength . - Pulse (SpO2 and NIBP) or heart (ECG) rate . - Temperature . - . End-tidal Co2 concentration (Et Co2) - Co2 waveform . - . Minimum inspired Co2 concentration (inCo2) - . Respiration rate
Additional options offered are: - Built-in printer with two channels of annotated waveform or text form of vital . signs - . Thoracic impedance respiration - Invasive pressure waveforms: systolic, diastolic, and mean values (IP, IP2) ● - . Second temperature channel and A temp - . Analog output
The Vitalmax 4000 is not intended to be used as apnea monitor or during MRI (Magnetic Resonance Imaging).
The Vitalmax 4100 CN is intended for use in the hospital/clinical environment to measure and monitor the following parameters: - ECG waveform . - NIBP systolic, diastolic, and mean arterial pressure values (MEAN or MAP) . - Blood oxygen saturation (SpO2 or Pulse oximetry) . - Sp02 waveform . - Pulse (SpO2 and NIBP) signal strength . - Pulse (SpO2 and NIBP) or heart (ECG) rate . - Temperature . - End-tidal Co2 concentration (Et Co2) . - Co2 waveform . - Minimum inspired Co2 concentration (inCo2) . - . Respiration rate - . Nitrous oxide concentration (N2O)
The Vitalmax 4100 G and Vitalmax 4100 A include these additional parameters: - End-tidal expired Halothane, Enflurane agent-gas concentration----------. (etHAL, etENF. etISO) - Inspired Halothane, Enflurane, or Isoflurane agent gas concentration (inHAL. . inENF, inISO) - Fractional inspired oxygen in gas concentration (Fio2 or %o2) .
Additional options offered for both models are: - Thoracic impedance respiration . - Invasive pressure waveform, systolic, diastolic and mean values (IP1, . IP2) - Second temperature channel and teperature difference [A temp] - Built-in strip chart recorder . - Sevoflurane, and Desflurane (etSev, inSev, etDes, inDes) . - Analog Output .
The Vitalmax 4100 is not intended to be used as apnea monitor or during MRI (Magnetic Resonance Imaging).
The Minipack 3000 and Minipack 3100 are intended for use in the hospital/clinical environment to measure and monitor the following parameters: - ECG waveform . - NIBP systolic, diastolic, and mean arterial pressure values (MEAN or MAP) . - Blood oxygen saturation (SpO2 or Pulse oximetry) . - SpO2 waveform - Pulse (SpO2 and NIBP) signal strength . - Pulse (SpO2 and NIBP) or heart (ECG) rate e - . Temperature - . End-tidal Co2 concentration (Et Co2) - Co2 waveform . - Minimum inspired Co2 concentration (inCo2) . - Respiration rate .
Additional options offered are: - Built-in printer with two channels of annotated waveform or text form of vital . sians - Thoracic impedance respiration - Invasive pressure waveforms: systolic, diastolic, and mean values (IP1, IP2) - Second temperature channel and A temp ● - . Analoq output
The vitalmax 3000 and Vitalmax 3100 are not intended to be used as apnea monitors or during MRI (Magnetic Resonance Imaging).
The Minipack 300 and Vitalmax 800 PLUS are intended for use in the hospital/clinical environment to measure and monitor the following parameters: - ECG waveform . - NIBP systolic, diastolic, and mean arterial pressure values (MEAN or MAP) ● - Blood oxygen saturation (SpO2 or Pulse oximetry) . - SpO2 waveform . - Pulse (SpO2 or NIBP) signal strength ● - Pulse (SpO2 and NIBP) or heart (ECG) rate . - Temperature . - End-tidal Co2 concentration (Et Co2) . - . Co2 waveform - Minimum inspired Co2 concentration (inCo2) ● - . Respiration rate
Additional options offered are: - . Thoracic impedance respiration - Add-on 27 ccolumn thermal printer (Minipack 300 Series) ● - Built-in printer with two channels of annotated waveform (Vitalmax 800 . PLUS) - Analoq output .
The Minipack 300 and Vitalmax 800 PLUS are not intended to be used as apnea monitors or during MRI (Magnetic Resonance Imaging).
Product codes
MHX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Hospital/clinical environment
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle image.
JAN 30 1596
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Iihan M. Bilqutay President Pace Tech Medical Monitors 510 Garden Avenue North Clearwater, FL 34615-4126
K970445 Re: Vitalmax 4000 Configured/Vitalmax 4000 Modular/Vitalmax 4100 Regulatory Class: II (Two) Product Code: 74 MHX Dated: November 5, 1997 Received: November 10, 1997
Dear Mr. Bilgutay:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The qeneral 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Iihan M. Bilgutay
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ....................................................................................................................................................................
2
INDICATION FOR USE STATEMENT
In accordance with the FDA new requirement, January 1, 1996 the "Indication For Use", attached, please find the indication for use for all of the devices included under the Premarket notification #K970445. These devices are: Vitalmax 4000 Configured / Vitalmax 4000 Modular / Vitalmax 4100 / Minipack 3000 / Minipack 3100 / Minipack 300 / Vitalmax 800 PLUS.
Vitalmax 4000 Configured / Modular
The Vitalmax 4000 is intended for use in the hospital/clinical environment to measure and monitor the following parameters:
- ECG waveform .
- NIBP systolic, diastolic, and mean arterial pressure values (MEAN or MAP) .
- Blood oxygen saturation (SpO2 or Pulse oximetry) .
- SpO2 waveform .
- Pulse (SpO2 and NIBP) signal strength .
- Pulse (SpO2 and NIBP) or heart (ECG) rate .
- Temperature .
- . End-tidal Co2 concentration (Et Co2)
- Co2 waveform .
- . Minimum inspired Co2 concentration (inCo2)
- . Respiration rate
Additional options offered are:
- Built-in printer with two channels of annotated waveform or text form of vital . signs
- . Thoracic impedance respiration
- Invasive pressure waveforms: systolic, diastolic, and mean values (IP, IP2) ●
- . Second temperature channel and A temp
- . Analog output
The Vitalmax 4000 is available in configured and modular form. The Vitalmax 4000 configured monitor is available in various models which offer the options of Co2, thoracic impedance respiration, printer, and invasive pressures.
The vitalmax 4000 is not intended to be used as apnea monitor or during MRI (Magnetic Resonance Imaging).
M. P
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number
3
Vitalmax 4100
The Vitalmax 4100 CN is intended for use in the hospital/clinical environment to measure and monitor the following parameters:
- ECG waveform .
- NIBP systolic, diastolic, and mean arterial pressure values (MEAN or MAP) .
- Blood oxygen saturation (SpO2 or Pulse oximetry) .
- Sp02 waveform .
- Pulse (SpO2 and NIBP) signal strength .
- Pulse (SpO2 and NIBP) or heart (ECG) rate .
- Temperature .
- End-tidal Co2 concentration (Et Co2) .
- Co2 waveform .
- Minimum inspired Co2 concentration (inCo2) .
- . Respiration rate
- . Nitrous oxide concentration (N2O)
The Vitalmax 4100 G and Vitalmax 4100 A include these additional parameters:
- End-tidal expired Halothane, Enflurane agent-gas concentration----------. (etHAL, etENF. etISO)
- Inspired Halothane, Enflurane, or Isoflurane agent gas concentration (inHAL. . inENF, inISO)
- Fractional inspired oxygen in gas concentration (Fio2 or %o2) .
Additional options offered for both models are:
- Thoracic impedance respiration .
- Invasive pressure waveform, systolic, diastolic and mean values (IP1, . IP2)
- Second temperature channel and teperature difference [A temp]
- Built-in strip chart recorder .
- Sevoflurane, and Desflurane (etSev, inSev, etDes, inDes) .
- Analog Output .
The Vitalmax 4100 is not intended to be used as apnea monitor or during MRI (Magnetic Resonance Imaging).
Minipack 3000/3100 - ---------------------------------------------------------------------------------------------------------------------------------------------------------
The Minipack 3000 and Minipack 3100 are intended for use in the hospital/clinical environment to measure and monitor the following parameters:
- ECG waveform .
- NIBP systolic, diastolic, and mean arterial pressure values (MEAN or MAP) .
- Blood oxygen saturation (SpO2 or Pulse oximetry) .
- SpO2 waveform
- Pulse (SpO2 and NIBP) signal strength .
4
- Pulse (SpO2 and NIBP) or heart (ECG) rate e
- . Temperature
- . End-tidal Co2 concentration (Et Co2)
- Co2 waveform .
- Minimum inspired Co2 concentration (inCo2) .
- Respiration rate .
Additional options offered are:
- Built-in printer with two channels of annotated waveform or text form of vital . sians
- Thoracic impedance respiration
- Invasive pressure waveforms: systolic, diastolic, and mean values (IP1, IP2) �
- Second temperature channel and A temp ●
- . Analoq output
The vitalmax 3000 and Vitalmax 3100 are not intended to be used as apnea monitors or during MRI (Magnetic Resonance Imaging).
Minipack 300/ Vitalmax 800 PLUS
The Minipack 300 and Vitalmax 800 PLUS are intended for use in the hospital/clinical environment to measure and monitor the following parameters:
- ECG waveform .
- NIBP systolic, diastolic, and mean arterial pressure values (MEAN or MAP) ●
- Blood oxygen saturation (SpO2 or Pulse oximetry) .
- SpO2 waveform .
- Pulse (SpO2 or NIBP) signal strength ●
- Pulse (SpO2 and NIBP) or heart (ECG) rate .
- Temperature .
- End-tidal Co2 concentration (Et Co2) .
- . Co2 waveform
- Minimum inspired Co2 concentration (inCo2) ●
- . Respiration rate
Additional options offered are:
- . Thoracic impedance respiration
- Add-on 27 ccolumn thermal printer (Minipack 300 Series) ●
- Built-in printer with two channels of annotated waveform (Vitalmax 800 . PLUS)
- Analoq output .
The Minipack 300 and Vitalmax 800 PLUS are not intended to be used as apnea monitors or during MRI (Magnetic Resonance Imaging).