(253 days)
InstruSafe® Instrument Protection System cassettes(trays) are used to organize and protect other medical devices that are sterlized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during STERIZONE VP4 sterlization Cycle 1. The Instrusate Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap rigid container. The Instrument Protection System casettes are not intended on their own to maintain sterility.
Summit Medical has validated the use of the Instrument Protection System cassettes in Cycle 1 of the STERIZONE VP4 sterilizer through demonstrations of sterilization efficacy using representative samples including general instruments, rigid and semi-rigid instruments with lumens, and flexible endoscopes. The validation provided information that has been used to establish design limits that are applied across the range of Instrument Protection System cassettes to ensure that all models fall within the validated limits for cassette ventilation, internal shelving, and weight:
- Minimum ventilation-to-volume ratio, general instruments: 0.073
- Minimum ventilation-to-volume ratio, flexible endoscopes: 0.263
- Maximum number of internal shelves: Two (2)
- Maximum cassette weight (including contents): 25 lbs/cassette
Refer to Table for the validated loads using Instrument Protection System cassettes. Refer to the sterilizer manufacturer's instructions for use to ensure that loads do not exceed the claimed limits for the sterilizer.
Summit Medical LLC InstruSafe Instrument Protection Systems are cassettes/trays used to enclose and hold surgical instruments and instrument accessories in an organized manner during the sterilization process and subsequent storage and transportation. The cassettes/trays do not have direct patient contact. The cassettes/trays by themselves do not maintain sterility. The cassettes/trays are different sizes of the same basic configuration: a rectangular base with latchable cover. The cassettes/trays have perforations to allow sterilant penetration. The cassettes/trays contain silicone inserts in the base and/or cover to hold, organize, and protect the surgical instruments within the cassette/tray during the sterilization process and subsequent storage and transportation.
The provided document, a 510(k) Premarket Notification for the InstruSafe Instrument Protection System, details the device's acceptance criteria and the studies conducted to demonstrate that it meets these criteria. This device is a medical accessory, specifically sterilization wrap, and the performance data focuses on its efficacy in the sterilization process, not on diagnostic accuracy of an AI/ML algorithm. Therefore, many of the standard questions regarding AI/ML device validation (e.g., sample size for test/training set, number of experts for ground truth, MRMC study, standalone performance) are not applicable in this context.
However, I can extract the relevant acceptance criteria and the performance results for this device, which are based on non-clinical testing for sterilization efficacy and device integrity.
Acceptance Criteria and Reported Device Performance
The device's performance was validated through a series of nonclinical tests designed to ensure its safety and effectiveness in the sterilization process. The acceptance criteria and the reported performance are summarized in the table below.
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Cleaning Validations (Manual, Mechanical, and Ultrasonic) FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (Issued March 2015) AAMI TIR30:2011 | To validate the effectiveness of manual, mechanical, and ultrasonic cleaning procedures specified in the Instructions for Use using the worst-case cassette in terms of product geometry, worst-case (coldest) processing temperatures, and artificial soil. | Micro BCA Protein Assay: Residual protein level $\leq$ 6.4 µg/cm² | |
| Total Organic Carbon assay: TOC $\leq$ 2.2 µg/cm² | Pass | ||
| Sterilization Efficacy Validation: Half-Cycle Overkill Approach ANSI/AAMI/ISO 14937:2009 | To demonstrate delivery of a minimum sterility assurance level (SAL) of 10^-6 to biological indicators (BIs) at difficult to sterilize locations in medical devices when validation loads are processed in the InstruSafe Instrument Protection System cassettes. Both wraps and rigid containers were used as sterile barriers. | Three (3) consecutive half cycles in which all biological indicators (BIs) are inactivated. | |
| Minimum BI population: 1 x 10^6 CFU/BI | Pass | ||
| Sterility maintenance via simulated use and shelf-life testing using coupon sterility tests at end of shelf life. ANSI/AAMI/ISO 11607:2019 ANSI/AAMI ST77:2013/(R)2018 | To demonstrate maintenance of sterility over the stated shelf life using simulated handling conditions when sterilization wrap is used as the sterile barrier for the worst-case cassette in terms of weight. | Sterility tests of coupons that were sterilized and stored in the wrapped cassettes shall be negative for growth after 366 days of simulated storage and handling. | Pass |
| Microbial Aerosol Challenge for Sterile Barrier Package Integrity | To demonstrate the integrity of sterilization wrap as a sterile barrier after exposure to Cycle 1 using a microbial aerosol challenge of $\geq$ 800 CFU/cm². | Sterility tests of coupons that were sterilized in Cycle 1 and then subjected to the microbial aerosol challenge in the wrapped cassette shall be negative. | Pass |
| Residual hydrogen peroxide testing ANSI/AAMI ST77:2013 ANSI/AAMI/ISO 11607-1:2019 ISO 10993-12:2012 | To demonstrate that levels of residual hydrogen peroxide on cassette materials were below safe levels after a worst-case exposure of three (3) consecutive iterations of Cycle 1. | The extracted residual hydrogen peroxide on device materials shall not exceed 997 ± 142 µg/cm², which was established as a safe level in K141163. | Pass |
| Biocompatibility of Subject Device (by cytotoxicity testing) ANSI/AAMI/ISO 10993-5 ANSI/AAMI/ISO 10993-12 | To evaluate the cytotoxicity potential of the test article using an in vitro cell culture assay. | Non-cytotoxic, a reactivity grade of $\leq$ 1 is scored based on histological interpretation of the test system. | Pass |
| Life Cycle / Simulated Use Life Validation FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (issued March 2015) | To validate the service life of the trays as stated in the Instructions for Use. | Visual inspection, component dimensional fit verification, functional closure/latch verification for 100 use cycles. | Pass |
| Cassette handle safety test. ANSI/AAMI ST77:2013 | To demonstrate that the handles on the InstruSafe cassettes could withstand a 100-lb load without deforming or failing. | No evidence of damage, deformation, or cracking of the handle after a 100-lb load is applied for 1 minute. | Pass |
Study Information (Relevant to Device Validation)
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Sample size used for the test set and the data provenance:
The document does not specify a distinct "test set" in the context of an AI/ML algorithm. Instead, the testing involved representative samples of instruments and cassettes under various loading conditions. These conditions are detailed in the "Description of InstruSafe Instrument Protect System Loads" table (pages 2-3 and 6-8 of the original document). For instance:- Load 4a: Three (3) IN-7323-R cassettes.
- Load 4b: Three (3) IN-0007-TF cassettes.
- Load 7a: Three (3) IN-7323-R cassettes.
- Load 7b: Three (3) IN-0006-TF cassettes.
- Load 8a: Three (3) cassettes (two IN-0003-R, one IN-0004-R).
- Load 8b: Two (2) IN-0003-TF cassettes.
The provenance of this data is from the manufacturer's internal validation studies, not from patient data, and it is prospective in nature as it involves planned experimental testing. The country of origin is not explicitly stated for the testing, but the applicant (Summit Medical LLC) is based in St. Paul, Minnesota, USA.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable. The device is a physical product (instrument protection system), not an AI/ML diagnostic tool. Ground truth is established through physical and chemical performance metrics (e.g., microbial inactivation, protein residue levels, structural integrity), not expert human interpretation. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This question is not applicable as there is no human interpretation or labeling involved. The "ground truth" is determined by objective laboratory measurements and standardized test protocols. -
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 question is not applicable as the device is not an AI/ML diagnostic tool and does not involve human readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is not an AI/ML algorithm. The performance established is the "standalone" performance of the physical device in meeting its intended function. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth is established through physical and biological measurements based on recognized standards (e.g., ANSI/AAMI/ISO standards, FDA guidance). Examples include:- Biological indicators (BIs): Used to confirm sterility assurance level (SAL).
- Chemical assays: Micro BCA Protein Assay and Total Organic Carbon (TOC) assay for cleaning validation.
- Physical inspection and load testing: For life cycle, handling, and structural integrity.
- Microbial challenge: For sterile barrier integrity.
- Cytotoxicity testing: To evaluate biocompatibility.
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The sample size for the training set:
This question is not applicable as there is no "training set" in the context of an AI/ML algorithm. -
How the ground truth for the training set was established:
This question is not applicable as there is no "training set" or AI/ML algorithm.
§ 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).