(7 days)
The Sved® Wound Treatment System is indicated for patients who would benefit from an AC-powered, portable suction device with battery backup that provides vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The Sved® Wound Treatment System is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts. The specifically designed SVAMP® dressing components are provided for irrigation to a wound with sterile saline or other applicable topical solutions. During and after irrigation, negative pressure can be applied to assist in the removal of infectious materials or other fluids.
The Sved® Wound Treatment System consists of the identical powered suction pump components and functions as the Svedman® Wound Treatment System, only housed in a smaller, lighter weight plastic enclosure with a built-in placement holder for the 300cc Sved® collection canister. The Svamp™ Wound Dressing components remain the same and are provided in Small, Medium, Large and XL sizes of the polyurethane foam dressing.
This document is a 510(k) summary for the Sved® Wound Treatment System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth is not present in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or report device performance in terms of metrics like sensitivity, specificity, accuracy, or any functional performance thresholds. The submission is based on demonstrating "substantial equivalence" to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (Focus is on substantial equivalence to predicate) | Not explicitly stated (Focus is on technological characteristics and identical functions to predicate) |
The document states: "The Sved® Wound Treatment System consists of the identical powered suction pump components and functions as the Svedman® Wound Treatment System, only housed in a smaller, lighter weight plastic enclosure..." and "The Sved® Wound Treatment System Unit is smaller in size and weighs less compared to the predicate powered suction pump, yet and when same technological characteristics and identical functions."
This implies the "acceptance criteria" are met if the new device functions identically to the predicate, even with physical changes like size and weight.
2. Sample Size Used for the Test Set and Data Provenance:
No information is provided regarding a test set sample size or data provenance. This document is a regulatory submission for premarket notification (510(k)), not a clinical trial report. Equivalence is typically established through engineering comparisons, bench testing, and comparisons of indications for use and technological features.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This type of information is pertinent to studies involving human interpretation or performance evaluation against a gold standard, which is not described here.
4. Adjudication Method for the Test Set:
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
No MRMC study is mentioned. This document is not a clinical study report.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical wound treatment system, not an AI algorithm.
7. The Type of Ground Truth Used:
Not applicable in the context of an AI device. For this physical device, the "ground truth" for substantial equivalence would be the established safe and effective performance of the predicate device.
8. The Sample Size for the Training Set:
Not applicable. This is a physical device, not a machine learning model.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
Summary of what the document does provide regarding "acceptance criteria" and "proof":
The core "acceptance criteria" for this 510(k) submission revolve around substantial equivalence to an existing legally marketed predicate device (ANTILIA™ Wound Irrigation System, K071301).
The "study" or "proof" presented is a comparison of:
- Indications for Use: The Sved® Wound Treatment System has the same indications for use as the predicate.
- Intended Use: The intended use for both devices is the same.
- Technological Characteristics: The new device employs the "same technological characteristics and identical functions" as the predicate's powered suction pump components, despite being housed in a smaller, lighter enclosure. The Svamp™ Wound Dressing components remain the same.
The document concludes that "The substantial equivalence for the Sved® Wound Treatment System is based on the same indications, intended use, and technological features of the predicate device." This is the "proof" presented in this regulatory context.
§ 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.