(102 days)
The Restore™ Modular Sterilization Tray System is intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses when used in conjunction with a FDA cleared sterilization wrap.
The Modular Sterilization Tray System may be used with common surgical instruments such as hammers, rasps, drivers, chisels, ringed-handled instruments, rongeurs, pickups, including but not limited to short-lumened devices etc. The validated total weight for tray and contents was 20 pounds.
Reusable Medical Device Challenge Conditions
Minimum Inner Diameter: 1.8 mm
Maximum Length: 4 inches
Number of lumens: 2
High Vacuum (pre-vacuum, three pulse, standard):
Temp: 270° F
Exposure Time: 4 Minutes
Cycle Dry Time (wrapped): 20 Minutes (minimum)
Cool Time: Varies according to load contents
NOTE: Cool drafts from air ducts or other air currents should be avoided during the cooling phase to avoid post-sterilization moisture caused by rapid cooling syndrome.
The Restore ™ Modular Sterilization Tray System is designed using materials that can be reused with steam sterilization methods. The Restore ™ system has an even distribution of holes in relation to its size for optimal steam penetration.
The basic system includes either a 10 x 20 x 4 inch or 10 x 10 x 4 inch aluminum tray with lids and a variety of insert tray assemblies and lids. The central function is an adjustable racking and multi-functioning stringer device, which is designed for the organization and alignment of surgical instruments for pre-sterilization cleaning decontamination, and sterilization cycles of surgical devices in healthcare facilities.
For the sterilization process, the tray system may be either wrapped in FDA-cleared sterilization wrap designed for this purpose or placed in a rigid container.
This request is regarding the K131455 510(k) submission for the Restore™ Modular Sterilization Tray System. The document provided outlines the device's intended use and performance within the context of sterilization, but does not describe an AI/ML-driven medical device.
Therefore, I cannot populate the table or provide information for questions 2-9 as the provided text relates to a physical medical device (sterilization tray) and does not involve AI/ML performance metrics, studies with human readers, or ground truth establishment for a diagnostic algorithm.
The core of the documentation focuses on physical device performance related to sterilization efficacy (e.g., steam penetration, dry time, material compatibility).
Here's the closest interpretation of the acceptance criteria and study that can be extracted from the provided text, focusing on the device's primary function of sterilization.
Acceptance Criteria and Device Performance (Based on Sterilization Validation):
| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance/Validation |
|---|---|---|
| Sterilization Efficacy (High Vacuum Steam) | Successful sterilization of common surgical instruments, including but not limited to short-lumened devices, when used in conjunction with an FDA cleared sterilization wrap. Validated total weight for tray and contents: 20 pounds. | Validated Parameters: |
- Temp: 270° F
- Exposure Time: 4 Minutes
- Cycle Dry Time (wrapped): 20 Minutes (minimum)
- Cool Time: Varies according to load contents (Note: Cool drafts from air ducts or other air currents should be avoided during the cooling phase to avoid post-sterilization moisture caused by rapid cooling syndrome).
- Reusable Medical Device Challenge Conditions: Minimum Inner Diameter 1.8 mm, Maximum Length 4 inches, Number of lumens 2.
- Pre-Vac Steam Sterilization Validation Parameters: High Vacuum (three pulse, standard).
Study Execution: "Cleaning and Sterilization Validation testing was performed by under GLP conditions by a contract test laboratory according to AAMI TIR30:2011 and AAMI TIR12:2010 standards. The testing validated the parameters for vacuum settings, temperature, exposure time, cycle dry time wrapped and in a sterilization container, and cool time." |
| Material Compatibility/Reusability | Device materials (aluminum, stainless steel, biomedical grade silicone, Ultem*HU1004 Resin) must be compatible with steam sterilization methods and allow for reuse. | "Designed using materials that can be reused with steam sterilization methods."
"Material Compatibility with sterilization process: Yes"
"ISO 10993 Biocompatible: Yes"
"Reusable: Yes" |
| Steam Penetration | Even distribution of holes in relation to its size for optimal steam penetration. | "The Restore ™ system has an even distribution of holes in relation to its size for optimal steam penetration."
"Each tray and lid contains evenly distributed hole pattern in relation to its size." |
Since this is not an AI/ML device, the following questions are not applicable to the provided document. I will state why for each:
- Sample sizes used for the test set and the data provenance: Not applicable. This is a physical device. "Test set" here refers to physical validation tests (e.g., sterilization cycles, material durability assays), not a data set for an algorithm. Data provenance (country of origin, retrospective/prospective) is irrelevant for this type of device validation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical sterilization tray is established through objective physical and microbiological testing (e.g., sterility testing, Bowie-Dick tests, temperature mapping), not expert consensus on images or diagnostic interpretations.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in diagnostic image interpretation, which is not relevant for this device.
- 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 physical medical device, not an AI/ML algorithm intended to assist human readers in tasks like image interpretation.
- 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.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is objective physical and microbiological validation of sterilization efficacy, material integrity, and reusability, based on established industry standards (AAMI TIR30:2011 and AAMI TIR12:2010). It's not a diagnostic "ground truth" derived from expert consensus or pathology.
- The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable. As there's no AI/ML training set, there's no ground truth to establish for it.
§ 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).