(73 days)
Not Found
No
The document describes a low-temperature sterilization system with pre-programmed cycles based on device type and configuration. There is no mention of AI or ML in the intended use, device description, or performance studies. The system appears to operate based on predefined parameters rather than learning or adapting.
No
This device is a sterilizer, intended for use in the terminal sterilization of medical devices, not for diagnosing, treating, or preventing disease in patients.
No
This device is a sterilizer that cleans and sterilizes medical devices and instruments; it does not diagnose medical conditions.
No
The device description clearly states that the V-PRO Low Temperature Sterilization Systems are "vaporized hydrogen peroxide sterilizers" and describes physical components and processes (conditioning phase, sterilize phase, aeration phase, use of VAPROX HC Sterilant). This indicates a hardware-based medical device with integrated software for control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities." This describes a process for making medical devices safe for reuse, not for performing diagnostic tests on biological samples.
- Device Description: The device is described as a "vaporized hydrogen peroxide sterilizer." This is a sterilization system, not a device designed to analyze samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays for diagnostic purposes
- Outputting diagnostic results
The device's function is to sterilize medical instruments, which is a crucial step in healthcare but is not a diagnostic activity.
N/A
Intended Use / 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-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:
- 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).
- 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
• 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).
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:
- 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).
- 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 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 1.2 mm ID and
§ 880.6860 Ethylene oxide gas sterilizer.
(a)
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.(b)
Classification. Class II (performance standards).
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:
- 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).
- 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:
- 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).
- 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 1.2 mm ID and 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:
-
- 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).
- 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:
- 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).
- 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
- 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:
- 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).
- 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). | VAPROX HC Sterilant (59% Hydrogen
Peroxide). |
| Accessories | Accessories were submitted under separate,
individual, concurrent 510(k)s and cover the
following:
• Self-contained biological indicator
• Biological indicator challenge pack
• Fast Acting Biological Indicator
• Chemical indicator
• Trays & Tray Accessories
• Pouches
• Tape | Accessories were submitted under separate,
individual, concurrent 510(k)s and cover the
following:
• Self-contained biological indicator
• Biological indicator challenge pack
• Fast Acting Biological Indicator
• Chemical indicator
• Trays & Tray Accessories
• Pouches
• Tape |
12
13
14
The proposed and predicate device are identical in all ways except their indications for use for the Lumen cycle and consequently their labeling (operator manual).
Table 5-2. Technological Characteristics 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/K172754) | V-PRO maX 2 Low Temperature
Sterilization System
(K190103) | | |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | 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. | 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 | Each Cycle can sterilize non-lumened
instruments with diffusion-restricted spaces | |
| | | Feature | V-PRO maX 2 Low Temperature
Sterilization System
(Predicate Device/K172754) | V-PRO maX 2 Low Temperature
Sterilization System
(K190103) |
| | | | 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. | 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-
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 two
instrument trays for a total weight of 50 lbs
(22.7 kg). | The Non Lumen Cycle can sterilize: + Non-
lumened instruments including non- lumenec
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-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 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: | 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 silicone mat and
light cord (if not integral to endoscope).
- One flexible endoscope with a light cord | 2. 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).
- One flexible endoscope with a light cord
(if not integral to endoscope) and mat and |
| | | | (if not integral to endoscope) and mat and | (if not integral to endoscope) and mat and |
| | | V-PRO maX 2 Low Temperature
Sterilization System
(Predicate Device/K172754) | V-PRO maX 2 Low Temperature
Sterilization System
(K190103) | |
| Feature | 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 Lumen Cycle can sterilize: †
Medical devices (including single, dual 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 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 | 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 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). | † 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 | The critical process parameters are:
• Time
• Chamber Temperature
• Vaporizer Temperature
• Chamber Pressure Prior to Injection | | |
| Feature | V-PRO maX 2 Low Temperature
Sterilization System
(Predicate Device/K172754) | V-PRO maX 2 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, Flexible or Fast
Non Lumen 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, Flexible or Fast
Non Lumen pre-programmed cycle. | | |
| Total Cycle
Time | Lumen Cycle - 52 minutes
Non Lumen Cycle - 28 minutes
Flexible Cycle - 35 minutes
Fast Non Lumen Cycle - 16 minutes | Lumen Cycle - 52 minutes
Non Lumen Cycle - 28 minutes
Flexible Cycle - 35 minutes
Fast Non Lumen Cycle - 16 minutes | | |
| Sterilant | VAPROX HC Sterilant (59% Hydrogen
Peroxide).
The same amount of sterilant is injected for
each of the sterilization pulses for all three
cycles. | VAPROX HC Sterilant (59% Hydrogen
Peroxide).
The same amount of sterilant is injected for
each of the sterilization pulses for all three
cycles. | | |
| Accessories | Accessories were submitted under separate,
individual, concurrent 510(k)s and cover the
following:
• Self-contained biological indicator
• Biological indicator challenge pack
• Fast Acting Biological Indicator
• Chemical indicator
• Trays & Tray Accessories
• Pouches | Accessories were submitted under separate,
individual, concurrent 510(k)s and cover the
following:
• Self-contained biological indicator
• Biological indicator challenge pack
• Fast Acting Biological Indicator
• Chemical indicator
• Trays & Tray Accessories
• Pouches | | |
15
16
17
The proposed and predicate device are identical in all ways except their indications for use for the Lumen cycle and consequently their labeling (operator manual).
Summarv of Non-Clinical Testing 6.
Non-clinical performance test was performed according to the test methodology listed below. The testing demonstrated that the subject device met the acceptance criteria described in the standard/methodology.
18
| Test | Result | Conclusion |
|---|---|---|
| 1/2 Cycle Modified | ||
| Total Kill Endpoint | ||
| Verification | Modified total kill end point analysis was | |
| demonstrated for the sterilizer cycles. The | ||
| standard injection weight of 2.1 g and at least one | ||
| lower injection weight resulted in all sterile | ||
| results within the validation load used to qualify | ||
| each sterilizer cycle. Partial positives or all | ||
| survive results were seen at lower injection | ||
| weights. | PASS | |
| Simulated Use Test | Simulated use testing verified the ability of the | |
| sterilizer cycles to sterilize medical devices under | ||
| worst-case processing conditions. | PASS |
7. Conclusions
Based on the intended use, technological characteristics and non-clinical performance data, the V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization System is as safe, as effective and performs as well or better than the legally marketed predicate device K172319, Class II (21 CFR 880.6860), product code MLR.
Based on the intended use, technological characteristics and non-clinical performance data, the V-PRO maX 2 Low Temperature Sterilization System is as safe, as effective and performs as well or better than the legally marketed predicate device K172754, Class II (21 CFR 880.6860), product code MLR.