(249 days)
The STERRAD® 50 Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. Because the cycle operates within a dry environment and at low temperatures, it is especially suitable for instruments sensitive to heat and moisture. (See list of recommended Materials in Section 3 of the Operator's Manual.)
The STERRAD® 50 Sterilizer can sterilize instruments which have diffusionrestricted spaces, such as the hinged portion of forceps and scissors.
Metal and nonmetal lumened instruments with inside diameters of 6 mm (¼ inch) or larger and lengths of 310 mm (12 inches) or shorter can be processed in the STERRAD® 50 Sterilizer. (See list of recommended Materials in Section 3 of the Operator's Manual.)
Additionally, medical devices with only a single stainless steel lumen which has an inside diameter of 3 mm (1/8 inch) or larger and a length of 400 mm (15 ¾ inches) or shorter can be processed in the STERRAD® 50 Sterilizer.
The STERRAD® 50 Sterilizer is a self-contained stand-alone system of hardware and software designed to sterilize certain medical instruments and devices, using a patented hydrogen peroxide gas plasma process. Sterilization is accomplished by injecting aqueous hydrogen peroxide into the vaporizer bowl where the solution is heated and transformed into a vapor, introducing this vapor into the process chamber under negative pressure and transforming the vapor into a gas plasma with RF electrical energy. The technology is particularly suited to the sterilization of heat and moisture sensitive instruments.
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, single-use biological and chemical indicators, printer paper and ink cartridges.
The sterilizer sits on a cart. The cart is designed for transportation of the sterilizer to its installation site, for mobility during servicing and as a structural support device.
Here's a breakdown of the acceptance criteria and study information for the STERRAD® 50 Sterilizer, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for a sterilizer are generally defined by achieving a certain Sterility Assurance Level (SAL), typically 10⁻⁶, meaning a 1 in a million chance of a non-sterile unit. The studies consistently aimed to demonstrate this SAL.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dose-Response Relationship (Hydrogen Peroxide) | Achieve SAL of 10⁻⁶ for various materials. | Achieved SAL of 10⁻⁶ for all materials tested with 360 µL or greater injection volume under half-cycle conditions. |
| Surface Sterilization (Medical Device Materials) | Achieve SAL of 10⁻⁶ for various substrate materials. | Achieved SAL of at least 10⁻⁶ for medical device surface sterilization with 720 µL and 1080 µL injection volumes under less than half-cycle conditions. |
| Mated Surfaces Sterilization | Achieve SAL of 10⁻⁶ for mated surfaces. | Achieved SAL of 10⁻⁶ for mated surface sterilization with no spore survivors observed under half-cycle conditions. |
| Lumen Sterilization | Achieve SAL of 10⁻⁶ for lumens (3 mm x 400 mm). | Achieved SAL of 10⁻⁶ for lumens with no spore survivors after half-cycle and modified Total-kill Endpoint tests. |
| Tyvek-Mylar Pouched Device Sterilization | Achieve SAL of 10⁻⁶ for pouched devices with lumens. | Achieved SAL of 10⁻⁶ with no spore survivors observed under half-cycle conditions for 3 mm x 400 mm stainless steel lumens in Tyvek-Mylar pouches. |
| Bacteriostasis Testing (Processed Carriers) | No bacteriostatic effect from processed carriers on B. stearothermophilus outgrowth. | No bacteriostatic effect indicated; all test carriers/materials demonstrated desired outgrowth within 14 days. |
| Sporicidal Microbiological Testing | Demonstrate sporicidal activity against B. subtilis and Clostridium sporogenes. | No growth observed on any carriers (silk suture loops, penicylinders) for B. subtilis and Clostridium sporogenes. |
| In-Use Sterility Testing | Successfully sterilize actual surgical instruments. | Successfully sterilized actual surgical instruments (open surfaces, mated/hinged surfaces, 3mm x 400mm lumens) from clinical use. |
| In-Use Bacteriostasis and Fungistasis Test | No bacteriostatic or fungistatic effects on processed instruments. | No bacteriostatic or fungistatic effects seen on stainless steel open, mated/hinged, and 3mm x 400mm lumened instruments when challenged with Cl. sporogenes, Candida albicans, or B. subtilis. |
| Simulated Use Testing (Organic/Inorganic Challenge) | Maintain effectiveness even with improper washing; achieve 6.1 log reduction with proper washing. | Sterilizer minimally affected by organic and inorganic challenge; effective at inactivating highly resistant spores in diffusion-restricted environments even without proper washing. Achieved 6.1 log reduction with proper washing. |
| Toxicity Testing of Processed Materials | No toxic sterilant residuals on processed materials. | Cytotoxicity and in vivo biocompatibility testing showed no toxic sterilant residuals. |
Study Details
-
Sample size used for the test set and the data provenance:
- Test Organism: B. stearothermophilus spores (at least 1 x 10⁶ endospores for most tests).
- Materials: Various materials representative of medical devices (e.g., metallic, polymer carriers, stainless steel). Specific quantities are not provided, but tests involved "various materials," "inoculated spore carriers," "mated biological indicator carriers," "stainless steel lumens," and "Tyvek pouched stainless steel lumens (Ten)."
- Data Provenance: The studies were conducted by Advanced Sterilization Products (ASP), a division of Johnson & Johnson Medical, Inc., in Irvine, CA, USA, as part of their 510(k) submission. This indicates a retrospective evaluation of the device's performance through laboratory testing. "In-Use Sterility Testing" involved devices used in routine surgeries at a local hospital, then transported to ASP for sterilization, making this aspect prospective for the sterilization step with used instruments.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth for all sterilization studies is established by microbiological culture for the presence or absence of viable spores. The text does not mention the number or specific qualifications of human experts (e.g., microbiologists) used to perform or interpret these culture results. However, the methodology aligns with standard microbiological validation practices for sterilizers.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in the conventional sense for a medical imaging or diagnostic device. The "ground truth" is determined by microbiological growth/no growth, which is an objective measurement based on established protocols. There is no mention of expert consensus or adjudication for these microbiological results.
-
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:
- No. This is a sterilization device, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies and AI-related effect sizes are not applicable.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is a sterilization device without an AI algorithm component. The performance evaluated is that of the sterilizer itself.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth used is microbiological culture data (presence/absence of B. stearothermophilus growth or other specified organisms). This is a direct measurement of sterility assurance. In the case of toxicity testing, "cytotoxicity and in vivo biocompatibility testing" provided the ground truth for residual toxicity.
-
The sample size for the training set:
- Not applicable. This is a physical device (sterilizer), not a machine learning model. There is no concept of a "training set" in the context of validating its sterilization efficacy.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device validation.
§ 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).