Search Results

Rx: Under the supervision of a healthcare professional, PuriCore Wound Hydrogel Spray Dressing is intended for management of wounds, including itch and pain relief, and to cleanse and moisten the wound bed. A moist wound and skin environment is beneficial to the healing process. It is intended for use on mechanically or surgically debrided wounds, Stage I-IV Pressure Ulcers, Partial and Full thickness Wounds, Diabetic Foot and Leg Ulcers, Post Surgical Wounds, First and Second Degree Burns, Grafted and Donor Sites, exit sites and intact skin, and various dermatoses, including contact dermatitis. It can be used during wound dressing changes to soften encrusted wound dressings.

OTC: PuriCore Wound Hydrogel Spray Dressing is intended for use to relieve itch and pain from minor skin irritations, minor lacerations, minor abrasions and minor burns, to cleanse and moisten the wound bed and for the management of minor cuts, exit sites and intact skin. It is also indicated for the management of minor irritation and pain from minor sunburn.

PuriCore Wound Hydrogel Spray Dressing is an aqueous hydrogel that aids in the removal of foreign objects such as dirt and debris from granulating wounds and forms a protective barrier that provides for a moist wound environment which loosens contaminated exudate, slough and other foreign materials within the wound bed. A moist wound environment is also supportive of the healing process by aiding autolytic debridement. PuriCore Wound Hydrogel Spray Dressing contains 0.050% Hypochlorous Acid that inhibits contamination within the hydrogel. The product is sprayable to aid / ease the application of the product. The device is presented as both a prescription product (that requires the physician to diagnose the disease state and prescribe the product) and for Over-The-Counter use.

The device is offered in a 4.0oz bottle with a manual spray pump configuration. The product is packaged in a PET bottle and a polypropylene spay cap which enables the user to manually spray the product directly onto a wound or wound dressing.

The device contains: Sodium Magnesium Fluorosilicate, Sodium Chloride, Water, Aqueous Phosphate Buffers, and Hypochlorous Acid (0.050%).

The provided text is a 510(k) Summary for the PuriCore Wound Hydrogel Spray Dressing. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or performing a study to prove performance against specific clinical efficacy metrics for a novel medical device. The document explicitly states "Non clinical product testing has proven that Puricore Wound Hydrogel Spray Dressing is substantially equivalent to the predicate devices".

Therefore, based solely on the provided text, I cannot extract information about acceptance criteria and a study proving the device meets those criteria in the way typically expected for a new device's clinical performance. The document describes pre-clinical testing for biocompatibility and shelf-life related attributes, which are important for safety and product stability, but not directly about clinical efficacy or specific functional performance criteria in a wound healing context beyond what the predicate devices are already cleared for.

Here's a breakdown of the requested information based on the provided text:

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

Since this 510(k) is about demonstrating substantial equivalence to existing predicate devices, the "acceptance criteria" are primarily that the PuriCore Wound Hydrogel Spray Dressing is as safe and effective as the predicates. The reported device performance is largely a confirmation of this equivalence through various non-clinical tests.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified. The document mentions "biocompatibility studies" and "Preservative Effectiveness testing" but does not detail the number of samples or subjects used for these specific tests.
• Data Provenance: The tests are "Pre-Clinical Testing." No country of origin is mentioned for the data itself, but the submission is to the U.S. FDA, implying compliance with U.S. regulatory standards. The data is retrospective in the sense that the tests were performed to support the 510(k) submission.

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

• Not applicable as this is a pre-clinical, non-human study for substantial equivalence rather than a clinical trial requiring expert consensus on outcomes. The "ground truth" for these tests would be established by the standardized methods and criteria of the specific ISO standards (e.g., ISO-10993-1 for biocompatibility) and other test protocols.

4. Adjudication method for the test set:

• Not applicable for the reported pre-clinical testing. Adjudication methods are typically relevant for human clinical trials or image interpretation studies where multiple expert opinions need to be reconciled.

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 not an AI-assisted device, nor does the document describe an MRMC study.

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

• Not applicable. This is not an algorithm or AI-based device.

7. The type of ground truth used:

• For the pre-clinical tests (biocompatibility, chemical stability, etc.), the "ground truth" is defined by the objective results against established scientific and regulatory standards/protocols (e.g., ISO-10993-1, USP preservative effectiveness tests).

8. The sample size for the training set:

• Not applicable. This is not an AI device that requires a training set. The term "training set" refers to data used to train machine learning models.

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

• Not applicable. (See #8)

Ask a specific question about this device

Under the supervision of healthcare professionals, Vashe Wound Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and / or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings.

Vashe® Wound Solution is a saline based wound cleanser that contains hypochlorous acid as a preservative that inhibits microbial contamination within the solution. Vashe® Wound Solution creates a moist environment and loosens contaminated exudate, slough and other foreign materials within the wound bed. As a result of mechanical action of solution moving across the wound bed, dirt, debris, and microorganisms are more readily removed. Moistening and cleansing a wound, such as by using Vashe Wound Solution, better allows for the natural healing process to take place. This device is presented as a prescription product that requires the physician to diagnose the disease state and prescribe the product.

The device is offered in three sizes of bottles, 4.0oz, 8.5oz, and 16.0oz and in two packaging configurations:

Configuration #1: A PET bottle with a laminated induction seal and a polypropylene flip-top-cap configuration enables the user to manually pour the solution directly onto a wound or wound dressing.

Configuration #2: The device is also offered in a PET bottle and a polypropylene cap (with septum configuration that forms the primary seal). The septum cap enables easy access to the solution by a healthcare professional by means of a vented spike connector.

The provided 510(k) summary for Vashe® Wound Solution (K131848) does not describe a study involving device performance against acceptance criteria in the typical sense of a clinical or analytical performance study with specific metrics like sensitivity, specificity, or quantifiable outcomes. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics, safety, and effectiveness, primarily through non-clinical testing.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable in the format requested, as the submission relies on demonstrating substantial equivalence, not on meeting specific, quantifiable performance targets for the device's intended use in treatment. The "performance" is primarily shown through a comparison to existing, legally marketed predicate devices and through non-clinical safety/stability testing.

Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets the implicit acceptance criteria is a compilation of non-clinical equivalency testing aimed at demonstrating substantial equivalence to predicate devices. This includes:

• Comparison of Technical Characteristics: A qualitative comparison highlighting similarities in chemical composition, mechanical action, intended use, and packaging/closure systems to K123072, K113820, K083355, and K111313.
• Biocompatibility Studies: In-vivo and in-vitro biocompatibility testing per ISO-10993-1 standards. These were conducted to prove the product is safe, particularly under worst-case scenarios for active ingredient concentration and pH.
• Shelf Life and Chemical Stability Testing: Non-clinical tests to evaluate the product's stability over its intended shelf life.
• Preservative Effectiveness Testing: To USP <51> standards, demonstrating the solution's ability to inhibit microbial contamination within the product.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated as a "test set" for a clinical performance evaluation. The non-clinical studies (biocompatibility, stability, preservative effectiveness) would have their own sample sizes for the materials tested, but these are not detailed in the summary. For example, for biocompatibility, it would involve a certain number of test replicates or animal subjects, but these specifics are missing.
• Data Provenance: Not specified for the non-clinical tests. It's implied these were conducted internally or by contract labs in support of the submission. The origin (e.g., country) is not mentioned. They would be considered prospective for the purpose of demonstrating equivalence for this submission.

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

Not applicable. This device is a solution, and the testing outlined is primarily chemical, physical, and biological in nature (biocompatibility, stability). There is no "ground truth" derived from expert consensus on images or clinical outcomes in the summary provided.

4. Adjudication method for the test set

Not applicable. No expert adjudication process is described as there isn't a "test set" requiring such a method for this type of device.

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 care solution, not an AI-powered diagnostic or imaging tool. Therefore, MRMC studies are not relevant.

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

Not applicable. This device is a physical solution, not an algorithm or AI.

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

Not applicable in the clinical sense. For the non-clinical tests:

• Biocompatibility: Ground truth is established by recognized international standards (ISO-10993-1) for evaluating biological response to medical devices.
• Chemical Stability: Ground truth is against established chemical specifications and analytical methods.
• Preservative Effectiveness: Ground truth is against microbial reduction targets defined by compendial standards (USP <51>).

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As above, there is no training set mentioned for this device.

Ask a specific question about this device

Vashe® Wound Therapy System (including Vashe® Wound Therapy Solution) is intended for cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.

The subject device includes a wound cleanser solution that is intended for cleansing, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. In addition, the subject device contains Free Available Chlorine (FAC) that inhibits contamination within the solution.

Vashe® Wound Therapy System consists of a Vashe® Wound Therapy Generator and Vashe® Wound Therapy+ Solution. The Vashe® Wound Therapy+ Solution is produced from a Vashe® Wound Therapy Generator. The generator is an electromechanical device containing an electromechanical cell, power supply, storage tank, pump, valve, tubing, various mechanical hardware, etc. The Vashe® Wound Therapy Solution is a clear solution with a controlled pH and containing free available chlorine at a designated concentration (ppm). Cleaning and debriding is caused by the physical action of the of the Vashe® Wound Therapy Solution moving across the wound while the hypochlorous acid acts as a preservative to ensure no growth of micro-organisms in the solution. In addition. The Vashe® Wound Therapy Solution also moistens and lubricates absorbent wound dressings.

The provided document describes the Vashe® Wound Therapy System and its 510(k) submission (K100918) for market clearance. The information focuses on demonstrating substantial equivalence to predicate devices and provides details on performance testing related to safety and biocompatibility, as well as the solution's ability to inhibit contamination.

However, the document does not contain the following information typically found in studies related to AI/algorithm-based medical devices:

• Acceptance Criteria for Device Performance (beyond safety and biological compatibility): The document establishes basic safety and inhibitory properties of the solution but does not specify performance metrics for "cleansing, irrigating, moistening, and debriding" with quantitative acceptance criteria.
• Study proving device meets acceptance criteria (in terms of clinical efficacy compared to a standard or a specific performance benchmark).
• Sample size for test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for training set.
• How ground truth for the training set was established.

Summary of available information from the document related to performance/testing:

The document describes performance testing primarily focused on safety, biocompatibility, and the preservative effectiveness of the Vashe® Wound Therapy Solution. It does not present a clinical study with specific performance metrics for the "cleansing, irrigating, moistening, and debriding" functions against pre-defined acceptance criteria.

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

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated for any clinical performance or efficacy studies. For the antimicrobial efficacy, 21 test microorganisms were used.
• Data Provenance: Not explicitly stated as being from a specific country or whether it was retrospective or prospective for a clinical efficacy study. The testing for generator safety (UL, Demko A/S) and toxicology/biocompatibility does not represent patient data.

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

• This information is not provided because no clinical efficacy study with expert interpretation of the results is described. The evaluations were laboratory-based (UL, Demko A/S, toxicology labs, microbiology labs).

4. Adjudication method for the test set:

• Not applicable/Not provided, as no clinical study amenable to such a method is described.

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 not an AI or imaging device, and no MRMC study was performed.

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

• Not applicable, as this is not an algorithm-based device.

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

• The "ground truth" for the tests performed was based on established laboratory testing standards:
  • Generator Safety: Compliance with UL and EN standards.
  • Biocompatibility: ISO 10993-5 (reactivity grade), bacterial mutation genotoxicity assay, acute oral toxicity studies, irritation/sensitization tests.
  • Antimicrobial Efficacy: USP 51 requirements, quantitative reduction against specific microorganisms (e.g., Staphyloccoccus aureus, Clostridium difficile endospores).

8. The sample size for the training set:

• Not applicable, as this is not a machine learning/AI device, and no training set was used.

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

• Not applicable, as this is not a machine learning/AI device.

Ask a specific question about this device

Vashe® Wound Therapy Solution is intended for OTC use for management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.

The subject device is a wound cleansing solution that is intended for cleansing, irrigating, debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris.

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for the Vashe® Wound Therapy Solution, a wound cleansing solution, and a letter from the FDA confirming its substantial equivalence to predicate devices.

The information primarily focuses on:

• Device Identification: Trade Name, Common Name, Classification Name, Product Code.
• Submitter and Contact Information.
• Predicate Devices: A list of previously cleared devices to which Vashe® Wound Therapy Solution is compared for substantial equivalence.
• Device Description: What the device is and its mechanical action.
• Indications for Use: What the device is intended for (management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin).
• Substantial Equivalence Argument: How it is similar in function and intended use to the predicate devices.
• Non-clinical Performance: A brief mention that pre-clinical testing demonstrated biocompatibility.
• FDA Clearance Letter: Confirmation of substantial equivalence and regulatory information.

There is no mention of:

• Specific acceptance criteria (e.g., performance metrics, thresholds).
• A formal study designed to demonstrate the device meets acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• MRMC comparative effectiveness study.
• Standalone algorithm performance.
• Type or establishment of ground truth.

The "Non-clinical Performance" section states: "Pre-clinical testing demonstrated biocompatibility of the Vashe® Wound Therapy Solution." This is the only mention of any testing, but it's limited to biocompatibility and does not involve performance metrics related to acceptance criteria for the indicated uses. The basis for clearance is substantial equivalence to already marketed predicate devices, not meeting specific performance criteria through a new clinical or benchmark study.

Ask a specific question about this device

Vashe® Wound Therapy System (including Vashe® Wound Therapy Solution) is intended for cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.

The subject device includes a wound cleanser solution that is intended for cleansing, irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. In addition, the subject device contains Free Available Chlorine (FAC) that inhibits contamination within the solution.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vashe® Wound Therapy System:

Based on the provided text, the Vashe® Wound Therapy System is a wound cleanser solution. The document is a 510(k) summary, which indicates a claim of substantial equivalence to previously cleared predicate devices, rather than a novel device requiring extensive clinical trials to establish new acceptance criteria.

The device is not an AI-powered one, and therefore the details you requested regarding AI performance (test set, training set, experts, MRMC studies, standalone performance) are not applicable.

Here's a breakdown of the information that is available:

Acceptance Criteria and Device Performance for Vashe® Wound Therapy System

The acceptance criteria for the Vashe® Wound Therapy System are not explicitly stated in terms of specific performance metrics within this 510(k) summary. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to existing legally marketed predicate devices. This means the device is considered acceptable if its performance is comparable to or safe and effective as the predicate devices for its intended indications for use.

The study that "proves the device meets the acceptance criteria" is a pre-clinical testing study that demonstrated biocompatibility. The 510(k) process relies heavily on demonstrating similarity to already approved devices rather than establishing new efficacy or performance benchmarks via clinical trials, especially for devices like wound cleansers.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) summary for a non-AI device. The "test set" here would refer to the subjects in the biocompatibility testing, but specific numbers are not provided.
• Data Provenance: The biocompatibility testing likely involved in-vitro and/or in-vivo animal studies, which are standard for such evaluations. The specific country of origin or whether it was retrospective/prospective is not mentioned.

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

• Not applicable as this is a non-AI device. Ground truth, in this context, would be the results of the biocompatibility tests themselves, assessed against established standards, not expert consensus on findings.

4. Adjudication Method for the Test Set

• Not applicable for a non-AI device. Adjudication methods are typically used in clinical studies or expert reviews of complex data (like medical images) where multiple interpretations are possible. Biocompatibility testing results are usually evaluated against pre-defined scientific standards.

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 not an AI product and does not involve human readers interpreting AI output.

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

• Not applicable. This device is not an AI algorithm. Its performance is inherent to the chemical composition and mechanical action of the solution itself.

7. The Type of Ground Truth Used

• The "ground truth" for the biocompatibility testing would be scientific standards and established biological responses to the test materials. This could involve cell viability assays, irritation tests, sensitization tests, and systemic toxicity tests, where the absence of adverse reactions against predefined thresholds constitutes "truth."

8. The Sample Size for the Training Set

• Not applicable as this is a non-AI device. There is no training set mentioned or implied.

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

• Not applicable as this is a non-AI device.

Ask a specific question about this device

Vashe® Wound Cleanser is intended for cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, postsurgical wounds, first and second degree burns, abrasions and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.

The subject device is a wound cleansing and disinfecting solution that is intended for cleansing, irrigating, debriding and disinfecting dermal wounds in addition to moistening and lubricating absorbent wound dressings. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. Vashe is offered in various volumes.

The provided text is a 510(k) Summary for the Vashe™ Wound Cleanser and an FDA clearance letter for a later submission (K092232) for Vashe® Wound Cleanser. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and supporting data for a new device's performance.

Therefore, many of the requested sections about acceptance criteria, detailed study design, ground truth, and sample sizes for testing and training sets cannot be extracted from this document in the typical sense applied to a performance study for, for example, an AI medical device.

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

1. Table of Acceptance Criteria and Reported Device Performance

Performance for wound cleansers is typically demonstrated through biocompatibility, chemical and physical properties, and a comparison of intended use to similar predicate devices. The document does not specify quantitative "acceptance criteria" in the format one might expect for a performance study (e.g., specific sensitivity/specificity thresholds). Instead, "performance" is implicitly demonstrated through substantial equivalence to existing, legally marketed devices.

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

The provided text does not describe a "test set" in the context of an algorithm or performance study involving specific data samples (e.g., patient images or cases). The "pre-clinical testing" for biocompatibility would have involved a sample size of test subjects (e.g., animals or in vitro cultures), but this specific information is not provided.

• Sample Size for Test Set: Not specified in the provided text for a "test set" for performance evaluation. The "pre-clinical testing" likely involved a sample size for biocompatibility testing, but details are not given.
• Data Provenance: Not applicable in the context of a "test set" for algorithm performance. The pre-clinical testing would have been conducted in a laboratory setting.

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

This information is not applicable/not provided. The device is a wound cleanser, not an AI diagnostic device that requires expert-established ground truth on a test set of medical cases. Biocompatibility testing is typically assessed by laboratory experts following standardized protocols, not by medical experts establishing "ground truth" on patient data.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. There is no "test set" or diagnostic assessment that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The device is a wound cleanser, not an AI system. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a wound cleanser, not an algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically used for AI medical devices (e.g., pathology, outcomes data) is not directly applicable here. For a wound cleanser, the "ground truth" for demonstrating safety and effectiveness relies on:

• Biocompatibility testing standards: Meeting established standards for non-toxicity, non-irritation, etc.
• Chemical and physical properties: Verifying the composition and stability of the solution.
• Clinical experience with predicate devices: Relying on the known safety and effectiveness of similar products already on the market.

8. The Sample Size for the Training Set

This information is not applicable. The device is a wound cleanser, not an AI system that requires a training set.

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

This information is not applicable. The device is a wound cleanser, not an AI system that requires a training set with established ground truth.

Ask a specific question about this device