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DuraBlue ™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:

• . Pre-vacuum steam at 270°F/132°C for 4 minutes
• . 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes
• Advanced Sterilization Products (ASP) STERRAD® 100S system. .
• . Advanced Sterilization Products (ASP) STERRAD® NX system, Standard and Advanced Cycles
• . Advanced Sterilization Products (ASP) STERRAD® 100NX system, Standard, Flex, Express, and DUO Cycles
• . Lumen, Non Lumen, and Flexible Cycles in the Amsco® V-PRO® 1, Amsco® V-PRO® 1 Plus and Amsco® V-PRO® max Low Temperature Sterilization Systems

The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of ' the enclosed device(s) until used.

For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200, and for 30 minutes for Models CH300, CH400, CH500 and CH600. Models CH400, CH500 and CH600 have been validated for pre-vacuum steam sterilization of two lumens 3 mm in diameter or larger and 400 mm in length or less.

For EO sterilization, the wrap has been validated for an aeration time of 8 hours at 55 ℃. Models CH400, CH500 and CH600 have been validated for EO sterilization of two lumens of 3 mm diameter or larger and 400 mm in length or less.

All models of DuraBlue™ Sterilization Wrap have been validated for Advanced Sterlization Products (ASP) STERRAD® 100S sterilization of lumens 2.5 mm in diameter or larger and 250 mm in length or less.

All models of DuraBlue™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX cycles in Table 1.

All models of DuraBlue™ Sterilization Wrap have been validated for use with the STERIS Amsco® V-PRO® cycles in Table 2. The DuraBlue™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed STERIS Amsco® V-PRO® sterilization cycles.

DuraBlue™ Sterlization Wraps are made from 100% polypropylene spunbond-meltblown-spunbond (SMS) trilaminate nonwoven fabric. Each double-layer wrap is comprised of a single sheet of SMS fabric that has been folded in half and sealed to itself on the three non-folded edges. This wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically. This product is for over-the-counter use only.

They are intended to be used to enclose another medical device that is to be sterilized by a health care provider using:

• Pre-vacuum steam at 270°F/132°C for 4 minutes .
• . 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes
• . Advanced Sterilization Products (ASP) STERRAD® 100S System
• Advanced Sterilization Products (ASP) STERRAD® NX System, Standard and Advanced . Cycles
• Advanced Sterilization Products (ASP) STERRAD® 100NX, Standard, Flex, Express, and . DUO cycles
• Lumen, Non Lumen, and Flexible Cycles by the STERIS Amsco® V-PRO® 1, Amsco® V-. PRO® 1 Plus and Amsco® V-PRO® MAX Low Temperature Sterilization Systems

The modification to the predicate devices is the clarification to the sterility maintenance information provided in the Indications for Use portion of the Instructions for Use labeling and involves extending the real-time aging data from 180 days to 365 days. This change is being made in order to comply with 21CFR880.6850 which states "A sterilization wrap (pack, sterilization wrapper, bag, or accessories) is a device intended to be used to enclose another medical device that is to be sterlized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used." Additionally, maintenance of package sterility was validated with realtime testing for a duration of 365 days for each indicated sterilization process.

Extensive performance testing has also been completed on DuraBlue™ Sterlization Wrap. Successful completion of the sterilization performance tests demonstrated that the wrap allows for sterlization of the enclosed contents and also maintains sterility of the enclosed devices. Physical properties testing included in this submission also supports the fact that the integrity of the wrap properties is not compromised after sterilization by the indicated sterilization processes and storage because the polypropylene material is inert and very stable.

This submission covers six different models of DuraBlue™ Sterilization Wrap. Each model is made from material of a different basis weight, though all models utilize the same material technology.

The provided text describes the DuraBlue™ Sterilization Wrap and elaborates on its acceptance criteria and the studies conducted to demonstrate its performance and substantial equivalence to predicate devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The device's performance was proven through "extensive performance testing" and "sterility validation studies" in accordance with applicable requirements recommended in the FDA's Guidance Document: "Premarket Notifications for Medical Sterilization Packaging System in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002)."

The primary modification for this 510(k) submission was the extension of real-time aging data from 180 days to 365 days to comply with regulations regarding maintaining sterility.

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

The document provides details of specific loads used for each type of sterilization validation study and for each wrap model (CH100 - CH600). These loads vary in composition (huck towels, drapes, metal mass, lumens) and weight.

• Pre-vacuum Steam Sterility Validation Studies:
  • CH100: 16 huck towels
  • CH200: 2 huck towels, 3 fluid-resistant drapes
  • CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs of metal mass
  • CH400: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 8 lbs of metal mass
  • CH500: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 12 lbs of metal mass
  • CH600: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 20 lbs of metal mass
• EO Sterility Validation Studies:
  • CH100: 16 huck towels
  • CH200: 2 huck towels, 2 fluid-resistant drapes, 2.5 lbs of metal mass
  • CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs of metal mass
  • CH400: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 7.5 lbs of metal mass
  • CH500: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 11.5 lbs of metal mass
  • CH600: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 19.5 lbs of metal mass
• Advanced Sterilization Products (ASP) STERRAD® 100S Sterility Validation Studies:
  • CH100: Metal Instruments
  • CH200 - CH600: 15 in. x 10 in. x 1.2 in. tray containing metal instruments
• Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX Sterility Validation Studies:
  • CH100 - CH600: 23 in. x 11 in. x 4 in. tray containing metal instruments
• STERIS Amsco® V-PRO® Sterility Validation Study:
  • CH100: Metal Instruments
  • CH200 - CH600: 17 in. x 10 in. x 3.5 in. tray containing metal instruments

The "Note" section on page 6 states: "The loads used in the Sterility Validation Study corresponded to the maximum wrapped package content weights in Table 3."

Data Provenance: The document does not specify the country of origin of the data. The studies are prospective in nature, as they involve testing the device's performance under various sterilization conditions and aging.

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

This information is not explicitly provided in the document. The studies performed are laboratory-based performance tests and sterility validation studies rather than analyses requiring expert interpretation of medical images or clinical outcomes. Therefore, the "ground truth" would be established by the results of standardized biological and physical tests and measurements, often conducted by trained technicians in controlled environments.

4. Adjudication Method for the Test Set:

This information is not applicable to this type of device submission. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies among multiple human readers in diagnostic studies. Here, the "test set" refers to physical samples undergoing rigorous laboratory tests.

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. This type of study is relevant for diagnostic devices where human readers interpret output, and the AI's assistance to human readers is being evaluated. The DuraBlue™ Sterilization Wrap is a sterilization packaging device, not a diagnostic tool requiring human interpretation aided by AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:

Not applicable in the context of an AI algorithm. The device itself is a physical product (sterilization wrap), and its performance is evaluated in a standalone manner (i.e., the wrap's ability to maintain sterility, its material properties, and compatibility with sterilization methods). There is no "algorithm" in the typical sense for this device.

7. The Type of Ground Truth Used:

The ground truth used for these studies is based on:

• Sterilization Efficacy: Demonstrated by the ability to achieve and maintain sterility, likely through biological indicator (BI) testing or other validated methods to confirm the absence of viable microorganisms.
• Microbial Barrier Properties: Assessed through aerosol challenge tests, measuring the ability of the wrap to prevent microbial ingress.
• Event-Related Shelf Life: Determined by real-time aging studies over 365 days, followed by integrity and sterility testing at various time points.
• Material Compatibility: Physical property testing (e.g., tensile strength, tear resistance) after sterilization, and chemical compatibility assessments to ensure the polypropylene material is not compromised.
• Biocompatibility: Standardized tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993 or similar standards.

Essentially, the "ground truth" is established by objective, measurable results from validated laboratory tests and standards.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical product, not an AI/ML model that requires a "training set" of data.

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

Not applicable. As there is no training set for an AI/ML model, this question does not apply.

Ask a specific question about this device

DuraBlue™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:

• Pre-vacuum steam at 270°F/132°C for 4 minutes .
• 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% . relative humidity for 60 minutes
• . Advanced Sterilization Products (ASP) STERRAD® 100S system.
• . Advanced Sterilization Products (ASP) STERRAD® NX system, Standard and Advanced Cycles
• Advanced Sterilization Products (ASP) STERRAD® 100NX system, Standard, Flex, Express, and . DUO Cycles
• Lumen, Non Lumen, and Flexible Cycles in the Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus . and Amsco® V-PRO™ maX Low Temperature Sterilization Systems

The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used.

DuraBlue™ Sterilization Wraps are double layer sterilization wraps made from 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric. They are intended to enclose another medical device that is to be sterilized by a health care provider using various sterilization methods (Pre-vacuum steam, 100% ethylene oxide (EO), Advanced Sterilization Products (ASP) STERRAD® systems, and STERIS Amsco® V-PRO™ systems). This wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically. The submission covers six different models of DuraBlue™ Sterilization Wrap, each made from material of a different basis weight but utilizing the same material technology.

Here's an analysis of the acceptance criteria and the study information provided for the DuraBlue™ Sterilization Wrap, structured as requested:

Acceptance Criteria and Device Performance for DuraBlue™ Sterilization Wrap

This submission (K130927) is a 510(k) summary for a modification to an already cleared device, DuraBlue™ Sterilization Wrap. The stated modification is a clarification to sterility maintenance information in the Instructions for Use labeling. Therefore, the acceptance criteria and performance data referenced are primarily from the underlying predicate device submissions (K123857, K123289, K120658) which established the original substantial equivalence based on performance testing.

The document does not explicitly state specific pass/fail acceptance criteria (e.g., "sterility assurance level of X" or "no positive microbial cultures") for each test. Instead, it refers to "validated" performance for various sterilization methods and loads. The reported device performance is that the wrap "has been validated" for these uses, meaning it met the implicit or explicit criteria of the validation studies conducted for the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific numerical sample sizes (n) for each test conducted for the predicate device submissions. Instead, it details the types of loads used to validate each model of sterilization wrap for different sterilization methods. These loads represent the "test set" and are described as follows:

• Pre-Vacuum Steam Sterility Validation Studies:
  • CH100: 16 huck towels.
  • CH200: 2 huck towels, 3 fluid-resistant drapes.
  • CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs of metal mass.
  • CH400: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 8 lbs of metal mass in a tray.
  • CH500: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 12 lbs of metal mass in a tray.
  • CH600: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 20 lbs of metal mass in a tray.
• EO Sterility Validation Studies:
  • CH100: 16 huck towels.
  • CH200: 2 huck towels, 2 fluid-resistant drapes, 2.5 lbs of metal mass.
  • CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs of metal mass.
  • CH400: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 7.5 lbs of metal mass in a tray.
  • CH500: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 11.5 lbs of metal mass in a tray.
  • CH600: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 19.5 lbs of metal mass in a tray.
• Advanced Sterilization Products (ASP) STERRAD® 100S Sterility Validation Studies:
  • CH100: Metal Instruments.
  • CH200 - CH600: 15 in. x 10 in. x 1.2 in. tray containing metal instruments.
• Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX Sterility Validation Studies:
  • CH100 - CH600: 23 in. x 11 in. x 4 in. tray containing metal instruments.
• STERIS Amsco® V-PRO™ Sterility Validation Studies:
  • CH100: Metal Instruments.
  • CH200 - CH600: 17 in. x 10 in. x 3.5 in. tray containing metal instruments.

Data Provenance: The studies were done as "Sterility Validation Studies" to support predicate device submissions, likely conducted in a controlled laboratory or testing facility setting, which implies a prospective design for testing the new device. The country of origin of the data is not specified, but since Cardinal Health 200, LLC is based in Waukegan, IL, USA, and the submission is to the FDA, it is highly likely the data was generated in the US or under US regulatory guidelines.

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

The document does not provide details on the number or qualifications of experts specifically establishing "ground truth" for these sterilization validation studies. For medical devices like sterilization wraps, ground truth for sterility is typically established through microbiology (e.g., spore log reduction, sterility tests) in conjunction with physical parameters (e.g., temperature, pressure readings) and chemical indicators, rather than human expert opinion on images or clinical cases. The validation would follow established standards (e.g., AAMI, ISO) for sterilization efficacy.

4. Adjudication Method for the Test Set

Not applicable. As this is a physical device subject to sterility validation, there is no "adjudication method" in the context of expert review for qualitative assessments (like in image analysis studies). Sterility is determined by direct measurement (e.g., microbial culture results) rather than consensus among human reviewers.

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 a sterilization wrap, not an AI-powered diagnostic tool, and therefore, no MRMC comparative effectiveness study involving human readers and AI assistance was conducted.

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

Not applicable. This device is a physical product (a sterilization wrap), not an algorithm or software requiring standalone performance testing in this context. The "standalone performance" refers to the wrap's ability to maintain sterility under various conditions when exposed to sterilization processes, independent of human interaction during the sterilization cycle itself. This is what the validation studies assessed.

7. The Type of Ground Truth Used

The ground truth used for these "Sterility Validation Studies" would be based on microbiological testing, adhering to industry standards for demonstrating sterility. This typically involves:

• Biological Indicators (BIs): Spore-laden strips or vials placed within the test loads. A successful validation demonstrates a specified log reduction of microbial spores (often a Sterility Assurance Level - SAL of 10^-6), meaning no growth of test organisms after exposure to the sterilization cycle.
• Physical Parameters: Monitoring and recording of physical parameters such as temperature, pressure, time, and sterilant concentration (for EO and vaporized hydrogen peroxide systems) to ensure they meet the defined cycle specifications.
• Chemical Indicators (CIs): Internal and external indicators showing exposure to sterilant, but not necessarily sterility.
• Package Integrity Testing: Post-sterilization testing to ensure the wrap maintains its sterile barrier integrity (e.g., burst strength, seal strength, microbial barrier testing).

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not a machine learning algorithm. Therefore, there is no "training set." The performance data is derived from validation studies of the device itself.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth established for a training set. The "ground truth" for the device's efficacy revolves around successful sterility validation as described in point 7.

Ask a specific question about this device

Cardinal Health DuraBlue™ Sterilization Wrap is intended to enclose another medical device that is to be sterilized by a health care provider using the following modalities:

• Pre-vacuum steam at 270°F/132°C for 4 minutes
• 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes

The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s). Maintenance of package sterility was validated with real-time aging testing for a duration of 180 days for each indicated modality.

For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200 and 30 minutes for Models CH300, CH400, CH500, and CH600. Models CH400, CH500, and CH600 have been validated for pre-vacuum steam sterilization of two lumens 3 mm in diameter or larger and 400 mm in length or less.

For EO sterilization, the wrap has been validated for an aeration time of 8 hours at 55℃. Models CH400, CH500, and CH600 have been validated for sterilization of two lumens of 3 mm diameter or larger and 400 mm in length or less for EO sterilization.

Cardinal Health DuraBlue™ Sterilization Wraps are double layer sterilization wraps made from 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric. They are intended to be used to enclose another medical device that is to be sterilized by a health care provider pre-vacuum steam at 270°F/132°C for 4 minutes, or 100% ethylene oxide (EO) with a concentration of 725-735 mgL at 131°F/55°C and 40%-80% relative humidity for 60 minutes. This wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically.

This submission covers six different models of Cardinal Heatth DuraBlue™ Sterilization Wrap. Each model is made from material of a different basis weight, though all models utilize the same material technology.

The provided text describes the DuraBlue™ Sterilization Wrap and its performance. Here's a breakdown of the requested information based on the document:

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

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

• Sample Size: The document does not explicitly state the numerical sample size for the "test set." Instead, it describes loads used for Sterility Validation Studies for each of the six DuraBlue™ Sterilization Wrap models (CH100-CH600) for both pre-vacuum steam and EO sterilization. These loads consist of specific quantities of huck towels, fluid-resistant drapes, fluid-resistant table covers, stacked tray liners, lumens, and metal mass. The "Note" clarifies that these loads corresponded to the maximum recommended wrapped package content weights.
• Data Provenance: The document does not specify the country of origin of the data. It states that the device is manufactured by Cardinal Health 200, LLC in McGaw Park, IL, USA. The studies are described as "Event-Related Shelf Life testing" and "Sterility Validation Studies." The study refers to "FDA's Guidance Document Premarket Notification 510(k) Submissions for Medical Sterilization Packaging System in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002)," suggesting these are prospective validation studies conducted to meet regulatory requirements. Thus, the data appears to be prospective.

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

This information is not provided in the document. The studies are described as "Sterilization Efficacy" and "Microbial Barrier Properties" testing, implying laboratory-based validation rather than expert-driven ground truth establishment.

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

This information is not provided in the document. The nature of the testing (sterilization efficacy, microbial barrier) does not typically involve adjudication by human experts in the same way imaging or clinical diagnostic studies might.

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. The device is a sterilization wrap, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

This is also not applicable. The device is a physical product (sterilization wrap) and does not involve an algorithm or AI. Its performance is evaluated through physical and microbiological testing.

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

The ground truth for the performance claims (e.g., sterilization efficacy, microbial barrier, sterility maintenance) is established through laboratory-based scientific testing and validation methodologies, often involving microbiology (e.g., spore kill, microbial challenge) and physical testing (e.g., material compatibility, aging). This is akin to a "gold standard" of direct physical and biological measurement, rather than expert consensus or pathology in a medical imaging context.

8. The sample size for the training set:

This is not applicable. As a physical product, the DuraBlue™ Sterilization Wrap does not have a "training set" in the context of machine learning or AI. Its design and material properties are based on engineering principles and prior knowledge, not iterative training on a data set.

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

This is not applicable for the same reasons mentioned in point 8.

Ask a specific question about this device

Cardinal Health DuraBlue™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using the following modalities:

• Johnson & Johnson STERRAD® 100NX system, Standard, Flex, Express, and DUO Cycles. .
• Johnson & Johnson STERRAD® NX system, Standard and Advanced Cycles .
  The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s). Maintenance of package sterility was validated with real-time aging testing for a duration of 180 days for each indicated modality.

Cardinal Health DuraBlue™ Sterlization Wraps are double layer sterilization wraps made from 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric. They are intended to enclose another medical device that is to be sterilized by a health care provider by Standard, Flex, Express, and Duo cycles of the Johnson & Johnson STERRAD® 100NX and the Standard and Advanced cycles of the Johnson & Johnson STERRAD® NX hydrogen peroxide gas plasma sterilization system. This wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically. The proposed DuraBlue™ Sterilization Wrap was validated for sterility maintenance after a period of 180 days.

Here's a breakdown of the acceptance criteria and study information for the DuraBlue™ Sterilization Wrap, based on the provided text:

DuraBlue™ Sterilization Wrap Acceptance Criteria and Study Information

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document specifies that "Each model is made from material of a different basis weight, though all models utilize the same material technology." There are six models (CH100, CH200, CH300, CH400, CH500, CH600). The "Sterility Maintenance Validation Study" used one of each model, with specific tray contents for each model. Therefore, the minimum sample size for the sterility maintenance test set would be 6 units (one of each model). However, performance testing also included sterilization efficacy, microbial barrier properties, material compatibility, and biocompatibility, which likely involved more samples and replicates for thorough validation. The exact total number of individual samples tested across all performance properties is not explicitly stated but would be expected to be higher than just 6.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, given that it's a 510(k) submission to the FDA, the testing would have been prospective to generate data for regulatory approval. The testing was conducted by Cardinal Health 200, LLC, located in McGaw Park, IL, USA, implying the studies were conducted in the USA or in facilities compliant with US regulatory standards.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the test set. For sterilization wrap, ground truth is typically empirical (e.g., microbial challenges, physical property measurements) rather than interpreted by human experts like in imaging studies. The "PASS" results would indicate that the measured performance met pre-defined, objective criteria.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method. For performance testing of a sterilization wrap (e.g., sterilization efficacy, microbial barrier), results are typically determined by objective laboratory measurements and testing protocols (e.g., biological indicator kill, physical integrity assessment) rather than subjective expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret outputs (e.g., radiology images) and the AI's impact on their performance is being assessed. Sterilization wrap performance is determined through objective material and microbiological testing.

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

Yes, the studies described are standalone (algorithm only, though this is not an "algorithm" in the AI sense, but rather the device itself). The performance tests (sterilization efficacy, microbial barrier, material compatibility, biocompatibility) directly evaluate the wrap's inherent properties and its interaction with the sterilization process, without human intervention in the performance measurement itself.

7. The Type of Ground Truth Used

The ground truth used for the performance testing of the DuraBlue™ Sterilization Wrap is primarily empirical and objective measurement-based:

• Sterilization Efficacy: Likely involves biological indicator (BI) kill results, confirming the sterility of enclosed contents after sterilization.
• Microbial Barrier Properties: Measured through aerosol challenge tests, evaluating the wrap's ability to prevent microbial ingress.
• Event Related Shelf Life (Sterility Maintenance): Real-time aging studies followed by sterility testing or integrity checks.
• Material Compatibility: Physical property testing (e.g., tensile strength, tear resistance) before and after sterilization to ensure the material is not compromised.
• Biocompatibility: In vitro and/or in vivo tests to confirm the material does not elicit adverse biological responses, in compliance with ISO 10993.

8. The Sample Size for the Training Set

The concept of a "training set" is typically applicable to machine learning algorithms. Since the DuraBlue™ Sterilization Wrap is a physical medical device and not an AI/ML algorithm, there is no training set in the conventional sense.

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

As there is no training set for this device, the question of how its ground truth was established is not applicable.

Ask a specific question about this device

Cardinal Health DuraBlue™ Sterilization Wrap is intended to enclose another medical device that is to be sterilized by a health care provider by the following modality:

• Standard and Advanced cycles of the STERRAD® NX Sterilization System .
  The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s). Maintenance of package sterility was validated with real-time testing for the following durations:
• 30 days following sterilization by STERRAD® NX (Standard and Advanced cycles) .
  All models of DuraBlue™ Sterilization Wrap have been validated for use with the following STERRAD® NX Sterilization Cycles.

Cardinal Health DuraBlue™ Sterilization Wraps are double layer sterilization wraps made from 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric. They are intended to be used to enclose another medical device that is to be sterilized by a health care provider by Standard and Advanced cycles of the STERRAD® NX hydrogen peroxide gas plasma sterilization system. This wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically.
This submission covers six different models of Cardinal Health DuraBlue™ Sterilization Wrap. Each model is made from material of a different basis weight, though all models utilize the same material technology.

The provided document describes the Cardinal Health DuraBlue™ Sterilization Wrap, its intended use, and the studies conducted to demonstrate its performance and substantial equivalence to predicate devices. However, it does not contain the level of detail typically found in a clinical study report for an AI/ML medical device, which would include specific acceptance criteria with numerical targets and the reported device performance against those targets.

Instead, the document focuses on regulatory approval for the sterilization wrap itself, demonstrating its ability to facilitate sterilization and maintain sterility. The "acceptance criteria" here are implied by the successful completion of various performance tests in accordance with FDA guidance for sterilization packaging systems.

Here's an attempt to structure the information based on your request, with noted limitations due to the nature of the source document:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a sterilization wrap, the "acceptance criteria" are not reported as numerical metrics like sensitivity or specificity (as would be for an AI diagnostic device). Instead, they are functional requirements for a sterilization packaging system. The performance is reported as successful completion of these requirements.

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

• Sample Size: The document mentions "Extensive performance testing" and "Sterility Maintenance Validation Study" and "performance tests." However, it does not specify a numerical sample size (e.g., number of wraps, number of test cycles, or number of individual tests) for these studies. It lists various load configurations for the six different wrap models (CH100-CH600) used in the Sterility Maintenance Validation Study, each with a 23 in. x 11 in. x 4 in. tray containing metal instruments.
• Data Provenance: The document does not explicitly state the country of origin. Given the manufacturer (Cardinal Health, located in McGraw Park, IL, USA) and the FDA 510(k) submission, it is highly likely that the studies were conducted in the USA. The studies appear to be prospective in nature, as they involve testing the device under specific conditions set up to validate its performance for sterilization and sterility maintenance.

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

This information is not applicable and therefore not provided in the document. The DuraBlue™ Sterilization Wrap is a sterile barrier system, not a diagnostic or AI device that requires expert ground truth for image interpretation or disease diagnosis. The "ground truth" for its performance is established through microbiological testing (sterilization efficacy and sterility maintenance) and physical material testing, rather than expert consensus on observational data.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments, typically for AI/ML devices where differences in expert opinions need to be reconciled to establish a robust ground truth. For this device, the outcomes are objective (e.g., presence/absence of microbial growth, material tear strength, seal integrity).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable and therefore not provided in the document. MRMC studies are designed to evaluate the performance of diagnostic tools when used by multiple readers across multiple cases, often comparing AI-assisted performance to unassisted human performance. The DuraBlue™ Sterilization Wrap is a medical device used for packaging, not for diagnostic interpretation, so such a study would not be relevant.

6. Standalone Performance Study (Algorithm Only)

This information is not applicable and therefore not provided in the document. The DuraBlue™ Sterilization Wrap is a physical product, not an algorithm or software. Its performance is inherent to its physical and material properties and how it interacts with the sterilization process, not an independent algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance of the DuraBlue™ Sterilization Wrap is established through objective laboratory testing:

• Microbiological assays: To confirm sterilization efficacy (e.g., kill rate of biological indicators) and maintenance of sterility (e.g., absence of microbial ingress after a specified period).
• Physical and chemical property testing: To assess material integrity, strength, porosity, and compatibility with the sterilization process (e.g., tensile strength, burst strength, visual inspection for damage, chemical compatibility with hydrogen peroxide plasma).

8. Sample Size for the Training Set

This information is not applicable and therefore not provided in the document. The DuraBlue™ Sterilization Wrap is a physical product and does not use machine learning algorithms that require a "training set" of data.

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

This information is not applicable and therefore not provided in the document, as there is no "training set" for this type of medical device.

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Cardinal Health DuraBlue™ Sterilization Wrap is intended to enclose another medical device that is to be sterilized by a health care provider by the following modalities:

• Pre-vacuum steam at 270°F/132°C for 4 minutes
• STERRAD® 100S system. .
• Lumen, Non Lumen, and Flexible Cycles in the Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus . and Amsco® V-PRO™ maX Low Temperature Sterilization Systems

The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s). Maintenance of package sterility was validated with real-time testing for the following durations:

• 180 days following sterilization by STERRAD 100S and Amsco® V-PRO™ (Lumen, Non Lumen, . and Flexible Cycles).
• 30 days following sterilization by pre-vacuum steam at 270°F/132°C for 4 minutes. .

Cardinal Health DuraBlue™ Sterilization Wrap is not indicated for use with gravity steam sterilization.

For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200, and for 30 minutes for Models CH300, CH400, CH500 and CH600. Models CH400, CH500 and CH600 have been validated for pre-vacuum steam sterilization of lumens 3 mm in diameter or larger and 400 mm in length or less. All models have been validated for STERRAD® 100S sterilization of lumens 2.5 mm in diameter or larger and 250 mm in length or less.

All models of DuraBlue™ Sterilization Wrap have been validated for use with the following Amsco® V-PRO™ cycles. The DuraBlue™ Sterilization Wrap was validated to be effectively aerated during the preprogrammed Amsco® V-PRO® sterilization cycles.

Cardinal Health DuraBlue™ Sterilization Wraps are double layer sterilization wraps made from 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric. They are intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 270°F/132°C for 4 minutes, STERRAD® 100S System and the Lumen, Non Lumen, or Flexible Cycles in 270 17102 0 for 4 mililates, STERM 1 Plus and Amsco® V-PRO™ MAX Low Temperature Sterilization Systems. This wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically.

This submission covers six different models of Cardinal Health DuraBlue™ Sterilization Wrap. Each model is made from material of a different basis weight, though all models utilize the same material technology.

The Cardinal Health DuraBlue™ Sterilization Wrap is intended to enclose medical devices for sterilization and to maintain sterility for specified durations. The acceptance criteria and supporting studies are detailed below, primarily focusing on the sterility maintenance aspect, as this is the key modification highlighted in the submission, and sterilization efficacy as a fundamental performance requirement.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly state the sample size for the "Event-Related Shelf Life testing" (which would be the primary test set for the sterility maintenance claim) or the "Extensive performance testing" for sterilization efficacy.

• Data Provenance: The studies are described as "real-time testing" for sterility maintenance and "extensive performance testing" for sterilization efficacy. The data is internally generated by Cardinal Health 200, LLC, a US-based company, suggesting the studies were conducted domestically. They are retrospective in the sense that the data is being presented post-collection as part of a 510(k) submission.

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

The document does not provide information about the number or qualifications of experts used to establish ground truth. For sterility and sterilization efficacy testing, ground truth is typically established through microbiological methods (e.g., sterility testing, biological indicators) and physical/chemical tests, rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

Not applicable. The tests described (sterility testing, physical properties testing) involve objective measurements rather than subjective assessments requiring adjudication or consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The device is a sterilization wrap, not an imaging or diagnostic device that typically involves human readers interpreting results.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "Event-Related Shelf Life testing" and "Extensive performance testing" demonstrate the performance of the wrap itself (the "algorithm only without human-in-the-loop performance" equivalent for this type of device) in achieving and maintaining sterility. The efficacy of the wrap is evaluated independently of human interpretation of a diagnostic output.

7. Type of Ground Truth Used

The ground truth used for these studies would be based on:

• Sterility: Absence of microbial growth in sterility tests (microbiological cultures).
• Sterilization Efficacy: Inactivation of biological indicators (spore tests) and successful passage of physical/chemical indicators for sterilization.
• Physical Properties: Objective measurements of material integrity (e.g., tensile strength, tear resistance, barrier properties) before and after sterilization/storage.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here as this is a physical medical device (sterilization wrap) undergoing performance testing, not an AI/machine learning algorithm.

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

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

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Cardinal Health DuraBlue™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131 F/55°Cand 40%-80% relative humidity for 60 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed devices for 30 days. The wrap has been validated for an aeration time of 8 hours at 55°C. Models CH400, CH500 and CH600 have been validated for sterilization of two lumens of 3mm diameter or larger and 400mm in length or less.

Cardinal Health DuraBlue™ Sterilization Wrap is not indicated for use with gravity steam sterilization.

Cardinal Health DuraBlue™ Sterilization Wraps are double layer sterlization wraps made from 100% polypropylene spunbond-mettblown-spunbond (SMS) fabric. Cardinal Health DuraBlue™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a heath care provider by 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterlity of the enclosed device(s) for 30 days. The wrap was validated for an aeration time for EO sterilization of 8 hours at 55°C. Models CH400, CH500 and CH600 have been validated for EO sterlization of two lumens 3 mm in diameter or larger and 400 mm in length or less. The wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterlized pack to be opened aseptically.

This submission covers six different models of Cardinal Health DuraBlue™ Sterilization Wrap. Each model is made from material of a different basis weight, though all models utilize the same material technology.

Here's a breakdown of the acceptance criteria and study information for the DuraBlue™ Sterilization Wrap, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail format for each test. Instead, it states that "Successful completion of the sterilization performance tests listed below demonstrated that the wrap both allows for sterilization of the enclosed contents and maintains sterility of the enclosed contents until opened." The reported performance is that the wrap did successfully pass these tests, demonstrating substantial equivalence to the predicate device.

• Maintains sterility of enclosed devices for 30 days.
• Compatible with EO parameters: 725-735 mg/L concentration, 131°F/55°C, 40%-80% relative humidity, 60 minutes exposure.
• Validated for 8 hours aeration time at 55°C.
• For CH400, CH500, CH600: Validated for sterilization of two lumens 3mm diameter or larger and 400mm length or less.
• Substantial equivalence to predicate (K082177 - KIMGUARD ONE-STEP Sterilization Wrap) in performance and safety attributes.
• Meets physical property requirements before and after EO exposure.
• Complies with applicable requirements of FDA's "Premarket Notification 510(k) Submissions for Medical Sterilization Packaging System in Health Care Facilities" draft guidance.
• Demonstrates acceptable EO residuals and biocompatibility per ISO 10993. | - "Successful completion of the sterilization performance tests listed below demonstrated that the wrap both allows for sterilization of the enclosed contents and maintains sterility of the enclosed contents until opened."
• "Performance and safety attributes are substantially equivalent to the predicate."
• "The physical properties of all wrap models have been characterized both before and after exposure to 100% ethylene oxide sterilization. The resulting data supports the conclusion that Cardinal Health DuraBlue™ Sterilization Wrap is substantially equivalent to the predicate, and the DuraBlue™ Sterilization Wraps are compatible with the identified 100% ethylene oxide sterilization parameters."
• "Data from testing demonstrates that the performance of the DuraBlue™ Sterilization Wrap is substantially equivalent to that of Kimberly-Clark KIMGUARD ONE-STEP Sterilization Wrap." |

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

• Sample Size: The document does not explicitly state the specific numerical sample sizes used for each test (e.g., how many wraps were tested for sterility maintenance, how many cycles for sterilization efficacy). It mentions that "Extensive performance testing has been completed" and details the specific "loads used in the validation studies" for each of the six models (CH100 to CH600). These loads represent the tested configurations for evaluating sterilization efficacy and pack integrity.
  • CH100: 16 huck towels
  • CH200: 2 huck towels, 2 fluid resistant drapes, 2.5 lbs metal mass
  • CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs metal mass
  • CH400: 4 stacked tray liners, 7.5 lbs metal mass in a tray
  • CH500: 4 stacked tray liners, 11.5 lbs metal mass in a tray
  • CH600: 4 stacked tray liners, 19.5 lbs metal mass in a tray
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It describes laboratory-based performance testing conducted to support the 510(k) submission.

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

This information is not provided in the document. The testing described is primarily laboratory-based performance testing of the physical properties and sterilization efficacy of the wrap itself, rather than studies requiring human expert interpretation of results (like medical imaging).

4. Adjudication Method for the Test Set:

This information is not applicable for the type of device and testing described. Adjudication methods (like 2+1 or 3+1) are typically used for studies where human experts are making judgments (e.g., diagnosing conditions from images) and their agreement needs to be resolved. The tests here involve measurable physical properties, sterility, and chemical residuals.

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 devices that are interpreted by human readers, often with or without AI assistance. The DuraBlue™ Sterilization Wrap is a medical packaging device, not a diagnostic tool, and involves no human "readers" in its performance evaluation in this context.

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

This is not applicable as the device is a physical sterilization wrap, not an algorithm or software. The performance tests are inherently "standalone" in that they evaluate the material itself and its interaction with the sterilization process, without human intervention during the actual sterilization or sterility maintenance phase.

7. The Type of Ground Truth Used:

The ground truth for the performance tests would be based on:

• Sterility Assessment: Typically involves biological indicator (BI) testing (e.g., showing inactivation of spores) and microbial challenge testing to confirm the sterilization process efficacy and the wrap's ability to maintain a sterile barrier. This is a scientific, objective measure.
• Physical Property Standards: Measurements of tear resistance, burst strength, porosity, etc., against predefined engineering specifications and industry standards.
• Chemical Analysis: Measurement of EO residuals in accordance with regulatory limits.
• Visual Inspection: For pack integrity, tears, or compromise.

Essentially, the ground truth is established through objective, standardized laboratory testing methods to demonstrate the physical, chemical, and biological performance of the wrap.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" in the context of this device. The DuraBlue™ Sterilization Wrap is a manufactured medical product that undergoes performance validation, not an artificial intelligence algorithm that requires a dataset for training.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as there is no training set for this device.

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