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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.

Vashe® Wound Therapy Solution is a wound cleanser solution that contains hypochlorous acid generated from sodium chloride solution through the proprietary electrochemical process. Hypochlorous acid acts as a preservative that inhibits microbial contamination within the solution. The device is presented as a prescription product that requires the practitioner to diagnose the disease state and prescribe the product.

Here's a breakdown of the acceptance criteria and study information for the Vashe® Wound Therapy Solution, based on the provided 510(k) summary:

The document does not detail a clinical study with human subjects, but rather focuses on non-clinical equivalency testing related to product specifications and stability. This is a common approach for 510(k) submissions where a device is substantially equivalent to a predicate device and the changes made do not significantly alter its fundamental scientific technology or intended use.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the modified device (Vashe® Wound Therapy Solution manufactured centrally) are primarily based on the chemical specifications of the solution, which were slightly expanded compared to the predicate device.

Note: The document states "Lower specification expanded pH at 3.5 to 6.75ppm", which appears to be a typo and should likely read "pH at 3.5 to 6.75". The predicate device had a pH specification of "5.3 to 6.75ppm".

Study Details

The provided 510(k) summary indicates non-clinical equivalency testing was conducted.

1. Sample size used for the test set and the data provenance: Not specified in terms of number of samples, but the testing was for Shelf Life and Chemical Stability of the modified product. The data provenance is internal to PuriCore Inc. as the manufacturing process was moved from on-site generation to central manufacturing at PuriCore in Malvern, PA.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For chemical stability testing, the "ground truth" is established by standard analytical chemistry methods and adherence to the defined chemical specifications.

3. Adjudication method for the test set: Not applicable. This was chemical and stability testing against predefined specifications.

4. 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 wound therapy solution, not an AI-powered diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a chemical solution, not an algorithm.

6. The type of ground truth used: For the non-clinical testing, the ground truth was chemical specifications and stability over time, assessed through analytical methods.

7. The sample size for the training set: Not applicable. This is a non-clinical submission for a chemical product, not a machine learning model.

8. How the ground truth for the training set was established: Not applicable.

Summary of Substantial Equivalence Justification

The core of the submission for Vashe® Wound Therapy Solution relies on demonstrating substantial equivalence to its predicate device (Vashe® Wound Therapy System, K100918) through non-clinical testing. The key changes are:

• Place of Production: Moving from on-site generation at the customer's location to central manufacturing at PuriCore Inc.
• Expanded Specifications: The acceptable range for Available Free Chlorine (AFC) and pH was slightly expanded.
• Shelf Life and Stability: Non-clinical testing was performed to ensure that the modified device, with its expanded specifications and centralized production, maintains chemical stability and preservative effectiveness (due to hypochlorous acid) throughout its shelf life, including under worst-case scenarios for initial and final concentrations and pH.

The conclusion drawn by PuriCore Inc. (and accepted by the FDA for 510(k) clearance) is that these modifications have not changed the Intended Use or altered the Fundamental Scientific Technology of the device, thereby demonstrating substantial equivalence.

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Under the supervision of a health care professional, Vashe® Skin and Wound Hydrogel is indicated for the management and relief of pain, burning and itching experienced with various dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis, as well as for the relief of pain from first and second degree burns, and aids to relieve dry waxy skin by maintaining a moist wound and skin environment. A moist wound and skin environment is beneficial to the healing process.

Vashe® Skin and Wound Hydrogel is an emollient containing, non oily hydrogel. The gel forms a protective barrier which retains moisture and provides relief of the burning and itching experienced with various dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. The Hydrogel when applied to diseased skin forms a protective barrier that helps to maintain a moist wound and skin environment. The product contains hypochlorous acid as a preservative. The Hydrogel will be supplied in plastic tottles as described in Section 3.2. The device is presented as a prescription product that requires the physician to diagnose the disease state and prescribe the product.

The document provided refers to a 510(k) premarket notification for a medical device called "Vashe® Skin & Wound Hydrogel". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for demonstrating performance against specific numerical acceptance criteria through a clinical study.

Therefore, the information you've requested regarding acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text because the 510(k) summary focuses on biocompatibility and preservative activity, not a clinical efficacy study with numerical performance metrics against specific conditions.

However, I can extract what is mentioned about the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of numerical performance for efficacy. The implied acceptance criteria for the Vashe® Skin & Wound Hydrogel is that it is safe for use and has effective preservative activity, similar to its predicate device.
• Reported Device Performance:
  • "Vashe® Skin and Wound Hydrogel is safe for use when in contact with abraded, breached or compromised skin."
  • "Vashe® Skin & Wound Hydrogel at its minimum recommended concentration demonstrates effective preservative activity and supports a preservative claim."

2. Sample size used for the test set and the data provenance: Not applicable. The studies mentioned are "in-vivo and in-vitro biocompatibility testing" and "preservative activity" testing, which are not typically presented with test set sample sizes or data provenance in the context of comparative clinical efficacy as one would expect for an AI/diagnostic device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The studies mentioned (biocompatibility and preservative activity) do not involve expert-established ground truth for interpreting clinical outcomes.

4. Adjudication method for the test set: Not applicable based on the nature of the described studies.

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, an MRMC comparative effectiveness study was not done. This device is a hydrogel, not an AI or diagnostic device that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hydrogel, not an algorithm.

7. The type of ground truth used:
* For biocompatibility: Adherence to ISO-10993 standards (likely comparing against established biological response limits).
* For preservative activity: Demonstrated effective preservative activity (likely against specific microbial challenges, though not detailed).

8. The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document indicates that the Vashe® Skin & Wound Hydrogel underwent the following testing:

• Study Type: In-vivo and in-vitro biocompatibility testing.
• Standards: ISO-10993 standards.
• Purpose: To demonstrate the device's safety when in contact with abraded, breached, or compromised skin.
• Conclusion: The results demonstrated that Vashe® Skin & Wound Hydrogel is safe for such use.
• Additional Study: Testing for preservative activity.
• Purpose: To ascertain if the hydrogel, at its minimum recommended concentration, could effectively act as a preservative.
• Conclusion: The device demonstrated effective preservative activity, supporting a preservative claim.

These studies were conducted to support the device's safety and preservative function, which are critical aspects of its substantial equivalence to the predicate device, Epicyn™ HydroGel (K102945). The 510(k) process primarily relies on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety and effectiveness, often through non-clinical testing and comparison to an existing predicate.

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Sterilox™ is a high level disinfectant system intended for processing heat sensitive medical devices when used according to the User Manual with an immersion time of ten (10) minutes at 30°C. Sterilox is a single use product generated on site by the Maxigen II (E200) generator for use at its MRC of 400-450 ppm (AFC). The Sterilox high level disinfectant is intended for processing only in an automated endoscope reprocessor or washer disinfector with FDA-cleared capability to maintain the solution temperature at 30°C.

The device is intended for use by qualified health care personnel trained in its use.

The Sterilox Liquid Chemical High Level Disinfectant System is an apparatus that produces a single use High Level Disinfectant by on-site electrochemical activation (electrolysis) of a dilute aqueous solution of sodium chloride (NaCl). The disinfectant is then circulated on the internal and external surfaces of re-usable heat-sensitive medical devices within a washer-disinfector AER with FDA-cleared capability to maintain the solution temperature at 30°C used in hospitals, clinics and various other health care settings. It is a device intended for use by qualified healthcare personnel trained in its use.

Here's an analysis of the provided text regarding the Sterilox™ High Level Disinfectant System, structured to answer your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific numerical sample sizes for each microbiological or toxicity test test set, other than:

• "Clinical In-Use": "No surviving microorganisms on any of the endoscopes tested" implies a sample size of multiple endoscopes, but the exact number isn't given.
• "Simulated Use Test": "inoculated scopes were processed in Sterilox and AER for 10 minutes at 30° C." implies multiple scopes, but quantity not specified.
• General Microbiological Tests (AOAC, EPA methods): These methods typically have defined sample sizes, but the report summarizes the results rather than detailing the experimental setup for each test performed on this specific device.

Data Provenance: The information provided generally describes laboratory testing (e.g., AOAC methods for efficacy, animal studies for toxicity). There is no explicit mention of data origin (e.g., country) for these studies. The "Clinical In-Use" implies real-world usage, making it prospective in nature for that specific part of the study. The remaining tests are laboratory studies.

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

There is no information in the provided text about the use of "experts" to establish ground truth in the way one might for diagnostic AI. The ground truth for the microbiological efficacy tests and toxicological tests is established by standardized laboratory methods (e.g., AOAC, EPA protocols) which inherently define what constitutes a positive or negative result. For instance, for sporicidal activity, the ground truth is whether spores are killed as per the method's criteria, not an expert's interpretation of an image.

4. Adjudication Method for the Test Set

Not applicable. This device is a high-level disinfectant, not an AI or diagnostic tool where expert adjudication of results would typically be employed. The tests are laboratory-based and use objective endpoints.

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

No. This is a chemical disinfectant, not a diagnostic imaging device or AI algorithm for human interpretation enhancement. Therefore, an MRMC study is not relevant or included in this submission.

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

Yes, in the sense that all efficacy and safety studies were conducted on the device itself (the Sterilox Liquid Chemical High Level Disinfectant System and its germicide solution), demonstrating its performance independently without a human interpretation component that would require "human-in-the-loop" considerations.

7. The Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily:

• Laboratory outcomes/direct measurements: For microbiological efficacy, it's the destruction or inactivation of specific microorganisms (e.g., spores, bacteria, fungi, viruses, mycobacteria) under specified conditions, measured by standard laboratory culture techniques.
• Physiological/toxicological responses: For toxicity, the ground truth is the observable response (or lack thereof) in animal models (e.g., irritation, sensitization, LD50 values, mutagenicity) against established biological endpoints.
• Chemical analysis: For residue data, the ground truth is the quantifiable level of Sterilox components remaining after rinsing.
• Physical observation: For material compatibility, the ground truth is visible changes, damage, or corrosion.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of supervised learning. The testing described is empirical validation against pre-defined performance standards.

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

Not applicable, as there is no training set for this type of device submission.

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Aquatine™ EC Endodontic Cleanser is intended to irrigate, cleanse and debride root canal systems.

Aquatine™ EC Endodontic Cleanser irrigates, cleanses and debrides. The mechanical action of the solution moving in the root canal facilitates easy removal of debris and necrotic pulp tissue from the root canal.

The Aquatine™ EC Endodontic Cleanser is deemed substantially equivalent based on non-clinical performance and biocompatibility data. The provided document, K061689, does not contain information about specific acceptance criteria or a study with detailed performance metrics, sample sizes, expert involvement, or comparative effectiveness studies that would be typical for an AI/ML powered device. Instead, the clearance is based on the device's similarity in function and intended use to existing legally marketed predicate devices and the fact that all components of Aquatine™ EC have been used in legally marketed devices.

Therefore, I cannot populate the table or answer the specific questions as the information is not present in the provided text. The document is a 510(k) summary and clearance letter for a non-AI/ML medical device, which explains why these details are absent.

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