(71 days)
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.
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance |
|---|---|
| Adherence to ISO 10993-1:1998 (Biological Compatibility) | No biocompatibility tests needed as no parts touch patient. |
| Adherence to EN 60601-1-2 (2001) (EMC) | "Software verification and product validation tests were performed and meet the acceptance criterion." (General Statement) |
| Adherence to EN ISO 61000-3-2 (2000) (Harmonic Current Emissions) | "Software verification and product validation tests were performed and meet the acceptance criterion." (General Statement) |
| Adherence to EN ISO 61000-3-3 (1995 + A1 2001) (Voltage Fluctuations/Flicker) | "Software verification and product validation tests were performed and meet the acceptance criterion." (General Statement) |
| Adherence to CEN EN 980:1996+A1:1999+A2:2001 (Graphical Symbols for Labeling) | Implied compliance through successful submission. |
| Adherence to EN ISO 14971 (03/2001) (Risk Management) | Implied compliance through successful submission. |
| Adherence to IEC 60601-1 (1988, 1991, 1995) (General Safety) | "Software verification and product validation tests were performed and meet the acceptance criterion." (General Statement) |
| Software verification and product validation | "Software verification and product validation tests were performed and meet the acceptance criterion." |
| Does not raise new issues of safety, efficacy, or performance compared to predicate | Statement provided: "does not raise any new issues of safety, efficacy, or performance of the product." |
| Substantial equivalence to predicate device (BlueSky VISTA™ Wound Vacuum System) | Conclusion: "The 510(k) for the ATMOS S 041 ™ device contains adequate information and data to enable FDA to determine substantial equivalence to the predicate device." |
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.
§ 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.