Search Results

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.

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.

Ask a specific question about this device

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 Sterilization chamber has a capacity of 4.4 cu. ft. (125 liters). It requires oxygen (94% pure and greater), electricity and the 125-280 Solution™ containing 50% hydrogen peroxide by weight. Both hydrogen peroxide and ozone are used in a multiphase process.

The STERIZONE® VP4 Sterilizer is equipped with a factory-programmed control system offering a unique sterilization cycle.

Processed medical instruments are ready to use immediately after the cycle ends; no aeration is required.

Polypropylene non-woven wrapping material, non-woven polyethylene (Tyvek™) with polyester/LDPE transparent film pouches, and vaporized hydrogen peroxide compatible aluminium containers using disposable polypropylene filters, are used as packaging for medical devices to be sterilized. Plastic and metal trays are also suitable packaging means when combined with polypropylene wraps.

A self-contained biological indicator containing spores of G. stearothermophilus, incorporated into a test pack, is recommended to monitor cycle performance.

The STERIZONE® VP4 Sterilizer could be installed as a free standing unit or recessed behind the wall.

No exhaust gas ventilation duct is required as long as the room is adequately ventilated.

The document is a 510(k) premarket notification for the STERIZONE® VP4 Sterilizer, which is intended for terminal sterilization of reusable medical devices in healthcare facilities. It provides information regarding the device's indications for use, its sterilization process, safety and effectiveness testing, and a comparison to predicate devices to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents "Performance Requirements for Effectiveness" and "Performance Requirements for Safety" for the STERIZONE® VP4 Sterilizer, along with the results.

2. Sample Size Used for the Test Set and Data Provenance:

The "Effectiveness" validation was demonstrated using a "representative sample of one or more device types and packaging, in seven separate validation loads" (Table 1 and 2, pages 2-3 and 7-8). Each load contained various medical instruments representing different geometries and packaging types. The specific number of individual devices or biological indicators within each load is not explicitly stated as a "sample size" in the way it might be for a clinical trial. Instead, the "overkill" approach mentions inoculating medical devices with 10^6 microorganisms, implying a high concentration of test organisms rather than a large count of unique physical samples being tested. This type of testing is generally prospective, designed specifically for validation. The country of origin of the data is not explicitly stated, but the applicant's address is in Quebec, Canada, suggesting Canadian provenance for at least some of the underlying work.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This type of sterilization efficacy testing does not typically rely on human expert consensus for "ground truth" in the same way as, for example, image interpretation. The ground truth for sterilization is established through microbiological testing (e.g., demonstrating the eradication of 10^6 microorganisms, achieving a sterility assurance level (SAL) of 10^-6), and chemical analysis for residue. The document does not specify the number or qualifications of experts involved in analyzing these microbiological and chemical results, as these are standardized laboratory procedures.

4. Adjudication Method for the Test Set:

Not applicable in the context of sterilization device validation. Adjudication methods like "2+1" are used in studies involving subjective human interpretation, such as clinical image reading. Sterilization efficacy is determined by objective microbiological and chemical tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret outputs, often looking at how AI assistance changes their performance. For a sterilizer, the focus is on the device's inherent ability to achieve sterility, not on human interpretation of data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the effectiveness testing describes the standalone performance of the STERIZONE® VP4 Sterilizer. The entire study focuses on the device's ability to sterilize medical devices on its own, independent of human intervention during the sterilization cycle once initiated. The "half-cycle validation testing," "simulated-use testing," and "in-use testing" all evaluate the device's performance directly.

7. The Type of Ground Truth Used:

The primary ground truth used for effectiveness testing is microbiological efficacy, specifically demonstrating a sterility assurance level (SAL) of 10^-6, which means a probability of one non-sterile item in a million. This is achieved through controlled inoculation of medical devices with a known quantity (10^6) of highly resistant microorganisms (e.g., Geobacillus stearothermophilus spores) and verifying their eradication after sterilization. Secondary ground truths include chemical analysis to ensure the absence of toxic residues and by-products.

8. The Sample Size for the Training Set:

This document does not describe a "training set" in the context of machine learning. The STERIZONE® VP4 Sterilizer is not an AI/ML device in the sense of requiring a training set of data for an algorithm to learn from. The "training" for a sterilization device would be the engineering design, development, and iterative testing that precedes the final validation studies.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as the device is not an AI/ML device that requires a training set and corresponding ground truth. The "ground truth" during the development and design phases would be based on established principles of microbiology, chemistry, and engineering for effective and safe sterilization.

Ask a specific question about this device