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510(k) Data Aggregation
(148 days)
SVED Wound Treatment System
The Cardinal Health NPWT SVED system is an integrated wound management system, indicated for the application of continual or intermittent negative pressure wound therapy to the wound as the device may promote wound healing by the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The system is intended for use in acute, extended and home care settings.
The SVED® Wound Treatment System is an AC-powered, portable suction device with battery backup that provides localized negative pressure wound therapy when used with the Cardinal NPWT Dressings to remove fluid, irrigation solutions and infectious materials from the wound. The system consists of a powered suction pump device with a built-in placement holder for the fluid collection canister, various sizes and shapes of polyurethane foam dressing, canister tubing with clamps and connectors, polyurethane drape with adhesive, and irrigation tubing with clamps and connectors. The system is intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The SVED ® Wound Treatment System provides care in the acute, extended and home care settings.
The provided text describes a 510(k) summary for the Sved® Wound Treatment System, which is a negative pressure wound therapy device. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of diagnostic accuracy, which is typically what such questions refer to when asking about "device performance" in medical AI/diagnostic devices.
Instead, the document details:
- Regulatory information: Device name, classification, predicate device, and intended use.
- Technological characteristics: Comparison to the predicate device, highlighting similar and differing features.
- Performance data (non-clinical): Electrical safety, EMC, software verification and validation, and a clinical usability study.
Therefore, many of the requested elements for a diagnostic performance study cannot be extracted from this document.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety | The system complies with the IEC 60601-1 standards for safety (implicitly accepted as meeting the standard). |
| EMC Compliance | The system complies with the IEC 60601-1-2 standard for EMC (implicitly accepted as meeting the standard). |
| Software V&V | Software verification and validation testing were conducted, and documentation was provided as recommended by FDA guidance. The software was considered a "Moderate" level of concern. (Acceptance is that V&V was completed according to guidance, ensuring safety and functionality as intended for a moderate-concern device). |
| Clinical Usability | A single-center, unblinded, observational, simulated use usability evaluation was conducted. Results were used to update the risk analysis plan and user manual, as needed. (Acceptance is that usability issues were identified and addressed, contributing to safe and effective use. Specific pass/fail criteria for usability are not stated, but the outcome implies an acceptable level of usability was achieved after any necessary revisions). |
| Pneumatic Performance (Implied) | The device operates at 70mmHg, 120mmHg & 150mmHg Pressure Ranges, and has continuous and intermittent treatment modes. (Implied acceptance is that these pressure ranges are maintained accurately and consistently, though specific performance metrics like pressure accuracy or flow rates are not detailed as acceptance criteria). |
2. Sample size used for the test set and the data provenance:
- Clinical Usability Test: 34 adult Healthcare Professionals (HCPs) and lay-user Subjects (patient/caregiver surrogates).
- Data Provenance: Single-center, simulated use. No specific country of origin is mentioned, but the FDA submission context usually implies US-based or internationally accepted standards. The study was prospective in its design (enrollment, training, guided tasks, interview).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to the usability study described. The study evaluated user interaction and potential use errors rather than diagnostic accuracy against a ground truth. For the software V&V, specific experts are not mentioned, but the V&V process itself aims to ensure compliance with design specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for the usability study. The usability study involved observation and interviews to capture user feedback and identify use errors rather than adjudicating a diagnostic outcome.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a negative pressure wound therapy system, not an AI-powered diagnostic tool for human readers. No MRMC study was described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI diagnostic algorithm. The device has software, but its "standalone" performance would be related to its mechanical and electronic functions (e.g., maintaining pressure, alarm functionality) rather than an AI-driven diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for a usability study. For electrical safety and EMC, the "ground truth" is adherence to the specified IEC standards. For software, the "ground truth" is adherence to software requirements and specifications.
8. The sample size for the training set:
- Not applicable. This document describes performance validation, not an AI model requiring a training set. The usability study involved a "training" phase for the participants, but this is distinct from an AI model's training set.
9. How the ground truth for the training set was established:
- Not applicable as there is no AI training set involved.
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(7 days)
SVED WOUND TREATMENT SYSTEM
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.
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