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.

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).

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, Temperature, End-tidal Co2 concentration (Et Co2), Co2 waveform, Minimum inspired Co2 concentration (inCo2), Respiration rate.

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.

None of the devices are intended to be used as apnea monitor or during MRI (Magnetic Resonance Imaging).

Device Description

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. 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 4100 CN, Vitalmax 4100 G, and Vitalmax 4100 A are described with various parameters they measure and monitor. 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 Minipack 3000 and Minipack 3100 are described with various parameters they measure and monitor. 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 (IP1, IP2), Second temperature channel and A temp, Analog output.

The Minipack 300 and Vitalmax 800 PLUS are described with various parameters they measure and monitor. 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), Analog output.

AI/ML Overview

The provided text describes an FDA 510(k) clearance letter for various patient monitoring devices (Vitalmax 4000, Vitalmax 4100, Minipack 3000/3100, Minipack 300/Vitalmax 800 PLUS).

This document does not contain information about acceptance criteria or a study proving device performance against such criteria. It is an FDA regulatory clearance letter indicating that the devices are substantially equivalent to previously marketed devices for the stated indications for use.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method.
MRMC comparative effectiveness study or human reader improvement with AI.
Standalone performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The letter explicitly states that the FDA reviewed a "Section 510(k) notification of intent to market the device" and "determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." This process generally involves demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering analysis, performance testing, and comparison, rather than extensive clinical studies with specific performance metrics and expert-adjudicated ground truth as might be seen for novel or higher-risk devices.

The listed parameters (ECG, NIBP, SpO2, Temperature, EtCO2, Respiration Rate, etc.) are the intended measurements and monitoring capabilities of the devices, not performance metrics or acceptance criteria derived from a specific study outlined in this document.

Summary

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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.

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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 ....................................................................................................................................................................

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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 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

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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 .

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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).

Regulation Number and Section

§ 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.