(318 days)
Not Found
Omega™ 1400 MRI monitoring system, Omron HEM 711AC
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities.
No
The device is a blood pressure monitor intended for measurement and display of physiological parameters, not for treating a condition or disease.
No
Explanation: The device measures physiological parameters like blood pressure and heart rate, which are used to monitor a patient's condition. While this information can be used in diagnosis, the device itself does not interpret the measurements to determine a disease state or condition. Its function is data acquisition, not diagnosis.
No
The device description explicitly states it is an "automatic non-invasive blood pressure (NIBP) measurement system" and mentions the use of "pressure cuffs," indicating it includes hardware components for taking blood pressure measurements.
Based on the provided text, the Testa"Be® monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease.
- The Testa"Be® monitor is described as an automatic oscillometric measuring system that takes non-invasive blood pressure measurements directly from the patient. It measures systolic pressure, diastolic pressure, mean arterial pressure, and heart rate.
The device's function is to directly measure physiological parameters from a living patient, not to analyze samples taken from the patient. This aligns with the definition of a non-invasive medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Testa'"Be® monitor is an automatic oscillometric measuring system designed to take non-invasive blood pressure measurements. It measures systolic pressure, diastolic pressure, mean arterial pressure and heart rate.
The Testa "BP® monitor is intended to be used on neonate, pediatric and adult populations during MR-examinations at a maximum magnetic field strength of 20mT.
Product codes
DXN
Device Description
The Testa" (820) Blood Pressure Monitor is an automatic non-invasive blood pressure (NIBP) measurement system that is intended for use in an MR-environment at a maximum magnetic field strength of 20mT. The completed system meets the requirements of AAMI standard SP10:2003+A1:2003. The Testal Pro design makes it possible to position the system within an RF-shielded MRI-room.
The Testa VBP® measures and displays:
- Systolic Pressure
- Diastolic Pressure
- Heart Rate (BPM)
- Mean Arterial Pressure (MAP)
MIPM will distribute pressure cuffs for use with the Testa" that are manufactured by other medical device manufacturing companies, and which are already cleared by FDA for sale in the USA.
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
neonate, pediatric and adult populations
Intended User / Care Setting
The device is intended to be used in the MRI-environment where patient care is provided by Healthcare Professionals, i.e. physicians, and nurses, trained on the use of the device, who will determine when use of the device is indicated based upon their professional assessment of the patient's medical condition.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Omega™ 1400 MRI monitoring system, Omron HEM 711AC
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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| assessment assessment consistent and definite programs and the |
Date: Date: Date: Date:
Page 1 of 2
510(k) Summary
AUG 1 3 2007
Introduction
This summary is intended to comply with requirements of the SMDA and 21CFR§807.92. FDA may make this summary available to the public within 30 days following a finding of substantial equivalence.
510(k) Applicant
Mammendorfer Institut für Physik und Medizin GmbH Oskar-von-Miller-Strasse 6 82291 Mammendorf Germany
510(k) Correspondent
Robert N. Clark, President and Senior Consultant Medical Device Regulatory Advisors, Inc. 13605 West 7th Ave. Golden, CO 80401 USA
Date Prepared
September 26, 2006
Trade Name of Device
Tesla NIBP
Common Name of Device
Patient Physiological Monitor (without arrhythmia detection)
Classification Name
Patient Physiological Monitor (without arrhythmia detection)
510(k) Classification
Class II under regulation 21 CFR 870.1130
Device Description and Intended Use
The Testa"(820) Blood Pressure Monitor is an automatic non-invasive blood pressure (NIBP) measurement system that is intended for use in an MR-environment at a maximum magnetic field strength of 20mT. The completed system meets the requirements of AAMI standard SP10:2003+A1:2003. The Testal Pro design makes it possible to position the system within an RF-shielded MRI-room.
1
| 510(k) Number: |
|---|
| ---------------- |
-2974
Date:
Page 2 of 2
The device is intended to be used in the MRI-environment where patient care is provided by Healthcare Professionals, i.e. physicians, and nurses, trained on the use of the device, who will determine when use of the device is indicated based upon their professional assessment of the patient's medical condition.
The Testa VBP® measures and displays:
-
- Systolic Pressure
-
- Diastolic Pressure
-
- Heart Rate (BPM)
-
- Mean Arterial Pressure (MAP)
MIPM will distribute pressure cuffs for use with the Testa" that are manufactured by other medical device manufacturing companies, and which are already cleared by FDA for sale in the USA.
Predicate Devices
Omega™ 1400 MRI monitoring system, as manufactured by Invivo Diagnostics Imaging.
Omron HEM 711AC, as manufactured by Omron Healthcare, Inc., Vernon Hills, IL.
Risk Management
This device has been designed to either completely eliminate or mitigate known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous application of a risk management program.
Mammendorfer Institut für Physik und Medizin GmbH believes that the Tesla NIBP is safe and effective when used as instructed by knowledgeable and trained personnel, and is substantially equivalent to the legally marketed predicate devices.
2
Public Health Service
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 2007
Medical Device Regulatory Advisors c/o Mr. Robert N. Clark President and Senior Consultant 13605 West 7th Ave. Golden, Colorado 80401
Re: K062974
Tesla NIBP Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: July 19, 2007 Received: July 23, 2007
Dear Mr. Clark:
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.
3
Page 2 - Mr. Robert N. Clark
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Bhimamor for
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
510(k) Number (if known):
Device Name: ____ TeslaMIBP®
Indications for Use:
The Testa'"Be® monitor is an automatic oscillometric measuring system designed to take non-invasive blood pressure measurements. It measures systolic pressure, diastolic pressure, mean arterial pressure and heart rate.
The Testa "BP® monitor is intended to be used on neonate, pediatric and adult populations during MR-examinations at a maximum magnetic field strength of 20mT.
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)
B.Brummer
Tesla NIBP 510(k) Submission Page 15 of 382
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