(238 days)
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:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance (as stated in the document) |
|---|---|---|
| Intended Use Parameters | Sterilization Method: Pre-vacuum steam at 270°F/132°C for 4 minutes OR 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. | |
| Function: Enclose medical device for sterilization and maintain sterility until opened. | ||
| Aeration Times (EtO): 8 hours at 55°C OR 12 hours at 43.3°C. | ||
| Dry Times (Pre-vacuum Steam): 20 minutes for Models 100 and 200; 30 minutes for Models 400, 500, and 600. | ||
| Exclusion: Not indicated for gravity steam sterilization. | ||
| KC300 Exclusion: Not indicated for pre-vacuum steam sterilization. | "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." (Implies meeting these specific criteria). | |
| Biocompatibility | Compliance with ISO 10993 methods (irritation and sensitization). | "Testing included biocompatibility (i.e., irritation and sensitization) in compliance with the methods of ISO 10993." "All results of testing met acceptance criteria." |
| Physical Integrity | "Testing included...physical integrity." "All results of testing met acceptance criteria." | |
| Sterility Maintenance | Ability to maintain sterility of pack contents after sterilization for up to 30 days under standard conditions. Defined content weights for each model (KC100: 3 lbs, KC200: 6 lbs, KC300: 9 lbs for EO, KC400: 13 lbs, KC500: 17 lbs, KC600: 25 lbs). | "The Wrap has also been tested for the ability to maintain sterility of pack contents after sterilization for up to 30 days under standard conditions." "All results of testing met acceptance criteria." The table "Wrap Model Recommendations" (Page 2/6) explicitly lists the maximum wrapped package content weights used in the sterility maintenance validation study. |
| Sterilant Penetration | "Testing included...sterilant penetration." "All results of testing met acceptance criteria." | |
| Dry Time | (Duplicated with Intended Use - Included for completeness) | (Duplicated with Intended Use - Included for completeness) |
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.
§ 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).