(150 days)
No
The document describes a sterilization system with preprogrammed cycles based on physical parameters (temperature, pressure, time, sterilant concentration). There is no mention of adaptive learning, pattern recognition, or any other characteristic typically associated with AI/ML. The performance studies focus on sterilization efficacy under various conditions, not on the performance of an AI/ML algorithm.
No.
This device is a sterilizer, intended for sterilizing medical devices, not for treating patients.
No
This device is a sterilizer intended for the terminal sterilization of medical devices, not for diagnosing medical conditions.
No
The device is a sterilization system that uses vaporized hydrogen peroxide and includes hardware components (the sterilizer itself) in addition to any controlling software.
Based on the provided text, 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 text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
- Reagents or calibrators
The device's function is to sterilize medical instruments, which is a crucial step in preventing the spread of infection in healthcare settings. This falls under the category of medical device processing, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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:
Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.
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 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 load 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
- 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 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
Product codes (comma separated list FDA assigned to the subject device)
MLR
Device Description
The V-PRO maX 2 Low Temperature Sterilization System is a new vaporized hydrogen peroxide sterilizer model to be added to the STERIS V-PRO family of sterilizers. As with the predicate device (K162413), the V-PRO maX 2 Sterilizer has three preprogrammed cycles (the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycle) with a fourth added (the Fast Non Lumen Cycle). The V-PRO maX 2 Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities. The V-PRO maX 2 Sterilizer uses VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Its 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare Facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The V-PRO maX 2 Low Temperature Sterilization System has the same intended use and different technological characteristics that do not raise different questions of safety and effectiveness as compared to the predicate device. Performance testing to assess and demonstrate substantial equivalence to the predicate is summarized below.
Test: AOAC Sporicidal Test
Result: All 720 carriers processed using 3 lots of EOSL sterilant were sterile.
Conclusion: PASS
Test: Determination of D-value and Total Kill Endpoint
Result: Greater than a 12 log reduction of the most resistant organism is achieved within all cycles (Lumen Cycle, Non Lumen Cycle, Flexible Cycle and Fast Non Lumen) of the V-PRO maX 2 Sterilizer.
Conclusion: PASS
Test: 1/2 Cycle Modified Total Kill Endpoint Verification
Result: Modified total kill end point analysis was demonstrated for all four V-PRO maX 2 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.
Conclusion: PASS
Test: 1/2 Cycle Sterilization Verification of Cycle Claims
Result:
- The Lumen Cycle reproducibly sterilizes single, dual and triple lumen devices under worst case conditions in 1/2 Cycle
- The Flexible Cycle reproducibly sterilizes 1 x 990 mm flexible endoscope lumens under worst case conditions in 1/2 Cycle
- The Non Lumen Cycle reproducibly sterilizes non-lumened devices under worst case conditions in 1/2 Cycle
- The Fast Non Lumen Cycle reproducibly sterilizes non-lumened devices under worst case conditions in 1/2 Cycle
Conclusion: PASS
Test: 1/2 Cycle Verification of Mated Surfaces
Result: Sterile efficacy was demonstrated for mated surfaces under worst case conditions
Conclusion: PASS
Test: Simulated Use Test
Result: Simulated use testing verified the ability of the V-PRO maX 2 Sterilizer cycles to sterilize medical devices under worst case processing conditions.
Conclusion: PASS
Test: In Use Test
Result: The in use investigation demonstrated the ability of the V-PRO maX 2 Sterilizer cycles to sterilize patient-soiled, clinically-cleaned, medical instruments.
Conclusion: PASS
Test: Biocompatibility
Result: Cytotoxicity and residue analysis of 23 materials have demonstrated biocompatibility after processing in the V-PRO 60 Sterilizer.
Conclusion: PASS
Test: Medical Device Material Compatibility
Result: Evaluation of medical devices after multiple cycles in the V-PRO maX 2 Sterilizer has demonstrated compatibility with 23 materials of construction.
Conclusion: PASS
Test: Final Process Qualification
Result: The V-PRO maX 2 Sterilizer final process qualification was successful for all four (4) sterilizer cycles.
Conclusion: PASS
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K102330, K112760, K112813, K120632, K131120
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure in profile, with three overlapping faces suggesting community and connection. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2018
STERIS Corporation Bill Brodbeck, Ph.D. Director, Regulatory Affairs 5960 Heisley Rd. Mentor, Ohio 44060
Re: K172754
Trade/Device Name: V-PRO® maX 2 Low Temperature Sterilization System Regulation Number: 21 CFR 880.6860 Regulation Name: Sterilizer, Ethylene Oxide Gas Regulatory Class: Class II Product Code: MLR Dated: January 9, 2018 Received: January 10, 2018
Dear Dr. Bill Brodbeck:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172754
Device Name
V-PRO® maX 2 Low Temperature Sterilization System
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: †
Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes.
t: The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).
The Fast Non Lumen Cycle can sterilize: *
Non-lumened instruments including non-luments, non-luments, 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 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. ++ 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: †
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
- 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 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 shows the logo for STERIS. The logo consists of the word "STERIS" in a bold, sans-serif font, with the registered trademark symbol to the right of the word. Below the word "STERIS" is a graphic of several horizontal, wavy lines in blue, resembling water waves.
510(k) Summary For
V-PRO® maX 2 Low Temperature Sterilization System
K172754
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact:
Bill Brodbeck Director, Regulatory Affairs Tel: 440-392-7690 Fax: 440-357-9198
Submission Date: February 6, 2018
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
5
1. Device Name
| Trade Name: | V-PRO® maX 2 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 is the V-PRO maX Low Temperature Sterilization System, cleared most recently under K162413.
The V-PRO maX Low Temperature Sterilization System prior clearances include Premarket Submissions K102330, K112760, K112813, K120632, K131120 and K162413.
| System to the predicate device is summarized in the table below. | ||
|---|---|---|
| Feature | V-PRO maX 2 Low Temperature | |
| Sterlization System | ||
| (Proposed Device) | V-PRO maX Low Temperature Sterlization | |
| System | ||
| (Predicate Device/K162413) | ||
| 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. |
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.
The Fast Non Lumen Cycle can
sterilize: * | The V-PRO 1, V-PRO 1 Plus and V-PRO
maX Low Temperature Sterilization Systems,
with VAPROX® HC Sterilant, are vaporized
hydrogen peroxide sterilizers intended for use
in the terminal sterilization of cleaned, rinsed
and dried metal and nonmetal medical devices
used in healthcare facilities. The three pre-
programmed sterilization cycles (Lumen
Cycle, Non Lumen Cycle, and Flexible Cycle)
operate at low pressure and low temperature
and are thus suitable for processing medical
devices sensitive to heat and moisture.
The V-PRO 1, V-PRO 1 Plus and V-PRO
maX Low Temperature Sterilization System's
Lumen Cycle, can sterilize:a
Lumened and non-lumened instruments
with diffusion-restricted spaces such as the
hinged portion of forceps and scissors Medical devices, including single, dual and
triple channeled rigid and semi-rigid |
| Feature | V-PRO maX 2 Low Temperature
Sterilization System
(Proposed Device) | V-PRO maX Low Temperature Sterilization
System
(Predicate Device/K162413) |
| | 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). | endoscopes, with the following configurations: a single channeled devices with a stainless steel lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length dual lumen devices with stainless lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length triple lumen devices with stainless steel lumens that are ≥ 1.2 mm ID and ≤ 275 mm in length ≥ 1.8 mm ID and ≤ 310 mm in length or ≥ 2.8 mm ID and ≤ 317 mm in length |
| | 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). | a The validation studies for all channel/ lumen configurations were conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs. |
| | The 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 load 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).
-
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 | The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Non Lumen Cycle can sterilize:b Non-lumened instruments including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened instruments with stainless steel or titanium diffusion-restricted areas such as the hinged portion of forceps or scissors. |
| | | b The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50.0 lbs. |
| | | The V-PRO maX Low Temperature Sterilization System's Flexible Cycle can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and |
| Feature | V-PRO maX 2 Low Temperature
Sterilization System
(Proposed Device) | V-PRO maX Low Temperature Sterilization
System
(Predicate Device/K162413) |
| | 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 † 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). | bronchoscopes in either of two load configurations: Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.c
The flexible endoscopes may contain either: a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length or two lumens with: one lumen that is ≥ 1 mm ID and ≤ 990 mm in length and the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length c The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope). One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors.d
The flexible endoscope can contain either: a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length or two lumens with: a single lumen that is ≥ 1 mm ID and ≤ 990 mm in length and the other lumen that is ≥ 1 mm and ≤ 850 mm in length d The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs. |
| Process
Parameters | The critical process parameters are:
Time Chamber Temperature Vaporizer Temperature Chamber Pressure Prior to Injection Sterilant Injection Weight | The critical process parameters are:
Time Chamber Temperature Vaporizer Temperature Chamber Pressure Prior to Injection Sterilant Injection Weight |
| Feature | V-PRO maX 2 Low Temperature
Sterlization System
(Proposed Device) | V-PRO maX Low Temperature Sterlization
System
(Predicate Device/K162413) |
| 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. | Programmable Logic Control (PLC). The
software allows user selection of either the
Lumen, Non Lumen, or Flexible 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 - 55 minutes
Non Lumen Cycle - 28 minutes
Flexible Cycle - 35 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. |
| | Sterilant Cup is read by an RFID reader. | The sterilant cup is read by a 2-D matrix code |
| 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 | The following accessories are available for the
V-PRO maX Low Temperature Sterilization
System
Self-contained biological indicator Biological indicator challenge pack Fast Acting Biological Indicator Chemical indicator Trays & Tray Accessories Pouches |
A comparison between the proposed V-PRO maX 2 Low Temperature Sterilization System to the predicate device is summarized in the table helow
6
TRADITIONAL PREMARKET NOTIFICATION
V-PRO® maX 2 Low Temperature Sterilization System
7
8
TRADITIONAL PREMARKET NOTIFICATION V-PRO® maX 2 Low Temperature Sterilization System
The proposed device has an intended use similar to the predicate with the differences being the addition of the Fast Non Lumen Cycle and slight modification to the text to allow conciseness and clarity. Both the predicate and proposed devices have the same technological characteristics. Although, the devices slightly differ, the provided descriptive characteristics and performance data demonstrate equivalence. Therefore, the proposed V-PRO maX 2 Low Temperature Sterilization System is substantially equivalent to the predicate device, the V-PRO maX Low Temperature Sterilization System.
3. Description of Device
The V-PRO maX 2 Low Temperature Sterilization System is a new vaporized hydrogen peroxide sterilizer model to be added to the STERIS V-PRO family of
9
sterilizers. The V-PRO product line currently consists of the Amsco V-PRO 1, Amsco V-PRO 1 Plus, V-PRO maX and V-PRO 60 Sterilizers.
As with the predicate device (K162413), the V-PRO maX 2 Sterilizer has three preprogrammed cycles (the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycle) with a fourth added (the Fast Non Lumen Cycle). The V-PRO maX 2 Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities.
The V-PRO maX 2 Sterilizer uses VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Its 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.
4. Intended Use
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: +
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 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 load configurations:
10
- 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 1 mm ID and