(222 days)
No
The summary explicitly states that the software "does not perform diagnostics" and "makes no diagnosis." It focuses on measurement, recording, and display of physiological signals, with physicians performing the diagnostic evaluations. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is described as a measurement, recording, and display system for physiological signals, not for treating any condition. Its intended use explicitly states, "The system is only for measurement, recording and display. It makes no diagnosis."
No
The text explicitly states: "The Software does not perform diagnostics. Physicians carry out diagnostics evaluations of this data. The system is only for measurement, recording and display. It makes no diagnosis."
No
The device description explicitly states that the ABPMpro consists of hardware components including a recorder, blood pressure cuff, and optional sensors. The software component is used to transfer and analyze data from this hardware.
Based on the provided information, the ABPMpro Ambulatory Blood Pressure Recorder is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- ABPMpro Function: The ABPMpro directly measures physiological signals from the human body (blood pressure, ECG, plethysmogram, body position, activity) using non-invasive methods (cuff, electrodes, sensors). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for acquiring and recording signals, and the software is for transferring and displaying this data. It explicitly states that the software does not perform diagnostics and that physicians carry out diagnostic evaluations of this data. The system is for "measurement, recording and display. It makes no diagnosis."
Therefore, the ABPMpro falls under the category of a medical device that directly measures physiological parameters from the patient, rather than an IVD that analyzes specimens.
N/A
Intended Use / Indications for Use
ABPMpro Ambulatory Blood Pressure Recorder is a Non-Invasive oscillometric and ECG device intended to acquire Ambulatory non-invasive Blood Pressure signals and 3 Channel ECG signals from the upper body surfaces. Cardiac rhythm is acquired via 3 Channel ECG signals. Additional physiological signals like plethysmogram, body position and activity are also measured. The Recorder is intended for adults and children who are over the age of 12 years. ABPMpro Software allows transfer of Blood Pressure-, ECG- and data from additional signals from the Recorder to a Windows-based PC-based computer program via USB cable for the purpose of creating reports and printouts. The Software does not perform diagnostics. Physicians carry out diagnostics evaluations of this data. The system is only for measurement, recording and display. It makes no diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
DSH, DXN
Device Description
The ABPMpro is a portable device for recording physiological signals. The ABPMpro is used as a long-term blood pressure as well as a long-term ECG device. The ABPMpro is a portable device worn on the upper arm by means of a cuff and used as an oscillometric 24h ambulatory blood pressure recorder. The ABPMpro consists of the following hardware: - . ABPMpro recorder with integrated accelerometer and position sensor; - . Brachial blood pressure cuff (3 sizes available) - . Optional: 3-channel ECG sensor - . Optional: Plethysmogram-sensor (LED) Following the completion of the patient recording session, the device, cuff and electrodes are removed from the patient. The ABPMPro is connected to the PC using the USB cable. With the downloaded ABPMpro Analyzer Software open on the PC, the user can download the recorded data. The user can select the patient data and begin analysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper body surfaces, upper arm. The ABPMpro sensor is located on the left upper chest.
Indicated Patient Age Range
Adults and children who are over the age of 12 years.
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D). Hospital, clinic and home use.
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
Clinical Testing: SOMNOmedics GmbH sponsored an open, prospective, clinical validation study to evaluate the accuracy of the APBMpro oscillometric, upper arm device for ambulatory blood pressure (BP) measurement in general population according to the AAMI/ESH/ISO and FDA recognized Universal Standard (ISO 81060-2:2018) both at rest (primary objective) and under dynamic exercise (secondary objective). The clinical investigation received Ethics Committee approval and was conducted in accordance with good clinical practice (GCP) as described in 21 CFR 812.28(a)(1).
General validation study: N=90 age between 12-76, Mean age 39.7 ± 15.1, male 47 (52%), female 43 (48%)
Ambulatory validation study: N=36 age between 22-65, mean age 40.9 ± 11.0, male 20 (56%), female 16 (44%)
Reference blood pressure: A calibrated (accuracy according to the test protocol for Boso Nova S, Jungingen, Germany is ± 1 mmHg), standard aneroid sphygmomanometer, was used for simultaneous auscultatory reference BP measurements by two observers, using a dual-head teaching stethoscope (Prestige Medical, Northridge, USA). Four different cuff sizes (14-21, 22-32, 33-41, >41 cm) were selected to meet the requirements of the AAMI/ESH/ISO universal standard.
Procedure: The 'same arm sequential method' described in the universal standard was used.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to confirm compliance to device specifications. All functions were verified to operate as designed. Signal recorded by the ABPMpro underwent performance testing demonstrating that all signal types being recorded comply with the performance criteria set forth by SOMNOmedics that includes the minimum performance specification recommended by the applicable standards for IEC 80601-2-30, which sets forth the definitive standard for devices intended for use in evaluating automated noninvasive sphygmomanometer, and IEC 60601-2-47 for ambulatory ECG.
Usability validation was performed under actual conditions within a clinical study to assess the effectiveness of implemented risk mitigations and confirm safety of the device when used as intended. No incidents of use-related errors were reported. The device was found to be safe and effective for the intended users, use, and use environments. The ABPMpro is not validated for use in exercise stress testing or strenuous exercise. Under certain circumstances, for instance transport in vehicles can have an impact on the measurement results.
Clinical Testing: SOMNOmedics GmbH sponsored an open, prospective, clinical validation study to evaluate the accuracy of the APBMpro oscillometric, upper arm device for ambulatory blood pressure (BP) measurement in general population according to the AAMI/ESH/ISO and FDA recognized Universal Standard (ISO 81060-2:2018) both at rest (primary objective) and under dynamic exercise (secondary objective). The clinical investigation received Ethics Committee approval and was conducted in accordance with good clinical practice (GCP) as described in 21 CFR 812.28(a)(1).
This study showed that the ABPMpro fulfils the accuracy criteria of the ISO 81060-2:2018, both in the general validation as well as in the ambulatory validation study. Thus, the device is recommended for clinical use in adolescents and adults.
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.
Vasomedical-Biox, K092785
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.
SOMNOscreen plus , K201054
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
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 27, 2023
SOMNOmedics GmbH % Cherita James Regulatory Consultant M Squared Associates/ a PPG Company 127 West 30th St Floor 9 New York, New York 10001
Re: K231104
Trade/Device Name: ABPMpro Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: DSH, DXN Dated: October 19, 2023 Received: October 19, 2023
Dear Cherita James:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231104
Device Name ABPMpro
Indications for Use (Describe)
ABPMoro Ambulatory Blood Pressure Recorder is a Non-Invasive oscillometric and ECG device intended to acquire Ambulatory non-invasive Blood Pressure signals and 3 Channel ECG signals from the upper body surfaces. Cardiac rhythm is acquired via 3 Channel ECG signals. Additional physiological signals like plethysmogram, body position and activity are also measured. The Recorder is intended for adults and children who are over the age of 12 years. ABPMpro Software allows transfer of Blood Pressure-, ECG- and data from additional signals from the Recorder to a Windows-based PC-based computer program via USB cable for the purpose of creating reports and printouts. The Software does not perform diagnostics. Physicians carry out diagnostics evaluations of this data. The system is only for measurement, recording and display. It makes no diagnosis."
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(K) SUMMARY
The following information is provided as required by 21 CFR § 807.87 for low impedance cream lic2® 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.
Sponsor: SOMNOmedics GmbH Am Sonnenstuhl 63 Randersacker, Germany D-97236
- Contact: Cherita James M Squared Associates/a PPG Comapny 127 West 30th Street 9th Floor New York, New York 10001 Ph: 347-954-0624 CJames(@MSquaredAssociates.com
Submitted Date:, October 19, 2023
Proprietary Name: ABPMpro
Common Name: ambulatory ECG and non-invasive blood pressure monitor and recorder
Regulatory Class: II
870.2800 Recorder, Magnetic Tape, Medical; 870.1130 System, Measurement, Regulation:
Blood-Pressure, Non-Invasive
Panel: Cardiovascular
Product Codes: DSH, DXN
Predicate Device: Primary- Vasomedical-Biox, K092785
Reference- SOMNOscreen plus , K201054
Device Description: The ABPMpro is a portable device for recording physiological signals. The ABPMpro is used as a long-term blood pressure as well as a long-term ECG device.
The ABPMpro is a portable device worn on the upper arm by means of a cuff and used as an oscillometric 24h ambulatory blood pressure recorder.
The ABPMpro consists of the following hardware:
- . ABPMpro recorder with integrated accelerometer and position sensor;
- . Brachial blood pressure cuff (3 sizes available)
- . Optional: 3-channel ECG sensor
- . Optional: Plethysmogram-sensor (LED)
Following the completion of the patient recording session, the device, cuff and electrodes are removed from the patient. The ABPMPro is connected to the PC using the USB cable. With the
5
downloaded ABPMpro Analyzer Software open on the PC, the user can download the recorded data. The user can select the patient data and begin analysis.
The device is intended for prescription use.
Indications for Use: ABPMpro Ambulatory Blood Pressure Recorder is a Non-Invasive oscillometric and ECG device intended to acquire Ambulatory non-invasive Blood Pressure signals and 3 Channel ECG signals from the upper body surfaces. Cardiac rhythm is acquired via 3 Channel ECG signals. Additional physiological signals like plethysmogram, body position and activity are also measured. The Recorder is intended for adults and children who are over the age of 12 years.
ABPMpro Software allows transfer of Blood Pressure-, ECG- and data from additional signals from the Recorder to a Windows-based PC-based computer program via USB cable for the purpose of creating reports and printouts. The Software does not perform diagnostics. Physicians carry out diagnostics evaluations of this data. The system is only for measurement, recording and display. It makes no diagnosis.
Performance: Performance testing was conducted to confirm compliance to device specifications. All functions were verified to operate as designed. Signal recorded by the ABPMpro underwent performance testing demonstrating that all signal types being recorded comply with the performance criteria set forth by SOMNOmedics that includes the minimum performance specification recommended by the applicable standards for IEC 80601-2-30, which sets forth the definitive standard for devices intended for use in evaluating automated noninvasive sphygmomanometer, and IEC 60601-2-47 for ambulatory ECG.
Usability validation was performed under actual conditions within a clinical study to assess the effectiveness of implemented risk mitigations and confirm safety of the device when used as intended. No incidents of use-related errors were reported. The device was found to be safe and effective for the intended users, use, and use environments. The ABPMpro is not validated for use in exercise stress testing or strenuous exercise. Under certain circumstances, for instance transport in vehicles can have an impact on the measurement results.
Standards
SOMNOmedics GmbH has demonstrated compliance with the following standards for the
6
ABPMpro.
| Standard |
|---|
| ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) |
| Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601- |
| 1:2005, MOD) |
| IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential |
| performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential |
| performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used |
| in the home healthcare environment |
| IEC 60601-2-47 Edition 2.0 2012-02 |
| Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of |
| ambulatory electrocardiographic systems |
| IEC 80601-2-30: Edition 2.0 2018-03 |
| Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of |
| automated non-invasive sphygmomanometers |
| IEC 62366-1:2015 + COR1:2016 Medical devices - Part 1: Application of usability engineering to medical devices |
| [Including CORRIGENDUM 1 (2016)] |
| ISO 14971:2007 Medical devices - Application of risk management to medical devices |
| IEC 62304:2006 + A1:2015 Medical device software - Software life cycle processes [Including Amendment 1 |
| (2016)] |
| ISO 81060-2 Third edition 2018-11 |
| Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type |
| ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a |
| risk management process |
| ISO 10993-5 Third edition 2009-06-01 |
| Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| ISO 10993-10 Fourth edition 2021-11 |
| Biological evaluation of medical devices - Part 10: Tests for skin sensitization |
Software validation and cybersecurity assessment for Tier 2 risk level are provided to support the substantial equivalence of the subject device to the predicates.
Clinical Testing: SOMNOmedics GmbH sponsored an open, prospective, clinical validation study to evaluate the accuracy of the APBMpro oscillometric, upper arm device for ambulatory blood pressure (BP) measurement in general population according to the AAMI/ESH/ISO and FDA recognized Universal Standard (ISO 81060-2:2018) both at rest (primary objective) and under dynamic exercise (secondary objective). The clinical investigation received Ethics Committee approval and was conducted in accordance with good clinical practice (GCP) as described in 21 CFR 812.28(a)(1).
Patient population
General validation study:
N=90 age between 12-76, Mean age 39.7 ± 15.1, male 47 (52%), female 43 (48%) Ambulatory validation study:
N=36 age between 22-65, mean age 40.9 ± 11.0, male 20 (56%), female 16 (44%) From Publication:
7
Reference blood pressure
A calibrated (accuracy according to the test protocol for Boso Nova S, Jungingen, Germany is ± 1 mmHg), standard aneroid sphygmomanometer, was used for simultaneous auscultatory reference BP measurements by two observers, using a dual-head teaching stethoscope (Prestige Medical, Northridge, USA). Four different cuff sizes (14-21, 22-32, 33-41, >41 cm) were selected to meet the requirements of the AAMI/ESH/ISO universal standard.
Procedure
The 'same arm sequential method' described in the universal standard was used.
This study showed that the ABPMpro fulfils the accuracy criteria of the ISO 81060-2:2018, both in the general validation as well as in the ambulatory validation study. Thus, the device is recommended for clinical use in adolescents and adults.
8
Substantial Equivalence Comparison
| Features /
Technical
Information | ABPMpro | Vasomedical-Biox
Primary predicate | SOMNOscreen plus
Reference predicate | Substantial
Equivalence |
|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DXN, DSH | DSH, DXN | MNR, OLV | |
| K-Number | Not yet assigned. | K092785 | K201054 | |
| Indications for Use: | ABPMpro Ambulatory Blood Pressure
Recorder is a Non-Invasive oscillometric
and ECG device intended to acquire
Ambulatory non-invasive Blood Pressure
signals and 3 Channel ECG signals from the
upper body surfaces. Cardiac rhythm is
acquired via 3 Channel ECG signals.
Additional physiological signals like
plethysmogram, body position and activity
are also measured. The Recorder is intended
for adults and children who are over the age
of 12 years.
ABPMpro Software allows transfer of
Blood Pressure-, ECG- and data from
additional signals from the Recorder to a
Windows based PC-based computer
program via USB cable for the purpose of
creating reports and printouts. The Software
does not perform diagnostics. Physicians
carry out diagnostics evaluations of this
data.
The system is only for measurement,
recording and display. It makes no
diagnosis. | Vasomedical-Biox Combined
Ambulatory ECG and Blood
Pressure Recorder is a Non-
Invasive oscillometric device
intended to acquire Ambulatory
3 Channel ECG signals and
non-invasive Blood Pressure
signals from the upper body
surfaces. Cardiac rhythm is
acquired via 3 Channel ECG
signals. The Recorders are
intended for adults and children
who are over the age of six
years.
Vasomedical-Biox Ambulatory
ECG CB Series Analysis
System Software allows
transfer of ECG and Blood
Pressure data from the
Recorder to a Windows based
PC-based computer program
via a removable and large
capacity storage card (SD) for
the purpose of creating reports
and printouts. The Software
does not perform diagnostics.
Physicians carry out
diagnostics evaluations of this
data.
The system is only for
measurement, recording and
display. It makes no diagnosis. | The SOMNOscreen®
plus is a non-life-
supporting portable
physiological signal
recording device
intended to be used for
testing adults and
children/adolescents
suspected of having
sleep-related breathing
disorders. | The Vaosimedical-Biox
Combined is for blood
pressure and ECG
measurements like the
ABPMpro. The
additional signals are
covered by the reference
predicate. The intended
patient population is
different. For
Vaosimedical-Biox
Combined the patient
population is adults and
children who are over
the age of six years. For
ABPMpro it is from 12
years old. The
Vaosimedical-Biox
Combined has just little
bit more range than the
ABPMpro. The signals
will be transferred to
software for display. No
diagnosis will be done
by the software. The
indications are similar. |
| Prescription Use | Yes | Yes | Yes | Same |
| Patient population | >12 yo | > 6 yo | >2 yo | Subject device has a |
| Features /
Technical
Information | ABPMpro | Vasomedical-Biox
Primary predicate | SOMNOscreen plus
Reference predicate | Substantial
Equivalence |
| | | | | more limited age range
that has been tested
clinically. |
| Use Environment | Hospital, clinic and home use | Hospital, clinic and home use | Hospital or clinic | Same as primary
predicate |
| Measurement
Range
B/P
Pulse rate | Heart Rate:
Measurement range: 28-260bpm
Accuracy: 5%
BP:
Measurement range: 0-300mmHg
Accuracy: 1.5% | BP:
Measurement range: Systolic:
50 - 260 mmHg
Diastolic: 30 - 180 mmHg | Heart rate:
18 to 300 bpm | The measurement range
for BP of the primary
predicate is covered by
the ABPMpro. The pulse
rate of the reference
device is more than the
ABPMpro. However,
from a medical
perspective the edges
will not be reached by a
human in this
application. |
| Channels | See table sensor comparison | See table sensor comparison | See table sensor
Comparison | See Table Sensor
Comparison below |
| Portable Design | Yes | Yes | Yes | Same |
| Number of Patients
can monitor
simultaneously | 1 | 1 | 1 | Same |
| Data Collection | Yes | Yes | Yes | Same |
| Report Generation | Optional | Optional | Optional | Same |
| Capable of Data
Transfer for Analysis
and Report
Generation | Yes | Yes | Yes | Same |
| Data Analysis
(Computer or
Computer Assisted) | Optional | Optional | Optional | Same |
| Data transfer to PC | Via USB cable. | Via flash card | Via flash card | Different but both are
common ways to
exchange data from a
device to the PC. |
| Power Supply | Rechargeable Li ION battery | AA Alkaline battery | Rechargeable Li ION
battery | Same as reference |
| Features /
Technical
Information | ABPMpro | Vasomedical-Biox
Primary predicate | SOMNOscreen plus
Reference predicate | Substantial
Equivalence |
| Operation time per
charge | 24 hours | 24 hours | - | Same as primary
predicate |
9
10
Sensor Comparison
| Features/Technical
Information | ABPMpro | Vasomedical-Biox
Primary predicate | SOMNOscreen plus
Reference predicate | Substantial Equivalence |
|-----------------------------------------------|--------------------------------------------------------|---------------------------------------|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Blood Pressure | Yes | Yes | No | SE to reference predicate. |
| ECG | Yes, 3 lead | Yes, 3 lead | Yes, 3 lead | SE to primary predicate. |
| Plethysmography-
measurement of pulse rate | Yes, sensor placed
beneath upper
portion of cuff | No | Yes, sensor within
the SpO2 finger clip | SE to reference predicate. |
| Activity and body position
(accelerometer) | Yes | No | Yes | SE to reference predicate. The Activity sensor of the
SSCplus is a separate sensor applied to the wrist,
while the ABPMpro sensor is located on the left
upper chest. |
11
Conclusion: The subject and predicate devices are all intended to measure, record and display physiological signals. The results of the performance testing for the ABPMpro, as well as the substantial equivalence comparison to the predicate devices, are adequate to support a conclusion for the safety and effectiveness of the device. There is no relevant difference in the indications for use or the intended use of the subject device and the predicate device. The subject device has the same principles of operation and technical characteristics as the previously cleared primary and reference predicates. The subject device fulfils the requirements according to IEC 80601-2-30, which sets forth the definitive standard for devices intended for use in evaluating automated non-invasive sphygmomanometer, IEC 60601-2-47 for ambulatory ECG and IEC 60601-1-11 for home use. Patient contacting components have been evaluated for biocompatibility.
The differences do not raise new issues regarding safety or effectiveness. The ABPMpro could be seen as substantial equivalent to the predicate device.