(222 days)
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.
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. The device is intended for prescription use.
The provided text details the 510(k) premarket notification for the SOMNOmedics GmbH ABPMpro device. It outlines the device's intended use and presents a summary of performance testing and substantial equivalence comparison to predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly present a table of "acceptance criteria" with quantitative targets alongside the device's performance. Instead, it states that performance testing was conducted to confirm "compliance to device specifications" and that recorded signals "comply with the performance criteria set forth by SOMNOmedics that includes the minimum performance specification recommended by the applicable standards."
The key standards referenced for performance are:
- IEC 80601-2-30: for automated non-invasive sphygmomanometers (blood pressure).
- IEC 60601-2-47: for ambulatory electrocardiographic systems (ECG).
The reported device performance based on the clinical study related to blood pressure measurement against a recognized standard (ISO 81060-2:2018) is the most direct evidence provided for meeting performance criteria:
| Measurement Parameter | Acceptance Criteria (Implicit through Standard Compliance) | Reported Device Performance (from Clinical Study) |
|---|---|---|
| Blood Pressure | Compliance with ISO 81060-2:2018 accuracy criteria | "fulfils the accuracy criteria of the ISO 81060-2:2018, both in the general validation as well as in the ambulatory validation study." |
| Heart Rate | Accuracy: 5% (from Measurement Range table) | Not explicitly reported for validation study, but stated as a specification. |
| BP Measurement Range | 0-300mmHg (from Measurement Range table) | Not explicitly reported for validation study, but stated as a specification. |
| Heart Rate Measurement Range | 28-260bpm (from Measurement Range table) | Not explicitly reported for validation study, but stated as a specification. |
2. Sample size used for the test set and the data provenance
The clinical testing data provenance is described as an "open, prospective, clinical validation study."
- General validation study (for blood pressure at rest): N = 90
- Age: 12-76 years (Mean age 39.7 ± 15.1)
- Gender: 47 male (52%), 43 female (48%)
- Ambulatory validation study (for blood pressure under dynamic exercise): N = 36
- Age: 22-65 years (Mean age 40.9 ± 11.0)
- Gender: 20 male (56%), 16 female (44%)
The country of origin for the data is not explicitly stated, but the sponsor is "SOMNOmedics GmbH Am Sonnenstuhl 63 Randersacker, Germany D-97236", which suggests the study may have been conducted in Germany or a location adhering to European standards. The study received "Ethics Committee approval" and was conducted "in accordance with good clinical practice (GCP) as described in 21 CFR 812.28(a)(1)," which are US regulations. This suggests a study potentially designed for US regulatory submission, but the exact location is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
For the blood pressure measurements, the ground truth was established by:
- Two observers provided simultaneous auscultatory reference BP measurements using a dual-head teaching stethoscope.
- Qualifications of experts: Not explicitly stated beyond "two observers." It's implied they are trained to accurately use the reference sphygmomanometer and stethoscope for auscultatory measurements.
4. Adjudication method for the test set
The method for establishing reference blood pressure was the "same arm sequential method" described in the Universal Standard (ISO 81060-2:2018). The involvement of "two observers" taking "simultaneous auscultatory reference BP measurements" suggests a form of consensus or comparison between them to establish the reference, as per the standard's requirements for validating automated sphygmomanometers. However, a specific adjudication method (e.g., 2+1, 3+1, averaging, arbitration) for discrepancies between the two observers is not explicitly described. The standard itself outlines how such measurements are to be handled.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was mentioned. The device, ABPMpro, does not appear to be an AI-assisted diagnostic tool; rather, it is a data acquisition and display device. 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." Therefore, a human-in-the-loop or AI assistance study involving human readers would not be applicable or expected for this device's stated function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The primary performance evaluation for the blood pressure measurement was the "accuracy" against the reference standard (ISO 81060-2:2018), which is a standalone performance assessment of the device's ability to accurately measure BP. For ECG, the compliance to IEC 60601-2-47 further indicates a standalone performance assessment of its signal acquisition capabilities.
7. The type of ground truth used
The ground truth for blood pressure measurements was established using:
- Expert Consensus/Reference Measurement: Simultaneous auscultatory reference BP measurements taken by two trained observers (using a calibrated standard aneroid sphygmomanometer and a dual-head teaching stethoscope). This aligns with the "expert consensus" category for reference standard measurements in clinical studies of measurement devices.
- Standardized Method: The "same arm sequential method" described in the ISO 81060-2:2018 Universal Standard.
8. The sample size for the training set
The document does not specify a training set or its sample size. This is typical for medical devices that are not "machine learning/AI" devices requiring a distinct training and test split for an algorithm. The "ABPMpro" is presented as a measurement and recording device, not one with a diagnostic AI algorithm that learns from data.
9. How the ground truth for the training set was established
As no training set is mentioned (see point 8), this information is not applicable.
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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"
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(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.
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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
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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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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
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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
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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:
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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.
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Substantial Equivalence Comparison
| Features /TechnicalInformation | ABPMpro | Vasomedical-BioxPrimary predicate | SOMNOscreen plusReference predicate | SubstantialEquivalence |
|---|---|---|---|---|
| Product Code | DXN, DSH | DSH, DXN | MNR, OLV | |
| K-Number | Not yet assigned. | K092785 | K201054 | |
| Indications for Use: | ABPMpro Ambulatory Blood PressureRecorder is a Non-Invasive oscillometricand ECG device intended to acquireAmbulatory non-invasive Blood Pressuresignals and 3 Channel ECG signals from theupper body surfaces. Cardiac rhythm isacquired via 3 Channel ECG signals.Additional physiological signals likeplethysmogram, body position and activityare also measured. The Recorder is intendedfor adults and children who are over the ageof 12 years.ABPMpro Software allows transfer ofBlood Pressure-, ECG- and data fromadditional signals from the Recorder to aWindows based PC-based computerprogram via USB cable for the purpose ofcreating reports and printouts. The Softwaredoes not perform diagnostics. Physicianscarry out diagnostics evaluations of thisdata.The system is only for measurement,recording and display. It makes nodiagnosis. | Vasomedical-Biox CombinedAmbulatory ECG and BloodPressure Recorder is a Non-Invasive oscillometric deviceintended to acquire Ambulatory3 Channel ECG signals andnon-invasive Blood Pressuresignals from the upper bodysurfaces. Cardiac rhythm isacquired via 3 Channel ECGsignals. The Recorders areintended for adults and childrenwho are over the age of sixyears.Vasomedical-Biox AmbulatoryECG CB Series AnalysisSystem Software allowstransfer of ECG and BloodPressure data from theRecorder to a Windows basedPC-based computer programvia a removable and largecapacity storage card (SD) forthe purpose of creating reportsand printouts. The Softwaredoes not perform diagnostics.Physicians carry outdiagnostics evaluations of thisdata.The system is only formeasurement, recording anddisplay. It makes no diagnosis. | The SOMNOscreen®plus is a non-life-supporting portablephysiological signalrecording deviceintended to be used fortesting adults andchildren/adolescentssuspected of havingsleep-related breathingdisorders. | The Vaosimedical-BioxCombined is for bloodpressure and ECGmeasurements like theABPMpro. Theadditional signals arecovered by the referencepredicate. The intendedpatient population isdifferent. ForVaosimedical-BioxCombined the patientpopulation is adults andchildren who are overthe age of six years. ForABPMpro it is from 12years old. TheVaosimedical-BioxCombined has just littlebit more range than theABPMpro. The signalswill be transferred tosoftware for display. Nodiagnosis will be doneby the software. Theindications are similar. |
| Prescription Use | Yes | Yes | Yes | Same |
| Patient population | >12 yo | > 6 yo | >2 yo | Subject device has a |
| Features /TechnicalInformation | ABPMpro | Vasomedical-BioxPrimary predicate | SOMNOscreen plusReference predicate | SubstantialEquivalence |
| more limited age rangethat has been testedclinically. | ||||
| Use Environment | Hospital, clinic and home use | Hospital, clinic and home use | Hospital or clinic | Same as primarypredicate |
| MeasurementRangeB/PPulse rate | Heart Rate:Measurement range: 28-260bpmAccuracy: 5%BP:Measurement range: 0-300mmHgAccuracy: 1.5% | BP:Measurement range: Systolic:50 - 260 mmHgDiastolic: 30 - 180 mmHg | Heart rate:18 to 300 bpm | The measurement rangefor BP of the primarypredicate is covered bythe ABPMpro. The pulserate of the referencedevice is more than theABPMpro. However,from a medicalperspective the edgeswill not be reached by ahuman in thisapplication. |
| Channels | See table sensor comparison | See table sensor comparison | See table sensorComparison | See Table SensorComparison below |
| Portable Design | Yes | Yes | Yes | Same |
| Number of Patientscan monitorsimultaneously | 1 | 1 | 1 | Same |
| Data Collection | Yes | Yes | Yes | Same |
| Report Generation | Optional | Optional | Optional | Same |
| Capable of DataTransfer for Analysisand ReportGeneration | Yes | Yes | Yes | Same |
| Data Analysis(Computer orComputer Assisted) | Optional | Optional | Optional | Same |
| Data transfer to PC | Via USB cable. | Via flash card | Via flash card | Different but both arecommon ways toexchange data from adevice to the PC. |
| Power Supply | Rechargeable Li ION battery | AA Alkaline battery | Rechargeable Li IONbattery | Same as reference |
| Features /TechnicalInformation | ABPMpro | Vasomedical-BioxPrimary predicate | SOMNOscreen plusReference predicate | SubstantialEquivalence |
| Operation time percharge | 24 hours | 24 hours | - | Same as primarypredicate |
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Sensor Comparison
| Features/TechnicalInformation | ABPMpro | Vasomedical-BioxPrimary predicate | SOMNOscreen plusReference 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 placedbeneath upperportion of cuff | No | Yes, sensor withinthe SpO2 finger clip | SE to reference predicate. |
| Activity and body position(accelerometer) | Yes | No | Yes | SE to reference predicate. The Activity sensor of theSSCplus is a separate sensor applied to the wrist,while the ABPMpro sensor is located on the leftupper chest. |
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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.
§ 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).