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

Q: Who is the manufacturer of V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System?

STERIS Corporation filed the 510(k) submission for V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System (K190103).

Q: What is the FDA product code for V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System?

MLR. It is classified under 21 CFR 880.6860 as a Class 2 device in the General Hospital panel.

Q: What is the regulatory pathway for V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System?

510(k) clearance (submission type: Special).

Q: What are the predicate devices for V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System?

V-PRO maX Low Temperature Sterilization System (K172319); V-PRO maX 2 Low Temperature Sterilization System (K172754).

Q: Who can help prepare an FDA 510(k) submission like V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K190103 · STERIS Corporation · MLR · Apr 5, 2019 · General Hospital

Device Facts

Record ID	K190103
Device Name	V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System
Applicant	STERIS Corporation
Product Code	MLR · General Hospital
Decision Date	Apr 5, 2019
Decision	SESE
Submission Type	Special
Regulation	21 CFR 880.6860
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems using VAPROX HC Sterilant are intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues. Each Cycle can sterilize non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle. The V-PRO maX 2 Low Temperature Sterilization Systems using VAPROX HC Sterilant are intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues. Each Cycle can sterilize non-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.

Device Story

V-PRO Low Temperature Sterilization Systems utilize vaporized hydrogen peroxide (VHP) via VAPROX HC Sterilant to terminally sterilize medical devices. Systems feature pre-programmed cycles (Lumen, Non-Lumen, Flexible, Fast Non-Lumen) operating at low pressure/temperature. Process involves conditioning, sterilization, and aeration phases; no post-cycle cool-down required. Used in healthcare facilities by clinical staff to process reusable surgical instruments. Output is a sterilized, ready-to-use device. Benefits include rapid turnaround and absence of toxic residues. Control system manages cycle parameters (time, temperature, pressure, sterilant weight) and stores up to 300 cycle data files for user review.

Clinical Evidence

Bench testing only. Validation studies performed using worst-case validation loads (e.g., 50 lbs for Non-Lumen, 19.65 lbs for Lumen cycles). Modified total kill endpoint verification demonstrated sterilization efficacy at standard and lower sterilant injection weights. Simulated use testing verified ability to sterilize medical devices under worst-case conditions.

Technological Characteristics

Vaporized hydrogen peroxide sterilizer; 59% hydrogen peroxide (VAPROX HC). Proprietary microcomputer control board; memory backup for settings/calibration. Connectivity: cycle data file storage/download. Sterilization cycles: Lumen, Non-Lumen, Flexible, Fast Non-Lumen. Materials: stainless steel/titanium for diffusion-restricted spaces.

Indications for Use

Indicated for terminal sterilization of cleaned, rinsed, and dried medical devices in healthcare facilities. Includes non-lumened instruments (general, rigid/flexible endoscopes), and specific lumen-containing devices (single, dual, triple channeled rigid/semi-rigid endoscopes) with defined internal diameter and length configurations. Contraindicated for materials other than stainless steel or titanium in diffusion-restricted spaces.

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 Low Temperature Sterilization System (K172319)
V-PRO maX 2 Low Temperature Sterilization System (K172754)

Submission Summary (Full Text)

{0}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K190103 ### Device Name V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems ### Indications for Use (Describe) The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems using VAPROX HC Sterilant are intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues. Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle. The V-PRO 1 Plus and V-PRO maX Sterilizers' Non Lumen Cycle can sterilize: t Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid and flexible endoscopes. t: The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg). The V-PRO maX Sterilizer's Flexible Cycle can sterilize: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations: 1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.* The flexible endoscopes may contain either: - · A single lumen that is ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length - Or two lumens with: - One lumen that is ≥ 1 mm ID and ≤ 990 mm in length - And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope). And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length. ** The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg). 2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. ** The flexible endoscope may contain either: • A single lumen that is > 1 mm ID and ≤ 1050 mm in length • Or two lumens with: One lumen that is ≥ 1 mm ID and ≤ 990 mm in length - And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length. ff The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg). The V-PRO 1, V-PRO 1 Plus and V-PRO maX Sterilizers' Lumen Cycle can sterilize: *Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations: · Single channeled devices with a stainless lumen that is ≥ 0.77 mm ID and ≤ 500 mm in length FORM FDA 3881 (7/17) {1}------------------------------------------------ • Single channeled devices with a stainless lumen that is ≥ 1.8 mm ID and ≤ 542 mm in length - · Dual channeled devices with stainless lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length · Triple channeled devices with stainless lumens that are either ≥ 1.2 mm ID and ≤ 275 mm in length ≥ 1.8 mm ID and ≤ 310 mm in length or ≥ 2.8 mm ID and ≤ 317 mm in length ↑ Validation testing for all lumen sizes was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg). Type of Use (Select one or both, as applicable) | | Prescription Use (Part 21 CFR 801 Subpart D) |X] Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190103 # Device Name V-PRO maX 2 Low Temperature Sterilization Systems # Indications for Use (Describe) The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues. Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle and Fast Non Lumen Cycle. The Non Lumen Cycle can sterilize: t Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid and flexible endoscopes. * The validation studies were conducted using a validation load consisting of two instrument travs for a total weight of 50 lbs (22.7 kg). The Fast Non Lumen Cycle can sterilize: *Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. * The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg). The Flexible Cycle can sterilize: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations: 1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.* The flexible endoscopes may contain either: • A single lumen that is ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length • Or two lumens with: - One lumen that is ≥ 1 mm ID and ≤ 990 mm in length - And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length * The validation studies were conducted with two flexible endoscopes, each packaged into a tray with sillicone mat and light cord (if not integral to endoscope). 2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. ** The flexible endoscope may contain either: - · A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length - Or two lumens with: - One lumen that is ≥ 1 mm ID and ≤ 990 mm in length - And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length. ** The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg). {3}------------------------------------------------ The Lumen Cycle can sterilize: f Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations: - Single channeled devices with a stainless lumen that is ≥ 0.77 mm ID and ≤ 500 mm in length - Single channeled devices with a stainless lumen that is ≥ 1.8 mm ID and ≤ 542 mm in length - · Dual channeled devices with stainless lumens that are > 0.77 mm ID and < 527 mm in length - · Triple channeled devices with stainless lumens that are either: > 1.2 mm ID and < 275 mm in length ≥ 1.8 mm ID and ≤ 310 mm in length or - ≥ 2.8 mm ID and ≤ 317 mm in length * Validation testing for all lumen sizes was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg). Type of Use (Select one or both, as applicable) ] Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 5, 2019 STERIS Corporation Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060 Re: K190103 Trade/Device Name: V-PRO® maX 2 Low Temperature Sterilization System, V-PRO® maX Low Temperature Sterilization System, V-PRO® 1 Plus Low Temperature Sterilization System, V-PRO® 1 Low Temperature Sterilization System Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: March 7, 2019 Received: March 8, 2019 Dear Anthony Piotrkowski: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {5}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA Page 2 has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for STERIS. The word STERIS is in a bold, serif font at the top of the logo. Below the word STERIS is a graphic of several horizontal, wavy lines in blue. The lines are stacked on top of each other, creating a visual effect of water or waves. # 510(k) Summary For # V-PRO® maX 2 Low Temperature Sterilization System, V-PRO® maX Low Temperature Sterilization System, V-PRO® 1 Plus Low Temperature Sterilization System, V-PRO® 1 Low Temperature Sterilization System STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198 Contact: Anthony Piotrkowski Director, Regulatory Affairs Tel: 440-392-7437 Fax: 440-357-9198 Email: tony_piotrkowski@steris.com Submission Date: March 7, 2019 Premarket Notification Number: K190103 {7}------------------------------------------------ {8}------------------------------------------------ | 1. Device Name Trade Name: | V-PRO® maX 2 Low Temperature Sterilization System, V-PRO® maX Low Temperature Sterilization System, V-PRO® 1 Plus Low Temperature Sterilization System, V-PRO® 1 Low Temperature Sterilization System | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Class: | Class II | | Common/usual Name: | Vapor Phase Hydrogen Peroxide Sterilizer | | Classification Name: | Sterilizer, Ethylene Oxide Gas | | Classification Number: | 21 CFR 880.6860 | | Product Code: | MLR | #### 2. Predicate Device The claimed primary predicate device for V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems is the V-PRO maX Low Temperature Sterilization System, cleared most recently under K172319. The claimed primary predicate device for the V-PRO® maX 2 Low Temperature Sterilization Systems is the V-PRO maX 2 Low Temperature Sterilization System, cleared most recently under K172754. #### 3. Description of Device The V-PRO Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers. The sterilizers have one or more of the following pre-programmed cycles (the Lumen Cycle, the Non Lumen Cycle, the Flexible Cycle and the Fast Non Lumen Cycle). The V-PRO Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities. {9}------------------------------------------------ The V-PRO Sterilizers uses VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The four preprogrammed cycles all utilize a conditioning phase, a sterilize phase and an aeration phase. The packaged sterilized devices are ready for use at the completion of the cycle, no cool down or aeration period is required following completion of the cycle. #### Indications for Use 4. The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems using VAPROX HC Sterilant are intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate and temperature, suitable for processing medical deving toxic residues. Each Cycle can sterilize non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle. # The V-PRO 1 Plus and V-PRO maX Sterilizers' Non Lumen Cycle can sterilize: * Non-lumened instruments including non- lumened general medical instruments, non-lumened rigid,semirigid and flexible endoscopes. * The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg). # The V-PRO maX Sterilizer's Flexible Cycle can sterilize: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations: - 1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain either: - A single lumen that is > 1 mm internal diameter (ID) and ≤ 1050 mm in length ● - Or two lumens with: - One lumen that is ≥ 1 mm ID and ≤ 990 mm in length - And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope). And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length. †† The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (ff not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg). 2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. ** The flexible endoscope may contain either: - . A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length - . Or two lumens with: - One lumen that is ≥ 1 mm ID and ≤ 990 mm in length - And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length. †† The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg). # The V-PRO 1. V-PRO 1 Plus and V-PRO maX Sterilizers' Lumen Cycle can sterilize: * Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations: - Single channeled devices with a stainless lumen that is ≥ 0.77 mm ID and ≤ 500 mm in length - Single channeled devices with stainless lumen that is ≥ 1.8 mm ID and ≤ 542 mm in length - . Dual channeled devices with stainless lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length - Triple channeled devices with stainless lumens that are either {10}------------------------------------------------ - ≥ 1.2 mm ID and ≤ 275 mm in length - ≥ 1.8 mm ID and ≤ 310 mm in length Of - ≥ 2.8 mm ID and ≤ 317 mm in length † Validation testing for all lumen sizes was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg). ## The V-PRO maX 2 Low Temperature Sterilization Systems using VAPROX HC Sterilant are intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues. Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle and the Fast Non Lumen Cycle. The Non Lumen Cycle can sterilize: * Non-luments including non- lumened general medical instruments, non- lumened rigid, semi-rigid and flexible endoscopes. * The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs ``` (22.7 kg). ``` The Fast Non Lumen Cycle can sterilize: * Non-luments including non- lumened general medical instruments, non- lumened rigid, semi-rigid and flexible endoscopes. * The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg). The Flexible Cycle can sterilize: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations: 1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain either: - A single lumen that is ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length - Or two lumens with: - One lumen that is ≥ 1 mm ID and ≤ 990 mm in length 트 - And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length * The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope). 2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. 11 The flexible endoscope may contain either: - A single lumen that is ≥ 1 mm ID and - < 1050 mm in length - Or two lumens with: - " One lumen that is ≥ 1 mm ID and ≤ 990 mm in length - And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length. - ** The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg). ### The Lumen Cycle can sterilize: † Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations: - Single channeled devices with a stainless lumen that is ≥ 0.77 mm ID and ≤ 500 mm in length - Single channeled devices with a stainless lumen that is ≥ 1.8 mm ID and ≤ 542 mm in length {11}------------------------------------------------ • Dual channeled devices with stainless lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length · Triple channeled devices with stainless lumens that are either: - ≥ 1.2 mm ID and ≤ 275 mm in length - ≥ 1.8 mm ID and ≤ 310 mm in length or - ≥ 2.8 mm ID and ≤ 317 mm in length * Validation testing for all lumen sizes was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg). #### ട്. Technological Characteristics The proposed and predicate devices are identical in all technological characteristics including but not limited to: fundamental scientific technology, composition, mechanism of action, components and accessories. No physical changes were made to the devices for this modification other than labeling (operator manual). # Table 5-1. Technological Characteristic Comparison between the proposed V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization System to the predicate device | | V-PRO 1, V-PRO 1Plus, V-PRO maX Low Temperature Sterilization System (Predicate Device – K172319) | V-PRO 1, V-PRO 1Plus, V-PRO maX Low Temperature Sterilization System (K190103) | |-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | | | | Intended Use and Indications for Use | The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems using VAPROX HC Sterilant are intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues. Each Cycle can sterilize non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle. | The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems using VAPROX HC Sterilant are intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues. Each Cycle can sterilize non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle. | | | The V-PRO 1 Plus and V-PRO maX Sterilizers' Non Lumen Cycle can sterilize: ‡ Non-lumened instruments including non- lumened general medical instruments, non- | The V-PRO 1 Plus and V-PRO maX Sterilizers' Non Lumen Cycle can sterilize: ‡ Non-lumened instruments including non- lumened general medical instruments, non- | | Feature | V-PRO 1, V-PRO 1Plus, V-PRO maX Low Temperature Sterilization System (Predicate Device - K172319) | V-PRO 1, V-PRO 1Plus, V-PRO maX Low Temperature Sterilization System (K190103) | | | lumened rigid, semi-rigid and flexible endoscopes. | lumened rigid, semi-rigid and flexible endoscopes. | | | ‡ The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg). | ‡ The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg). | | | The V-PRO maX Sterilizer's Flexible Cycle can sterilize: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations: 1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain either: A single lumen that is ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length Or two lumens with: - One lumen that is ≥ 1 mm ID and ≤ 990 mm in length - And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope). And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length. †† The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg). 2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments.†† The flexible endoscope may contain either: A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length Or two lumens with: One lumen that is ≥ 1 mm ID and ≤ 990 mm in length - And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length. †† The validation studies were conducted with a flexible endoscope in a tray with | 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: wo flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain either: a. A single lumen that is ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length b. Or two lumens with: - One lumen that is ≥ 1 mm ID and ≤ 990 mm in length - And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope). And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length. †† The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg). he flexible endoscope with a light cord (if not egral to endoscope) and mat and additional n-lumened instruments.†† The flexible doscope may contain either: A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length Or two lumens with: One lumen that is ≥ 1 mm ID and ≤ 990 mm in length - And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length. †† The validation studies were conducted with a flexible endoscope in a tray with | | Feature | V-PRO 1, V-PRO 1Plus, V-PRO maX Low Temperature Sterilization System (Predicate Device – K172319) | V-PRO 1, V-PRO 1Plus, V-PRO maX Low Temperature Sterilization System (K190103) | | | silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg). The V-PRO 1, V-PRO 1 Plus and V-PRO | silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg). The V-PRO 1, V-PRO 1 Plus and V-PRO | | | maX Sterilizers' Lumen Cycle can sterilize: † Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations: Single channeled devices with a stainless lumen that is ≥ 0.77 mm ID and ≤ 500 mm in length Dual channeled devices with stainless lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length Triple channeled devices with stainless lumens that are either ≥ 1.2 mm ID and ≤ 275 mm in length ≥ 1.8 mm ID and ≤ 310 mm in length or ≥ 2.8 mm ID and ≤ 317 mm in length † Validation testing for all lumen sizes was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg). | maX Sterilizers' Lumen Cycle can sterilize: † Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations: Single channeled devices with a stainless lumen that is ≥ 0.77 mm ID and ≤ 500 mm in length Single channeled devices with stainless lumen that is ≥ 1.8 mm ID and ≤ 542 mm in length Dual channeled devices with stainless lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length Triple channeled devices with stainless lumens that are either ≥ 1.2 mm ID and ≤ 275 mm in length ≥ 1.8 mm ID and ≤ 310 mm in length or ≥ 2.8 mm ID and ≤ 317 mm in length † Validation testing for all lumen sizes was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg). | | Process Parameters | The critical process parameters are: Time Chamber Temperature Vaporizer Temperature Chamber Pressure Prior to Injection Sterilant Injection Weight | kg). The critical process parameters are: Time Chamber Temperature Vaporizer Temperature Chamber Pressure Prior to Injection Sterilant Injection Weight | | Feature | V-PRO 1, V-PRO 1Plus, V-PRO maX Low Temperature Sterilization System (Predicate Device - K172319) | V-PRO 1, V-PRO 1Plus, V-PRO maX Low Temperature Sterilization System (K190103) | | Software/ Firmware Controlled | Control system consists of a proprietary microcomputer control board and peripheral function circuit boards, located within the control housing. A memory backup system maintains user settings and calibration data indefinitely. Up to 300 cycle data files can be stored for review or downloading by the user. The software allows user selection of either the Lumen, Non Lumen or Flexible pre- programmed cycle. | Control system consists of a proprietary microcomputer control board and peripheral function circuit boards, located within the control housing. A memory backup system maintains user settings and calibration data indefinitely. Up to 300 cycle data files can be stored for review or downloading by the user. The software allows user selection of either the Lumen, Non Lumen or Flexible pre- programmed cycle. | | Total Cycle Time | Lumen Cycle - 55 minutes Non Lumen Cycle - 28 minutes Flexible Cycle - 35 minutes | Lumen Cycle - 55 minutes Non Lumen Cycle - 28 minutes Flexible Cycle - 35 minutes | | Sterilant | VAPROX HC Sterilant (59% Hydrogen Peroxide).…

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

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

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