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.

Each Cycle can sterilize non-luments 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 Fast Non Lumen Cycle.

The Non Lumen Cycle can sterilize: †

Non-lumened instruments including non-luments, non-luments, non-lumened 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 Fast Non Lumen Cycle can sterilize: *

Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes.

The validation studies were conducted using a validation load consisting of one pouched instrument tray 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 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 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 mm in length
- And the other lumen that is ≥ 1 mm ID and ≤ 850 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) and mat and additional non-lumened instruments. ++ The flexible endoscope may contain either:

• A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length

• Or two lumens with:

One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length.

** The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg).

The Lumen Cycle can sterilize: †

Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:

Single channeled devices with a stainless lumen that is > 0.77 mm ID and ≤ 500 mm in length
Dual channeled devices with stainless lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length
· Triple channeled devices with stainless lumens that are either:
- ≥ 1.2 mm ID and ≤ 275 mm in length
- 1.8 mm ID and < 310 mm in length

≥ 2.8 mm ID and ≤ 317 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 instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg).

Device Description

The V-PRO maX 2 Low Temperature Sterilization System is a new vaporized hydrogen peroxide sterilizer model to be added to the STERIS V-PRO family of sterilizers. The V-PRO product line currently consists of the Amsco V-PRO 1, Amsco V-PRO 1 Plus, V-PRO maX and V-PRO 60 Sterilizers.

As with the predicate device (K162413), the V-PRO maX 2 Sterilizer has three preprogrammed cycles (the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycle) with a fourth added (the Fast Non Lumen Cycle). The V-PRO maX 2 Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities.

The V-PRO maX 2 Sterilizer uses VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Its four preprogrammed cycles all utilize 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 provided text describes the V-PRO® maX 2 Low Temperature Sterilization System, a medical device for sterilizing instruments. It is a 510(k) premarket notification, indicating it is intended to be substantially equivalent to a predicate device, not a new type of device requiring extensive clinical trials for efficacy. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to performance tests demonstrating substantial equivalence to the predicate device and the general efficacy of the sterilization process.

Here's an breakdown based on your request, interpreting "acceptance criteria" as the required successful outcomes of the performance tests for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Name	Acceptance Criteria (Implied)	Reported Device Performance
AOAC Sporicidal Test	All carriers must be sterile, demonstrating killing of spores.	All 720 carriers processed using 3 lots of EOSL sterilant were sterile.
Determination of D-value and Total Kill Endpoint	Achieve greater than a 12 log reduction of the most resistant organism within all cycles.	Greater than a 12 log reduction of the most resistant organism is achieved within all cycles (Lumen Cycle, Non Lumen Cycle, Flexible Cycle and Fast Non Lumen) of the V-PRO maX 2 Sterilizer.
1/2 Cycle Modified Total Kill Endpoint Verification	All sterile results within the validation load for standard and at least one lower injection weight. Partial positives or all survive results seen at even lower injection weights.	Modified total kill end point analysis was demonstrated for all four V-PRO maX 2 Sterilizer cycles. The standard injection weight of 2.1 g and at least one lower injection weight resulted in all sterile results within the validation load used to qualify each sterilizer cycle. Partial positives or all survive results were seen at lower injection weights.
1/2 Cycle Sterilization Verification of Cycle Claims	Each cycle must reproducibly sterilize specified load configurations under worst-case conditions in 1/2 cycle.	- The Lumen Cycle reproducibly sterilizes single, dual and triple lumen devices under worst case conditions in 1/2 Cycle.- The Flexible Cycle reproducibly sterilizes 1 x 990 mm flexible endoscope lumens under worst case conditions in 1/2 Cycle.- The Non Lumen Cycle reproducibly sterilizes non-lumened devices under worst case conditions in 1/2 Cycle.- The Fast Non Lumen Cycle reproducibly sterilizes non-lumened devices under worst case conditions in 1/2 Cycle.
½ Cycle Verification of Mated Surfaces	Demonstrate sterile efficacy for mated surfaces under worst-case conditions.	Sterile efficacy was demonstrated for mated surfaces under worst case conditions.
Simulated Use Test	Verify the ability of the sterilizer cycles to sterilize medical devices under worst-case processing conditions.	Simulated use testing verified the ability of the V-PRO maX 2 Sterilizer cycles to sterilize medical devices under worst case processing conditions.
In Use Test	Demonstrate the ability of the sterilizer cycles to sterilize patient-soiled, clinically-cleaned, medical instruments.	The in use investigation demonstrated the ability of the V-PRO maX 2 Sterilizer cycles to sterilize patient-soiled, clinically-cleaned, medical instruments.
Biocompatibility	Demonstrate biocompatibility of materials after processing.	Cytotoxicity and residue analysis of 23 materials have demonstrated biocompatibility after processing in the V-PRO 60 Sterilizer (implicitly considered relevant for V-PRO maX 2).
Medical Device Material Compatibility	Demonstrate compatibility of medical devices with the sterilization process after multiple cycles.	Evaluation of medical devices after multiple cycles in the V-PRO maX 2 Sterilizer has demonstrated compatibility with 23 materials of construction.
Final Process Qualification	Successful qualification for all sterilizer cycles.	The V-PRO maX 2 Sterilizer final process qualification was successful for all four (4) sterilizer cycles.

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

The document primarily discusses device performance and sterilization efficacy, not diagnostic accuracy where "test sets" of patient data are typically used. Instead, the "test set" here refers to the biological indicators (BIs) and test loads used in the sterilization efficacy studies.

AOAC Sporicidal Test: "All 720 carriers processed using 3 lots of EOSL sterilant were sterile." This implies a total of 720 biological indicators (carriers).
Other Efficacy Tests (D-value, Total Kill, 1/2 Cycle Verification, Simulated Use, In Use): These tests involve specific "validation loads" and "worst-case conditions."
- Non Lumen Cycle: Validation load of two instrument trays for a total weight of 50 lbs (22.7 kg).
- Fast Non Lumen Cycle: Validation load of one pouched instrument tray for a total weight of 11 lbs (5 kg).
- Flexible Cycle (Load Config 1): Two flexible endoscopes, each packaged into a tray with silicone mat and light cord.
- Flexible Cycle (Load Config 2): One flexible endoscope in a tray with silicone mat and light cord, plus an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg).
- Lumen Cycle: A maximum of 20 lumens per load, using a validation load of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg).
- "Patient-soiled, clinically-cleaned, medical instruments" were used for the in-use test.

Data Provenance: The studies were conducted by the device manufacturer (STERIS Corporation) internally as part of their premarket notification for the Food and Drug Administration (FDA) in the USA. These are laboratory and simulated/actual use tests, not human data. The context implies these are prospective tests designed to prove the device's performance.

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

This information is not applicable in the context of device sterilization validation. "Ground truth" for sterilization is established by scientific principles of microbial inactivation (e.g., whether biological indicators containing a known number of resistant spores are killed), rather than expert consensus on interpretive tasks. The methodology for assessing sterility (e.g., incubation of biological indicators) relies on established microbiological techniques.

4. Adjudication Method for the Test Set:

Not applicable. Sterility tests involve objective outcomes (growth or no growth of microorganisms). There is no "adjudication" in the sense of resolving disagreements between human readers, as for an AI diagnostic tool.

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 medical images or data, and AI might assist in that interpretation. This document is about a sterilization device, which does not involve human interpretation of output in that manner.

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

The device itself is a "standalone" sterilizer. Its performance is evaluated purely on its ability to sterilize medical instruments, without human intervention in the sterilization process once initiated. The tests performed (e.g., AOAC Sporicidal Test, D-value determination) are indeed standalone assessments of the device's efficacy. There is no "human-in-the-loop" concept for the primary function of sterilization.

7. The Type of Ground Truth Used:

The ground truth used for these performance tests is microbiological eradication/inactivation.

For the AOAC Sporicidal Test, D-value, and Total Kill Endpoint, the ground truth is the absence of viable microorganisms (specifically, highly resistant bacterial spores like Geobacillus stearothermophilus). This is determined by standard microbiological culture techniques (e.g., incubating biological indicators and observing for growth).
For the "In Use Test," the ground truth for successful sterilization of patient-soiled instruments would similarly be the absence of microbial growth from processed items.
For biocompatibility and material compatibility, the ground truth is established through standardized cytotoxicity assays and visual / functional assessment of materials following repeated processing.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical sterilizer and not an AI/machine learning model that undergoes "training." Its operational parameters are designed and validated based on scientific principles of sterilization, not statistical inference from a training dataset derived from "training examples."

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

Not applicable, as there is no "training set" in the context of this traditional device validation.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 9, 2018

STERIS Corporation Bill Brodbeck, Ph.D. Director, Regulatory Affairs 5960 Heisley Rd. Mentor, Ohio 44060

Re: K172754

Trade/Device Name: V-PRO® maX 2 Low Temperature Sterilization System Regulation Number: 21 CFR 880.6860 Regulation Name: Sterilizer, Ethylene Oxide Gas Regulatory Class: Class II Product Code: MLR Dated: January 9, 2018 Received: January 10, 2018

Dear Dr. Bill Brodbeck:

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172754

Device Name

V-PRO® maX 2 Low Temperature Sterilization System

Indications for Use (Describe)

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.

The Non Lumen Cycle can sterilize: †

Non-lumened instruments including non-luments, non-luments, non-lumened 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 Fast Non Lumen Cycle can sterilize: *

Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes.

The validation studies were conducted using a validation load consisting of one pouched instrument tray 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 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 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 mm in length
- And the other lumen that is ≥ 1 mm ID and ≤ 850 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) and mat and additional non-lumened instruments. ++ The flexible endoscope may contain either:

• A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length

• Or two lumens with:

One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length.

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The Lumen Cycle can sterilize: †

Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:

Single channeled devices with a stainless lumen that is > 0.77 mm ID and ≤ 500 mm in length
Dual channeled devices with stainless lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length
· Triple channeled devices with stainless lumens that are either:
- ≥ 1.2 mm ID and ≤ 275 mm in length
- 1.8 mm ID and < 310 mm in length

≥ 2.8 mm ID and ≤ 317 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 instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg).

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/4/Picture/0 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a bold, sans-serif font, with the registered trademark symbol to the right of the word. Below the word "STERIS" is a graphic of several horizontal, wavy lines in blue, resembling water waves.

510(k) Summary For

V-PRO® maX 2 Low Temperature Sterilization System

K172754

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

Contact:

Bill Brodbeck Director, Regulatory Affairs Tel: 440-392-7690 Fax: 440-357-9198

Submission Date: February 6, 2018

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

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1. Device Name

Trade Name:	V-PRO® maX 2 Low Temperature SterilizationSystem
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 Low Temperature Sterilization System, cleared most recently under K162413.

The V-PRO maX Low Temperature Sterilization System prior clearances include Premarket Submissions K102330, K112760, K112813, K120632, K131120 and K162413.

System to the predicate device is summarized in the table below.
Feature	V-PRO maX 2 Low TemperatureSterlization System(Proposed Device)	V-PRO maX Low Temperature SterlizationSystem(Predicate Device/K162413)
Indicationsfor Use	The V-PRO maX 2 Low TemperatureSterilization Systems using VAPROX HCSterilant are intended for use in theterminal sterilization of properly prepared(cleaned, rinsed and dried) medicaldevices in Healthcare Facilities. Thepreprogrammed sterilization cyclesoperate at low pressure and temperature,suitable for processing medical devices.Each Cycle can sterilize non-lumenedinstruments with diffusion-restrictedspaces such as the hinged portion offorceps and scissors. Only stainless steelor titanium diffusion-restricted spacesshould be processed in the Non LumenCycle and the Fast Non Lumen Cycle.The Fast Non Lumen Cycle cansterilize: *	The V-PRO 1, V-PRO 1 Plus and V-PROmaX Low Temperature Sterilization Systems,with VAPROX® HC Sterilant, are vaporizedhydrogen peroxide sterilizers intended for usein the terminal sterilization of cleaned, rinsedand dried metal and nonmetal medical devicesused in healthcare facilities. The three pre-programmed sterilization cycles (LumenCycle, Non Lumen Cycle, and Flexible Cycle)operate at low pressure and low temperatureand are thus suitable for processing medicaldevices sensitive to heat and moisture.The V-PRO 1, V-PRO 1 Plus and V-PROmaX Low Temperature Sterilization System'sLumen Cycle, can sterilize:aLumened and non-lumened instrumentswith diffusion-restricted spaces such as thehinged portion of forceps and scissors Medical devices, including single, dual andtriple channeled rigid and semi-rigid
Feature	V-PRO maX 2 Low TemperatureSterilization System(Proposed Device)	V-PRO maX Low Temperature SterilizationSystem(Predicate Device/K162413)
	Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.* The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).	endoscopes, with the following configurations: a single channeled devices with a stainless steel lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length dual lumen devices with stainless lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length triple lumen devices with stainless steel lumens that are ≥ 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
	The Non Lumen Cycle can sterilize: ‡Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.‡ The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).	a The validation studies for all channel/ lumen configurations were 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 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 load configurations:1. Two flexible endoscopes with a light cord (if not integral 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 mm in length And the other lumen that is ≥ 1 mm ID and ≤ 850 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).2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. †† The flexible endoscope may contain either: A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length	The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Non Lumen Cycle can sterilize:b Non-lumened instruments including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened instruments with stainless steel or titanium diffusion-restricted areas such as the hinged portion of forceps or scissors.
		b The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50.0 lbs.
		The V-PRO maX Low Temperature Sterilization System's Flexible Cycle can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and
Feature	V-PRO maX 2 Low TemperatureSterilization System(Proposed Device)	V-PRO maX Low Temperature SterilizationSystem(Predicate Device/K162413)
	One lumen that is ≥ 1 mm ID and ≤ 990 mm in length And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length. †† The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg).The Lumen Cycle can sterilize: † Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations: Single channeled devices with a stainless lumen that is ≥ 0.77 mm ID and ≤ 500 mm in length Dual channeled devices with stainless lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length Triple channeled devices with stainless lumens that are 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 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 instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg).	bronchoscopes in either of two load configurations: Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.cThe flexible endoscopes may contain either: a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length or two lumens with: one lumen that is ≥ 1 mm ID and ≤ 990 mm in length and the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length c 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) and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors.dThe flexible endoscope can contain either: a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length or two lumens with: a single lumen that is ≥ 1 mm ID and ≤ 990 mm in length and the other lumen that is ≥ 1 mm and ≤ 850 mm in length d The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.
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
Feature	V-PRO maX 2 Low TemperatureSterlization System(Proposed Device)	V-PRO maX Low Temperature SterlizationSystem(Predicate Device/K162413)
Software/FirmwareControlled	Control system consists of a proprietarymicrocomputer control board andperipheral function circuit boards, locatedwithin the control housing. A memorybackup system maintains user settingsand calibration data indefinitely. Up to300 cycle data files can be stored forreview or downloading by the user.The software allows user selection ofeither the Lumen, Non Lumen, Flexibleor Fast Non Lumen pre-programmedcycle.	Programmable Logic Control (PLC). Thesoftware allows user selection of either theLumen, Non Lumen, or Flexible pre-programmed cycle.
TotalCycleTime	Lumen Cycle - 52 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 35 minutesFast Non Lumen Cycle – 16 minutes	Lumen Cycle - 55 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 35 minutes
Sterilant	VAPROX HC Sterilant (59% HydrogenPeroxide).The same amount of sterilant is injectedfor each of the sterilization pulses for allthree cycles.	VAPROX HC Sterilant (59% HydrogenPeroxide).The same amount of sterilant is injected foreach of the sterilization pulses for all threecycles.
	Sterilant Cup is read by an RFID reader.	The sterilant cup is read by a 2-D matrix code
Accessories	Accessories were submitted underseparate, individual, concurrent 510(k)sand cover the following:Self-contained biological indicator Biological indicator challenge pack Fast Acting Biological Indicator Chemical indicator Trays & Tray Accessories Pouches	The following accessories are available for theV-PRO maX Low Temperature SterilizationSystemSelf-contained biological indicator Biological indicator challenge pack Fast Acting Biological Indicator Chemical indicator Trays & Tray Accessories Pouches

A comparison between the proposed V-PRO maX 2 Low Temperature Sterilization System to the predicate device is summarized in the table helow

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TRADITIONAL PREMARKET NOTIFICATION

V-PRO® maX 2 Low Temperature Sterilization System

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TRADITIONAL PREMARKET NOTIFICATION V-PRO® maX 2 Low Temperature Sterilization System

The proposed device has an intended use similar to the predicate with the differences being the addition of the Fast Non Lumen Cycle and slight modification to the text to allow conciseness and clarity. Both the predicate and proposed devices have the same technological characteristics. Although, the devices slightly differ, the provided descriptive characteristics and performance data demonstrate equivalence. Therefore, the proposed V-PRO maX 2 Low Temperature Sterilization System is substantially equivalent to the predicate device, the V-PRO maX Low Temperature Sterilization System.

3. Description of Device

The V-PRO maX 2 Low Temperature Sterilization System is a new vaporized hydrogen peroxide sterilizer model to be added to the STERIS V-PRO family of

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sterilizers. The V-PRO product line currently consists of the Amsco V-PRO 1, Amsco V-PRO 1 Plus, V-PRO maX and V-PRO 60 Sterilizers.

4. Intended Use

The Non Lumen Cycle can sterilize: +

Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.

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 Fast Non Lumen Cycle can sterilize: *

Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.

The validation studies were conducted using a validation load consisting of one pouched instrument tray 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 Surgical Care) and bronchoscopes in either of the two load 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 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 mm in length
- And the other lumen that is ≥ 1 mm ID and ≤ 850 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) and mat and additional non-luments. ** The flexible endoscope may contain either:

· A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length
· Or two lumens with:
- . One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
- . And the other lumen is > 1 mm ID and < 850 mm in length.

ff The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg).

The Lumen Cycle can sterilize: أ

Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:

• Single channeled devices with a stainless lumen that is ≥ 0.77 mm ID and ≤ 500 mm in length

• Dual channeled devices with stainless lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length

· Triple channeled devices with stainless lumens that are 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 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 instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg).

Description of Safety and Substantial Equivalence ട്.

The V-PRO maX 2 Low Temperature Sterilization System has the same intended use and different technological characteristics that do not raise different questions of safety and effectiveness as compared to the predicate device. Performance testing to assess and demonstrate substantial equivalence to the predicate is summarized below.

Test	Result	Conclusion
AOAC SporicidalTest	All 720 carriers processed using 3 lots of EOSLsterilant were sterile.	PASS
Test	Result	Conclusion
Determination of D-value and Total KillEndpoint	Greater than a 12 log reduction of the mostresistant organism is achieved within all cycles(Lumen Cycle, Non Lumen Cycle, Flexible Cycleand Fast Non Lumen) of the V-PRO maX 2Sterilizer.	PASS
1/2 Cycle ModifiedTotal Kill EndpointVerification	Modified total kill end point analysis wasdemonstrated for all four V-PRO maX 2Sterilizer cycles. The standard injection weightof 2.1 g and at least one lower injection weightresulted in all sterile results within the validationload used to qualify each sterilizer cycle. Partialpositives or all survive results were seen at lowerinjection weights.	PASS
1/2 CycleSterilizationVerification ofCycle Claims	• The Lumen Cycle reproducibly sterilizessingle, dual and triple lumen devices underworst case conditions in 1/2 Cycle• The Flexible Cycle reproducibly sterilizes 1 x990 mm flexible endoscope lumens underworst case conditions in 1/2 Cycle• The Non Lumen Cycle reproducibly sterilizesnon-lumened devices under worst caseconditions in 1/2 Cycle• The Fast Non Lumen Cycle reproduciblysterilizes non-lumened devices under worstcase conditions in 1/2 Cycle	PASS
½ Cycle Verificationof Mated Surfaces	Sterile efficacy was demonstrated for matedsurfaces under worst case conditions	PASS
Simulated Use Test	Simulated use testing verified the ability of theV-PRO maX 2 Sterilizer cycles to sterilizemedical devices under worst case processingconditions.	PASS
In Use Test	The in use investigation demonstrated the abilityof the V-PRO maX 2 Sterilizer cycles to sterilizepatient-soiled, clinically-cleaned, medicalinstruments.	PASS
Biocompatibility	Cytotoxicity and residue analysis of 23 materialshave demonstrated biocompatibility afterprocessing in the V-PRO 60 Sterilizer.	PASS
Medical DeviceMaterialCompatibility	Evaluation of medical devices after multiplecycles in the V-PRO maX 2 Sterilizer hasdemonstrated compatibility with 23 materials ofconstruction.	PASS
Final ProcessQualification	The V-PRO maX 2 Sterilizer final processqualification was successful for all four (4)sterilizer cycles.	PASS

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TRADITIONAL PREMARKET NOTIFICATION

V-PRO® maX 2 Low Temperature Sterilization System

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The V-PRO maX 2 Low Temperature Sterilization System has been tested for conformity and is certified to the following standards:

EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control and laboratory use. General requirements; Part 1: General Requirements
. EN 61326-1:2006 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements

6. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as well as the legally marketed predicate device K162413, 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).