(87 days)
Not Found
No
The device description focuses on standard physiological measurement techniques (Korotkoff sounds, optical sensor, oscillometric) and microprocessor control, with no mention of AI or ML terms or concepts. The performance studies listed are related to electrical safety and electromagnetic compatibility, not AI/ML algorithm validation.
No
This device is a monitor that measures and displays blood pressure, heart rate, and oxygen saturation. It does not provide any therapeutic intervention or treatment.
Yes
The device measures and displays physiological parameters (blood pressure, heart rate, SpO2) that are used by healthcare professionals to monitor and assess a patient's health status, which falls under the definition of a diagnostic device.
No
The device description explicitly mentions hardware components such as a microprocessor, electric pump, valves, and an optical finger sensor, indicating it is not software-only.
Based on the provided information, the SunTech Medical Tango M2 NIBP monitor with optional Pulse Oximeter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Tango M2 measures blood pressure and oxygen saturation directly from the patient's body (using a cuff and finger sensor). It does not analyze samples like blood, urine, or tissue.
- The intended use and device description clearly state it measures physiological parameters directly from the patient. It uses Korotkoff sounds and an optical finger sensor, which are in-vivo measurement techniques.
Therefore, the Tango M2 falls under the category of a medical device used for patient monitoring, but not an IVD.
N/A
Intended Use / Indications for Use
Tango M2 is a non-invasive blood pressure monitor, with the optional capability to monitor oxygen saturation (SpO2), for use in cardiac or exercise stress testing. It measures and displays a patient's systolic and diastolic blood pressure, and with the SpO2 option, percent oxygen saturation of arterial blood.
Use Tango M2 only with adult patients, while they undergo cardiac or exercise stress test under the supervision of a physician.
The SunTech Medical Tango M2 NIBP monitor with optional Pulse Oximeter is indicated for use in measuring and displaying blood pressure, heart rate, functional oxygen saturation of arterial hemoglobin (SpO2) of adult patients in hospitals, medical facilities, and subacute environments.
Product codes (comma separated list FDA assigned to the subject device)
DXN, DQA (from predicate device section, but listed as classification name for subject device)
Device Description
The Tango M2, a microprocessor based blood pressure monitor and oxygen saturation measurement system intended to be used with stress-test systems, 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 M2 has the ability to make blood pressure and saturation measurements at predetermined intervals (normally from a schedule determined by the physician), or on demand. Additionally, the TangoM2 has the ability to make an Oscillometric blood pressure determination at the command of the operator while the patient is stationary.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Cardiac or exercise stress testing under the supervision of a physician; hospitals, medical facilities, and subacute environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Tango M2 has been tested to the applicable requirements of the following standards and requirements. These tests have indicated passing results.
- IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements . for basic safety and essential performance
- IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
K122401
Page 7-2
Medical®
SunTech Medical, Inc. Special 510(k) Submission Tango M2 510(k) Summary
NOV 2 2012
(1) Submitter information
| Name: | SunTech Medical, Inc |
|---|---|
| Address: | 507 Airport Boulevard |
| Suite 117 | |
| Morrisville, North Carolina 27560-8200 | |
| Telephone: | 919.654.2334 |
| FAX: | 919.654.2301 |
| Contact person: | Chuck Setzer (Official Correspondent). |
| SunTech Medical | |
| 507 Airport Boulevard | |
| Suite 117 | |
| Morrisville, North Carolina 27560-8200 | |
| Date prepared: | 02AUG2012 |
(2) Name of Device
| Trade Name: | Tango M2 Blood Pressure Monitor |
|---|---|
| Common Name: | Noninvasive blood pressure measurement system |
| Classification name: | System, Measurement, Blood Pressure, Non- |
| Invasive, DXN 870.1130 | |
| Oximeter, DQA, 870.2700 |
(3) Legally-marketed predicate devices
The Tango M2 is a modification of the Tango+ Blood Pressure Monitor, K053209 and Tango Blood Pressure Monitor, K970629.
The Tango M2 is substantially equivilent to these devices.
(4) Description
The Tango M2, a microprocessor based blood pressure monitor and oxygen saturation measurement system intended to be used with stress-test systems, 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 M2 has the ability to make blood pressure and saturation measurements at predetermined intervals (normally from a schedule determined by the physician), or on
507 Airport Blvd., Suite 117, Morrisville, NC 27560-8200 · Fax 919-654-2301 · www.SunTechMed.com
1
SunTech Medical Tango M2 - Special 510(k)
demand. Additionally, the TangoM2 has the ability to make an Oscillometric blood pressure determination at the command of the operator while the patient is stationary.
(5) Intended Use
Tango M2 is a non-invasive blood pressure monitor, with the optional capability to monitor oxygen saturation (SpO2), for use in cardiac or exercise stress testing. It measures and displays a patient's systolic and diastolic blood pressure, and with the SpO2 option, percent oxygen saturation of arterial blood.
Use Tango M2 only with adult patients, while they undergo cardiac or exercise stress test under the supervision of a physician.
The intended use of the Tango M2, as described in its labeling, has not changed as a result of the modifications to the original device.
(6) Comparison to Predicate Devices
The device has the same basic construction as the predicate devices. Both modified and original devices share the same specifications, measurement ranges, and intended uses. The devices are manufactured from the same types of materials using the same production methods and are intended for the same patient populations.
(7) Testing and Validations
The Tango M2 has been tested to the applicable requirements of the following standards and requirements. These tests have indicated passing results.
- IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements . for basic safety and essential performance
- IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
(8) Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this premarket notification, SunTech Medical concludes that the Tango M2 is safe, effective and substantially equivalent to the predicate devices described herein.
page 2 of 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
SunTech Medical, Inc. c/o Mr. Chuck Setzer 507 Airport Blvd, Suite 117 Morrisville, NC 27560
2 2012 NOV
Re: K122401
Trade/Device Name: Tango M2 Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 · Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN Dated: October 3, 2012 Received: October 4, 2012
Dear Mr. Setzer:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
3
Page 2 - Mr. Chuck Setzer
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for use
K122401 510(k) Number (if known): __
Device Name: Tango M2 Noninvasive Blood Pressure Monitor
Indications for Use:
The SunTech Medical Tango M2 NIBP monitor with optional Pulse Oximeter is indicated for use in measuring and displaying blood pressure, heart rate, functional oxygen saturation of arterial hemoglobin (SpO2) of adult patients in hospitals, medical facilities, and subacute environments.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
t (Division Sign-Off) Division of Cardiovascular Devices
Page 1 of 1
510(k) Number K122401