The V-PRO 1, V-PRO 1 Plus and V-PRO maX 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. 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.

The V-PRO 1 Plus and V-PRO maX Sterilizers' Non Lumen Cycle can sterilize:
Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid and flexible endoscopes.

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 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
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 V-PRO 1, V-PRO 1 Plus and V-PRO maX Sterilizers' 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
Single channeled devices with a stainless lumen that is ≥ 1.8 mm ID and ≤ 542 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

The V-PRO maX 2 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.
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- lumened general medical instruments, non- lumened rigid, semi-rigid and flexible endoscopes.

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 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
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 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
Single channeled devices with a stainless lumen that is ≥ 1.8 mm ID and ≤ 542 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

Device Description

The V-PRO Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers. The sterilizers have one 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 uses VAPROX HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The 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

This document describes the V-PRO Low Temperature Sterilization Systems, specifically the V-PRO 1, V-PRO 1 Plus, V-PRO maX, and V-PRO maX 2 models. The information provided focuses on their indications for use and the validation studies conducted to prove their effectiveness.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes two main tests to demonstrate the device meets acceptance criteria for sterilization efficacy. The acceptance criteria for biological indicators (BIs) are generally defined by a "total kill endpoint," meaning no microbial growth after sterilization, which is achieved at a specific sterilant injection weight. The "simulated use test" acceptance criteria are that the sterilizer cycles successfully sterilize medical devices under worst-case conditions.

Acceptance Criteria	Reported Device Performance
1/2 Cycle Modified Total Kill Endpoint Verification:	Modified total kill endpoint analysis was demonstrated for the 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. (Implies the device successfully sterilizes at specified sterilant levels and has a clear kill endpoint.)
Simulated Use Test:	Simulated use testing verified the ability of the sterilizer cycles to sterilize medical devices under worst-case processing conditions. (Implies the device meets its sterilization claims under challenging real-world scenarios).

Acceptance Criteria

Reported Device Performance

1/2 Cycle Modified Total Kill Endpoint Verification:

Modified total kill endpoint analysis was demonstrated for the 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. (Implies the device successfully sterilizes at specified sterilant levels and has a clear kill endpoint.)

Simulated Use Test:

Simulated use testing verified the ability of the sterilizer cycles to sterilize medical devices under worst-case processing conditions. (Implies the device meets its sterilization claims under challenging real-world scenarios).

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

The document doesn't explicitly state a "test set" in the context of a typical AI/ML study (e.g., number of images, cases). Instead, it refers to "validation loads" and "lumen sizes" for sterilization efficacy testing.

Validation Loads: Various validation loads are described depending on the specific cycle (Non Lumen, Flexible, Lumen) and device model.
- V-PRO 1 Plus and V-PRO maX (Non Lumen Cycle): Two instrument trays for a total weight of 50 lbs (22.7 kg).
- V-PRO maX (Flexible Cycle, Configuration 1): Two flexible endoscopes, each packaged into a tray with a silicone mat and light cord.
- V-PRO maX (Flexible Cycle, Configuration 2): One flexible endoscope in a tray with a silicone mat and light cord, plus an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg).
- V-PRO 1, V-PRO 1 Plus, V-PRO maX (Lumen Cycle): A maximum of 20 lumens per load. The validation studies used a load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg).
- V-PRO maX 2 (Non Lumen Cycle): Two instrument trays for a total weight of 50 lbs (22.7 kg).
- V-PRO maX 2 (Fast Non Lumen Cycle): One pouched instrument tray for a total weight of 11 lbs (5 kg).
- V-PRO maX 2 (Flexible Cycle, Configuration 1): Two flexible endoscopes, each packaged into a tray with a silicone mat and light cord.
- V-PRO maX 2 (Flexible Cycle, Configuration 2): One flexible endoscope in a tray with a silicone mat and light cord, plus an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg).
- V-PRO maX 2 (Lumen Cycle): A maximum of 20 lumens per load. The validation studies used a load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg).
Data Provenance: The document does not specify the country of origin of the data. The studies are described as "validation studies" and "non-clinical performance tests," implying they were conducted prospectively to validate the sterilization claims of the device.

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

This information is not provided. In the context of sterilization validation, "ground truth" is typically established through microbiological methods (e.g., culturing biological indicators to confirm sterility or lack thereof) rather than expert interpretation of medical images or case data. Therefore, the concept of "experts" in the traditional sense of clinical opinion is not directly applicable to this type of device validation. The "experts" would likely be microbiologists or validation engineers.

4. Adjudication Method for the Test Set:

Not applicable. As described above, the "ground truth" for sterilization efficacy is typically determined by objective microbiological culture results (growth/no growth of biological indicators), not by subjective expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. These devices are sterilizers, and their performance is evaluated based on direct microbiological efficacy, not on the improvement of human reader performance using AI assistance. The document explicitly states the studies are "non-clinical performance tests."

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

This question is not applicable in the context of this device. The V-PRO systems are sterilization machines, not AI algorithms designed to assist human interpretation. Their "standalone" performance is the validation of their sterilization efficacy without human intervention in the sterilization process itself. The software controls the sterilization cycle, and its performance is part of the overall device validation.

7. The Type of Ground Truth Used:

The ground truth for these validation studies is primarily:

Microbiological Sterility (Biological Indicators): The "total kill endpoint verification" test indicates the use of biological indicators (BIs) which contain a known number of resistant microorganisms (e.g., Geobacillus stearothermophilus spores). Sterility is achieved when no growth of these microorganisms is detected after processing.
Physical and Chemical Parameters: The document mentions "critical process parameters" such as "Time, Chamber Temperature, Vaporizer Temperature, Chamber Pressure Prior to Injection, Sterilant Injection Weight." These parameters are controlled and monitored to ensure the cycle performs optimally, contributing to the "ground truth" that appropriate conditions for sterilization were met.

8. The Sample Size for the Training Set:

This information is not provided, and the concept of a "training set" in the context of machine learning is not directly applicable to these physical sterilization devices. The physical properties and mechanisms of sterilization are based on established scientific principlesvalidated through controlled experiments, not through training an algorithm on a dataset. The formulation of the VAPROX HC Sterilant and the design of the sterilization cycles are based on research and development, not on a machine learning training set.

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

Not applicable, as there is no mention of a "training set" for an AI/ML algorithm within the provided text for these sterilization devices. The "ground truth" for the development and validation of these sterilizers is based on established methods in microbiology and validated sterilization principles (e.g., D-value determination, overkill methods) which define what constitutes a sterile condition and how to achieve it.

Summary

{0}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K190103

Device Name

V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems

Indications for Use (Describe)

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.

The V-PRO 1 Plus and V-PRO maX Sterilizers' Non Lumen Cycle can sterilize:

t Non-lumened instruments including non-lumened general medical instruments, non-lumened 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 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).

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).

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.

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 V-PRO 1, V-PRO 1 Plus and V-PRO maX Sterilizers' 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

FORM FDA 3881 (7/17)

{1}------------------------------------------------

• Single channeled devices with a stainless lumen that is ≥ 1.8 mm ID and ≤ 542 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).

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K190103

Device Name

V-PRO maX 2 Low Temperature Sterilization Systems

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:

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

The validation studies were conducted using a validation load consisting of two instrument travs 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 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 sillicone 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.

{3}------------------------------------------------

The Lumen Cycle can sterilize:

f 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
Single channeled devices with a stainless lumen that is ≥ 1.8 mm ID and ≤ 542 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)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 5, 2019

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

Re: K190103

Trade/Device Name: V-PRO® maX 2 Low Temperature Sterilization System, V-PRO® maX Low Temperature Sterilization System, V-PRO® 1 Plus Low Temperature Sterilization System, V-PRO® 1 Low Temperature Sterilization System Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: March 7, 2019 Received: March 8, 2019

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.

{5}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA

Page 2

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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 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

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for STERIS. The word STERIS is in a bold, serif font at the top of the logo. Below the word STERIS is a graphic of several horizontal, wavy lines in blue. The lines are stacked on top of each other, creating a visual effect of water or waves.

510(k) Summary For

V-PRO® maX 2 Low Temperature Sterilization System, V-PRO® maX Low Temperature Sterilization System, V-PRO® 1 Plus Low Temperature Sterilization System, V-PRO® 1 Low Temperature Sterilization System

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

Contact:

Anthony Piotrkowski Director, Regulatory Affairs Tel: 440-392-7437 Fax: 440-357-9198 Email: tony_piotrkowski@steris.com

Submission Date: March 7, 2019

Premarket Notification Number: K190103

{7}------------------------------------------------

{8}------------------------------------------------

1. Device NameTrade Name:	V-PRO® maX 2 Low Temperature SterilizationSystem, V-PRO® maX Low TemperatureSterilization System, V-PRO® 1 Plus LowTemperature Sterilization System, V-PRO® 1Low Temperature Sterilization 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 for V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems is the V-PRO maX Low Temperature Sterilization System, cleared most recently under K172319.

The claimed primary predicate device for the V-PRO® maX 2 Low Temperature Sterilization Systems is the V-PRO maX 2 Low Temperature Sterilization System, cleared most recently under K172754.

3. Description of Device

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

The sterilizers have one 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.

{9}------------------------------------------------

The V-PRO Sterilizers uses VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The 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.

Indications for Use 4.

The V-PRO 1, V-PRO 1 Plus and V-PRO maX 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 and temperature, suitable for processing medical deving toxic residues. 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.

The V-PRO 1 Plus and V-PRO maX Sterilizers' Non Lumen Cycle can sterilize:

Non-lumened instruments including non- lumened general medical instruments, non-lumened rigid,semirigid 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 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:

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).

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 (ff 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).

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 V-PRO 1. V-PRO 1 Plus and V-PRO maX Sterilizers' 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
Single channeled devices with stainless lumen that is ≥ 1.8 mm ID and ≤ 542 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

{10}------------------------------------------------

≥ 1.2 mm ID and ≤ 275 mm in length
≥ 1.8 mm ID and ≤ 310 mm in length Of
- ≥ 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).

The V-PRO maX 2 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 Non Lumen Cycle can sterilize: * Non-luments 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-luments 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 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 트
- 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. 11 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
Single channeled devices with a stainless lumen that is ≥ 1.8 mm ID and ≤ 542 mm in length

{11}------------------------------------------------

• 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).

ട്. 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).

Table 5-1. Technological Characteristic Comparison between the proposed V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization System to the predicate device

{12}------------------------------------------------

{13}------------------------------------------------

{14}------------------------------------------------

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

Table 5-2. Technological Characteristics Comparison between the proposed V-PRO maX 2 Low Temperature Sterilization System to the predicate device.

{15}------------------------------------------------

{16}------------------------------------------------

{17}------------------------------------------------

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

Summarv of Non-Clinical Testing 6.

Non-clinical performance test was performed according to the test methodology listed below. The testing demonstrated that the subject device met the acceptance criteria described in the standard/methodology.

{18}------------------------------------------------

Test	Result	Conclusion
1/2 Cycle ModifiedTotal Kill EndpointVerification	Modified total kill end point analysis wasdemonstrated for the sterilizer cycles. Thestandard injection weight of 2.1 g and at least onelower injection weight resulted in all sterileresults within the validation load used to qualifyeach sterilizer cycle. Partial positives or allsurvive results were seen at lower injectionweights.	PASS
Simulated Use Test	Simulated use testing verified the ability of thesterilizer cycles to sterilize medical devices underworst-case processing conditions.	PASS

7. Conclusions

Based on the intended use, technological characteristics and non-clinical performance data, the V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization System is as safe, as effective and performs as well or better than the legally marketed predicate device K172319, Class II (21 CFR 880.6860), product code MLR.

Based on the intended use, technological characteristics and non-clinical performance data, the V-PRO maX 2 Low Temperature Sterilization System is as safe, as effective and performs as well or better than the legally marketed predicate device K172754, 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 maXLow Temperature Sterilization System(Predicate Device – K172319)	V-PRO 1, V-PRO 1Plus, V-PRO maXLow Temperature Sterilization System(K190103)
Feature
IntendedUse andIndicationsfor Use	The V-PRO 1, V-PRO 1 Plus and V-PROmaX Low Temperature SterilizationSystems using VAPROX HC Sterilant areintended for use in the terminal sterilizationof properly prepared (cleaned, rinsed anddried) medical devices in HealthcareFacilities. The preprogrammed sterilizationcycles operate at low pressure andtemperature, suitable for processing medicaldevices without leaving toxic residues.Each Cycle can sterilize non-lumenedinstruments with diffusion-restricted spacessuch as the hinged portion of forceps andscissors. Only stainless steel or titaniumdiffusion-restricted spaces should beprocessed in the Non Lumen Cycle.	The V-PRO 1, V-PRO 1 Plus and V-PROmaX Low Temperature SterilizationSystems using VAPROX HC Sterilant areintended for use in the terminal sterilizationof properly prepared (cleaned, rinsed anddried) medical devices in HealthcareFacilities. The preprogrammed sterilizationcycles operate at low pressure andtemperature, suitable for processing medicaldevices without leaving toxic residues.Each Cycle can sterilize non-lumenedinstruments with diffusion-restricted spacessuch as the hinged portion of forceps andscissors. Only stainless steel or titaniumdiffusion-restricted spaces should beprocessed in the Non Lumen Cycle.
	The V-PRO 1 Plus and V-PRO maXSterilizers' Non Lumen Cycle cansterilize:‡ Non-lumened instruments including non-lumened general medical instruments, non-	The V-PRO 1 Plus and V-PRO maXSterilizers' Non Lumen Cycle cansterilize:‡ Non-lumened instruments including non-lumened general medical instruments, non-
Feature	V-PRO 1, V-PRO 1Plus, V-PRO maXLow Temperature Sterilization System(Predicate Device - K172319)	V-PRO 1, V-PRO 1Plus, V-PRO maXLow Temperature Sterilization System(K190103)
	lumened rigid, semi-rigid and flexibleendoscopes.	lumened rigid, semi-rigid and flexibleendoscopes.
	‡ The validation studies were conductedusing a validation load consisting of twoinstrument trays for a total weight of 50 lbs(22.7 kg).	‡ The validation studies were conductedusing a validation load consisting of twoinstrument trays for a total weight of 50 lbs(22.7 kg).
	The V-PRO maX Sterilizer's FlexibleCycle can sterilize:Single or dual lumen surgical flexibleendoscopes (such as those used in ENT,Urology and Surgical Care) andbronchoscopes in either of the twoconfigurations:1. Two flexible endoscopes with a lightcord (if not integral to endoscope) andmat with no additional load. * Theflexible endoscopes may contain either:A single lumen that is ≥ 1 mminternal diameter (ID) and ≤ 1050mm 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 IDand ≤ 850 mm in length The validation studies were conducted withtwo flexible endoscopes, each packagedinto a tray with silicone mat and light cord(if not integral to endoscope).And the other lumen is ≥ 1 mm IDand ≤ 850 mm in length.†† The validation studies were conductedwith a flexible endoscope in a tray withsilicone mat and light cord (if not integralto endoscope). Also included in the loadwere an additional instrument tray and onepouch for a total weight of 24 lbs (11 kg).2. One flexible endoscope with a lightcord (if not integral to endoscope) andmat and additional non-lumenedinstruments.†† The flexible endoscopemay contain either:A single lumen that is ≥ 1 mm IDand ≤ 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 IDand ≤ 850 mm in length. †† The validation studies were conductedwith a flexible endoscope in a tray with	The V-PRO maX Sterilizer's FlexibleCycle can sterilize:Single or dual lumen surgical flexibleendoscopes (such as those used in ENT,Urology and Surgical Care) andbronchoscopes in either of the twoconfigurations:wo flexible endoscopes with a lightcord (if not integral to endoscope) andmat with no additional load. * Theflexible endoscopes may contain either:a. A single lumen that is ≥1 mm internal diameter(ID) and ≤ 1050 mm inlengthb. Or two lumens with:- One lumen that is ≥ 1 mm ID and ≤990 mm in length- And the other lumen that is ≥ 1 mm IDand ≤ 850 mm in lengthThe validation studies were conducted withtwo flexible endoscopes, each packagedinto a tray with silicone mat and light cord(if not integral to endoscope).And the other lumen is ≥ 1 mm IDand ≤ 850 mm in length.†† The validation studies were conductedwith a flexible endoscope in a tray withsilicone mat and light cord (if not integral toendoscope). Also included in the load werean additional instrument tray and one pouchfor a total weight of 24 lbs (11 kg).he flexible endoscope with a light cord (if notegral to endoscope) and mat and additionaln-lumened instruments.†† The flexibledoscope may contain either:A single lumen that is ≥ 1 mm IDand ≤ 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 IDand ≤ 850 mm in length. †† The validation studies were conductedwith a flexible endoscope in a tray with
Feature	V-PRO 1, V-PRO 1Plus, V-PRO maXLow Temperature Sterilization System(Predicate Device – K172319)	V-PRO 1, V-PRO 1Plus, V-PRO maXLow Temperature Sterilization System(K190103)
	silicone mat and light cord (if not integralto endoscope). Also included in the loadwere an additional instrument tray and onepouch for a total weight of 24 lbs (11 kg).The V-PRO 1, V-PRO 1 Plus and V-PRO	silicone mat and light cord (if not integral toendoscope). Also included in the load werean additional instrument tray and one pouchfor a total weight of 24 lbs (11 kg).The V-PRO 1, V-PRO 1 Plus and V-PRO
	maX Sterilizers' Lumen Cycle cansterilize:† Medical devices (including single, dualand triple channeled rigid and semi-rigidendoscopes) with the followingconfigurations:Single channeled devices with astainless lumen that is ≥ 0.77 mmID and ≤ 500 mm in length Dual channeled devices withstainless lumens that are ≥ 0.77mm ID and ≤ 527 mm in length Triple channeled devices withstainless lumens that are either≥ 1.2 mm ID and ≤ 275 mm inlength ≥ 1.8 mm ID and ≤ 310 mm inlength or≥ 2.8 mm ID and ≤ 317 mm inlength † Validation testing for all lumen sizes wasconducted using a maximum of 20 lumensper load. Hospital loads should not exceedthe maximum number of lumens validatedby this testing. The validation studies wereperformed using a validation loadconsisting of two instrument trays and twopouches for a total weight of 19.65 lbs (8.9kg).	maX Sterilizers' Lumen Cycle cansterilize:† Medical devices (including single, dualand triple channeled rigid and semi-rigidendoscopes) with the followingconfigurations:Single channeled devices with astainless lumen that is ≥ 0.77 mmID and ≤ 500 mm in length Single channeled devices withstainless lumen that is ≥ 1.8 mm IDand ≤ 542 mm in length Dual channeled devices withstainless lumens that are ≥ 0.77mm ID and ≤ 527 mm in length Triple channeled devices withstainless lumens that are either≥ 1.2 mm ID and ≤ 275 mm inlength ≥ 1.8 mm ID and ≤ 310 mm inlength or≥ 2.8 mm ID and ≤ 317 mm inlength † Validation testing for all lumen sizes wasconducted using a maximum of 20 lumensper load. Hospital loads should not exceedthe maximum number of lumens validatedby this testing. The validation studies wereperformed using a validation loadconsisting of two instrument trays and twopouches for a total weight of 19.65 lbs (8.9kg).
ProcessParameters	The critical process parameters are:Time Chamber Temperature Vaporizer Temperature Chamber Pressure Prior to Injection Sterilant Injection Weight	kg).The critical process parameters are:Time Chamber Temperature Vaporizer Temperature Chamber Pressure Prior to Injection Sterilant Injection Weight
Feature	V-PRO 1, V-PRO 1Plus, V-PRO maXLow Temperature Sterilization System(Predicate Device - K172319)	V-PRO 1, V-PRO 1Plus, V-PRO maXLow Temperature Sterilization System(K190103)
Software/FirmwareControlled	Control system consists of a proprietarymicrocomputer control board and peripheralfunction circuit boards, located within thecontrol housing. A memory backup systemmaintains user settings and calibration dataindefinitely. Up to 300 cycle data files canbe stored for review or downloading by theuser.The software allows user selection of eitherthe Lumen, Non Lumen or Flexible pre-programmed cycle.	Control system consists of a proprietarymicrocomputer control board and peripheralfunction circuit boards, located within thecontrol housing. A memory backup systemmaintains user settings and calibration dataindefinitely. Up to 300 cycle data files canbe stored for review or downloading by theuser.The software allows user selection of eitherthe Lumen, Non Lumen or Flexible pre-programmed cycle.
Total CycleTime	Lumen Cycle - 55 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 35 minutes	Lumen Cycle - 55 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 35 minutes
Sterilant	VAPROX HC Sterilant (59% HydrogenPeroxide).	VAPROX HC Sterilant (59% HydrogenPeroxide).
Accessories	Accessories were submitted under separate,individual, concurrent 510(k)s and cover thefollowing:• Self-contained biological indicator• Biological indicator challenge pack• Fast Acting Biological Indicator• Chemical indicator• Trays & Tray Accessories• Pouches• Tape	Accessories were submitted under separate,individual, concurrent 510(k)s and cover thefollowing:• Self-contained biological indicator• Biological indicator challenge pack• Fast Acting Biological Indicator• Chemical indicator• Trays & Tray Accessories• Pouches• Tape

Feature	V-PRO maX 2 Low TemperatureSterilization System(Predicate Device/K172754)	V-PRO maX 2 Low TemperatureSterilization System(K190103)
Indicationsfor Use	The V-PRO maX 2 Low TemperatureSterilization Systems using VAPROX HCSterilant are intended for use in the terminalsterilization of properly prepared (cleaned,rinsed and dried) medical devices inHealthcare Facilities. The preprogrammedsterilization cycles operate at low pressureand temperature, suitable for processingmedical devices without leaving toxicresidues.	The V-PRO maX 2 Low TemperatureSterilization Systems using VAPROX HCSterilant are intended for use in the terminalsterilization of properly prepared (cleaned,rinsed and dried) medical devices inHealthcare Facilities. The preprogrammedsterilization cycles operate at low pressureand temperature, suitable for processingmedical devices without leaving toxicresidues.
		Each Cycle can sterilize non-lumenedinstruments with diffusion-restricted spaces	Each Cycle can sterilize non-lumenedinstruments with diffusion-restricted spaces
		Feature	V-PRO maX 2 Low TemperatureSterilization System(Predicate Device/K172754)	V-PRO maX 2 Low TemperatureSterilization System(K190103)
			such as the hinged portion of forceps andscissors. Only stainless steel or titaniumdiffusion-restricted spaces should beprocessed in the Non Lumen Cycle and theFast Non Lumen Cycle.	such as the hinged portion of forceps andscissors. Only stainless steel or titaniumdiffusion-restricted spaces should beprocessed in the Non Lumen Cycle and theFast Non Lumen Cycle.
			The Non Lumen Cycle can sterilize: + Non-lumened instruments including non- lumenedgeneral medical instruments, non- lumenedrigid, semi-rigid and flexible endoscopes.+ The validation studies were conductedusing a validation load consisting of twoinstrument trays for a total weight of 50 lbs(22.7 kg).	The Non Lumen Cycle can sterilize: + Non-lumened instruments including non- lumenecgeneral medical instruments, non- lumenedrigid, semi-rigid and flexible endoscopes.+ The validation studies were conductedusing a validation load consisting of twoinstrument trays for a total weight of 50 lbs(22.7 kg).
			The Fast Non Lumen Cycle cansterilize: Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexibleendoscopes. The validation studies were conductedusing a validation load consisting of onepouched instrument tray for a total weightof 11 lbs (5 kg).	The Fast Non Lumen Cycle can sterilize:Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexibleendoscopes. The validation studies were conductedusing a validation load consisting of onepouched instrument tray for a total weight of11 lbs (5 kg).
			The Flexible Cycle can sterilize:Single or dual lumen surgical flexibleendoscopes (such as those used in ENT,Urology and Surgical Care) andbronchoscopes in either of the twoconfigurations:	The Flexible Cycle can sterilize:Single or dual lumen surgical flexibleendoscopes (such as those used in ENT,Urology and Surgical Care) andbronchoscopes in either of the twoconfigurations:
			1. Two flexible endoscopes with a lightcord (if not integral to endoscope) and matwith no additional load.* The flexibleendoscopes may contain either:• A single lumen that is ≥ 1 mm internaldiameter (ID) and ≤ 1050 mm in length• Or two lumens with:One lumen that is ≥ 1 mm IDand ≤ 990 mm in lengthAnd the other lumen that is ≥ 1mm ID and ≤ 850 mm in length* The validation studies were conductedwith two flexible endoscopes, eachpackaged into a tray with silicone mat andlight cord (if not integral to endoscope).2. One flexible endoscope with a light cord	2. Two flexible endoscopes with a light cord(if not integral to endoscope) and mat withno additional load.* The flexibleendoscopes may contain either:• A single lumen that is ≥ 1 mm internaldiameter (ID) and ≤ 1050 mm in length• Or two lumens with:One lumen that is ≥ 1 mm IDand ≤ 990 mm in lengthAnd the other lumen that is ≥ 1mm ID and ≤ 850 mm in length* The validation studies were conductedwith two flexible endoscopes, eachpackaged into a tray with silicone mat andlight cord (if not integral to endoscope).2. One flexible endoscope with a light cord(if not integral to endoscope) and mat and
			(if not integral to endoscope) and mat and	(if not integral to endoscope) and mat and
		V-PRO maX 2 Low TemperatureSterilization System(Predicate Device/K172754)	V-PRO maX 2 Low TemperatureSterilization System(K190103)
Feature	additional non-lumened instruments.†† Theflexible 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 IDand ≤ 990 mm in lengthAnd the other lumen is ≥ 1 mmID and ≤ 850 mm in length.†† The validation studies were conductedwith a flexible endoscope in a tray withsilicone mat and light cord (if not integral toendoscope). Also included in the load werean additional instrument tray and one pouchfor a total weight of 24 lbs (11 kg).The Lumen Cycle can sterilize: †Medical devices (including single, dual and	additional non-lumened instruments.†† Theflexible 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 IDand ≤ 990 mm in lengthAnd the other lumen is ≥ 1 mmID and ≤ 850 mm in length.†† The validation studies were conductedwith a flexible endoscope in a tray withsilicone mat and light cord (if not integral toendoscope). Also included in the load werean additional instrument tray and one pouchfor a total weight of 24 lbs (11 kg).The Lumen Cycle can sterilize: †Medical devices (including single, dual and
	triple channeled rigid and semi-rigidendoscopes) with the followingconfigurations:• Single channeled devices with a stainlesslumen that is ≥ 0.77 mm ID and ≤ 500 mmin length• Dual channeled devices with stainlesslumens that are ≥ 0.77 mm ID and ≤ 527mm in length• Triple channeled devices with stainlesslumens that are either:≥ 1.2 mm ID and ≤ 275 mm in length≥ 1.8 mm ID and ≤ 310 mm in lengthor≥ 2.8 mm ID and ≤ 317 mm in length	triple channeled rigid and semi-rigidendoscopes) with the followingconfigurations:• Single channeled devices with a stainlesslumen that is ≥ 0.77 mm ID and ≤ 500 mmin length• Single channeled devices with a stainlesslumen that is ≥ 1.8 mm ID and ≤ 542 mmin length• Dual channeled devices with stainlesslumens that are ≥ 0.77 mm ID and ≤ 527mm in length• Triple channeled devices with stainlesslumens that are either:≥ 1.2 mm ID and ≤ 275 mm in length≥ 1.8 mm ID and ≤ 310 mm in lengthor≥ 2.8 mm ID and ≤ 317 mm in length
	† Validation testing for all lumen sizes wasconducted using a maximum of 20 lumensper load. Hospital loads should not exceedthe maximum number of lumens validatedby this testing. The validation studies wereperformed using a validation load consistingof two instrument trays and two pouches fora total weight of 19.65 lbs (8.9 kg).	† Validation testing for all lumen sizes wasconducted using a maximum of 20 lumensper load. Hospital loads should not exceedthe maximum number of lumens validatedby this testing. The validation studies wereperformed using a validation load consistingof two instrument trays and two pouches fora total weight of 19.65 lbs (8.9 kg).
ProcessParameters	The critical process parameters are:• Time• Chamber Temperature• Vaporizer Temperature• Chamber Pressure Prior to Injection	The critical process parameters are:• Time• Chamber Temperature• Vaporizer Temperature• Chamber Pressure Prior to Injection
Feature	V-PRO maX 2 Low TemperatureSterilization System(Predicate Device/K172754)	V-PRO maX 2 Low TemperatureSterilization System(K190103)
Software/FirmwareControlled	Control system consists of a proprietarymicrocomputer control board and peripheralfunction circuit boards, located within thecontrol housing. A memory backup systemmaintains user settings and calibration dataindefinitely. Up to 300 cycle data files canbe stored for review or downloading by theuser.The software allows user selection of eitherthe Lumen, Non Lumen, Flexible or FastNon Lumen pre-programmed cycle.	Control system consists of a proprietarymicrocomputer control board and peripheralfunction circuit boards, located within thecontrol housing. A memory backup systemmaintains user settings and calibration dataindefinitely. Up to 300 cycle data files canbe stored for review or downloading by theuser.The software allows user selection of eitherthe Lumen, Non Lumen, Flexible or FastNon Lumen pre-programmed cycle.
Total CycleTime	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% HydrogenPeroxide).The same amount of sterilant is injected foreach of the sterilization pulses for all threecycles.	VAPROX HC Sterilant (59% HydrogenPeroxide).The same amount of sterilant is injected foreach of the sterilization pulses for all threecycles.
Accessories	Accessories were submitted under separate,individual, concurrent 510(k)s and cover thefollowing:• 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 thefollowing:• Self-contained biological indicator• Biological indicator challenge pack• Fast Acting Biological Indicator• Chemical indicator• Trays & Tray Accessories• Pouches