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K Number
K090445
Device Name
ATMOS C361/C451 SUCTION PUMP
Manufacturer
ATMOS INC.
Date Cleared
2009-02-27

(7 days)

Product Code
BTA
Regulation Number
878.4780
Type
Traditional
Panel
SU
Reference & Predicate Devices
K042943
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ATMOS C361/C451 Suction Pump™ device is intended for aspiration and collection of secretions, body fluids and tissue from wounds during surgery or at the patient's bedside.

Device Description

The ATMOS C361/C451 device is an AC/DC-powered surgical suction unit. With a direct docking and direct docking disposable system, hose connection errors are not possible. There is only one connection for the hose to the patient. The connection from the jar to the pump is integrated in the container lid.

The ATMOS C361/C451 is centered on a silent diaphragm-type pump which generates a vacuum inside the collection jar, allowing secretions to be withdrawn and collected. Using a vacuum regulator and the vacuum-gauge, the target vacuum and airflow rate can be adjusted.

AI/ML Overview

The provided 510(k) summary for the ATMOS C361/C451 Suction Pump™ is for a medical device and therefore does not include information pertaining to algorithm performance, acceptance criteria, ground truth, or study details typically found in AI/ML device submissions. This document is a traditional 510(k) for a hardware device and evaluates substantial equivalence to a predicate device based on technological characteristics and intended use, not on AI-driven performance metrics.

Therefore, I cannot provide the requested information. The document explicitly states:

  • "The C361/C451 Suction Pump does not raise any new issues of safety, efficacy, or performance of the product."
  • "The 510(k) for the ATMOS C361/C451 Suction Pump™ device contains adequate information and data to enable FDA to determine substantial equivalence to the predicate device."

These statements indicate that the device was evaluated against existing standards and a predicate device (NOUVAG AG - VACUSON 40 AND VACUSON 60) based on its physical and functional characteristics, not on data-driven performance metrics for an algorithm.

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.