LogoFDA 510(k) Search
K Number
K974061
Device Name
RECHARGEABLE BATTERY PART NUMBER GL825-200
Manufacturer
ALEXANDER MFG. CO.
Date Cleared
1998-01-16

(81 days)

Product Code
DXN
Regulation Number
870.1130
Type
Traditional
Panel
CV
Reference & Predicate Devices
K831232
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Replacement battery for Physio-Control 802565-01 Life Stat 200 Blood Pressure Monitor, 510(k) Number K831232.

This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

Device Description

Replacement battery for Physio-Control 802565-01 Life Stat 200 Blood Pressure Monitor, 510(k) Number K831232.

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) clearance letter for the GL825-200 replacement battery does not contain information about acceptance criteria or a study demonstrating device performance as it pertains to AI/ML software.

The document is a standard clearance letter for a medical device (a replacement battery) and focuses on the regulatory determination of substantial equivalence to a predicate device. It addresses:

  • Device Name: GL825-200
  • Intended Use: Replacement battery for Physio-Control 802565-01 Life Stat 200 Blood Pressure Monitor.
  • Regulatory Classification: Class II
  • Substantial Equivalence: A determination that the device is substantially equivalent to legally marketed predicate devices.
  • Regulatory Responsibilities: Information regarding annual registration, good manufacturing practices, labeling, etc.

There is no mention of:

  • Performance metrics (sensitivity, specificity, AUC)
  • Sample sizes for test or training sets
  • Ground truth establishment
  • Expert review or adjudication
  • Multi-reader multi-case (MRMC) studies
  • Standalone performance studies

Therefore, I cannot fulfill your request to describe acceptance criteria and a study given the provided input. This type of information is typically found in design validation reports or clinical study summaries, which are not part of this 510(k) clearance 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).