(91 days)
K 964235
Not Found
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML components or capabilities.
No.
The device is for monitoring and storing blood pressure data, not for treating a condition.
Yes
The device monitors, accumulates, and stores physiological data (heart beat, systolic, and diastolic data) to assess a patient's blood pressure over a period of time, which is inherently a diagnostic function.
No
The device description explicitly states it is a "fully automatic table model device that measures blood pressure by means of an inflatable cuff on the upper arm," indicating it includes hardware components.
Based on the provided information, the Mobil-O-Graph ABPM system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Mobil-O-Graph function: The Mobil-O-Graph ABPM system measures blood pressure directly from the patient's upper arm using an inflatable cuff and the oscillometric principle. This is a non-invasive measurement taken in vivo (within the living body), not in vitro (in glass/outside the body) on a sample.
- Intended Use: The intended use describes monitoring and storing blood pressure data from an individual adult patient. This aligns with a physiological measurement device, not an IVD.
Therefore, the Mobil-O-Graph ABPM system is a medical device for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mobil-O-Graph NG ABPM system is an automated, microprocessor controlled blood pressure monitor which monitors, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual adult patient (in the patient's environment) for a session which may last 24 to 48 hours.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Mobil-O-Graph NG ABPM (24 hour Automatic Blood Pressure Monitor) is a fully automatic table model device that measures blood pressure by means of an inflatable cuff on the upper arm. It employs the Oscillometric Principle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adult
Intended User / Care Setting
Not Found
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): 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.
K 964235
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
K072446/51
p1/2
Image /page/0/Picture/1 description: The image shows the letters "MTC" in a large, bold, serif font. The letters are black against a white background. There is a horizontal line below the letters, and a smaller letter "M" to the right of the "C".
Media Trade Corporation
11820 Red Hibiscus Drive - Bonita Springs, FL 34135 Tel (239) 948-2001 -- Fax (239) 948-2002 E-mail: mediatradecorp@gmx.net Web: www.mediatradecorp.com
510(k) Summary
| Submitter's Name: | NOV 29 2007
Guenter Ginsberg
Media Trade Corporation |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 11820 Red Hibiscus Drive
Bonita Springs, FL 34135 |
| Phone: | (239) 948-2001 |
| Fax: | (239) 948-2002 |
| E-mail: | mediatradecorp@gmx.net
g.ginsberg@gmx.net |
| Contact: | Guenter Ginsberg |
| Date of Summary: | August 10, 2007 |
| Trade Name: | Mobil-O-Graph NG, 24 h ABP-Control |
| Establishment: | I.E.M. GmbH
Registration No. 9617476
Cockerillstrasse 69
52222 Stolberg, Germany |
| Classification | System, Measurement, Blood Pressure, Non-
Invasive
Product Code: DXN
Regulation No. 870.1130
Class: II
Panel: 74 (Cardiovascular) |
1
K072446/51
p2/2
Page -2- (510k Summary)
| Predicate Device: | ABPM Mobil-O-Graph Blood Pressure Monitor
K 964235
Also manufactured by I.E.M. GmbH of Stolberg,
Germany |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | The Mobil-O-Graph NG ABPM (24 hour
Automatic Blood Pressure Monitor) is a fully
automatic table model device that measures blood
pressure by means of an inflatable cuff on the upper
arm. It employs the Oscillometric Principle. |
| Intended Use: | The Mobil-O-Graph NG ABPM system is an
automated, microprocessor controlled blood
pressure monitor which monitors, accumulates and
stores: heart beat (rate), systolic and diastolic data
of an individual adult patient (in the patient's
environment) for a session which may last 24 to 48
hours. |
| Technological Characteristics: | The Mobil-O-Graph NG ABPM has the same
general design and performance characteristics as
the predicate device from I.E.M. GmbH. The main
difference is the physical size, shape and weight,
as well as the option to be interfaced with regular
computers via infrared or Bluetooth technology.
The Mobil-O-Graph NG ABPM has the same
intended use, general design and incorporates
similar materials and components, hence should
therefore raise no new questions of safety and
effectiveness.
This submitter concludes that the Mobil-O-Graph
NG ABPM is therefore substantially equivalent to
the predicate device "ABPM Mobil-O-Graph Blood
Pressure Monitor by the same Establishment: I.E.M.
GmbH of Stolberg, Germany. |
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle faces right and is positioned in the upper right portion of the seal. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", arranged in a circular fashion around the edge of the seal.
NDV 2 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Media Trade Corporation c/o Mr. Guenter Ginsberg President 11820 Red Hibiscus Drive Bonita Springs, FL 34135
Re: K072446
Mobil-O-Graph NG 24h ABP-Control Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system. Regulatory Class: Class II (two) Product Code: DXN Dated: November 14, 2007 Received: November 15, 2007
Dear Mr. Ginsberg:
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. Guenter Ginsberg
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 yours,
Blymmlmon fo
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:
Indications For Use: The Mobil-O-Graph ABPM system is an automated, microprocessor controlled blood pressure monitor which monitors, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual adult patient (in the patient's environment) for a session which may last 24 to 48 hours.
Prescription Use X AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blumstein
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number 122440