TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM

K053209 · Suntech Medical, Inc. · DXN · Jan 5, 2006 · Cardiovascular

Device Facts

• Record ID: K053209
• Device Name: TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM
• Applicant: Suntech Medical, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Jan 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The SunTech Medical Tango+ Pulse Oximeter and NIBP monitor is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and blood pressure of adult patients in hospitals, medical facilities, and subacute environments.

Device Story

Microprocessor-based ambulatory blood pressure and oxygen saturation monitor; used as adjunct to exercise stress testing systems. Inputs: Korotkoff sounds for blood pressure; optical finger sensor for SpO2. Operation: internal electric pump inflates cuff; two valves control deflation; SpO2 updated once per second. Used in hospitals, medical facilities, and subacute environments; operated by clinicians. Output: displays diastolic/systolic blood pressure, heart rate, and SpO2. Assists clinicians in monitoring patient physiological status during stress tests.

Clinical Evidence

Clinical validation performed for the SpO2 system. Bench testing conducted for electrical safety (EN 60601-1) and electromagnetic compatibility (EN 60601-1-2, ANSI/AAMI SP10). Components underwent biocompatibility testing.

Technological Characteristics

Microprocessor-based system. NIBP sensing via Korotkoff sounds; SpO2 sensing via optical finger sensor. Internal electric pump and dual-valve deflation system. Electrical safety per EN 60601-1; EMC per EN 60601-1-2 and ANSI/AAMI SP10. Biocompatible components.

Indications for Use

Indicated for adult patients in hospitals, medical facilities, and subacute environments for measurement and display of functional oxygen saturation (SpO2), pulse rate, and blood pressure.

Regulatory Classification

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.

Predicate Devices

• SunTech Tango (K970629)
• Nonin Avant 2120 (K031487)

Submission Summary (Full Text)

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K 053209

SunTech Medical Inc. 510(k) Submission Tango + System for Non-Invasive Blood Pressure and Per Cent Oxygen Saturation

> 510(K) Summary June 22, 2005

# (1) Submitter information

| Name : | SunTech Medical Inc. |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 507 Airport Boulevard<br>Morrisville, NC 27560 |
| Telephone: | 1 919 654-2300 |
| Contact person: | David Gallick (Official Correspondent).<br>SunTech Medical Inc.<br>507 Airport Boulevard<br>Morrisville, NC 27560<br>1 919 654 2332 |

June 22, 2005 Date prepared :

# (2) Name of Device

| Trade Name: | Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement<br>System |
|----------------------|--------------------------------------------------------------------------------------------------|
| Common Name: | Automated Blood Pressure Monitor and Oxygen Saturation measurement<br>device |
| Classification name: | System, measurement, blood pressure, non-invasive, systolic and/or<br>diastolic, 74JOE, 870.1130 |

# (3) Legally-marketed predicate devices

SunTech Tango, K970629

Nonin Avant 2120, K031487

page 1 of 2

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#### Page 5-2

# (3) Description

1 11e Tango+, a microprocessor based ambulatory blood pressure monitor and oxygen saturation measurement system intended to be used with stress-test sytems, uses Korotkoff sounds to determine blood pressure and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. Tango+ has the ability to make blood pressure at predetermined intervals (normally from a schedule determined by the physician), or on demand. Saturation measurements are updated once per second.

### (4) Intended Use

The Tango+ is intended to be used as an adjunct to exercise stress testing devices. It is intended to measure and display diastolic and systolic blood pressure, heart rate, and percentage of oxygen saturation in arterial blood (SpO2) in adult patients during stress tests.

### (5) Performance Data

#### (a) Non-clinical tests

The Tango+ will have passed the following tests:

- for Electrical Safety EN 60601-1 .
- l EN 60601-1-2 for Electromagnetic Compatibility ANSI/AAMI SP10

The oxygen saturation system has been thoroughly tested.

The components have had biocompatibility tests.

(b) Clinical tests

The SpO2 system was validated in a clinical test.

### (6) Conclusion

The Tango+ Automated Blood Pressure and Oxygen Saturation Monitor system is equivalent in safety and efficacy to the legally-marketed predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 5 2006

SunTech Medical, Inc. c/o Mr. David Gallick VP of Engineering 507 Airport Boulevard Morrisville, NC 27560

Re: K053209

Trade Name: Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement System Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: November 09, 2005 Received: November 16, 2005

Dear Mr. Gallick:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 – Mr. David Gallick

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bhimmarfor

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SunTech Medical

、

√(k) Number (if known): K053209

Indications for Use Form

Device Name: Tango+

Indications for Use:

The SunTech Medical Tango+ Pulse Oximeter and NIBP monitor is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and blood pressure of adult patients in hospitals, medical facilities, and subacute environments.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhimmer

n Sign-Off) Division of Cardiova 510(k) Nich ber