(148 days)
The Perpak™ Sterilization Tyvek Pouch is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the LOWTEM Crystal 120 Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.
The Perpak™ Sterilization Tyyek Pouch is intended to be used to contain medical devices to be terminally sterilized in the LOWTEM Crystal 120 Sterilization System. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the LOWTEM Crystal 120 Sterilization System. After completion of the sterilization process, the Pouch/Roll maintains sterility of the enclosed medical devices until the seal is opened up to 3 years post sterilization.
The device in question is a Perpak™ Sterilization Tyvek Pouch. The document describes several performance tests that demonstrate the device meets its acceptance criteria.
The following information is presented:
1. A table of acceptance criteria and the reported device performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM F 1929; ISO 11607-1 | Dye penetration Test (Seal Integrity Test) | No leaks | Pass |
| ASTM F88/F88M; ISO 11607-1 | Seal Peel Test | > 0.6kg.f | Pass |
| ASTM F 2251 | Thickness Variations | Film: 70 ± 10 µm (0.07 ± 0.01mm) | |
| Tyvek: 89~282 µm (0.089 ~ 0.282 mm) | Pass | ||
| ASTM D 503 | Tensile strength of Tyvek® | Tensile strength: Spec > 117 N | |
| Elongation: Spec > 10% | Pass | ||
| ASTM D882 | Tensile strength of plastic film | 1) Spec > 300 kg.f/cm² |
- Elongation: Spec > 50 % | Pass |
| ASTM F1140 | Burst Strength | > 1kg.f/ cm² | Pass |
| ASTM D1922 | Tear Resistance of Tyvek | MD: Spec > 3,400m N
TD: Spec > 2,000mN | Pass |
| ASTM D1922 | Tear Resistance of plastic film | MD: Spec > 260m N
TD: Spec > 170mN | Pass |
| ASTM F1608 | Microbial Barrier | Log Reduction Value ≥4, ≥99.99% | Pass |
| Sterilant penetration test | Sterilant penetration test of the Perpak Sterilization Tyvek Pouch, Roll using the half-cycle validation of the LOWTEM Crystal 120 Sterilizer | All Negative | Pass |
| Microbial Barrier, Packaging Integrity | Microbial Barrier, Packaging Integrity performance of the Perpak Sterilization Tyvek Pouch, Roll | All processed Cycle tapes, CI strips and SCBI exhibited complete color change and all processed SCBIs were negative for growth. | Pass |
| Sterility test | Sterility test for medical devices packaged with KM Perpak pouch-LOWTEM | Medical devices packaged in KM Perpak TM sterilization pouches after LOWTEM Crystal 120 sterilization cycle have been verified to maintain the sterility (up to 3 years post sterilization, as per indications for use). | Pass |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the exact sample sizes used for each test. However, it indicates tests were conducted on "unaged and aged (3 years accelerated aging) devices, before and after sterilization". The data provenance is not specified, but the applicant, KM Corp., is based in the Republic of Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests performed are laboratory-based physical and microbiological tests with objective criteria, rather than subjective assessments by human experts.
4. Adjudication method for the test set:
Not applicable, as the tests are objective and based on established industry standards and predefined acceptance criteria.
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 device is a sterilization pouch and not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical product, not an algorithm. The performance tests are for the physical integrity and function of the pouch.
7. The type of ground truth used:
The ground truth for these tests is based on established industry standards (e.g., ASTM, ISO standards) and predefined scientific/engineering criteria for physical properties (e.g., tensile strength, burst strength, thickness variation), seal integrity (dye penetration), microbial barrier efficacy (log reduction value), sterilant penetration, and sterility maintenance. For the sterilant penetration and microbial barrier/packaging integrity tests, the ground truth is based on objective indicators like "All Negative" growth or "complete color change" of indicators.
8. The sample size for the training set:
Not applicable. This device is a physical product, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 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).