V-PRO® 1 Plus and V-PRO® maX Low Temperature

K160433 · STERIS Corporation · MLR · Jul 6, 2016 · General Hospital

Device Facts

• Record ID: K160433
• Device Name: V-PRO® 1 Plus and V-PRO® maX Low Temperature
• Applicant: STERIS Corporation
• Product Code: MLR · General Hospital
• Decision Date: Jul 6, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6860
• Device Class: Class 2

Intended Use

The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and are thus suitable for processing medical devices sensitive to heat and moisture.

Device Story

V-PRO 1 Plus and V-PRO maX are vaporized hydrogen peroxide (VHP) sterilizers for heat/moisture-sensitive medical devices. Devices are placed in a chamber; user selects pre-programmed cycle (Lumen, Non Lumen, or Flexible) via GUI. System uses VAPROX HC Sterilant (59% hydrogen peroxide). Process involves conditioning (chamber prep), sterilization (VHP exposure at low pressure), and aeration (residual removal). No post-cycle cool-down required. Used in healthcare facilities by trained staff. Output is sterilized, ready-to-use medical equipment. Benefits include rapid, low-temperature terminal sterilization of complex instruments, including those with diffusion-restricted areas or specific lumen geometries.

Clinical Evidence

Bench testing only. Validation included modified total kill endpoint verification, sterilization verification of cycle claims, simulated use testing, and final process qualification. Performance confirmed using biological indicators (SCBI) and chemical indicators under worst-case conditions (e.g., 50 lb load for Non Lumen Cycle).

Technological Characteristics

Vaporized hydrogen peroxide (VHP) sterilizer. Chamber: 136 L welded aluminum. V-PRO 1 Plus: stainless steel side panels; V-PRO maX: plastic side panels. Process parameters: time, chamber/vaporizer temperature, pressure, sterilant injection weight. Connectivity: onboard printer. Sterilant: VAPROX HC (59% H2O2).

Indications for Use

Indicated for terminal sterilization of cleaned, rinsed, and dried metal and nonmetal medical devices in healthcare facilities. Includes lumened/non-lumened instruments, rigid/semi-rigid/flexible endoscopes, and devices with diffusion-restricted spaces (e.g., hinged forceps/scissors). Specific lumen configurations (ID/length) and load weights (up to 50 lbs for Non Lumen Cycle) are defined for Lumen, Non Lumen, and Flexible cycles.

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 1 Plus/ V-PRO maX Low Temperature Sterilization System (K131120)

Submission Summary (Full Text)

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

July 6, 2016

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

Re: K160433

Trade/Device Name: V-PRO® 1 Plus and V-PRO® maX Low Temperature Sterilization Systems Regulation Number: 21 CFR 880.6860 Regulation Name: Sterilizer, Ethylene Oxide Gas Regulatory Class: II Product Code: MLR Dated: June 9, 2016 Received: June 10, 2016

Dear Dr. Brodbeck:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

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

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

Teiashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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) K160433

## Device Name

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

## Indications for Use (Describe)

The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and are thus suitable for processing medical devices sensitive to heat and moisture.

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle can sterilize:(a)

- Lumened and non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations: (a)
- o single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
- o dual channeled devices with stainless steel lumens that are > 0.77 mm ID and < 527 mm in length

o triple channeled devices with stainless steel lumens that are

- ≥ 1.2 mm ID and ≤ 275 mm in length
- ≥ 1.8 mm ID and ≤ 310 mm in length
- or
- > 2.8 mm ID and < 317 mm in length
- (a) The validation studies for all channel/lumen configurations were conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.

The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Non Lumen Cycle can sterilize: (0) Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes and non-luments with stainless steel or titanium diffusion-restricted areas such as the hinged portion of forceps or scissors.

- (b) The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 50 lbs.
The V-PRO maX Low Temperature Sterilization System's Flexible Cycle can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of two load configurations:

- 1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. (c) The flexible endoscopes may contain either:
- · a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length
- · or two lumens with:
- · one lumen that is > 1 mm ID and < 990 mm in length
- · and the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length
- (c) The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).

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- 2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffiusion-restricted areas such as the hinged portion of forceps or scissors.(d) The flexible endoscope can contain either:
- · a single lumen that is > 1 mm ID and < 1050 mm in length
- · or two lumens with:
- one lumen that is ≥ 1 mm ID and ≤ 990 mm in length
- · and the other lumen that is ≥ 1 mm and ≤ 850 mm in length
- (d) The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (ff not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.

The parameters for the three V-PRO Cycles are as follows:

| Table 1: Parameters for V-PRO Cycles | | | | | |
|--------------------------------------|----------------------------|-----------------|----------------------------------|-----------------------------------------------|---------------------------------------|
| Sterilization Cycle | Sterilant<br>injection (g) | # of Injections | Sterilant Exposure<br>Time (min) | Chamber Pressure<br>Prior to Injection (Torr) | Chamber/Vaporizer<br>Temperature (°C) |
| Lumen | 2.1 | 4 | 32 | 0.4 | 50/60 |
| Non Lumen | 2.1 | 4 | 12 | 1 | 50/60 |
| Flexible | 2.1 | 4 | 12 | 0.4 | 50/60 |

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary For V-PRO® 1 Plus and V-PRO® maX Low Temperature Sterilization Systems

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

Bill Brodbeck Contact: Director, Regulatory Affairs

Email: William [e-mail] Telephone: [phone] Fax No: [phone]

Summary Date: June 9, 2016

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

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#### 1. Device Name

| Trade Name: | V-PRO® 1 Plus and V-PRO® maX Low Temperature<br>Sterilization Systems |
|----------------------|-----------------------------------------------------------------------|
| Device Class: | Class II |
| Common/usual Name: | Vapor Phase Hydrogen Peroxide Sterilizer |
| Classification Name: | Sterilizer, Ethylene Oxide Gas<br>21 CFR 880.6860<br>Product Code MLR |

#### 2. Predicate Devices

Primary predicate claimed is V-PRO 1 Plus/ V-PRO maX Low Temperature Sterilization System cleared under K131120.

V-PRO® 1 Plus Low Temperature Sterilization System was originally cleared under K083097 with modifications cleared under K102394, K111810, K112813 and K120632.

V-PRO® maX Low Temperature Sterilization System was originally cleared under K102330 with modifications cleared under K112760, and K120632.

Comparison between the proposed V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems to the predicate devices is summarized in the table below.

| Feature | V-PRO 1 Plus/V-PRO maX Low<br>Temperature Sterilization System<br>(Proposed Device) | V-PRO 1 Plus/V-PRO maX Low<br>Temperature Sterilization System<br>(Predicate Devices/K131120) |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The V-PRO 1, V-PRO 1 Plus and V-PRO<br>maX Low Temperature Sterilization<br>Systems, with VAPROX® HC Sterilant, are<br>vaporized hydrogen peroxide sterilizers<br>intended for use in the terminal sterilization<br>of cleaned, rinsed and dried metal and<br>nonmetal medical devices used in healthcare<br>facilities. The three pre-programmed<br>sterilization cycles (Lumen Cycle, Non<br>Lumen Cycle, and Flexible Cycle) operate<br>at low pressure and low temperature and are<br>thus suitable for processing medical devices<br>sensitive to heat and moisture.<br><br>The V-PRO 1, V-PRO 1 Plus and V-PRO | The Amsco V-PRO 1, V-PRO 1 Plus and V-<br>PRO maX Low Temperature Sterilization<br>Systems, with VAPROX® HC Sterilant, are<br>vaporized hydrogen peroxide sterilizers<br>intended for use in the terminal sterilization<br>of cleaned, rinsed and dried reusable metal<br>and nonmetal medical devices used in<br>healthcare facilities. The three pre-<br>programmed sterilization cycles (Lumen<br>Cycle, Non Lumen Cycle, and Flexible<br>Cycle) operate at low pressure and low<br>temperature and are thus suitable for<br>processing medical devices sensitive to heat<br>and moisture.<br><br>The Amsco V-PRO 1, V-PRO 1 Plus and |
| Feature | V-PRO 1 Plus/V-PRO maX Low<br>Temperature Sterilization System<br>(Proposed Device) | V-PRO 1 Plus/V-PRO maX Low<br>Temperature Sterilization System<br>(Predicate Devices/K131120) |
| | maX Low Temperature Sterilization<br>System's Lumen Cycle, can sterilize:a<br>• Lumened and non-lumened<br>instruments with diffusion-restricted<br>spaces such as the hinged portion of<br>forceps and scissors<br>• Medical devices, including single,<br>dual and triple channeled rigid and<br>semi-rigid endoscopes, with the<br>following configurations: a<br>o single channeled devices with a<br>stainless steel lumen that is ><br>0.77 mm internal diameter (ID)<br>and ≤ 500 mm in length<br>o dual lumen devices with stainless<br>lumens that are ≥ 0.77 mm ID<br>and ≤ 527 mm in length<br>o triple lumen devices with stainless<br>steel lumens that are<br>• ≥ 1.2 mm ID and ≤ 275 mm<br>in length<br>• ≥ 1.8 mm ID and ≤ 310 mm<br>in length<br>or<br>• ≥ 2.8 mm ID and ≤ 317 mm<br>in length<br>a The validation studies for all<br>channel/ lumen configurations were<br>conducted using a maximum of<br>twenty (20) lumens per load.<br>Hospital loads should not exceed<br>the maximum number of lumens<br>validated by this testing. The<br>validation studies were performed<br>using a validation load consisting<br>of two instrument trays and two<br>pouches for a total weight of<br>19.65 lbs. | V-PRO maX Low Temperature Sterilization<br>System's Lumen Cycle, can sterilize:a<br>• Lumened and non-lumened<br>instruments with diffusion-restricted<br>spaces such as the hinged portion of<br>forceps and scissors<br>• Medical devices, including single,<br>dual and triple channeled rigid and<br>semi-rigid endoscopes, with the<br>following configurations: a<br>o single channeled devices with a<br>stainless steel lumen that is ><br>0.77 mm internal diameter (ID)<br>and ≤ 500 mm in length<br>o dual lumen devices with stainless<br>lumens that are ≥ 0.77 mm ID<br>and ≤ 527 mm in length<br>o triple lumen devices with stainless<br>steel lumens that are<br>• > 1.2 mm ID and ≤ 275 mm<br>in length<br>• ≥ 1.8 mm ID and ≤ 310 mm<br>in length<br>or<br>• ≥ 2.8 mm ID and ≤ 317 mm<br>in length<br>a The validation studies for all<br>channel/ lumen configurations were<br>conducted using a maximum of<br>twenty (20) lumens per load.<br>Hospital loads should not exceed<br>the maximum number of lumens<br>validated by this testing. The<br>validation studies were performed<br>using a validation load consisting<br>of two instrument trays and two<br>pouches for a total weight of<br>19.65 lbs. |
| | The V-PRO 1 Plus and V-PRO maX Low<br>Temperature Sterilization Systems' Non<br>Lumen Cycle, the subject of this<br>submission, can sterilize:b<br>• Non-lumened instruments including<br>non-lumened rigid, semi-rigid and<br>flexible endoscopes and non-lumened<br>instruments with stainless steel or<br>titanium diffusion-restricted areas such<br>as the hinged portion of forceps or<br>scissors.<br>b The validation studies were conducted<br>using a validation load consisting of<br>two instrument trays for a total weight | The Amsco V-PRO 1 Plus and V-PRO maX<br>Low Temperature Sterilization Systems'<br>Non Lumen Cycle, cleared under K083097,<br>K102394 and K111810, can sterilize:b<br>• Non-lumened instruments including<br>non-lumened rigid, semi-rigid and<br>flexible endoscopes and non-lumened<br>instruments with stainless steel<br>diffusion-restricted areas such as the<br>hinged portion of forceps or scissors.<br>b The validation studies were conducted<br>using a validation load consisting of<br>two instrument trays and two pouches<br>for a total weight of 19.65 lbs. |
| Feature | V-PRO 1 Plus/V-PRO maX Low<br>Temperature Sterilization System<br>(Proposed Device)<br>of 50.0 lbs. | V-PRO 1 Plus/V-PRO maX Low<br>Temperature Sterilization System<br>(Predicate Devices/K131120) |
| | The V-PRO maX Low Temperature<br>Sterilization System's <b>Flexible Cycle</b> , can<br>sterilize single or dual lumen surgical<br>flexible endoscopes (such as those used in<br>ENT, Urology and Surgical Care) and<br>bronchoscopes in either of two load<br>configurations:<br>1. Two flexible endoscopes with a light<br>cord (if not integral to endoscope) and<br>mat with no additional load.c<br>The flexible endoscopes may contain<br>either: | The Amsco V-PRO maX Low Temperature<br>Sterilization System's <b>Flexible Cycle</b> ,<br>cleared under K102330 and K112760, can<br>sterilize single or dual lumen surgical<br>flexible endoscopes (such as those used in<br>ENT, Urology and Surgical Care) and<br>bronchoscopes in either of two load<br>configurations:<br>1. Two flexible endoscopes with a light<br>cord (if not integral to endoscope) and<br>mat with no additional load.c<br>The flexible endoscopes may contain<br>either: |
| | a single lumen that is ≥ 1 mm ID<br>and ≤ 1050 mm in length or two lumens with:<br>one lumen that is ≥ 1 mm ID and ≤<br>990 mm in length and the other<br>lumen that is ≥ 1 mm ID and ≤<br>850 mm in length | a single lumen that is ≥ 1 mm ID<br>and ≤ 1050 mm in length or two lumens with:<br>one lumen that is ≥ 1 mm ID and ≤<br>998 mm in length and the other<br>lumen that is ≥ 1 mm ID and ≤<br>850 mm in length |
| | The validation studies were conducted<br>with two flexible endoscopes, each packaged<br>into a tray with silicone mat and light cord (if<br>not integral to endoscope). | The validation studies were conducted<br>with two flexible endoscopes, each packaged<br>into a tray with silicone mat and light cord (if<br>not integral to endoscope). |
| | 2. One flexible endoscope with a light<br>cord (if not integral to endoscope) and<br>mat and additional non-lumened<br>instruments including instruments with<br>diffusion-restricted areas such as the<br>hinged portion of forceps or scissors.d | 2. One flexible endoscope with a light<br>cord (if not integral to endoscope) and<br>mat and additional non-lumened<br>instruments including instruments with<br>diffusion-restricted areas such as the<br>hinged portion of forceps or scissors.d |
| | The flexible endoscope can contain<br>either: a single lumen that is ≥ 1 mm ID<br>and ≤ 1050 mm in length or two lumens with:<br>a single lumen that is ≥ 1 mm ID<br>and ≤ 990 mm in length and the<br>other lumen that is ≥ 1 mm and ≤<br>850 mm in length | The flexible endoscope can contain<br>either: a single lumen that is ≥ 1 mm ID<br>and ≤ 1050 mm in length or two lumens with:<br>a single lumen that is ≥ 1 mm ID<br>and ≤ 998 mm in length and the<br>other lumen that is ≥ 1 mm and ≤<br>850 mm in length |
| | The validation studies were conducted<br>with a flexible endoscope in a tray with silicone<br>mat and light cord (if not integral to<br>endoscope). Also included in the load were an<br>additional instrument tray and one pouch for a<br>total load weight of 24.0 lbs. | The validation studies were conducted<br>with a flexible endoscope in a tray with silicone<br>mat and light cord (if not integral to<br>endoscope). Also included in the load were an<br>additional instrument tray and one pouch for a<br>total load weight of 24.0 lbs. |
| Feature | V-PRO 1 Plus/V-PRO maX Low<br>Temperature Sterilization System<br>(Proposed Device) | V-PRO 1 Plus/V-PRO maX Low<br>Temperature Sterilization System<br>(Predicate Devices/K131120) |
| Process<br>Parameters | The critical process parameters are:<br>• Time<br>• Chamber Temperature<br>• Vaporizer Temperature<br>• Chamber Pressure Prior to Injection<br>• Sterilant Injection Weight | The critical process parameters are:<br>• Time<br>• Chamber Temperature<br>• Vaporizer Temperature<br>• Chamber Pressure Prior to Injection<br>• Sterilant Injection Weight |
| Software/<br>Firmware<br>Controlled | Programmable Logic Control (PLC). The<br>software allows user selection of either the<br>Lumen, Non Lumen, or Flexible pre-<br>programmed cycle. | Programmable Logic Control (PLC). The<br>software allows user selection of either the<br>Lumen, Non Lumen, or Flexible pre-<br>programmed cycle. |
| Total<br>Cycle<br>Time | Lumen Cycle - 55 minutes<br>Non Lumen Cycle - 28 minutes<br>Flexible Cycle - 35 minutes | Lumen Cycle - 55 minutes<br>Non Lumen Cycle - 28 minutes<br>Flexible Cycle - 35 minutes |
| Sterilant | VAPROX HC Sterilant (59% Hydrogen<br>Peroxide).<br>The same amount of sterilant is injected for<br>each of the sterilization pulses for all three<br>cycles. | VAPROX HC Sterilant (59% Hydrogen<br>Peroxide).<br>The same amount of sterilant is injected for<br>each of the sterilization pulses for all three<br>cycles. |
| Accessories | The following accessories are available for<br>the V-PRO maX Low Temperature<br>Sterilization System<br>• Self-contained biological indicator<br>• Biological indicator challenge pack<br>• Chemical indicator<br>• Trays & Tray Accessories<br>• Pouches | The following accessories are available for<br>the V-PRO maX Low Temperature<br>Sterilization System<br>• Self-contained biological indicator<br>• Biological indicator challenge pack<br>• Chemical indicator<br>• Trays & Tray Accessories<br>• Pouches |

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## K160433/ S001 STERIS Response to Request for Additional Information V-PRO® 1 Plus and V-PRO® maX Low Temperature Sterilization Systems

The proposed devices have an intended use similar to the predicates with the same technological characteristics. Although, the indications differ slightly, the provided performance data demonstrate equivalence. Therefore, the proposed V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems are substantially equivalent to the predicate devices, the V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems.

#### 3. Description of Device

The V-PRO 1 Plus and V-PRO maX Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Devices that meet the criteria described within the indications for use and composed of compatible materials are placed within the sterilization chamber and the appropriate cycle selected through the graphic user interface. The preprogrammed cycles all utilize a conditioning phase which prepares the chamber, a sterilize phase in which loaded devices are exposed to the sterilizing agent, VHP, at low pressure and an aeration phase to remove residual hydrogen peroxide. 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.

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The V-PRO 1 Plus Low Temperature Sterilization System provides two cycle options, Lumen and Non Lumen. The sterilizer contains a 136 L welded aluminum chamber with two shelves for device loading, an onboard printer to provide cycle printouts, a cup interface where the VAPROX HC cups are loaded, a display for the graphic user interface and the components necessary to achieve the desired cvcle parameters (injection cylinder, vaporizer, vacuum pump and catalytic converter). The side panels of the sterilizer are composed of stainless steel.

The V-PRO maX Low Temperature Sterilization System provides three cycle options, Lumen, Non Lumen and Flexible. The sterilizer contains a 136 L welded aluminum chamber with two shelves for device loading, an onboard printer to provide cycle printouts, a cup interface where the VAPROX HC cups are loaded, a display for the graphic user interface and the components necessary to achieve the desired cycle parameters (injection cylinder, vacuum pump and catalytic converter). The side panels of the sterilizer are composed of plastic.

The purpose of this pre-market notification is to modify the maximum load weight for the Non Lumen Cycle from 19.65 to 50 lbs, to add titanium diffusion-restricted areas to the indications for use of the Non Lumen Cycle, and to remove the term "reusable" from indications for use statement.

#### 4. Intended Use

The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles [Lumen Cycle, Non Lumen Cycle, and Flexible Cycle (V-PRO maX Sterilizer only)] operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle can sterilize:4

- Lumened and non-lumened instruments with diffusion-restricted spaces . such as the hinged portion of forceps and scissors
- Medical devices, including single, dual and triple channeled rigid and . semi-rigid endoscopes, with the following configurations: 4
- O single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
- dual channeled devices with stainless steel lumens that are ≥ 0.77 O mm ID and ≤ 527 mm in length
- triple channeled devices with stainless steel lumens that are o
- ≥ 1.2 mm ID and ≤ 275 mm in length

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- ≥ 1.8 mm ID and ≤ 310 mm in length
or

- ≥2.8 mm ID and ≤ 317 mm in length
- a The validation studies for all channel/lumen configurations were conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.

The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Non Lumen Cycle, the subject of this submission, can sterilize:'0

Non-lumened instruments including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened instruments with stainless steel or titanium diffusion-restricted areas such as the hinged portion of forceps or scissors.

The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs.

The V-PRO maX Low Temperature Sterilization System's Flexible Cycle, can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT. Urology and Surgical Care) and bronchoscopes in either of two load configurations:

- Two flexible endoscopes with a light cord (if not integral to endoscope) and 1. mat with no additional load. °
The flexible endoscopes may contain either:

- . a single lumen that is > 1 mm ID and < 1050 mm in length
- . or two lumens with:
- . one lumen that is > 1 mm ID and < 990 mm in length
- and the other lumen that is > 1 mm ID and < 850 mm in length .
- C The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).
- One flexible endoscope with a light cord (if not integral to endoscope) and 2. mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. 4

The flexible endoscope can contain either:

- a single lumen that is > 1 mm ID and < 1050 mm in length .
- . or two lumens with:
- . one lumen that is > 1 mm ID and < 990 mm in length

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- and the other lumen that is > 1 mm and ≤ 850 mm in length ●
- d The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.

## The parameters for the three V-PRO Cycles are as follows:

| Sterilization<br>Cycle | Sterilant<br>injection<br>(g) | # of<br>Injections | Sterilant<br>Exposure<br>Time (min) | Chamber<br>Pressure<br>Prior to<br>Injection<br>(Torr) | Chamber/<br>Vaporizer<br>Temperature<br>(°C) |
|------------------------|-------------------------------|--------------------|-------------------------------------|--------------------------------------------------------|----------------------------------------------|
| Lumen | 2.1 | 4 | 32 | 0.4 | 50/60 |
| Non Lumen | 2.1 | 4 | 12 | 1 | 50/60 |
| Flexible | 2.1 | 4 | 12 | 0.4 | 50/60 |

#### 5. Summary of Nonclinical Tests

The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems have the same or similar intended use and the same technological characteristics as compared to the predicate devices. Performance testing to assess and demonstrate substantial

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equivalence to the predicates is summarized below.

| | | Conclusion | |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Test | Result | V-PRO 1<br>Plus/V-PRO<br>max Low<br>Temperature<br>Sterilization<br>System<br>(Proposed<br>Device) | V-PRO 1<br>Plus/V-PRO<br>max Low<br>Temperature<br>Sterilization<br>System<br>(Predicate<br>Devices/K131<br>120) |
| ½ Cycle Modified<br>Total Kill<br>Endpoint<br>Verification | Modified total kill end point analysis was<br>demonstrated for the Non Lumen Cycle.<br>The standard injection weight of 2.1 g and<br>at least one lower injection weight resulted<br>in all sterile results within the validation<br>load. Partial positives or all survive<br>results were seen at lower injection<br>weights. | PASS | PASS |
| ½ Cycle<br>Sterilization<br>Verification of<br>Cycle Claims | The Non Lumen Cycle reproducibly<br>sterilizes non-lumened devices, mated<br>surfaces and device tray accessories<br>contact sites under worst case conditions<br>in ½ Cycle | PASS | PASS |
| Simulated Use<br>Test | Simulated use testing verified the ability<br>of the Non Lumen Cycle to sterilize<br>medical devices under worst case<br>processing conditions. | PASS | PASS |
| Final Process<br>Qualification | The Non Lumen Cycle final process<br>qualification was successful. Manual<br>inspection of the process parameter data<br>confirmed that all cycle specifications<br>were met. | PASS | PASS |
| Sterilizer<br>Accessories<br>Performance | Three lots of VERIFY® V24 Self-<br>Contained Biological Indicator (SCBI)<br>were reproducibly sterilized under worst<br>case ½ cycle conditions. Three lots of<br>SCBI process indicators (PIs) exhibited a<br>passing color change and all SCBIs were<br>negative for growth under worst case full<br>cycle conditions. Three lots of VERIFY®<br>HPU chemical indicator exhibited<br>complete color change under worst case<br>full cycle conditions. Test articles were<br>effectively sterilized under worst case ½<br>cycle conditions when packaged in:<br>• Vis -U-All Low Temperature<br>Pouches or<br>• V-PRO Sterilization Trays | PASS | PASS |

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#### 6. Conclusion

The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems Non Lumen Cycle has been validated to meet the established performance criteria. The results of the V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Non Lumen Cycle verification studies demonstrate that the sterilizers perform as intended. Based on the intended uses, technological characteristics and non-clinical performance data, the subject devices (V-PRO 1 Plus and V-PRO maX) are as safe, as effective and perform at least as safely and effectively as the legally marketed predicate device (K131120), Class II (21 CFR 880.6860), product code MLR.