Search Results

OTC: May be used for superficial wounds and abrasions and minor burns.

Rx: Under the supervision of health care professionals for the local management of partial- and full-thickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first-degree and partial-thickness burns including management of abrasions and burns associated with dermabrasions and laser resurfacing.

G4Derm / G4Derm Plus Synthetic Wound Matrix is a sterile, biodegradable hydrogel matrix supplied in a prefilled syringe ready for topical use as primary wound dressing, with or without the use of an optional nozzle. The hydrogel in G4Derm / G4Derm Plus is composed of an aqueous solution of synthetic peptide (≥ 98% sterile water). The device is completely non-animal tissue and non-cellular derived.

G4Derm / G4Derm Plus forms a three-dimensional hydrogel scaffold, which, at a basic structural level, is composed of a matrix of interwoven fibrils formed from individual peptide monomers. This woven network structure, or matrix barrier, is similar to the microarchitecture of endogenous extracellular matrix ("ECM"). This structure also functions as a matrix that holds and donates water to underlying tissue, while providing an effective barrier to cover and protect the wound against the external environment, namely against bacterial penetration.

G4Derm / G4Derm Plus Synthetic Wound Matrix forms a clear, biodegradable hydrogel without expansion in volume. During dressing changes, the unincorporated or unintegrated material may be removed without causing trauma to the underlying tissue by gently flushing / wiping the wound.

The provided text describes the G4Derm / G4Derm Plus Synthetic Wound Matrix and its substantial equivalence to a predicate device, Woun'Dres® Collagen Hydrogel (K991202), and two reference devices, PuraDERM (K193085/K143058) and Excellagen (K110318). However, the document does not include a specific table of acceptance criteria or detailed reported device performance in a quantitative manner that would allow for a direct comparison with specific numerical targets.

Based on the information provided, here's a breakdown of the available data:

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

The document does not provide a formal table with specific numerical acceptance criteria and corresponding reported device performance values. Instead, it states that "Gel4Med / G4Derm Plus Synthetic Wound Matrix is substantially equivalent in intended use, indications for use, device design, function, physical properties, principles of operation, instructions for use, biocompatibility, safety, and performance to the predicate device." It also mentions that "Any differences in the technological characteristics of the subject device when compared to the predicate have been successfully evaluated using appropriate scientific methods."

The general performance attributes assessed are:

• Safety: Demonstrated through biocompatibility testing (ISO 10993-1) and human skin irritation testing.
• Effectiveness: Demonstrated through in vivo performance testing in a wound healing animal model.
• Sterility: Achieved a minimum sterility assurance level of 10^-6 in accordance with ISO 17665.
• Antibacterial barrier effectiveness: Tested in vitro.

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

• Test Set Sample Size: The document mentions "a large animal wound healing model" for performance testing. However, it does not specify the exact number of animals or wounds used in this in vivo study. It also mentions "Human Skin Irritation Test" and "antibacterial barrier effectiveness testing (in vitro)" but does not provide sample sizes for these tests.
• Data Provenance: The animal model is described as a "GLP pre-clinical performance testing in wound healing animal model". The location or country of origin of this study is not specified. The human skin irritation test is described as "clinical (human skin irritation) testing," but no further details on the population or location are provided. The in-vitro antibacterial barrier effectiveness testing, by its nature, is laboratory-based and not tied to patient cohorts.

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):

This information is not provided in the document. The studies mentioned (animal wound healing, human skin irritation, in vitro antibacterial testing) do not typically involve experts establishing "ground truth" in the same way, for example, diagnostic imaging studies do. Instead, their endpoints are measured objectively (e.g., wound closure rates, irritation scores, bacterial counts).

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

This information is not applicable and therefore not provided, as the studies described are not subjective assessments requiring adjudication like in diagnostic image interpretation.

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:

This information is not applicable and therefore not provided. The device described is a synthetic wound matrix, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable and therefore not provided, as the device is a physical wound dressing and not an algorithm.

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

The "ground truth" for the performance evaluation of the wound matrix would be based on objective biological and physical measurements from the studies conducted:

• Animal performance testing: Likely measured outcomes related to wound healing, such as wound closure rates, reduction in wound size, tissue regeneration, and histological assessments. These are direct biological outcomes.
• Biocompatibility testing: Assesses the device's interaction with biological systems using standardized tests, leading to objective safety profiles.
• Human skin irritation testing: Measures physiological responses of the skin to the device.
• Antibacterial barrier effectiveness: Measures the device's ability to prevent bacterial penetration in an in vitro setup.

8. The sample size for the training set:

This information is not applicable and therefore not provided. As this is not an AI/ML device, there is no "training set" in the context of machine learning.

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

This information is not applicable and therefore not provided, as there is no training set for this device.

Ask a specific question about this device

PuraStat-OM adheres to oral tissue and forms a protective barrier over the wound to prevent further irritation and contamination. It provides a moist wound environment required for optimal wound healing.

Manages pain of, for example:

• All types of oral wounds, mouth sores, injuries and ulcers of the oral mucosa
• Canker sores and cold sores
• Irritation and traumatic ulcers such as those caused by various appliances such as braces, brackets, full and partial dentures and palatal expanders
• Soft tissue pain from orthodontics
• Aphthous ulcers
• Extraction site pain
• Oral mucositis and stomatitis (may be caused by chemotherapy or radiotherapy)

PuraStat-OM is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as an oral hydrogel wound dressing with the sterile application nozzle. The gel's primary mode of action is that it adheres to the wound surface, conforms to the contours of the wound, and protects the wound from contamination and irritation by forming a protective barrier that is similar to the natural mucosa. It also creates and maintains a moist wound environment, which is necessary for the natural healing process.

PuraStat-OM is completely non-animal and non-plant derived and contains no drugs or biologics that might present a risk of allergic reaction or skin irritation.

Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume.

Here's an analysis of the provided text, focusing on acceptance criteria and supporting study details:

Device: PuraStat-OM (an oral hydrogel wound dressing)
Predicate Device: McMerlin Dental Company's SOCKIT!® Oral Hydrogel Wound Dressing (K063148)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a pass/fail quantifiable manner for the purpose of demonstrating substantial equivalence. Instead, it describes a comparison of technological characteristics and performance data between the subject device (PuraStat-OM) and the predicate device (SockIt!® Gel) to argue for their substantial equivalence. The "criteria" are implicitly defined by the properties measured and compared.

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

The study described is nonclinical performance (bench testing) and GLP biocompatibility testing.

• Sample Size for Test Set: Not explicitly stated with a specific number of units for each test. The document refers to "PuraStat-OM" and "SockIt!® Gel" being tested, implying samples of each device were used. For biocompatibility, testing is typically done on multiple samples.
• Data Provenance: The biocompatibility testing was conducted as per ISO 10993-1 and consistent with FDA Guidance, indicating standard laboratory practices. The bench testing (complex modulus, viscosity, pH, etc.) was a "side-by-side comparison" of the subject and predicate devices. This is retrospective in the sense that it compares a new device to an already marketed predicate, but the testing itself would have been conducted prospectively for the submission. The origin of the data is laboratory testing.

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

N/A. This document describes nonclinical, laboratory-based performance testing and biocompatibility assessments, not a study requiring human readers or expert-established ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

N/A. Not applicable to nonclinical performance or biocompatibility testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not mentioned as this submission focuses on nonclinical and bench testing to demonstrate substantial equivalence based on technological characteristics and biocompatibility, not comparative effectiveness with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This is a physical medical device (hydrogel), not an imaging/AI algorithm.

7. The Type of Ground Truth Used

For the biocompatibility tests (e.g., Cytotoxicity, Sensitization, Irritation), the "ground truth" is defined by established biological safety standards and methodologies (ISO 10993-1). For the bench tests (e.g., Complex Modulus, Viscosity, pH), the "ground truth" is the measured values obtained using validated laboratory methods and instruments. These are objective physical and chemical properties.

8. The Sample Size for the Training Set

N/A. This is not an AI/machine learning device that requires a training set.

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

N/A. Not applicable.

Ask a specific question about this device

PuraStat-GI is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding.

PuraStat-GI is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a hemostat. The gel is delivered to the intended application site(s) via a commercially available endoscopic catheter that is attached to the gel syringe via the polypropylene adapter.

PuraStat-GI is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation.

Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraStat-GI achieves hemostatic effects by forming a hydrogel matrix barrier that blocks the flow of blood at the site of application.

The provided text describes a 510(k) premarket notification for the device PuraStat-GI, a hemostatic device for intraluminal gastrointestinal use.

It details bench testing, animal studies, and clinical studies of the device. However, it does not explicitly state specific acceptance criteria (e.g., "The device must achieve hemostasis in X% of cases with Y% confidence interval"). Instead, it presents reported device performance and implies that these results demonstrate substantial equivalence to a predicate device, thereby meeting the FDA's requirements for market clearance.

Therefore, the response below will present the reported device performance from the provided text and note the absence of explicitly stated numerical acceptance criteria.

Acceptance Criteria and Study Details for PuraStat-GI

While the document does not explicitly list specific numerical "acceptance criteria" that the device must meet (e.g., "hemostasis rate must be >X%"), it presents the performance data of PuraStat-GI from three clinical studies, alongside a comparison to a predicate device in bench and animal testing, to demonstrate substantial equivalence. The implied acceptance is that the device's performance is comparable to or better than established benchmarks in terms of safety and effectiveness for its intended use.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

Note: The acceptance criteria are "implied" based on the presentation of data to support device clearance, rather than explicit numerical targets defined in the document.

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

The provided text details three clinical studies that serve as the "test set" for human performance data for PuraStat-GI:

• Subramaniam (2019): N=100 patients
• de Nucci (2020): N=77 patients
• Subramaniam (2020): N=46 patients

Total clinical patients: 223 patients.

Data Provenance: The document states these are "results of three clinical studies of the use of PuraStat® that have been reported in the literature." This indicates these were likely retrospective analyses of previously conducted and published clinical trials. The specific countries of origin for these studies are not specified in the provided document.

Additionally, a GLP gastrointestinal mucosal defect study was conducted in a porcine model with a comparative side-by-side assessment against the predicate device. The sample size for this animal study is not specified.

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

The document does not provide information on the number of experts used to establish ground truth in the clinical studies, nor their specific qualifications. Typically, clinical study results (like hemostasis success, re-bleed rates, and adverse events) are determined by the treating physicians and study investigators, who are medical professionals specializing in endoscopy and gastroenterology, but their specific roles in "ground truth" establishment are not detailed here.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the clinical studies presented.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The clinical studies presented solely evaluate the performance of PuraStat-GI itself. There is no mention of human readers (clinicians) assessing cases with and without AI assistance, as would be typical for an MRMC study comparing AI-assisted performance to human-only performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the clinical studies presented, along with the animal and bench testing, represent "standalone" performance of the PuraStat-GI device. The device is a physical hemostatic agent, not an AI algorithm. Its performance metrics (hemostasis rate, re-bleed rate, etc.) are a direct measure of the device's efficacy without human-in-the-loop assistance in the sense of an AI diagnostic. The human "in the loop" delivers the device, but the device's hemostatic action is independent.

7. The Type of Ground Truth Used

The ground truth for the clinical studies appears to be based on clinical outcomes and physician assessment during and after endoscopic procedures. This includes:

• Observation of hemostasis during endoscopy.
• Follow-up for delayed bleeding or re-bleeding events.
• Reporting of adverse events.

For the animal study, the ground truth was also based on direct observation of hemostasis and re-bleeding rates in the porcine model.

8. The Sample Size for the Training Set

The document does not mention a training set for PuraStat-GI. PuraStat-GI is a medical device (hemostatic gel), not a machine learning or AI algorithm that typically requires a training set. The clinical studies, animal studies, and bench tests are for validation and performance assessment, not for training.

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

As PuraStat-GI is not an AI algorithm, there is no "training set" in the conventional sense, and thus no ground truth was established for a training set. The development of the device itself would have involved extensive research and pre-clinical testing, but these are not referred to as a "training set" in the context of this document.

Ask a specific question about this device

PuraDerm Gel is indicated for the hydration and management of partial and full thickness wounds, such as press, leg ulcers, diabetic ulcers, surgical wounds, and abrasions and burns associated with dermabrasion and laser resurfacing.

PuraDerm Gel consists of a synthetic, peptide-based hydrogel material provided in a prefilled syringe. PuraDerm Gel is comprised of 2.5% (w/v) of a synthetic repeating peptide (acetyl-[arginyl-alany]-asparty]-alany] 4-amide tetrahydrochloride in sterile water for injection. The peptide is synthesized by standard solid-phase chemistry with no raw materials of animal or cellular origin.

The PuraDerm Gel solution is sterile-filtered and filled into 5-ml syringes made of cyclo-olefin polymers with a high-density polyethylene plunger and a butyl rubber head cap and gasket. Each syringe is filled with either 1, 3, or 5 ml of gel.

PuraDerm Gel forms a three-dimensional hydrogel scaffold, which, at a basic structural level, is composed of a matrix of nanofibrils formed from individual peptide monomers. These fibrils are 10-20 nm in diameter and are interwoven to create an ordered structure with 50-100 nm pore sizes. This woven network structure, or matrix barrier, is similar to the microarchitecture of endogenous extracellular matrix ("ECM").

The gel is delivered to the intended application site(s) via a polypropylene applicator nozzle tip.

The provided FDA 510(k) document for PuraDerm Gel (K193085) does not describe an acceptance criterion or a study that proves the device meets an acceptance criterion.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices. Substantial equivalence means that the new device is as safe and effective as a legally marketed device that does not require premarket approval. This is achieved by showing that the device has the same intended use and the same technological characteristics as the predicate, or that differences in technological characteristics do not raise different questions of safety and effectiveness.

Here's why the requested information isn't present:

• No new performance data: The document explicitly states: "Because there is no change to the device, source material, or manufacturing compared to the predicate K143058, the existing biocompatibility, sterilization, and shelf life information from K143058 fully applies. GLP pyrogenicity testing showed that the device is considered to be nonpyrogenic. New performance testing was not necessary to support the additional indications or the updates to the IFU."
• Focus on equivalence: The entire "Substantial Equivalence Discussion" (Section 6) and "Conclusions" (Section 8) are dedicated to comparing the proposed device with the predicates based on their characteristics and indications for use, rather than presenting results from a new performance study against defined acceptance criteria.

Therefore, I cannot populate the requested table and details because the provided text explicitly states that new performance testing was not done and thus no acceptance criteria or study results for K193085 are discussed.

The document essentially leverages the prior clearance (K143058) for its technical characteristics and expands its indications based on equivalence to another predicate (K991202) for those specific indications.

Ask a specific question about this device

PuraSinus® is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help to control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process.

PuraSinus® is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate and formation of nasal adhesions during the post-operative period.

PuraSinus® is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a wound dressing with or without the optional sterile application nozzle. PuraSinus® forms a moist wound environment that is supportive of the healing process and allows non-traumatic removal of the secondary dressing without damaging newly formed tissue.

PuraSinus® is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation.

Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraSinus® can be easily rinsed away by gently flushing the wound with sterile saline, without causing trauma to the underlying wound.

This document ("510(k) Summary for PuraSinus®") does not describe an AI/ML device, nor does it present the acceptance criteria and study proving a device meets those criteria in a format applicable to AI/ML device performance. This is a 510(k) submission for a medical device (a bioresorbable nasal dressing and sinus stent) where the key demonstration of substantial equivalence relies on comparison to a predicate device through bench testing and a small retrospective case series, rather than formal performance goals met by an AI/ML algorithm.

Therefore, many of the requested categories for defining acceptance criteria and study details for an AI/ML device cannot be extracted from the provided text. However, I can still interpret the information regarding the "performance data" that was presented to support the device.

Here's an analysis based on the provided text, interpreted as much as possible in the context of your request for device performance, but noting the relevant limitations due to the nature of the device:

Device Name: PuraSinus®

Type of Device: Bioresorbable nasal dressing and sinus stent (not an AI/ML device)

Acceptance Criteria and Reported Device Performance (as far as applicable to this non-AI device):

Study Details (as derived from the text):

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

   • Test Set Sample Size: 19 sequential patients.
   • Data Provenance: Retrospective case series. The country of origin is not explicitly stated but implied to be where the clinical institution(s) conducting the FESS procedures are located (no specific country mentioned).

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

   • Not applicable in the AI/ML sense. The "ground truth" for the clinical performance (re-bleeding, adhesion formation, adverse events) would have been established by the treating physicians/surgeons during post-operative patient follow-up. The document does not specify the number or qualifications of these clinical evaluators.

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

   • Not explicitly described. Clinical outcomes (adhesions, re-bleeding, adverse events) were reported, presumably as direct observations during patient follow-up, not through a formal adjudication process like one used for AI/ML image review.

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 not an AI/ML device. The "comparison" was PuraSinus® performance to literature reported performance of a predicate device (MeroGel®).
   • Comparison: PuraSinus® showed an adhesion rate of 16% compared to a literature-reported adhesion rate of 27% for MeroGel® in similar procedures. This is a comparison of device outcome, not human reader performance.

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

   • Not applicable as this is not an AI/ML device.

6. The type of ground truth used:

   • Clinical Outcomes/Observations: Directly observed post-operative clinical outcomes (adhesion formation, re-bleeding, adverse events) by treating physicians.
   • Bench Test Results: Quantitative measurements from laboratory tests (Complex Modulus, Viscosity, Injection Force).
   • Rabbit Model: In vivo animal study data for material comparison.

7. The sample size for the training set:

   • Not applicable, as this is not an AI/ML device that requires a "training set."

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

   • Not applicable, as this is not an AI/ML device.

Summary of Device Performance Evidence (based on the provided text):

The primary evidence presented to demonstrate the substantial equivalence and performance of PuraSinus® focused on:

• Bench Testing: Comparative physical and mechanical properties of PuraSinus® and the predicate device (MeroGel®).
• Animal Model: A side-by-side comparison in a rabbit model to address material differences between PuraSinus® and MeroGel®, concluding no impact on safety or effectiveness.
• Retrospective Case Series (Human Data): A small series (19 patients) showing favorable clinical outcomes (no re-bleeding, low and mild adhesion rates) compared to literature data for the predicate device.

The document emphasizes that PuraSinus® is the "identical product" to the previously cleared PuraDerm Gel (K140358), leveraging its biocompatibility and product characterization studies.

The acceptance of this device by the FDA (as indicated by the clearance letter K183015) was based on the provided data demonstrating substantial equivalence to the predicate device, not on meeting specific, pre-defined performance thresholds for an AI/ML algorithm.

Ask a specific question about this device