(269 days)
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.
| Acceptance Criteria (Sterility Maintenance Duration) | Reported Device Performance |
|---|---|
| Pre-Vacuum Steam Sterilization | |
| KC100 and KC200 Models: At least 30 days | At least 30 days |
| KC300, KC400, KC500, KC600 Models: At least 1 year | At least 1 year |
| EO Sterilization | |
| KC100 and KC200 Models: At least 30 days | At least 30 days |
| KC300, KC400, KC500, KC600 Models: At least 1 year | At least 1 year |
| V-PRO Cycles | |
| All Models (KC100-KC600): At least 30 days | At least 30 days |
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.
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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
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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.
§ 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).