K Number
K970629
Device Name
TANGO NON-INVASIVE BLOOD PRESSURE MONITOR
Date Cleared
1998-01-02

(317 days)

Product Code
Regulation Number
870.1130
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tango Blood Pressure Monitor is intended for use as an aid or adjunct to ECG exercise stress testing, measuring and displaying an adult patients systolic and diastolic blood pressures.
Device Description
The Tango Monitor has two operating modes, Dimensional K-Sound (DKA) and Oscillometry. In the Oscillometric mode the Tango NIBP monitor measures: 1. Systolic Pressure (mmHg) 2. Diastolic Pressure (mmHg) 3. Pulse Rate (beats per minute) In the Dimensional K-Sound mode (DKA) the Tango NIBP monitor measures: 1. Systolic Pressure (mmHg) 2. Diastolic Pressure (mmHg) 3. Heart Rate (beats per minute) Depending on the mode the Monitor is in one of the following waveforms are displayed: 1. R-Wave trigger signal (DKA) 2. K-sound waveforms (DKA) 3. or Oscillometric pressure pulses (Oscillometric)
More Information

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No
The document describes standard blood pressure measurement techniques (Oscillometry and Dimensional K-Sound) and does not mention AI or ML.

No.
The device is described as a monitor intended to measure and display blood pressure and heart rate, which are diagnostic or monitoring functions, not therapeutic. Its intended use as an "aid or adjunct to ECG exercise stress testing" also points to a monitoring role.

No
The device measures and displays blood pressure and heart rate as an aid or adjunct to stress testing. It does not provide a diagnosis.

No

The device description explicitly mentions "operating modes" and the measurement of physical parameters like pressure and pulse rate, implying the use of hardware components (like a cuff and sensor) to acquire these measurements, not just software processing of existing data.

Based on the provided information, the Tango Blood Pressure Monitor is not an In Vitro Diagnostic (IVD) device.

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 about a person's health. This testing is performed outside of the body (in vitro).
  • Tango Monitor Function: The Tango Blood Pressure Monitor measures blood pressure and heart/pulse rate directly from the patient's arm using non-invasive methods (cuff and sensors). It does not analyze specimens taken from the body.
  • Intended Use: The intended use clearly states it measures and displays blood pressure and heart/pulse rate as an aid to ECG exercise stress testing. This is a physiological measurement taken directly from the patient.

Therefore, the Tango Blood Pressure Monitor falls under the category of a non-invasive physiological monitoring device, not an IVD.

N/A

Intended Use / Indications for Use

The Tango Blood Pressure Monitor is intended for use as an aid or adjunct to ECG exercise stress testing, measuring and displaying an adult patients systolic and diastolic blood pressures.

Product codes

DXN

Device Description

The Tango Monitor has two operating modes, Dimensional K-Sound (DKA) and Oscillometry.

In the Oscillometric mode the Tango NIBP monitor measures:

  1. Systolic Pressure (mmHg)
  2. Diastolic Pressure (mmHg)
  3. Pulse Rate (beats per minute)

In the Dimensional K-Sound mode (DKA) the Tango NIBP monitor measures:

  1. Systolic Pressure (mmHg)
  2. Diastolic Pressure (mmHg)
  3. Heart Rate (beats per minute)

Depending on the mode the Monitor is in one of the following waveforms are displayed:

  1. R-Wave trigger signal (DKA)
  2. K-sound waveforms (DKA)
  3. or Oscillometric pressure pulses (Oscillometric)

Mentions image processing

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Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

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Anatomical Site

Arm

Indicated Patient Age Range

The Tango monitor is limited to adult use, the age range for the unit is 18 and older.

Intended User / Care Setting

The Tango NIBP monitor is intended to be operated by a nurse, physician or clinician for stress/exercise tests. The Tango is only intended to be used in a hospital, clinic and stress test lab.

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

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Key Metrics

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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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§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Rockville MD 20857

JAN - 2 100

Mr. David Gallick Quality Assurance Manager SunTech Medical Instruments, Inc. 8917 Glenwood Avenue Raleigh, NC 27612

Re: K970629 Tango Non-Invasive Blood Pressure Monitor Requlatory Class: II (Two) Product Code: DXN Dated: November 3, 1997 Received: November 4, 1997

Dear Mr. David Gallick:

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 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 (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 assumptions. Failure to comply with the GMP regulation may result in 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. David Gallick

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. Callshan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and . _ _ _ _ ... Radiological Health

Enclosure

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510(k) Number (if known): K970629

Tango Non-invasive Blood Pressure Monitor Device Name:

Indications For Use:

..

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See Attached Sheet

(PLRASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number______________________________________________________________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Prescription Use X (Per 21 CFR 801.109) .......................................................................................

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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SunTech Medical Instruments Tango Non-invasive Stress BP Test Monitor JAN - 1 1998

The Tango Blood Pressure Monitor is intended for use as an aid or adjunct to ECG exercise stress testing, measuring and displaying an adult patients systolic and diastolic blood pressures. : :

The Tango Monitor has two operating modes, Dimensional K-Sound (DKA) and Oscillometry.

In the Oscillometric mode the Tango NIBP monitor measures:

    1. Systolic Pressure (mmHg)
    1. Diastolic Pressure (mmHg)
    1. Pulse Rate (beats per minute)

In the Dimensional K-Sound mode (DKA) the Tango NIBP monitor measures:

    1. Systolic Pressure (mmHg)
    1. Diastolic Pressure (mmHg)
    1. Heart Rate (beats per minute)

Depending on the mode the Monitor is in one of the following waveforms are displayed:

    1. R-Wave trigger signal (DKA)
    1. K-sound waveforms (DKA)
    1. or Oscillometric pressure pulses (Oscillometric)

Intended Patient Population

The Tango NIBP-monitor is only intended for use as a stress test monitor. The unit is not intended for use with children, neonates or geriatics. The Tango monitor is limited to adult use, the age range for the unit is 18 and older. Arm sizes are limited to the following cuff sizes:

Small Adult 18cm - 26 cm Adult 25 cm - 35 cm Large Adult 33 cm - 47 cm

Intended Operators and Environment

The Tango NIBP monitor is intended to be operated by a nurse, physician or clinician for stress/exercise tests. The Tango is only intended to be used in a hospital, clinic and stress test lab. There are no circumstances were the Tango NIBP monitor would be operated by a patient or outside of hospital, clinic or stress test lab.

The Tango has been tested and meets the environmental operating conditions required by AAMI SP10. Refer to Appendix B1 for the AAMI SP10 test results.