(253 days)
The Turbett Instrument Pod is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days until used. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with the Turbett Surgical filters.
The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270F (132C) and exposure time of 4 minutes.
. The TS1500 Container may be loaded to a maximum weight of 375 lbs. in any tray. Minimum drying time for loads up to 140 lbs. is 10 minutes, for loads up to 375 lbs. 30 minutes.
. The TS1200 Container may be loaded to a maximum weight of 120 lbs. in any tray. Minimum drving time is 10 minutes.
The TS1000 Container may be loaded to a maximum weight of 100 lbs. not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes.
The system was validated with 1mm x 500mm lumens. .
Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Instrument Pod.
The Turbett Instrument Pod is a rigid sterilization container with a fenestrated door holding a single-use filter. The container is designed to be used in a steam autoclave and hold multiple open trays containing surgical instruments. Trays within the container are separated by dividers to ensure separation and maximum steam exposure. The container is available in three sizes (TS1500 34"x24"x22"; TS1200 34" x17" x22"; TS1000 23" x17" x 22"). The original container (TS1500) has been validated to sterilize 375 lbs. of instruments along with the dividers. The validation was conducted with 15 instrument trays at 25 lbs. each to represent the most challenging case. Additional containers include the TS1200 and TS1000 sizes which can hold 120 lbs. of instruments. Sterilized instruments can be transported and stored for up to 30 days within the closed container.
The Turbett Instrument Pod is loaded into the autoclave with a dedicated transfer carriage. The container is constructed of 304 stainless steel with an anodized aluminum filter housing/door.
The use of a single-use disposable filter cartridge installed in the fenestrated door eliminates the need for a sealed gasket found on other rigid containers. The omission of a reusable gasket eliminates contamination risks due to failed reusable gaskets.
The provided text describes the non-clinical testing performed for the Turbett Instrument Pod, a rigid sterilization container. The study aims to demonstrate that the device meets acceptance criteria for sterilization efficacy, thermal profile, and transportation shelf life.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Type of Testing | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Pre-vacuum sterilization efficacy (AAMI ST77, ISO 17665-1) | Demonstrate Sterilization Capabilities | 10-6 SAL (Sterility Assurance Level) | PASSED |
| Thermal Profile (AAMI ST77) | Demonstrate Heat Penetration in Load | Minimum temperature of 270°F (132°C) achieved within 2 minutes and maintained. | PASSED |
| Transportation Shelf life Study (AAMI ST77, Modified ASTM D4169-14) | Simulate transportation followed by a shelf life study. | No growth 30 days following sterilization, loading, unloading, and transport. | PASSED |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test sets for any of the studies (pre-vacuum sterilization efficacy, thermal profile, or transportation shelf life).
The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Implicitly, since these are design validation tests, they would be prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not mention the use of experts to establish ground truth for this device. The testing described is hardware-centric (sterilization, heat penetration, biological growth), and ground truth is based on physical and microbiological measurements against predefined scientific/engineering criteria (e.g., SAL, temperature, presence of growth).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The concept of adjudication methods (like 2+1, 3+1) is typically relevant for studies involving human interpretation of data, such as medical image analysis. Since this study involves testing of a physical sterilization container against engineering and microbiological standards, adjudication methods are not applicable and are not mentioned.
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
This is not an AI/software device. Therefore, no MRMC comparative effectiveness study was done, and this question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an algorithm or AI device. Therefore, no standalone performance study in the context of an algorithm was done. The studies listed (sterilization efficacy, thermal profile, transportation shelf life) are inherently standalone in the sense that they evaluate the device's performance against objective criteria, not in conjunction with human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for these tests is based on:
- Sterility Assurance Level (SAL): A predefined microbiological standard of 10^-6, meaning a 1 in a million chance of a non-sterile unit.
- Physical Measurements: Specific temperature and time parameters (270°F (132°C) minimum temperature achieved within 2 minutes and maintained).
- Microbiological Culture Results: Absence of microbial growth after specified conditions and timeframes.
Essentially, the "ground truth" is defined by established scientific and engineering standards for sterilization and material handling, as outlined by AAMI ST77, ISO 17665-1, and ASTM D4169-14.
8. The sample size for the training set
This device does not involve machine learning or AI, so there is no training set in the typical sense.
9. How the ground truth for the training set was established
As there is no training set, this question is not applicable.
§ 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).