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K Number
K990638
Device Name
ANEROID SPHYGMOMANOMETER
Manufacturer
GENMED, INC.
Date Cleared
1999-10-07

(223 days)

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

These devices are intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Knorokoff sounds. This device is indicated for use by medical personnel or for home use.

Device Description

Genmed Aneroid Sphygmomanometer

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a Genmed Aneroid Sphygmomanometer. It declares the device substantially equivalent to legally marketed predicate devices for the measurement of systolic and diastolic pressure on adults, for use by medical professionals or in the home.

However, the document does NOT contain information about:

  1. A table of acceptance criteria and the reported device performance.
  2. Sample size used for the test set and data provenance.
  3. Number of experts used to establish ground truth for the test set and their qualifications.
  4. Adjudication method for the test set.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done and its effect size.
  6. If a standalone performance study was done.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
  8. The sample size for the training set.
  9. How the ground truth for the training set was established.

This is a regulatory clearance document, not a clinical study report or a technical performance evaluation. Therefore, it does not detail the specific performance metrics or studies used to demonstrate the device meets acceptance criteria, beyond the FDA's determination of "substantial equivalence" to a predicate device. Substantial equivalence typically relies on demonstrating that the new device has the same intended use and technological characteristics as the predicate, or if it has different characteristics, that it does not raise different questions of safety and effectiveness. This often involves adherence to recognized standards and sometimes limited performance testing, but the specifics are not included in this letter.

§ 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).