LogoFDA 510(k) Search
K Number
K103042
Device Name
ATMOS E 201 THORAX AND ATMOS S 201 THORAX
Manufacturer
ATMOS INC.
Date Cleared
2011-04-15

(183 days)

Product Code
BTA
Regulation Number
878.4780
Type
Traditional
Panel
SU
Reference & Predicate Devices
K080212,K043582
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ATMOS E 201 Thorax and the ATMOS S 201 Thorax are indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious material from a patient's respiratory support system after surgery. The general indication of the ATMOS S 201 Thorax and the ATMOS E 201 Thorax is thoracic drainage.

Device Description

The ATMOS S 201 Thorax and ATMOS E 201 Thorax drainage suction units are devices for mobile thoracic drainage. The devices are intended for short-time (

AI/ML Overview

This 510(k) summary does not contain the acceptance criteria or a study proving the device meets acceptance criteria.

The document (510(k) Summary of Safety and Effectiveness for the ATMOS S 201 Thorax and ATMOS E 201 Thorax) states:

  • "The ATMOS S 201 Thorax and ATMOS E 201 Thorax devices have been designed and tested to applicable safety standards and do not raise any new issues of safety, efficacy, or performance of the product."
  • "The 510(k) for the ATMOS S 201 Thorax and ATMOS E 201 Thorax devices contains adequate information and data to enable FDA to determine substantial equivalence to the predicate devices. The device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey."

However, it does not provide details on specific acceptance criteria, performance metrics, or the actual study results that demonstrate the device meets any specific performance targets. It relies on the claim of "substantial equivalence" to predicate devices and adherence to voluntary safety standards, rather than detailing a specific performance study with acceptance criteria.

Therefore, I cannot provide the requested information from the provided text.

§ 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.