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K Number
K173197
Device Name
Reusable NIBP Cuff
Manufacturer
Orantech Inc.
Date Cleared
2018-08-21

(323 days)

Product Code
DXQ,DXO
Regulation Number
870.1120
Type
Traditional
Panel
CV
Reference & Predicate Devices
K112544
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonate, infant, child and adult sizes.

Device Description

The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. The reusable NIBP cuff has 9 models with different size for different population with different arm size.

AI/ML Overview

This document is a 510(k) summary for a Reusable NIBP Cuff, not an AI/ML medical device submission. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and study details for an AI-powered device.

The document discusses the substantial equivalence of the Reusable NIBP Cuff to an existing predicate device based on:

  • Intended use and Indications for Use: An accessory for non-invasive blood pressure measurement systems, non-sterile, reusable, available in various sizes.
  • Technical specifications: Material, tube number, limb circumference range, repeated inflation limits, pressure limits, sterility, biocompatibility.
  • Performance Data: Non-clinical tests according to ISO 81060-1 (Non-Invasive Sphygmomanometers), ISO 10993-5 (In Vitro cytotoxicity), and ISO 10993-10 (irritation and skin sensitization).
  • Clinical test: Explicitly stated as "not required" for this device.

None of the requested information regarding AI/ML device performance, acceptance criteria, sample sizes for AI model testing, expert consensus, MRMC studies, or ground truth establishment for AI is present in this regulatory submission for a physical medical device.

§ 870.1120 Blood pressure cuff.

(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).