ABPM 7100, Hypertension Management Software

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure in profile, with three overlapping heads suggesting a sense of community and support. The figure is positioned within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling it. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 19, 2016 I.E.M. GmbH Hella Witt Regulatory Affairs Cockerillstr.69 Stolberg, 52222 DE Germany Re: K153557 Trade/Device Name: ABPM 7100, Hypertension Management Software version 5.0 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 15, 2016 Received: June 20, 2016 Dear Hella Witt: 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours. Mude Jellman for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K153557 Device Name ABPM 7100 used with the application software Hypertension Management Software (HMS) Indications for Use (Describe) The ABPM 7100 is an automated, microprocessor controlled ambulatory blood pressure monitor (ABPM) which records, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual patient (in the patient's environment) for a session which may last 24 hours. Ambulatory monitoring is not supported for the 14-20 cm cuff size. It is used with a standard upper-arm cuff for blood pressure measurement. The ABPM 7100 in combination with the Hypertension Management Software (HMS) provides a derived ascending aortic blood pressure wave form and a range of central indices. It is used in those adult patients, where information related to the ascending aortic blood pressure is desired, but in 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) | <span style="text-decoration: underline;"><b> <svg height="16" width="16"> <rect height="16" style="fill:white;stroke:black;stroke-width:1" width="16"></rect> <path d="M2 2 L 14 14 M 14 2 L 2 14" stroke="black" stroke-width="2"></path> </svg> </b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span> <svg height="16" width="16"> <rect height="16" style="fill:white;stroke:black;stroke-width:1" width="16"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff *PRAStaff@fda.hhs.gov* *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* {3}------------------------------------------------ # Section 05: 510(k) Summary #### Submission Sponsor and Correspondent I.E.M. GmbH (Industrielle Entwicklung Medizintechnik und Vertriebsgesellschaft mbH) Cockerillstraße 69 52222 Stolberg Germany Phone: +49 2402 9500 75 Fax: +49 2402 9500 11 Contact: Hella Witt FDA Establishment Registration # 9617476 Date prepared: December 2015 #### Device identification | Trade Name | ABPM 7100 with Hypertension Management Software | |----------------------------|-------------------------------------------------| | Common name: | Noninvasive blood pressure measurement system | | Classification Regulation: | CFR 870.1130 | | Product Code: | DXN | | Device Class: | Class II | | Classification Panel: | Cardiovascular | #### Legally Marketed Predicate Device K140928, ABPM 7100 PWA with Hypertension Management Software Client Server 4.7 Image /page/3/Picture/20 description: The image shows a logo with the letters 'I' and 'M'. The 'I' is in a smaller font and is placed to the left of a gray sphere. A white shape that resembles the letter 'E' is on the sphere. The letter 'M' is in a larger font and is placed to the right of the sphere. {4}------------------------------------------------ # Device Description The ABPM 7100 applies the oscillometric principle for blood pressure measurements. The ABPM 7100 consists of the following hardware: - the ABPM 7100 recorder - - the brachial blood pressure cuff - The ABPM 7100 is available with five different cuff sizes to adapt to the patient's arm size. Initially, the device is prepared for a new patient and measurements are started. Measurement data is recorded and stored in the device's memory. The data can then be transmitted to a computer in the physician's office via Bluetooth or cable for storage, presentation and analysis. Central Blood Pressure (CBP) calculation is realized through Pulse Wave Analysis, conducted by the Hypertension Management Software with CBP Upgrade. # Indications for Use: - The ABPM 7100 is an automated, microprocessor controlled ambulatory blood ● pressure monitor (ABPM) which records, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual patient (in the patient's environment) for a session which may last 24 hours. Ambulatory monitoring is not supported for the 14-20 cm cuff size. - . It is used with a standard upper-arm cuff for blood pressure measurement. - The ABPM 7100 in combination with the Hypertension Management Software ● (HMS) provides a derived ascending aortic blood pressure wave form and a range of central arterial indices. It is used in those adult 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. Image /page/4/Picture/15 description: The image shows a logo with the letters 'I' and 'M'. To the right of the 'I' is a sphere. The letters are in a bold, sans-serif font. The logo appears to be for a company or organization, but without additional context, it is difficult to determine the specific purpose or industry. {5}------------------------------------------------ Image /page/5/Picture/4 description: The image shows a logo with the letters "IEM" in a stylized design. The "E" is white and appears to be overlaid on a gray sphere, while the "I" and "M" are in a bold, sans-serif font and are positioned to the left and right of the sphere, respectively. The overall design is simple and modern, with a focus on the three letters. ## Device Comparison Summary | Trade name | ABPM 7100 | ABPM 7100 | |-------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------| | Manufacturer | I.E.M GmbH | I.E.M GmbH | | 510(k) Number | K140928 | K153557 | | Product Code | DXN | DXN | | Regulation Number | 870.1130 | 870.1130 | | Class | II | II | | Regulation Name | Non-Invasive blood pressure<br>measurement system | Non-Invasive blood pressure<br>measurement system | | Sterile | non-sterile | non-sterile | | Single-Use | NO | NO | | Power | 2 alkaline 1.5 V batteries (AA) or<br>rechargeable 1.2 V (AA) | 2 alkaline 1.5 V batteries (AA) or<br>rechargeable 1.2 V (AA) | | Measurement<br>principle | Oscillometric | Oscillometric | | Complies with ISO<br>81060-2 | YES | YES | | Cuff | 4 cuff sizes | 5 cuff sizes | | Latex free | YES | YES | | Complies with ISO<br>10993-1 | YES | YES | | Electrical safety<br>testing passed | YES | YES | Table A : Device technical comparison {6}------------------------------------------------ Image /page/6/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 gray sphere. The letter 'E' is white and appears to be overlaid on the sphere, creating a three-dimensional effect. The overall design is simple and modern. | | Table B: Comparison IEM Analysis Software<br>Hypertension Management | | |----------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------| | | Hypertension Management<br>Software Client Server<br>(HMS CS) | Hypertension Management<br>Software (HMS) | | Trade name<br>analysis software | | | | Software version | HMS CS 4.7-US | HMS 5.0 | | Manufacturer | I.E.M GmbH | I.E.M GmbH | | 510(k) Number | K140928 | K153557 | | Product Code | DXN | DXN | | Regulation Number | 870.1130 | 870.1130 | | Class | II | II | | Regulation Name | Non-Invasive blood pressure<br>measurement system | Non-Invasive blood pressure<br>measurement system | | Patient<br>management | List, select from list, modify,<br>delete, import, export | List, select from list, modify,<br>delete, import, export | | Overview of<br>measurement data | Overview of all measurements<br>with date/time and type | Overview of all measurements<br>with date/time and type | | Print report with<br>patient data, graph<br>and comments | YES | YES | | Pulse Wave<br>Analysis | Generally accessible with HMS<br>CS 4.7 | Accessible with HMS 5.0 and<br>CBP Upgrade license | | Compatibility with<br>other devices | Common database for the data<br>collected by compatibly I.E:M.<br>devices | Compatibility with ABPM 7100 | Table B: Technical comparison analysis software #### Substantial Equivalence Discussion Full blood pressure measurement technology, hardware including electrical components, sensors and safety circuits are the same as of the cleared device. The embedded device software (=firmware) algorithms for blood pressure measurement are the same. {7}------------------------------------------------ ## Section 05: 510(k) Summary Image /page/7/Picture/14 description: The image shows a logo with the letters 'I' and 'M' in a bold, sans-serif font. To the right of the 'I' and slightly above the baseline, there is a shaded sphere with a white, curved shape on its surface, possibly representing a stylized 'E' or a crescent. The overall design is simple and modern, with a focus on the letters and the geometric shape. Functionality and technology for read-out, storage, evaluation and display of data related to ambulatory blood pressure monitoring (ABPM) and Pulse Wave Analysis is substantially equivalent. Modifications for the customization of the software followed written internal procedures that implement the processes described in FDA Guidance "General Principles of Software Validation", and Risk Management conducted in accordance with ISO 14971. All required software testing was completed as part of the software verification and validation, and all tests passed. Following device modifications, the ABPM 7100 in combination with the Hypertension Management Software (HMS) meets all the requirements for overall design. Testing confirms that the design output meets the design inputs. The ABPM 7100 with HMS passed all testing, which supports the claims of substantial equivalence and safe operation. The ABPM 7100 passed all testing in accordance with applicable voluntary standards for Electrical safety, electromagnetic compatibility and biocompatibility. Performance testing according to recognized standards confirms compliance with the particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment. Accuracy testing of blood pressure measurements was conducted in sitting position with adults and children (age group 3-12 years), and covered the new cuff size (14-20 cm). Erqometer validation conducted for ambulatory monitoring did not include the new cuff size (14-20 cm) The clinical validation demonstrates adequate NIBP accuracy in accordance with ISO 81060-2, and shows that product specifications are met in compliance to the intended use. Accuracy tests were conducted according to ISO 81060-2: 2013 - -Section 5.2.4.2 (same arm sequential measurements), and - । Section 5.2.6 (additional requirements for use in ambulatory monitoring), applying the opposite arm simultaneous method for the ergometer validation. {8}------------------------------------------------ Image /page/8/Picture/4 description: The image shows a logo with the letters "I" and "M" next to a sphere. The sphere has a white section that looks like a "E" on it. The letters and sphere are all in shades of gray, and there is a slight shadow under the logo. # Test results - Same arm sequential measurements (ISO 81060-2): | Mean error of determination (Criterion 1) | | | | |-------------------------------------------------------------------------------|----------------------|-------------------------------------------|----------| | | Mean error and (sd) | Acceptance for mean error<br>and sd | Judgment | | SBP | 1.9 mmHg (6.6 mmHg) | $\pm$ 5.0 mmHg (8.0 mmHg) | Pass | | DBP | -2.0 mmHg (5.5 mmHg) | $\pm$ 5.0 mmHg (8.0 mmHg) | Pass | | Standard deviation of averaged paired determination per subject (Criterion 2) | | | | | | Standard deviation | Maximum permissible<br>standard deviation | Judgment | | SBP | 5.44 mmHg | 6.68 mmHg | Pass | | DBP | 4.48 mmHg | 6.65 mmHg | Pass | ## Test results – Ambulatory monitoring (ergometer validation) | Mean error of determination (Criterion 1) | | | | |-------------------------------------------------------------------------------|----------------------|-------------------------------------------|----------| | | Mean error and (sd) | Acceptance for mean error<br>and sd | Judgment | | SBP | -0.2 mmHg (7.2mmHg) | ± 5.0 mmHg (8.0 mmHg) | Pass | | DBP | -1.2 mmHg (6.3 mmHg) | ± 5.0 mmHg (8.0 mmHg) | Pass | | Standard deviation of averaged paired determination per subject (Criterion 2) | | | | | | Standard deviation | Maximum permissible<br>standard deviation | Judgment | | SBP | 4.00 mmHg | 6.95 mmHg | Pass | | DBP | 4.04 mmHg | 6.84 mmHg | Pass | {9}------------------------------------------------ ## Section 05: 510(k) Summary ## Conclusion From Risk Assessment and device testing I.E.M. concludes that the modified device performs as well and is as save as the predicate device. Performance testing confirms that product specifications are met in accordance with the technological characteristics and the intended use. The modified ABPM 7100 meets all the stated requirements for overall design, performance, biocompatibility, electrical safety and electromagnetic compatibility. The device passed all testing in accordance with the applicable voluntary international standards. The ABPM 7100 with Hypertension Management Software are substantially equivalent to the predicate device ABPM 7100 with HMS CS. Image /page/9/Picture/9 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 shape on its surface that resembles the letter 'E'. The letters and sphere are arranged in a way that suggests a three-dimensional perspective, with the sphere appearing slightly behind and above the letters.