(94 days)
KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to enclose another medical device that is to be sterilized by a healthcare provider using:
- Gravity Steam at 250°F/121°C for 30 minutes. .
KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the KIMGUARD ONE-STEP Sterilization Wrap:
Acceptance Criteria and Device Performance for KIMGUARD® ONE-STEP® Sterilization Wrap
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Sterilization Efficacy (Gravity Steam) | Passed |
| Sterilant Penetration | Passed |
| Package Integrity/Physical Properties | Passed |
| Drying and Aeration | Passed |
| Maintenance of Package Integrity | Passed |
| Biocompatibility (pre- and post-sterilization) | Passed |
| Maintenance of Package Sterility (Duration) | 30 days |
Note: The document states that "All results of testing met the same acceptance criteria as the predicate devices demonstrating substantial equivalence to the predicate devices." While specific, numerical acceptance criteria are not explicitly detailed (e.g., minimum tensile strength), the "Passed" designation for each category indicates successful fulfillment of the established criteria, which are identical to those of the predicate devices (K082177 and K091685). The specific loads and weights for each wrap model also represent acceptance criteria for their respective uses.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample size used for the test sets (e.g., how many wraps were tested for sterilant penetration). However, it lists the types of loads used in the "Sterility Maintenance Validation Study" for each wrap model:
- KC100: 1 tray liner 20" x 25", 12.5" x 9" x 1" Tray, 1 lb of metal mass
- KC200: 1 tray liner 20" x 25", 10" x 20" x 3 ½ Tray, 3 lbs of metal mass
- KC300: 1 tray liner 20" x 25", 10" x 20" x 3 ½Tray, 6 lbs of metal mass
- KC400: 1 tray liner 20" x 25", 10" x 20" x 3 ½ Tray, 10 lbs of metal mass
- KC500: 1 tray liner 20" x 25", 11" x 22" x 3 ½Tray, 12 lbs of metal mass
- KC600: 1 tray liner 20" x 25", 11" x 22" x 3 ½Tray, 20 lbs of metal mass
The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective. It is implied to be prospective testing conducted for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests described are nonclinical, laboratory-based performance tests rather than studies requiring human expert interpretation for ground truth establishment.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable as the tests are nonclinical performance evaluations rather than interpretive studies requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not conducted. This type of study is typically for evaluating diagnostic or interpretive AI systems, not packaging materials.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical sterilization wrap, not an algorithm or AI system. The performance evaluation is inherently "standalone" in the sense that it assesses the physical product's characteristics and functionality.
7. The Type of Ground Truth Used
The ground truth for the nonclinical tests appears to be established scientific and regulatory standards/methods for sterilization packaging performance. This would include methods for assessing sterilant penetration, package integrity (e.g., burst strength, seal integrity), drying, aeration, and maintenance of sterility (e.g., microbial barrier testing). The "results of testing met the same acceptance criteria as the predicate devices," implying a comparison against established performance benchmarks for similar products.
8. The Sample Size for the Training Set
This is not applicable. The KIMGUARD ONE-STEP Sterilization Wrap is a physical medical device, not an AI or Machine Learning algorithm that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above.
§ 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).