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The Bioderm, Inc. foam dressing is an external wound dressing designed to help maintain a moist healing environment, manage exudate, and protect the wound from contamination. The dressing is indicated for the management of the following types of wounds:

Partial and full-thickness wounds, moderate to heavily exudating wounds such as; lower extremity ulcers including; venous stasis ulcers, arterial ulcers, or mixed etiology (venous & arterial) and post surgical incisions, pressure sores, and diabetic foot ulcers.

Partial thickness wounds such as; donor sites, abrasions, lacerations, and superficial burns.

Other indications include; a drainage dressing for tracheostomy, G-tube, J-tube, Penrose drain, chest tube, or sump drain, as well as a secondary or cover dressing for packed wounds.

The device has not changed from those approved under Bioderm, Inc. K982778 and consist of square, hydrophilic foam pads for wound care and square foam pads with a slit to fit around tracheostomy or gastrostomy tubes. The device provides a means to absorb exudate from draining wounds.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Bioderm Foam Wound Dressing:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices, particularly those seeking 510(k) clearance, the "acceptance criteria" are typically defined by demonstrating substantial equivalence to a legally marketed predicate device. This often involves showing that the new device has the same technological characteristics and similar performance. In this case, the acceptance criteria are related to the biological safety and non-toxicity of the materials.

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

The provided document details non-clinical laboratory tests, primarily on biological samples rather than human clinical data.

• Primary Skin Irritation: Albino rabbits (specific number not given, but typically a small group for such tests).
• Kilgman Maximization Study: Not specified, but generally performed on a small group of animals (e.g., guinea pigs).
• Systemic Injection Test: Albino Swiss mice (specific number not given, but generally a small group).
• 14 Day Repeated Intravenous Toxicity Study: Not specified, but typically a small group of animals (e.g., rabbits, rodents).
• Cytotoxicity-Agar Diffusion Test: L929 mammalian cells (in vitro).
• Hemolysis Rabbit Blood: Rabbit blood (in vitro).

Data Provenance: These are pre-clinical (animal and in-vitro) studies. The sponsor is Rynel Ltd. Inc., Boothbay, Maine, and the test facility is Toxicon Laboratories. The country of origin for the animals/biological material is not explicitly stated but is presumed to be local to the test facility (USA). All tests appear to be prospective in nature, as they were specifically conducted for this evaluation.

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

For these non-clinical biological tests, the "ground truth" is established by adherence to standard laboratory protocols and interpretations by qualified laboratory personnel. The document does not specify the number or qualifications of individual experts who "established the ground truth" in the way clinical studies might for image interpretation. Instead, the validity relies on:

• Accredited Test Facility: Toxicon Laboratories.
• Standardized Protocols: Reference to standards like USP XXIII for cytotoxicity.
• Expert Interpretation: Implied expertise of the scientists and technicians at Toxicon Laboratories in conducting and interpreting these specific toxicology and biocompatibility assays.

4. Adjudication Method for the Test Set

Not applicable for these types of non-clinical laboratory tests. Adjudication methods like "2+1" (two readers agree, third resolves discrepancy) are relevant for human interpretation tasks (e.g., radiology reads), not for direct biological assay results.

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 submission is for a foam wound dressing, not a diagnostic imaging AI algorithm. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this device's clearance.

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

Not applicable. This is a physical medical device (wound dressing), not an algorithm or AI-based device.

7. The Type of Ground Truth Used

The ground truth for these tests is based on direct biological and chemical measurements and observations according to established laboratory protocols and scientific standards, aimed at assessing biocompatibility and safety. This is distinct from expert consensus, pathology (though histopathology was used in one test), or outcomes data in a clinical trial.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model. There is no "training set" in the context of device development described here.

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

Not applicable for the same reason as above.

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The Bioderm, Inc. foam dressing is an external wound dressing designed to help maintain a moist wound healing environment and manage exudate.

The dressing is indicated for the local management of the following types of wounds:

1. Partial and full thickness wounds, moderate to heavily exudating wounds such as;
   a. venous stasis ulcers.
   b. pressure sores.
   c. post operative incisions.
   d. diabetic ulcers.
2. Partial thickness wounds such as;
   a. abrasions.
   b. lacerations.
   c. donor sites.
   d. superficial burns.
3. Other indications include;
   a. drainage dressing for tracheostomy and gastrostomy tubs.

Bioderm Foam Wound Dressing

This document is a 510(k) clearance letter from the FDA for a wound dressing, not a study describing the acceptance criteria and performance of a device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be extracted from the provided text.

The document primarily states that the Bioderm Foam Wound Dressing is substantially equivalent to legally marketed predicate devices and outlines its approved indications for use and certain labeling limitations. It does not contain any performance data or study results demonstrating the device meets specific acceptance criteria.

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The BioDerm BTF Wound Dressing is a sterile thin film dressing intended for over-the-counter use and prescription use. The BioDerm BTF consists of a transparent, polyurethane film backed with a hypoallergenic pressure sensitive adhesive. The BTF is permeable to moisture vapor and oxygen and intended to maintain a moist wound healing environment. A moist wound environment allows atolytic debridement.

OTC Indications for Use:

• Abrasions, lacerations, minor/superficial cuts;
• Minor scalds, minor burns;
• Minor irritations to the skin

Under the Care of a Health Care Professional:

• Leg ulcers, pressure ulcers (stages I and II);
• Surgical wounds (post operative wounds, donor sites);
• 1st and 2nd degree burns;
• Cover and protect catheter sites and wounds;
• Securement of medical appliances;
• Catheter securing device;
• Dermal lesions:
• Non-exuding to minimally exuding wounds

The BioDerm BTF Thin Film Wound Dressing is a sterile thin film dressing which consists of a polyurethane film backed with a hypoallergenic pressure sensitive adhesive. The BTF is a transparent dressing which is permeable to moisture vapor and oxygen and intended to provide a moist wound healing environment to facilitate the normal wound healing process. The BTF Thin Film Wound Dressing provides a barrier to bacteri and external contaminates.

This submission describes a 510(k) premarket notification for the BioDerm BTF Thin Film Wound Dressing, seeking substantial equivalence to already marketed devices. The study provided focuses on biocompatibility testing rather than device performance benchmarks related to its primary function (wound healing).

Here's an analysis of the provided information:

Acceptance Criteria and Device Performance

The core of this submission is demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and biocompatibility. There are no explicit performance acceptance criteria in terms of wound healing rates or infection reduction that the device is quantitatively measured against. Instead, the acceptance is based on meeting safety standards (biocompatibility) and having similar characteristics and intended use to legally marketed predicate devices.

Table 1: Biocompatibility Testing and Results

Note: The document explicitly states: "Based upon the results of biocompatability tests, the device is safe and effective for its intended purpose." This is the key "acceptance criteria" met in the provided study.

Study Details for Biocompatibility Testing

1. Sample Size used for the test set and the data provenance:

   • The document does not specify the sample size used for each biocompatibility test (e.g., number of animals or human subjects/volunteers).
   • Data Provenance: Not explicitly stated, but these types of tests are typically conducted in a laboratory setting, often by contract research organizations specializing in medical device biocompatibility. The country of origin is not mentioned. The nature of these tests is prospective, as they are performed specifically for device evaluation before market entry.

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

   • For biocompatibility tests, "ground truth" is established by the standardized protocols (e.g., ISO 10993-1) and performed by trained laboratory personnel. Typically, experts in toxicology or pathology review the results against the criteria. The document does not specify the number or qualifications of these particular experts, but their expertise would be implicit in the adherence to ISO standards.

3. Adjudication method for the test set:

   • Not applicable in the traditional sense for biocompatibility testing. The "adjudication" is the assessment of the test results against the pass/fail criteria outlined in the ISO standards, performed by the testing laboratory and reviewed by the submitter.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. This type of study is more common for imaging devices or diagnostic aids where human interpretation is a critical component.

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

   • No, this device is a physical wound dressing and does not involve an algorithm or AI.

6. The type of ground truth used:

   • The "ground truth" for the biocompatibility study is defined by the established scientific and regulatory standards (ISO 10993-1) for assessing biological responses to medical devices. These standards dictate what constitutes an acceptable biological reaction (e.g., no irritation, no sensitization).

7. The sample size for the training set:

   • Not applicable. Biocompatibility testing does not involve a training set as would be used in machine learning or AI development.

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

   • Not applicable, as there is no training set for this type of evaluation.

Additional Notes from the Submission:

• Substantial Equivalence: The primary strategy of this 510(k)_ is to demonstrate substantial equivalence to existing predicate devices (Smith & Nephew OpSite, 3M Tegaderm, Hollister Simplicare, J&J Bioclusive MVP, Innovative Technologies Transparent Thin Film). This is done through a comparative table highlighting similar materials, visibility, packaging, adhesive, moisture vapor permeability, sterilization, intended use, and bacterial barrier characteristics.
• No Clinical Efficacy Study: There is no mention of a human clinical trial to demonstrate wound healing efficacy, infection reduction, or other performance characteristics of the dressing itself. The biocompatibility tests address safety. For 510(k) submissions, clinical data are often not required if substantial equivalence can be demonstrated through technological characteristics and non-clinical performance (like biocompatibility).
• Limitations on Labeling: The FDA's response letter (pages 3-4) imposes specific limitations on what the device can be labeled for, such as not for third-degree burns, not having an accelerating effect on wound healing, not being a long-term dressing or artificial skin, and not being a "treatment or cure." These limitations reflect the scope of the substantial equivalence determination and the data provided.

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• 1. Venous Stasis Ulcers
• 2. Pressure Ulcers
• 3. Diabetic Ulcers
• 4. Surgical Wounds

Bioderm Calcium Alginate Wound Dressing

This document is a marketing clearance letter for a medical device (Bioderm Calcium Alginate Dressing) and does not contain the specific information required to complete your request. The letter confirms that the device is substantially equivalent to existing devices based on its stated indications for use but does not provide details of acceptance criteria, study methodologies, or performance data.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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• 1. Venous stasis ulcers.
• 2. Pressure sores Stages 1, 2, 3, & 4.
• 3. Ulcers triggered by trauma.
• 4. Drainage dressing for tracheostomy and gastrostomy tubes.
• 5. Post operative incisions.

Bioderm Foam wound Dressing

The provided text is a 510(k) clearance letter from the FDA for a wound dressing, not a study report or a document detailing acceptance criteria and device performance. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document only states that the device, "Bioderm Foam Wound Dressing," is "substantially equivalent" to legally marketed predicate devices for the following indications for use:

• Venous stasis ulcers.
• Pressure sores Stages 1, 2, 3, & 4.
• Ulcers triggered by trauma.
• Drainage dressing for tracheostomy and gastrostomy tubes.
• Post operative incisions.

It also lists limitations on labeling claims, such as not being labeled for use on third-degree burns, or as having an accelerating effect on wound healing.

To provide the requested information, a different type of document, such as a clinical study report or a detailed summary of the premarket submission, would be necessary.

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The BioDerm® EID® is an external male catheter intended for the management of urinary incontinence in males. It facilitates urine drainage into a urine collection bag.

BioDerm® EID® MALE EXTERNAL INCONTINENCE DEVICE

This document, K963950, is a 510(k) summary for the BioDerm® EID® Male External Incontinence Device. It primarily focuses on demonstrating substantial equivalence to a predicate device and biocompatibility.

It does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

The document states:

• Indications for Use: The BioDerm® EID® is an external male catheter intended for the management of urinary incontinence in males. It facilitates urine drainage into a urine collection bag.
• Biocompatibility: The results of the biocompatibility tests show the device to be safe for its intended purpose.
• Substantial Equivalence: The BioDerm® EID® male external catheter is substantially equivalent to the Hollister PolyTech™, non-latex, self-adhesive urinary external catheter predicate device.

Therefore, I cannot provide the requested information in the format of acceptance criteria and performance study details because this 510(k) summary does not contain that level of detail regarding performance criteria or studies beyond basic biocompatibility and general safety for its intended purpose through substantial equivalence.

The questions you've asked (about sample size, ground truth, expert qualifications, etc.) are typically associated with studies evaluating the diagnostic or predictive performance of a device (e.g., an AI-powered image analysis tool). This device, an external catheter, is a physical medical device, and its "performance" is assessed differently, primarily through its physical properties, biocompatibility, and functional outcome (facilitating urine drainage), often compared to existing devices.

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Ask a specific question about this device