(52 days)
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 STERRAD® NX® [Standard Cvcle. Advanced Cvcle] STERRAD® 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO 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.
Test results validated that KIMGUARD* ONE-STEP* Sterilization Wraps (KC300, KC400, KC500, and KC600) allowed sterilization of the enclosed devices by the Advanced Sterilization Products STERRAD® Sterilization Systems (STERRAD® 50, 100S, 200, NX® [Standard Cycle and Advanced Cycle] and 100NX® [Standard Cycle, EXPRESS Cycle, DUO Cycle]).
The KIMGUARD* ONE-STEP* Sterilization Wrap (Models KC300, KC400, K500, KC600) have been validated for use with the STERRAD® 50, STERRAD® 100S, STERRAD® 200, STERRAD® NX® and STERRAD® 100NX® cycles in Table 1.
KIMGUARD* ONE-STEP* Sterilization Wrap Recommendations for Use with the Advanced Sterilization Products STERRAD® Sterilization Systems are provided in Table 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 rectangular fabric produced using a threelayer SMS (spunbond-meltblown-spunbond) 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 acceptance criteria are that the KIMGUARD® ONE-STEP® Sterilization Wrap maintains sterility until used, after being sterilized by the referenced STERRAD® Sterilization Systems.
Here's the summary of the study:
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintenance of 180-Day Package Integrity | Passed |
| Allow sterilization of enclosed devices | Passed with all specified STERRAD® systems and cycles |
| Maintain sterility of enclosed devices until used | Passed |
2. Sample Size and Data Provenance for Test Set:
The document does not explicitly state the specific sample sizes for each test in the test set. It mentions "Test results validated" and "Performance testing was conducted," implying a test set was used. The data provenance is not specified (e.g., country of origin). It's a nonclinical study, so it wouldn't be retrospective or prospective in the human study sense.
3. Number of Experts and Qualifications for Ground Truth of Test Set:
This information is not provided in the document. As this is a non-clinical device (sterilization wrap), it's unlikely that "experts" in the medical sense (like radiologists) were used to establish ground truth for performance tests like package integrity or sterilization efficacy. Ground truth would be based on validated scientific and engineering testing protocols.
4. Adjudication Method for the Test Set:
The document does not mention an adjudication method. For non-clinical performance tests, adjudication (e.g., 2+1, 3+1 for human readers) is typically not applicable. The results are usually objectively measured against predefined pass/fail criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or evaluative devices where human interpretation is involved. This device is a sterilization wrap, and its effectiveness is determined by objective physical and biological tests.
6. Standalone Performance:
Yes, a standalone (algorithm only without human-in-the-loop performance) study was done, as this is a physical product being tested for its intrinsic performance (package integrity, ability to allow sterilization). The study involved "Performance testing" and "nonclinical tests" as described.
7. Type of Ground Truth Used:
The ground truth used for these tests would be based on:
- Standardized microbiological testing (to confirm sterilization efficacy and sterility maintenance).
- Physical integrity testing methods (to assess package integrity).
- Chemical indicators or biological indicators (for sterilization effectiveness).
- The tests adhere to established standards and protocols for sterilization validation and sterile barrier system performance.
8. Sample Size for the Training Set:
The concept of a "training set" is not applicable here as this is a physical device being evaluated for its performance through testing, not an AI/algorithm being trained on data.
9. How the Ground Truth for the Training Set Was Established:
As mentioned in point 8, the concept of a "training set" is not applicable to this type of device and study.
§ 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).