K Number
K123961
Date Cleared
2013-04-05

(100 days)

Product Code
Regulation Number
N/A
Panel
SU
Reference & Predicate Devices
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Sentrex BioSponge MPD is indicated in the dressing and management of:

  • Full thickness and partial thickness wounds .
  • . Pressure ulcers
  • Venous ulcers .
  • . Ulcers caused by mixed vascular etiologies
  • Diabetic ulcers
  • First and second degree burns .
  • . Donor sites and other bleeding surface wounds
  • . Abrasions
  • . Trauma wounds healing by secondary intention
  • Dehisced wounds .
  • . Surgical wounds
  • Dehisced surgical wounds
  • Grafts

The Sentrex BioSponge MPD may be cut to size.

The Sentrex BioSponge MPD is indicated for wounds with moderate to high amounts of exudate, and may be used in conjunction with negative pressure wound therapy (NPWT).

Device Description

The Sentrex BioSponge MPD is a sterile, porous, soft chitosan sponge dressing that provides a moist healing environment to support wound healing. The dressing is made of chitosan, a naturally occurring, biodegradable, biocompatible polysaccharide derived from shellfish. The shells are processed and chemically treated. Once in bandage form, they are sterilized by gamma irradiation and packed in a heat-sealed foil laminate pouch. The Sentrex BioSponge MPD may be moistened with saline in accordance with physician recommendation.

When moistened, the Sentrex BioSponge MPD is a highly conformable dressing that maintains contact with the wound surface. The Sentrex BioSponge MPD provides a moist wound environment, which may help minimize wound trauma at dressing changes. In vivo data has shown that the Sentrex BioSponge MPD may be used in conjunction with negative pressure wound therapy (NPWT).

The Sentrex BioSponge MPD is provided in the following sizes (I x w x h):

2.5cm x 10cm x 0.6cm 2.5cm x 20cm x 0.6cm 5cm x 5cm x 0.6cm 5cm x 10cm x 0.6cm 5cm x 15cm x 0.6cm 10cm x 10cm x 0.6cm 10cm x 15cm x 0.6cm 10cm x 20cm x 0.6cm

2.5cm x 10cm x 1cm 2.5cm x 20cm x 1cm 5cm x 5cm x 1cm 5cm x 10cm x 1cm 5cm x 15cm x 1cm 10cm x 10cm x 1cm 10cm x 15cm x 1cm 10cm x 20cm x 1cm

AI/ML Overview

The provided document describes a 510(k) premarket application for the Sentrex BioSponge MPD, a wound dressing. The focus of the application is on establishing substantial equivalence to previously cleared predicate devices and introducing a new claim for use in conjunction with Negative Pressure Wound Therapy (NPWT).

However, the document does not contain the level of detail typically found in studies for AI/ML-driven medical device performance, especially regarding specific acceptance criteria metrics (like sensitivity, specificity, accuracy, etc.), test set details, expert qualifications, or MRMC studies.

Instead, the document focuses on:

  • Technological Characteristics: Stating that the Sentrex BioSponge MPD has the same technological characteristics as a previously cleared predicate device (K112191).
  • Nonclinical Testing: Highlighting "New in vivo testing" performed to demonstrate compatibility with NPWT.
  • Substantial Equivalence: Asserting equivalence based on intended use, device description, product technical/material characteristics, and performance characteristics compared to predicate devices.

Given this, I can only extract information relevant to the study mentioned, which is "New in vivo testing" for NPWT compatibility, and the general basis for regulatory acceptance.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format you requested (e.g., sensitivity, specificity, or specific numerical targets). The acceptance is based on demonstrating substantial equivalence to predicate devices and showing compatibility with NPWT.

Acceptance Criteria (Implied)Reported Device Performance
Substantial equivalence to predicate devicesSentrex BioSponge MPD is considered "as safe and as effective, with substantially equivalent performance to the predicate devices" based on intended use, device description, product technical/material characteristics, and performance characteristics.
Compatibility with Negative Pressure Wound Therapy (NPWT)"New in vivo testing has been performed ... to demonstrate that the Sentrex BioSponge MPD may be used in conjunction with negative pressure wound therapy (NPWT)." "In vivo data has shown that the Sentrex BioSponge MPD may be used in conjunction with negative pressure wound therapy (NPWT)."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "New in vivo testing" but does not specify the sample size for this testing or the provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth and Qualifications

Not applicable. This type of information is generally relevant for AI/ML device studies where ground truth is established by human experts interpreting data. The testing mentioned in this document is "in vivo," implying biological or animal studies, not expert interpretation of image or other clinical data.

4. Adjudication Method for the Test Set

Not applicable for this type of in vivo testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI assistance on human readers, which is not the focus of this device approval. The device is a wound dressing, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance

Not applicable. The Sentrex BioSponge MPD is a physical wound dressing, not an algorithm.

7. Type of Ground Truth Used

For the "new in vivo testing" demonstrating compatibility with NPWT, the "ground truth" would be biological outcomes observed in the in vivo model (likely animal studies, though not explicitly stated) related to wound healing characteristics and successful use with NPWT.

8. Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve AI/ML models that require training sets.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

N/A