(211 days)
The STERRAD NX® Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization. The STERRAD NX Sterilize instruments which have diffusionrestricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with the following materials and dimensions can be processed in the STERRAD NX Sterilizer STANDARD cycle:
Single channel stainless steel lumens with
- . An inside diameter of 1 mm or larger and a length of 150 mm or shorter-
. An inside diameter of 2 mm or larger and a length of 400 mm or shorter Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD NX Sterilizer ADVANCED cycle:
Single channel stainless steel lumens with
An inside diameter of 1 mm or larger and a length of 500 mm or shorter1 ● Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscope with
- An inside diameter of 1 mm or larger and length of 850 mm or shorter2 ●
The STERRAD NX Sterilizer is a self-contained, stand-alone system of hardware and software designed to sterilize medical instruments and devices using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting a 59% aqueous hydrogen peroxide solution into the vaporizer subassembly where the solution is then concentrated and is vaporized at relatively low temperatures through a process that utilizes a combination of heating and sub-ambient pressures created by an on-board vacuum pump. The vaporized hydrogen peroxide is then introduced into the chamber under sub-ambient pressure to allow perfusion of the hydrogen peroxide throughout the chamber and, facilitating hydrogen peroxide contact with the surfaces to be sterilized. The vapor in the chamber is transformed into gas plasma using electrical energy. The chamber is then vented to allow the sterilization chamber to return to atmospheric pressure. This process is repeated an additional time to complete a full STERRAD NX Sterilization cycle (i.e., the full sterilization cycle is composed of two identical half-cycles). The STERRAD NX Sterilizer has two cleared sterilization cycles, the STANDARD and ADVANCED Cycles, both of which follow the general process described here.
The hardware for the STERRAD NX Sterilizer consists of a sterilizer chamber, constructed with aluminum, and a variety of instruments and components which are housed in a covered frame. Other major components of the system are constructed from passivated stainless steel. Viton (a copolymer of vinylidene fluoride and hexafluoropropylene), Ultem (polyetherimide), and structural foam. The sterilizer also uses accessories such as reusable instrument trays, printer paper, and an optional movable cart. The STERRAD NX Sterilizer can be placed directly on a table, counter top, or on the movable STERRAD NX cart.
The STERRAD NX Sterilizer uses a disposable sterilant cassette that contains a 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. As previously described, the hydrogen peroxide is concentrated before introduction into the sterilizer chamber and its concentration is monitored during the cycle. The sterilizer cancels the cycle if the hydrogen peroxide monitor data does not meet the pre-defined minimum concentration specification.
The modified STERRAD NX Sterilizer, which is the subject of this submission, incorporates a new vacuum pump and associated mounting components to improve the pump's durability. The new vacuum pump utilizes an oil warming element to maintain an optimum operating temperature range for the vacuum pump's oil during the periods of pump inactivation in-between reprocessing cycles. This modification will be implemented through hardware changes with no impact on the system software.
The technological characteristics associated with the sterilization process for the modified STERRAD NX Sterilizer are identical to those of the previously cleared STERRAD NX Sterilizer. In addition, the hardware changes associated with the described modification do not affect the cleared sterilization cycles or the manner by which the STERRAD NX Sterilizer is operated by the customer.
The provided document is a 510(k) premarket notification for a medical device: the STERRAD NX® Sterilizer with a new vacuum pump. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, not for proving effectiveness of a new technology (like an AI algorithm) through clinical trials. Therefore, the information requested in your prompt regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment for AI models is largely not applicable to this document.
The document describes a modification to an existing sterilizer (changing the vacuum pump) and focuses on demonstrating that this change does not negatively impact the device's existing performance or safety.
However, I can extract the closest analogous information from the document to answer your prompt, focusing on the verification testing conducted for the sterilizer's modification.
Summary of Device Performance and Acceptance Criteria (as applicable to a non-AI device modification):
This document describes a design modification (new vacuum pump) to an existing medical device, the STERRAD NX Sterilizer. The "acceptance criteria" here relate to demonstrating that the new component does not compromise the sterilizer's function or safety, and maintains the established efficacy of sterilization. Since this is not an AI device, concepts like "sensitivity," "specificity," or specific performance metrics for model predictions are not relevant. Instead, the acceptance criteria relate to functional performance and sterility assurance.
The studies conducted are primarily non-clinical design verification tests. There were no clinical studies submitted for this specific 510(k) notification.
Here's the breakdown of the information requested, adapting it to the content of the document:
-
A table of acceptance criteria and the reported device performance:
Acceptance Criterion (Design Input Verified) Reported Device Performance (Verification Testing Outcome) Vacuum Pump Performance: * Time to warm up across different power settings Pass * Pump startup across different power settings Pass * Pump current draw Pass * Environmental specifications Pass * Noise generation Pass * Time to pump an enclosed space to a defined pressure Pass * Fitment Pass * Weight (impact on total device weight, mentioned in comparison table) Modified device weighs 10 lb more, deemed acceptable * Qualitative verification of features (e.g., drain valve, liftable feature) Pass Sterilization Efficacy (for STANDARD and ADVANCED Cycles with new pump): * Sterility Assurance Level (SAL) of 10⁻⁶ for Geobacillus stearothermophilus (Biological Indicators - BIs) with no growth observed. This demonstrates no impact to efficacy. Pass (No growth observed on test BIs) Safety and Compatibility: * Biocompatibility (continued applicability of predicate data) Applicable * Electromagnetic compatibility (EMC) (continued applicability of predicate data) Applicable (no anticipated impact from notified body) * Electrical Safety (conformance to specific standards: CAN/CSA-C22.2 No. 61010-1, CAN/CSA-C22.2 No. 61010-2-040, UL 61010-1, IEC/EN 61010-1, IEC/EN 61010-2-40) Conforms to applicable standards * Software Verification and Validation (continued applicability of predicate data - no software changes) Applicable -
Sample sizes used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of units or test runs for the vacuum pump verification tests. For the sterilization efficacy testing, it mentions "test BIs" (Biological Indicators) but doesn't quantify the number used. For lumen validation, specifies "a maximum of 10 lumens per load" and "only one flexible endoscope per sterilization cycle."
- Data Provenance: The data is generated from non-clinical design verification testing performed by the manufacturer, Advanced Sterilization Products. The location or specific date of data generation isn't explicitly stated beyond the submission date (February 16, 2017). It is prospective with respect to the design modification.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document describes engineering and sterility validation, not AI algorithm performance requiring expert human interpretation as ground truth. The "ground truth" for sterilization efficacy is the sterility assurance level (SAL) demonstrated by no growth of highly resistant biological indicators.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None applicable. This is not a human-in-the-loop diagnostic study requiring expert adjudication. The "adjudication" is based on objective measurements and established sterilization standards.
-
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:
- No MRMC study was done. This is not an AI-assisted diagnostic device, but a sterilizer. The document explicitly states: "No clinical data is being submitted in support of this Premarket Notification."
-
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable. This is a physical sterilizer, not an algorithm. The "standalone" performance relates to the sterilizer's ability to achieve sterility on its own, which was tested.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for sterilization efficacy is established by objective microbial biological indicator testing. Specifically, the absence of growth of Geobacillus stearothermophilus to demonstrate a Sterility Assurance Level (SAL) of 10⁻⁶. This is a universally accepted method for validating sterilization processes. Other "ground truths" were successful mechanical and electrical performance according to engineering specifications and safety standards.
-
The sample size for the training set:
- Not applicable. This is not an AI device that uses a "training set." The device's operational parameters and design are based on engineering principles and previous validation, not machine learning.
-
How the ground truth for the training set was established:
- Not applicable. As above, no training set was used.
§ 880.6860 Ethylene oxide gas sterilizer.
(a)
Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.(b)
Classification. Class II (performance standards).