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510(k) Data Aggregation
(323 days)
Innovacyn, Inc.
Puracyn® Plus Antimicrobial Irrigation Solution is applied with irrigation to cleanse and remove debris from wounds.
Puracyn® Plus Antimicrobial Irrigation Solution is a wound irrigation formula that contains hypochlorous acid as an antimicrobial preservative to inhibit the growth of micro-organisms within the solution.
Puracyn® Plus Antimicrobial Irrigation Solution is supplied sterile in 1000 mL and 3000 mL flexible LLDPE bag configurations. Each bag is packaged in a sealed foil pouch.
This document describes the FDA's decision regarding Innovacyn, Inc.'s Puracyn® Plus Antimicrobial Irrigation Solution (K232080).
Here's an analysis of the provided text with respect to your questions about acceptance criteria and study details:
The provided text is a 510(k) summary for a medical device that aims to demonstrate substantial equivalence to a predicate device. It does not describe a study involving a particular device meeting acceptance criteria in the sense of a clinical performance study with human subjects, AI systems, or diagnostic accuracy metrics. Instead, it focuses on the device's characteristics and various types of performance testing related to its manufacturing, safety, and physical properties to show that it is as safe and effective as a previously cleared device.
Therefore, many of your questions, particularly those related to AI assistance, human readers, diagnostic performance, and ground truth in a clinical context, are not applicable to the information presented.
Here's what can be extracted based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit "acceptance criteria" in a tabular format with corresponding reported device performance for clinical efficacy or diagnostic accuracy. Instead, it lists various performance tests conducted to support safety and effectiveness, implicitly asserting that the device met the requirements of these tests.
No direct "acceptance criteria" and "reported device performance" table is present for clinical/diagnostic efficacy.
However, the "Comparison of Technological Characteristics" table can be interpreted as a comparison against the predicate device, implying that the subject device's characteristics meet or are equivalent to the predicate's.
| Characteristic | Subject Device (Puracyn® Plus Antimicrobial Irrigation Solution - K232080) | Primary Predicate (Puracyn Plus™ Skin and Wound Care - K133542) | Implied "Acceptance" / Equivalence |
|---|---|---|---|
| Composition | Purified water, Hypochlorous acid, phosphates | Purified water, Hypochlorous acid, phosphates | Equivalent chemical composition. |
| Description | Clear, colorless solution packaged in flexible plastic bags | Clear, colorless, non-sterile solution packaged in plastic PET bottles | Essentially equivalent in physical appearance and solution type, with differences in packaging material and sterility status noted and addressed by compliance with relevant standards. |
| Volume | 1000 mL, 3000 mL | 1000 ml to 55 ml | Volume differences are noted as not raising new questions of safety and effectiveness. |
| Indications For Use | Applied with irrigation to cleanse and remove debris from wounds. | Professional Use: Intended for use by healthcare professionals for cleansing, irrigating, moistening, and debriding to remove wound debris from acute and chronic dermal lesions that are partial or full thickness wounds such as 1st and 2nd-degree burns, stage I - IV pressure ulcers, diabetic ulcers, stasis ulcers, abrasions and minor skin irritations, post-surgical wounds, grafted and donor sites, in addition to moistening and lubricating absorbent wound dressings. | The subject device's indications are narrower ("cleanse and remove debris from wounds") but fall within the scope of the predicate's broader indications, and are deemed substantially equivalent in effect for the specified use. The wording difference is noted as not raising new questions of safety and effectiveness. |
| Mechanism(s) of Action | Mechanical action of fluid moving across the wound aids in removal of foreign objects. | Mechanical action of fluid moving across the wound aids in removal of foreign objects such as dirt and debris. | Equivalent mechanism of action. |
| Antimicrobial Preservative | Preservative: Hypochlorous acid | Preservative: Hypochlorous acid | Equivalent preservative. |
| Microbial Control and Sterility | Meets USP and USP | Meets USP | The subject device meets additional sterility requirements (USP ) compared to the predicate, which strengthens its safety profile, not posing new questions. |
| Biocompatibility | Meets ISO 10993-1 requirements | Meets ISO 10993-1 requirements | Equivalent biocompatibility standards. |
| Use | Multiple use within a single patient | Multiple use for multiple patients | "Multiple use within a single patient" for the subject device is a more restrictive use case than "multiple use for multiple patients" for the predicate. This difference is noted as not raising new questions of safety and effectiveness, implying it is equally safe or safer. |
The performance testing section lists general tests to ensure safety and quality, not clinical efficacy:
- Stability Studies per ICH Q1A(R2)
- Biocompatibility studies in accordance with ISO10993-1
- Packaging Testing in accordance with ISO 11607-1 and ISO 11607-2
- Sterilization in accordance with ISO 11737-1 and 11737-2
- Endotoxin Testing per USP
- Preservative Antimicrobial Effectiveness Testing per USP
- Sterility Testing per USP
- Bioburden Testing per USP and USP
For these tests, the implied acceptance criterion is "meets the standard" (e.g., "Meets USP "). The document asserts that these studies were "performed to support the safety and effectiveness" and contribute to the conclusion of substantial equivalence.
2. Sample size used for the test set and the data provenance
Not applicable in the context of clinical performance or diagnostic accuracy. The performance tests listed are laboratory and materials tests. Sample sizes for these tests (e.g., number of units for stability, packaging, or sterility testing) are not detailed in this summary. Data provenance is not described as it relates to patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert-established ground truth for a test set (e.g., in imagery or diagnostic interpretation). The "ground truth" for the performance tests would be defined by the specifications of the standards themselves (e.g., a certain level of sterility, a certain shelf-life).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no adjudication method described as this is not a study involving subjective interpretation of 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. The device is an antimicrobial irrigation solution, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the listed performance tests, the "ground truth" is defined by the industry and regulatory standards themselves (e.g., USP, ISO standards for sterility, biocompatibility, stability). For example, the "ground truth" for sterility is the absence of viable microorganisms as determined by USP . For biocompatibility, it's compliance with ISO 10993-1.
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. This is not a machine learning or AI device, so there is no "training set" or establishment of ground truth for it.
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(238 days)
INNOVACYN, INC.
For Over-the-Counter Use: Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel is intended for OTC use to relieve itch and pain from minor skin irritations, minor lacerations, minor abrasions and minor burns, including sunburns. Hydrogel is also intended to moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement and is beneficial to wound management and the healing process.
For Professional Use: Puracyn® Plus Antimicrobial Hydrogel Professional Formula is intended for use by healthcare professionals to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions, as indicated below. Puracyn® Plus Antimicrobial Hydrogel Professional Formula relieves itch and pain associated with dermal irritation, sores, injuries and ulcers of dermal tissue in addition to moistening absorbent wound dressings. Puracyn® Plus Antimicrobial Hydrogel Professional Formula is indicated for the management of partial or full thickness wounds such as 1st and 2nd degree burns, stage I - IV pressure ulcers, diabetic and stasions and skin irritations, surgical wounds (donor and graft sites, incisions), trauma wounds, and various dermatoses including atopic dermatitis.
Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel and the Puracyn® Plus Antimicrobial Hydrogel Professional Formula are opaque and pH balanced hydrogel dressings that are topically applied to skin and wound areas. The gel provides relief from itching and pain, and helps maintain a moist wound environment to assist with the wound healing process. The hydrogel dressings will be supplied in various packaging configurations. Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel and the Puracyn® Plus Antimicrobial Hydrogel Professional Formula contain hypochlorous acid, a known antimicrobial, which serves as a preservative to inhibit the growth of microorganisms in the hydrogel.
This document is a 510(k) premarket notification summary for the medical device Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel and Puracyn® Plus Antimicrobial Hydrogel Professional Formula. It is a submission to the FDA seeking a determination of substantial equivalence to predicate devices, not primarily a report on a clinical study with detailed acceptance criteria and performance data in the context of an AI/human reader study.
As such, the document does not contain the specific information requested regarding acceptance criteria related to device performance in a clinical setting, sample sizes for test and training sets, the number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or detailed ground truth establishment as would be found in a clinical study report for a diagnostic or AI-assisted device.
The document focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Intended Use/Indications for Use
- Technological Characteristics (e.g., active ingredients, formulation, mechanism of action)
- Non-Clinical Testing (e.g., stability, biocompatibility, antimicrobial effectiveness for product preservation).
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and study proving device meets those criteria because that detailed level of clinical performance data for a complex AI/diagnostic device is not present in this 510(k) summary for a wound hydrogel.
The "Non-Clinical Testing" section mentions "Antimicrobial/Preservative Effectiveness Testing per modified USP ". This refers to benchtop microbiological testing to ensure the product itself remains sterile or inhibits microbial growth within the product, not clinical effectiveness on a wound or a comparative study of a diagnostic/AI device.
For clarity, I will explain what is in the document regarding "acceptance criteria" in the context of a 510(k) for this type of device, which is primarily demonstrating similarity and safety/effectiveness through non-clinical means.
Understanding "Acceptance Criteria" in this Context:
In a 510(k) submission for a non-diagnostic, non-AI device like a wound hydrogel, "acceptance criteria" for demonstrating substantial equivalence are typically aligned with:
- Technological Equivalence: The new device's technology, materials, and principle of operation are similar to legally marketed predicate devices.
- Performance Benchmarks (Non-Clinical): The device meets established standards for safety and basic function, such as:
- Stability: The product remains effective and safe over its shelf life (e.g., pH, viscosity, active ingredient concentration, sterility maintained).
- Biocompatibility: The materials used are not harmful to biological systems (e.g., ISO10993-1 testing results are within acceptable limits).
- Preservative Effectiveness: The preservative (hypochlorous acid) effectively inhibits microbial growth within the product for its intended shelf life (e.g., passing modified USP criteria for specified microorganisms).
- Intended Use Equivalence: The proposed indications for use are the same as or very similar to predicate devices, and the differences do not raise new questions of safety or effectiveness.
Study Proving Device Meets Acceptance Criteria (as described in this document):
The studies mentioned are non-clinical and focus on product characteristics, not clinical outcomes on patients with wounds in a comparative study against standard care.
Here's how the provided information relates to the closest interpretation of your request, adjusted for the nature of the document:
1. Table of "Acceptance Criteria" (interpreted as non-clinical performance and equivalence to predicates) and Reported Device Performance
| "Acceptance Criteria" (for 510(k) Submission) | Reported Device Performance (as stated in document) |
|---|---|
| Intended Use Equivalence | "There are no differences between the subject and predicate devices with respect to intended use." (Page 6) |
| Technological Equivalence | "The subject devices are similar in technology to the predicate devices in that the products are topical hydrogels which encourage autolytic debridement and protect the wound against contamination. The products contain viscosity enhancing agents which impart hydrogel characteristics, as well as hypochlorous acid and/or sodium hypochlorite as preservatives." (Page 6) |
| Biocompatibility (e.g., meeting ISO10993-1 standards) | "As supported by biocompatibility testing according to ISO10093-1, hydrogels are biologically safe." (Page 6) |
| Antimicrobial/Preservative Effectiveness (e.g., USP ) | "Expanded testing consistent with USP supports that the Free Available Chlorine (FAC) inhibits microbial contamination within the product." "Puracyn® Plus hydrogels contain hypochlorous acid, a known antimicrobial preservative, which is shown to inhibit the growth of microorganisms such as Candida albicans, Aspergillus brasiliensis, acinetobacter albumin, Vancomycinresistant Enterococcus (VRE), Escherichia coli, Pseudomonas aeruginosa, Staphylococcus epidermidis, and Methicillin-resistant Staphylococcus aureus (MRSA) in the hydrogel." (Page 4, 6) |
| Stability (e.g., maintaining properties over shelf life) | "Stability Studies" were performed. (Page 6) Specific acceptance values not detailed in summary, but completion indicated passing. |
2. Sample size used for the test set and the data provenance: Not applicable. This document refers to non-clinical laboratory testing and a submission for substantial equivalence, not a clinical trial with patient "test sets." The "data provenance" mentioned would be laboratory data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a diagnostic test is not established for this type of device in this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 diagnostic device.
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.): The "ground truth" for the non-clinical tests would be the established scientific methods and standards (e.g., ISO10993-1 for biocompatibility, USP for preservative effectiveness) which have defined criteria for "passing."
8. The sample size for the training set: Not applicable. This refers to laboratory and product characteristic data, not machine learning model training.
9. How the ground truth for the training set was established: Not applicable.
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(161 days)
INNOVACYN, INC.
OTC: Puracyn Plus™ Skin and Wound Care is intended for the management of minor skin wounds including minor lacerations, minor abrasions, minor cuts, minor bums and intact skin, in addition to moistening and lubricating absorbent wound dressings.
Professional Use: Puracyn Plus™ Skin and Wound Care is intended for use by healthcare professionals for cleansing, irrigating, moistening, and debriding to remove wound debris from acute and chronic dermal lesions that are partial or full thickness wounds such as 1st and 2nd degree burns, stage 1 - 1V pressure ulcers, stasis ulcers, abrasions and minor skin irritations, post-surgical wounds, grafted and donor sites, in addition to moistening and lubricating absorbent wound dressings.
Puracyn Plus™ Skin and Wound Care is a clear hypotonic solution topically applied to skin and wound areas. The subject device is a wound management and cleansing solution that is intended for cleansing, irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings (e.g. gauze). 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. Puracyn Plus™ Skin and Wound Care will be supplied in food grade 4 oz. plastic PET bottles with spray inserts and caps.
The provided text describes the regulatory clearance for Puracyn Plus™ Skin and Wound Care, a wound cleanser. It focuses on demonstrating substantial equivalence to predicate devices rather than a direct clinical performance study with acceptance criteria in the sense of accuracy, sensitivity, or specificity commonly associated with AI/software devices. Therefore, the information requested in the prompt, especially concerning performance metrics, sample sizes, ground truth establishment, and expert involvement, is largely not applicable to this type of medical device submission.
However, I can extract the relevant information that is present in the document.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a wound cleanser, the "acceptance criteria" are not based on diagnostic performance metrics. Instead, they are related to safety and stability for its intended use.
| Acceptance Criteria / Performance Aspect | Reported Device Performance (as stated or implied) |
|---|---|
| Biocompatibility | Meets ISO 10993 standards; non-cytotoxic, non-sensitizing, non-irritating, and non-toxic. |
| Stability | Stable for at least 11 months when stored at 25°C/60%RH±2% Stability Conditions. |
| Intended Use | Cleansing, irrigating, moistening, and debriding dermal wounds and moistening absorbent wound dressings (OTC: minor skin wounds; Professional Use: acute and chronic dermal lesions like burns, pressure ulcers, diabetic ulcers, etc.). |
| Mechanism of Action | Mechanical action of fluid removing foreign objects (dirt, debris). |
| Chemical/Physical Characteristics | Clear hypotonic solution. |
| Antimicrobial Activity | Contains a preservative that may help inhibit growth of microorganisms within the solution (not presented as an acceptance criterion but as a characteristic). |
| Manufacturing | Manufactured under Good Manufacturing Practices (GMP) guidelines. |
| Substantial Equivalence | Deemed substantially equivalent to predicate devices (Vashe® Wound Therapy Solution, Nixall™ Wound and Skin Care) based on similarity of use indications, functionality, chemical and physical characteristics, antimicrobial activity, and biocompatibility. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable in the context of diagnostic accuracy. The biocompatibility and stability tests would have involved specific sample sizes as per ISO standards and internal protocols, but these numbers are not disclosed in this summary.
- Data provenance: Not explicitly stated for specific tests. Biocompatibility testing is a standard laboratory procedure. Stability testing would be conducted in a controlled lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/diagnostic devices (e.g., confirmed disease state) is not relevant for a wound cleanser's performance evaluation in this context. The "truth" for biocompatibility is absence of adverse biological reactions, and for stability, it's maintaining specified properties over time.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept is for resolving discrepancies in expert labeling or diagnoses, which is not part of a wound cleanser's evaluation for substantial equivalence.
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 or diagnostic imaging device that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical wound cleanser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Biocompatibility: General biological safety standards (ISO 10993 series), which involve objective laboratory tests rather than expert consensus on a diagnosis.
- Stability: Chemical and physical property measurements over time against predetermined specifications.
- Intended Use/Mechanism: Based on the known properties of hypotonic solutions and established medical practices for wound cleansing.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/machine learning model.
Summary of the Study:
The "study" described is a regulatory submission to demonstrate substantial equivalence for Puracyn Plus™ Skin and Wound Care to legally marketed predicate devices (Vashe® Wound Therapy Solution and Nixall™ Wound and Skin Care). This is a common pathway for many medical devices, particularly those that are not novel in their fundamental technology or intended use.
The key aspects of this demonstration were:
- Biocompatibility Testing (ISO 10993): To establish the safety of the product for topical application. The results confirmed it was non-cytotoxic, non-sensitizing, non-irritating, and non-toxic.
- Stability Testing: To show the product maintained its properties over a specified shelf-life (at least 11 months at 25°C/60%RH±2%).
- Comparison of Indications for Use: The intended uses for both OTC and professional settings were found to be similar to the predicate devices.
- Comparison of Device Technological Characteristics: The product's nature as a clear hypotonic solution, its mechanism of action (mechanical removal of debris), and the presence of a preservative were compared and found similar to predicates.
- Manufacturing Practices: Stated adherence to Good Manufacturing Practices (GMP).
The conclusion of the "study" (the 510(k) submission) was that Puracyn Plus™ Skin and Wound Care is substantially equivalent to the cited predicate devices based on similarities in use indications, functionality, chemical and physical characteristics, antimicrobial activity (referring to the preservative), and biocompatibility. The FDA concurred with this determination, allowing the device to be marketed.
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