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:

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

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

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

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

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

AI/ML Overview

This document is a 510(k) clearance letter for the SunTech Medical Instruments Tango Non-Invasive Blood Pressure Monitor. It does not contain the detailed study information typically requested for acceptance criteria and device performance evaluation. The letter primarily confirms that the device is substantially equivalent to a predicate device already on the market.

However, I can extract the intended use, operating modes, and some patient indications from the provided text, which are foundational to understanding what a full study would need to address. The document explicitly mentions that the device "meets the environmental operating conditions required by AAMI SP10," but it does not provide the specific performance data for blood pressure accuracy itself, which is what your request largely focuses on ("reported device performance").

Therefore, I must state that the detailed information you are requesting about acceptance criteria and the study that proves the device meets the acceptance criteria is not present in the provided text. The text does not include:

A table of acceptance criteria and reported device performance (beyond compliance with AAMI SP10 for environmental operating conditions).
Sample sizes used for test sets.
Data provenance.
Number of experts for ground truth or their qualifications.
Adjudication methods.
MRMC comparative effectiveness study details.
Standalone performance details for clinical accuracy.
Type of ground truth used for clinical accuracy.
Sample size for the training set.
How ground truth for the training set was established.

Based on the provided text, the following information related to the device and its intended use can be inferred, which would be crucial for establishing acceptance criteria in a dedicated performance study:

Device Name: Tango Non-Invasive Blood Pressure Monitor

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."

Operating Modes and Measured Parameters:

Oscillometric mode:
- Systolic Pressure (mmHg)
- Diastolic Pressure (mmHg)
- Pulse Rate (beats per minute)
Dimensional K-Sound mode (DKA):
- Systolic Pressure (mmHg)
- Diastolic Pressure (mmHg)
- Heart Rate (beats per minute)

Intended Patient Population:

Adults (18 years and older)
Not intended for use with children, neonates, or geriatrics.
Arm sizes limited to specific cuff sizes: Small Adult (18cm - 26 cm), Adult (25 cm - 35 cm), Large Adult (33 cm - 47 cm).

Intended Operators and Environment:

Operators: Nurse, physician, or clinician for stress/exercise tests.
Environment: Hospital, clinic, and stress test lab. Not to be operated by a patient or outside these environments.

Environmental Operating Conditions:

"The Tango has been tested and meets the environmental operating conditions required by AAMI SP10." (Note: Specific performance data for this is not provided in the text; only the claim of compliance).

To answer your request thoroughly, a different type of document, such as a clinical study report or a detailed section from the 510(k) submission describing performance testing, would be needed. The provided FDA clearance letter confirms regulatory approval based on substantial equivalence but does not detail the underlying performance studies.

Summary

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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.

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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:

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) .......................................................................................

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.

Regulation Number and Section

§ 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).