(124 days)
The U-RIGHT TD-3124B Blood Pressure Monitoring System is intended to be used to measure the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. This system should only be used for the testing on people over 18 years of age and over.
The kit of U-RIGHT TD-3124B Blood Pressure Monitoring System consists of two main products: the Blood Pressure Monitor and the pressure cuff. The product has been designed and tested to work together as a system to produce accurate blood pressure measurements.
Here's an analysis of the provided text regarding the U-RIGHT TD-3124B Blood Pressure Monitoring System, focusing on the acceptance criteria and study information:
Summary of Acceptance Criteria and Study Findings for U-RIGHT TD-3124B Blood Pressure Monitoring System
The provided 510(k) summary for the U-RIGHT TD-3124B Blood Pressure Monitoring System does not contain specific acceptance criteria or details of a de novo clinical study proving the device meets those criteria. Instead, it relies on a demonstration of substantial equivalence to a predicate device (U-RIGHT TD-3135 Blood Pressure Monitoring System, K112274).
The core of the submission is that the U-RIGHT TD-3124B has "the same performance characteristics as the predicate device" and that "Software verification and validation, and design validation confirmed that the performance, safety and effectiveness... are equivalent to the predicate device." This implies that the predicate device likely met certain performance criteria, and the new device is demonstrated to be equivalent to that. However, the details of those original performance criteria or the studies that established them for the predicate are not included in this document.
Therefore, many of the requested sections below cannot be fully populated as they would be for a direct study demonstrating compliance with de novo acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document does not explicitly state acceptance criteria or direct performance results for the U-RIGHT TD-3124B outside of its established equivalence to the predicate. Therefore, this section will reflect that the device's performance is considered equivalent to its predicate.
| Acceptance Criterion (Implicit, based on equivalence to predicate) | Reported Device Performance (vs. Predicate) |
|---|---|
| Accuracy of Systolic Blood Pressure Measurement | Performance confirmed to be equivalent to the predicate device (U-RIGHT TD-3135 Blood Pressure Monitoring System, K112274) through software verification/validation and design validation. |
| Accuracy of Diastolic Blood Pressure Measurement | Performance confirmed to be equivalent to the predicate device (U-RIGHT TD-3135 Blood Pressure Monitoring System, K112274) through software verification/validation and design validation. |
| Accuracy of Pulse Rate Measurement | Performance confirmed to be equivalent to the predicate device (U-RIGHT TD-3135 Blood Pressure Monitoring System, K112274) through software verification/validation and design validation. |
| Safety and Effectiveness | Confirmed to be equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in this document. The submission references "software verification and validation, and design validation" implying testing was conducted, but the specific sample sizes for clinical performance evaluation (if any were performed on the new device, beyond equivalence testing) are not provided.
- Data Provenance: Not specified. Given the reliance on substantial equivalence, any clinical data supporting the new device's performance would likely be comparative, but no details are given. The predicate device's data provenance is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The document does not describe a study involving expert-established ground truth for the U-RIGHT TD-3124B's performance. Its performance is based on equivalence to a predicate.
4. Adjudication Method for the Test Set
Not applicable. No details of a direct clinical study with adjudication are provided for the U-RIGHT TD-3124B.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study is not mentioned or implied in this 510(k) summary. This type of study is more common for diagnostic imaging devices where human interpretation is a key component.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in essence, the "performance characteristics" and "software verification and validation, and design validation" would pertain to the standalone operation of the device. The U-RIGHT TD-3124B is a non-invasive blood pressure monitoring system, so its performance is evaluated as a standalone algorithm/device without human-in-the-loop assistance in the sense of a diagnostic interpretation task.
7. Type of Ground Truth Used
For the U-RIGHT TD-3124B itself, the "ground truth" for its performance is implicitly derived from its established equivalence to the predicate device. For blood pressure monitors, ground truth typically involves simultaneous measurements using a highly accurate reference method (e.g., intra-arterial measurement or a validated auscultatory method by trained observers). This document does not detail how the predicate's original ground truth was established, nor does it specify direct ground truth measurements for the new device beyond its validation as equivalent.
8. The Sample Size for the Training Set
Not applicable. The U-RIGHT TD-3124B is a blood pressure monitor based on oscillometric technology, not an AI/machine learning device that would require a "training set" in the conventional sense for model development. Its verification and validation would involve engineering and design validation, and potentially clinical studies comparing it to a reference standard or predicate, rather than training an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable. As explained in point 8, there is no "training set" for this type of device in the context of machine learning.
§ 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).