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KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:

· Pre-vacuum steam at 270°F / 132°C for 4 minutes. The wrap was validated for dry times of 20 minutes for models KC100 and KC200.

· 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 was validated for aeration times for EO sterilization of 8 hours at 43.3 °C for models KC100 and KC200.

KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

Test results validated that KIMGUARD* ONE-STEP* Sterilization Wraps (KC100, KC200) allowed sterilization of the enclosed devices by the ethylene oxide sterilization and by pre-vacuum cycles.

These models of the KIMGUARD* ONE-STED* Sterilization Wrap have been validated for use with the ethylene oxide and pre-vacuum cycles in Table 1 (see page 2 of 2)

KIMGUARD* ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap ultrasonically seamed on two edges. This allows for convenient wrapping with two sheets simultaneously.

The sheets of sterilization wrap are square or rectanqular fabric produced using a three-layer SMS (spunbond-meltblown-spunbond) process. The wrap fabric (white or blue color) is composed of polypropylene with the addition of less than 2% by weight of phthalocvanine blue pigment (blue fabric only), less than 1% by weight titanium dioxide pigment, and less than 0.009% by weight of a potassium phosphate anti-static treatment. The wrap allows a sterilized package to be opened aseptically.

This FDA 510(k) summary describes KIMGUARD® ONE-STEP® Sterilization Wrap intended to enclose medical devices for sterilization and maintain sterility.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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)

The document does not explicitly state the specific sample sizes used for the "Maintenance of 365-Day Package Integrity," "Sterilant Penetration," and "Biocompatibility" tests. For the KIMGUARD® ONE-STEP® Sterilization Wrap Recommendations for Use (Table 1), the "test set" can be considered the specific configurations of loads used to validate the maximum wrapped package content weights:

• KC100: 16 huck towels (17"x 29") weighing 3 lbs.
• KC200: 2 huck towels (17"x 29"), 2 fluid resistant U-drapes (68"x 109"), 1 fluid resistant universal bar drape (70" x 108") weighing 6 lbs.

The data provenance is not explicitly mentioned as country of origin, but the applicant is Halyard Health, located in Alpharetta, GA, USA. The studies appear to be prospective as they were conducted to validate the device's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This product is a sterilization wrap, not an AI/imaging device. Therefore, the concept of "experts" to establish ground truth in the context of diagnostic interpretation is not applicable here. The validation involves standardized performance tests for sterilization and material properties. Compliance with relevant standards (e.g., ISO 10993 for biocompatibility) would be performed by qualified personnel in testing laboratories.

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

Not applicable for this type of device and study. Adjudication methods are typically used in clinical studies involving interpretation by multiple readers.

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/imaging device.

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

Not applicable. This is not an AI software. The device itself (the sterilization wrap) has a standalone performance (its ability to maintain sterility and allow sterilant penetration). The nonclinical tests essentially evaluate this "standalone" performance.

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

The "ground truth" for this device's performance is established by:

• Quantitative measurements and observations based on standardized test methods for:
  • Sterilant penetration (ensuring the sterilant reaches the enclosed medical device).
  • Microbiological challenge (implied by "maintenance of sterility" tests, indicating no microbial ingress).
  • Physical integrity tests to confirm the wrap remains intact over time, preventing contamination.
  • Biocompatibility tests according to ISO standards, which involve specific physiological responses.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

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

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KIMGUARD ONE-STEP® Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using:

• V-PRO® 60 Low Temperature Sterilization System that include:
  • o Lumen Cycle
  • Non Lumen Cycle o
  • Flexible Cycle O

KIMGUARD* ONE-STEP® Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

KIMGUARD* ONE-STEP® Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap that is ultrasonically seamed on two edges. This seamed configuration allows for convenient wrapping of an article using two sheets simultaneously.

The blue or white sheets of sterilization wrap are square or rectangular fabric produced using a three-layer SMS (spunbound-meltblown-spunbound) process. The blue wrap fabric is composed of polypropylene with the addition of less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of anti-static treatment. The white sheet has the same material composition but contains no blue pigment. The wrap allows a sterilized package to be opened aseptically.

I am sorry, but based on the provided document, the information required to compose the detailed response for "acceptance criteria and the study that proves the device meets the acceptance criteria" as requested is not available. The document is a 510(k) summary for a sterilization wrap, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics in the format requested for a device that typically involves AI or human interpretation.

Specifically, the document states:

• "All results of testing met acceptance criteria demonstrating that the KIMGUARD* ONE-STEP® Sterilization Wrap allows sterilization of contents by the V-PRO® 60 Low Temperature Sterilization System (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) and maintains sterility of contents until used."
• It lists a "Summary of Testing Performed" table with "Results" as "Passed" for "Sterilant Penetration", "Maintenance of Package Integrity (30 Days)", "Performance Testing", and "Material Biocompatibility."

However, it does not provide:

1. A table of specific acceptance criteria and reported device performance (e.g., quantifiable metrics like sensitivity, specificity, accuracy, or other performance thresholds with numerical results). The results are simply stated as "Passed."
2. Sample sizes used for the test set and data provenance.
3. Number of experts and their qualifications used to establish ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study details.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document describes a medical device (sterilization wrap) which functions as a physical barrier and facilitator of sterilization, not an AI-powered diagnostic or interpretive device. Therefore, the types of studies and performance metrics typically associated with AI/software-as-a-medical-device (SaMD) are not applicable here.

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KIMGUARD* ONE-STEP* Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using:

• . Sterilucent PSD-85 Hydrogen Peroxide Sterilizer that include:
  • Lumen Cycle and o
  • Non-Lumen Cycle. o

KIMGUARD* ONE-STEP* Sterlization Wrap (KC100, KC200, KC300 and KC600) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

Test results validated that KIMGUARD ONE-STEP® Sterilization Wraps (KC100, KC300, KC400, KC500, and KC600) allowed sterilization of the enclosed devices by the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (i.e., both the Lumen and Non-Lumen Cycles). Additionally, the KIMGUARD ONE-STEP® Sterilization Wrap was validated to allow effective aeration under the pre-programmed PSD-85 Sterilization Cycles.

The PSD-85 Lumen Cycle has been validated to sterilize a load of up to ten (10) pounds (combined pouch and wrapped tray load) containing a maximum of ten (10) single channel stainless steel lumens per load with the following dimensions:

• · An inside diameter of 1 mm or larger and a length of 60 mm or shorter;
• An inside diameter of 2 mm or larger and a length of 250 mm or shorter;

· An inside diameter of 3 mm or larger and a length of 350 mm or shorter.

The PSD-85 Non-Lumen Cycle has been validated to sterilize a load of up to 25 pounds (combined pouch and wrapped tray load).

All models of the KIMGUARD ONE-STEP® Sterilization Wrap (KC100, KC300, KC400, KC500, and KC600) have been validated for use with the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer cycles in Table 1.

KIMGUARD* ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap that is ultrasonically seamed on two edges. This seamed configuration allows for convenient wrapping of an article using two sheets simultaneously.

The sheets of sterilization wrap are square or rectangular fabric produced using a threelayer SMS (spunbound-meltblown-spunbound) process. The wrap fabric is composed of polypropylene with the addition of less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of antistatic treatment. The wrap allows a sterilized package to be opened aseptically.

This document is a 510(k) premarket notification for KIMGUARD* ONE-STEP* Sterilization Wrap. It asserts substantial equivalence to a previously cleared predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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)

The document does not explicitly state the sample sizes for the testing of the sterilization wrap. It refers to "Test results validated" and "Real-time testing" but does not provide details on the number of units tested.

The data provenance is not specified in terms of country of origin. The studies are nonclinical tests conducted by the manufacturer (Halyard Health, formerly Kimberly-Clark Health Care).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the device is a sterilization wrap, not a diagnostic or AI-driven device requiring expert interpretation for ground truth. The "ground truth" for this type of device is established by objective performance criteria (e.g., microbial ingress, sterility testing, material compatibility) defined by regulatory standards and scientific methodologies, not human expert consensus.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient data by human readers. The tests performed for this sterilization wrap are objective, nonclinical performance tests.

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

This information is not applicable. MRMC studies and AI assistance benefits are relevant to diagnostic devices or software that aid human interpretation. This document pertains to a physical sterilization wrap.

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

This information is not applicable. This refers to a medical device in the form of a physical sterilization wrap, not an algorithm.

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

The ground truth for the performance of the sterilization wrap is established through various objective nonclinical tests based on recognized standards and methodologies. These include:

• Microbiological testing: To assess sterilant penetration and maintenance of sterility (e.g., bacterial challenge tests, sterility assurance level (SAL)).
• Physical and material property testing: To evaluate material compatibility, integrity, and aeration properties.
• Real-time shelf-life studies: To confirm the duration for which sterility is maintained.

The document explicitly states that testing was done "in accordance with the applicable requirements recommended in Pre-Market Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002)." This guidance outlines the scientific methods to establish the "ground truth" for such devices.

8. The sample size for the training set

This information is not applicable. This refers to a manufactured product (sterilization wrap) rather than a machine learning model, so there is no training set in the context of AI.

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

This information is not applicable for the same reason as above; there is no training set for a machine learning model.

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KIMGUARD* ONE-STEP* Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using:

Advanced Sterilization Products STERRAD® Sterilization Systems that include: STERRAD® 50, 100S, and 200 STERRAD® NX® [Standard Cvcle. Advanced Cvcle] STERRAD® 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle]

KIMGUARD* ONE-STEP* Sterilization Wraps are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

Test results validated that KIMGUARD* ONE-STEP* Sterilization Wraps (KC300, KC400, KC500, and KC600) allowed sterilization of the enclosed devices by the Advanced Sterilization Products STERRAD® Sterilization Systems (STERRAD® 50, 100S, 200, NX® [Standard Cycle and Advanced Cycle] and 100NX® [Standard Cycle, EXPRESS Cycle, DUO Cycle]).

The KIMGUARD* ONE-STEP* Sterilization Wrap (Models KC300, KC400, K500, KC600) have been validated for use with the STERRAD® 50, STERRAD® 100S, STERRAD® 200, STERRAD® NX® and STERRAD® 100NX® cycles in Table 1.

KIMGUARD* ONE-STEP* Sterilization Wrap Recommendations for Use with the Advanced Sterilization Products STERRAD® Sterilization Systems are provided in Table 2.

KIMGUARD® ONE-STEP® Sterilization Wrap is comprised of two sheets of KIMGUARD® Sterilization Wrap ultrasonically seamed on two edges. This allows for convenient wrapping with two sheets simultaneously.

The sheets of sterilization wrap are square or rectangular fabric produced using a threelayer SMS (spunbond-meltblown-spunbond) process. The wrap fabric is composed of polypropylene with the addition of less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of a potassium phosphate anti-static treatment. The wrap allows a sterilized package to be opened aseptically.

The acceptance criteria are that the KIMGUARD® ONE-STEP® Sterilization Wrap maintains sterility until used, after being sterilized by the referenced STERRAD® Sterilization Systems.

Here's the summary of the study:

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for Test Set:
The document does not explicitly state the specific sample sizes for each test in the test set. It mentions "Test results validated" and "Performance testing was conducted," implying a test set was used. The data provenance is not specified (e.g., country of origin). It's a nonclinical study, so it wouldn't be retrospective or prospective in the human study sense.

3. Number of Experts and Qualifications for Ground Truth of Test Set:
This information is not provided in the document. As this is a non-clinical device (sterilization wrap), it's unlikely that "experts" in the medical sense (like radiologists) were used to establish ground truth for performance tests like package integrity or sterilization efficacy. Ground truth would be based on validated scientific and engineering testing protocols.

4. Adjudication Method for the Test Set:
The document does not mention an adjudication method. For non-clinical performance tests, adjudication (e.g., 2+1, 3+1 for human readers) is typically not applicable. The results are usually objectively measured against predefined pass/fail criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or evaluative devices where human interpretation is involved. This device is a sterilization wrap, and its effectiveness is determined by objective physical and biological tests.

6. Standalone Performance:
Yes, a standalone (algorithm only without human-in-the-loop performance) study was done, as this is a physical product being tested for its intrinsic performance (package integrity, ability to allow sterilization). The study involved "Performance testing" and "nonclinical tests" as described.

7. Type of Ground Truth Used:
The ground truth used for these tests would be based on:

• Standardized microbiological testing (to confirm sterilization efficacy and sterility maintenance).
• Physical integrity testing methods (to assess package integrity).
• Chemical indicators or biological indicators (for sterilization effectiveness).
• The tests adhere to established standards and protocols for sterilization validation and sterile barrier system performance.

8. Sample Size for the Training Set:
The concept of a "training set" is not applicable here as this is a physical device being evaluated for its performance through testing, not an AI/algorithm being trained on data.

9. How the Ground Truth for the Training Set Was Established:
As mentioned in point 8, the concept of a "training set" is not applicable to this type of device and study.

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KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to enclose another medical device that is to be sterilized by a healthcare provider using:

• Gravity Steam at 250°F/121°C for 30 minutes. .
  KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

KIMGUARD* ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap that is ultrasonically seamed on two edges. This seamed configuration allows for convenient wrapping of an article using two sheets simultaneously.

The sheets of sterilization wrap are square or rectangular fabric produced using a threelayer SMS (spunbound-meltblown-spunbound) process. The wrap fabric is composed of polypropylene with the addition of less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of antistatic treatment. The wrap allows a sterilized package to be opened aseptically.

Here's an analysis of the provided text regarding the acceptance criteria and study for the KIMGUARD ONE-STEP Sterilization Wrap:

Acceptance Criteria and Device Performance for KIMGUARD® ONE-STEP® Sterilization Wrap

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "All results of testing met the same acceptance criteria as the predicate devices demonstrating substantial equivalence to the predicate devices." While specific, numerical acceptance criteria are not explicitly detailed (e.g., minimum tensile strength), the "Passed" designation for each category indicates successful fulfillment of the established criteria, which are identical to those of the predicate devices (K082177 and K091685). The specific loads and weights for each wrap model also represent acceptance criteria for their respective uses.

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

The document does not explicitly state the specific numerical sample size used for the test sets (e.g., how many wraps were tested for sterilant penetration). However, it lists the types of loads used in the "Sterility Maintenance Validation Study" for each wrap model:

• KC100: 1 tray liner 20" x 25", 12.5" x 9" x 1" Tray, 1 lb of metal mass
• KC200: 1 tray liner 20" x 25", 10" x 20" x 3 ½ Tray, 3 lbs of metal mass
• KC300: 1 tray liner 20" x 25", 10" x 20" x 3 ½Tray, 6 lbs of metal mass
• KC400: 1 tray liner 20" x 25", 10" x 20" x 3 ½ Tray, 10 lbs of metal mass
• KC500: 1 tray liner 20" x 25", 11" x 22" x 3 ½Tray, 12 lbs of metal mass
• KC600: 1 tray liner 20" x 25", 11" x 22" x 3 ½Tray, 20 lbs of metal mass

The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective. It is implied to be prospective testing conducted for regulatory 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 tests described are nonclinical, laboratory-based performance tests rather than studies requiring human expert interpretation for ground truth establishment.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable as the tests are nonclinical performance evaluations rather than interpretive studies requiring adjudication.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is typically for evaluating diagnostic or interpretive AI systems, not packaging materials.

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

This is not applicable. The device is a physical sterilization wrap, not an algorithm or AI system. The performance evaluation is inherently "standalone" in the sense that it assesses the physical product's characteristics and functionality.

7. The Type of Ground Truth Used

The ground truth for the nonclinical tests appears to be established scientific and regulatory standards/methods for sterilization packaging performance. This would include methods for assessing sterilant penetration, package integrity (e.g., burst strength, seal integrity), drying, aeration, and maintenance of sterility (e.g., microbial barrier testing). The "results of testing met the same acceptance criteria as the predicate devices," implying a comparison against established performance benchmarks for similar products.

8. The Sample Size for the Training Set

This is not applicable. The KIMGUARD ONE-STEP Sterilization Wrap is a physical medical device, not an AI or Machine Learning algorithm that requires a "training set" in the computational sense.

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

This is not applicable for the reasons stated above.

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KIMGUARD* ONE-STEP* Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using:

• Advanced Sterilization Products STERRAD® Sterilization Systems that include: STERRAD® 50, 100S, and 200 o
  • STERRAD® NX® [Standard Cycle, Advanced Cycle] o
  • STERRAD® 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO o Cycle]

KIMGUARD* ONE-STEP* Sterilization Wraps are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

KIMGUARD® ONE-STEP® Sterilization Wrap is comprised of two sheets of KIMGUARD® Sterilization Wrap ultrasonically seamed on two sides. This allows for convenient wrapping with two sheets simultaneously.

The sheets of sterilization wrap are square or rectangular fabric produced using a three-layer SMS (spunbound-meltblown-spunbound) process. The wrap fabric is composed of polypropylene with the addition of less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of a potassium phosphate anti-static treatment. The wrap allows a sterilized package to be opened aseptically.

The provided text describes the KIMGUARD® ONE-STEP® Sterilization Wrap and validation studies demonstrating its performance. However, it does not involve an AI device or a study comparing AI with human readers. Therefore, several sections of your request are not applicable.

Here's the information that can be extracted from the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • The document does not specify the exact sample sizes (e.g., number of wraps, number of sterilization cycles, number of instruments) used for the performance tests (Sterilant Penetration, Package Integrity, Maintenance of Package Integrity, Material Compatibility, Shelf Life, Biocompatibility).
   • The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective testing conducted by the manufacturer for regulatory submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a performance study for a physical medical device (sterilization wrap), not an AI diagnostic device requiring expert ground truth establishment.

3. Adjudication method for the test set: Not applicable. (See point 2)

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established through objective engineering and microbiological testing standards for sterilization wraps. This involves:

   • Verification of the ability to allow sterilant penetration.
   • Demonstration of package integrity (e.g., preventing microbial ingress).
   • Proof of material compatibility with sterilization methods.
   • Shelf life studies to ensure long-term integrity.
   • Biocompatibility testing to ensure safety of the material.
   • These are based on established scientific and regulatory guidelines for sterilization products.

7. The sample size for the training set: Not applicable. This is not an AI model, so there is no training set.

8. How the ground truth for the training set was established: Not applicable. (See point 7)

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KIMGUARD ONE-STEP* Sterilization Wraps 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 or 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. KIMGUARD ONE-STEP* Sterilization Wrap is also intended to be used in the Amsco® V-PRO™ 1 Low Temperature Sterilization System's cycle, the Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PROTM 1 Cvcle) and Non Lumen Cycles, and the V-PRO™ Low Temperature Sterilization System's Flexible Cycle. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened within the period of time for which performance data demonstrating maintenance of sterility has been provided. The wrap was validated for aeration times for EO sterilization of 8 hours at 55 °C or 12 hours at 43.3 °C. The KIMGUARD ONE-STEP* Sterilization Wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100 and 200, and for 30 minutes for Models 300, 400, 500, and 600. The KIMGUARD ONE-STEP* Sterilization Wrap was validated to be effectively aerated during the pre-programmed V-PRO™, the V-PRO™ 1 Plus, and the V-PRO™ Flexible Sterilization Cycles.

KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization.

KIMGUARD ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap ultrasonically seamed on two sides. This allows for convenient wrapping with two sheets simultaneously. The sheets of sterilization wrap are square or rectanqular fabric produced usinq a polypropylene three-layer SMS (spunbond-meltblown-spunbond) process.

The KIMGUARD ONE-STEP* Sterilization Wrap is intended to maintain the sterility of enclosed medical devices until opened, after being sterilized by prevacuum steam, 100% ethylene oxide (EO), or specific Amsco® V-PRO™ Low Temperature Sterilization System cycles.

Here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the KIMGUARD ONE-STEP* Sterilization Wrap are related to its ability to maintain sterility after various sterilization methods for specified durations. The reported device performance indicates that the wraps meet these criteria.

Note regarding other criteria: The document also mentions other validated parameters, which, while not presented in a table format with specific acceptance criteria and performance data like sterility maintenance, were assessed for the device. These include:

• Aeration times for EO sterilization: 8 hours at 55 °C or 12 hours at 43.3 °C.
• Dry times for pre-vacuum steam sterilization: 20 minutes for Models 100 and 200; 30 minutes for Models 300, 400, 500, and 600.
• Effective aeration during V-PRO™, V-PROTM 1 Plus, and V-PROTM Flexible Sterilization Cycles.
• Biocompatibility (irritation and sensitization) in compliance with ISO 10993.
• Sterilant penetration characteristics.
• Physical integrity.

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

The document provides specific details for the maximum wrapped package content weights and descriptions of loads used in the sterility maintenance validation studies for each wrap model and sterilization cycle. These descriptions indicate the specific items (e.g., huck towels, fluid-resistant drapes, metal mass) and their quantities/weights that constituted the 'samples' or 'test sets' used for validating sterility maintenance.

• Pre-Vacuum Steam and Ethylene Oxide Sterilization Cycles (Table 1):

  • KC100 (3 lbs): 16 huck towels (17"x 29")
  • KC200 (6 lbs): 2 huck towels (17"x 29"), 2 fluid resistant U-drape (68"x109"), 1 fluid resistant universal bar drape (70" x 108")
  • KC300 (9 lbs):
    • Pre-Vacuum Steam: 15 huck towels (17"x 29"), 1 small fluid resistant drape (60"x 76"), 5 lbs of metal mass
    • EO: 16 huck towels, 2 fluid resistant large drapes (76"x100"), 1 fluid resistant small drape (76"x60"), 1 fluid resistant table cover (60"x 90")
  • KC400 (13 lbs): 4 tray liners 20" x 25" stacked, 10" x 10" x 3 ½ " tray containing 11 lbs of metal mass
  • KC500 (17 lbs): 4 tray liners 20" x 25" stacked, 10" x 10" x 3 ½ " tray containing 15 lbs of metal mass
  • KC600 (25 lbs): 4 tray liners 20" x 25" stacked, 10" x 10" x 3 ½ " tray containing 23 lbs of metal mass

• Amsco V-PRO™ Low Temperature Sterilization System (Table 2):

  • KC100 (3 lbs): 3 lbs metal mass, 6 forceps
  • KC200 (6.5 lbs): 2.5 lbs metal mass, 6 forceps, V-PRO tray (17" x 10" x 3½") at 4 lbs
  • KC300 (9 lbs): 5 lbs metal mass, 6 forceps, V-PRO tray (17" x 10" x 3½") at 4 lbs
  • KC400 (10 lbs): 6 lbs metal mass, 6 forceps, V-PRO tray (17" x 10" x 3½") at 4 lbs
  • KC500 (10 lbs): 5 lbs metal mass, 6 forceps, V-PRO tray (21" x 10" x 3½") at 5 lbs
  • KC600 (10 lbs): 5 lbs metal mass, 6 forceps, V-PRO tray (21" x 10" x 3½") at 5 lbs

The document does not specify the exact number of replicates (i.e., how many times each load/wrap combination was tested) within these studies. The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a country of origin, but it is part of a 510(k) submission to the US FDA, implying the studies were conducted to meet US regulatory requirements.

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. For sterility maintenance studies of this nature, the "ground truth" is typically established through microbiological culture methods to detect microbial ingress, rather than expert interpretation of images or other subjective assessments.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method, as the sterility maintenance testing would involve objective laboratory assessments (e.g., growth or no-growth in culture media) rather than subjective expert review needing 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. The device is a sterilization wrap, not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI assistance are irrelevant to its evaluation.

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

This is not applicable for the same reasons as #5. The device is a physical product, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for sterility maintenance testing would be based on microbiological assay results (i.e., sterility testing). If a wrapped package is challenged and subsequently tested for the presence of viable microorganisms, the absence of growth would indicate sterility was maintained. This is a direct, objective measure of the device's primary function in this context. Other aspects like biocompatibility (ISO 10993) would use endpoints specified by that standard.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product and does not involve AI or machine learning models that require a "training set."

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

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

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KIMGUARD ONE-STEP* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider in the Amsco V-PRO 1 Low Temperature Sterilization System's Cycle or the Amsco V-PRO 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PRO 1 Cycle) and Non Lumen Cycles. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened. The wrap was validated to be effectively aerated during the pre-programmed V-PRO 1 and V-PRO 1 Plus Sterilization Cycles.

The KIMGUARD ONE-STEP* Sterilization Wrap is identical to the predicate in intended use, design, materials, and performance. The KIMGUARD ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap ultrasonically seamed on two sides. This allows for convenient wrapping with two sheets simultaneously. The sheets of sterilization wrap are square or rectangular fabric produced using a polypropylene three-layer SMS (spunbondmeltblown-spunbond) process.

The provided text describes the acceptance criteria and the summary of testing for the KIMGUARD ONE-STEP* Sterilization Wrap.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document describes a "Summary of Testing" that was conducted to demonstrate the performance of the KIMGUARD ONE-STEP* Sterilization Wrap.

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

• Test Set (General): The document states that testing included "biocompatibility in compliance with the methods of ISO 10993, sterilant penetration, and physical integrity." It indicates that "All results of testing met acceptance criteria." However, specific sample sizes for these tests are not provided.
• Test Set (Sterility Maintenance): The table detailing "Wrap Model Recommendations" describes specific test loads used in the "Sterility Maintenance Validation Study". These loads represent a sample set for evaluating the ability of each wrap model to maintain sterility. For instance:
  • KC100: 3 lbs metal mass, 6 forceps
  • KC200: 2.5 lbs metal mass, 6 forceps, V-PRO tray (17" x 10" x 3½") at 4 lbs
  • All other models had similar specified loads (e.g., 5 lbs metal mass, 6 forceps, specific V-PRO tray sizes).
• Data Provenance: The document does not specify the country of origin of the data. It is a 510(k) submission to the FDA for a device manufactured by Kimberly-Clark Corporation, which suggests the testing was likely conducted in accordance with US regulatory requirements or international standards recognized by the US. The testing appears to be prospective as it was conducted to support the 510(k) submission for the additional indication for use.

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 tests described (biocompatibility, sterilant penetration, physical integrity, sterility maintenance) are laboratory-based performance tests, not clinical studies requiring expert interpretation of results in the same way, for example, a diagnostic imaging AI would. The "ground truth" for these tests would typically be established by validated scientific methods and measurements rather than expert consensus on subjective evaluations.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided in the document. The described tests are objective laboratory measurements, not subjective evaluations requiring adjudication by multiple experts.

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-assisted diagnostic tool or an imaging device involving human readers or AI. Therefore, no MRMC comparative effectiveness study was performed.

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

This is not applicable. The device is a physical product (sterilization wrap), not an algorithm or AI system.

7. The type of ground truth used:

The ground truth for the tests described is based on:

• Objective Laboratory Measurements: For biocompatibility (ISO 10993), sterilant penetration, and physical integrity, the ground truth is established through standardized laboratory procedures and measurement techniques as defined by relevant industry standards and guidance documents.
• Performance Validation based on Controlled Conditions: For sterility maintenance, the ground truth is established by demonstrating the wrap's ability to maintain sterility of specific, validated test loads for a defined period (up to 30 days) under standard conditions. This involves microbiology testing to confirm the absence of viable microorganisms.

8. The sample size for the training set:

This is not applicable. The device is a physical product, not a machine learning model or AI, and therefore does not have a "training set" in the context of AI development. The document refers to "testing" and "validation studies" for product performance.

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

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

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The KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap is 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. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened. The KC300 Model ONE-STEP* wrap was validated for dry times for pre-vacuum steam sterilization of 30 minutes.

KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization.

The KC 300 Model KIMGUARD ONE-STEP* Sterilization Wrap was previously cleared for use in K082177 for use with an ethylene oxide sterilization method of 100% ethylene oxide (EtO) with a concentration of 725-735 mg/L at 131°F/ 55°C and 40% - 80% relative humidity for 60 minutes.

The KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap is identical to the predicate KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap in K082177 in design, materials, and intended use (the intended use is being expanded in this 510(k) notification to include pre-vacuum steam sterilization in addition to the previously cleared indication for use with ethylene oxide sterilization). The KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap ultrasonically seamed on two sides. This allows for convenient wrapping with two sheets simultaneously. The sheets of sterilization wrap are square or rectangular fabric produced using a polypropylene three-layer SMS (spunbondmeltblown-spunbond) process.

The KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap was tested for biocompatibility (irritation and sensitization), sterilant penetration, dry time, and physical integrity based on the applicable requirements recommended in the Draft Guidance for Industry and FDA titled "Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities" (March 7, 2002).

All reported results met the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for Test Set:

The specific sample sizes for each test mentioned (biocompatibility, sterilant penetration, dry time, physical integrity) are not detailed in the provided text. The data provenance is also not explicitly stated, but it can be inferred that these studies were conducted internally or by a contracted laboratory by Kimberly-Clark Health Care as part of their 510(k) submission to the FDA in the USA. The studies are retrospective as they were conducted to support a premarket notification.

3. Number of Experts and Qualifications for Ground Truth:

This section is not applicable as the described tests for a sterilization wrap do not typically involve human expert interpretation of results to establish ground truth in the same way as, for example, image analysis or disease diagnosis. The evaluation of test results (e.g., bacterial growth, physical integrity, moisture levels) is based on objective measurements against established scientific and regulatory standards.

4. Adjudication Method for Test Set:

Not applicable for this type of device and testing. The tests are laboratory-based and assessed against pre-defined scientific criteria rather than requiring adjudication of subjective interpretations.

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

Not applicable. This type of study involves human readers interpreting cases, often with AI assistance, and is relevant for diagnostic or interpretive medical devices. The Kimberly-Clark ONE-STEP* Sterilization Wrap is a sterile barrier system and its performance is evaluated through laboratory and physical tests, not through human reader interpretation.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This device is a physical product (sterilization wrap), not an algorithm or software. Its performance is inherent in its material properties and design, tested through physical and biological challenges.

7. Type of Ground Truth Used:

The ground truth for the performance of the sterilization wrap is established through objective laboratory measurements and scientific standards as outlined in the "Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002)" and ISO 10993 for biocompatibility.

• Biocompatibility: Absence of irritation and sensitization as per ISO 10993 standards.
• Sterilant Penetration: Successful sterilization of enclosed devices, typically evidenced by biological indicator (e.g., spore strip) conversion or chemical indicator changes.
• Dry Time: Achievement of specified dry times without residual moisture.
• Physical Integrity/Sterility Maintenance: Absence of microbial ingress into the wrapped package for a specified duration (e.g., 30 days), determined through microbial challenge tests and physical assessments of the barrier properties.

8. Sample Size for the Training Set:

Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.

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

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

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KIMGUARD ONE-STEP* Sterilization Wrap is 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 or by 100% ethylene oxide (EtO) 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 also to maintain sterility of the enclosed device(s) until opened. The wrap was validated for aeration times for EO sterilization of 8 hours at 55 °C or 12 hours at 43.3 °C. The wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100 and 200, and for 30 minutes for Models 400, 500, and 600.

KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization.

The KC300 Model KIMGUARD ONE-STEP Sterilization Wrap is not indicated for use for pre-vacuum steam sterilization.

See Wrap Model Recommendations on Page 3.

The KIMGUARD ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap ultrasonically seamed on two sides. This allows for convenient wrapping with two sheets simultaneously. The sheets of sterilization wrap are square or rectangular fabric produced using a polypropylene three-layer SMS (spunbond-meltblown-spunbond) process.

Here's a breakdown of the acceptance criteria and study information for the KIMGUARD ONE-STEP* Sterilization Wrap, based on the provided text:

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 explicitly state the numerical "sample size" for a dedicated "test set" in the context of typical AI/software validation. Instead, it describes various performance tests.

• Sample Size for Sterility Maintenance Validation: The document details the specific items and their weights used for each model in the sterility maintenance validation study (e.g., KC100: 16 huck towels weighing 3 lbs, KC400: 4 tray liners + 11 lbs of metal mass). This implies a certain number of packages and contents were prepared and tested for each model.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of medical device testing for regulatory submission, these are almost certainly prospective laboratory and/or simulated use studies conducted in a controlled environment, likely within the United States or a country adhering to similar regulatory standards.

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 primarily focused on the physical and functional performance of the sterilization wrap itself, not on interpretation by human experts.

4. Adjudication Method for the Test Set:

This information is not provided as the testing primarily involves objective measurements of material properties, sterilization efficacy, and sterility maintenance, rather than subjective assessments requiring expert 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. The KIMGUARD ONE-STEP* Sterilization Wrap is a physical medical device (sterilization wrap), not an AI algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be relevant.

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.

7. The type of ground truth used:

The "ground truth" for the various tests would be based on:

• Physical and Chemical Standards: For biocompatibility (ISO 10993), sterilant penetration, dry time, and physical integrity, the ground truth is established by validated laboratory assays and adherence to specified performance thresholds and industry standards (e.g., absence of irritation/sensitization, successful sterilant penetration, specified dry times, maintaining physical integrity).
• Microbiological Standards: For sterility maintenance, the ground truth is the absence of microbial growth in the packaged contents after the specified sterilization process and storage period, assessed using standard microbiological testing methods.
• Pre-defined Parameters: For sterilization cycle parameters (temperature, time, concentration, humidity) and aeration/dry times, the ground truth is whether the device performed effectively within those pre-defined parameters.

8. The sample size for the training set:

This is not applicable. As a physical medical device, there is no "training set" in the context of an AI algorithm. The device's performance is established through direct physical, chemical, and microbiological testing.

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

This is not applicable for the reasons stated in point 8.

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