V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System

K182568 · STERIS Corporation · MLR · Jan 3, 2019 · General Hospital

Device Facts

• Record ID: K182568
• Device Name: V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
• Applicant: STERIS Corporation
• Product Code: MLR · General Hospital
• Decision Date: Jan 3, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6860
• Device Class: Class 2

Intended Use

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.

Device Story

V-PRO s2 and V-PRO 60 are vaporized hydrogen peroxide (VHP) sterilizers for healthcare facilities. Devices use VAPROX HC Sterilant (59% hydrogen peroxide) to achieve terminal sterilization. Operation involves pre-programmed cycles (Lumen, Non Lumen, Flexible, and Fast for s2) consisting of conditioning, sterilization, and aeration phases. Input: cleaned, rinsed, dried, and packaged medical instruments. Output: sterile, ready-to-use devices with no required cool-down. Operated by healthcare staff in clinical settings. System monitors critical parameters (time, chamber temperature, vaporizer temperature, chamber pressure) via microcomputer control board. Performance validated through D-value determination, total kill endpoint verification, and simulated/in-use testing with patient-soiled instruments. Benefits include low-temperature processing of heat-sensitive devices without toxic residues.

Clinical Evidence

Bench testing only. Studies included D-value and total kill endpoint verification, 1/2 cycle modified total kill endpoint analysis, surface and mated surface sterilization efficacy, simulated use testing with worst-case loads, and in-use testing with patient-soiled, clinically-cleaned instruments. Biocompatibility (cytotoxicity and residue analysis) was confirmed. All tests passed.

Technological Characteristics

Vaporized hydrogen peroxide (VHP) sterilizer. Uses VAPROX HC Sterilant (59% H2O2). Microcomputer control system with memory backup. Standards: IEC 61010-1:2010, IEC 61010-2-040:2015, IEC 61326-1:2012 (s2) / 2006 (V-PRO 60). Operates at low pressure/temperature. Dimensions/form factor: Cabinetry-based sterilizer.

Indications for Use

Indicated for terminal sterilization of cleaned, rinsed, and dried medical devices in healthcare facilities. Includes non-lumened instruments, rigid/semi-rigid/flexible endoscopes, and stainless steel/titanium instruments with diffusion-restricted spaces. Specific cycle configurations support single, dual, and triple-channeled rigid endoscopes and flexible endoscopes (ENT, Urology, Surgical Care, bronchoscopes) with defined lumen ID and length constraints.

Regulatory Classification

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.

Predicate Devices

• V-PRO 60 Low Temperature Sterilization System (K172319)

Submission Summary (Full Text)

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January 3, 2019

STERIS Corporation Bill Brodbeck Director, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060

Re: K182568

Trade/Device Name: V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene oxide gas sterilizer Regulatory Class: Class II Product Code: MLR Dated: November 26, 2018 Received: November 27, 2018

Dear Bill Brodbeck:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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.html; 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 ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Elizabeth F. Claverie -S

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

Enclosure

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# Indications for Use

510(k) Number (if known)

K182568

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, 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
- · 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
- $\[$ 2 mm (~5/64") ID and $\[$ 400 mm (~15 3/4") in length
- ≥ 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

@ 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 lbs (5 kg). Hospital loads

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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") internal diameter (ID) and ≤ 410 mm (16-9/64") 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).

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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# Indications for Use

510(k) Number (if known)

K182568

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, semi-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") 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
- $\\≥$ 2 mm (~5/64") ID and $\\le$ 400 mm (~15 3/4") in length
- $\\ge$ 0.76 mm (~1/32") ID and $\\le$ 233 mm (~9 11/64") in length
- $\\ge$ 1.0 mm (~3/64") ID and $\\le$ 254 mm (~10") 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 luad 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 $\\ge$ 0.77 mm (~1/32") internal diameter (ID) and $\\le$ 410 mm (16-9/64") in length
- · Triple channeled devices with stainless steel lumens that are either:
- $\\ge$ 1.2 mm (~3/64") ID and $\\le$ 275 mm (~10-53/64") in length
- $\\ge$ 1.8 mm (~5/64") ID and $\\le$ 310 mm (~12-13/64") in length or

$\\ge$ 2.8 mm (~7/64") ID and $\\le$ 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).

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Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary For V-PRO® s2 and V-PRO 60 Low Temperature Sterilization Systems

# K182568

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Contact: Bill Brodbeck Director, Regulatory Affairs

Telephone: [phone] Fax No: [phone]

Summary Date: November 26, 2018

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

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#### 1. Device Name

| K#: | K182568 |
|------------------------|------------------------------------------------|
| Trade Name: | V-PRO® s2 Low 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 Devices

V-PRO® 60 Low Temperature Sterilization System (originally cleared under K140498 with additional material compatibility claims cleared under K162413 and most recently, K172319)

| | V-PRO s2 Low Temperature<br>Sterlization System<br>(Proposed Device) | V-PRO 60 Low Temperature Sterlization<br>System<br>(Predicate Device/K172319) |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | | |
| Indications<br>for Use | The V-PRO® s2 Low Temperature<br>Sterilization System using VAPROX® HC<br>Sterilant is intended for use in the terminal<br>sterilization of properly prepared (cleaned,<br>rinsed and dried) medical devices in<br>Healthcare Facilities. The pre-<br>programmed sterilization cycles operate at<br>low pressure and low temperature, suitable<br>for processing medical devices without<br>leaving toxic residues.<br><br>Each Cycle can sterilize non-lumened<br>instruments and instruments with<br>diffusion-restricted spaces such as the<br>hinged portion of forceps and scissors.<br><br>The V-PRO s2 Sterilizer Non Lumen<br>Cycle can sterilize:‡<br>Non-lumened instruments including non-<br>lumened general medical instruments, non-<br>lumened rigid, semi-rigid and flexible<br>endoscopes.<br>‡ The validation studies were conducted | The V-PRO 60 Low Temperature<br>Sterilization System using VAPROX® HC<br>Sterilant is intended for use in the terminal<br>sterilization of properly prepared (cleaned,<br>rinsed and dried) medical devices in<br>Healthcare Facilities. The pre-programmed<br>sterilization cycles operate at low pressure<br>and low temperature, suitable for processing<br>medical devices without leaving toxic<br>residues.<br><br>Each Cycle can sterilize non-lumened<br>instruments with diffusion-restricted spaces<br>such as the hinged portion of forceps and<br>scissors. Only stainless steel or titanium<br>diffusion restricted spaces should be<br>processed in the Non Lumen Cycle.<br><br>The V-PRO 60 Sterilizer's Non Lumen<br>Cycle can sterilize:‡<br>Non-lumened instruments including non-<br>lumened general medical instruments, non-<br>lumened rigid, semi-rigid and flexible |
| Feature | V-PRO s2 Low Temperature<br>Sterlization System<br>(Proposed Device) | V-PRO 60 Low Temperature Sterlization<br>System<br>(Predicate Device/K172319) |
| | using a validation load consisting of one<br>instrument tray for a total weight of 25 lbs<br>(11.3 kg). | endoscopes.<br><br>$\ddagger$ The validation studies were conducted using<br>a validation load consisting of one instrument<br>tray and one pouch for a total weight of 12 lbs<br>(5.4 kg). |
| | The V-PRO s2 Sterilizer Fast Cycle can<br>sterilize: $\ddagger$<br>Medical devices (including single, dual<br>and triple channeled rigid and semi-rigid<br>endoscopes) with the following<br>configurations:<br>• Single or dual channeled devices with<br>stainless steel lumens that are ≥ 0.77<br>mm (~1/32") internal diameter (ID)<br>and ≤ 410 mm (~16-9/64") in length<br>• Triple channeled devices with<br>stainless steel lumens that are either:<br>≥ 1.2 mm (~3/64") ID and ≤ 275 mm<br>(~10-53/64") in length<br>≥ 1.8 mm (~5/64") ID and ≤ 310 mm<br>(~12-13/64") in length<br>or<br>≥ 2.8 mm (~7/64") ID and ≤ 317 mm<br>(12-31/64") in length<br>Non-lumened instruments including non-<br>lumened general medical instruments, non-<br>lumened rigid, semi-rigid and flexible<br>endoscopes.<br>$\ddagger$ Validation testing for all lumen sizes was<br>conducted using a maximum of eight (8)<br>lumens per load. Hospital loads should not<br>exceed the maximum number of lumens<br>validated by this testing. Validation testing<br>was conducted using a validation load<br>consisting of one pouched instrument tray<br>and two pouched devices outside of the tray<br>with a total weight of 4.0 lbs (~1.8kg). | The V-PRO 60 Sterilizer's Flexible Cycle<br>can sterilize: @<br>One surgical flexible endoscope (such as<br>those used in ENT, Urology and Surgical<br>Care) or bronchoscope with light cord (if<br>not integral to endoscope) and mat without<br>additional load. The flexible endoscope<br>may be a single or dual lumen device with<br>lumens that are > 1 mm (~3/64") ID and <<br>990 mm (38-63/64") in length.<br>@ The validation studies were conducted<br>using a validation load consisting of one<br>instrument tray containing one flexible<br>endoscope, with silicone mat, instrument<br>organizers and light cord (if not integral to<br>scope). |
| | The V-PRO s2 Sterilizer Flexible Cycle<br>can sterilize: @<br>One surgical flexible endoscope (such as<br>those used in ENT, Urology and Surgical<br>Care) or bronchoscope with light cord (if<br>not integral to endoscope), mat, and<br>additional load.<br>• The flexible endoscope may be a<br>single or dual lumen device with<br>lumens that are ≥ 1 mm (~3/64") ID<br>and ≤ 990 mm (38-63/64") in length.<br>• Additional load, up to 11 lb (5 kg)<br>can include stainless steel lumens<br>with the following dimensions<br>○ ≥ 2 mm (~5/64") ID and ≤ 400<br>mm (~15 3/4") in length | The V-PRO 60 Sterilizer's Lumen Cycle<br>can sterilize: ^<br>Medical devices (including single, dual and<br>triple channeled rigid and semi-rigid<br>endoscopes) with the following<br>configurations:<br>• Single or dual channeled devices with<br>stainless steel lumens that are ≥ 0.77<br>mm (~1/32") internal diameter (ID) and<br>≤ 410 mm (16-9/64") in length<br>• Triple channeled devices with stainless<br>steel lumens that are either:<br>≥ 1.2 mm (~3/64") ID and ≤ 275 mm<br>(~10-55/64") in length<br>≥ 1.8 mm (~5/64") ID and ≤ 310 mm<br>(~12-13/64") in length<br>or<br>≥ 2.8 mm (~7/64") ID and ≤ 317 mm<br>(12-31/64") in length<br>^ Validation testing for all lumen sizes was<br>conducted using a maximum of twelve (12)<br>lumens per load. Hospital loads should not<br>exceed the maximum number of lumens<br>validated by this testing. The validation studies<br>were performed using a validation load<br>consisting of one instrument tray and two<br>pouches for a total weight of 11 lbs (5.0 kg). |
| Feature | V-PRO s2 Low Temperature<br>Sterlization System<br>(Proposed Device) | V-PRO 60 Low Temperature Sterlization<br>System<br>(Predicate Device/K172319) |
| | mm (~9 11/64") in length<br>○ ≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length<br>@ The validation studies were conducted<br>using a validation load consisting of two<br>instrument trays. One tray contained one<br>flexible endoscope, with silicone mat,<br>instrument organizers and light cord (if not<br>integral to scope), and the second tray<br>contained additional load and twelve (12)<br>stainless steel lumens for a total load weight<br>of 11 lbs (5 kg). Hospital loads should not<br>exceed the maximum number of lumens<br>validated by this testing.<br><br>The V-PRO s2 Sterilizer Lumen Cycle can<br>sterilize: ^<br>Medical devices (including single, dual<br>and triple channeled rigid and semi-rigid<br>endoscopes) with the following<br>configurations:<br>• Single or dual channeled devices with<br>stainless steel lumens that are ≥ 0.77<br>mm internal diameter (ID) and ≤ 410<br>mm in length<br>• Triple channeled devices with<br>stainless steel lumens that are either:<br>≥ 1.2 mm (~3/64") ID and ≤ 275 mm<br>(~10-53/64") in length<br>≥ 1.8 mm (~5/64") ID and ≤ 310 mm<br>(~12-13/64") in length<br>or<br>≥ 2.8 mm (~7/64") ID and ≤ 317 mm<br>(12-31/64") in length<br>^ Validation testing for all lumen<br>sizes was conducted using a<br>maximum of twelve (12) stainless<br>steel lumens per load. Hospital loads<br>should not exceed the maximum<br>number of lumens validated by this<br>testing. The validation studies were<br>performed using a validation load<br>consisting of one instrument tray and<br>two pouches for a total weight of 11<br>lbs (5.0 kg). | |
| Process<br>Parameters | The critical process parameters are:<br>• Time<br>• Chamber Temperature<br>• Vaporizer Temperature<br>• Chamber Pressure Prior to Injection | The critical process parameters are:<br>• Time<br>• Chamber Temperature<br>• Vaporizer Temperature<br>• Chamber Pressure Prior to Injection |
| Feature | V-PRO s2 Low Temperature<br>Sterilization System<br>(Proposed Device) | V-PRO 60 Low Temperature Sterilization<br>System<br>(Predicate Device/K172319) |
| Software/<br>Firmware<br>Controlled | Control system consists of a<br>microcomputer control board and<br>peripheral function circuit boards, located<br>within the control housing. A memory<br>backup system maintains cycle settings<br>and current cycle information. | Control system consists of a microcomputer<br>control board and peripheral function circuit<br>boards, located within the control housing.<br>A memory backup system maintains cycle<br>settings and current cycle information. |
| | The software allows user selection of<br>either the Lumen, Non Lumen, Flexible or<br>Fast pre-programmed cycle. | The software allows user selection of either<br>the Lumen, Non Lumen, or Flexible pre-<br>programmed cycle. |
| Total<br>Cycle Time | Lumen Cycle - 60 minutes<br>Non Lumen Cycle - 28 minutes<br>Flexible Cycle - 38 minutes<br>Fast Cycle - 19 minutes | Lumen Cycle - 60 minutes<br>Non Lumen Cycle - 28 minutes<br>Flexible Cycle - 38 minutes |
| Sterilant | VAPROX HC Sterilant (59% Hydrogen<br>Peroxide).<br>1.1 g of sterilant is used for each sterilant<br>injection for all four cycles. | VAPROX HC Sterilant (59% Hydrogen<br>Peroxide).<br>1.1 g of sterilant is used for each sterilant<br>injection for all three cycles |
| Accessories | Accessories are to be submitted under<br>separate, individual, 510(k)s and cover the<br>following:<br>Self-contained biological indicatorBiological indicator challenge packFast Acting Biological IndicatorChemical indicatorTrays & Tray AccessoriesPouchesTape | Accessories are to be submitted under<br>separate, individual, 510(k)s and cover the<br>following:<br>Self-contained biological indicatorBiological indicator challenge packFast Acting Biological IndicatorChemical indicatorTrays & Tray AccessoriesPouchesTape |

A comparison between the proposed V-PRO s2 Low Temperature Sterilization System to the predicate device is summarized in the table below.

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The proposed device has an intended use similar to the predicate with the same technological characteristics. The indications for use differ between the two devices with the proposed device carrying the additional Fast Cycle, removal of restrictions on claims regarding diffusion-restricted spaces for all cycles, increased maximum load capacity claims for the Non Lumen Cycle and expanded load claims for the Flexible Cycle. Additional convenience features have also been included with the proposed device. Although, the devices slightly differ in their design and additional convenience items and features, the provided descriptive characteristics and performance data demonstrate equivalence. Therefore, the proposed V-PRO s2 Low Temperature Sterilization System is substantially equivalent to the predicate device, the V-PRO 60 Low Temperature Sterilization System.

A comparison between the proposed modifications to the V-PRO 60 Low Temperature Sterilization System to the most recently cleared predicate device is summarized in the table below.

| Feature | V-PRO 60 Low Temperature Sterilization System<br>(Proposed Device) | V-PRO 60 Low Temperature Sterilization System<br>(Predicate Device/K172319) |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | V-PRO 60 Low Temperature<br>Sterlization System<br>(Proposed Device) | V-PRO 60 Low Temperature Sterlization<br>System<br>(Predicate Device/K172319) |
| Feature | | |
| Indications<br>for Use | The V-PRO® s 60 Low Temperature<br>Sterilization System using VAPROX® HC<br>Sterilant is intended for use in the terminal<br>sterilization of properly prepared (cleaned,<br>rinsed and dried) medical devices in<br>Healthcare Facilities. The pre-<br>programmed sterilization cycles operate at<br>low pressure and low temperature, suitable<br>for processing medical devices without<br>leaving toxic residues.<br><br>Each Cycle can sterilize non-lumened<br>instruments and instruments with<br>diffusion-restricted spaces such as the<br>hinged portion of forceps and scissors.<br><br>The V-PRO 60 Sterilizer Non Lumen<br>Cycle can sterilize:‡<br>Non-lumened instruments including non-<br>lumened general medical instruments, non-<br>lumened rigid, semi-rigid and flexible<br>endoscopes.<br><br>‡ The validation studies were conducted<br>using a validation load consisting of one<br>instrument tray for a total weight of 25 lbs<br>(11.3 kg). | The V-PRO 60 Low Temperature<br>Sterilization System using VAPROX® HC<br>Sterilant is intended for use in the terminal<br>sterilization of properly prepared (cleaned,<br>rinsed and dried) medical devices in<br>Healthcare Facilities. The pre-programmed<br>sterilization cycles operate at low pressure<br>and low temperature, suitable for processing<br>medical devices without leaving toxic<br>residues.<br><br>Each Cycle can sterilize non-lumened<br>instruments with diffusion-restricted spaces<br>such as the hinged portion of forceps and<br>scissors. Only stainless steel or titanium<br>diffusion restricted spaces should be<br>processed in the Non Lumen Cycle.<br><br>The V-PRO 60 Sterilizer's Non Lumen<br>Cycle can sterilize:‡<br>Non-lumened instruments including non-<br>lumened general medical instruments, non-<br>lumened rigid, semi-rigid and flexible<br>endoscopes.<br><br>‡ The validation studies were conducted using<br>a validation load consisting of one instrument<br>tray and one pouch for a total weight of 12 lbs<br>(5.4 kg). |
| | The V-PRO 60 Sterilizer Flexible Cycle<br>can sterilize: @<br>One surgical flexible endoscope (such as<br>those used in ENT, Urology and Surgical<br>Care) or bronchoscope with light cord (if<br>not integral to endoscope), mat, and<br>additional load.<br>The flexible endoscope may be a<br>single or dual lumen device with<br>lumens that are ≥ 1 mm (~3/64") ID<br>and ≤ 990 mm (38-63/64") in length. Additional load, up to 11 lb (5 kg) can<br>include stainless steel lumens with the<br>following dimensions ≥ 2 mm (~5/64") ID and ≤ 400<br>mm (~15 3/4") in length ≥ 0.76 mm (~1/32") ID and ≤ 233<br>mm (~9 11/64") in length ≥ 1.0 mm (~3/64") ID and ≤ 254<br>mm (~10") in length @ The validation studies were conducted<br>using a validation load consisting of two<br>instrument trays. One tray contained one<br>flexible endoscope, with silicone mat,<br>instrument organizers and light cord (if not | The V-PRO 60 Sterilizer's Flexible Cycle<br>can sterilize: @<br>One surgical flexible endoscope (such as<br>those used in ENT, Urology and Surgical<br>Care) or bronchoscope with light cord (if<br>not integral to endoscope) and mat without<br>additional load. The flexible endoscope<br>may be a single or dual lumen device with<br>lumens that are > 1 mm (~3/64") ID and < 990 mm (38-63/64") in length.<br><br>@ The validation studies were conducted<br>using a validation load consisting of one<br>instrument tray containing one flexible<br>endoscope, with silicone mat, instrument<br>organizers and light cord (if not integral to<br>scope). |
| | | The V-PRO 60 Sterilizer's Lumen Cycle<br>can sterilize: ^<br>Medical devices (including single, dual and<br>triple channeled rigid and semi-rigid<br>endoscopes) with the following<br>configurations: Single or dual channeled devices with<br>stainless steel lumens that are ≥ 0.77 |
| Feature | V-PRO 60 Low Temperature<br>Sterlization System<br>(Proposed Device) | V-PRO 60 Low Temperature Sterlization<br>System<br>(Predicate Device/K172319)…