Search Results

SURGISEAL Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations. SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures

SURGISEAL® Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. It incorporates the Teardrop applicator that consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. The Stylus and Twist applicators contain the identical adhesive formula and incorporate a plastic ampoule, which houses the adhesive, contained within the double longer plastic sleeves with an attached applicator tip. When SURGISEAL is applied to the skin with these applicators, it polymerizes in minutes.

The provided document is a 510(k) premarket notification for topical skin adhesives (Surgiseal Topical Skin Adhesive, Surgiseal Stylus Topical Skin Adhesive, Surgiseal Twist Topical Skin Adhesive). It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm or performance study.

Therefore, the information required to populate most of the sections of your request (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this document. This document is related to a medical device approval and not a software or AI algorithm approval.

However, I can provide information on acceptance criteria that are implicitly or explicitly mentioned for the biocompatibility and sterilization aspects of the device, which are part of its overall safety and effectiveness.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information (Not provided in the document):

2. Sample sizes used for the test set and the data provenance: Not applicable in the context of an AI/ML algorithm evaluation; for biocompatibility, sample sizes for in vitro or in vivo tests are part of the ISO standards but not detailed here. The studies were previously conducted on predicate devices. Data provenance would be related to the lab conducting the biocompatibility tests.
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 biocompatibility and sterilization is based on established scientific methods and standards.
4. Adjudication method 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, as this is not an AI/ML device.
6. 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.
7. The type of ground truth used:
   • For Biocompatibility: The "ground truth" is defined by the biological response of cells/tissues to the material, as assessed by standardized tests (e.g., cytotoxicity, irritation, sensitization assays) according to ISO-10993.
   • For Sterilization: The "ground truth" is the sterility assurance level (SAL) achieved, verified by validated sterilization cycles and appropriate microbiological testing, according to ISO 11137 and ISO 11135.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The document describes a 510(k) submission for new topical skin adhesive products (Surgiseal Topical Skin Adhesive, Surgiseal Stylus Topical Skin Adhesive, Surgiseal Twist Topical Skin Adhesive). The "study" or rather, the evidence presented to ensure safety and effectiveness and demonstrate substantial equivalence, relies primarily on:

• Identity of Technological Characteristics: The device's formulation (monomeric 2-octyl cyanoacrylate) and mode of action are identical to previously cleared predicate devices.
• Biocompatibility Testing: Prior biocompatibility testing conducted on the predicate devices (SURGISEAL Teardrop (K082993), SURGISEAL Stylus (K130474), and SURGISEAL Twist (K130474)) in accordance with ISO-10993 was leveraged. This testing confirmed the materials were non-toxic, non-irritating, non-sensitizing, and biocompatible. No new biocompatibility testing was required because the subject devices are identical to the predicates in terms of materials.
• Sterilization Validation: Validation of sterilization methods (electron beam and gamma irradiation for Surgiseal, and gamma followed by ethylene oxide for Stylus and Twist) was conducted according to international standards (ISO 11137-2:2006, ISO 11135-1:2008, ISO 11135-2:2008). This ensures the devices are supplied sterile.
• Shelf-Life Determination: A 2-year shelf life was established, implying stability testing was performed, though details of this testing are not provided in this specific document snippet.
• Microbial Barrier Properties (In vitro): In vitro studies showed SURGISEAL acts as a physical barrier to microbial penetration as long as the adhesive film remains intact. However, the document explicitly states that clinical studies were not conducted to demonstrate microbial barrier properties, and a correlation between microbial barrier properties and a reduction in infection has not been established.

In essence, the "study" for this 510(k) submission is a demonstration that the new devices are substantially equivalent to already approved predicate devices regarding their materials, design, intended use, and performance characteristics, supported by prior testing data and adherence to recognized standards for biocompatibility and sterilization.

Ask a specific question about this device

SURGISEAL Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations.

SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures.

SURGISEAL® Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. It incorporates the Teardrop applicator that consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. The Stylus applicator incorporates the identical adhesive formula but incorporates the Stylus applicator that consists of a plastic ampoule, which houses the adhesive, contained with the longer plastic sleeve within a longer plastic sleeve with an attached applicator tip. When SURGISEAL is applied to the skin with either Applicator, it polymerizes in minutes.

In vitro studies have shown that SURGISEAL acts as a physical barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established.

The provided document describes a 510(k) submission for SURGISEAL® Topical Skin Adhesive and SURGISEAL Stylus™ Topical Skin Adhesive. The submission is for a labeling change to include a "Microbial Barrier description." The document explicitly states: "In vitro studies have shown that SURGISEAL acts as a physical barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established." Furthermore, it clarifies that the 510(k) submission is for a labeling change to characterize the ease, safety, or effective use of the product based on extensive bench performance testing, which has demonstrated to be safe & efficacious.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of clinical studies, ground truth, sample sizes, and expert adjudication cannot be extracted accurately for the microbial barrier claim, as no clinical studies were performed. The "Performance Testing" section mentions "Microbial Barrier Tests and Film Thickness determinations for each of the two applicators" as bench tests.

However, based on the information provided about the bench performance testing for the microbial barrier property, here's what can be inferred and stated:

1. Table of acceptance criteria and the reported device performance:

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

• Sample size: Not specified in the provided text for the in vitro microbial barrier studies.
• Data provenance: "In vitro studies," meaning laboratory-based studies. The location/country of the lab is not specified, but it's a retrospective assessment of prior in vitro work.

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

• Not applicable. The ground truth for in vitro microbial barrier studies would typically be established through standardized microbiological testing protocols, not human expert consensus.

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

• Not applicable as it was an in vitro laboratory test, not a subjective assessment requiring human adjudication.

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. The submission is for a topical skin adhesive, not an AI-assisted diagnostic or interpretive device.

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

• No, not applicable. This is for a medical device (topical skin adhesive), not an algorithm.

7. The type of ground truth used:

• For the microbial barrier claim: The ground truth was based on the results of in vitro microbiological testing demonstrating the physical barrier property.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or algorithm-based device requiring a training set in that context. The "training" here refers to the development and testing of the physical adhesive product.

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

• Not applicable in the context of a "training set" for an algorithm. The development of the adhesive product was likely based on various bench tests and physicochemical characterizations to achieve desired properties, which would serve as "ground truth" for product development.

Ask a specific question about this device

SURGISEAL Topical Skin Adhesive is Intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations.

SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures.

SURGISEAL® Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. Each applicator consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. This applicator tray with sponge tip is contained in an outer Tyvek pouch. When SURGISEAL is applied to the skin, it polymerizes in minutes.

The provided text describes a 510(k) submission for the SURGISEAL® Topical Skin Adhesive, focusing on labeling changes and sterilization methods. However, it does not include specific quantitative acceptance criteria or a study detailing device performance against such criteria in the manner requested by the prompt for an AI-related device.

The information primarily discusses:

• Device Identification and Classification: Name, type, class, regulatory information.
• Predicate Devices: SURGISEAL® Topical Skin Adhesive (K082993) and Dermabond Advanced (K100423).
• Reason for Submission: Labeling change and inclusion of gamma sterilization.
• Device Description: 2-octyl cyanoacrylate formulation with D&C Violet #2.
• Indications for Use: Topical application to hold closed easily approximated skin edges of wounds (surgical incisions, punctures from minimally invasive surgery, simple trauma-induced lacerations), potentially with deep dermal sutures.
• Technological Characteristics & Substantial Equivalence: Claims equivalence to the predicate SURGISEAL® device. Discusses biocompatibility (referencing previous testing for K082993) and performance testing (stated that performance testing from K082993 is the same, with additional bench testing to support modifications, but no details are provided). Mentions terminal sterilization by electron beam identical to the predicate, and new gamma irradiation.
• Shelf-Life: Adoption of the current predicate's two-year shelf-life.
• FDA Correspondence: A letter from the FDA determining substantial equivalence for K130329.

Based on the provided text, the following information cannot be extracted or is not applicable in the context of an AI device performance study:

1. Table of Acceptance Criteria and Reported Device Performance: This document does not present quantitative acceptance criteria (e.g., sensitivity, specificity, AUC thresholds) or specific performance metrics of the device in a clinical study. It states that "extensive bench performance testing" was done but provides no data.
2. Sample Size used for the test set and data provenance: Not applicable. No clinical test set data is provided. The biocompatibility and performance testing refer to previous submissions (K082993) or unspecified "additional bench testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: Not applicable. This is a medical device (topical skin adhesive), not an AI diagnostic/imaging device that would typically involve MRMC studies.
6. If a standalone performance (algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable in the AI sense. The "ground truth" for a skin adhesive would typically relate to wound closure efficacy, tensile strength, infection rates, cosmetic outcome, etc., which are not detailed in this summary.
8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information relevant to "acceptance criteria" and "study":

• Acceptance Criteria (Implied): The device is considered to meet "acceptance criteria" by demonstrating substantial equivalence to legally marketed predicate devices (SURGISEAL® Topical Skin Adhesive K082993 and Dermabond Advanced K100423) in terms of Indications for Use, technological characteristics, biocompatibility, performance, and sterilization methods. The specific performance data supporting this equivalence is referenced as originating from the predicate device's submission (K082993) and "additional bench testing" for the current modification, but no raw data or numerical targets are given in this summary.
• Study Proving Acceptance Criteria:
  • Biocompatibility: Testing was previously conducted on the predicate device (SURGISEAL K082993) per ISO-10993. The results from those studies (non-toxic, non-irritating, non-sensitizing, biocompatible) are deemed supportive for the proposed device due to lack of changes to surface-contacting materials.
  • Performance Testing: "The performance testing provided in the Premarket Notification K082993 is the same." Additionally, "Additional bench testing was performed to support the modification to the currently marketed product." No details of this additional bench testing (e.g., type of tests, results, sample sizes) are provided in this summary.
  • Sterilization and Shelf-Life: The modified device uses electron beam (identical to predicate K082993) and new gamma irradiation, both in accordance with ISO 11137-2:2006. Shelf-life is adopted from the predicate as 2 years, based on no impact from labeling changes on expiration date.

In conclusion, this document primarily asserts substantial equivalence through reference to prior studies and unspecified bench testing, rather than presenting a detailed independent study with specific performance metrics and acceptance criteria for the current submission.

Ask a specific question about this device

SURGISEAL Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations.

SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures.

SURGISEAL Stylus and Stylus Twist Topical Skin Adhesive are sterile, professional liquid topical skin adhesives containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2. Each applicator is comprised of a plastic ampoule container contained within an applicator sleeve with the applicator tip.

This Stylus applicator tray is contained in an outer Tyvek pouch. When SURGISEAL is applied to the skin, it polymerizes in minutes.

Here's a summary of the acceptance criteria and study findings for the SURGISEAL Stylus™ and Stylus Twist™ Topical Skin Adhesives, based on the provided text:

Acceptance Criteria and Device Performance

The submission discusses performance criteria generally, stating that the new applicator designs "demonstrated that the applicator design modification to the currently marketed product does not impact the performance specification criteria identified for the SURGISEAL product family." Specific numerical acceptance criteria are not provided in the excerpt.

The general performance attributes tested and the qualitative results are:

Study Details

Here's the breakdown of the study details based on the provided text:

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

   • Test Set Sample Size: Not explicitly stated in terms of number of units or measurements for each performance test. The biocompatibility tests mention specific "Lots" (e.g., Lot James A, Lot x 5923, Lot 121512i), implying multiple samples were tested from these production batches.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be bench testing ("In-vitro," "bench performance testing") and animal studies (implied by "Intracutaneous Reactivity," "Primary Skin Irritation"), rather than clinical studies on human subjects, based on the descriptive nature of the provided summary. All data appears to be retrospective as it compares to an already marketed device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for these performance and biocompatibility tests is based on objective, standardized test methods (e.g., ISO standards) and measurable outcomes, rather than expert interpretation of images or clinical cases.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. As the tests are objective and based on standardized protocols with pass/fail criteria or measurements, there's no mention of an adjudication process by human experts.

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 device is a topical skin adhesive, not an AI-powered diagnostic or assistive tool for human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is a product for wound closure, not an algorithm. The performance tests are for the physical and biological characteristics of the adhesive and its applicator.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the biocompatibility tests is defined by the objective results of the ISO 10993 standards (e.g., absence of cytotoxic effect, dermal reactions, or irritations). For the performance tests, the ground truth is against pre-established "performance specification criteria identified for the SURGISEAL product family" (presumably internal quantitative targets for flexibility, viscosity, set-time, etc.).

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

8. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

SURGISEAL Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations.

SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures.

SURGISEAL® Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-ocylt cyanoacrylate) formulation and the colorant D&C Violet #2. Each applicator consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. This applicator tray with sponge tip is contained in an outer Tyvek pouch.

This document describes the regulatory submission for SURGISEAL® Topical Skin Adhesive, specifically focusing on a labeling change rather than a new device or a new AI/Machine Learning (AI/ML) device. Therefore, many of the requested criteria related to AI/ML or direct performance studies are not explicitly stated or applicable in this context.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not applicable for this particular submission type:

1. Table of acceptance criteria and the reported device performance:

The document describes performance testing relative to a predicate device and specifications, rather than detailing specific acceptance criteria with numerical targets.

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

The document mentions "Additional bench testing was performed to support the modification to the currently marketed product," but it does not specify the sample size for this bench testing. Similarly, data provenance (e.g., country of origin, retrospective/prospective) is not provided.

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

This information is not applicable or provided as this submission is for a labeling change to a medical device (topical skin adhesive), not an AI/ML device requiring expert ground truth for interpretation of images or clinical data. The performance is assessed through bench tests.

4. Adjudication method for the test set:

This is not applicable or provided as the evaluation relies on physical bench tests, not expert interpretation requiring adjudication.

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 is not applicable as the submission is for a topical skin adhesive, not an AI/ML medical device.

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

This is not applicable as the submission is for a topical skin adhesive, not an AI/ML medical device.

7. The type of ground truth used:

For the performance testing mentioned, the "ground truth" would be defined by the specifications and established performance benchmarks of the predicate device and industry standards for wound closure products. For biocompatibility, the ground truth was established by adherence to ISO-10993 standards.

8. The sample size for the training set:

This is not applicable as this is not an AI/ML device and therefore does not involve a training set.

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

This is not applicable as this is not an AI/ML device and therefore does not involve a training set.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "extensive bench performance testing" and biocompatibility testing.

• Biocompatibility Testing: Previously conducted on the currently marketed device, SURGISEAL (K082993), per the International Standard ISO-10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing." The results considered the device non-toxic, non-irritating, non-sensitizing, and biocompatible. No additional biocompatibility testing was deemed necessary for this K123936 submission as the subject device is identical to K082993.
• Performance Testing: "Additional bench testing was performed to support the modification to the currently marketed product." These tests included:
  • Wound closure strength
  • Set-time
  • Linear coverage
  • Film thickness
  • Tissue approximation time

The document states: "In all cases, the modified labeled SURGISEAL Topical Skin Adhesive met specifications and demonstrated equivalence to the predicate device(s)."

The overall conclusion is: "Based on extensive bench performance testing, the modified labeled device, SURGISEAL has demonstrated to be substantially equivalent to its predicate devices from a safety and performance perspective, and has demonstrated that a single layer of the low viscosity product maintains approximation of wound edges."

Ask a specific question about this device

SurgiSeal ™Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations. SurgiSeal ™Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.

SURGISEALTM Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2. Each applicator consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. This applicator tray with sponge tip is contained in an outer Tyvek pouch. When SURGISEAL is applied to the skin, it polymerizes in minutes.

The provided text is a Premarket Notification Summary (510(k)) for the SurgiSeal Topical Skin Adhesive. This document focuses on demonstrating substantial equivalence to a predicate device (Dermabond) based on bench testing and biocompatibility. It is not a study that provides detailed acceptance criteria and reported performance for a device against a pre-defined set of metrics from a clinical or imaging study.

Therefore, many of the requested fields cannot be directly extracted from this document, as they pertain to clinical or AI algorithm performance studies, which are not described here.

Here's a breakdown of what can be inferred or stated based on the provided text, and what cannot:

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

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

• Sample Size for Test Set: Not specified. The document refers to "bench tests" and "animal tests" but does not provide details on sample sizes or specific methodologies for these tests.
• Data Provenance: Not specified. The nature of the tests (bench, animal) implies laboratory conditions, but no geographic origin is mentioned, nor whether it was retrospective or prospective (these terms are more relevant to clinical studies).

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)

• Not applicable. The tests described are laboratory-based (adhesion, biocompatibility, animal healing) and do not involve human expert interpretation or ground truth establishment in the way an imaging diagnostic device would.

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

• Not applicable. This is not a study involving human interpretation or adjudication 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. This is not an AI device or a diagnostic device involving human readers.

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

• Not applicable. This is a medical device (topical skin adhesive), not an algorithm.

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

• For the bench tests (adhesion, biocompatibility, moisture vapor transmission): The "ground truth" would be established by the standardized test methodologies themselves and the physical/chemical properties measured according to those standards.
• For animal tests: Histological analysis, wound healing assessments, or other physiological markers would likely serve as the "ground truth," but details are not provided.

8. The sample size for the training set

• Not applicable. This document describes premarket notification for a physical medical device, not a machine learning algorithm that requires a training set.

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

• Not applicable. As above, this is not a machine learning algorithm.

Ask a specific question about this device