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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.

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 (

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.

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The ATMOS S041 Wound™ is a suction device intended for aspiration and collection of secretions and body fluids from wounds and is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing. ATMOS S041 is appropriate for use on the following wounds:

• · Pressure ulcers
• · Diabetic/neuropathic ulcers
• · Venous insufficiency ulcers
• Traumatic wounds
• · Post-operative and dehisced surgical wounds
• Explored fistulas
• · Skin flaps and grafts

The ATMOS S 041 Wound is a device to remove bodily fluids for wound drainage and can be used by patients over an extended period of time as recommended by a physician. The device has a rechargeable battery and therefore is portable. A microprocessor controlled electronic battery charging unit in the suction device guarantees the safe charging of the battery, and overcharging of the battery.
The ATMOS S 041 Wound itself is not a sterile device but can use disposable (sterile) items from other manufacturers but these items are not a part of the S 041, (e.g. various hose sets, containers, trocars and catheters) which have been designed for the wound drainage.

The ATMOS S041 Wound is a medical device designed for wound drainage by removing bodily fluids. The summary provided mainly focuses on demonstrating substantial equivalence to a predicate device (BlueSky VISTA™ Wound Vacuum System) and adherence to various safety and performance standards, rather than proving the device meets specific acceptance criteria based on a clinical study or performance metrics like sensitivity/specificity.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria for device performance (e.g., suction efficiency, battery life in a clinical context, wound healing rates). Instead, the acceptance criteria are related to compliance with safety and performance standards.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a "test set" in the context of patient data or clinical performance. The "tests" performed are primarily non-clinical safety and performance evaluations against applicable standards. Therefore, information on sample size for patient data or data provenance (country of origin, retrospective/prospective) is not applicable/not provided for this type of submission which focuses on substantial equivalence based on technical characteristics and adherence to standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Since a clinical "test set" with patient data requiring expert ground truth is not described in this document, this information is not applicable/not provided. The ground truth here relates to the adherence of the device to technical standards, which is evaluated through engineering and quality assurance processes.

4. Adjudication Method for the Test Set:

Again, as there is no mention of a "test set" involving patient data and human readers/diagnosticians, an adjudication method is not applicable/not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not mentioned or described. This submission focuses on a 510(k) pathway, demonstrating substantial equivalence to a predicate device, and primarily addresses technical and safety standards. It does not appear to involve a comparative effectiveness study with human readers (AI vs. without AI assistance).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This device (ATMOS S041 Wound) is a physical medical device (a powered suction pump), not an AI algorithm. Therefore, a "standalone algorithm performance" study is not applicable.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the compliance with established national and international safety and performance standards for medical devices (e.g., ISO, EN, IEC standards) and the technical specifications of the device itself. This is assessed through "Software verification and product validation tests" and engineering evaluations.

8. The Sample Size for the Training Set:

This device is not an AI algorithm, so there is no concept of a "training set" in the machine learning sense. The device is validated against engineering specifications and regulatory standards.

9. How the Ground Truth for the Training Set Was Established:

As there is no "training set" for an AI algorithm, this question is not applicable. The ground truth for the device's design and manufacturing is established through the adherence to Quality System Regulations (QSR) and the referenced safety and performance standards.

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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.

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.

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.

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