(190 days)
The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.
The STERIZONE® VP4 Sterilizer (VP4) is a self-contained stand-alone device, using vaporized hydrogen peroxide and ozone in a multiphase process. The VP4 offers a single sterilization cycle intended for general instruments, flexible endoscopes (including single, dual, and multi-channel devices), and rigid-channel devices (including single-channel and doublechannel rigid endoscopes).
Lumen claims for the VP4 have been expanded to include double and multiple-channel devices with no more than four channels.
This document describes the STERIZONE® VP4 Sterilizer, a device for terminal sterilization of reusable medical devices. The primary purpose of the submission is to expand the lumen claims for flexible endoscopes.
Here's an analysis of the provided text for acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for this device is the achievement of a sterility assurance level (SAL) of 10^-6. The reported device performance indicates that this SAL was achieved.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterility Assurance Level (SAL) of 10^-6 | Achieved (demonstrated through "overkill" approach and half-cycle testing on directly inoculated medical devices) |
2. Sample Size Used for the Test Set and Data Provenance
The test set consisted of nine separate validation loads, as described in Table 1 (pages 2-3 and 5-6). Each load contained a representative sample of one or more device types and packaging. The specific contents of each validation load are detailed, including various surgical instruments and different types of endoscopes (single-channel flexible, multi-channel flexible, rigid, and semi-rigid channeled instruments).
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data. However, given that this is a premarket notification to the FDA, it is highly likely that the data was generated prospectively as part of the device's validation testing. The applicant's address in Canada suggests the studies may have been conducted there or in collaboration with Canadian institutions, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device validation (sterilization) does not typically involve human experts establishing "ground truth" in the way that image interpretation for diagnostics would. Instead, the ground truth for sterilization effectiveness is established through microbiological testing. For this device, the "overkill" approach was used, involving directly inoculated medical devices. The performance is measured by the complete killing of highly resistant microorganisms (e.g., bacterial spores as biological indicators). Therefore, experts in microbiology and sterilization validation would design and oversee these tests, but the "truth" is an objective, measurable outcome (sterility). The document does not specify the number or specific qualifications of such experts, but it is implied that these studies were conducted by qualified personnel in accordance with established standards (ANSI/AAMI/ISO 14937).
4. Adjudication Method for the Test Set
Not applicable. As described above, the effectiveness of a sterilizer is determined by objective microbiological testing, not by expert adjudication of various interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is a sterilization device, not an imaging or diagnostic device that requires human interpretation. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the effectiveness testing described is a standalone performance evaluation of the STERIZONE® VP4 Sterilizer. The device's ability to sterilize medical instruments to a specified SAL is assessed independently of human intervention during the sterilization cycle itself. The testing focused purely on the physical and chemical processes of the sterilizer.
7. The Type of Ground Truth Used
The ground truth used is microbiological proof of sterility, specifically demonstrating a Sterility Assurance Level (SAL) of 10^-6. This is achieved by challenging the sterilizer with a high number of highly resistant microorganisms (typically bacterial spores as biological indicators) directly inoculated onto medical devices. The complete inactivation of these microorganisms after a half-cycle exposure ensures that a full cycle would achieve the required SAL.
8. The Sample Size for the Training Set
Not applicable in the conventional sense of machine learning. This device is a physical sterilizer and its performance is based on well-understood physical/chemical principles, not a machine learning model that requires a "training set." The "training" for such a device would be its engineering design and optimization, which is not described in terms of a data set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained in point 8, there isn't a "training set" with associated ground truth in the context of this physical device. The device's design and parameters are established through engineering principles, scientific understanding of sterilization, and iterative testing/optimization based on microbiological efficacy.
§ 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).