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Hydrofera Blue READY - Border is intended as an external dressing for use in local management of moderate to heavily exuding wounds such as pressure ulcers, donor sites, venous stasis ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions, and other external wounds inflicted by trauma.

Hydrofera Blue READY - Border is a sterile absorptive foam dressings made of polyurethane (PU) foam, with methylene blue and gentian violet concentrations of at least 0.00005 g/g each with a combined total concentration of less than or equal to 0.0007 g/g. The dressings include an outer polyurethane film backing with silicone adhesive border.

This document describes the acceptance criteria and performance of the Hydrofera Blue READY - Border device, a wound dressing, as part of its 510(k) submission (K190268) to the FDA.

1. Table of Acceptance Criteria and Reported Device Performance:

• 10 gram-negative Organisms tested: 10 experienced ≥ 6 log reduction |
  | Zone of Inhibition (AATCC 147-2011) | No zone of inhibition | No evidence of growth surrounding the Dressing |
  | Dye Leachable | ) | Non-pyrogenic | Device is considered non-pyrogenic. |
  | Biocompatibility (Local effects after implantation per ISO 10993-6) | Considered passing | In the rabbit muscle study, the device was considered passing. |
  | Biocompatibility (Acute systemic toxicity per ISO 10993-11) | No signs of acute systemic toxicity | Device showed no signs of acute systemic toxicity. |
  | Biocompatibility (Hemolysis/Interaction with blood per ASTM Hemolysis Test) | Passed | Passed |
  | Biocompatibility (Toxicology Risk Assessment per ISO 10993-1, 10993-11, 10993-3, 10993-17, 10993-18, 21726, and 14971) | Toxicity not expected from intended use | Toxicity is not expected from the intended use of the device. (Note: product has not been tested or evaluated on pediatric or neonatal patient populations). |

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

The document does not explicitly state the sample sizes for each test in the acceptance criteria table. However, it indicates:

• Antibacterial Efficacy (ASTM E2149-10 modified): 8 gram-positive organisms and 10 gram-negative organisms were tested. The specific number of replicates or samples per organism is not provided.
• Other In Vitro Tests: Standard laboratory testing was performed (e.g., LAL Endotoxin, Wicking Speed, Fluid Retention, Dye Leacheable). The number of samples for these tests is generally small and typical for in vitro device characterization, but not specifically quantified in this summary.
• Biocompatibility: Testing was conducted according to ISO 10993 standards and included animal studies (rabbit for pyrogenicity, implantation, and acute systemic toxicity), but the specific number of animals or samples per test is not detailed in this summary.

Data Provenance: All data appears to be from non-clinical, in vitro, and animal studies conducted to demonstrate device performance and safety. There is no information regarding country of origin, or whether the data is retrospective or prospective, beyond the tests being performed "in support of the substantial equivalence determination." This is typically laboratory data derived from testing performed by or for the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• This submission relies entirely on non-clinical (bench and animal) testing. It does not involve a clinical study with a "test set" requiring expert ground truth establishment in the context of diagnostic or interpretive performance.
• Therefore, there were no experts used to establish ground truth for a test set in the way one would for an AI-powered diagnostic device (e.g., radiologists interpreting images). The "ground truth" for these tests is defined by the objective metrics and outcomes of the established laboratory and animal test methods (e.g., bacterial log reduction, ppm of leachable dye, absence of cytotoxic effects).

4. Adjudication Method for the Test Set:

• Since there is no "test set" requiring expert interpretation or consensus for ground truth (as explained above), there was no adjudication method used. The results are direct measurements or observations from standardized tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This device is a wound dressing, not a diagnostic imaging device or an AI-assisted interpretation tool. The submission states, "No clinical data was required to support substantial equivalence."

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

• Not applicable. This device is a physical wound dressing and does not involve any algorithm or AI component. Therefore, no standalone performance evaluation in that context was performed.

7. The Type of Ground Truth Used:

The ground truth for the performance and safety evaluations are based on objective, standardized laboratory and animal testing results (bench data and in vivo animal study outcomes), verified against predefined acceptance criteria for each test. This includes:

• Microbiological growth/reduction data.
• Chemical concentration measurements.
• Physical property measurements (wicking speed, fluid retention, peel strength).
• Biological responses in cytotoxicity, sensitization, irritation, pyrogenicity, implantation, acute systemic toxicity, and hemolysis tests.

8. The Sample Size for the Training Set:

• Not applicable. This device does not use machine learning or AI models, so there is no "training set."

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

• Not applicable. As there is no training set, no ground truth was established for it.

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Hydrofera Blue PU Antibacterial Wound Dressings are intended as external dressings for use in local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions and other external wound inflicted by trauma.

Hydrofera Blue PU Antibacterial Dressing is a sterile absorptive foam dressing made of bacteriostatic polyurethane (PU) foam, Methylene blue (less than or equal to 0.00035g/g) and Crystal violet {less than or equal to 0.00035g/g]. The Hydrofera Blue PU dressing is a dry absorbent wound dressing. The foam contains two antimicrobials that provide broad- spectrum antimicrobial protection in the foam: 1. Methylene Blue- a known inorganic antimicrobial/ antifungal, widely accepted to kill gram negative bacteria 2. Gentian Violet (Crystal violet) a known inorganic antimicrobial/antifungal widely accepted to kill gram positive bacteria

The Hydrofera Blue PU Antibacterial Dressing is an absorbent wound dressing intended for the local management of various external wounds.

Here's an analysis of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

• Did not cause sensitization reactions.
• Meets requirements for cytotoxicity (no cell death).
• Did not cause acute systemic toxicity.
• Considered non-irritant. |
  | Sterility | Sterilized by Gamma irradiation or electron beam radiation. | Sterilized by Gamma irradiation or electron beam radiation. |
  | Physical Performance | Functional similarity to predicate devices in areas like dressing flexibility, wound environment suitability (dry to wet), and non-adhesive nature. | Flexible, suitable for dry to wet wound environments, non-adhesive. |
  | Indications for Use | Same intended use as predicate devices for local management of various wound types. | Intended for local management of pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions, and other external wounds. |

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

The provided document describes in-vitro testing and does not mention human subject studies or a "test set" in the context of clinical performance evaluation. The "data provenance" for the in-vitro antimicrobial and biocompatibility testing is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond being performed for this premarket notification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. The study primarily involves in-vitro antimicrobial activity and biocompatibility testing, not clinical studies with expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. This was not a clinical study involving human readers or assessment of clinical outcomes requiring adjudication.

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 wound dressing, not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This device is a wound dressing, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of the Hydrofera Blue PU Antibacterial Dressing was established through:

• Laboratory-based In-vitro Testing: For antimicrobial activity, the ground truth was determined by observing the growth inhibition or killing of specific microbial strains under controlled laboratory conditions.
• Standard Biocompatibility Testing (ISO 10993): The ground truth for biocompatibility was established against predefined criteria and endpoints specified in ISO 10993 standards (e.g., absence of cytotoxicity, irritation, sensitization, systemic toxicity).

8. The Sample Size for the Training Set

Not applicable. This refers to a medical device's performance study, not an AI/algorithm where training sets are relevant.

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

Not applicable. This refers to a medical device's performance study, not an AI/algorithm where training sets are relevant.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is detailed under the "In Vitro Antimicrobial Testing" and "Biocompatibility per ISO 10993" sections of the 510(k) submission.

• In Vitro Antimicrobial Testing: This testing compared the Hydrofera Blue PU dressing's antimicrobial spectrum to its predicate devices (Hydrofera K# 013462 and Retro Tech K#060832). The results demonstrated that the Hydrofera Blue PU dressing exhibits activity against a broad range of microorganisms, including many listed for the predicate devices and additional strains. This established its performance equivalence in antimicrobial function.
• Biocompatibility Testing (per ISO 10993): This included specific tests for sensitization, irritation, systemic toxicity, and cytotoxicity. The conclusions drawn from these tests directly state that:
  • The dressing extracts did not cause skin irritation or sensitization reactions.
  • The dressing meets the requirements for cytotoxicity (no cell death).
  • The dressing did not cause acute systemic toxicity.
  • The dressing is considered non-irritant.

The submission concludes that "The above testing demonstrates that the Hydrofera Blue PU Antibacterial Wound Dressing is safe and effective and performs as well as the predicate devices," thereby meeting the acceptance criteria for substantial equivalence. The FDA, in its letter, concurred that the device is "substantially equivalent" based on this information.

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Hydrofera Bacteriostatic Wound Dressings are intended to use in the management of wounds such as minor cuts and scalds, abrasions, lacerations, and minor irritations of the skin.

Please contact a Healthcare professional before using this product if you are unsure whether you have any of these conditions or if you are unsure what type of wound you have.

Hydrofera BacteriostaticWound Dressings may also be used under the care of a Healthcare professional for use as external dressings in local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, díabetic ulcers, abrasions, lacerations, superficial burns, post surgical incisions, and other external wounds inflicted by trauma.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding the Hydrofera Bacteriostatic Wound Dressing. It declares substantial equivalence to a predicate device and outlines regulatory compliance. However, it does not contain the specific information required to answer your questions about acceptance criteria and study details.

The provided text does not include any information about:

1. Acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, adjudication method, MRMC effectiveness study, standalone performance study, type of ground truth, or training set details for any study.

This document is a regulatory approval letter, not a study report. To obtain the information you're looking for, you would need access to the actual 510(k) submission documentation, which would include the performance data and potentially the study details that led to this approval.

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Hydrofera Bacteriostatic Wound Dressings are intended as external dressings for use in local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, disbetic ulcers, abrasions, lacerations, and superficial hi post-surgical incisions, and other external wounds inflicted by trauma.

Hydrofera Bacteriostatic Wound Dressings are blue in color and manufactured from a pure white synthetic material with absorbent sponge-like characteristics. The two pigments have been added to render the material bacteriostatic.

This 510(k) summary (K013462) describes a wound dressing and does not contain the detailed information required to answer all parts of your request. This type of regulatory submission focuses on demonstrating substantial equivalence to existing devices rather than presenting a performance study with specific acceptance criteria and detailed test results as would be found in a clinical trial report or a more extensive engineering test report.

Based on the provided text, here's what can be extracted and what information is not available:

Information from the document:

• Device Proprietary Name: Hydrofera Bacteriostatic Wound Dressing
• Device Common Name: Wound dressing external use
• Intended Use: External dressings for use in local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, and superficial post-surgical incisions, and other external wounds inflicted by trauma.
• Predicate Devices: Ultrafera wound dressing (K964614) and Hydrofera Bacteriostatic Nasal Dressing (K983276)
• Sterility: Sterilized by either gamma or electron beam radiation to an SAL 10-6.

Based on the provided text, the following information is NOT available and therefore cannot be included in the table:

1. A table of acceptance criteria and the reported device performance: This document is a 510(k) summary, which focuses on substantial equivalence. It does not contain performance acceptance criteria or a study detailing device performance against such criteria. The "Performance standards: None" entry refers to the absence of specific FDA-mandated performance standards for this unclassified device type, not a lack of internal performance testing.
2. Sample sized used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
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 a physical wound dressing, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical wound dressing, not an algorithm.
7. The type of ground truth used: Not applicable for this type of device and submission.
8. The sample size for the training set: Not applicable for this type of device and submission.
9. How the ground truth for the training set was established: Not applicable for this type of device and submission.

The 510(k) summary indicates that "safety and effectiveness information will be provided for this marketed device upon request by interested persons." This suggests that performance data may exist but is not part of this summary document. For a physical device like a wound dressing, performance data would typically involve biocompatibility testing, tensile strength, absorption rates, bacteriostatic efficacy (as claimed by the device name, though not detailed in this summary), and potentially clinical observations for efficacy, but these details are absent from the provided 510(k) summary.

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POST OPERATIVE PACKING AFTER SEPTAL RHINOPLASTIC, OR TURBINATE SURGERY.

BACTERISTATIC NASAL DRESSING

I'm sorry, but this document does not contain the information requested. The document is a 510(k) clearance letter from the FDA for a device called "Hydrofera Bacteristatic Nasal Dressing." It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

However, the letter does not include any details about acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, ground truth establishment, or any information related to multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

This document is purely a regulatory clearance notice and does not delve into the specific technical or clinical study data that would inform such a description.

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Hydrofera TM ophthalmic sponges are intended as external wicking device for use in local management of fluids during cataract surgery.

Ophthalmic Sponge

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for an ophthalmic sponge and outlines regulatory information, but it does not detail any acceptance criteria, study methodologies, performance metrics, or ground truth establishment for a device.

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The absorbent dressing is indicated for use in hip arthroplasty.

Not Found

This document is a 510(k) clearance letter from the FDA for a device called "Hydrofera Femoral Wick." It does not contain any information about acceptance criteria, device performance results, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The letter explicitly states that the device is "substantially equivalent" to predicate devices, which is the basis for its clearance, rather than being cleared based on a specific performance study against pre-defined acceptance criteria.

Therefore, I cannot provide the requested information from this document.

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