(162 days)
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
| Acceptance Criteria (Measured Performance) | Reported Device Performance (Results) |
|---|---|
| Maintain Sterility (for Pre-vacuum steam sterilization at 270°F / 132°C for 4 minutes with 20 minutes dry time) | Passed |
| Maintain Sterility (for 100% ethylene oxide (EO) at 725-735 mg/L, 131°F / 55°C, 40-80% RH for 60 minutes with 8 hours aeration at 43.3°C or 12 hours at 55°C) | Passed |
| Maintenance of 365-Day Package Integrity (sterility maintenance) | Passed |
| Ethylene Oxide Sterilant Penetration | Passed |
| Pre-Vacuum Steam Sterilant Penetration | Passed |
| Post Sterilization Biocompatibility Testing (Cytotoxicity, ISO 10993-5: 2009; Irritation, ISO 10993-10:2010; Sensitization, ISO 10993-10: 2010) | Passed |
| Maximum Wrapped Package Content Weights for KC100 (Very Light Weight Package) | Up to 3 lbs. (Tested with 16 huck towels (17"x 29")) |
| Maximum Wrapped Package Content Weights for KC200 (Light Weight Package) | Up to 6 lbs. (Tested with 2 huck towels (17"x 29"), 2 fluid resistant U-drapes (68"x 109"), 1 fluid resistant universal bar drape (70" x 108")) |
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.
§ 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).