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K Number
K970629
Device Name
TANGO NON-INVASIVE BLOOD PRESSURE MONITOR
Manufacturer
SUNTECH MEDICAL INSTRUMENTS, INC.
Date Cleared
1998-01-02

(317 days)

Product Code
DXN
Regulation Number
870.1130
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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)
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.

§ 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).