(356 days)
The APTIMAX™ Instrument Trays are designed to encase surgical instruments for sterilization in steam, ethylene oxide and STERRAD Sterilization Systems.
The APTIMAX™ Instrument Trays and accessories are designed to encase surgical instruments for sterilization.
The APTIMAX™ Instrument Trays and accessories were previously indicated for use only with the Sterrad® Sterilization Systems. This Premarket Notification expands the Indications for Use for the APTIMAX™ Instrument Trays and accessories to also include their use in prevacuum steam and ethylene oxide sterilization cycles.
The APTIMAX™ Instrument Tray, Instrument Tray Mat and Instrument Tray Holder are intended to encase surgical instruments for sterilization in steam (with the exception of gravity displacement cycles), ethylene oxide and STERRAD® Sterilization Systems.
The instrument tray, available in various sizes, is injection molded with a Liguid Crystal Polymer, which is compatible with various sterilization systems such as the STERRAD® Sterilization System, steam sterilizers and ethylene oxide sterilizers.
The tray is designed with a high perforation area on the lid. base and side panels to enhance diffusion of sterilant during sterilization. The hole size and spacing is the same in all trays to enable the use of a common design instrument tray mats and holders.
Prior to sterilization, the tray is over-packaged with a microbial barrier, such as polypropylene CSR wrap or pouch, which is compatible with the sterilization method for maintaining sterility after sterilization.
Accessories for the APTIMAX™ Instrument Tray include the Instrument Tray Holder and the Instrument Tray Mat. The holder and mat are designed to secure and provide protection of delicate endoscopic and microsurgical instruments in the APTIMAX™ Instrument Tray.
The instrument holder and mat, available in various sizes, are manufactured from a silicone material. which is compatible with various sterilization systems such as the STERRAD® Sterilization system, steam sterilizers and ethylene oxide sterilizers.
The provided text describes validation testing for a medical device (APTIMAX™ Instrument Tray and Accessories) to demonstrate its efficacy and material compatibility with various sterilization methods. It does not contain information about an AI/ML powered medical device, therefore many of the requested fields cannot be filled.
Here's an analysis of the provided text based on the request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Efficacy Testing (Sterility Assurance) | |
| Ethylene Oxide: Achieve 6-log spore reduction after a half-cycle exposure. | All test samples were found to be sterile, demonstrating a 6-log spore reduction after half-cycle exposure (using B. globigii endospores, >10^6). |
| Prevacuum & Flash Steam (Tray & Mat): Lethality achieved at minimum temperature and half cycle with maximum load. | Lethality was achieved with a 1.5 minute half-cycle (at 131.7 °C) for both prevacuum and flash cycles. No growth was observed at half cycle for three consecutive runs (using B. stearothermophilus endospores, >10^6). |
| Prevacuum & Flash Steam (Tray Holder): Lethality achieved at minimum temperature and half cycle with maximum load. | Lethality was achieved with a 1.5 minute half-cycle (at 131.7 °C) for both prevacuum and flash cycles. No growth was observed at half cycle for three consecutive runs (using B. stearothermophilus endospores, >10^6). |
| STERRAD 100 System: Achieve minimum Sterility Assurance Level (SAL) of 10^-6 at half-cycle with minimum injection volume. | Complete inactivation of challenge biological indicators was achieved for three consecutive runs at half-cycle with minimum injection volume. Results demonstrated a minimum SAL of 10^-6 (using B. stearothermophilus endospores, >10^6). |
| STERRAD 100S System: Achieve minimum Sterility Assurance Level (SAL) of 10^-6 at half-cycle with minimum injection volume. | Complete inactivation of challenge biological indicators was achieved for three consecutive runs at half-cycle with minimum injection volume. Results demonstrated a minimum SAL of 10^-6 (using B. stearothermophilus endospores, >10^6). |
| STERRAD 50 System: Achieve minimum Sterility Assurance Level (SAL) of 10^-6 at half-cycle with minimum injection volume. | Complete inactivation of challenge biological indicators was achieved for three consecutive runs at half-cycle with minimum injection volume. Results demonstrated a minimum SAL of 10^-6 (using B. stearothermophilus endospores, >10^6). |
| Material Compatibility (Ethylene Oxide): Residuals below limits proposed in the Federal Register of June 23, 1978. | Residual results for Ethylene Oxide, Ethylene Chlorohydrin, and Ethylene Glycol were far below the proposed limits. |
| Material Compatibility (Steam Sterilization): No change in surface characteristics and physical properties (tensile strength) within acceptable limits after 50 cycles. | No change in surface characteristics observed after 50 cycles. Physical properties (tensile strength) had changes within acceptable limits. |
| Material Compatibility (STERRAD 100 System): No change in surface characteristics and physical properties (tensile strength) within acceptable limits (10^6) per worst-case location, and one glass substrate spore carrier for STERRAD 50, tested over "three consecutive runs." |
- Ethylene Oxide Residuals: Tensile bars (representative of tray and mat-holder material) tested after full-cycle exposure. Number not explicitly stated.
- Steam Material Compatibility: One 180 mm x 75 mm x 30 mm Instrument Tray, plus tensile bars (fabricated from the same raw materials as mat and holder), processed for "fifty steam cycles."
- STERRAD 100 Material Compatibility: APTIMAX Trays and Tensile bars (representative of tray and mat/holder material) processed for "one hundred full cycles."
Data Provenance: The studies were conducted by Advanced Sterilization Products (ASP), a US-based company. The nature of these non-clinical, validation studies indicates they are prospective in the sense that the experiments were specifically designed and executed to test the device performance as part of the 510(k) submission. There is no mention of country of origin of the data beyond the company's location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of device and study. The "ground truth" here is the biological outcome of sterility (presence or absence of microbial growth) or physical/chemical property changes, which are determined by laboratory testing, not expert consensus.
4. Adjudication Method for the Test Set
This is not applicable to these non-clinical validation studies. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies for human interpretation of imaging or other medical data.
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 applicable. This submission is for a physical medical device (instrument tray) and its compatibility with sterilization systems, not an AI/ML powered device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This submission is for a physical medical device.
7. The Type of Ground Truth Used
The ground truth used in these validation studies is primarily microbiological and material-science based:
- Microbiological Sterility: Absence of microbial growth from biological indicators (B. globigii, B. stearothermophilus endospores) after sterilization cycles. This is an objective laboratory outcome.
- Material Compatibility: Physical property measurements (tensile strength, hardness) and visual inspection for surface characteristics after multiple sterilization cycles. This is an objective measurement against defined acceptable limits.
- Chemical Residuals: Quantitative analysis of chemical residues (Ethylene Oxide, Ethylene Chlorohydrin, Ethylene Glycol) compared against established safety limits.
8. The Sample Size for the Training Set
This is not applicable. This is a physical medical device, not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. This is a physical medical device, not an AI/ML device that requires a training set.
§ 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).