(176 days)
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
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterilant Penetration | Passed |
| Material Compatibility/Biocompatibility (post-sterilization) | Passed |
| Performance Testing (Post-Sterilization) | Passed |
| Maintenance of Package Integrity (180 Days) | Passed |
| Allows sterilization of enclosed medical devices by Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (Lumen and Non-Lumen Cycles) | Test results validated that KIMGUARD ONE-STEP® Sterilization Wraps allowed sterilization of the enclosed devices by the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer. |
| Allows effective aeration under pre-programmed PSD-85 Sterilization Cycles | KIMGUARD ONE-STEP® Sterilization Wrap was validated to allow effective aeration under the pre-programmed PSD-85 Sterilization Cycles. |
| Maintenance of sterility until used | KIMGUARD* ONE-STEP* Sterilization Wrap is intended to allow sterilization and also maintain sterility of the enclosed device(s) until used. Real-time testing following sterilization using Sterilucent PSD-85 Hydrogen Peroxide Sterilizer supports maintenance of package sterility for 180 days. |
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.
§ 880.6850 Sterilization wrap.
(a)
Identification. 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 sterilized 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.(b)
Classification. Class II (performance standards).