(56 days)
The V-PRO maX 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.
Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
The V-PRO maX Sterilizers' Non Lumen Cycle can sterilize: t
Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid, semi-rigid and flexible endoscopes.
t The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).
The V-PRO maX Sterilizer's Flexible Cycle can sterilize:
Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations:
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Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain single or dual channel lumens that are ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length. * The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).
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One flexible endoscope with a light cord (if not integral to endoscope accessories and mat, and additional instruments. ** The flexible endoscope may contain single or dual channel lumens that are ≥ 1 mm ID and ≤ 1050 mm in length
Additional instruments may include non-lumened or lumened medical devices with the following configurations:
Single, dual or triple channel stainless steel lumen that is ≥ 0.48 mm ID and ≤ 100 mm in length
** The validation studies were conducted with a flexible endoscope accessories, silicone mat, light cord (if not integral to endoscope) and 5 stainless steel lumens. Also included in the load was a tray with additional instruments and silicone mat for a total weight of 24 lbs (11 kg).
The V-PRO maX Sterilizers' Lumen Cycle can sterilize: * Medical devices with the following configurations:
· Single, dual or triple channeled stainless steel lumen that are:
- ≥ 0.77 mm ID and ≤ 527 mm in length
- ≥ 0.8 mm ID and ≤ 542 mm in length
- ≥ 0.48 mm ID and ≤ 100 mm in length
- · Dead end lumen that is ≥ 1.3 mm ID and ≤ 73 mm in length
- · Rigid non-metallic lumen (such as those used in endoscope sheaths, take-apart forceps and trocars) that are:
- ≥ 3 mm ID and ≤ 298 mm in length
- · ≥ 4 mm ID and
The V-PRO Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers.
The sterilizers have three or more of 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 Systems are intended for terminal sterilization of cleaned, rinsed, dried, and packaged reusable surgical instruments used in healthcare facilities.
The V-PRO Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The four preprogrammed cycles all use a conditioning phase, a sterilize phase and an aeration phase. The packaged sterilized devices are ready for use at the completion of the cycle, no cool down or aeration period is required following completion of the cycle.
The manufacturer is seeking 510(k) clearance for modifications to the V-PRO maX and V-PRO maX 2 Low Temperature Sterilization Systems. These modifications involve changes to the indications for use, specifically by simplifying claims descriptions for Flexible and Lumen Cycles, adding stainless steel lumen claims to the Flexible Cycle, adding non-metallic and stainless steel lumen claims to the Lumen Cycle, and adding diffusion-restricted materials for Non Lumen and Fast Non Lumen Cycles. No physical changes were made to the devices, only changes to the labeling (operator manual).
Here's an analysis of the acceptance criteria and the study presented:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a dedicated table for each performance outcome. Instead, it reports "PASS" for all tests, indicating that the device met the internal established criteria for each study. The underlying acceptance for sterilization efficacy is typically a complete kill of biological indicators, resulting in sterility.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| ½ Cycle Verification of Mated Surfaces | Demonstration of sterile efficacy for mated surfaces under worst-case conditions in the V-PRO Sterilizer cycles. (Implicitly, this means achieving sterility for the tested items.) | Sterile efficacy was demonstrated for mated surfaces under worst-case conditions in the V-PRO Sterilizer cycles. (PASS) |
| ½ Cycle Efficacy | Achieving all sterile results within the validation load used to qualify each sterilizer cycle when using the standard injection weight. (Implicitly, this means achieving sterility for the tested items.) | The standard injection weight resulted in all sterile results within the validation load used to qualify each sterilizer cycle. (PASS) |
| Simulated Use Test | Verification of the ability of the sterilizer cycles to sterilize medical devices under worst-case processing conditions. (Implicitly, this means achieving sterility for the tested items simulating real-world usage.) | Simulated use testing verified the ability of the sterilizer cycles to sterilize medical devices under worst-case processing conditions. (PASS) |
| In Use Test | Demonstration of the ability of the V-PRO Sterilizer cycles to sterilize patient-soiled, clinically-cleaned, medical instruments. (Implicitly, this means achieving sterility for the tested items in a clinical setting.) | The in use investigation demonstrated the ability of the V-PRO Sterilizer cycles to sterilize patient-soiled, clinically-cleaned, medical instruments. (PASS) |
2. Sample Size Used for the Test Set and Data Provenance:
- 1/2 Cycle Verification of Mated Surfaces: The document does not explicitly state the sample size for this test. It refers to "mated surfaces" and "worst-case conditions."
- 1/2 Cycle Efficacy: The document does not explicitly state the sample size. It refers to "the validation load used to qualify each sterilizer cycle."
- Simulated Use Test: The document does not explicitly state the sample size. It refers to "medical devices" and "worst-case processing conditions."
- In Use Test: The document does not explicitly state the sample size. It refers to "patient-soiled, clinically-cleaned, medical instruments."
For all tests, the provenance of the data (country of origin, retrospective or prospective) is not explicitly stated. However, given the context of a 510(k) submission to the U.S. FDA, it is highly probable that the studies were conducted in accordance with recognized standards, likely within the U.S. or using internationally recognized protocols acceptable to the FDA. The nature of these sterilization validation studies often involves prospective testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of information is not applicable to this submission. The "device" in question is a sterilization system, not a diagnostic or AI-driven decision support system that requires expert interpretation to establish ground truth (e.g., presence/absence of disease in an image). The "ground truth" in sterilization validation is binary: either sterility is achieved (e.g., biological indicator shows no growth) or it is not. This is typically determined by laboratory analysis of biological indicators, not expert consensus.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons mentioned above. Adjudication methods like 2+1 or 3+1 are used when there's subjective interpretation involved, such as in image analysis by multiple readers. Sterilization efficacy is an objective outcome measured by biological indicators.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is a sterilization system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical sterilization system, not an algorithm.
7. The type of ground truth used:
The ground truth used for these sterilization studies is based on biological indicator (BI) kill and potentially chemical indicator (CI) response, which are direct measures of sterilization efficacy. In sterilization validation, biological indicators containing a known resistant microorganism (e.g., Geobacillus stearothermophilus) are exposed to the sterilization process. The "ground truth" that sterility has been achieved is established when these biological indicators show no growth after incubation, indicating that the microorganisms have been inactivated. This is an objective, laboratory-derived ground truth.
8. The Sample Size for the Training Set:
This is not applicable. The device is a physical sterilization system. There is no "training set" in the context of machine learning. The "training" and "validation" in this field refer to the rigorous process of developing and confirming the sterilization cycle parameters to reliably achieve sterility across a defined range of medical devices and load configurations.
9. How the ground truth for the training set was established:
This is not applicable for the reasons stated above. There is no machine learning training set. The "ground truth" for establishing sterilization parameters is derived from extensive scientific and engineering studies testing the lethality of the sterilant under various conditions, typically using biological indicators and physical parameter monitoring. This involves determining the "D-value" (decimal reduction time) of the biological indicator organism and then designing a cycle that provides a sufficient "sterility assurance level" (SAL), often 10^-6, meaning a one-in-a-million chance of a non-sterile item.
§ 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).