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:

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).
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 < 424 mm in length

Validation testing for all lumen sizes was conducted using a maximum of 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 trays with silicone mats for a total weight of 19.65 lbs (8.9 kg).

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

September 9, 2022

Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060

Re: K222093

Trade/Device Name: V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: August 17, 2022 Received: August 18, 2022

Dear Anthony Piotrkowski:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Clarence W. Murray, III, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222093

Device Name

V-PRO maX Low Temperature Sterilization System

Indications for Use (Describe)

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:

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).
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 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 < 424 mm in length

Validation testing for all lumen sizes was conducted using a maximum of 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 trays with silicone mats for a total weight of 19.65 lbs (8.9 kg).

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Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the STERIS logo. To the left of the word STERIS is a blue image of what appears to be water waves. The word STERIS is in all caps and in a bold, sans-serif font.

510(k) Summary For

V-PRO® maX Low Temperature Sterilization Systems and V-PRO® maX 2 Low Temperature Sterilization Systems

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Contact:	Anthony PiotrkowskiDirector, Regulatory AffairsTel: 440-392-7437Fax: 440-357-9198Email: tony_piotrkowski@steris.com
Submission Date:	September 5, 2022
Premarket Notification Number:	K222093

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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Device Name 1.

Trade Name:	V-PRO® maX Low Temperature SterilizationSystem and V-PRO maX 2 Low TemperatureSterilization System
Device Class:	Class II
Common/usual Name:	Vapor Phase Hydrogen Peroxide Sterilizer
Classification Name:	Sterilizer, Ethylene Oxide Gas
Classification Number:	21 CFR 880.6860
Product Code:	MLR

2. Predicate Device

The claimed primary predicate device is the V-PRO maX and maX 2 Low Temperature Sterilization Systems, cleared most recently under K190103.

Table 5-1. A comparison between the proposed V-PRO maX Low Temperature Sterilization
System to the predicate device

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Table 5-2. A comparison between the proposed V-PRO maX 2 Low Temperature Sterilization System to the predicate device

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The proposed and predicate device are identical in all ways except their indications for use and consequently their labeling (operator manual).

3. Description of Device

The V-PRO Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers.

4. Intended Use / Indications for Use

The V-PRO Low Temperature Sterilization Systems using VAPROX HC Sterilant are 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.

The Indications for use are detailed in Tables 5.1 and 5.2 above. The differences between the proposed devices and predicate include:

Simplification of claims description for the Flexible and Lumen Cycles on both sterilizers
Addition of stainless steel lumen claims to Flexible Cycle on both sterilizers -
Addition of non-metallic and stainless steel lumen claims to Lumen Cycle on both sterilizers
Addition of diffusion restricted materials for Non Lumen and Fast Non Lumen -Cycles on both sterilizers

న్. Technological Characteristics

The proposed and predicate devices are identical in all technological characteristics including but not limited to: fundamental scientific technology, composition, mechanism of action, components and accessories. No physical changes were made to the devices for this modification other than labeling (operator manual).

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6. Summary of Testing to Support Substantial Equivalence

The proposed devices have the same intended use and the same technological characteristics as the predicate devices. Performance testing to assess and demonstrate substantial equivalence, based on risk assessment of the proposed change to the predicate is summarized below.

Test	Result	Conclusion
½ CycleVerification ofMated Surfaces	Sterile efficacy was demonstrated for mated surfacesunder worst case conditions in the V-PRO Sterilizercycles.	PASS
½ Cycle Efficacy	The standard injection weight resulted in all sterile resultswithin the validation load used to qualify each sterilizercycle.	PASS
Simulated UseTest	Simulated use testing verified the ability of the sterilizercycles to sterilize medical devices under worst-caseprocessing conditions.	PASS
In Use Test	The in use investigation demonstrated the ability of the V-PRO Sterilizer cycles to sterilize patient-soiled,clinically-cleaned, medical instruments.	PASS

7. Conclusions

The V-PRO maX Low Temperature Sterilization System has met the established performance criteria. Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performed as well as the legally marketed predicate device K190103, Class II (21 CFR 880.6860), product code MLR.

The V-PRO maX 2 Low Temperature Sterilization System has met the established performance criteria. Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performed as well as the legally marketed predicate device K190103, Class II (21 CFR 880.6860), product code MLR.

Regulation Number and Section

§ 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).

	V-PRO 1, V-PRO 1Plus, V-PRO maX LowTemperature Sterilization System(Predicate Device – K190103)	V-PRO maX Low Temperature SterilizationSystem (Modified Device) K222093
Feature

IntendedUse andIndicationsfor Use	The V-PRO 1, V-PRO 1 Plus and V-PRO maX LowTemperature Sterilization Systems using VAPROX HCSterilant are intended for use in the terminalsterilization of properly prepared (cleaned, rinsed anddried) medical devices in Healthcare Facilities. Thepreprogrammed sterilization cycles operate at lowpressure and temperature, suitable for processingmedical devices without leaving toxic residues.	The V-PRO maX Low Temperature SterilizationSystem using VAPROX HC Sterilant is intended foruse in the terminal sterilization of properly prepared(cleaned, rinsed and dried) medical devices inHealthcare Facilities. The preprogrammed sterilizationcycles operate at low pressure and temperature,suitable for processing medical devices without leavingtoxic residues.
	Each Cycle can sterilize non-lumened instruments withdiffusion-restricted spaces such as the hinged portionof forceps and scissors. Only stainless steel or titaniumdiffusion-restricted spaces should be processed in theNon Lumen Cycle.	Each Cycle can sterilize non-lumened instruments withdiffusion-restricted spaces such as the hinged portionof forceps and scissors.
	The V-PRO 1 Plus and V-PRO maX Sterilizers' NonLumen Cycle can sterilize: ‡Non-lumened instruments including non-lumenedgeneral medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.‡ The validation studies were conducted using avalidation load consisting of two instrument trays for atotal weight of 50 lbs (22.7 kg).	The V-PRO maX Sterilizers' Non Lumen Cycle cansterilize: ‡Non-lumened instruments including non-lumenedgeneral medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.‡ The validation studies were conducted using avalidation load consisting of two instrument trays for atotal weight of 50 lbs (22.7 kg).
	The V-PRO maX Sterilizer's Flexible Cycle cansterilize:Single or dual lumen surgical flexible endoscopes(such as those used in ENT, Urology and SurgicalCare) and bronchoscopes in either of the two loadconfigurations:	The V-PRO maX Sterilizer's Flexible Cycle cansterilize:Single or dual lumen surgical flexible endoscopes(such as those used in ENT, Urology and SurgicalCare) and bronchoscopes in either of the twoconfigurations:
Feature	V-PRO 1, V-PRO 1Plus, V-PRO maX LowTemperature Sterilization System(Predicate Device – K190103)	V-PRO maX Low Temperature SterilizationSystem (Modified Device) K222093
	1. Two flexible endoscopes with a light cord (if notintegral to endoscope) and mat with no additional load.* The flexible endoscopes may contain either:• A single lumen that is ≥ 1 mm internal diameter (ID)and ≤ 1050 mm in length• Or two lumens with:■ One lumen that is ≥ 1 mm ID and ≤ 990 mmin length■ And the other lumen that is ≥ 1 mm ID and ≤850 mm in length* The validation studies were conducted with twoflexible endoscopes, each packaged into a tray withsilicone mat and light cord (if not integral toendoscope).	1. Two flexible endoscopes with a light cord (if notintegral to endoscope) and mat with no additional load.* The flexible endoscopes may contain single or dualchannel lumens that are ≥ 1 mm internal diameter (ID)and ≤ 1050 mm in length.* The validation studies were conducted with twoflexible endoscopes, each packaged into a tray withsilicone mat and light cord (if not integral toendoscope).
	2. One flexible endoscope with a light cord (if notintegral to endoscope) and mat and additional non-lumened instruments. †† The flexible endoscope maycontain either:• A single lumen that is ≥ 1 mm ID and ≤ 1050 mm inlength• Or two lumens with:■ One lumen that is ≥ 1 mm ID and ≤ 990 mmin length■ And the other lumen is ≥ 1 mm ID and ≤ 850mm in length.†† The validation studies were conducted with a flexibleendoscope in a tray with silicone mat and light cord (ifnot integral to endoscope). Also included in the loadwere an additional instrument tray and one pouch for atotal weight of 24 lbs (11 kg).	2. One flexible endoscope with a light cord (if notintegral to endoscope), endoscope accessories and mat,and additional instruments. †† The flexible endoscopemay contain single or dual channel lumens that are ≥ 1mm ID and ≤ 1050 mm in length■ Additional instruments may include non-lumenedor lumened medical devices with the followingconfigurations:■ Single, dual or triple channel stainless steellumen that is■ ≥ 0.48 mm ID and ≤ 100 mm in length†† The validation studies were conducted with a flexibleendoscope in a tray with endoscope accessories,silicone mat, light cord (if not integral to endoscope)and 5 stainless steel lumens. Also included in the loadwas a tray with additional instruments and silicone matfor a total weight of 24 lbs (11 kg).
	The V-PRO 1, V-PRO 1 Plus and V-PRO maXSterilizers' Lumen Cycle can sterilize: †Medical devices (including single, dual and triplechanneled rigid and semi-rigid endoscopes) with thefollowing configurations:• Single channeled devices with a stainless lumen thatis ≥ 0.77 mm ID and ≤ 500 mm in length• Single channeled devices with a stainless lumen thatis ≥ 1.8 mm ID and ≤ 542 mm in length• Dual channeled devices with stainless lumens thatare ≥ 0.77 mm ID and ≤ 527 mm in length• Triple channeled devices with stainless lumens thatare either:■ ≥ 1.2 mm ID and ≤ 275 mm in length■ ≥ 1.8 mm ID and ≤ 310 mm in length or■ ≥ 2.8 mm ID and ≤ 317 mm in length† Validation testing for all lumen sizes was conductedusing a maximum of 20 lumens per load. Hospitalloads should not exceed the maximum number oflumens validated by this testing. The validation studieswere performed using a validation load consisting oftwo instrument trays and two pouches for a total weight	The V-PRO maX Sterilizers' Lumen Cycle cansterilize: † Medical devices with the followingconfigurations:• Single, dual or triple channeled stainless steel lumenthat 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 inlength• Rigid non-metallic lumen (such as those used inendoscope sheaths, take-apart forceps and trocars)that are:■ ≥ 3 mm ID and ≤ 298 mm in length■ ≥ 4 mm ID and ≤ 424 mm in length† Validation testing for all lumen sizes was conductedusing a maximum of 20 lumens per load. Hospitalloads should not exceed the maximum number oflumens validated by this testing. The validation studieswere performed using a validation load consisting oftwo trays with silicone mats for a total weight of 19.65lbs (8.9 kg).
Feature	V-PRO 1, V-PRO 1Plus, V-PRO maX LowTemperature Sterilization System(Predicate Device – K190103)	V-PRO maX Low Temperature SterilizationSystem (Modified Device) K222093
ProcessParameters	The critical process parameters are:• Time• Chamber Temperature• Vaporizer Temperature• Chamber Pressure Prior to Injection• Sterilant Injection Weight	The critical process parameters are:• Time• Chamber Temperature• Vaporizer Temperature• Chamber Pressure Prior to Injection• Sterilant Injection Weight
Software/FirmwareControlled	Control system consists of a proprietarymicrocomputer control board and peripheral functioncircuit boards, located within the control housing. Amemory backup system maintains user settings andcalibration data indefinitely. Up to 300 cycle data filescan be stored for review or downloading by the user.	Control system consists of a proprietarymicrocomputer control board and peripheral functioncircuit boards, located within the control housing. Amemory backup system maintains user settings andcalibration data indefinitely. Up to 300 cycle data filescan be stored for review or downloading by the user.
TotalCycleTime	The software allows user selection of either the Lumen,Non Lumen or Flexible pre-programmed cycle.Lumen Cycle - 55 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 35 minutes	The software allows user selection of either the Lumen,Non Lumen or Flexible pre-programmed cycle.Lumen Cycle - 55 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 35 minutes
Sterilant	VAPROX HC Sterilant (59% Hydrogen Peroxide).	VAPROX HC Sterilant (59% Hydrogen Peroxide).
Accessories	Accessories were submitted under separate, individual,concurrent 510(k)s and cover the following:• Self-contained biological indicator• Biological indicator challenge pack• Fast Acting Biological Indicator• Chemical indicator• Trays & Tray Accessories• Pouches	Accessories were submitted under separate, individual,concurrent 510(k)s and cover the following:• Self-contained biological indicator• Biological indicator challenge pack• Fast Acting Biological Indicator• Chemical indicator• Trays & Tray Accessories• Pouches

Feature	V-PRO maX 2 Low Temperature Sterilization System (Predicate Device/K190103)	V-PRO maX 2 Low Temperature Sterilization System (Modified Device) K222093
	The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant are 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.	The V-PRO maX 2 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.
Indicationsfor Use	Each Cycle can sterilize non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle and the Fast Non Lumen Cycle.	Each Cycle can sterilize non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
	The Non Lumen Cycle can sterilize: ‡Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.	The Non Lumen Cycle can sterilize: ‡Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.
Feature	V-PRO maX 2 Low Temperature SterilizationSystem (Predicate Device/K190103)	V-PRO maX 2 Low Temperature SterilizationSystem (Modified Device) K222093
	† The validation studies were conducted using avalidation load consisting of two instrument trays for atotal weight of 50 lbs (22.7 kg).	† The validation studies were conducted using avalidation load consisting of two instrument trays for atotal weight of 50 lbs (22.7 kg).
	The Fast Non Lumen Cycle can sterilize:Non-lumened instruments including non-lumenedgeneral medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. The validation studies were conducted using avalidation load consisting of one pouched instrumenttray for a total weight of 11 lbs (5 kg).	The Fast Non Lumen Cycle can sterilize:Non-lumened instruments including non-lumenedgeneral medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. The validation studies were conducted using avalidation load consisting of one pouched instrumenttray for a total weight of 11 lbs (5 kg).
	The Flexible Cycle can sterilize:Single or dual lumen surgical flexible endoscopes(such as those used in ENT, Urology and SurgicalCare) and bronchoscopes in either of the twoconfigurations:1. Two flexible endoscopes with a light cord (if notintegral to endoscope) and mat with no additionalload.* The flexible endoscopes may contain either:• A single lumen that is ≥ 1 mm internal diameter(ID) and ≤ 1050 mm in length• Or two lumens with:One lumen that is ≥ 1 mm ID and ≤ 990mm in lengthAnd the other lumen that is ≥ 1 mm ID and≤ 850 mm in length* The validation studies were conducted with twoflexible endoscopes, each packaged into a tray withsilicone mat and light cord (if not integral to	The Flexible Cycle can sterilize:Single or dual lumen surgical flexible endoscopes(such as those used in ENT, Urology and SurgicalCare) and bronchoscopes in either of the twoconfigurations:1. Two flexible endoscopes with a light cord (if notintegral to endoscope) and mat with no additionalload.* The flexible endoscopes may contain single ordual channel lumens that are ≥ 1 mm internal diameter(ID) and ≤ 1050 mm in length.* The validation studies were conducted with twoflexible endoscopes, each packaged into a tray withsilicone mat and light cord (if not integral toendoscope).
	endoscope).2. One flexible endoscope with a light cord (if notintegral to endoscope) and mat and additional non-lumened instruments. †† The flexible endoscope maycontain either:• A single lumen that is ≥ 1 mm ID and ≤ 1050 mmin length• Or two lumens with:One lumen that is ≥ 1 mm ID and ≤ 990mm in lengthAnd the other lumen is ≥ 1 mm ID and ≤850 mm in length.†† The validation studies were conducted with a flexibleendoscope in a tray with silicone mat and light cord (ifnot integral to endoscope). Also included in the loadwere an additional instrument tray and one pouch for atotal weight of 24 lbs (11 kg).	2. One flexible endoscope with a light cord (if notintegral to endoscope), endoscope accessories, mat andadditional non-lumened instruments. †† The flexibleendoscope may contain single or dual channel lumensthat are ≥ 1 mm ID and ≤ 1050 mm in length■ Additional instruments may include non-lumenedor lumened medical devices with the followingconfigurations:■ Single, dual or triple channel stainless steellumen that is ≥ 0.48 mm ID and ≤ 100 mm inlength†† The validation studies were conducted with a flexibleendoscope in a tray with endoscope accessories,silicone mat, light cord (if not integral to endoscope)and 5 stainless steel lumens. Also included in the loadwas a tray with additional instruments, and silicone matfor a total weight of 24 lbs (11 kg).
	The Lumen Cycle can sterilize: †Medical devices (including single, dual and triplechanneled rigid and semi-rigid endoscopes) with thefollowing configurations:• Single channeled devices with a stainless lumen thatis ≥ 0.77 mm ID and ≤ 500 mm in length	The Lumen Cycle can sterilize: †Medical devices with the following configurations:• Single, dual or triple channeled stainless steel lumenthat are:• ≥ 0.77 mm ID and ≤ 527 mm in length• ≥ 0.8 mm ID and ≤ 542 mm in length
Feature	V-PRO maX 2 Low Temperature SterilizationSystem (Predicate Device/K190103)	V-PRO maX 2 Low Temperature SterilizationSystem (Modified Device) K222093
	• Single channeled devices with a stainless lumen thatis $\ge$ 1.8 mm ID and $\le$ 542 mm in length	• $\ge$ 0.48 mm ID and $\le$ 100 mm in length
	• Dual channeled devices with stainless lumens thatare $\ge$ 0.77 mm ID and $\le$ 527 mm in length	• Dead end lumen that is $\ge$ 1.3 mm ID and $\le$ 73 mm inlength
	• Triple channeled devices with stainless lumens thatare either:	• Rigid non-metallic lumen (such as those used inendoscope sheaths, take-apart forceps and trocars)that are:
	$\ge$ 1.2 mm ID and $\le$ 275 mm in length$\ge$ 1.8 mm ID and $\le$ 310 mm in lengthor$\ge$ 2.8 mm ID and $\le$ 317 mm in length	• $\ge$ 3 mm ID and $\le$ 298 mm in length• $\ge$ 4 mm ID and $\le$ 424 mm in length
	† Validation testing for all lumen sizes was conductedusing a maximum of 20 lumens per load. Hospitalloads should not exceed the maximum number oflumens validated by this testing. The validation studieswere performed using a validation load consisting oftwo instrument trays and two pouches for a total weightof 19.65 lbs (8.9 kg).	† Validation testing for all lumen sizes was conductedusing a maximum of 20 lumens per load. Hospitalloads should not exceed the maximum number oflumens validated by this testing. The validation studieswere performed using a validation load consisting oftwo instrument trays and two pouches for a total weightof 19.65 lbs (8.9 kg).
ProcessParameters	The critical process parameters are:• Time• Chamber Temperature• Vaporizer Temperature• Chamber Pressure Prior to Injection• Sterilant Injection Weight	The critical process parameters are:• Time• Chamber Temperature• Vaporizer Temperature• Chamber Pressure Prior to Injection• Sterilant Injection Weight
Software/FirmwareControlled	Control system consists of a proprietarymicrocomputer control board and peripheral functioncircuit boards, located within the control housing. Amemory backup system maintains user settings andcalibration data indefinitely. Up to 300 cycle data filescan be stored for review or downloading by the user.The software allows user selection of either the Lumen,Non Lumen, Flexible or Fast Non Lumen pre-programmed cycle.	Control system consists of a proprietarymicrocomputer control board and peripheral functioncircuit boards, located within the control housing. Amemory backup system maintains user settings andcalibration data indefinitely. Up to 300 cycle data filescan be stored for review or downloading by the user.The software allows user selection of either the Lumen,Non Lumen, Flexible or Fast Non Lumen pre-programmed cycle.
TotalCycleTime	Lumen Cycle - 52 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 35 minutesFast Non Lumen Cycle – 16 minutes	Lumen Cycle - 52 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 35 minutesFast Non Lumen Cycle – 16 minutes
Sterilant	VAPROX HC Sterilant (59% Hydrogen Peroxide).The same amount of sterilant is injected for each of thesterilization pulses for all four cycles.	VAPROX HC Sterilant (59% Hydrogen Peroxide).The same amount of sterilant is injected for each of thesterilization pulses for all four cycles.
	Sterilant Cup is read by an RFID reader.	Sterilant Cup is read by an RFID reader.
Accessories	Accessories were submitted under separate, individual,concurrent 510(k)s and cover the following:• Self-contained biological indicator• Biological indicator challenge pack• Fast Acting Biological Indicator• Chemical indicator• Trays & Tray Accessories• Pouches	Accessories were submitted under separate, individual,concurrent 510(k)s and cover the following:• Self-contained biological indicator• Biological indicator challenge pack• Fast Acting Biological Indicator• Chemical indicator• Trays & Tray Accessories• Pouches
	• Tape	• Tape