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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 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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