(162 days)
KimGuard Smart-Fold* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by prevacuum steam at 270°F/132°C for 4 minutes or by 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 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 131°F/ 55°C or 12 hours at 110°F/ 43.3°C. The KimGuard Smart-Fold* Sterilization Wrap was validated for dry times for prevacuum steam sterilization of 20 minutes for Model KC250 and for dry times of 30 minutes for Models KC450, KC550 and KC650.
KimGuard Smart-Fold* Sterilization Wrap is comprised primarily of two pieces of KimGuard Sterilization Wrap fabric (the blue base layer and the white intermediate layer). The fabric is a nonwoven spunbondmeltblown-spunbond (SMS) fabric composed of a top (inner) layer of spunbond, a center laver of meltblown, and a bottom (outer) layer of spunbond. SMS nonwoven fabrics are composed of polypropylene and white titanium dioxide and phthalocyanine blue pigments. Two strips of blue SMS are adhesively bonded to the white SMS intermediate layer for added strength. The reinforcement strips also contain a "reference line" feature designed to indicate proper sterilization tray placement to the user. Adhesive tape strips with release liners are included to secure the inner layers of the package. Users remove the release liners and use these adhesive strips to secure the wrap prior to sterilization. The Smart-Fold product also incorporates handles and pulls tabs comprised of blue SMS material and adhesive branding labels for aseptic opening.
Here's an analysis of the provided text regarding the KimGuard Smart-Fold Sterilization Wrap, broken down by your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria alongside reported numerical device performance results for direct comparison. Instead, it states that "All test results met acceptance criteria." The acceptance criteria mentioned are qualitative and relate to the successful fulfillment of certain functional and safety requirements.
| Acceptance Criteria (Implied) | Reported (Met) Performance |
|---|---|
| Sterilant Penetration (Steam and EO) | Met |
| Maintain Sterility of Pack Contents (up to 30 days) | Met |
| Dry Time (Steam Sterilization - KC250: 20 min; KC450/KC550/KC650: 30 min) | Met |
| Aeration Time (EO Sterilization - 8 hours at 131°F/55°C or 12 hours at 110°F/43.3°C) | Met |
| Physical Integrity (post-sterilization) | Met |
| Biocompatibility (Irritation and Sensitization) | Met |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify an exact numerical sample size for each test conducted. It describes the "Maximum Wrapped Package Content Weights Used in Sterility Maintenance Validation Study" and "Descriptions of Loads Used in Sterility Maintenance Validation Study" for each wrap model, which indicate the types and maximum weights of items tested within the wraps.
- KC250: 6 lbs. (e.g., 2 huck towels, 2 fluid-resistant U-drapes, 1 fluid-resistant universal bar drape)
- KC450: 13 lbs. (e.g., 4 tray liners, 10x10x3.5 inch tray with 11 lbs. metal mass)
- KC550: 17 lbs. (e.g., 4 tray liners, 10x10x3.5 inch tray with 15 lbs. metal mass)
- KC650: 25 lbs. (e.g., 4 tray liners, 10x10x3.5 inch tray with 23 lbs. metal mass)
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to testing conducted "in compliance with the applicable requirements recommended in Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002)," suggesting it was conducted specifically for this submission, implying a prospective study design for regulatory approval.
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 testing described focuses on the physical and functional performance of the sterilization wrap itself, rather than diagnostic interpretation requiring expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided, as the tests described are objective measures of device performance (e.g., sterility maintenance, dry time, physical integrity) rather than subjective assessments that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a sterile barrier system, not a diagnostic imaging or screening tool that would involve human readers interpreting cases with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
Not applicable. This device is a physical product (sterilization wrap) and does not involve an algorithm. The performance described is its standalone function in maintaining sterility and allowing sterilization.
7. The Type of Ground Truth Used
The ground truth used for this device's testing is based on:
- Objective measurements of sterility: Demonstrated by the ability to prevent microbial ingress and maintain a sterile environment for a specified duration (up to 30 days).
- Physical and material property evaluations: Ensuring the wrap retains its integrity, permits sterilant penetration, and has appropriate dry/aeration times.
- Biocompatibility testing: Ensuring the materials are safe for patient contact.
These are established through standardized laboratory and performance testing methods relevant to sterilization wraps.
8. Sample Size for the Training Set
Not applicable. This device is a physical product and does not involve machine learning or AI, and therefore no "training set" is used.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set or machine learning algorithm is involved 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).