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For the fecal management of patients with little or no bowel control and for patients whose stool is semi-liquid or liquid

ConvaTec Fecal Management System

The provided text is a 510(k) Premarket Notification for the ConvaTec Fecal Management System. It primarily focuses on demonstrating substantial equivalence to a predicate device and biocompatibility testing. The document does not contain information about acceptance criteria or a study proving performance against such criteria. Therefore, I cannot extract the requested information from the provided text.

Here's a breakdown of what is and is not in the document:

What is present:

• Device Name: ConvaTec Fecal Management System
• Applicant: ConvaTec
• Intended Use/Indications: Fecal management for patients with little or no bowel control and for patients whose stool is semi-liquid or liquid.
• Predicate Device: Indwelling Fecal Management System (K012113)
• Classification: Gastrointestinal tube and accessories, 21 CFR 876.5980, Class II
• Biocompatibility Testing: States that testing was done according to ISO 10993 Part I (FDA modified matrix) and concluded the device is non-sensitizing, non-cytotoxic, and non-irritating.
• Regulatory Outcome: 510(k) clearance (substantial equivalence determination).

What is not present (and is required for your request):

• Specific acceptance criteria for device performance.
• Any study results (clinical or performance bench testing beyond biocompatibility) demonstrating the device meets performance criteria.
• Sample sizes for test sets, data provenance, ground truth establishment for a performance study.
• Information about expert involvement for ground truth, adjudication methods, or MRMC studies.
• Standalone algorithm performance or training set details.

A 510(k) submission, especially for a device demonstrating substantial equivalence, often does not include detailed performance studies with acceptance criteria in the same way a de novo or PMA submission might. The "performance" in this context is often inferred from the predicate device and relevant bench testing (like biocompatibility and basic functional tests not detailed here).

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For Over-The Counter Use, DuoDERM Hydroactive Gel Wound Dressing may be used for abrasions, lacerations, minor cuts, minor scalds and burns, and skin tears. Under the supervision of a healthcare professional, DuoDERM Hydroactive Gel may be used for the hydration and management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers and skin conditions resulting from radiation dermatitis.

DuoDERM Hydroactive Gel Wound Dressing is substantially equivalent to Carrasyn Hydrogel Wound Dressing. The products are equivalent in intended use and function. Both products provide a moist wound healing environment. DuoDERM Hydroactive Gel Wound Dressing is also capable of absorbing exudate.

The provided text is related to a 510(k) Premarket Notification for a wound dressing and does not contain information about acceptance criteria or a study that proves the device meets such criteria.

The document primarily focuses on establishing "substantial equivalence" of the DuoDERM® Hydroactive® Gel Wound Dressing to a predicate device (Carrasyn® Hydrogel Wound Dressing) for regulatory approval. This is a common pathway for medical devices where a new device is compared to an already legally marketed device, demonstrating that it is as safe and effective.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document does not describe performance metrics, statistical analysis, sample sizes for test or training sets, expert qualifications, or details of a study designed to prove specific acceptance criteria.

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For Over The Counter use, Aquacel Hydrofiber Wound Dressing may be used for: abrasions, minor cuts and minor scalds and burns. Under the supervision of a health care professional, Aquacel may be used for wounds such as: leg ulcers, pressure ulcers (Stages I-IV), and diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological), burns (first and second degree); management of surgical or traumatic wounds that have been left to heal by secondary intention; local management of wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds.

Aquacel Hydrofiber Wound Dressing is a non-absorbable wound dressing.

The provided text is a 510(k) premarket notification for the AQUACEL™ Hydrofiber™ Wound Dressing. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

Instead, it states: "Data/information supporting the safety of Aquacel Hydrofiber Wound Dressing was presented in Premarket Notification K943258. All testing was performed in accordance with Good Laboratory Practice Regulations." This indicates that safety data was submitted previously and is referenced here, but the specifics of that data or any performance criteria are not included in this document.

Therefore, I cannot provide the requested information from the given text. The text focuses on regulatory approval based on substantial equivalence rather than detailed performance study results against specific acceptance criteria.

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DuoDERM Hydroactive Gel is designed for the hydration and management of partial and full thickness wounds such as pressure sores, leg ulers, and diabetic ulcers. DuoDERM Hydroactive Gel provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the secondary dressing without damaging newly formed tissue.

The concept of DuoDERM Hydroactive Gel is not significantly different from other commercially available dressings intended for use in the management of wounds. DuoDERM Hydroactive Gel is indicated for use on partial and full thickness wounds such as pressure ulcers and diabetic ulcers. The gel is used for the management of wounds requiring hydration.

The provided document is a 510(k) Premarket Notification for DuoDERM® Hydroactive® Gel from 1997. This type of submission is for medical devices, specifically wound dressings, and does not involve AI or algorithms that would have acceptance criteria for performance metrics like sensitivity, specificity, or AUC.

Therefore, most of the requested information regarding acceptance criteria for a device's performance, sample sizes for test and training sets, expert consensus, MRMC studies, or standalone algorithm performance, is not applicable to this document.

However, I can extract information relevant to the substantial equivalence claim and indications for use.

Here's a breakdown of what can be extracted or inferred from the provided text, and what is not applicable:

1. A table of acceptance criteria and the reported device performance

• Not Applicable in the traditional sense of AI/algorithm performance. The acceptance criteria for this type of device are primarily related to safety, equivalence to a predicate device, and the validity of stated indications for use. Performance is typically assessed through demonstrating substantial equivalence to a legally marketed predicate device (SignaDRESS Hydrocolloid Dressing) based on intended use and function, as well as safety data.
• Implied Acceptance Criteria for Claims: The FDA's limitations on labeling indicate the types of claims that were not accepted without further premarket notification:
  • Not labeled for use on third-degree burns.
  • Not labeled as having any accelerating effect on the rate of wound healing or epithelization.
  • Not labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
  • Not labeled as a treatment or a cure for any type of wound.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Applicable. This is a medical device (wound dressing) submission. The concept of "test sets" in the context of an algorithm's performance data does not apply here. The submission refers to "Data/information supporting the safety of DuoDERM Hydroactive Gel was presented in Premarket Notification K931618." This implies previous testing for safety, but specific sample sizes or study designs are not detailed in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable. Ground truth in the context of expert consensus for algorithm evaluation is not relevant to this device submission.

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

• Not Applicable. Adjudication methods are for resolving discrepancies in expert labeling or model outputs, not for wound dressings.

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. There is no AI or software involved with "human readers" in this submission.

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 in the context of algorithm performance. The "ground truth" for this device relates to its safety and effectiveness for its intended use, which would have been established through preclinical testing and potentially clinical data (though not detailed here beyond referring to a previous submission, K931618). For a wound dressing, this would typically involve biocompatibility testing, sterility, and possibly wound healing assessments in animal or human studies to support claims.

8. The sample size for the training set

• Not Applicable. There is no "training set" for a physical device like a wound dressing.

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

• Not Applicable.

Summary of Relevant Information from the Document:

• Device Name: DuoDERM® Hydroactive® Gel
• Predicate Device: SignaDRESS Hydrocolloid Dressing
• Statement of Equivalence: DuoDERM Hydroactive Gel is substantially equivalent to SignaDRESS Hydrocolloid Dressing in intended use and function.
• Intended Use/Indications for Use: Hydration and management of partial and full-thickness wounds such as pressure sores, leg ulcers, and diabetic ulcers. Provides a moist wound environment supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the secondary dressing.
• Contraindications: Individuals with a known sensitivity to the gel or its components.
• Safety Data Reference: Data/information supporting the safety was presented in Premarket Notification K931618. All testing was performed in accordance with Good Laboratory Practice Regulations.
• FDA Limitations/Non-Accepted Claims:
  • Not for use on third-degree burns.
  • No accelerating effect on the rate of wound healing or epithelization.
  • Not a long-term, permanent, or no-change dressing, or artificial skin.
  • Not a treatment or cure for any type of wound.

The provided text describes a traditional medical device premarket notification, not a submission for an AI or software algorithm. Therefore, the specific criteria and study details requested in the prompt related to AI performance metrics are not present and do not apply.

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DuoDERM Hydroactive Paste is designed to be used with a secondary dressing such as DuoDERM Dressings for the local management of exudating dermal ulcers, including full thickness wounds, such as leg ulcers, pressure ulcers and diabetic ulcers.

The concept of DuoDERM Hydroactive Paste is not significantly different from other commercially available absorbent dressings intended for use in the management of exudating wounds. DuoDERM Hydroactive Paste is indicated for use on exudating dermal ulcers, including full thickness wounds such as leg ulcers, pressure ulcers and diabetic ulcers. It is used in association with other DuoDERM® dressings.

The provided documents pertain to a 510(k) Premarket Notification for DuoDERM® Hydroactive® Paste (K973807). This submission is for a medical device used for wound care, not an AI/ML-driven device. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/ML device is not applicable to this document.

The document discusses the substantial equivalence of the DuoDERM® Hydroactive® Paste to another commercially available device (SignaDRESS Hydrocolloid Dressing) based on intended use and dressing characteristics, rather than performance metrics from a specific study against acceptance criteria.

The key points from the document are:

• Device: DuoDERM® Hydroactive® Paste.
• Purpose of 510(k): To request clearance for claims specific to the moist wound healing environment created by the paste.
• Indication for Use: Management of exudating dermal ulcers, including full thickness wounds such as leg ulcers, pressure ulcers, and diabetic ulcers, used in association with other DuoDERM® dressings.
• Substantial Equivalence: To ConvaTec's SignaDRESS Hydrocolloid Dressing, based on equivalent intended use and dressing characteristics.
• Safety Data: Supported by Premarket Notification K881302 and performed in accordance with Good Laboratory Practice Regulations.
• Limitations (from FDA letter):
  • May not be labeled for use on third-degree burns.
  • May not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
  • May not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
  • May not be labeled as a treatment or a cure for any type of wound.

Since this is a submission for a traditional medical device (wound care paste) and not an AI/ML product, the questions posed about AI/ML specific study design, performance metrics, and data characteristics cannot be answered from the provided text.

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DuoDERM Extra Thin CGF Dressings is indicated for use on chronic wounds-dry to lightly exuding dermal ulcers, including diabetic ulcers; acute wounds (e.g., post operative wounds); and as a protective dressing for areas at risk for skin breakdown. DuoDERM Extra Thin CGF Dressing provides a moist wound environment that is necessary for the healing process.

The concept of DuoDERM Extra Thin CGF Dressing is not significantly different from other commercially available absorbent dressings intended to manage exudating wounds.

This document is a 510(k) Pre-Market Notification for a medical device (DuoDERM Extra Thin CGF Dressing). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way a diagnostic AI device would.

Therefore, the information requested (acceptance criteria, specific study details, ground truth establishment, sample sizes for training/test sets, MRMC studies, etc.) is not present in the provided text.

Here's a breakdown of why and what information is available:

• Type of Device: DuoDERM Extra Thin CGF Dressing is an absorbent dressing for wound management. It's a physical medical device, not a diagnostic algorithm or AI system.
• Regulatory Pathway: The submission is a 510(k), which aims to show "substantial equivalence" to a legally marketed predicate device. This typically involves comparing characteristics, intended use, and performance data if relevant, but not necessarily a "study that proves the device meets the acceptance criteria" in the sense of an algorithmic performance evaluation.
• Focus of the Document: The document explicitly states: "The concept of DuoDERM Extra Thin CGF Dressing is not significantly different from other commercially available absorbent dressings intended to manage exudating wounds." and "DuoDERM Extra Thin CGF Dressing is substantially equivalent to SignaDRESS Hydrocolloid Dressing. The two products are equivalent in intended use and dressing characteristics."

Information that is available (but doesn't align with the requested table/study details):

• Device Name: DuoDERM® Extra Thin® CGF Dressing
• K-Number: K973716
• Predicate Device: SignaDRESS™ Hydrocolloid Dressing
• Intended Use/Indications: Chronic wounds (dry to lightly exudating dermal ulcers, including diabetic ulcers), acute wounds (e.g., post-operative wounds), and as a protective dressing for areas at risk for skin breakdown. It "provides a moist wound environment that is necessary for the healing process."
• Safety Data Provenance: "Data/information supporting the safety of DuoDERM Extra Thin CGF Dressing was presented in Premarket Notifications K891696 and K925990. All testing was performed in accordance with Good Laboratory Practice Regulations." This indicates prior submissions and GLP compliance for safety, but not a new clinical performance study for this specific 510(k).
• Limitations imposed by FDA: The FDA letter explicitly states limitations on labeling for this device (e.g., not for third-degree burns, not to claim accelerated healing, not as a long-term dressing, not a cure). These are regulatory conditions rather than performance acceptance criteria derived from a study.

In summary, none of the specific points (numbered 1-9) about acceptance criteria and a performance study for an AI/diagnostic device can be answered from the provided text because this document pertains to a physical wound dressing seeking substantial equivalence and does not describe such a study.

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CombiDERM ACD is a moisture retentive dressing and is indicated for use on exuding chronic dermal ulcers including full-thickness wounds, such as pressure ulcers, leg ulcers and diabetic ulcers, and on acute wounds such as abrasions, lacerations, biopsies, and oven and closed surgical wounds. The dressing provides a moist wound environment that is supportive of the healing process.

CombiDERM ACD is a moisture retentive dressing and is indicated for use on exuding chronic dermal ulcers, including full thickness wounds such as pressure ulcers and diabetic ulcers and for acute wounds, such as abrasions, lacerations, biopsies, and open and closed surgical wounds. CombiDERM ACD wicks exudate away from the wound and provides a moist wound environment that is supportive of the healing process. The moist environment aids autolytic debridement and allows non-traumatic removal of the dressing without damaging newly formed tissue.

The provided text is a 510(k) Premarket Notification for a medical device (CombiDERM™ ACD™ Absorbent Cover Dressing) to the FDA. It details the device's description, intended use, and comparison to a predicate device, as well as a subsequent FDA clearance letter. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving the device meets them.

The document discusses:

• Device description and equivalence: CombiDERM ACD is a moisture-retentive dressing, substantially equivalent to SignaDRESS Hydrocolloid Dressing (K962590).
• Indications for use: Exuding chronic dermal ulcers (pressure, leg, diabetic) and acute wounds (abrasions, lacerations, biopsies, surgical wounds).
• Contraindications: Known sensitivity to the dressing or its components.
• Biocompatibility tests: Demonstrated non-irritating, non-cytotoxic, non-hemolytic, weak allergenic potential (conducted per Good Laboratory Practices).
• FDA clearance: K973717, cleared on December 17, 1997, with specific limitations on labeling claims.

The document does not include:

1. A table of acceptance criteria and reported device performance: This would typically involve specific metrics (e.g., absorption rate, wear time, conformability) with defined pass/fail thresholds and actual test results.
2. Details of a study proving the device meets acceptance criteria: While biocompatibility tests are mentioned, they are not presented as a "study" with a specific design, sample size, or detailed results against predefined acceptance criteria.
3. Sample size used for a test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, or ground truth establishment for a training set. These are typically associated with performance studies, especially those involving AI or diagnostic accuracy, which are not relevant to this medical device submission.

Therefore, based on the provided text, I cannot provide the requested information. The document confirms biocompatibility and substantial equivalence but does not detail a study or specific acceptance criteria in the manner you've outlined.

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