(860 days)
K 855127
K 855127
No
The description focuses on standard microprocessor-controlled blood pressure monitoring and data storage, with no mention of AI or ML algorithms for analysis or interpretation. The mention of a "computer program to display a pre-digitized patient image file" and running under a "computer operating system" describes basic software functionality, not AI/ML.
No
The device is a blood pressure monitor used for monitoring, accumulating, and storing heart beat, systolic, and diastolic data. While it provides data for healthcare providers, it does not directly treat or alleviate a disease or condition, which is a characteristic of a therapeutic device. It is a diagnostic/monitoring device.
Yes
The device is a blood pressure monitor that records, stores, and plays back patient data, which is used by healthcare providers to monitor an individual's health, fitting the definition of a diagnostic device.
No
The device description explicitly states it is a "portable device" and a "computerized blood pressure system," implying the inclusion of hardware components for blood pressure monitoring and data acquisition, not just software for data processing and display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device monitors and stores blood pressure data from an individual adult patient in the patient's environment. This is a measurement taken directly from the patient's body, not from a sample of bodily fluid or tissue that is analyzed in vitro (outside the body).
- Device Description: The description reinforces that it's a blood pressure system for clinical applications, again focusing on direct patient measurement.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
In summary, the device is a medical device used for physiological monitoring (blood pressure), not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
This portable device, the ABPM Mobil-o- Graph "" Blood Pressure Monitor manufactured by I.E.M. GmbII is an automated, microprocessor controlled blood pressure monitor which monitors, accumulates and stores: heart beat (rate) systolic und diastolic data of a individual adult-patient (in the patient's environment) for a session which may last 24 to 48 hours.
Product codes
74DSK, 74DXN
Device Description
ABPM Nobil-o- Graph™ Blood Pressure Monitor, Model ABP Control is a computerized blood pressure system designed for clinical applications to allow physicians or other health care providers to record, store, and playback patient data.
Mentions image processing
Both devices use a computer program to display a pre-digitized patient image file. Both devices run under a computer operating system. Both devices use the computer operating system to access the displayed image.
Mentions AI, DNN, or ML
Both use a proprietary algorithm.
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult-patient
Intended User / Care Setting
physicians or other health care providers / clinical applications, patient's environment
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
This device has performance characteristics substantially equivalent to its predicate device yet includes improvements to facilitate the various clinical applications for which it is intended.
This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy.
Key Metrics
Not Found
Predicate Device(s)
K 855127
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
Exhibit 16 Summary of Safety & Effectiveness for ABPM Mobil-o- Graph ™ Blood Pressure Monitor, Model ABP Control
ABPM Nobil-o- Graph™ Blood Pressure Monitor, Model ABP Control is a computerized blood pressure system designed for clinical applications to allow physicians or other health care providers to record, store, and playback patient data.
As such, this device is a Class II device, having Classification Name ABPM Mobil-o- Graph ™ Blood Pressure Monitor , Model ABP Control.
Product Nomenclature | Classification Number | Regulation Number |
---|---|---|
Blood Pressure Computer | 74DSK | 870.1110 |
Non-Invasive Blood Pressure | ||
Measurement System | 74DXN | 870.1130 |
I. E.M. GmbH has determined that this device is substantially equivalent to a predicate medical device which is currently in commerce as the Ultralite Ambulatory Blood Pressure Monitor, Model SL 90202, manufactured by Space Labs, Incorporated of Redwood, Washington (determined substantially equivalent via K 855127). A determination of substantial equivalence is based upon:
Both the ABPM Mobil-o- Graph tm Blood Pressure Monitor, Model ABP Control and Ultralite Ambulatory Blood Pressure Monitor, Model SL 90202 are blood pressure monitors for clinical applications, to allow physicians or other health care providers to record, store, and playback patient data. Both devices use a computer program to display a pre-digitized patient image file. Both devices run under a computer operating system. Both devices use the computer operating system to access the displayed image.
Both devices record, store, and playback patient data Both devices retain an electronically stored sample. Both act on that sample using mathematical computations. Both use a proprietary algorithm. Both use computer programming in a computer operating system.
The ABPM Mobil-o- Graph tm Blood Pressure Monitor, Model ABP Control has benefited from design, development, testing and procedures that conform to Good Manufacturing Procedures. This device has performance characteristics substantially equivalent to its predicate device yet includes improvements to facilitate the various clinical applications for which it is intended.
This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy. I.E.M. GmbH continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.
CERTIFICATION:
I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.
1 Mr. Uwe Korth Director, Product Services I.E.M. GmbH Industrielle Entwicklung Medizintechnik und Vertriebsgesellschaft mbH Cockerillstraße 69 D-52222 Stolberg
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a series of flowing lines, representing health and human services.
MAR - 2 1999
Industrielle Entwicklung Medizintecknik und Vertriebsgesellschaft GmbH c/o Mr. Richard Keen Compliance Consultants 1151 Hope Street Stamford, CT 06907
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
K964235 Re: Mobil-O-Graph™ Blood Pressure Monitor, Model ABP Control Regulatory Class: II (Two) Product Code: 74 DXN February 5, 1999 Dated: Received: February 9, 1999
Dear Mr. Keen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 ecommerce p, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Richard Keen
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Calla Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
From :
10(K) number assigned 510(K) Number (If known): Device Name: __ ABPM Mobil-o- Graph "" Blood Pressure Monitors, Model ABI' Control __ Indications for Use
This portable device, the ABPM Mobil-o- Graph "" Blood Pressure Monitor manufactured by I.E.M. GmbII is an automated, microprocessor controlled blood pressure monitor which monitors, accumulates and stores: heart beat (rate) systolic und diastolic data of a individual adult-patient (in the patient's environment) for a session which may last 24 to 48 hours.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thresl. Shruka
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number 1964) 55
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)