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K Number
K231250
Device Name
Digital Blood Pressure Monitor
Manufacturer
Guangdong Genial Technology Co., Ltd.
Date Cleared
2023-11-28

(211 days)

Product Code
DXN
Regulation Number
870.1130
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Digital Blood Pressure Monitor is intended to measure (systolic and diastolic) and pulse rate of adults.

Device Description

Not Found

AI/ML Overview

This FDA 510(k) clearance letter for the Digital Blood Pressure Monitor, Model GT-701, does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria.

The document is a regulatory clearance stating that the device is substantially equivalent to legally marketed predicate devices. It lists the regulation number, name, and product code, along with general information about FDA regulations and contact information.

Specifically, the following information is NOT available in the provided text:

  1. A table of acceptance criteria and the reported device performance: This document does not present any performance data, acceptance criteria (e.g., accuracy standards like ISO 81060-2 limits), or a direct comparison.
  2. Sample size used for the test set and the data provenance: There is no mention of a test set, sample size, or the origin of any data (country, retrospective/prospective).
  3. Number of experts used to establish the ground truth for the test set and their qualifications: No information about expert involvement or ground truth establishment is present.
  4. Adjudication method: Not discussed.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is typically for evaluating AI-assisted interpretation, which is not applicable to a blood pressure monitor. As such, no such study or its effect size is mentioned.
  6. Standalone performance study: While the device is a standalone product, the document does not describe the study itself or its results.
  7. Type of ground truth used: Not specified, as no study details are provided. For a blood pressure monitor, the "ground truth" would typically come from a highly accurate reference measurement method.
  8. Sample size for the training set: Not applicable for this type of device, as blood pressure monitors do not typically use machine learning training sets in the same way AI algorithms do. Even if it did, the information is not provided.
  9. How the ground truth for the training set was established: Not applicable and not provided.

In summary, the provided FDA clearance letter confirms the regulatory status of the device but does not include the detailed technical study results or acceptance criteria that would typically be found in a performance study report or a summary of safety and effectiveness data (SSED). To answer your questions, one would need access to the actual 510(k) submission or relevant performance study reports conducted by the manufacturer.

§ 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).