(87 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SunTech Medical Tango M2 Blood Pressure Monitor:
Unfortunately, the provided text does not contain the detailed acceptance criteria or the specific study results that comprehensively prove the device meets these criteria in the format requested. The document is primarily a 510(k) summary for a Special 510(k) submission, focusing on establishing substantial equivalence for a modified device rather than presenting a de novo performance study.
Here's what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the given text. The document states that the Tango M2 has been tested to applicable standards and requirements, and these tests "have indicated passing results," but it does not specify what those acceptance criteria were for blood pressure accuracy (e.g., mean difference and standard deviation compared to a reference method) or the actual results achieved.
2. Sample size used for the test set and the data provenance:
This information is not provided. The 510(k) summary does not detail a specific clinical test set for performance validation, as it is a Special 510(k) based on modifications to an existing device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. As no detailed performance study is presented, there's no mention of experts establishing a ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable to this device. The Tango M2 is a blood pressure monitor, not an AI-assisted diagnostic imaging device used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a standalone blood pressure monitor ("algorithm only" in the sense that it automatically determines blood pressure). However, the document does not present a standalone performance study with specific results. It references "Korotkoff sounds to determine blood pressure," which is the underlying method, but no detailed performance numbers are given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not explicitly stated in the provided document. For blood pressure monitors, the "ground truth" during validation typically involves a reference standard method like invasive arterial line measurements or auscultation by trained observers (often two observers blinded to each other's readings and the device reading), following protocols like ISO 81060-2. The document infers a reliance on established methods by stating "uses Korotkoff sounds to determine blood pressure," which is a standard method for reference.
8. The sample size for the training set:
This information is not applicable and not provided. Blood pressure monitors using Korotkoff sounds are typically based on established physiological principles and signal processing, not on machine learning models requiring extensive "training sets" in the modern AI sense.
9. How the ground truth for the training set was established:
This information is not applicable and not provided for the reasons mentioned above.
Summary of available information:
The document states that the Tango M2 is a non-invasive blood pressure monitor that uses Korotkoff sounds and an optical finger sensor for oxygen saturation. It measures and displays systolic and diastolic blood pressure, and optionally SpO2, for adult patients during cardiac or exercise stress testing under physician supervision.
The basis for regulatory acceptance is substantial equivalence to predicate devices (Tango+ K053209 and Tango K970629). The crucial statement regarding performance is: "The Tango M2 has been tested to the applicable requirements of the following standards and requirements. These tests have indicated passing results." The listed standards are:
- 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.
While these standards cover safety and EMC, they don't explicitly define blood pressure measurement accuracy acceptance criteria (which would typically be covered by standards like ISO 81060-2 or AAMI SP10). The document implicitly relies on the fact that the specifications and measurement ranges are the same as the predicate devices, which were previously cleared based on their performance.
In conclusion, this 510(k) summary provides evidence of safety and EMC compliance and asserts substantial equivalence, but it does not present a detailed performance study with specific acceptance criteria and outcome data as you've requested for a new device's performance validation.
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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 BoulevardSuite 117Morrisville, North Carolina 27560-8200 |
| Telephone: | 919.654.2334 |
| FAX: | 919.654.2301 |
| Contact person: | Chuck Setzer (Official Correspondent).SunTech Medical507 Airport BoulevardSuite 117Morrisville, 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 870.1130Oximeter, 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
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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.
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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.
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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
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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
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510(k) Number K122401
§ 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).