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Dynarex Xeroform Petrolatum Dressing is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate.

The Dynarex Xeroform Petrolatum Dressing is a sterile, single use, non-adherent dressing consisting of non-woven absorbent gauze saturated with Xeroform with 3% Bismuth Tribromophenate in a petrolatum blend. Packaged in paper metalized chevron pouches and available in Sizes: 2" x 2" ( Item #: 3051), 1" x 8" ( Item #: 3052), 4" x 4" ( Item #: 3053), 5" x 9" ( Item #: 3054). Dynarex Xeroform Petrolatum Dressing gauze is a type of medical dressing and has ingredients finely wovens mesh medical gauze infused with a blend of petrolatum and 3% Bismuth Tribromophenate.

This document is a 510(k) premarket notification for the Dynarex Xeroform Petrolatum Dressing, claiming substantial equivalence to a predicate device. This type of submission generally focuses on demonstrating similarity to an existing device rather than presenting a novel clinical study with acceptance criteria in the typical sense for algorithm performance.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/algorithm, cannot be fully provided from this document. The document describes the device's physical and biological properties and compares them to a predicate device to establish substantial equivalence.

However, I can extract information related to "acceptance criteria" and "studies" from the perspective of demonstrating the device's safety and effectiveness compared to a predicate device, as required for a 510(k).

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" largely refer to demonstrating the new device's characteristics are similar to or meet the performance of a legally marketed predicate device. The performance is reported by showing that the new device meets established standards or has similar characteristics.

• Material 1: 3% Bismuth Tribromophenate
• Material 2: Petrolatum | - Substrate: Cotton Gauze
• Material 1: 3% Bismuth Tribromophenate
• Material 2: Petrolatum |
  | Single Use | Yes | Yes |
  | Color | Yellowish | Yellowish |
  | Dimensions | 1x8"/2x2"/4x4"/5x9"/4"x3yds | 1x8"/2x2"/4x4"/5x9" |
  | Sterility | Sterile ISO 11137-2: 2013 to a 10^6^ SAL | Sterile ISO 11137-2: 2013 to a 10^6^ SAL |
  | Pouch Packaging | Metalized chevron pouches | PET / ALPET / PE (implicitly demonstrating equivalence or acceptable difference) |
  | Biocompatibility | Meets all applicable requirements per ISO 10993-3, -4, -5, -10, -11 (as implied for the predicate device to be legally marketed). | Meets all of the requirements, as applicable, to ISO 10993-3: 2014 Genotoxicity, ISO 10993-4: 2006 / ASTM F756: Hemolysis, ISO 10993-5:2009 Cytotoxicity, ISO 10993-10: 2010 Skin Sensitization and Primary Skin Irritation. ISO 10993-11: 2006 Systemic Toxicity. |

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable in the context of an AI model's test set. The submission focuses on device characteristics and compliance with standards. For biocompatibility, the sample sizes are determined by the specific ISO 10993 tests (e.g., cell cultures for cytotoxicity, animal models for systemic toxicity), but these details are not provided in this summary.
• Data Provenance: Not applicable for an AI model. The data relates to material testing and standard compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not applicable as this is a medical device (petrolatum dressing), not an AI/algorithmic device that requires expert-established ground truth for performance evaluation in a clinical setting. Standard testing is done in labs.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable for this type of medical device submission.

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 as this is not an AI/algorithmic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable as this is not an AI/algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the aspects tested (biocompatibility, sterility, physical properties), the "ground truth" is established by:
  • International Standards: e.g., ISO 10993 series for biocompatibility, ISO 11137-2 for sterilization.
  • Material Specifications: Chemical composition (3% Bismuth Tribromophenate, petrolatum), physical forms (cotton gauze).
  • Validated Test Methods: Procedures for inspecting appearance, coating, cutting edges, size, heat sealing, weight, and count (as described in Quality Assurance Testing).

8. The sample size for the training set

• Not applicable as this is not an AI/algorithmic device.

9. How the ground truth for the training set was established

• Not applicable as this is not an AI/algorithmic device.

Studies that prove the device meets the "acceptance criteria" (i.e., demonstrates substantial equivalence):

The document explicitly states the studies and standards used to prove the device's characteristics and performance are comparable to the predicate device, thereby demonstrating it meets the "acceptance criteria" for substantial equivalence:

• Biocompatibility Testing (Section 18):

  • Standards Used: ISO 10993-3: 2014 Genotoxicity, ISO 10993-4: 2006 / ASTM F756: Hemolysis, ISO 10993-5:2009 Cytotoxicity, ISO 10993-10: 2010 Skin Sensitization and Primary Skin Irritation, ISO 10993-11: 2006 Systemic Toxicity.
  • Result: "The device meets all of the requirements, as applicable, to [these ISO standards]." This demonstrates the device is acceptably biocompatible.

• Sterilization Validation (Section 17):

  • Standard Used: ISO 11137-2: 2013.
  • Result: The dressing is sterilized via gamma radiation to a 10^6^ SAL (Sterility Assurance Level), complying with the standard.

• Quality Assurance Testing (Section 15):

  • Methods: "Documented testing procedures are in place." Initial inspection includes visual characteristics (appearance, coating, cutting edges, size, heat sealing). Final inspection includes these tests plus weight and count inspection.
  • Results: These tests "demonstrate the device meets its defined specifications."

• Physical Properties (Section 14):

  • Proof: "Certificates of Analysis showing the standards / testing referenced by the manufacturer which would define the physical properties of the petrolatum and 3% bismuth tribromophenate used in the device manufacturing are attached." (These certificates are referenced but not included in the provided text).

The overarching "study" is the compilation of these tests and their results, which collectively aim to demonstrate that the Dynarex Xeroform Petrolatum Dressing is substantially equivalent to the Kendall Xeroform Petrolatum Wound Dressing, based on their similar intended use, design, materials, and performance, as summarized in the "Table of Comparison" (Table 1) and confirmed by compliance with relevant standards.

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