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K Number
K052727
Device Name
ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350
Manufacturer
ROSSMAX INTERNATIONAL LTD.
Date Cleared
2005-12-16

(78 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

S380, K350 are non-invasive blood pressure monitors that are used for measuring systolic, diastolic blood pressure and pulse rate. The cuff circumference is 13.5~22cm for adult individual in a home environment.

Device Description

Not Found

AI/ML Overview

While the provided text describes the FDA's clearance of the Rossmax S380 and K350 Blood Pressure Monitors (K052727), it does not contain the detailed information required to fulfill your request regarding acceptance criteria and the specific study that proves the device meets those criteria.

The document is a clearance letter, indicating that the device has been deemed "substantially equivalent" to legally marketed predicate devices. This means it has met the regulatory requirements for market entry, but it does not intrinsically detail the technical performance studies and their specific results that led to this determination.

Here's a breakdown of why I cannot provide the requested information from this document:

  • No Acceptance Criteria Table or Reported Performance: The document is a regulatory approval letter, not a performance study report. It does not list specific acceptance criteria (e.g., accuracy ranges for blood pressure measurements) or the actual performance metrics achieved by the device in testing.
  • No Information on Sample Size, Data Provenance, Experts, or Adjudication: These details are typically found in the clinical or performance study reports submitted to the FDA, which are not part of this clearance letter.
  • No MRMC, Standalone, or Ground Truth Details: The document does not discuss MRMC studies, standalone algorithm performance, or how ground truth was established for any testing.
  • No Training Set Information: Similarly, details about the training set size or how its ground truth was established would be in a technical report, not an FDA clearance letter.

To obtain the information you're looking for, you would typically need to:

  1. Access the full 510(k) submission: Sometimes, the FDA makes portions or summaries of 510(k) submissions publicly available. These often include more detailed information about performance testing.
  2. Refer to the manufacturer's documentation: The device's official instructions for use or technical specifications would likely contain greater detail on its performance claims and the standards it meets.
  3. Look for published clinical studies: If the device has been the subject of independent clinical research, those papers would contain the requested methodological details.

In summary, the provided FDA clearance letter K052727 confirms the market approval of the Rossmax S380 and K350 Blood Pressure Monitors but does not contain the specific performance study details, acceptance criteria, or methodological information you requested.

§ 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).