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GCI Sterilization Wrappers are intended to be used to enclose reusable textile-based medical devices, such as surgical gowns, towels, and drapes, for sterilization by a health care provider. They are designed to allow effective steam sterilization of the enclosed textile items and to maintain sterility until use, for up to 28 days.

GCI Sterilization Wrapper sizes and validated load limitations are as follows:

GCI Sterilization Wrappers are reusable through 38 wash, dry, and sterilization cycles. Pack assembly should follow established folding, assembly, and wrapping procedures as defined by the clinical staff for aseptic presentation of the pack and its contents. Closure can include autoclave tape and elastomer closures.

Sterilization: A prevacuum steam sterilization cycle (4 minutes exposure at 132°C, Dry Time: 30 minutes) has been validated.

GCI Sterilization Wrappers are intended to enclose a textile-based medical device for sterilization and maintain sterility of the enclosed device until used.

The proposed devices are medical devices that are provided non-sterile. They may be reused up to 38 times. They are available in multiple sizes to accommodate textile-based medical devices, ranging from 18"x18" to 60"x60". The size is indicated by color coding of the wrap borders for easy identification.

Load sizes should be large enough to prevent too much overlapping of the wrapper material (such that all but one side of the wrapper should be a single layer when properly folded) to allow appropriate sterilant penetration. Load sizes should be small enough to overlap by at least 2 inches on the remaining side to ensure there are no gaps.

This document pertains to the 510(k) clearance for GCI Sterilization Wrappers, a Class II medical device. The information provided outlines the non-clinical performance data used to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Discussion of Study Proving Device Meets Acceptance Criteria:

The document states that performance testing was conducted in alignment with FDA guidance documents "Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities" and "Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities."

Testing was also conducted to relevant standards including:

• ASTM D5587: Tearing Strength
• 16 CFR 1610: Flammability
• AATCC 127: Water Resistance: Hydrostatic Pressure
• AATCC 42: Water Resistance: Impact Penetration
• ISO 10993-5: Biocompatibility - Cytotoxicity
• ISO 10993-10: Biocompatibility - Irritation and Sensitization
• ISO 9073: (Not directly referenced in table, but listed as a standard used for testing)
• ASTM D5034: Breaking Strength
• AAMI TIR 12: Use Life and Reprocessing Effectiveness
• AAMI TIR 30: Use Life and Reprocessing Effectiveness
• ANSI/AAMI/ISO 17665-1: Sterilization Validation and Sterility Maintenance

All testing results are reported to have "passed pre-determined acceptance criteria," supporting the performance of the subject device.

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

• Sample Size for Test Set: The document does not explicitly state the specific number of samples used for each individual test. It mentions that "All testing results passed pre-determined acceptance criteria," suggesting that sufficient samples were tested to meet the statistical requirements of the respective standards.
• Data Provenance: The document indicates that George Courey Inc. is located in Laval, Quebec, Canada. While the testing itself is described as "Performance testing was conducted," the specific location or country of origin where these tests were physically performed is not detailed. The data is retrospective in the context of the 510(k) submission, as these tests were completed prior to the submission for clearance.

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 to this type of device and study. The "ground truth" for the performance characteristics of sterilization wrappers is established by objective, standardized laboratory tests and international/national standards (e.g., ISO, ASTM, AAMI). Expert consensus by medical professionals is not typically used to establish the ground truth for properties like tearing strength, flammability, or water resistance of a material. For "Sterilization Validation" (SAL of 10-6), the "ground truth" is a measurable scientific endpoint achieved through validated sterilization cycles, not expert opinion.

4. Adjudication method for the test set:

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation tasks where human readers make subjective assessments that might require a tie-breaking or consensus mechanism. For materials testing and performance validation of a sterilization wrapper, the results are objective measurements against defined acceptance criteria, not subjective interpretations 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 to this device. An MRMC study is relevant for diagnostic imaging AI or other applications where human interpretation is involved. GCI Sterilization Wrappers are a physical barrier device, and their performance is evaluated through laboratory-based physical, chemical, and microbiological testing, not human reader assessments.

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

This is not applicable. This is not an AI-powered diagnostic algorithm or software device. The product is a physical sterilization wrapper, and its performance is evaluated through material science and sterilization efficacy tests.

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

The "ground truth" for the performance of the GCI Sterilization Wrappers is based on objective measurements and adherence to established industry standards and regulatory guidance documents. This includes:

• Physical Property Measurements: Tearing strength, breaking strength, water resistance, linting, flammability are all quantifiable physical properties measured using standardized test methods.
• Biocompatibility Testing: Cytotoxicity, irritation, and sensitization are evaluated using established in vitro and in vivo models according to ISO 10993 standards, yielding objective results (e.g., "Non-Cytotoxic").
• Sterilization Efficacy and Maintenance: Sterilization validation (achieving SAL of 10-6) and sterility maintenance are determined through microbiological testing and barrier integrity assessments under controlled conditions, adhering to ANSI/AAMI/ISO 17665-1.
• Use Life and Reprocessing Effectiveness: Confirmed through repeated cycling and performance evaluation according to AAMI TIR12 and TIR30.

There is no subjective "ground truth" derived from expert consensus, pathology, or outcomes data in the traditional sense for this product.

8. The sample size for the training set:

This is not applicable. The GCI Sterilization Wrappers are a physical product, not a software algorithm that requires a "training set" in the context of machine learning or AI. The rigorous testing described is a validation process, not a training process.

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

This is not applicable for the same reasons as #8. There is no training set for this type of medical device.

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GCI surgical gown is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 2 barrier classification.

GCI Surgical Gowns are intended to be used during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate materials. The gown is available in multiple sizes. They are provided non- sterile and intended to be sterilized prior to use. They are reusable up to 75 uses. Per ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel intended for use in health care facilities, the proposed devices meet the requirements for 2, as indicated by their labeling.

This document describes the non-clinical performance testing of the GCI Surgical Gown to demonstrate its substantial equivalence to a legally marketed predicate device (K211422).

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for each non-clinical test. However, the tests are laboratory-based performance tests of the device itself (GCI Surgical Gown). The data provenance is from non-clinical laboratory testing performed to specific standards (e.g., AATCC, ASTM, ISO) to verify the device met design specifications. The country of origin of the data is not explicitly stated, but the submission is to the US FDA by a Canadian company (George Courey, Inc.), suggesting the testing was performed to international standards. This is retrospective testing performed on the final device.

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

This section is not applicable as the ground truth for this type of device (surgical gown) is established through objective, standardized physical and biological performance tests, not through expert human assessment of images or clinical data. The "ground truth" is defined by the acceptance criteria of the specified international standards.

4. Adjudication method for the test set

This section is not applicable. The outcome of non-clinical, objective tests is not subject to adjudication in the same manner as expert consensus for clinical image interpretation. The tests yield quantitative results that are compared directly against predefined numerical or qualitative acceptance criteria specified in the relevant standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The device is a surgical gown, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and assessment of human reader improvement with AI are irrelevant to this submission.

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

This section is not applicable. The device is a physical surgical gown, not an algorithm.

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

The ground truth used for this device is based on objective, standardized measurements and biological assessments as defined by international and national standards. For example:

• Physical properties (e.g., water resistance, strength) are evaluated against quantitative thresholds.
• Biocompatibility is evaluated against qualitative (e.g., "non-cytotoxic," "not an irritant") outcomes determined by specified in-vitro or in-vivo biological tests.

8. The sample size for the training set

This section is not applicable. The device is a physical product (surgical gown) that does not utilize machine learning or AI, and therefore does not have a "training set" in the computational sense.

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

This section is not applicable for the same reasons as #8.

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