(85 days)
The KC300 Model 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. 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 KC300 Model ONE-STEP* wrap was validated for dry times for pre-vacuum steam sterilization of 30 minutes.
KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization.
The KC 300 Model KIMGUARD ONE-STEP* Sterilization Wrap was previously cleared for use in K082177 for use with an ethylene oxide sterilization method of 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 KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap is identical to the predicate KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap in K082177 in design, materials, and intended use (the intended use is being expanded in this 510(k) notification to include pre-vacuum steam sterilization in addition to the previously cleared indication for use with ethylene oxide sterilization). The KC300 Model 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 (spunbondmeltblown-spunbond) process.
The KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap was tested for biocompatibility (irritation and sensitization), sterilant penetration, dry time, and physical integrity based on the applicable requirements recommended in the Draft Guidance for Industry and FDA titled "Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities" (March 7, 2002).
All reported results met the acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility (Irritation) | Compliant with ISO 10993 methods | Met acceptance criteria |
| Biocompatibility (Sensitization) | Compliant with ISO 10993 methods | Met acceptance criteria |
| Sterilant Penetration | Not explicitly stated, but implies effective penetration for sterilization | Met acceptance criteria |
| Dry Time (Pre-Vacuum Steam) | Validated for 30 minutes | Met acceptance criteria (validated for 30 minutes) |
| Physical Integrity | Ability to maintain sterility of pack contents for up to 30 days under standard conditions | Met acceptance criteria |
2. Sample Size and Data Provenance for Test Set:
The specific sample sizes for each test mentioned (biocompatibility, sterilant penetration, dry time, physical integrity) are not detailed in the provided text. The data provenance is also not explicitly stated, but it can be inferred that these studies were conducted internally or by a contracted laboratory by Kimberly-Clark Health Care as part of their 510(k) submission to the FDA in the USA. The studies are retrospective as they were conducted to support a premarket notification.
3. Number of Experts and Qualifications for Ground Truth:
This section is not applicable as the described tests for a sterilization wrap do not typically involve human expert interpretation of results to establish ground truth in the same way as, for example, image analysis or disease diagnosis. The evaluation of test results (e.g., bacterial growth, physical integrity, moisture levels) is based on objective measurements against established scientific and regulatory standards.
4. Adjudication Method for Test Set:
Not applicable for this type of device and testing. The tests are laboratory-based and assessed against pre-defined scientific criteria rather than requiring adjudication of subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study involves human readers interpreting cases, often with AI assistance, and is relevant for diagnostic or interpretive medical devices. The Kimberly-Clark ONE-STEP* Sterilization Wrap is a sterile barrier system and its performance is evaluated through laboratory and physical tests, not through human reader interpretation.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This device is a physical product (sterilization wrap), not an algorithm or software. Its performance is inherent in its material properties and design, tested through physical and biological challenges.
7. Type of Ground Truth Used:
The ground truth for the performance of the sterilization wrap is established through objective laboratory measurements and scientific standards as outlined in the "Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002)" and ISO 10993 for biocompatibility.
- Biocompatibility: Absence of irritation and sensitization as per ISO 10993 standards.
- Sterilant Penetration: Successful sterilization of enclosed devices, typically evidenced by biological indicator (e.g., spore strip) conversion or chemical indicator changes.
- Dry Time: Achievement of specified dry times without residual moisture.
- Physical Integrity/Sterility Maintenance: Absence of microbial ingress into the wrapped package for a specified duration (e.g., 30 days), determined through microbial challenge tests and physical assessments of the barrier properties.
8. Sample Size for the Training Set:
Not applicable. This device is a physical product, not an AI/ML algorithm 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).