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Indications for Over-the-Counter Use: Hydrolyzed Collagen/Ag Wound Gel is indicated for the management of minor burns, superficial cuts, lacerations, abrasions and minor irritation of the skin.

Indications for Prescription Use: Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, first and second degree burns, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.

Hydrolyzed Collagen/Ag Wound Gel for OTC use is a change in label of the previously approved Hydrolyzed Collagen/Ag Wound Gel with Silver (K061227), for Rx use, to permit its use by the general public without the need for a physician's prescription. The proposed Hydrolyzed Collagen/Ag Wound Gel for OTC use is the identical hydrolyzed collagen wound gel formulation manufactured using the same manufacturing process and conforming to the same specifications as the Collagen Ag Wound Gel (K061227) with elemental silver as a preservative that reduces the growth of bacteria within the dressing.

Hydrolyzed Collagen/Ag Wound Gel contains a high concentration of water bound to the hydrolyzed collagen which maintains a moist wound environment as it manages wound healing. The high concentration of hydrolyzed collagen in the gel provides for greater moisture absorption capacity into the gel supporting silver retention within the gel. Hydrolyzed Collagen/Ag Wound gel is provided in a patient ready, one (1) ounce, collapsible tube.

The provided text describes a 510(k) submission for a medical device called Hydrolyzed Collagen/Ag Wound Gel, seeking approval for Over-The-Counter (OTC) use. The submission focuses on demonstrating substantial equivalence to a predicate device and provides non-clinical performance data.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative or numerical format that is commonly seen for diagnostic devices (e.g., sensitivity, specificity thresholds). Instead, the acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device (SilverMed Antimicrobial Wound Gel, K073019) and meeting established biological safety standards. The "performance" refers to non-clinical test results.

• Indications for use (OTC and Rx): Matched the predicate device's indications.
• Product Code: FRO (matched).
• Rx/OTC Status: New submission is for OTC, predicate is already OTC & Rx (the purpose of this submission is to achieve OTC status, which the predicate has).
• Physical Form: Hydrogel (matched).
• Product Description: Type I Bovine Collagen (matched).
• Animal Tissue Source: Dermis (matched).
• Preserved: Yes (matched, both use elemental silver).
• Dermal Irritant: No (matched - predicate is non-irritant, device passed ISO intracutaneous reactivity).
• Cytotoxic: No (matched - predicate is non-cytotoxic, device passed Cytotoxicity test with grade 1).
• Dermal Sensitizer: No (matched - predicate is non-sensitizer, device passed ISO Guinea Pig Maximization Sensitization).
• Product Classification: Dressing, wound, drug, unclassified (matched).
• Elemental Silver as Preservative: Both use elemental silver for controlling bacterial bioburden within the gel dressing. |
  | Biological Safety (ISO 10993) | Met:
• Cytotoxicity (Exhibit I): Grade 1 cytotoxic grade (considered non-cytotoxic for medical devices).
• ISO Guinea Pig Maximization Sensitization (Exhibit II): Negative sensitization incidence for all test animals (non-sensitizer).
• ISO Intracutaneous Reactivity (Exhibit III): Considered a non-irritant. |
  | Microbial Control (in-vitro) | Met: Found to control bacterial growth within the hydrogel. |
  | Manufacturing and Formulation Consistency | The device is the "identical hydrolyzed collagen wound gel formulation manufactured using the same manufacturing process and conforming to the same specifications as the Collagen Ag Wound Gel (K061227)" (which was the Rx version). |

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

• Sample Size for Test Set: Not explicitly stated as a "test set" in the context of clinical trials or AI model evaluation. The non-clinical tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Microbial Control) would have used defined sample sizes for their respective in-vitro or animal models, but these specific numbers are not detailed in the summary. For example, animal studies like Guinea Pig Maximization would involve a specific number of animals, but the exact count isn't provided.
• Data Provenance:
  • Country of Origin: Not specified for the non-clinical tests.
  • Retrospective or Prospective: These are non-clinical, in-vitro, or animal studies, not retrospective or prospective clinical studies on humans.

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

This section is not applicable as the submission does not involve clinical data with human expert-derived ground truth for performance evaluation in the typical sense of AI/diagnostic device evaluation. The "ground truth" for the non-clinical tests would be the established scientific methods and readings for cytotoxicity, sensitization, irritation, and microbial growth in a lab setting, interpreted by qualified laboratory personnel following ISO standards.

4. Adjudication Method for the Test Set:

This is not applicable as there is no independent "test set" requiring expert adjudication in the context of this 510(k) submission. The non-clinical tests are standard laboratory procedures with objective endpoints.

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:

No. A MRMC comparative effectiveness study was not done. The device is a wound gel, not an AI-assisted diagnostic or imaging tool that would involve human readers.

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

No. The device is a wound gel, not an algorithm.

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

For the non-clinical data, the "ground truth" is based on:

• Established ISO Standard Methods: The biological safety tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity) are conducted and interpreted according to the defined protocols of ISO 10993 standards.
• In-vitro Microbial Growth Assays: Laboratory measurements of bacterial growth inhibition.

8. The sample size for the training set:

Not applicable. This device is a wound gel, not an AI algorithm requiring a training set. The term "training set" is relevant to machine learning/AI models.

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

Not applicable. As above, there is no AI algorithm or training set for this device.

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Collagen/Ag Wound Gel is an absorbent wound dressing that provides a moist wound environment and affects the proliferation of bacteria which have been absorbed into the wound gel. Collagen/Ag gel is useful in the management of full and partial thickness wounds including dermal ulcers, leg ulcers, superficial wounds, first and second degree burns and donor sites.

Pressure ulcers (Stages I - IV) Venous stasis ulcers Diabetic ulcers Ulcers resulting from arterial insufficiency Surgical wounds Traumatic wounds First and second degree burns Superficial wounds Grafted wounds and donor sites

Hydrolyzed Collagen/Ag Wound Gel is a line extension of the previously approved HyCure® Hydrolyzed Collagen (K955506). Collagen/Ag gel is the identical hydrolyzed collagen wound gel formulation with 1.0% silver oxide added to inhibit the growth of microbes that are absorbed into the wound gel. The addition of silver oxide to the HyCure® formulation does not affect the safety or efficacy of Collagen/Ag gel. HyCure® Hydrolyzed Collagen Wound Gel contains a high concentration of water bound to the hydrolyzed collagen which maintains a moist wound environment as it manages wound healing. Collagen/Ag Wound gel is provided in a patient ready dispensible tube.

The provided text describes the 510(k) premarket notification for "Hydrolyzed Collagen/Ag Wound Gel," a medical device. However, it does not contain a study that establishes acceptance criteria or proves the device meets specific performance metrics.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means that instead of conducting a new study to prove efficacy and safety according to defined acceptance criteria, the manufacturer argues that their new device is as safe and effective as other similar devices already on the market.

Therefore, many of the requested details about acceptance criteria, study data, sample size, ground truth, and expert involvement are not applicable to this type of regulatory submission as presented. The submission relies on non-clinical data for specific aspects (cytotoxicity and microbial control) rather than broad clinical performance studies.

Here's an attempt to answer the questions based on the provided text, flagging where information is not available or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable for overall device performance. For the cytotoxicity and microbial control evaluations, specific sample sizes are not mentioned.
• Data Provenance: The in vitro evaluations (cytotoxicity, microbial control) are non-clinical studies. The country of origin for these specific tests is not stated in the provided text.

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

• Not applicable. No clinical test set requiring expert ground truth establishment for overall device performance is described. The cytotoxicity and microbial control evaluations would have been conducted in a laboratory setting, not typically requiring "experts" in the sense of clinicians establishing ground truth for patient outcomes.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring adjudication is described.

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

• No. An MRMC study was not done. The document explicitly states: "Collagen/Ag gel has not been studied in a clinical setting."

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

• Yes, in spirit, for specific aspects. While not an "algorithm," the in vitro tests for cytotoxicity and microbial control were standalone evaluations of the device's properties, without human interaction with the wound gel in a clinical setting.

7. The Type of Ground Truth Used

• Not applicable for overall device performance. For the non-clinical tests:
  • Cytotoxicity: The ground truth would be based on established laboratory standards and observation of cell viability/response to the material.
  • Microbial Control: The ground truth would be based on quantitative microbiological assays measuring bacterial growth inhibition in vitro.

8. The Sample Size for the Training Set

• Not applicable. There is no mention of a training set as this is not an AI/Machine Learning device. The regulatory submission focuses on demonstrating substantial equivalence and presents non-clinical data.

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

• Not applicable. As above, no training set is relevant to this submission.

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For the management of oral wounds and sores, including:

• Denture sores
• Oral ulcers (non-infected or viral)
• Oral dicorp (surgical wounds)
• Suture sites
• Burns
• Extraction sites
• Surgical wounds
• Traumatic wounds

Not Found

The provided text is a letter from the FDA regarding a medical device, Hycure Oral/Hycure Oral Smart Gel, and discusses its regulatory classification, labeling limitations, and substantial equivalence.

It does not contain any information about acceptance criteria, device performance, studies, sample sizes, ground truth establishment, or expert involvement for a medical device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

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(for the indications for use stated in the enclosure)

Not Found

This document is a marketing clearance letter from the FDA for the HYCURE™ device, a wound dressing. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The letter only states that the device is substantially equivalent to legally marketed predicate devices and outlines limitations on labeling claims.

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