(246 days)
The Getinge/Castle Series 100 Steam Sterilizers (Straightline) with the PACS 2000 controls is an upgrade of an existing microcomputer control system for a comprehensive line of health care reusable medical reprocessing equipment. The PACS 2000 controls an intended to be used for the control of a variety of equipment including washers, washing/disinfectors, washer/sterilizers and sterilizers. This submittal is made for the PACS 2000 controls applied to the Getinge/Castle (Straightline) line of steam sterilizer models (see attachment Section 18 - Competitive Comparison). The Series 100 (Straightline) sterilizer line includes two sizes, A 16" x 16" x 26" chamber having a volume 3.9 cubic feet and a 20" x 20" x 38" chamber having a volume 8.8 cubic feet. Both chamber sizes include single and double door sterilizers with a power door offered on the single door model only. The Series 100 Steam Sterilizer (Straightline) includes gravity (Model 122) and prevacuum (Model 133) steam sterilizers for healthcare facilities and moist heat (Model 123) sterilizes for laboratories and industrial uses. The latter applications are addressed in this submittal for the rare occasion health care facilities may use them. The to be cleared for each of the models are as follows:
For the Model 122
- P 1 GRAV WRAP 1 Gravity Cycle 30 minute exposure at 250°F and 30 minute dry
- P2 GRAV WRAP 2 Gravity Cycle 10 minute exposure at 275°F and 30 minute dry
- P3 FLASH 3+ Gravity Cycle with 3 minute exposure at 275°F and 0 minute dry
- P4 FLASH 10+ Gravity Cycle with 10 minute exposure at 275°F and 0 minute dry
For the Model 123
- P 1 GRAV WRAP 1 Gravity Cycle 30 minute exposure at 250°F and 30 minute dry
- P4 FLASH 3+ Gravity Cycle 3 minute exposure at 275°F and o minutes dry
For the Model 133
- P1 PREVA WRAP Prevacuum Cycle 3 minute exposure at 275°F and 16 minute dry
- P2 PREVA WRP1 Prevacuum Cycle 3 minute exposure at 275°F and 3 minute dry
- P3 FLASH 3+ Gravity Cycle 3 minute exposure at 275°F and 0 minute dry
- P4 FLASH 10+ Gravity Cycle 10 minute exposure at 275°F and 0 minute dry
- P5 VAC LEAK TST Air leak Test 3 minute exposure at 268°F and 15 min. leak test
The Castle Series 100 Sterilizers (Straightline) is an upgrade of an existing microcomputer control system intended to be used with hospital steam sterilizers. Specifically, PACS 2000 controls applied to the Series 100 (Straightline) Steam Sterilizer are to be used with "Castle" brand sterilizers manufactured by Getinge/Castle, Inc. for use in industrial, laboratory, and health care facility environments. These sterilizers are intended to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids not intended for direct patient contact)
The difference between predicate sterilizer controls and the PACS 2000 controls is that the PACS 2000 controls are provided with more modern microprocessor/software, and interactive operator interface. The chamber vessel and piping remain unchanged.
This is a submission for a steam sterilizer, which is a physical device, not an AI/ML powered device. Therefore, many of the requested categories are not applicable.
Here's the information about acceptance criteria and study as requested, with explanations of why some categories are not relevant:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Castle Series 100 Steam Sterilizers are primarily derived from established industry standards for steam sterilization. The reported performance is the established sterilization cycles.
| Acceptance Criteria (Standard) | Reported Device Performance (Cleared Cycles) |
|---|---|
| ANSI/AAMI ST-8 - 1994: Hospital Steam Sterilizers (General requirements for safety and effectiveness) | Model 122 (Gravity): |
- Wrapped Linen Packs: 30 min @ 250°F, 30 min dry
- Wrapped Hard Goods: 10 min @ 275°F, 30 min dry
- Unwrapped Nonporous Instruments (Flash): 3 min @ 275°F, 0 min dry
- Unwrapped Porous Instruments (Flash): 10 min @ 275°F, 0 min dry
Model 123 (Gravity):
- Wrapped Linen Packs and Hard Goods: 30 min @ 250°F, 30 min dry
- Unwrapped Nonporous Instruments (Flash): 3 min @ 275°F, 0 min dry
Model 133 (Prevacuum):
- Wrapped Hard Goods: 3 min @ 275°F, 16 min dry
- Linen Packs & Single Wrapped Hard Goods: 3 min @ 275°F, 3 min dry
- Unwrapped Nonporous Instruments (Flash): 3 min @ 275°F, 0 min dry
- Unwrapped Porous Instruments (Flash): 10 min @ 275°F, 0 min dry
- Air Leak Test: 3 min @ 268°F, 15 min leak test |
| AAMI ST37-1996: Flash Sterilization: Steam Sterilization of Patient Care Items for Immediate Use | Cycles as described above for "Flash" sterilization (e.g., 3 min @ 275°F for unwrapped nonporous instruments). |
| CAN/CSA-Z314.7-M91: Effective Sterilization in Hospitals by the Steam Process (ref. AAMI ST8-1988) | Cycles as described above, demonstrating effective steam sterilization. |
| GGS-1340A: Federal Specification Sterilizer, Surgical Instrument and Supply Gravity Air Removal, Non-Portable (Heat and Moisture Stable) | Cycles as described above, demonstrating compliance with federal specifications for sterilizers. |
| Sterility Assurance Level (SAL) of at least 10⁻⁶ | Achieved through "half cycle analysis" validation testing. |
| UL544 and CSA C22.2 No. 151: Product safety standards for medical devices | The product has been designed to meet these safety requirements. (Compliance is stated, specific performance metrics are not detailed in this summary for these standards.) |
| ASME pressure vessel code, Section VIII | The vessel is designed, constructed, and certified to this code. (Compliance is stated, specific performance metrics are not detailed in this summary.) |
2. Sample size used for the test set and the data provenance
The study involved "evaluation studies consisting of fabric and instrument loads (wrapped and unwrapped)". No specific numerical sample size (e.g., number of test runs, number of biological indicators) is provided in this summary.
Data Provenance: The studies were performed by Getinge/Castle, Inc. as part of the device validation. The location is not specified beyond the company's US address. This is a prospective study as it involves specific validation testing of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a steam sterilizer, the "ground truth" for sterilization effectiveness is established through standardized microbiological testing (e.g., biological indicators, half-cycle analysis) that demonstrates a sterility assurance level (SAL). This does not typically involve human experts establishing a "ground truth" in the same way as, for example, image interpretation. The standards themselves are developed by experts in the field of sterilization.
The report mentions "accepted half cycle analysis," which refers to a standard method of validating sterilization cycles using biological indicators.
4. Adjudication method for the test set
Not applicable. The validation of a steam sterilizer's performance involves objective microbiological testing and physical parameter measurement, not subjective interpretation requiring adjudication among experts.
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 steam sterilizer, a physical medical device, 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 does not involve an algorithm providing standalone interpretations. The device itself performs the sterilization process.
7. The type of ground truth used
The type of ground truth used is microbiological sterility (demonstrated by a Sterility Assurance Level (SAL) of at least 10⁻⁶), as determined by "half cycle analysis" and adherence to the performance requirements of the cited industry standards (e.g., ANSI/AAMI ST-8, AAMI ST37). This typically involves:
- Biological Indicators (BIs): Spore strips or suspensions containing a known number of highly resistant bacterial spores, which are processed through the sterilizer and then cultured to confirm their inactivation.
- Physical Monitoring: Temperature, pressure, and time readouts from the sterilizer to ensure parameters meet the cycle specifications.
8. The sample size for the training set
Not applicable. This device does not use machine learning, so there is no "training set." The development of the device's control system and cycles would be based on engineering principles and knowledge of sterilization science.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML model, this question is not relevant. The "ground truth" for the device's design and development would be based on the scientific principles of microbial inactivation and the requirements outlined in the relevant sterilization standards.
§ 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).