(157 days)
Not Found
No
The summary describes a standard automated blood pressure monitor and associated software for data management and display. There is no mention of AI, ML, or related concepts like training/test sets, algorithms, or performance metrics typically associated with AI/ML devices. The "Augmentation Index AIx" is a physiological parameter, not an indicator of artificial intelligence.
No
The device is used for monitoring, accumulating, and storing blood pressure data, and providing central arterial indices, rather than directly treating a condition.
Yes
The device monitors, accumulates, and stores heart rate, systolic, and diastolic data, and in combination with software, provides a derived ascending aortic blood pressure waveform and central arterial indices for evaluation by a health professional, all of which are diagnostic functions.
No
The device description explicitly lists hardware components: the ABPM 7100 monitor and the brachial blood pressure cuff. While software is part of the system, it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The ABPM 7100 is an ambulatory blood pressure monitor. It measures blood pressure and related indices directly on the patient's body (in vivo) using a cuff. It does not analyze samples taken from the body.
- Intended Use: The intended use describes monitoring blood pressure and central arterial indices in an individual patient. This is a physiological measurement, not an in vitro test.
Therefore, the ABPM 7100 falls under the category of a physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ABPM 7100 is an automated microprocessor controlled ambulatory blood pressure monitor (ABPM) which monitors, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual adult patient's environment) for a session which may last 24 hours.
The ABPM 7100 in combination with Hypertension Management Software (HMS-CS) provides a derived ascending aortic blood pressure waveform and a range of central indices. Use of the Augmentation Index AIx only is restricted to patients of age 40 and above.
It is used with a standard cuff blood pressure measurement.
It is used in those patients where information related to the ascending aortic blood pressure is desired but in the opinion of the physician, the risk of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The ABPM 7100 consist of the following hardware:
- the ABPM 7100 monitor
- the brachial blood pressure cuff -
The ABPM 7100 is available with three different cuff sizes (S, M, L, XL) to adapt to the patient's arm size.
Patient data is stored in the device's memory. The data can then be transmitted to a computer in the physician's office via Bluetooth and Cable. The recordings are displayed for the evaluation by the health professional by the application of the Hypertension Management Software Client Server ("HMS CS").
The ABPM 7100 is used together with the application software the Hypertension Management Software Client Server (HMS-CS 4.7-US) as a system.
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 patient (Use of the Augmentation Index AIx only is restricted to patients of age 40 and above)
Intended User / Care Setting
Physician's office
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)
Performance testing
The ABPM 7100 is substantially equivalent to the predicate device (K110603) - Mobil-O-Graph 24h PWA used in combination with Hypertension Management Software Client Server (HMS-CS 4.3). The hardware, both electrical and non electrical, is identical.
The Electrical Safety test reports presented for the Mobil-O-Graph 24h PWA are equally applicable to the ABPM 7100. The tests were performed according to IEC 60601-1 Medical electrical equipment – Part 1: General requirements for safety and IEC 80601-2-30 Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers.
Software testing
The HMS CS application software was developed and tested according to written internal Procedures that implement the processes described in FDA quidance "General Principles of Software Validation", FDA Guidance for the "Content of Premarket Submissions for Software Contained in Medical Devices"; - and Risk Management was conducted in accordance with ISO 14971.
All required software testing was completed as part of the software verification and validation and all tests passed.
Electrical safety
General requirements for safety were tested according to IEC 60601-1 Medical electrical equipment - Part 1: General requirements for safety.
Electromagnetic compatibility
Electromagnetic compatibility testing covering the emission and immunity of the device was tested according to IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests.
Biocompatibility
All components (brachial blood pressure cuff) in contact with the patient are unchanged from the predicate device (K110603) - Mobil-O-Graph 24h PWA in combination with Hypertension Management Software Client Server (HMS-CS 4.3).
Summary
The ABPM 7100 meets all the stated requirements for overall design, performance, biocompatibility, and electrical safety. Testing according to written protocols confirms that the design outputs meet the design inputs.
The ABPM 7100 passed all testing stated above.
The ABPM 7100 complies with the applicable voluntary standards for biocompatibility, electrical safety and electromagnetic compatibility. The device passed all the testing in accordance with national and international standards.
Clinical Performance Data
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing performed with Mobil-O-Graph 24h PWA (predicate device) remain applicable for the ABPM 7100.
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top and left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2014
I.E.M. GmbH c/o Mr. Arne Briest Regulatory Affairs Cockerillstraße 69 52222 Stolberg Germany
Re: K140928
Trade/Device Name: ABPM 7100 PWA with Hypertension Management Software Client Server 4.7 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN Dated: July 11, 2014 Received: July 14, 2014
Dear Mr. Briest:
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.
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
1
Page 2 - Mr. Arne Briest
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours. 2014.09.15 15:32:05 -04'00'
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K140928
Device Name
ABPM 7100 used with the application software the Hypertension Management Software Client Server (HMS-CS)
Indications for Use (Describe)
The ABPM 7100 is an automated microprocessor controlled ambulatory blood pressure monitor (ABPM) which monitors, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual adult patient's environment) for a session which may last 24 hours.
The ABPM 7100 in combination with Hypertension Management Software (HMS-CS) provides a derived ascending aortic blood pressure waveform and a range of central indices. Use of the Augmentation Index AIx only is restricted to patients of age 40 and above.
It is used with a standard cuff blood pressure measurement.
It is used in those patients where information related to the ascending aortic blood pressure is desired but in the opinion of the physician, the risk of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/4 description: The image shows a logo with the letters 'I' and 'M' in a bold, sans-serif font. To the right of the 'I' is a shaded sphere with a white, stylized 'E' on its surface. The 'I' and 'M' are positioned on either side of the sphere, creating a balanced and modern design. The logo is presented in grayscale, with the sphere having a gradient effect to give it a three-dimensional appearance.
Section 06- Executive Summary
Submission Sponsor and Correspondent 1.
I.E.M. GmbH
(Industrielle Entwicklung Medizintechnik und Vertriebsgesellschaft mbH)
Cockerillstraße 69
52222 Stolberg
Germany
Phone: +49 (0)2402 - 9500 0
+49 (0)2402 - 9500 11 Fax:
Contact: Mr. Arne Briest
Homepage: www.iem.de
FDA Establishment Registration #: 9617476
Date Prepared 2.
April 4, 2014
Device Identification 3.
| Trade/Proprietary Name: | ABPM 7100 used with Hypertension Management Software
Client Server (HMS-CS) | |
|----------------------------|--------------------------------------------------------------------------------|--|
| Common/Usual Name: | Noninvasive blood pressure measurement system | |
| Classification Name: | System, Measurement, Blood-Pressure, Non-Invasive | |
| Classification Regulation: | CFR 870.1130 | |
| Product Code: | DXN | |
| Device Class: | Class II | |
| Classification Panel: | Cardiovascular | |
4
Image /page/4/Picture/4 description: The image shows a logo with the letters 'IEM' in a stylized design. The 'I' and 'M' are in a bold, sans-serif font and are positioned on either side of a sphere. The sphere has a white shape on it that resembles a stylized 'E'. The overall design is simple and modern, with a focus on the letters and the spherical element.
4. Legally Marketed Predicate Device
K110603 Mobil-O-Graph 24h PWA and HMS CS Version 4.3 by l.E.M. GmbH
-
- Device Description:
The ABPM 7100 consist of the following hardware:
- Device Description:
-
the ABPM 7100 monitor
-
the brachial blood pressure cuff -
The ABPM 7100 is available with three different cuff sizes (S, M, L, XL) to adapt to the patient's arm size.
Patient data is stored in the device's memory. The data can then be transmitted to a computer in the physician's office via Bluetooth and Cable. The recordings are displayed for the evaluation by the health professional by the application of the Hypertension Management Software Client Server ("HMS CS").
The ABPM 7100 is used together with the application software the Hypertension Management Software Client Server (HMS-CS 4.7-US) as a system.
Image /page/4/Figure/14 description: The image shows a diagram of the ABPM 7100 system. The ABPM 7100 device is shown on the left, and a computer with management software is shown on the right. Arrows indicate the flow of data between the device and the computer, with Bluetooth and RS232 cable communication. The software is labeled as HMS CS form I.E.M.
Major System Components
Figure 06-1 Major System Components
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Image /page/5/Picture/4 description: The image shows a logo with the letters "I" and "M" in a bold, sans-serif font. To the upper left of the letters is a gray sphere with a white shape on it that resembles the letter "E". The sphere appears to be casting a shadow on the white background. The logo is simple and modern in design.
6. Indications for Use:
The ABPM 7100 is an automated microprocessor controlled ambulatory blood pressure monitor (ABPM) 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 hours.
The ABPM 7100 in combination with Hypertension Management Software Client Server (HMS-CS) provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. Use of the Augmentation Index Aix only is restricted to patients of age 40 and above.
It is used with a standard cuff blood pressure measurement.
It is used in those patients where information related to the ascending aortic blood pressure is desired but in the opinion of the physician, the risk of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.
7. Substantial Equivalence Discussion
The following table A and B compares the ABPM 7100 to the predicate device with respect to technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
The intended use of both the ABPM 7100 and the predicate are identical.
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Image /page/6/Picture/4 description: The image shows a logo with the letters 'I' and 'M' in a bold, sans-serif font. The letter 'I' is positioned to the left of a shaded sphere, and the letter 'M' is to the right. A stylized letter 'E' is overlaid on the sphere, creating a three-dimensional effect. The logo has a clean and modern design.
Device Comparison Summary:
Table A – Device Comparison Table
| Manufacturer | I.E.M. GmbH | I.E.M. GmbH |
|---|---|---|
| ABPM 7100 | Mobil-O-Graph | |
| (in combination with | (24h PWA in combination with | |
| Trade name | Hypertension Management | Hypertension Management |
| Software Client Server | Software Client Server | |
| (HMS-CS 4.7-US)) | (HMS-CS 4.3) | |
| 510(k) Number | TBD | K110603 |
| Product Code | DXN | DXN |
| Regulation Number | 870.1130 | 870.1130 |
| Class | II | II |
| Regulation Name | Non-Invasive blood pressure | Non-Invasive blood pressure |
| measurement system | measurement system | |
| Sterile | non-sterile | non-sterile |
| Single-Use | NO | NO |
| Power | 2 alkaline 1,5 V batteries (AA) or | 2 alkaline 1,5 V batteries (AA) or |
| rechargeable 1.2 V (AA) | rechargeable 1.2 V (AA) | |
| Cuffs | Identical | |
| Communication: | ||
| Bluetooth, USB | ||
| connector, Infrared, | ||
| Serial RS232 | YES | YES |
| Latex free | YES | YES |
| Complies with ISO | ||
| 10993-1 | YES | YES |
| Electrical safety | ||
| testing passed | YES | YES |
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Image /page/7/Picture/4 description: The image shows a logo with the letters 'IEM' in a stylized design. The 'I' is a simple, bold letter, while the 'E' is integrated into a sphere, partially obscuring it. The 'M' is also a bold letter, positioned to the right of the sphere. The overall design is clean and modern, with a focus on the acronym 'IEM'.
Table B – Software Comparison Table
| Manufacturer | I.E.M. GmbH | I.E.M. GmbH |
|---|---|---|
| Trade name | HMS-CS 4.7 US | HMS-CS 4.3 US |
| 510(k) Number | TBD | K110603 |
| Product Code | DXN | DXN |
| Regulation Number | 870.1130 | 870.1130 |
| Class | II | II |
| Regulation Name | Non-Invasive blood pressure measurement system | Non-Invasive blood pressure measurement system |
| Patient management | List, select from list, modify, delete, import, export | List, select from list, modify, delete, import, export |
| Overview of measurement data | Overview of all measurements with date/time and type | Overview of all measurements with date/time and type |
| Print report with patient data, graph and comments | YES | YES |
| Common database for the data collected by the compatible devices | YES | YES |
| Compatibility with other devices | HMS-CS may only be used in the United States with devices currently cleared by the FDA. | HMS-CS may only be used in the United States with devices currently cleared by the FDA. |
Non-Clinical Performance Data 8.
As part of demonstrating safety and effectiveness of ABPM 7100 and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, I.E.M. completed a number of tests.
8
Performance testing
The ABPM 7100 is substantially equivalent to the predicate device (K110603) - Mobil-O-Graph 24h PWA used in combination with Hypertension Management Software Client Server (HMS-CS 4.3). The hardware, both electrical and non electrical, is identical.
The Electrical Safety test reports presented for the Mobil-O-Graph 24h PWA are equally applicable to the ABPM 7100. The tests were performed according to IEC 60601-1 Medical electrical equipment – Part 1: General requirements for safety and IEC 80601-2-30 Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers.
Software testing
The HMS CS application software was developed and tested according to written internal Procedures that implement the processes described in FDA quidance "General Principles of Software Validation", FDA Guidance for the "Content of Premarket Submissions for Software Contained in Medical Devices"; - and Risk Management was conducted in accordance with ISO 14971.
All required software testing was completed as part of the software verification and validation and all tests passed.
Electrical safety
General requirements for safety were tested according to IEC 60601-1 Medical electrical equipment - Part 1: General requirements for safety.
Electromagnetic compatibility
Electromagnetic compatibility testing covering the emission and immunity of the device was tested according to IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests.
9
Image /page/9/Picture/4 description: The image shows a logo with a stylized design. The logo features a gray sphere with a white "E" shape cut out of it. To the right of the sphere are the letters "M" in a bold, sans-serif font. The overall design is simple and modern.
Biocompatibility
All components (brachial blood pressure cuff) in contact with the patient are unchanged from the predicate device (K110603) - Mobil-O-Graph 24h PWA in combination with Hypertension Management Software Client Server (HMS-CS 4.3).
Summary
The ABPM 7100 meets all the stated requirements for overall design, performance, biocompatibility, and electrical safety. Testing according to written protocols confirms that the design outputs meet the design inputs.
The ABPM 7100 passed all testing stated above.
The ABPM 7100 complies with the applicable voluntary standards for biocompatibility, electrical safety and electromagnetic compatibility. The device passed all the testing in accordance with national and international standards.
9. Clinical Performance Data
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing performed with Mobil-O-Graph 24h PWA (predicate device) remain applicable for the ABPM 7100.
10
Image /page/10/Picture/4 description: The image shows a logo with the letters 'I', 'E', and 'M'. The 'I' and 'M' are in a bold, sans-serif font and are positioned on either side of a sphere. The sphere has the letter 'E' on it, which is stylized to appear as if it is wrapping around the sphere. The overall design is simple and modern, with a focus on the letters and the spherical element.
10. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
It has been shown in this 510(k) submission that the difference between the ABPM 7100 together with the HMS CS 4.7-US application software and the predicate devices do not raise any questions regarding its safety and effectiveness.
Performance testing and compliance with voluntary standards, demonstrate that the ABPM 7100 and the HMS CS 4.7-US application software are substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use.
The ABPM 7100 and the HMS CS application software, as designed and manufactured, are determined to be substantially equivalent to the referenced predicate devices.