(92 days)
The Turbett Surgical 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 Turbett Surgical Filters.
The unit is intended to be used in a pre-vacuum steam sterilizers with a pre-vacuum cycle of 270°F (132°C) and exposure time of 4 minutes.
- The TS1500 Container may be loaded to a maximum weight of 375 lbs., not to exceed 25 lbs. in any tray. Minimum drying time for loads up to 140lbs. is 10 minutes, for loads up to 375 lbs. is 30 minutes.
- The TS1200 Container may be loaded to a maximum weight of 300 lbs., not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes for loads up to120 lbs. and 30 minutes for loads up to 300 lbs.
- 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 0.7 mm x 500 mm and 1.0 mm x 850 mm rigid and flexible lumens.
Use only uncovered, perforated, or wire mesh general delivery trays within the Turbett Surgical Instrument Pod.
The Turbett Surgical Instrument Pod is a multi-tray 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. Unwrapped, uncovered, perforated sterilization trays are stacked into the container, separated by anodized aluminum dividers, which allow steam to evenly penetrate and allow condensation to drain.
The container is manufactured from 304 stainless steel sheet metal and bar stock. The container is sealed on all sides except one which is the door / filter panel.
The single fenestrated door consists of two perforated anodized aluminum panels which cover the exposed container side wall. A custom-made disposable filter consisting of 2 layers of filter paper separated by a layer of compressible single-use gasket material is placed between the two perforated metal panels of the door. Spring loaded latches compress the anodized aluminum door frame with filter assembly to the container for a secure seal.
The Turbett Surgical Instrument Pod is loaded into the auto clave with a dedicated transfer mechanism and cart.
The provided FDA 510(k) clearance letter and summary for the Turbett Surgical Instrument Pod does not describe an AI/ML device or a study involving human readers or ground truth derived from expert consensus, pathology, or outcomes data. Instead, it describes a rigid sterilization container used for medical instruments.
Therefore, many of the requested details about acceptance criteria and study design for an AI/ML device (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI) are not applicable to this medical device submission.
The "study" in this context refers to non-clinical performance testing of the physical sterilization container.
Here's the information that can be extracted and presented based on the provided document, framed within the context of hardware device performance testing:
Device Description
The Turbett Surgical Instrument Pod is a multi-tray rigid sterilization container designed to enclose other medical devices for sterilization by a healthcare provider. It allows sterilization of enclosed materials and maintains sterility for up to 30 days. It is intended for use in pre-vacuum steam sterilizers with specific temperature and exposure times. The container is made of stainless steel and aluminum, includes a single-use filter, and accommodates various sizes of instrument loads and lumens.
Acceptance Criteria and Reported Device Performance
The device's performance was evaluated through a series of non-clinical tests to demonstrate its safety and effectiveness as a sterilization container. The acceptance criteria were based on medical device sterilization standards.
Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Sterilization Efficacy | Log reduction of 10⁻⁶ sterility assurance level | Pass |
| Thermal Profile | Demonstrate various locations within the container can reach and maintain exposure temperature | Pass |
| Dry Time | Pre/Post weight difference less than 0.2% and no visible moisture after specified drying time (TS1500: 10 mins for loads up to 140lbs, 30 mins for loads up to 375 lbs; TS1200: 10 mins for loads up to 120 lbs, 30 mins for loads up to 300 lbs; TS1000: 10 mins) | Pass |
| 30 Day Event Related Shelf Life | Contents remain sterile post 30-Day Shelf-life. | Pass |
| Cleaning Validation | Residual Protein and Total Carbon within test limits (Protein level of less than 6.4 µg/cm² and Total Carbon level of less than 2.2 µg/cm²) | Pass |
| Microbial Aerosol Challenge | Demonstrate maintenance of sterility by no growth of internal test coupons following exposure to microbial aerosol | Pass |
| Usability | Demonstrate that the device can be used by representative users under simulated use conditions without producing patterns of failures that could result in negative clinical impact to patients or injury to users. Verify use of the IFU is effective. Determine whether the use related safety issues associated with using the device have been adequately mitigated. | Pass |
Study Details (Non-Clinical Performance Testing)
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Sample size used for the test set and data provenance:
- The document does not specify exact sample sizes (e.g., number of containers tested) for each non-clinical test.
- It mentions three specific container models (TS1500, TS1200, TS1000) and indicates that the system was validated with specific rigid and flexible lumens (0.7 mm x 500 mm and 1.0 mm x 850 mm for the subject device).
- Data provenance: Not explicitly stated, but typically for 510(k) submissions, non-clinical tests are conducted by the manufacturer or accredited testing laboratories in a controlled environment as part of the design validation process. This is a prospective testing design to meet regulatory standards.
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Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable in the context of AI/ML. For this physical device, "ground truth" is established by adherence to recognized consensus standards for sterilization and medical device testing (e.g., ANSI/AAMI ST77:2013, ANSI/AAMI ST79:2007, TIR 30:2011, ANSI/AAMI HE75:2013). The "experts" are the qualified personnel within the testing laboratories who perform the tests according to these validated methods.
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Adjudication method:
- Not applicable. This is not a human-in-the-loop or interpretation-based task that would require adjudication. Results are quantitative measurements against defined criteria.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size of improvements:
- No. This is not a study assessing human reader interpretation of images or data.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used:
- The "ground truth" for this device's performance is defined by established consensus standards and validated chemical/physical/biological testing methods (e.g., sterility assurance levels, gravimetric measurements for dryness, chemical residue analysis, microbial growth/no-growth observations).
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The sample size for the training set:
- Not applicable. No AI/ML training set is mentioned or implied.
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How the ground truth for the training set was established:
- Not applicable. No AI/ML training set is mentioned or implied.
Summary regarding AI/ML criteria: The provided document pertains to a physical medical device (sterilization container) and its non-clinical performance testing. It does not involve AI/ML, human readers, image analysis, or expert consensus-based ground truth typical of AI/ML device clearances.
§ 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).