(157 days)
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.
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.
The provided document, a 510(k) premarket notification for the ABPM 7100 PWA with Hypertension Management Software Client Server 4.7, indicates that no dedicated clinical performance study was conducted to prove the device meets acceptance criteria. Instead, the submission relies on the device being substantially equivalent to a legally marketed predicate device (K110603 Mobil-O-Graph 24h PWA and HMS CS Version 4.3 by I.E.M. GmbH).
Here's a breakdown of the requested information based on the provided text, with "N/A" (Not Applicable) where the information is explicitly stated as not being required or not performed:
1. Table of Acceptance Criteria and Reported Device Performance
Since no specific clinical performance study was conducted for the ABPM 7100 to establish new acceptance criteria and demonstrate performance against them, this table is not explicitly available in the provided document. The primary "acceptance criteria" here is substantial equivalence to the predicate device, which implies meeting its performance characteristics. The document focuses on non-clinical performance data and compliance with standards.
| Acceptance Criteria (Implied by Predicate Equivalence & Standards Compliance) | Reported Device Performance (ABPM 7100) |
|---|---|
| Hardware | |
| Electrical Safety (IEC 60601-1, IEC 80601-2-30 compliance) | Passed Electrical Safety tests according to IEC 60601-1 and IEC 80601-2-30. (Note: The electrical safety test reports for the predicate (Mobil-O-Graph 24h PWA) are considered equally applicable to the ABPM 7100 as the hardware is identical.) |
| Electromagnetic Compatibility (IEC 60601-1-2 compliance) | Passed electromagnetic compatibility testing (emission and immunity) according to IEC 60601-1-2. |
| Biocompatibility (ISO 10993-1 compliance for patient-contacting parts) | All patient-contacting components (brachial blood pressure cuff) are unchanged from the predicate device. Stated as complying with ISO 10993-1. |
| Overall Design & Performance (General Safety & Effectiveness) | Meets all stated requirements for overall design, performance, biocompatibility, and electrical safety. Testing according to written protocols confirms that design outputs meet design inputs. The device passed all stated testing. |
| Software | |
| Software Verification & Validation (FDA guidance, ISO 14971 Risk Management) | HMS CS application software developed and tested according to written internal procedures implementing FDA guidance ("General Principles of Software Validation," "Content of Premarket Submissions for Software Contained in Medical Devices") and ISO 14971 Risk Management. All required software testing was completed as part of verification and validation, and all tests passed. |
| Clinical Performance | N/A - No clinical testing was required or performed. The device's safety and efficacy are based on the predicate device's proven market history and substantial equivalence. The non-clinical testing performed with the predicate device (Mobil-O-Graph 24h PWA) remains applicable for the ABPM 7100 due to identical hardware and software principles. The intended use of both devices is identical, and the technological characteristics are considered the same, or differences do not raise new questions of safety/effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: N/A (No clinical test set was used for the ABPM 7100 as part of this submission). The non-clinical performance tests mentioned relate to hardware and software validation, not clinical performance on human subjects for efficacy.
- Data Provenance: N/A (No clinical data was generated for the ABPM 7100). The document mentions that the predicate device has been "on the market for many years" with "proven safety and efficacy," implying historical clinical use, but not specific data relevant to a new test set for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A (No clinical test set was required or used). The "ground truth" for non-clinical tests is based on engineering standards and specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A (No clinical test set was required or used).
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
- N/A (This device is an ambulatory blood pressure monitor; it does not involve "readers" or "cases" in the context of an MRMC study typically seen for imaging AI. There is no AI assistance aspect described for human interpretation).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device performs automated measurements and provides derived values such as ascending aortic blood pressure waveform and central indices. Its performance described relates to the accuracy and reliability of these automated measurements and derivations. While not explicitly called "standalone performance" in the AI sense, the non-clinical tests validate the algorithm and hardware operating independently to produce these measurements.
- However, the document states: "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." This indicates it's a system (device + software) that produces outputs, intended to be evaluated by a healthcare professional ("in the opinion of the physician"). The software's performance was tested according to validation procedures, implying its algorithms operate in a "standalone" fashion to process data and generate outputs.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical hardware tests, the "ground truth" would be established by the specifications and acceptance limits defined in the relevant international standards (e.g., IEC 60601-1 for electrical safety, IEC 80601-2-30 for non-invasive sphygmomanometers, ISO 10993-1 for biocompatibility, IEC 60601-1-2 for EMC).
- For the software, the "ground truth" for its verification and validation would be established by functional and performance requirements derived from its design inputs and intended use, verified against those requirements according to internal procedures and FDA guidance.
- No clinical ground truth (like expert consensus on actual patient conditions or pathology) was used for this submission for the ABPM 7100, as no clinical testing was performed.
8. The sample size for the training set
- N/A (No de novo clinical training set for algorithms was mentioned or implied for this device). The device relies on established principles of blood pressure measurement and arterial waveform analysis, likely incorporating algorithms developed through previous research or calibration data, but the submission does not detail a new "training set" for the ABPM 7100 itself.
9. How the ground truth for the training set was established
- N/A (No de novo clinical training set was mentioned).
§ 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).