(154 days)
The self-sealing sterilization pouches are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 100 - 120 minutes at 50 °C with a relative humidity between 60 - 85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch maintains the enclosed devices sterile up until one year post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.
The pouches are manufactured from a medical grade paper that is thermally sealed to a laminated film on the left, right, and bottom of pouch. The fourth side has an adhesive strip that is used to seal the paper to the film prior to sterilization of the enclosed medical device. The pouches contain external indicators used to indicate the pouches were processed via steam or EO sterilization.
The provided text describes the 510(k) summary for the Medicom Self Sealing – Sterilization Pouch. This device is a sterilization pouch with external chemical indicators, not an AI/ML-driven medical device for diagnosis or treatment. Therefore, the questions related to clinical studies, human readers, ground truth, and training sets for an AI/ML model are not applicable to this submission.
However, I can extract information related to the device's acceptance criteria and how its performance was evaluated for substantial equivalence.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Medicom Self Sealing Sterilization Pouch) |
|---|---|---|
| Material Compatibility | Equivalent to predicate (Winner® Self Seal pouch) | Demonstrated equivalence to predicate through side-by-side testing. |
| Sterility Maintenance | Maintains sterility up to one year post-sterilization. | Claimed to maintain sterility up to one year post-sterilization (based on the intended use statement). |
| Chemical Indicator Efficacy | Complies with ISO 11140-1:2005 for steam and EO indicators. | Demonstrated efficacy for indicating steam and EO sterilization processes. Substantial equivalence testing conducted against the predicate device. |
| Sterilant Penetration | Equivalent to predicate. | Demonstrated equivalence to predicate through side-by-side testing. |
| Drying Time | Equivalent to predicate. | Demonstrated equivalence to predicate through side-by-side testing. |
| Aeration | Equivalent to predicate. | Demonstrated equivalence to predicate through side-by-side testing. |
| Biocompatibility | Equivalent to predicate. | Demonstrated equivalence to predicate through side-by-side testing. |
| Package Integrity | Equivalent to predicate. | Demonstrated equivalence to predicate through side-by-side testing. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a "Comparison Testing" and "Substantial Equivalence" assessment against a legally marketed predicate device, the Winner® Self Seal Sterilization pouch (K051242), and relevant recognized standards, specifically ISO 11140-1:2005 for chemical indicators.
Non-Applicability for AI/ML Specific Questions:
The following questions are not applicable to this 510(k) submission as it concerns a physical medical device (sterilization pouch) and not an AI/ML diagnostic or therapeutic algorithm:
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" refers to physical samples of the device and predicate, not data for an AI/ML model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, in the context of AI/ML ground truth. For this device, "ground truth" would be the verified performance of the predicate device and compliance with established ISO standards for physical characteristics and chemical indicator performance.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
Summary of the Device Evaluation Approach:
The evaluation of the Medicom Self Sealing Sterilization Pouch for 510(k) clearance relied on demonstrating substantial equivalence to a predicate device. This was achieved through:
- Side-by-side testing: Comparing the new device directly with the predicate (Winner® Self Seal pouch) across several key performance parameters including:
- Sterilant Penetration
- Drying Time
- Aeration
- Biocompatibility
- Package Integrity
- Compliance with recognized standards: Specifically, the chemical indicators were evaluated against ISO 11140-1:2005 for efficacy.
- Material Compatibility: Shown to be equivalent to the predicate.
- Sterility Maintenance: The intended use statement claims sterility maintenance for up to one year, which would typically be supported by accelerated or real-time aging studies and microbiological challenge tests, the specifics of which are not detailed in this summary but are implicit requirements for such a claim.
The 510(k) summary indicates that these comparisons and compliance demonstrations were sufficient for the FDA to determine substantial equivalence and allow the device to be marketed.
§ 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).