The V-PRO® s2 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 low temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.

The V-PRO s2 Sterilizer Non Lumen Cycle can sterilize: t
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 instrument tray for a total weight of 25 lbs (11.3 kg).

The V-PRO s2 Sterilizer Fast Cycle can sterilize:*
Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:

Single or dual channeled devices with stainless steel lumens that are ● > 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (~16-9/64") in length
≥ 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length.
Triple channeled devices with stainless steel lumens that are either: ● ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") in length
1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length or
≥ 2.8 mm (~7/64") ID and ≤ 317 (12-31/64") mm in length

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

Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. Validation testing was conducted using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg).

The V-PRO s2 Sterilizer Flexible Cycle can sterilize: ®
One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.

The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm (~3/64") ID and ≤ 990 mm (38-63/64") in length.
Additional load, up to 11 lb (5 kg) can include stainless steel lumens with ● the following dimensions
≥ 0.76 mm (~1/32") ID and ≤ 233 mm (~9 11/64") in length
≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length
≥ 1.8 mm (~5/64") ID and ≤ 542 mm (~21 5/16") in length

@ The validation studies were conducted using a validation load consisting of two instrument travs. One tray contained one flexible endoscope, with silicone mat. instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing.

The V-PRO s2 Sterilizer Lumen Cycle can sterilize: ^
Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:

. Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm in length and ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (21 5/16") in length.
Triple channeled devices with stainless steel lumens that are either: . > 1.2 mm (~3/64") ID and < 275 mm (~10-53/64") in length > 1.8 mm (~5/64") ID and < 310 mm (~12-13/64") in length or
≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length ^ Validation testing for all lumen sizes was conducted using a maximum of twelve
(12) stainless steel 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 one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg).

V-PRO 60 Low Temperature Sterilization System
The V-PRO® 60 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 low temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.

The V-PRO 60 Sterilizer Non Lumen Cycle can sterilize: t 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 instrument tray for a total weight of 25 lbs (11.3 kg).

The V-PRO 60 Sterilizer Flexible Cycle can sterilize: @
One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.

The flexible endoscope may be a single or dual lumen device with lumens . that are ≥ 1 mm (~3/64") internal diameter (ID) and ≤ 990 mm (38-63/64") in.
Additional load, up to 11 lb (5 kg) can include stainless steel lumens with . the following dimensions
≥ 0.76 mm (~1/32") ID and ≤ 233 mm (~9 11/64") in length
≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length
≥ 1.8 mm (~5/64") ID and ≤ 542 mm (~21 5/16") in length

@ The validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing.

The V-PRO 60 Sterilizer Lumen Cycle can sterilize: ^
Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:

. Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm (~1/32") ID and ≤ 410 mm (16-9/64") in length > 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length.
Triple channeled devices with stainless steel lumens that are either: ● > 1.2 mm (~3/64") ID and < 275 mm (~10-53/64") in length ≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length or
≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length

^ Validation testing for all lumen sizes was conducted using a maximum of twelve (12) stainless steel 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 one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg).

Device Description

The V-PRO s2 Sterilizer contains the same three sterilization cycles as V-PRO 60 Sterilizer (the Lumen. Non Lumen and Flexible Cycles) with one additional cycle (the Fast Cycle). The V-PRO s2 Sterilizer contains a cabinetry modification and is free-standing as opposed to the cart-mounted V-PRO 60 Sterilizer.

The V-PRO 60 Low Temperature Sterilization System is a vaporized hydrogen peroxide sterilizer model that currently exists in the STERIS V-PRO family of sterilizers. The current proposed device claims are intended to modify the indications for use statement.

The V-PRO s2 and V-PRO 60 Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried and packaged surgical instruments used in healthcare facilities and utilizes VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The pre-programmed 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 information provided describes the acceptance criteria and a study proving the device meets these criteria for the V-PRO® 60 Low Temperature Sterilization Systems and V-PRO® s2 Low Temperature Sterilization Systems.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Measured Performance)	Reported Device Performance
For V-PRO s2 Sterilizer Non Lumen Cycle:Sterilization of non-lumened instruments (including non-lumened general medical instruments, non-lumened rigid, semi-rigid, and flexible endoscopes) with a maximum load of one instrument tray weighing 25 lbs (11.3 kg).	PASS: Validation studies were conducted using a validation load consisting of one instrument tray for a total weight of 25 lbs (11.3 kg).
For V-PRO s2 Sterilizer Fast Cycle:Sterilization of medical devices including single, dual, and triple channeled rigid and semi-rigid endoscopes with specific lumen configurations:- Single/dual channeled stainless steel lumens: ≥ 0.77 mm ID and ≤ 410 mm length, OR ≥ 1.8 mm ID and ≤ 542 mm length.- Triple channeled stainless steel lumens: ≥ 1.2 mm ID and ≤ 275 mm length, OR ≥ 1.8 mm ID and ≤ 310 mm length, OR ≥ 2.8 mm ID and ≤ 317 mm length.Maximum of eight (8) lumens per load. Validation load of one pouched instrument tray and two pouched devices outside the tray with a total weight of 4.0 lbs (~1.8kg).	PASS: Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load. Validation testing was conducted using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg). (New claim for ≥ 1.8 mm ID x ≤ 542 mm length added and demonstrated.)
For V-PRO s2 Sterilizer Flexible Cycle:Sterilization of one surgical flexible endoscope (single or dual lumen, ≥ 1 mm ID and ≤ 990 mm length) or bronchoscope with light cord (if not integral).Additional load, up to 11 lb (5 kg), including stainless steel lumens with:- ≥ 0.76 mm ID and ≤ 233 mm length- ≥ 1.0 mm ID and ≤ 254 mm length- ≥ 1.8 mm ID and ≤ 542 mm length.Validation load of two instrument trays (one with flexible endoscope, mat, organizers, light cord; second with additional load and twelve stainless steel lumens) for a total load weight of 11 lbs (5 kg).	PASS: Validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg). (New claim for ≥ 1.8 mm ID x ≤ 542 mm length added and demonstrated; previous 2mm ID x 400mm length removed as it falls within the new claim).
For V-PRO s2 Sterilizer Lumen Cycle:Sterilization of medical devices including single, dual, and triple channeled rigid and semi-rigid endoscopes with specific lumen configurations:- Single/dual channeled stainless steel lumens: ≥ 0.77 mm ID and ≤ 410 mm length, OR ≥ 1.8 mm ID and ≤ 542 mm length.- Triple channeled stainless steel lumens: ≥ 1.2 mm ID and ≤ 275 mm length, OR ≥ 1.8 mm ID and ≤ 310 mm length, OR ≥ 2.8 mm ID and ≤ 317 mm length.Maximum of twelve (12) stainless steel lumens per load. Validation load of one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg).	PASS: Validation testing for all lumen sizes was conducted using a maximum of twelve (12) stainless steel lumens per load. The validation studies were performed using a validation load consisting of one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg). (New claim for ≥ 1.8 mm ID x ≤ 542 mm length added and demonstrated.)
General Sterilization Effectiveness:Successful sterilization (achieving a Sterility Assurance Level, typically 10^-6, meaning a 1 in a million chance of a non-sterile unit) as demonstrated by biological indicators (BI) in ½ cycle total kill endpoint verification and simulated use tests.	PASS: - ½ Cycle Modified Total Kill Endpoint Verification: Demonstrated for sterilizer cycles. Standard injection weight of 1.1 g and at least one lower injection weight resulted in all sterile results within the validation load. Partial positives or all survive results were seen at lower injection weights. - Simulated Use Test: Verified the ability of the sterilizer cycles to sterilize medical devices under worst-case processing conditions.

The tables for V-PRO 60 cycles are identical to the V-PRO s2 cycles for Non Lumen, Flexible, and Lumen cycles, indicating the same acceptance criteria and performance were met for V-PRO 60.

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

The document explicitly states:

"Validation studies were conducted using a validation load consisting of one instrument tray for a total weight of 25 lbs (11.3 kg)" for the Non Lumen Cycle.
"Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load... using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg)" for the Fast Cycle.
"Validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope... and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg)" for the Flexible Cycle.
"Validation testing for all lumen sizes was conducted using a maximum of twelve (12) stainless steel lumens per load... using a validation load consisting of one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg)" for the Lumen Cycle.

The specific number of individual sterilization cycles performed for these validation studies (e.g., number of replicates for the biological indicator and simulated use tests) is not explicitly stated in the provided text.

Data Provenance: The document implies these studies were conducted by STERIS Corporation, the manufacturer, in support of their 510(k) submission to the FDA. The nature of these tests (validation studies, half-cycle kill, simulated use) strongly suggests they are prospective, experimentally designed studies within a controlled environment. The country of origin for the data is not specified beyond the fact that the company is located in Mentor, Ohio, USA, and is submitting to the U.S. FDA.

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

This is an electromechanical sterilization device, not an AI or imaging device that typically uses human experts for ground truth. The "ground truth" for sterilization devices is established by microbiological testing (biological indicators) and chemical indicators which show whether a Sterility Assurance Level (SAL) has been met. These are objective, quantitative measures of microbial inactivation.

Therefore, the concept of "experts" to establish ground truth in the traditional sense (e.g., radiologists for image interpretation) does not apply here. The "experts" would be the microbiologists and engineers who design, execute, and interpret the standardized sterilization test methods.

4. Adjudication Method for the Test Set

Not applicable in the context of an AI device requiring consensus from multiple readers. For sterilization devices, the results of biological indicator and chemical indicator tests (e.g., growth/no growth, color change) are objective and typically do not require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a sterilization device, not an AI diagnostic tool. No human readers or AI assistance in a diagnostic context are involved.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a physical sterilization system, not an algorithm. The device performance itself is the "standalone" performance in its intended function.

7. Type of Ground Truth Used

The ground truth used is based on biological indicators (BIs) and simulated use testing.

Biological Indicators: Viable spores of a highly resistant microorganism (e.g., Geobacillus stearothermophilus) are placed in challenging locations within the device or test load. After the sterilization cycle, these BIs are cultured. No growth indicates successful sterilization to a defined Sterility Assurance Level (SAL).
Simulated Use Testing: Involves placing inoculated test devices (with the resistant microorganism) into the sterilizer and running the cycle to verify sterilization effectiveness under conditions simulating actual use.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not a machine learning model that requires a training set. The "design" and "development" of such a system would involve engineering principles and iterative testing, not algorithmic training on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a device of this type.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 9, 2019

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

Re: K190917

Trade/Device Name: V-PRO 60 Low Temperature Sterilization Systems, V-PRO s2 Low Temperature Sterilization Systems Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: April 8, 2019 Received: April 9, 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.

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

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

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 David Krause, PhD Acting Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known)

Device Name

V-PRO® s2 Low Temperature Sterilization System

Indications for Use (Describe)

The V-PRO s2 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 low temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.

The V-PRO s2 Sterilizer Non Lumen Cycle can sterilize: t

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 instrument tray for a total weight of 25 lbs (11.3 kg).

The V-PRO s2 Sterilizer Fast Cycle can sterilize: t

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

· Single or dual channeled devices with stainless steel lumens that are
0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (~16-9/64") in length
≥ 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length

· Triple channeled devices with stainless steel lumens that are either:

≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") in length
≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length
or
≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length

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

Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing was conducted using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg).

The V-PRO s2 Sterilizer Flexible Cycle can sterilize: @

One surgical flexible endoscope (such as those used in ENT. Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.

· The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm in length
· Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions
≥ 0.76 mm (~1/32") ID and ≤ 233 mm (~9 11/64") in length
≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length
≥ 1.8 mm (~5/64") ID and ≤ 542 mm (~21-5/16") in length

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

tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 1bs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing.

The V-PRO s2 Sterilizer Lumen Cycle can sterilize: ^

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

· Single or dual channeled devices with stainless steel lumens that are
≥ 0.77 mm (~1/32") ID and ≤ 410 mm (16-9/64") in length
≥ 1.8 mm (~5/64) ID x ≤ 542 mm (~21-5/16") in length
· Triple channeled devices with stainless steel lumens that are either:
≥ 1.2 mm (~3/64") ID and < 275 mm (~10-53/64") in length
≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length

≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length
^ Validation testing for all lumen sizes was conducted using a maximum of twelve (12) stainless 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 one instrument tray and two pouches for a total weight of 11 Ibs (5.0 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."

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

Indications for Use

510(k) Number (if known)

Device Name

V-PRO® 60 Low Temperature Sterilization System

Indications for Use (Describe)

The V-PRO® 60 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 low temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.

The V-PRO 60 Sterilizer Non Lumen Cycle can sterilize: t

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

The validation studies were conducted using a validation load consisting of one instrument tray for a total weight of 25 lbs (11.3 kg).

The V-PRO 60 Sterilizer Flexible Cycle can sterilize: @

One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.

The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm (~3/64") internal diameter (ID) and ≤ 990 mm (38-63/64'') in length
· Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions
≥ 0.76 mm (~1/32") ID and ≤ 233 mm (~9-11/64") in length
≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length
≥ 1.8mm (~5/64") ID and ≤ 542 mm (~21-5/16") in length

@ The validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel load weight of 11 1bs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing.

The V-PRO 60 Sterilizer Lumen Cycle can sterilize: ^

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

· Single or dual channeled devices with stainless steel lumens that are
- ≥ 0.77 mm (~1/32") ID and ≤ 410 mm (16-9/64") in length
- ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") length
· Triple channeled devices with stainless steel lumens that are either:
≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") in length
≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length
or
≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length

^ Validation testing for all lumen sizes was conducted using a maximum of twelve (12) stainless seel 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 one instrument tray and two pouches for a total weight of 11 Ibs (5.0 kg).

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

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.qov

"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."

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

Image /page/6/Picture/0 description: The image shows the STERIS logo. The word "STERIS" is in large, bold, black font at the top of the image. Below the word 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 waves.

510(k) Summary For

V-PRO® 60 Low Temperature Sterilization Systems and V-PRO®s2 Low Temperature Sterilization Systems

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

Tony Piotrkowski Contact: Director, Regulatory Affairs

Telephone: (440) 392-7437 Fax No: (440) 357-9198

Summary Date: May 8, 2019

Premarket Notification Number: K190917

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

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

1. Device Name

Trade Name:	V-PRO® 60 Low Temperature SterilizationSystems and V-PRO® s2 Low TemperatureSterilization Systems
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
Predicate Devices
Primary Predicate: K182568	V-PRO® s2 and V-PRO® 60 Low TemperatureSterilization Systems
Reference Device: K190103	V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX and V-

Description of Devices 3.

Systems

PRO® maX 2 Low Temperature Sterilization

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

Intended Use / Indications for Use 4.

V-PRO s2 Low Temperature Sterilization System

Each Cycle can sterilize non-luments and instruments with diffusionrestricted spaces such as the hinged portion of forceps and scissors.

The V-PRO s2 Sterilizer Non Lumen Cycle can sterilize: t

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 instrument tray for a total weight of 25 lbs (11.3 kg).

The V-PRO s2 Sterilizer Fast Cycle can sterilize:*

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

Single or dual channeled devices with stainless steel lumens that are ● > 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (~16-9/64") in length
- ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length.
Triple channeled devices with stainless steel lumens that are either: ● ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") in length
- 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length or
- ≥ 2.8 mm (~7/64") ID and ≤ 317 (12-31/64") mm in length

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

Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. Validation testing was conducted using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg).

The V-PRO s2 Sterilizer Flexible Cycle can sterilize: ®

One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.

The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm (~3/64") ID and ≤ 990 mm (38-63/64") in length.
Additional load, up to 11 lb (5 kg) can include stainless steel lumens with ● the following dimensions

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

≥ 0.76 mm (~1/32") ID and ≤ 233 mm (~9 11/64") in length

≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length
≥ 1.8 mm (~5/64") ID and ≤ 542 mm (~21 5/16") in length

The V-PRO s2 Sterilizer Lumen Cycle can sterilize: ^

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

. Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm (~1/32") ID and ≤ 410 mm (16-9/64") in length and ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length.
Triple channeled devices with stainless steel lumens that are either: . > 1.2 mm (~3/64") ID and < 275 mm (~10-53/64") in length > 1.8 mm (~5/64") ID and < 310 mm (~12-13/64") in length or

≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length ^ Validation testing for all lumen sizes was conducted using a maximum of twelve

(12) stainless steel 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 one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg).

V-PRO 60 Low Temperature Sterilization System

Each Cycle can sterilize non-luments and instruments with diffusionrestricted spaces such as the hinged portion of forceps and scissors.

The V-PRO 60 Sterilizer Flexible Cycle can sterilize: @

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

One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.

The flexible endoscope may be a single or dual lumen device with lumens . that are ≥ 1 mm (~3/64") internal diameter (ID) and ≤ 990 mm (38-63/64") in.
Additional load, up to 11 lb (5 kg) can include stainless steel lumens with . the following dimensions
- ≥ 0.76 mm (~1/32") ID and ≤ 233 mm (~9 11/64") in length
- ≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length
- ≥ 1.8 mm (~5/64") ID and ≤ 542 mm (~21 5/16") in length

The V-PRO 60 Sterilizer Lumen Cycle can sterilize: ^

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

. Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm (~1/32") ID and ≤ 410 mm (16-9/64") in length > 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length.
Triple channeled devices with stainless steel lumens that are either: ● > 1.2 mm (~3/64") ID and < 275 mm (~10-53/64") in length ≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length or
- ≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length

5. Technological Characteristics

Shown below is a comparison between the modified V-PRO s2 Low Temperature Sterilization System to the predicate device.

Feature	V-PRO s2 Low TemperatureSterilization System(Modified Device)/K190917	V-PRO s2 Low TemperatureSterilization System(Predicate Device/K182568)
---------	-------------------------------------------------------------------------------	--------------------------------------------------------------------------------

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

STERIS Corporation Special Premarket Notification [510(k)] Modifications to V-PRO® s2 and V-PRO® 60 Low Temperature Sterilization Systems

Indicationsfor Use	The V-PRO® s2 Low TemperatureSterilization System using VAPROX® HCSterilant is intended for use in the terminalsterilization of properly prepared (cleaned,rinsed and dried) medical devices inHealthcare Facilities. The pre-programmedsterilization cycles operate at low pressureand low temperature, suitable for processingmedical devices without leaving toxicresidues.	The V-PRO® s2 Low TemperatureSterilization System using VAPROX® HCSterilant is intended for use in the terminalsterilization of properly prepared (cleaned,rinsed and dried) medical devices inHealthcare Facilities. The pre-programmedsterilization cycles operate at low pressureand low temperature, suitable for processingmedical devices without leaving toxicresidues.
	Each Cycle can sterilize non-lumenedinstruments and instruments with diffusion-restricted spaces such as the hinged portionof forceps and scissors.	Each Cycle can sterilize non-lumenedinstruments and instruments with diffusion-restricted spaces such as the hinged portionof forceps and scissors.
	The V-PRO s2 Sterilizer Non Lumen Cyclecan sterilize:‡Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexibleendoscopes.	The V-PRO s2 Sterilizer Non Lumen Cyclecan sterilize:‡Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexibleendoscopes.

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

	V-PRO s2 Low Temperature	V-PRO s2 Low Temperature
Feature	Sterilization System	Sterilization System
	(Modified Device/K190917)	(Predicate Device/K182568)
	‡ The validation studies were conducted usinga validation load consisting of one instrument	‡ The validation studies were conducted usinga validation load consisting of one instrument
	tray for a total weight of 25 lbs (11.3 kg).	tray for a total weight of 25 lbs (11.3 kg).

	The V-PRO s2 Sterilizer Fast Cycle can	The V-PRO s2 Sterilizer Fast Cycle can
	sterilize:‡	sterilize:‡
	Medical devices (including single, dual and	Medical devices (including single, dual and
	triple channeled rigid and semi-rigid	triple channeled rigid and semi-rigid
	endoscopes) with the following	endoscopes) with the following
	configurations:	configurations:
	• Single or dual channeled devices with	• Single or dual channeled devices with
	stainless steel lumens that are	stainless steel lumens that are ≥ 0.77
	≥ 0.77 mm (~1/32") internal diameter	mm (~1/32") internal diameter (ID)
	(ID) and ≤ 410 mm (~16-9/64") in	and ≤ 410 mm (~16-9/64") in length
	length	• Triple channeled devices with stainless
	≥ 1.8 mm (~5/64) ID x ≤ 542 mm	steel lumens that are either:
	(~21 5/16") in length	≥ 1.2 mm (~3/64") ID and ≤ 275 mm
	• Triple channeled devices with stainless	(~10-53/64") in length
	steel lumens that are either:	≥ 1.8 mm (~5/64") ID and ≤ 310 mm
	≥ 1.2 mm (~3/64") ID and ≤ 275 mm	(~12-13/64") in length
	(~10-53/64") in length	or
	≥ 1.8 mm (~5/64") ID and ≤ 310 mm	≥ 2.8 mm (~7/64") ID and ≤ 317 mm
	(~12-13/64") in length	(12-31/64") in length
	or	Non-lumened instruments including non-
	≥ 2.8 mm (~7/64") ID and ≤ 317 mm	lumened general medical instruments, non-
	(12-31/64") in length	lumened rigid, semi-rigid and flexible
	Non-lumened instruments including non-	endoscopes.
	lumened general medical instruments, non-	‡ Validation testing for all lumen sizes was
	lumened rigid, semi-rigid and flexible	conducted using a maximum of eight (8)
	endoscopes.	lumens per load. Hospital loads should not
	‡ Validation testing for all lumen sizes was	exceed the maximum number of lumens
	conducted using a maximum of eight (8)	validated by this testing. Validation testing
	lumens per load. Hospital loads should not	was conducted using a validation load
	exceed the maximum number of lumens	consisting of one pouched instrument tray and
	validated by this testing. Validation testing	two pouched devices outside of the tray with a
	was conducted using a validation load	total weight of 4.0 lbs (~1.8kg).
	consisting of one pouched instrument tray and
	two pouched devices outside of the tray with a	The V-PRO s2 Sterilizer Flexible Cycle can
	total weight of 4.0 lbs (~1.8kg).	sterilize: @
	The V-PRO s2 Sterilizer Flexible Cycle can	One surgical flexible endoscope (such as
	sterilize: @	those used in ENT, Urology and Surgical
	One surgical flexible endoscope (such as	Care) or bronchoscope with light cord (if
	those used in ENT, Urology and Surgical	not integral to endoscope), mat, and
	Care) or bronchoscope with light cord (if	additional load.
	not integral to endoscope), mat, and	• The flexible endoscope may be a
	additional load.	single or dual lumen device with
	• The flexible endoscope may be a	lumens that are ≥ 1 mm (~3/64") ID
	single or dual lumen device with	and ≤ 990 mm (38-63/64") in length.
	lumens that are ≥ 1 mm (~3/64") ID	• Additional load, up to 11 lb (5 kg) can
	and ≤ 990 mm (38-63/64") in length.	include stainless steel lumens with the
	• Additional load, up to 11 lb (5 kg) can	following dimensions
	include stainless steel lumens with the	○ ≥ 2 mm (~5/64") ID and ≤ 400
	following dimensions	mm (~15 3/4") in length
		○ ≥ 0.76 mm (~1/32") ID and ≤ 233
Feature	V-PRO s2 Low TemperatureSterilization System(Modified Device/K190917)	V-PRO s2 Low TemperatureSterilization System(Predicate Device/K182568)
	≥ 0.76 mm (~1/32") ID and ≤ 233 mm(~9 11/64") in length≥ 1.0 mm (~3/64") ID and ≤ 254 mm(~10") in length≥ 1.8 mm (~5/64") ID and ≤ 542 mm(~21-5/16") in length@ The validation studies were conductedusing a validation load consisting of twoinstrument trays. One tray contained oneflexible endoscope, with silicone mat,instrument organizers and light cord (if notintegral to scope), and the second traycontained additional load and twelve (12)stainless steel lumens for a total load weight of11 lbs (5 kg). Hospital loads should not exceedthe maximum number of lumens validated bythis testing.	≥ 1.0 mm (~3/64") ID and ≤ 254mm (~10") in length@ The validation studies were conductedusing a validation load consisting of twoinstrument trays. One tray contained oneflexible endoscope, with silicone mat,instrument organizers and light cord (if notintegral to scope), and the second traycontained additional load and twelve (12)stainless steel lumens for a total load weight of11 lbs (5 kg). Hospital loads should not exceedthe maximum number of lumens validated bythis testing.
	The V-PRO s2 Sterilizer Lumen Cycle cansterilize: ^Medical devices (including single, dual andtriple channeled rigid and semi-rigidendoscopes) with the followingconfigurations:Single or dual channeled devices withstainless steel lumens that are≥ 0.77 mm internal diameter (ID) and≤ 410 mm in length ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (215/16") in length Triple channeled devices with stainlesssteel lumens that are either:≥ 1.2 mm (~3/64") ID and ≤ 275 mm(~10-53/64") in length≥ 1.8 mm (~5/64") ID and ≤ 310 mm(~12-13/64") in lengthor≥ 2.8 mm (~7/64") ID and ≤ 317 mm(12-31/64") in length ^ Validation testing for all lumen sizeswas conducted using a maximum oftwelve (12) stainless steel lumens perload. Hospital loads should not exceedthe maximum number of lumensvalidated by this testing. The validationstudies were performed using avalidation load consisting of oneinstrument tray and two pouches for a	The V-PRO s2 Sterilizer Lumen Cycle cansterilize: ^Medical devices (including single, dual andtriple channeled rigid and semi-rigidendoscopes) with the followingconfigurations:Single or dual channeled devices withstainless steel lumens that are ≥ 0.77mm internal diameter (ID) and ≤ 410mm in length Triple channeled devices with stainlesssteel lumens that are either:≥ 1.2 mm (~3/64") ID and ≤ 275 mm(~10-53/64") in length≥ 1.8 mm (~5/64") ID and ≤ 310 mm(~12-13/64") in lengthor≥ 2.8 mm (~7/64") ID and ≤ 317 mm(12-31/64") in length ^ Validation testing for all lumen sizeswas conducted using a maximum oftwelve (12) stainless steel lumens perload. Hospital loads should not exceedthe maximum number of lumensvalidated by this testing. The validationstudies were performed using avalidation load consisting of oneinstrument tray and two pouches for atotal weight of 11 lbs (5.0 kg).
	total weight of 11 lbs (5.0 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 s2 Low TemperatureSterilization System(Modified Device/K190917)	V-PRO s2 Low TemperatureSterilization System(Predicate Device/K182568)
Software/FirmwareControlled	Control system consists of a microcomputercontrol board and peripheral function circuitboards, located within the control housing.A memory backup system maintains cyclesettings and current cycle information.The software allows user selection of eitherthe Lumen, Non Lumen, Flexible or Fastpre-programmed cycle.	Control system consists of a microcomputercontrol board and peripheral function circuitboards, located within the control housing.A memory backup system maintains cyclesettings and current cycle information.The software allows user selection of eitherthe Lumen, Non Lumen, or Flexible pre-programmed cycle.
Total CycleTime	Lumen Cycle - 60 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 38 minutesFast Cycle - 19 minutes	Lumen Cycle - 60 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 38 minutesFast Cycle - 19 minutes
Sterilant	VAPROX HC Sterilant (59% HydrogenPeroxide).1.1 g of sterilant is used for each sterilantinjection for all four cycles.	VAPROX HC Sterilant (59% HydrogenPeroxide).1.1 g of sterilant is used for each sterilantinjection for all three cycles
Accessories	Accessories include:● Self-contained biological indicator● Biological indicator challenge pack● Fast Acting Biological Indicator● Chemical indicator● Trays & Tray Accessories● Pouches● Tape	Accessories include:● Self-contained biological indicator● Biological indicator challenge pack● Fast Acting Biological Indicator● Chemical indicator● Trays & Tray Accessories● Pouches● Tape

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

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

STERIS Corporation Special Premarket Notification [510(k)] Modifications to V-PRO® s2 and V-PRO® 60 Low Temperature Sterilization Systems

The proposed device is identical to the predicate except for modification to the indications for use to allow sterilization of single and dual lumen stainless steel lumened devices with the following dimensions: ≥ 1.8 mm ID x ≤ 542 mm length in the Lumen, flexible and fast cycles. Note that with the addition of the 1.8mm x 542mm stainless steel lumen claim, the previous claim (2mm ID x 400mm length) that falls within the new claim has been removed from the Flexible Cycle.

Shown below is comparison of the modifications to the V-PRO 60 Low Temperature Sterilization System to the most recently cleared predicate device.

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

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

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

STERIS Corporation Special Premarket Notification [510(k)] Modifications to V-PRO® s2 and V-PRO® 60 Low Temperature Sterilization Systems

The proposed device is identical to the predicate except for modification to the indications for use to allow sterilization of single and dual lumen stainless steel lumened devices with the following dimensions: ≥ 1.8 mm ID x ≤ 542 mm length in the Lumen, flexible and fast cycles. Note that with the addition of the 1.8mm x 542 mm stainless steel lumen claim, the previous claim (2mm ID x 400mm length) that falls within the new claim has been removed from the Flexible Cycle.

The Reference Devices, V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX and V-PRO® maX 2 Low Temperature Sterilization Systems are 136 L chamber sterilizers. They have the same technological characteristics, mechanism of action and intended use as the proposed devices were cleared in K190103 for the same modification to the indications for use described in this submission.

6. Summary of Nonclinical Tests

The modified sterilizers have the same intended use and same technological characteristics as the predicate devices. Performance testing for the subject device were identical to the methods used to validate predicate device. Shown below is a summary of those methods below.

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

STERIS Corporation Special Premarket Notification [510(k)] Modifications to V-PRO® s2 and V-PRO® 60 Low Temperature Sterilization Systems

Test	Result	Conclusion
1/2 Cycle ModifiedTotal Kill EndpointVerification	½ Cycle modified total kill end point analysiswas demonstrated for the sterilizer cycles. Thestandard injection weight of 1.1 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. Conclusion

Based on the intended use, technological characteristics and non-clinical performance data, the V-PRO® 60 Low Temperature Sterilization System and V-PRO® s2 Low Temperature Sterilization System is as safe, as effective and performs as well as or better than the legally marketed predicate device K182568, Class II (21 CFR 880.6860), product code MLR.

Regulation Number and Section

§ 878.5070 Air-handling apparatus for a surgical operating room.

(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

	V-PRO 60 Low TemperatureSterilization System(Proposed Device/K190917)	V-PRO 60 Low TemperatureSterilization System(Predicate Device/K182568)
Feature
Indicationsfor Use	The V-PRO® s 60 Low TemperatureSterilization System using VAPROX® HCSterilant is intended for use in the terminalsterilization of properly prepared (cleaned,rinsed and dried) medical devices inHealthcare Facilities. The pre-programmedsterilization cycles operate at low pressureand low temperature, suitable for processingmedical devices without leaving toxicresidues.Each Cycle can sterilize non-lumenedinstruments and instruments with diffusion-	The V-PRO®s 60 Low TemperatureSterilization System using VAPROX® HCSterilant is intended for use in the terminalsterilization of properly prepared (cleaned,rinsed and dried) medical devices inHealthcare Facilities. The pre-programmedsterilization cycles operate at low pressureand low temperature, suitable for processingmedical devices without leaving toxicresidues.Each Cycle can sterilize non-lumenedinstruments and instruments with diffusion-
Feature	V-PRO 60 Low TemperatureSterilization System(Proposed Device/K190917)	V-PRO 60 Low TemperatureSterilization System(Predicate Device/K182568)
	restricted spaces such as the hinged portionof forceps and scissors.	restricted spaces such as the hinged portionof forceps and scissors.
	The V-PRO 60 Sterilizer Non Lumen Cyclecan sterilize:‡Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexibleendoscopes.‡ The validation studies were conducted usinga validation load consisting of one instrumenttray for a total weight of 25 lbs (11.3 kg).	The V-PRO 60 Sterilizer Non Lumen Cyclecan sterilize:‡Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexibleendoscopes.‡ The validation studies were conducted usinga validation load consisting of one instrumenttray for a total weight of 25 lbs (11.3 kg).
	The V-PRO 60 Sterilizer Flexible Cycle cansterilize: @One surgical flexible endoscope (such asthose used in ENT, Urology and SurgicalCare) or bronchoscope with light cord (ifnot integral to endoscope), mat, andadditional load.The flexible endoscope may be a singleor dual lumen device with lumens thatare ≥ 1 mm (~3/64") ID and ≤ 990 mm(38-63/64") in length. Additional load, up to 11 lb (5 kg) caninclude stainless steel lumens with thefollowing dimensions ≥ 0.76 mm (~1/32") ID and ≤ 233 mm(~9 11/64") in length ≥ 1.0 mm (~3/64") ID and ≤ 254 mm(~10") in length ≥ 1.8 mm (~5/64") ID and ≤ 542 mm(~21 5/16") in length @ The validation studies were conductedusing a validation load consisting of twoinstrument trays. One tray contained oneflexible endoscope, with silicone mat,instrument organizers and light cord (if notintegral to scope), and the second traycontained additional load and twelve (12)stainless steel lumens for a total load weight of11 lbs (5 kg). Hospital loads should not exceedthe maximum number of lumens validated bythis testing.	The V-PRO 60 Sterilizer Flexible Cycle cansterilize: @One surgical flexible endoscope (such asthose used in ENT, Urology and SurgicalCare) or bronchoscope with light cord (ifnot integral to endoscope), mat, andadditional load.The flexible endoscope may be a singleor dual lumen device with lumens thatare ≥ 1 mm (~3/64") ID and ≤ 990 mm(38-63/64") in length Additional load, up to 11 lb (5 kg) caninclude stainless steel lumens with thefollowing dimensions ≥ 2 mm (~5/64") ID and ≤ 400 mm(~15 3/4") in length ≥ 0.76 mm (~1/32") ID and ≤233mm (~9 11/64") in length ≥ 1.0 mm (~3/64") ID and ≤ 254mm (~10") in length @ The validation studies were conductedusing a validation load consisting of twoinstrument trays. One tray contained oneflexible endoscope, with silicone mat,instrument organizers and light cord (if notintegral to scope), and the second traycontained additional load and twelve (12)stainless steel lumens for a total load weight of11 lbs (5 kg). Hospital loads should not exceedthe maximum number of lumens validated bythis testing.
	The V-PRO 60 Sterilizer Lumen Cycle cansterilize: ^Medical devices (including single, dual andtriple channeled rigid and semi-rigidendoscopes) with the followingconfigurations:Single or dual channeled deviceswith stainless steel lumens that are	The V-PRO 60 Sterilizer Lumen Cycle cansterilize: ^Medical devices (including single, dual andtriple channeled rigid and semi-rigidendoscopes) with the followingconfigurations:Single or dual channeled deviceswith stainless steel lumens that are>0.77 mm (~1/32") internal
Feature	V-PRO 60 Low TemperatureSterilization System(Proposed Device/K190917)	V-PRO 60 Low TemperatureSterilization System(Predicate Device/K182568)
	≥ 0.77 mm (~1/32") internaldiameter (ID) and ≤ 410 mm (16-9/64") in length≥ 1.8 mm (~5/64") ID x ≤ 542mm (21 5/16") in length• Triple channeled devices withstainless steel lumens that areeither:≥ 1.2 mm (~3/64") ID and ≤ 275mm (~10-53/64") in length≥ 1.8 mm (~5/64") ID and ≤ 310mm (~12-13/64") in lengthor≥ 2.8 mm (~7/64") ID and ≤ 317mm (12-31/64") in length^ Validation testing for all lumen sizeswas conducted using a maximum oftwelve (12) stainless steel lumens perload. Hospital loads should not exceed themaximum number of lumens validated bythis testing. The validation studies wereperformed using a validation loadconsisting of one instrument tray and twopouches for a total weight of 11 lbs (5.0kg).	diameter (ID) and ≤ 410 mm (16-9/64") in length• Triple channeled devices withstainless steel lumens that areeither:≥ 1.2 mm (~3/64") ID and ≤ 275mm (~10-53/64") in length≥ 1.8 mm (~5/64") ID and ≤ 310mm (~12-13/64") in lengthor≥ 2.8 mm (~7/64") ID and ≤ 317mm (12-31/64") in length^ Validation testing for all lumen sizes wasconducted using a maximum of twelve (12)stainless steel lumens per load. Hospitalloads should not exceed the maximumnumber of lumens validated by this testing.The validation studies were performedusing a validation load consisting of oneinstrument tray and two pouches for a totalweight of 11 lbs (5.0 kg).
ProcessParameters	The critical process parameters are:• Time• Chamber Temperature• Vaporizer Temperature• Chamber Pressure Prior to Injection• Sterilant Injection Weight	The critical process parameters are:• Time• Chamber Temperature• Vaporizer Temperature• Chamber Pressure Prior to Injection• Sterilant Injection Weight
Software/FirmwareControlled	Control system consists of a microcomputercontrol board and peripheral function circuitboards, located within the control housing.A memory backup system maintains cyclesettings and current cycle informationindefinitely.The software allows user selection of eitherthe Lumen, Non Lumen, or Flexible pre-programmed cycle.	Control system consists of a microcomputercontrol board and peripheral function circuitboards, located within the control housing.A memory backup system maintains cyclesettings and current cycle informationindefinitely.The software allows user selection of eitherthe Lumen, Non Lumen, or Flexible pre-programmed cycle.
TotalCycle Time	Lumen Cycle - 60 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 38 minutes	Lumen Cycle - 60 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 38 minutes
Sterilant	VAPROX HC Sterilant (59% HydrogenPeroxide).1.1 g of sterilant is used for each sterilantinjection for all three cycles.	VAPROX HC Sterilant (59% HydrogenPeroxide).1.1 g of sterilant is used for each sterilantinjection for all three cycles.
Feature	V-PRO 60 Low TemperatureSterilization System(Proposed Device/K190917)	V-PRO 60 Low TemperatureSterilization System(Predicate Device/K182568)
Accessories	Accessories include:• Self-contained biological indicator• Biological indicator challenge pack• Fast Acting Biological Indicator• Chemical indicator• Trays & Tray Accessories• Pouches• Tape	Accessories include:• Self-contained biological indicator• Biological indicator challenge pack• Fast Acting Biological Indicator• Chemical indicator• Trays & Tray Accessories• Pouches• Tape