(182 days)
The 3M™ V.A.C.® Peel and Place Dressing is intended to be applied in an acute, extended, or home care setting where product application is conducted by or under the supervision of a qualified healthcare professional. It is an accessory to the 3M™ Negative Pressure Wound Therapy System.
When used on open wounds, the system is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
When used on closed surgical incisions, they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
The 3M™ V.A.C. ® Peel and Place Dressing Kit is a sterile, single use all in one dressing comprised of a semi-occlusive drape and foam dressing kitted together with a SensaTRAC Pad and Tubeset. The perforations in the silicone layer expose the acrylic adhesive coated on the polyurethane film. The acrylic adhesive secures the periwound and the silicone layer primarily provides a seal for negative pressure. The polyurethane foam assists with manifolding negative pressure across the wound and periwound.
The one-piece all-in-one dressing and drape are similar to the Dermatac Drape and Granufoam Dressing, most recently cleared under 510(k) K212320, which are provided in a two piece design.
This document, a 510(k) premarket notification for the 3M™ V.A.C. ® Peel and Place Dressing Kit, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving independent device performance against specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for training/test sets, expert adjudication methods, and MRMC studies for an AI/CAD-like device is not present in this document.
The document primarily describes a medical wound care dressing and focuses on non-clinical testing (bench testing, biocompatibility, simulated-use) to show it functions as intended and is equivalent to previously cleared devices. There is no AI or software component described that would necessitate studies with ground truth, expert readers, or performance metrics like sensitivity/specificity for a diagnostic or AI-assisted system.
However, based on the provided text, I can infer and summarize the relevant information as follows, highlighting what is included and what is explicitly stated as not applicable or not done:
Acceptance Criteria and Device Performance (as inferred for a non-AI medical device):
Since this is a wound care dressing, "acceptance criteria" here refer to demonstrating that the device performs its intended physical functions and is safe and effective, similar to its predicate. The "performance" is measured through various non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from tests performed) | Reported Device Performance (from "Performance Data" section) |
|---|---|
| Negative Pressure Maintenance: Maintain negative pressure within specifications and manage fluid exudate without unexpected alarms. | "V.A.C.® Negative Pressure Maintenance System Test demonstrates the 3M™ V.A.C.® Peel and Place Dressing maintains negative pressure within specifications and manages fluid exudate without unexpected alarms." |
| Package Integrity: Maintain sterile barrier throughout labeled shelf life. | "Package Integrity testing to ensure the sterile barrier is maintained throughout its labeled shelf life." |
| Product Performance after ETO Sterilization: Function as intended throughout labeled shelf life (including dressing extensibility, moisture vapor transmission rate, peel adhesion force, release liner testing). | "Product performance testing of dressing components after Ethylene Oxide (ETO) sterilization to verify the product functions as intended throughout its labeled shelf life. This included: Dressing Extensibility, Moisture Vapor Transmission Rate, Peel Adhesion Force, Release Liner Testing." |
| Simulated-Use Safety & Effectiveness: Found to be safe and effective for intended users, uses, and use environments during simulated-use. | "The 3M™ V.A.C. ® Peel and Place Dressing and associated labeling was evaluated via simulated-use testing with users representative of the use specification and has been found to be safe and effective for the intended users, uses and use environments." Also stated: "The testing generated strong evidence that the 3M™ V.A.C. ® Peel and Place Dressing has been found to be safe and effective for the intended users, uses and use environments." |
| Biocompatibility: Favorable results for relevant endpoints (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-mediated pyrogenicity, Subacute Systemic Toxicity, Genotoxicity, Implantation). | "The product had favorable biocompatibility test data for all relevant endpoints." Specific tests listed include: MEM Elution, Guinea Pig Maximization Sensitization, Intracutaneous Reactivity, Acute Systemic Injection, Rabbit pyrogenicity test, 32-day Repeated Dose Subacute Toxicity, Bacterial Mutagenicity - Ames Assay, In Vitro Mouse Lymphoma with Extended Treatment. |
| Overall Functionality: Function as intended and test results as expected. | "In all instances, the 3M™ V.A.C. ® Peel and Place Dressing functioned as intended and all test results observed were as expected." |
Regarding AI-specific criteria (which are not relevant to this traditional medical device):
2. Sample size used for the test set and the data provenance:
- Not applicable as this is not an AI/diagnostic device. The "test set" here refers to the physical samples used in bench testing and simulated-use. Specific sample sizes for these tests are not provided in the document, but the tests performed are listed. Data provenance (country, retrospective/prospective) is not relevant for this type of physical device testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" in the AI/diagnostic sense. Simulated-use testing involved "users representative of the use specification," implying qualified healthcare professionals, but the number and specific qualifications are not detailed beyond "qualified healthcare professional" for product application.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication process similar to AI model evaluation is described.
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 is not an AI-assisted device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No "ground truth" as understood in AI/diagnostic validation. The "ground truth" for this device's performance is adherence to engineering specifications, physical properties, and biological safety standards as determined by laboratory and simulated-use testing.
8. The sample size for the training set:
- Not applicable. This device does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set or machine learning model involved.
Summary of Conclusions from the Document:
The document concludes that the "minor differences in technology do not raise any new questions of safety" and that the "performance data established by the predicate, including biocompatibility, shelf-life testing and bench testing demonstrate substantial equivalence to the predicate." It explicitly states, "Clinical and Pre-clinical testing were not necessary to demonstrate equivalence," indicating that the non-clinical tests performed were deemed sufficient for this 510(k) submission.
§ 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.