(240 days)
KIMGUARD* 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 or by 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 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 EtO sterilization of 8 hours at 55 ℃ or 12 hours at 43.3 ℃. The wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100, 200, and 300 and for dry times of 30 minutes for Models 400, 500, and 600.
KIMGUARD* Sterilization Wrap is not indicated for use for gravity steam sterilization.
The sheets of sterilization wrap are square or rectangular fabric produced using a polypropylene three-layer SMS (spunbond-meltblown-spunbond) process.
The KIMGUARD* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600) underwent testing to demonstrate substantial equivalence to predicate devices and adherence to performance standards. The study primarily focused on the physical and functional aspects of the sterilization wrap.
1. Table of Acceptance Criteria and Reported Device Performance
The provided information indicates that "All results of testing met acceptance criteria." While specific numerical acceptance criteria are not explicitly detailed for each test, the general acceptance is that the device should function effectively as a sterilization wrap, allowing sterilization, maintaining sterility, and demonstrating appropriate physical integrity and biocompatibility.
| Test Category | Acceptance Criteria (Explicitly stated or inferred) | Reported Device Performance |
|---|---|---|
| Intended Use | To enclose a medical device for sterilization by pre-vacuum steam (270°F/132°C for 4 min) or 100% ethylene oxide (EtO, 725-735 mg/L at 131°F/55°C & 40-80% RH for 60 min). To allow sterilization and maintain sterility until opened. Validated aeration for EtO: 8 hours at 55°C or 12 hours at 43.3°C. Validated dry times for pre-vacuum steam: 20 min for KC100, KC200, KC300; 30 min for KC400, KC500, KC600. Not for gravity steam sterilization. | Device meets all stated intended use parameters, including sterilization methods, maintenance of sterility, and specific aeration and dry times. The wrap is not indicated for gravity steam sterilization, aligning with its intended use. |
| Biocompatibility | Compliance with ISO 10993 methods for irritation and sensitization. (Inferred: No adverse biological reactions upon contact). | Biocompatibility testing (irritation and sensitization) was conducted in compliance with ISO 10993, and all results met acceptance criteria. |
| Sterilant Penetration | (Inferred: Allows adequate penetration of sterilant to successfully sterilize enclosed device). | Testing for sterilant penetration was performed, and all results met acceptance criteria. |
| Dry Time | Specific validated dry times for pre-vacuum steam sterilization: 20 min for KC100, KC200, KC300; 30 min for KC400, KC500, KC600. | Testing for dry time was performed, and all results met acceptance criteria, confirming the validated dry times for each model. |
| Physical Integrity | (Inferred: The wrap maintains its structural integrity during and after sterilization, resisting tears, punctures, or other damage that would compromise sterility). Specific maximum wrapped package content weights for sterility maintenance validation: KC100 (3 lbs), KC200 (6 lbs), KC300 (9 lbs), KC400 (13 lbs), KC500 (17 lbs), KC600 (25 lbs). | Testing for physical integrity was performed, and all results met acceptance criteria. The wraps maintained sterility of pack contents for up to 30 days under standard conditions for the specified maximum package weights. |
| Sterility Maintenance | Ability to maintain sterility of pack contents after sterilization for up to 30 days under standard conditions. (Inferred: No microbial ingress). | The wrap has been tested for the ability to maintain sterility of pack contents after sterilization for up to 30 days under standard conditions, and all results met acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test set (biocompatibility, sterilant penetration, dry time, physical integrity, sterility maintenance). However, it does detail the maximum wrapped package content weights used in the sterility maintenance validation study for each wrap model, which implicitly defines the types and quantities of materials tested within the wraps.
- KC100: 3 lbs (16 huck towels)
- KC200: 6 lbs (2 huck towels, 2 fluid resistant U-drapes, 1 fluid resistant universal bar drape)
- KC300: 9 lbs (For Pre-Vacuum Steam: 15 huck towels, 1 small fluid resistant drape, 5 lbs of metal mass; For EtO: 16 huck towels, 2 fluid resistant large drapes, 1 fluid resistant small drape, 1 fluid resistant table cover)
- KC400: 13 lbs (4 tray liners, 10"x10"x3.5" tray with 11 lbs metal mass)
- KC500: 17 lbs (4 tray liners, 10"x10"x3.5" tray with 15 lbs metal mass)
- KC600: 25 lbs (4 tray liners, 10"x10"x3.5" tray with 23 lbs metal mass)
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective testing conducted by or for Kimberly-Clark Corporation according to regulatory guidance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study (sterilization wrap performance) does not typically involve human experts establishing a "ground truth" for a test set in the way an AI diagnostic device would. Instead, the "ground truth" is established by adherence to recognized scientific and regulatory standards and testing methodologies, such as those 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)" and ISO 10993 for biocompatibility. The "experts" in this context would be the skilled technicians, scientists, and engineers who conducted the laboratory tests and interpreted the results against established pass/fail criteria. Their specific qualifications are not detailed in the summary.
4. Adjudication Method for the Test Set
Not applicable. As described above, this study does not involve human interpretation or subjective assessment that would require an adjudication method like 2+1 or 3+1. The tests are objective and quantitative based on defined performance standards.
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 a study for a physical device (sterilization wrap), not an AI diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The ground truth used in this study is based on:
- Established Performance Standards: Adherence to the 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)."
- International Standards: Compliance with ISO 10993 for biocompatibility (irritation and sensitization).
- Functional Validation: Demonstrating effective sterilization, maintenance of sterility for a specified period (30 days), and specified dry times for steam sterilization, all of which are observable and measurable outcomes based on validated testing protocols.
- Physical Properties: Measurement of physical integrity (e.g., resistance to compromise).
These are objective, empirically verifiable criteria for the performance of a sterilization wrap.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 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).