(141 days)
No
The document describes a low-temperature sterilization system with pre-programmed cycles based on physical parameters (pressure, exposure to VHP). There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is a sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried medical devices. It is used to prepare other devices for therapeutic use, but it does not directly provide therapy itself.
No
This device is a sterilizer, intended for the terminal sterilization of medical devices, not for diagnosing medical conditions.
No
The device is a physical sterilization system that uses vaporized hydrogen peroxide and includes hardware components such as a chamber, shelves, printer, cup interface, display, injection cylinder, vaporizer, vacuum pump, and catalytic converter. While it has a graphic user interface (software), it is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the V-PRO systems 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." This describes a process for making medical devices safe for use, not a test performed on biological samples to diagnose a condition.
- Device Description: The device description details the sterilization process using vaporized hydrogen peroxide and the physical components of the sterilizer. It does not mention any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies described focus on the effectiveness of the sterilization process (e.g., "Modified Total Kill Endpoint Verification," "Sterilization Verification of Cycle Claims," "Simulated Use Test"). These are tests to ensure the device can properly sterilize medical instruments, not tests to evaluate the performance of a diagnostic assay.
IVD devices are specifically designed to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The V-PRO systems sterilize medical devices that are used on or in the human body.
N/A
Intended Use / Indications for Use
The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and are thus suitable for processing medical devices sensitive to heat and moisture.
The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle can sterilize:(a)
- Lumened and non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations: (a)
- o single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
- o dual channeled devices with stainless steel lumens that are > 0.77 mm ID and 2.8 mm ID and 1 mm ID and 1 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
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 6, 2016
STERIS Corporation Dr. Bill Brodbeck Director, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060
Re: K160433
Trade/Device Name: V-PRO® 1 Plus and V-PRO® maX Low Temperature Sterilization Systems Regulation Number: 21 CFR 880.6860 Regulation Name: Sterilizer, Ethylene Oxide Gas Regulatory Class: II Product Code: MLR Dated: June 9, 2016 Received: June 10, 2016
Dear Dr. Brodbeck:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (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 yours,
Teiashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160433
Device Name
V-PRO® 1 Plus and V-PRO® maX Low Temperature Sterilization Systems
Indications for Use (Describe)
The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and are thus suitable for processing medical devices sensitive to heat and moisture.
The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle can sterilize:(a)
- Lumened and non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations: (a)
- o single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
- o dual channeled devices with stainless steel lumens that are > 0.77 mm ID and 2.8 mm ID and 1 mm ID and 1 mm ID and Department of Health and Human Services Food and Druq 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 word STERIS is in all capital letters and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines in blue.
510(k) Summary For V-PRO® 1 Plus and V-PRO® maX Low Temperature Sterilization Systems
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Bill Brodbeck Contact: Director, Regulatory Affairs
Email: William Brodbeck@steris.com Telephone: (440) 392-7690 Fax No: (440) 357-9198
Summary Date: June 9, 2016
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
5
1. Device Name
| Trade Name: | V-PRO® 1 Plus and V-PRO® maX Low Temperature
Sterilization Systems |
|----------------------|-----------------------------------------------------------------------|
| Device Class: | Class II |
| Common/usual Name: | Vapor Phase Hydrogen Peroxide Sterilizer |
| Classification Name: | Sterilizer, Ethylene Oxide Gas
21 CFR 880.6860
Product Code MLR |
2. Predicate Devices
Primary predicate claimed is V-PRO 1 Plus/ V-PRO maX Low Temperature Sterilization System cleared under K131120.
V-PRO® 1 Plus Low Temperature Sterilization System was originally cleared under K083097 with modifications cleared under K102394, K111810, K112813 and K120632.
V-PRO® maX Low Temperature Sterilization System was originally cleared under K102330 with modifications cleared under K112760, and K120632.
Comparison between the proposed V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems to the predicate devices is summarized in the table below.
| Feature | V-PRO 1 Plus/V-PRO maX Low
Temperature Sterilization System
(Proposed Device) | V-PRO 1 Plus/V-PRO maX Low
Temperature Sterilization System
(Predicate Devices/K131120) |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | 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 | The Amsco 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 reusable 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 Amsco V-PRO 1, V-PRO 1 Plus and |
| Feature | V-PRO 1 Plus/V-PRO maX Low
Temperature Sterilization System
(Proposed Device) | V-PRO 1 Plus/V-PRO maX Low
Temperature Sterilization System
(Predicate Devices/K131120) |
| | 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 endoscopes, with the
following configurations: a
o single channeled devices with a
stainless steel lumen that is >
0.77 mm internal diameter (ID)
and ≤ 500 mm in length
o dual lumen devices with stainless
lumens that are ≥ 0.77 mm ID
and ≤ 527 mm in length
o 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
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. | 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 endoscopes, with the
following configurations: a
o single channeled devices with a
stainless steel lumen that is >
0.77 mm internal diameter (ID)
and ≤ 500 mm in length
o dual lumen devices with stainless
lumens that are ≥ 0.77 mm ID
and ≤ 527 mm in length
o 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
a The validation studies for all
channel/ lumen configurations were
conducted using a maximum of
twenty (20) lumens per load.
Hospital loads should not exceed
the maximum number of lumens
validated by this testing. The
validation studies were performed
using a validation load consisting
of two instrument trays and two
pouches for a total weight of
19.65 lbs. |
| | The V-PRO 1 Plus and V-PRO maX Low
Temperature Sterilization Systems' Non
Lumen Cycle, the subject of this
submission, can sterilize: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 | The Amsco V-PRO 1 Plus and V-PRO maX
Low Temperature Sterilization Systems'
Non Lumen Cycle, cleared under K083097,
K102394 and K111810, can sterilize:b
• Non-lumened instruments including
non-lumened rigid, semi-rigid and
flexible endoscopes and non-lumened
instruments with stainless steel
diffusion-restricted areas such as the
hinged portion of forceps or scissors.
b The validation studies were conducted
using a validation load consisting of
two instrument trays and two pouches
for a total weight of 19.65 lbs. |
| Feature | V-PRO 1 Plus/V-PRO maX Low
Temperature Sterilization System
(Proposed Device)
of 50.0 lbs. | V-PRO 1 Plus/V-PRO maX Low
Temperature Sterilization System
(Predicate Devices/K131120) |
| | The V-PRO maX Low Temperature
Sterilization System's Flexible Cycle , can
sterilize single or dual lumen surgical
flexible endoscopes (such as those used in
ENT, Urology and Surgical Care) and
bronchoscopes in either of two load
configurations:
- Two flexible endoscopes with a light
cord (if not integral to endoscope) and
mat with no additional load.c
The flexible endoscopes may contain
either: | The Amsco V-PRO maX Low Temperature
Sterilization System's Flexible Cycle ,
cleared under K102330 and K112760, can
sterilize single or dual lumen surgical
flexible endoscopes (such as those used in
ENT, Urology and Surgical Care) and
bronchoscopes in either of two load
configurations: - Two flexible endoscopes with a light
cord (if not integral to endoscope) and
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 | 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 ≤
998 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). | 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 including instruments with
diffusion-restricted areas such as the
hinged portion of forceps or scissors.d | 2. 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 | 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 ≤ 998 mm in length and the
other lumen that is ≥ 1 mm 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 load weight of 24.0 lbs. | 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. |
| Feature | V-PRO 1 Plus/V-PRO maX Low
Temperature Sterilization System
(Proposed Device) | V-PRO 1 Plus/V-PRO maX Low
Temperature Sterilization System
(Predicate Devices/K131120) |
| 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 |
| Software/
Firmware
Controlled | Programmable Logic Control (PLC). The
software allows user selection of either the
Lumen, Non Lumen, or Flexible 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 - 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).
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 | The following accessories are available for
the V-PRO maX Low Temperature
Sterilization System
• Self-contained biological indicator
• Biological indicator challenge pack
• 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
• Chemical indicator
• Trays & Tray Accessories
• Pouches |
6
7
8
K160433/ S001 STERIS Response to Request for Additional Information V-PRO® 1 Plus and V-PRO® maX Low Temperature Sterilization Systems
The proposed devices have an intended use similar to the predicates with the same technological characteristics. Although, the indications differ slightly, the provided performance data demonstrate equivalence. Therefore, the proposed V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems are substantially equivalent to the predicate devices, the V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems.
3. Description of Device
The V-PRO 1 Plus and V-PRO maX Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Devices that meet the criteria described within the indications for use and composed of compatible materials are placed within the sterilization chamber and the appropriate cycle selected through the graphic user interface. The preprogrammed cycles all utilize a conditioning phase which prepares the chamber, a sterilize phase in which loaded devices are exposed to the sterilizing agent, VHP, at low pressure and an aeration phase to remove residual hydrogen peroxide. The packaged sterilized devices are ready for use at the completion of the cycle, no cool down or aeration period is required following completion of the cycle.
9
The V-PRO 1 Plus Low Temperature Sterilization System provides two cycle options, Lumen and Non Lumen. The sterilizer contains a 136 L welded aluminum chamber with two shelves for device loading, an onboard printer to provide cycle printouts, a cup interface where the VAPROX HC cups are loaded, a display for the graphic user interface and the components necessary to achieve the desired cvcle parameters (injection cylinder, vaporizer, vacuum pump and catalytic converter). The side panels of the sterilizer are composed of stainless steel.
The V-PRO maX Low Temperature Sterilization System provides three cycle options, Lumen, Non Lumen and Flexible. The sterilizer contains a 136 L welded aluminum chamber with two shelves for device loading, an onboard printer to provide cycle printouts, a cup interface where the VAPROX HC cups are loaded, a display for the graphic user interface and the components necessary to achieve the desired cycle parameters (injection cylinder, vacuum pump and catalytic converter). The side panels of the sterilizer are composed of plastic.
The purpose of this pre-market notification is to modify the maximum load weight for the Non Lumen Cycle from 19.65 to 50 lbs, to add titanium diffusion-restricted areas to the indications for use of the Non Lumen Cycle, and to remove the term "reusable" from indications for use statement.
4. Intended Use
The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles [Lumen Cycle, Non Lumen Cycle, and Flexible Cycle (V-PRO maX Sterilizer only)] operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.
The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle can sterilize:4
- Lumened and non-lumened instruments with diffusion-restricted spaces . such as the hinged portion of forceps and scissors
- Medical devices, including single, dual and triple channeled rigid and . semi-rigid endoscopes, with the following configurations: 4
- O single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
- dual channeled devices with stainless steel lumens that are ≥ 0.77 O mm ID and ≤ 527 mm in length
- triple channeled devices with stainless steel lumens that are o
- ≥ 1.2 mm ID and ≤ 275 mm in length
10
-
≥ 1.8 mm ID and ≤ 310 mm in length
or -
≥2.8 mm ID and ≤ 317 mm in length
-
a The validation studies for all channel/lumen configurations were conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.
The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Non Lumen Cycle, the subject of this submission, can sterilize:'0
Non-lumened instruments including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened instruments with stainless steel or titanium diffusion-restricted areas such as the hinged portion of forceps or scissors.
The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs.
The V-PRO maX Low Temperature Sterilization System's Flexible Cycle, can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT. Urology and Surgical Care) and bronchoscopes in either of two load configurations:
-
Two flexible endoscopes with a light cord (if not integral to endoscope) and 1. mat with no additional load. °
The flexible endoscopes may contain either: -
. a single lumen that is > 1 mm ID and 1 mm ID and 1 mm ID and 1 mm ID and 1 mm ID and 1 mm and ≤ 850 mm in length ●
-
d The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.
The parameters for the three V-PRO Cycles are as follows:
| Sterilization
Cycle | Sterilant
injection
(g) | # of
Injections | Sterilant
Exposure
Time (min) | Chamber
Pressure
Prior to
Injection
(Torr) | Chamber/
Vaporizer
Temperature
(°C) |
|------------------------|-------------------------------|--------------------|-------------------------------------|--------------------------------------------------------|----------------------------------------------|
| Lumen | 2.1 | 4 | 32 | 0.4 | 50/60 |
| Non Lumen | 2.1 | 4 | 12 | 1 | 50/60 |
| Flexible | 2.1 | 4 | 12 | 0.4 | 50/60 |
5. Summary of Nonclinical Tests
The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems have the same or similar intended use and the same technological characteristics as compared to the predicate devices. Performance testing to assess and demonstrate substantial
12
equivalence to the predicates is summarized below.
| Conclusion | |||
|---|---|---|---|
| Test | Result | V-PRO 1 | |
| Plus/V-PRO | |||
| max Low | |||
| Temperature | |||
| Sterilization | |||
| System | |||
| (Proposed | |||
| Device) | V-PRO 1 | ||
| Plus/V-PRO | |||
| max Low | |||
| Temperature | |||
| Sterilization | |||
| System | |||
| (Predicate | |||
| Devices/K131 |
- |
| ½ Cycle Modified
Total Kill
Endpoint
Verification | Modified total kill end point analysis was
demonstrated for the Non Lumen Cycle.
The standard injection weight of 2.1 g and
at least one lower injection weight resulted
in all sterile results within the validation
load. Partial positives or all survive
results were seen at lower injection
weights. | PASS | PASS |
| ½ Cycle
Sterilization
Verification of
Cycle Claims | The Non Lumen Cycle reproducibly
sterilizes non-lumened devices, mated
surfaces and device tray accessories
contact sites under worst case conditions
in ½ Cycle | PASS | PASS |
| Simulated Use
Test | Simulated use testing verified the ability
of the Non Lumen Cycle to sterilize
medical devices under worst case
processing conditions. | PASS | PASS |
| Final Process
Qualification | The Non Lumen Cycle final process
qualification was successful. Manual
inspection of the process parameter data
confirmed that all cycle specifications
were met. | PASS | PASS |
| Sterilizer
Accessories
Performance | Three lots of VERIFY® V24 Self-
Contained Biological Indicator (SCBI)
were reproducibly sterilized under worst
case ½ cycle conditions. Three lots of
SCBI process indicators (PIs) exhibited a
passing color change and all SCBIs were
negative for growth under worst case full
cycle conditions. Three lots of VERIFY®
HPU chemical indicator exhibited
complete color change under worst case
full cycle conditions. Test articles were
effectively sterilized under worst case ½
cycle conditions when packaged in:
• Vis -U-All Low Temperature
Pouches or
• V-PRO Sterilization Trays | PASS | PASS |
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6. Conclusion
The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems Non Lumen Cycle has been validated to meet the established performance criteria. The results of the V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Non Lumen Cycle verification studies demonstrate that the sterilizers perform as intended. Based on the intended uses, technological characteristics and non-clinical performance data, the subject devices (V-PRO 1 Plus and V-PRO maX) are as safe, as effective and perform at least as safely and effectively as the legally marketed predicate device (K131120), Class II (21 CFR 880.6860), product code MLR.