(423 days)
The V-PRO 1 Low Temperature Sterilization System and Vaprox® HC Hydrogen Peroxide Sterilant (59%) are intended for use in terminal sterilization of cleaned, rinsed, and dried, reusable metal and nonmetal medical devices used in healthcare facilities.
The V-PRO 1 Low Temperature Sterilization System can sterilize*:
- Instruments with diffusion-restricted spaces such as the hinged portion of . forceps and scissors.
- Medical devices with a single stainless steel lumen with: .
- an inside diameter of 1 mm or larger and a length of 125 mm or shorter o
- an inside diameter of 2 mm or larger and a length of 250 mm or shorter o
- an inside diameter of 3 mm or larger and a length of 400 mm or shorter o
- The validation testing for all lumen sizes was conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs,
The STERIS Amsco V-PRO Low Temperature Sterilizer is a self contained standalone device, using vaporized hydrogen peroxide as the sterilant. The sterilizer is intended for use in the terminal sterilization of cleaned, rinsed, and dried, reusshle metal and nonmetal medical devices used in healthcare facilities. The sterilization cycle operates at low pressure and temperatures, and is therefore suits ator processing medical devices sensitive to heat and moisture. The hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into a vaporization chamber where the solution is heated and converted to a vapor, and then introduced into the sterilizer chamber under negative pressure.
The equipment (hardware) for the V-PRO 1 Sterilizer is similar to that of the predicate device (Sterrad 100S Sterilizer System). The hardware consists of a welded frame onto which is mounted the sterilization chamber along with a variety of instruments and components, controls, piping, vacuum pump, housed in a covered frame of stainless steel panels. The V-PRO 1 Sterilizer also uses accessories such as disposable multiple use sterilant cartridge, reusable instrument trays, printer paper and ink cartridges.
Acceptance Criteria and Device Performance for Amsco® V-PRO™ 1 Low Temperature Sterilization System
This document describes the acceptance criteria and the study used to demonstrate that the Amsco® V-PRO™ 1 Low Temperature Sterilization System meets these criteria, as derived from the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the Amsco® V-PRO™ 1 Low Temperature Sterilization System is sterility, defined as a Sterility Assurance Level (SAL) of 10⁻⁶. This means that the probability of a single viable microorganism remaining on an item after sterilization is one in a million.
The studies presented extensively use "sterility" of all tested items as the performance metric, indicating that no viable microorganisms (specifically Geobacillus stearothermophilus spores) were recovered after processing.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Sterility (SAL of 10⁻⁶) | All tested items across various scenarios (surface, mated, lumen, pouched, simulated use, in-use) were sterile. An "all kill endpoint" was demonstrated for 2, 3, and 4 pulse cycles, establishing an SAL of 10⁻⁶. |
| Effective for Surface Sterilization | All coupons tested in ½ cycles were sterile, demonstrating efficacy on various medical device materials. |
| Effective for Mated Surfaces | All coupons (metallic and polymer carriers) tested in ½ cycles were sterile, demonstrating efficacy on closely-opposed surfaces. |
| Effective for Lumen Sterilization | All lumens of various sizes (1x125mm, 2x250mm, 3x400mm) were sterile after ½ cycle. |
| Effective for Tyvek/Mylar Pouched Devices | All lumens of various sizes in pouches were sterile after ½ cycle. |
| Effective under Reduced Peroxide (Worst-Case Lumen) | All 3x400mm lumens were sterile at standard (2.1g) and reduced (1.457g) hydrogen peroxide injection weights. |
| No Toxic Sterilant Residuals | Cytotoxicity and in vivo biocompatibility testing showed no toxic sterilant residuals. |
| Sterility in Simulated Use Conditions | All 114 device sites across 16 devices were sterile after full cycle with and without cleaning. |
| Sterility in In-Use Clinical Conditions | All 42 device sites across 12 devices were sterile after full cycle with clinical soiling and cleaning. |
| Software Validation | Software validation complied with FDA's "moderate level of concern" recommendations. |
| Risk Management | Software and equipment risk management plans and analyses (FMECA, FTA) were performed. |
| Compliance with Standards | Met UL 61010-1, CSA 22.2 No. 1010.1, MDD 93/42/EEC, EN61010-1, EN60601-1-2. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly use the term "test set" in the context of machine learning. Instead, it describes various validation studies for the sterilizer's performance. The sample sizes for these studies are:
- Surface Sterilization of Medical Device Materials: "a wide variety of medical device materials" (specific number not given, but refers to multiple coupons).
- Mated Surfaces: "metallic and polymer carriers" (specific number not given, but includes stainless steel, Ultem, Radel, Delrin, Noryl).
- Lumen Sterilization - Worst Case Lumen Size: Three lumen sizes (1x125mm, 2x250mm, 3x400mm stainless steel) were tested to determine the worst case.
- Half Cycle Verification at Multiple Peroxide Injection Weights Worse Case Lumen Size: The 3x400mm lumen was tested at five injection weights. "All lumens" were sterile at two specific weights. The validation testing for all lumen sizes was conducted using a maximum of twenty (20) lumens per load.
- Half Cycle Verification of Lumen Claims: Three lumen sizes (1x125mm, 2x250mm, 3x400mm) were tested. "All lumens of each size" were sterile.
- Tyvek/Mylar Pouched Device Sterilization: Test articles of lumen sizes of 1x125mm, 2x250mm, and 3x400mm stainless steel were used. "All lumens of each size" were sterile.
- AOAC Sporicidal carrier testing: "None of the carriers" demonstrated growth.
- Modified Total Kill Endpoint Bracket Testing: Cycles consisting of 1, 3, and 4 pulses were evaluated. Two-pulse cycles were evaluated in a prior study.
- Simulated Use Testing: A total of 16 devices with 19 inoculated sites (multiple sites per device, lumens and surface sites) were tested in each cycle, with three replicate cycles performed with and without cleaning conditions. This equates to a total of 114 device sites tested.
- In-Use Sterility Testing: A total of 12 devices were tested with 14 inoculated sites evaluated. This equates to a total of 42 device sites tested across three trials.
Data Provenance: The data appears to be prospective and internal to STERIS Corporation, generated purely for the purpose of validating the device. The "In-Use" testing mentions devices used in "routine surgeries at a local hospital," indicating some practical application for that specific test, but the overall testing is laboratory-controlled. Country of origin is not explicitly stated but implied to be the US given the submission to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device validation (sterilizer) typically relies on microbiological testing rather than expert human interpretation of images or observations. Therefore, the concept of "experts" establish ground truth in the way it applies to diagnostic AI is not directly applicable here.
The "ground truth" for sterility is established through:
- Presence or absence of growth of Geobacillus stearothermophilus: This is a direct biological measure.
- AOAC Sporicidal carrier testing: This adheres to specific guidelines and methods established by a scientific association.
While trained microbiologists would conduct and interpret these tests, the decision of "sterile" or "not sterile" is based on observable biological outcomes (e.g., bacterial growth) and validated test protocols, not subjective expert consensus in the same vein as a physician reading an image.
4. Adjudication Method for the Test Set
Given the nature of microbiological testing, an "adjudication method" involving multiple experts resolving discrepancies is generally not applicable. The endpoints (growth/no growth) are typically objective.
The "overkill" method for validation implies a rigorous approach where the device is tested under conditions that are more challenging than typical use, ensuring a wide margin of safety. If any growth were observed, it would typically lead to a failure of that test condition, requiring re-evaluation or modification of the process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that assist human readers in interpreting medical data (e.g., radiologists reading images). The Amsco® V-PRO™ 1 Low Temperature Sterilization System is a standalone sterilization device and does not involve human interpretation in its primary function.
6. Standalone (Algorithm Only Without Human-In-The-Loop Performance) Study
Yes, the entire series of physical validation studies constitutes a standalone performance evaluation of the sterilization device. The device's ability to achieve sterility is tested directly, without human intervention in the sterilization process itself or in the primary assessment of sterility (which is microbiologically determined).
7. The Type of Ground Truth Used
The primary ground truth used is microbiological evidence of sterility, specifically the absence of viable Geobacillus stearothermophilus spores.
- This is achieved by inoculating samples with a known resistant microorganism, subjecting them to the sterilization process, and then culturing them to detect any surviving organisms.
- Secondary ground truths include toxicity testing (cytotoxicity, in vivo biocompatibility) to ensure no harmful residuals.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. The Amsco® V-PRO™ 1 Low Temperature Sterilization System is a physical sterilization device, not a machine learning algorithm that requires training data. The validation studies described are testing the physical device's performance, not "training" it.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of this device, this question is not applicable.
§ 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).