(183 days)
This Premarket Notification is to expand the Indications for Use for the STERRAD 50 Sterilizer (K981625) and the STERRAD 100S Sterilizer (K991999) to include titanium as a compatible material and to expand the lumen sizes to include medical devices with only a single stainless steel lumen in the following configurations:
- An inside diameter of 1 mm or larger and a length of 125 mm or shorter
- An inside diameter of 2 mm or larger and a length of 250 mm or shorter .
The validation testing for these two new lumen sizes was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.
For information pertaining to previously cleared materials and lumen sizes, please reference K981625 and K991999.
The STERRAD® 50 & 100S Sterilizers are self-contained stand-alone systems of hardware and software designed to sterilize medical instruments and devices using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into the vaporizer bowl where the solution is heated and transformed into a vapor, introducing the vapor into the process chamber under negative pressure and transforming the vapor into a gas plasma with radio frequency (RF) electrical energy.
The equipment (hardware and software) for the STERRAD® 50 & 100S Sterilizers is the same as that of the predicate devices. The hardware consists of a sterilization chamber onto which is mounted a variety of instruments and components, housed in a covered frame. The system also uses accessories such as disposable sterilant cassettes, reusable instrument trays, printer paper and ink cartridges.
Here's a breakdown of the acceptance criteria and the studies conducted for the STERRAD® 50 and STERRAD® 100S Sterilization Systems, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Goal) | Reported Device Performance (STERRAD® 50 & 100S) |
|---|---|
| Sterilizing medical devices with titanium surfaces | Achieved a Sterility Assurance Level (SAL) of at least 10^-6 for medical device surface sterilization in the complete sterilization process. |
| Sterilizing stainless steel lumens: | |
| - 1 mm inside diameter (ID) or larger and 125 mm or shorter | Achieved an SAL of 10^-6 in a full sterilization cycle. SLRs for simulated use (unwashed/washed) were 6.1/6.0 (STERRAD 50) and 6.1/6.2 (STERRAD 100S). |
| - 2 mm inside diameter (ID) or larger and 250 mm or shorter | Achieved an SAL of 10^-6 in a full sterilization cycle. SLRs for simulated use (unwashed/washed) were 6.9/6.9 (STERRAD 50) and 7.0/6.9 (STERRAD 100S). |
| Sterilizing lumens in Tyvek-Mylar pouches | Achieved an SAL of 10^-6 in a full sterilization cycle for stainless steel lumens (1 mm ID x 125 mm long and 2 mm ID x 250 mm long) packaged in STERRAD Sterilization pouches, validating the use of these pouches. |
| Sterilization efficacy with organic/inorganic challenge (simulated use) | The process was not affected by the presence of an organic and inorganic challenge, as indicated by the achieved SALs and SLR (Sterility Log Reduction) values (e.g., SLR 6.1 to 7.0 across various lumen sizes and conditions, demonstrating effective sterilization even with soil). |
The In-Use testing demonstrated that the STERRAD® 50 and 100S Sterilization Systems were effective sterilizers of stainless steel lumen devices. |
| No cytotoxicity or toxic residuals on processed materials | Cytotoxicity test results indicated that titanium materials processed did not induce in vitro cytotoxicity. Residues testing showed no toxic sterilant residuals. |
Note: SAL of 10^-6 means there is a one in a million chance of a non-sterile unit. SLR values of 6.0 or higher indicate a 6-log reduction in microbial population, which is a common standard for sterilization.
2. Sample Size and Data Provenance
- Test Set Sample Sizes:
- Titanium Surface Sterilization: Not explicitly stated, but performed with "titanium materials representative of the materials commonly used in re-usable medical devices."
- Lumen Sterilization: Not explicitly stated, but for the validation loads, a "maximum of 10 lumens per load" was used for the 1mm x 125mm and 2mm x 250mm lumens. The half-cycle validation tests used sufficient materials to demonstrate the SAL.
- Tyvek-Mylar Pouched Device Sterilization: Not explicitly stated, but conducted with 1mm x 125mm and 2mm x 250mm stainless steel lumens in pouches.
- Simulated Use Testing: Not explicitly stated how many devices, but used "devices representative of lumen claims."
- In-Use Sterility Testing: Not explicitly stated how many devices, but used "Devices representative of lumen claims for the STERRAD® 50 Sterilization System" that were "used in routine surgeries at local hospitals."
- Data Provenance: Retrospective and prospective. The In-Use Sterility Testing involved devices "used in routine surgeries at local hospitals," suggesting data collected from real-world usage scenarios (retrospective element) which were then transported for prospective testing with the STERRAD systems. The other validation testing appears to be prospectively designed lab studies. No specific country of origin is mentioned beyond "local hospitals" for the in-use testing, implying a US-based context given the FDA submission.
3. Number of Experts and Qualifications for Ground Truth
- This information is not provided in the summary. The ground truth for sterilization is typically established through microbiological testing (e.g., demonstrating the death of a highly resistant test organism), rather than expert interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set
- This information is not applicable as the studies are primarily microbiological challenge tests for sterilization efficacy, not human interpretation tasks requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was mentioned or performed. The device is a sterilizer, meaning its performance is assessed by its ability to render medical devices sterile, not by human interpretation or diagnosis. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this type of device.
6. Standalone Performance Study
- Yes, standalone performance studies were done. All the validation tests described (Surface Sterilization, Lumen Sterilization, Tyvek-Mylar Pouched Device Sterilization, Simulated Use Testing, In-Use Sterility Testing, Toxicity Testing) are assessing the algorithm/system-only performance of the STERRAD® 50 and 100S sterilizers without human intervention in the sterilization process itself. The "overkill" approach used in the validation testing directly assesses the system's ability to achieve a robust sterility assurance level.
7. Type of Ground Truth Used
- The primary ground truth used is microbiological evidence of sterility, specifically:
- Inactivation of B. stearothermophilus endospores: This is a highly resistant bacterial spore used as a biological indicator to challenge sterilization processes. Its inactivation to a specific Sterility Assurance Level (SAL) (e.g., 10^-6) or log reduction (e.g., 6-log reduction) serves as the ground truth for effective sterilization.
- Sterility Assessment: Direct assessment of the absence of viable microorganisms after processing.
- Toxicity testing: Used to establish ground truth that no cytotoxic effects or toxic residuals remain.
8. Sample Size for the Training Set
- This information is not applicable. The STERRAD® Sterilization System is a physical-chemical sterilization device, not an AI/ML algorithm that is "trained" on data in the traditional sense. Its operation is based on pre-defined scientific principles of hydrogen peroxide gas plasma sterilization, not on learning from a dataset.
9. How Ground Truth for the Training Set Was Established
- This information is not applicable for the reasons stated above. The system's "operating parameters" or "settings" are developed through scientific and engineering principles, not through a "training set" with established ground truth. The validation studies described in the summary are designed to prove the device meets performance criteria, not to train it.
§ 880.6860 Ethylene oxide gas sterilizer.
(a)
Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.(b)
Classification. Class II (performance standards).