LogoFDA 510(k) Search
K Number
K992388
Device Name
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4200
Manufacturer
ROSSMAX INTERNATIONAL LTD.
Date Cleared
1999-08-03

(15 days)

Product Code
DPW
Regulation Number
870.2100
Type
Special
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. Limited to patient over 18 years and wrist circumference between 5.3 to 7.7 inches.

Device Description

ROSSMAX Automatic Wristwatch Blood Pressure Monitor, model RM-4200

AI/ML Overview

This FDA clearance letter for the ROSSMAX Automatic Wristwatch Blood Pressure Monitor (Model RM-4200) indicates that the device has been found substantially equivalent to predicate devices. However, it does not provide the detailed information about the acceptance criteria or the specific study that proves the device meets (or met) those criteria.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be stated based on the provided text:

  • Device Name: ROSSMAX Automatic Wristwatch Blood Pressure Monitor, Model RM-4200
  • Intended Use: To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. Limited to patients over 18 years and wrist circumference between 5.3 to 7.7 inches.

The document does not contain the following information:

  1. A table of acceptance criteria and the reported device performance: This letter is a clearance for market, not the study report itself.
  2. Sample size used for the test set and the data provenance: Not mentioned.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
  4. Adjudication method for the test set: Not mentioned.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned, and generally not applicable for a blood pressure monitor.
  6. If a standalone performance (algorithm only) was done: The device is a physical product directly measuring blood pressure; "algorithm only" performance would not be its primary evaluation.
  7. The type of ground truth used: Not mentioned. For blood pressure monitors, ground truth typically involves simultaneous measurements with a validated reference device (e.g., mercurial sphygmomanometer by a trained observer).
  8. The sample size for the training set: Not mentioned.
  9. How the ground truth for the training set was established: Not mentioned.

Conclusion: The provided FDA clearance letter attests to the device's substantial equivalence to a predicate device, allowing it to be marketed. However, it does not include the detailed technical study results, acceptance criteria, or methodological specifics of the validation studies that led to this clearance. Such information would typically be found in the 510(k) submission itself, not in the clearance letter.

§ 870.2100 Cardiovascular blood flowmeter.

(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).