V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System

K222093 · Steris · MLR · Sep 9, 2022 · General Hospital

Device Facts

• Record ID: K222093
• Device Name: V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System
• Applicant: Steris
• Product Code: MLR · General Hospital
• Decision Date: Sep 9, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6860
• Device Class: Class 2

Intended Use

The V-PRO maX Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues.

Device Story

V-PRO maX/maX 2 are vaporized hydrogen peroxide (VHP) sterilizers; use VAPROX HC Sterilant (59% hydrogen peroxide). Input: cleaned, rinsed, dried, and packaged reusable surgical instruments. Operation: preprogrammed cycles (Lumen, Non Lumen, Flexible, Fast Non Lumen) consisting of conditioning, sterilization, and aeration phases; operates at low pressure/temperature. Output: terminally sterilized medical devices ready for immediate use. Used in healthcare facilities; operated by trained staff. Benefits: rapid sterilization of heat/moisture-sensitive devices without toxic residues; no post-cycle aeration required.

Clinical Evidence

Bench testing only. Efficacy demonstrated via half-cycle verification, simulated use testing, and in-use investigation using patient-soiled, clinically-cleaned medical instruments. All tests passed, confirming sterilization efficacy for the expanded load configurations.

Technological Characteristics

Vaporized hydrogen peroxide sterilizer; uses VAPROX HC (59% H2O2). Proprietary microcomputer control board; RFID reader for sterilant cup. Cycles: Lumen, Non Lumen, Flexible, Fast Non Lumen. Connectivity: memory backup for cycle data storage/download. Sterilization: low pressure/temperature VHP exposure.

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 specific stainless steel or non-metallic lumened devices (single, dual, triple channel, or dead-end) within specified ID and length configurations.

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 maX and maX 2 Low Temperature Sterilization Systems (K190103)

Submission Summary (Full Text)

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September 9, 2022

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

Re: K222093

Trade/Device Name: V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: August 17, 2022 Received: August 18, 2022

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 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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Clarence W. Murray, III, PhD Acting Assistant 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

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## Indications for Use

510(k) Number (if known) K222093

#### Device Name

V-PRO maX Low Temperature Sterilization System

### Indications for Use (Describe)

The V-PRO maX Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues.

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

The V-PRO maX Sterilizers' Non Lumen Cycle can sterilize: t

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

t The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).

The V-PRO maX Sterilizer's Flexible Cycle can sterilize:

Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain single or dual channel lumens that are ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length. * The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).

2. One flexible endoscope with a light cord (if not integral to endoscope accessories and mat, and additional instruments. ** The flexible endoscope may contain single or dual channel lumens that are ≥ 1 mm ID and ≤ 1050 mm in length

Additional instruments may include non-lumened or lumened medical devices with the following configurations:

Single, dual or triple channel stainless steel lumen that is ≥ 0.48 mm ID and ≤ 100 mm in length

** The validation studies were conducted with a flexible endoscope accessories, silicone mat, light cord (if not integral to endoscope) and 5 stainless steel lumens. Also included in the load was a tray with additional instruments and silicone mat for a total weight of 24 lbs (11 kg).

The V-PRO maX Sterilizers' Lumen Cycle can sterilize: * Medical devices with the following configurations:

· Single, dual or triple channeled stainless steel lumen that are:

- ≥ 0.77 mm ID and ≤ 527 mm in length
- ≥ 0.8 mm ID and ≤ 542 mm in length
- ≥ 0.48 mm ID and ≤ 100 mm in length
- · Dead end lumen that is ≥ 1.3 mm ID and ≤ 73 mm in length
- · Rigid non-metallic lumen (such as those used in endoscope sheaths, take-apart forceps and trocars) that are:
- ≥ 3 mm ID and ≤ 298 mm in length
- · ≥ 4 mm ID and < 424 mm in length

* Validation testing for all lumen sizes was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two trays with silicone mats for a total weight of 19.65 lbs (8.9 kg).

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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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Image /page/4/Picture/0 description: The image shows the STERIS logo. To the left of the word STERIS is a blue image of what appears to be water waves. The word STERIS is in all caps and in a bold, sans-serif font.

# 510(k) Summary For

# V-PRO® maX Low Temperature Sterilization Systems and V-PRO® maX 2 Low Temperature Sterilization Systems

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

| Contact: | Anthony Piotrkowski<br>Director, Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Submission Date: | September 5, 2022 |
| Premarket Notification Number: | K222093 |

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

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#### Device Name 1.

| Trade Name: | V-PRO® maX Low Temperature Sterilization<br>System and V-PRO maX 2 Low Temperature<br>Sterilization System |
|------------------------|------------------------------------------------------------------------------------------------------------|
| Device Class: | Class II |
| Common/usual Name: | Vapor Phase Hydrogen Peroxide Sterilizer |
| Classification Name: | Sterilizer, Ethylene Oxide Gas |
| Classification Number: | 21 CFR 880.6860 |
| Product Code: | MLR |

#### 2. Predicate Device

The claimed primary predicate device is the V-PRO maX and maX 2 Low Temperature Sterilization Systems, cleared most recently under K190103.

| Table 5-1. A comparison between the proposed V-PRO maX Low Temperature Sterilization | | |
|--------------------------------------------------------------------------------------|--|--|
| System to the predicate device | | |

| | V-PRO 1, V-PRO 1Plus, V-PRO maX Low<br>Temperature Sterilization System<br>(Predicate Device – K190103) | V-PRO maX Low Temperature Sterilization<br>System (Modified Device) K222093 |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | | |
| | | |
| Intended<br>Use and<br>Indications<br>for Use | The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low<br>Temperature Sterilization Systems using VAPROX HC<br>Sterilant are intended for use in the terminal<br>sterilization of properly prepared (cleaned, rinsed and<br>dried) medical devices in Healthcare Facilities. The<br>preprogrammed sterilization cycles operate at low<br>pressure and temperature, suitable for processing<br>medical devices without leaving toxic residues. | The V-PRO maX Low Temperature Sterilization<br>System using VAPROX HC Sterilant is intended for<br>use in the terminal sterilization of properly prepared<br>(cleaned, rinsed and dried) medical devices in<br>Healthcare Facilities. The preprogrammed sterilization<br>cycles operate at low pressure and temperature,<br>suitable for processing medical devices without leaving<br>toxic residues. |
| | Each Cycle can sterilize non-lumened instruments with<br>diffusion-restricted spaces such as the hinged portion<br>of forceps and scissors. Only stainless steel or titanium<br>diffusion-restricted spaces should be processed in the<br>Non Lumen Cycle. | Each Cycle can sterilize non-lumened instruments with<br>diffusion-restricted spaces such as the hinged portion<br>of forceps and scissors. |
| | The V-PRO 1 Plus and V-PRO maX Sterilizers' Non<br>Lumen Cycle can sterilize: ‡<br>Non-lumened instruments including non-lumened<br>general medical instruments, non-lumened rigid, semi-<br>rigid and flexible endoscopes.<br>‡ The validation studies were conducted using a<br>validation load consisting of two instrument trays for a<br>total weight of 50 lbs (22.7 kg). | The V-PRO maX Sterilizers' Non Lumen Cycle can<br>sterilize: ‡<br>Non-lumened instruments including non-lumened<br>general medical instruments, non-lumened rigid, semi-<br>rigid and flexible endoscopes.<br>‡ The validation studies were conducted using a<br>validation load consisting of two instrument trays for a<br>total weight of 50 lbs (22.7 kg). |
| | The V-PRO maX Sterilizer's Flexible Cycle can<br>sterilize:<br>Single or dual lumen surgical flexible endoscopes<br>(such as those used in ENT, Urology and Surgical<br>Care) and bronchoscopes in either of the two load<br>configurations: | The V-PRO maX Sterilizer's Flexible Cycle can<br>sterilize:<br>Single or dual lumen surgical flexible endoscopes<br>(such as those used in ENT, Urology and Surgical<br>Care) and bronchoscopes in either of the two<br>configurations: |
| Feature | V-PRO 1, V-PRO 1Plus, V-PRO maX Low<br>Temperature Sterilization System<br>(Predicate Device – K190103) | V-PRO maX Low Temperature Sterilization<br>System (Modified Device) K222093 |
| | 1. Two flexible endoscopes with a light cord (if not<br>integral to endoscope) and mat with no additional load.<br>* The flexible endoscopes may contain either:<br>• A single lumen that is ≥ 1 mm internal diameter (ID)<br>and ≤ 1050 mm in length<br>• Or two lumens with:<br>■ One lumen that is ≥ 1 mm ID and ≤ 990 mm<br>in length<br>■ And the other lumen that is ≥ 1 mm ID and ≤<br>850 mm in length<br>* The validation studies were conducted with two<br>flexible endoscopes, each packaged into a tray with<br>silicone mat and light cord (if not integral to<br>endoscope). | 1. Two flexible endoscopes with a light cord (if not<br>integral to endoscope) and mat with no additional load.<br>* The flexible endoscopes may contain single or dual<br>channel lumens that are ≥ 1 mm internal diameter (ID)<br>and ≤ 1050 mm in length.<br>* The validation studies were conducted with two<br>flexible endoscopes, each packaged into a tray with<br>silicone mat and light cord (if not integral to<br>endoscope). |
| | 2. One flexible endoscope with a light cord (if not<br>integral to endoscope) and mat and additional non-<br>lumened instruments. †† The flexible endoscope may<br>contain either:<br>• A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in<br>length<br>• Or two lumens with:<br>■ One lumen that is ≥ 1 mm ID and ≤ 990 mm<br>in length<br>■ And the other lumen is ≥ 1 mm ID and ≤ 850<br>mm in length.<br>†† The validation studies were conducted with a flexible<br>endoscope in a tray with silicone mat and light cord (if<br>not integral to endoscope). Also included in the load<br>were an additional instrument tray and one pouch for a<br>total weight of 24 lbs (11 kg). | 2. One flexible endoscope with a light cord (if not<br>integral to endoscope), endoscope accessories and mat,<br>and additional instruments. †† The flexible endoscope<br>may contain single or dual channel lumens that are ≥ 1<br>mm ID and ≤ 1050 mm in length<br>■ Additional instruments may include non-lumened<br>or lumened medical devices with the following<br>configurations:<br>■ Single, dual or triple channel stainless steel<br>lumen that is<br>■ ≥ 0.48 mm ID and ≤ 100 mm in length<br>†† The validation studies were conducted with a flexible<br>endoscope in a tray with endoscope accessories,<br>silicone mat, light cord (if not integral to endoscope)<br>and 5 stainless steel lumens. Also included in the load<br>was a tray with additional instruments and silicone mat<br>for a total weight of 24 lbs (11 kg). |
| | The V-PRO 1, V-PRO 1 Plus and V-PRO maX<br>Sterilizers' Lumen Cycle can sterilize: †<br>Medical devices (including single, dual and triple<br>channeled rigid and semi-rigid endoscopes) with the<br>following configurations:<br>• Single channeled devices with a stainless lumen that<br>is ≥ 0.77 mm ID and ≤ 500 mm in length<br>• Single channeled devices with a stainless lumen that<br>is ≥ 1.8 mm ID and ≤ 542 mm in length<br>• Dual channeled devices with stainless lumens that<br>are ≥ 0.77 mm ID and ≤ 527 mm in length<br>• Triple channeled devices with stainless lumens that<br>are either:<br>■ ≥ 1.2 mm ID and ≤ 275 mm in length<br>■ ≥ 1.8 mm ID and ≤ 310 mm in length or<br>■ ≥ 2.8 mm ID and ≤ 317 mm in length<br>† Validation testing for all lumen sizes was conducted<br>using a maximum of 20 lumens per load. Hospital<br>loads should not exceed the maximum number of<br>lumens validated by this testing. The validation studies<br>were performed using a validation load consisting of<br>two instrument trays and two pouches for a total weight | The V-PRO maX Sterilizers' Lumen Cycle can<br>sterilize: † Medical devices with the following<br>configurations:<br>• Single, dual or triple channeled stainless steel lumen<br>that are:<br>• ≥ 0.77 mm ID and ≤ 527 mm in length<br>• ≥ 0.8 mm ID and ≤ 542 mm in length<br>• ≥ 0.48 mm ID and ≤ 100 mm in length<br>• Dead end lumen that is ≥ 1.3 mm ID and ≤ 73 mm in<br>length<br>• Rigid non-metallic lumen (such as those used in<br>endoscope sheaths, take-apart forceps and trocars)<br>that are:<br>■ ≥ 3 mm ID and ≤ 298 mm in length<br>■ ≥ 4 mm ID and ≤ 424 mm in length<br>† Validation testing for all lumen sizes was conducted<br>using a maximum of 20 lumens per load. Hospital<br>loads should not exceed the maximum number of<br>lumens validated by this testing. The validation studies<br>were performed using a validation load consisting of<br>two trays with silicone mats for a total weight of 19.65<br>lbs (8.9 kg). |
| Feature | V-PRO 1, V-PRO 1Plus, V-PRO maX Low<br>Temperature Sterilization System<br>(Predicate Device – K190103) | V-PRO maX Low Temperature Sterilization<br>System (Modified Device) K222093 |
| 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 | Control system consists of a proprietary<br>microcomputer control board and peripheral function<br>circuit boards, located within the control housing. A<br>memory backup system maintains user settings and<br>calibration data indefinitely. Up to 300 cycle data files<br>can be stored for review or downloading by the user. | Control system consists of a proprietary<br>microcomputer control board and peripheral function<br>circuit boards, located within the control housing. A<br>memory backup system maintains user settings and<br>calibration data indefinitely. Up to 300 cycle data files<br>can be stored for review or downloading by the user. |
| Total<br>Cycle<br>Time | The software allows user selection of either the Lumen,<br>Non Lumen or Flexible pre-programmed cycle.<br>Lumen Cycle - 55 minutes<br>Non Lumen Cycle - 28 minutes<br>Flexible Cycle - 35 minutes | The software allows user selection of either the Lumen,<br>Non Lumen or Flexible pre-programmed cycle.<br>Lumen Cycle - 55 minutes<br>Non Lumen Cycle - 28 minutes<br>Flexible Cycle - 35 minutes |
| Sterilant | VAPROX HC Sterilant (59% Hydrogen Peroxide). | VAPROX HC Sterilant (59% Hydrogen Peroxide). |
| Accessories | Accessories were submitted under separate, individual,<br>concurrent 510(k)s and cover the following:<br>• Self-contained biological indicator<br>• Biological indicator challenge pack<br>• Fast Acting Biological Indicator<br>• Chemical indicator<br>• Trays & Tray Accessories<br>• Pouches | Accessories were submitted under separate, individual,<br>concurrent 510(k)s and cover the following:<br>• Self-contained biological indicator<br>• Biological indicator challenge pack<br>• Fast Acting Biological Indicator<br>• Chemical indicator<br>• Trays & Tray Accessories<br>• Pouches |

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### Table 5-2. A comparison between the proposed V-PRO maX 2 Low Temperature Sterilization System to the predicate device

| Feature | V-PRO maX 2 Low Temperature Sterilization System (Predicate Device/K190103) | V-PRO maX 2 Low Temperature Sterilization System (Modified Device) K222093 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant are intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues. | The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues. |
| Indications<br>for Use | Each Cycle can sterilize non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle and the Fast Non Lumen Cycle. | Each Cycle can sterilize non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. |
| | The Non Lumen Cycle can sterilize: ‡<br>Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. | The Non Lumen Cycle can sterilize: ‡<br>Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. |
| Feature | V-PRO maX 2 Low Temperature Sterilization<br>System (Predicate Device/K190103) | V-PRO maX 2 Low Temperature Sterilization<br>System (Modified Device) K222093 |
| | † The validation studies were conducted using a<br>validation load consisting of two instrument trays for a<br>total weight of 50 lbs (22.7 kg). | † The validation studies were conducted using a<br>validation load consisting of two instrument trays for a<br>total weight of 50 lbs (22.7 kg). |
| | The Fast Non Lumen Cycle can sterilize:*<br>Non-lumened instruments including non-lumened<br>general medical instruments, non-lumened rigid, semi-<br>rigid and flexible endoscopes.<br>* The validation studies were conducted using a<br>validation load consisting of one pouched instrument<br>tray for a total weight of 11 lbs (5 kg). | The Fast Non Lumen Cycle can sterilize:*<br>Non-lumened instruments including non-lumened<br>general medical instruments, non-lumened rigid, semi-<br>rigid and flexible endoscopes.<br>* The validation studies were conducted using a<br>validation load consisting of one pouched instrument<br>tray for a total weight of 11 lbs (5 kg). |
| | The Flexible Cycle can sterilize:<br>Single or dual lumen surgical flexible endoscopes<br>(such as those used in ENT, Urology and Surgical<br>Care) and bronchoscopes in either of the two<br>configurations:<br>1. Two flexible endoscopes with a light cord (if not<br>integral to endoscope) and mat with no additional<br>load.* The flexible endoscopes may contain either:<br>• A single lumen that is ≥ 1 mm internal diameter<br>(ID) and ≤ 1050 mm in length<br>• Or two lumens with:<br>One lumen that is ≥ 1 mm ID and ≤ 990<br>mm in length<br>And the other lumen that is ≥ 1 mm ID and<br>≤ 850 mm in length<br>* The validation studies were conducted with two<br>flexible endoscopes, each packaged into a tray with<br>silicone mat and light cord (if not integral to | The Flexible Cycle can sterilize:<br>Single or dual lumen surgical flexible endoscopes<br>(such as those used in ENT, Urology and Surgical<br>Care) and bronchoscopes in either of the two<br>configurations:<br>1. Two flexible endoscopes with a light cord (if not<br>integral to endoscope) and mat with no additional<br>load.* The flexible endoscopes may contain single or<br>dual channel lumens that are ≥ 1 mm internal diameter<br>(ID) and ≤ 1050 mm in length.<br>* The validation studies were conducted with two<br>flexible endoscopes, each packaged into a tray with<br>silicone mat and light cord (if not integral to<br>endoscope). |
| | endoscope).<br>2. One flexible endoscope with a light cord (if not<br>integral to endoscope) and mat and additional non-<br>lumened instruments. †† The flexible endoscope may<br>contain either:<br>• A single lumen that is ≥ 1 mm ID and ≤ 1050 mm<br>in length<br>• Or two lumens with:<br>One lumen that is ≥ 1 mm ID and ≤ 990<br>mm in length<br>And the other lumen is ≥ 1 mm ID and ≤<br>850 mm in length.<br>†† The validation studies were conducted with a flexible<br>endoscope in a tray with silicone mat and light cord (if<br>not integral to endoscope). Also included in the load<br>were an additional instrument tray and one pouch for a<br>total weight of 24 lbs (11 kg). | 2. One flexible endoscope with a light cord (if not<br>integral to endoscope), endoscope accessories, mat and<br>additional non-lumened instruments. †† The flexible<br>endoscope may contain single or dual channel lumens<br>that are ≥ 1 mm ID and ≤ 1050 mm in length<br>■ Additional instruments may include non-lumened<br>or lumened medical devices with the following<br>configurations:<br>■ Single, dual or triple channel stainless steel<br>lumen that is ≥ 0.48 mm ID and ≤ 100 mm in<br>length<br>†† The validation studies were conducted with a flexible<br>endoscope in a tray with endoscope accessories,<br>silicone mat, light cord (if not integral to endoscope)<br>and 5 stainless steel lumens. Also included in the load<br>was a tray with additional instruments, and silicone mat<br>for a total weight of 24 lbs (11 kg). |
| | The Lumen Cycle can sterilize: †<br>Medical devices (including single, dual and triple<br>channeled rigid and semi-rigid endoscopes) with the<br>following configurations:<br>• Single channeled devices with a stainless lumen that<br>is ≥ 0.77 mm ID and ≤ 500 mm in length | The Lumen Cycle can sterilize: †<br>Medical devices with the following configurations:<br>• Single, dual or triple channeled stainless steel lumen<br>that are:<br>• ≥ 0.77 mm ID and ≤ 527 mm in length<br>• ≥ 0.8 mm ID and ≤ 542 mm in length |
| Feature | V-PRO maX 2 Low Temperature Sterilization<br>System (Predicate Device/K190103) | V-PRO maX 2 Low Temperature Sterilization<br>System (Modified Device) K222093 |
| | • Single channeled devices with a stainless lumen that<br>is $\ge$ 1.8 mm ID and $\le$ 542 mm in length | • $\ge$ 0.48 mm ID and $\le$ 100 mm in length |
| | • Dual channeled devices with stainless lumens that<br>are $\ge$ 0.77 mm ID and $\le$ 527 mm in length | • Dead end lumen that is $\ge$ 1.3 mm ID and $\le$ 73 mm in<br>length |
| | • Triple channeled devices with stainless lumens that<br>are either: | • Rigid non-metallic lumen (such as those used in<br>endoscope sheaths, take-apart forceps and trocars)<br>that are: |
| | $\ge$ 1.2 mm ID and $\le$ 275 mm in length<br>$\ge$ 1.8 mm ID and $\le$ 310 mm in length<br>or<br>$\ge$ 2.8 mm ID and $\le$ 317 mm in length | • $\ge$ 3 mm ID and $\le$ 298 mm in length<br>• $\ge$ 4 mm ID and $\le$ 424 mm in length |
| | † Validation testing for all lumen sizes was conducted<br>using a maximum of 20 lumens per load. Hospital<br>loads should not exceed the maximum number of<br>lumens validated by this testing. The validation studies<br>were performed using a validation load consisting of<br>two instrument trays and two pouches for a total weight<br>of 19.65 lbs (8.9 kg). | † Validation testing for all lumen sizes was conducted<br>using a maximum of 20 lumens per load. Hospital<br>loads should not exceed the maximum number of<br>lumens validated by this testing. The validation studies<br>were performed using a validation load consisting of<br>two instrument trays and two pouches for a total weight<br>of 19.65 lbs (8.9 kg). |
| 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 | Control system consists of a proprietary<br>microcomputer control board and peripheral function<br>circuit boards, located within the control housing. A<br>memory backup system maintains user settings and<br>calibration data indefinitely. Up to 300 cycle data files<br>can be stored for review or downloading by the user.<br><br>The software allows user selection of either the Lumen,<br>Non Lumen, Flexible or Fast Non Lumen pre-<br>programmed cycle. | Control system consists of a proprietary<br>microcomputer control board and peripheral function<br>circuit boards, located within the control housing. A<br>memory backup system maintains user settings and<br>calibration data indefinitely. Up to 300 cycle data files<br>can be stored for review or downloading by the user.<br><br>The software allows user selection of either the Lumen,<br>Non Lumen, Flexible or Fast Non Lumen pre-<br>programmed cycle. |
| Total<br>Cycle<br>Time | Lumen Cycle - 52 minutes<br>Non Lumen Cycle - 28 minutes<br>Flexible Cycle - 35 minutes<br>Fast Non Lumen Cycle – 16 minutes…