(156 days)
Consolidated SSR and SR MC-Series Steam Sterilizers are intended for use by health care facilities. They are to be used to sterilize wrapped and unwrapped surgical instruments, linens, and liquids (liquids not intended for direct patient contact) by means of pressurized steam.
The Consolidated SR and SSR Series Sterilizers are for general purpose gravity or vacuum steam sterilization of heat and moisture-stabile goods, surgical instruments, and supplies. All models utilize both gravity/downward air displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 16 cycles can be easily accessed and are password protected. All cycle phases are sequenced and monitored by the Mark V control system, providing both audible and visual notification of deviation from certain operating parameters. These sterilizers can either be supplied for connection to direct building steam supply of 50-80 PSI of pressure or come equipped with an integral, electrically heated steam generator.
The provided text describes a 510(k) summary for the Consolidated SSR and SR MC-Series Steam Sterilizers, Models: SSR-2A, SSR-3A, and SR-24E.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in terms of performance metrics like sterilization rates or specific temperature/pressure ranges that must be met. Instead, it asserts that the device's functionality and conformance were determined through testing. The "reported device performance" is implicitly that it did meet these unstated requirements.
| Acceptance Criteria (Inferred from "Performance Testing") | Reported Device Performance |
|---|---|
| Device functionality as a steam sterilizer | Functionality determined to be acceptable through biological and physical testing. |
| Conformance to design input requirements | Conformance determined to be acceptable through biological and physical testing. |
| Substantial equivalence to predicate device (Getinge/Castle "Castle Series 100HC", K994314) in design, materials, construction, and intended use. | The Consolidated SR and SSR Series Steam Sterilizers are stated to be substantially equivalent to the predicate in design, materials, construction, and intended use, raising no new safety and efficacy concerns. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Biological and physical testing was conducted to determine device functionality and conformance to design input requirements."
- Sample Size for the Test Set: Not specified. The document does not provide details on the number of sterilization cycles, biological indicators, or physical measurements performed.
- Data Provenance: Not explicitly stated, but given that Consolidated Machine Corp. is a Boston, MA-based company and the FDA review process is for marketing in the US, the testing would presumably be conducted in the US. The document does not indicate if the data was retrospective or prospective, but performance testing for a new device would typically be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an autoclave (steam sterilizer) and its performance is evaluated against physical and biological indicators, not expert interpretations of images or clinical data. "Ground truth" in this context would be the successful sterilization of materials as indicated by validated biological and physical methods.
4. Adjudication Method for the Test Set
Not applicable. (See explanation for point 3).
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 medical device (steam sterilizer), 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 is a medical device, not an algorithm. The device's performance is inherently "standalone" in its sterilization function, without human-in-the-loop performance beyond operation and loading.
7. The Type of Ground Truth Used
The ground truth used for evaluating the performance of a steam sterilizer would typically be established through:
- Biological Indicators (BIs): Spore strips or vials containing highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) that, when cultured after a sterilization cycle, show no growth if sterilization was successful.
- Physical Indicators: Measurement of temperature, pressure, and time during the sterilization cycle using calibrated sensors to ensure parameters meet specified sterilization conditions.
- Chemical Indicators: Color-changing strips or tags that indicate exposure to steam and/or specific sterilization conditions, though these do not prove sterility alone.
- Load Specifications and Cycle Parameters: The "ground truth" and benchmark for performance are adhering to validated cycles and ensuring the device can consistently achieve these predefined, effective sterilization parameters for various loads (wrapped/unwrapped instruments, linens, liquids).
The document states, "Biological and physical testing was conducted," which aligns with the typical ground truth methods for these types of devices.
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not a machine learning model, so there is no "training set" in the AI sense. The design and validation of the sterilizer are based on engineering principles and regulatory standards, not iterative training on a data set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See explanation for point 8).
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).