(9 days)
The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture- stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles.
The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues.
The V-PRO s2 Low Temperature Sterilization System using VAPROX® HC Sterilant are intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues.
The RAS Racks are used in the RAS Cycle of the AMSCO 7052HP Single-Chamber Washer/Disinfector and the AMSCO 7053HP Single-Chamber Washer/Disinfector for the effective cleaning, rinsing, intermediate level disinfection and drying of reusable da Vinci® X/Xi and S/Si EndoWrist® instruments.
The V-PRO® 60 Low Temperature Sterilization System using VAPROX® HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues.
The AMSCO 600 Steam Sterilizer uses saturated steam, generated from a house steam utility (e.g. boiler system) or from a steam generator, to sterilize heat-stable health care products.
The V-PRO Low Temperature Sterilization System is a vaporized hydrogen peroxide sterilizer. It has the following pre-programmed cycles (the Lumen Cycle, the Non Lumen Cycle, the Flexible Cycle and the Fast Non Lumen Cycle). The V-PRO Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities.
The V-PRO s2 Sterilizer executes four sterilization cycles (the Lumen, Non Lumen, Flexible Cycles and Fast Cycle). The V-PRO s2 Sterilizer contains a cabinetry modification and is free-standing.
The RAS Racks are designed to enable the mechanical cleaning, rinsing, and disinfection of up to twelve (12) robotic-assisted surgery instruments in a compatible washer-disinfector.
The V-PRO s2 Sterilizer executes four sterilization cycles (the Lumen, Non Lumen, Flexible Cycles and Fast Cycle). The V-PRO s2 Sterilizer contains a cabinetry modification and is free-standing.
The provided FDA 510(k) summary describes several sterilization and washer-disinfector systems. The acceptance criteria and testing detailed are for modifications related to component obsolescence (oscillator replacement, coin cell battery to super capacitor, flash memory component alternates and associated software updates). The document does not describe a study related to AI or human-in-the-loop performance. Therefore, questions related to expert consensus, MRMC studies, effect size, and standalone algorithm performance are not applicable.
Here's an analysis of the acceptance criteria and supporting studies for the component modifications across the various devices:
1. Table of Acceptance Criteria and Reported Device Performance
Across all devices (AMSCO 600 Steam Sterilizer, V-PRO maX 2, V-PRO s2, V-PRO 60 Low Temperature Sterilization Systems, and RAS Racks/Cycle), the acceptance criteria and performance for the specific modifications are consistent:
| Test | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| ½ Cycle sterility assurance Test (for Sterilizers) | All biological indicators must show no growth after a ½ Cycle exposure with a worst-case load. | Pass |
| Critical parameters test (for RAS Racks/Cycle) | Compare the cycle data of RAS cycle between modified and new Kodiak controllers to confirm the cleaning efficiency. | Pass |
| Software test | Verify sterilizer can set and read RTC, bootloader can load and run software application and verify proper operation of applications using serial flash. | Pass |
| Software confirmation test (for RAS Racks/Cycle) | Ensure proper version, proper parameters are in the cycles for proper operation of cycles. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes (e.g., number of cycles, number of biological indicators) used for these non-clinical performance tests. It refers to "worst-case load" for the sterility assurance tests.
The provenance of the data is non-clinical performance testing conducted by the manufacturer, STERIS Corporation. The country of origin is implicitly the United States, given STERIS's address in Mentor, Ohio, and the FDA submission. The studies are retrospective in the sense that they are proving the modified device performs equivalently to the original validated design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as the studies described are non-clinical performance tests verifying device functionality and sterility/cleaning efficacy, not diagnostic or interpretive tasks requiring human expert ground truth. The "ground truth" for these tests is defined by established sterilization and cleaning standards (e.g., "no growth" for biological indicators, confirmed cleaning efficiency).
4. Adjudication Method for the Test Set
This question is not applicable for non-clinical performance tests. The results (e.g., growth/no growth, successful software operation) are typically objective and determined by laboratory analysis or automated system checks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states that the modifications "has no impact on the device performance" compared to the predicate device because the changes are related to component obsolescence, not a change in the fundamental operating principle or intended use that would require a comparison of human reader effectiveness.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The devices are sterilization and cleaning equipment, not algorithms that perform diagnostic or interpretive functions. The software tests performed are focused on verifying the proper functioning of the embedded system software controlling the sterilizers/washer-disinfectors, not standalone interpretive performance.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical tests is based on:
- Biological indicator results: "No growth" post-sterilization, indicating successful killing of microorganisms. This is a direct measure of sterility.
- Physical and chemical parameters verification: Ensuring cycle data (time, temperature, pressure, sterilant injection weight) for sterilizers and cleaning/thermal disinfection parameters for the washer-disinfector (temperature, time, chemical dosing, pump pressure) meet pre-defined specifications.
- Software functionality: Verification that the embedded software correctly sets and reads Real-Time Clock (RTC), loads and runs applications, and ensures proper operation using serial flash memory.
- Cleaning efficiency: For the RAS Racks/Cycle, comparison of cycle data between modified and original controllers to confirm equivalent cleaning efficiency.
These "ground truths" are derived from validated operational parameters and expected biological/physical outcomes inherent to sterilization and cleaning processes, as per industry standards and internal validation protocols.
8. The Sample Size for the Training Set
This question is not applicable. These are hardware/software modifications to existing medical devices, not AI/ML algorithms that require a separate training set. The "associated software updates" are to accommodate new hardware components (flash memory, super capacitor) and ensure the existing validated sterilization/cleaning cycles continue to operate as intended.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" in the context of these device modifications.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.