(56 days)
Not Found
No
The document describes a sterilization system with pre-programmed cycles based on physical parameters (temperature, pressure, time, sterilant concentration) and device characteristics (lumens, non-lumens). 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 defined conditions, not on the performance of an AI/ML algorithm.
No
The device is a sterilizer for medical devices, not a therapeutic device. It is used to prepare instruments for medical procedures, but it does not directly treat or diagnose patients.
No
Explanation: The device is a sterilization system intended for terminal sterilization of medical devices, not for diagnosing medical conditions.
No
The device description clearly states it is a "vaporized hydrogen peroxide sterilizer" and describes physical components and processes (conditioning, sterilize, aeration phases using VHP). This indicates a hardware device with integrated software, 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 the system is for the "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 substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device's function is to sterilize medical instruments, which is a crucial step in healthcare but is distinct from in vitro diagnostics.
N/A
Intended Use / Indications for Use
The V-PRO maX Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues.
Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
The V-PRO maX Sterilizers' Non Lumen Cycle can sterilize: t
Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid, semi-rigid and flexible endoscopes.
t The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).
The V-PRO maX Sterilizer's Flexible Cycle can sterilize:
Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations:
-
Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain single or dual channel lumens that are ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length. * The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).
-
One flexible endoscope with a light cord (if not integral to endoscope accessories and mat, and additional instruments. ** The flexible endoscope may contain single or dual channel lumens that are ≥ 1 mm ID and ≤ 1050 mm in length
Additional instruments may include non-lumened or lumened medical devices with the following configurations:
Single, dual or triple channel stainless steel lumen that is ≥ 0.48 mm ID and ≤ 100 mm in length
** The validation studies were conducted with a flexible endoscope accessories, silicone mat, light cord (if not integral to endoscope) and 5 stainless steel lumens. Also included in the load was a tray with additional instruments and silicone mat for a total weight of 24 lbs (11 kg).
The V-PRO maX Sterilizers' Lumen Cycle can sterilize: * Medical devices with the following configurations:
· Single, dual or triple channeled stainless steel lumen that are:
- ≥ 0.77 mm ID and ≤ 527 mm in length
- ≥ 0.8 mm ID and ≤ 542 mm in length
- ≥ 0.48 mm ID and ≤ 100 mm in length
- · Dead end lumen that is ≥ 1.3 mm ID and ≤ 73 mm in length
- · Rigid non-metallic lumen (such as those used in endoscope sheaths, take-apart forceps and trocars) that are:
- ≥ 3 mm ID and ≤ 298 mm in length
- · ≥ 4 mm ID and
§ 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/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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
September 9, 2022
Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060
Re: K222093
Trade/Device Name: V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: August 17, 2022 Received: August 18, 2022
Dear Anthony Piotrkowski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Clarence W. Murray, III, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222093
Device Name
V-PRO maX Low Temperature Sterilization System
Indications for Use (Describe)
The V-PRO maX Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues.
Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
The V-PRO maX Sterilizers' Non Lumen Cycle can sterilize: t
Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid, semi-rigid and flexible endoscopes.
t The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).
The V-PRO maX Sterilizer's Flexible Cycle can sterilize:
Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations:
-
Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain single or dual channel lumens that are ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length. * The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).
-
One flexible endoscope with a light cord (if not integral to endoscope accessories and mat, and additional instruments. ** The flexible endoscope may contain single or dual channel lumens that are ≥ 1 mm ID and ≤ 1050 mm in length
Additional instruments may include non-lumened or lumened medical devices with the following configurations:
Single, dual or triple channel stainless steel lumen that is ≥ 0.48 mm ID and ≤ 100 mm in length
** The validation studies were conducted with a flexible endoscope accessories, silicone mat, light cord (if not integral to endoscope) and 5 stainless steel lumens. Also included in the load was a tray with additional instruments and silicone mat for a total weight of 24 lbs (11 kg).
The V-PRO maX Sterilizers' Lumen Cycle can sterilize: * Medical devices with the following configurations:
· Single, dual or triple channeled stainless steel lumen that are:
- ≥ 0.77 mm ID and ≤ 527 mm in length
- ≥ 0.8 mm ID and ≤ 542 mm in length
- ≥ 0.48 mm ID and ≤ 100 mm in length
- · Dead end lumen that is ≥ 1.3 mm ID and ≤ 73 mm in length
- · Rigid non-metallic lumen (such as those used in endoscope sheaths, take-apart forceps and trocars) that are:
- ≥ 3 mm ID and ≤ 298 mm in length
- · ≥ 4 mm ID and 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 STERIS logo. To the left of the word STERIS is a blue image of what appears to be water waves. The word STERIS is in all caps and in a bold, sans-serif font.
510(k) Summary For
V-PRO® maX Low Temperature Sterilization Systems and V-PRO® maX 2 Low Temperature Sterilization Systems
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (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: | September 5, 2022 |
| Premarket Notification Number: | K222093 |
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
5
Device Name 1.
| Trade Name: | V-PRO® maX Low Temperature Sterilization
System and 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 and maX 2 Low Temperature Sterilization Systems, cleared most recently under K190103.
| Table 5-1. A comparison between the proposed V-PRO maX Low Temperature Sterilization | ||
|---|---|---|
| System to the predicate device |
| | V-PRO 1, V-PRO 1Plus, V-PRO maX Low
Temperature Sterilization System
(Predicate Device – K190103) | V-PRO maX Low Temperature Sterilization
System (Modified Device) K222093 |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | | |
| | | |
| Intended
Use and
Indications
for Use | The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low
Temperature Sterilization Systems using VAPROX HC
Sterilant are intended for use in the terminal
sterilization of properly prepared (cleaned, rinsed and
dried) medical devices in Healthcare Facilities. The
preprogrammed sterilization cycles operate at low
pressure and temperature, suitable for processing
medical devices without leaving toxic residues. | The V-PRO maX Low Temperature Sterilization
System using VAPROX HC Sterilant is intended for
use in the terminal sterilization of properly prepared
(cleaned, rinsed and dried) medical devices in
Healthcare Facilities. The preprogrammed sterilization
cycles operate at low pressure and temperature,
suitable for processing medical devices without leaving
toxic residues. |
| | Each Cycle can sterilize non-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. | Each Cycle can sterilize non-lumened instruments with
diffusion-restricted spaces such as the hinged portion
of forceps and scissors. |
| | 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, 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 V-PRO maX Sterilizers' 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 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 load
configurations: | 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: |
| Feature | V-PRO 1, V-PRO 1Plus, V-PRO maX Low
Temperature Sterilization System
(Predicate Device – K190103) | V-PRO maX Low Temperature Sterilization
System (Modified Device) K222093 |
| | 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). | 1. Two flexible endoscopes with a light cord (if not
integral to endoscope) and mat with no additional load. - The flexible endoscopes may contain single or dual
channel lumens that are ≥ 1 mm internal diameter (ID)
and ≤ 1050 mm in length. - The validation studies were conducted with two
flexible endoscopes, each packaged into a tray with
silicone mat and light cord (if not integral to
endoscope). |
| | 2. One flexible endoscope with a light cord (if not
integral to endoscope) 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). | 2. One flexible endoscope with a light cord (if not
integral to endoscope), endoscope accessories and mat,
and additional instruments. †† The flexible endoscope
may contain single or dual channel lumens that are ≥ 1
mm ID and ≤ 1050 mm in length
■ Additional instruments may include non-lumened
or lumened medical devices with the following
configurations:
■ Single, dual or triple channel stainless steel
lumen that is
■ ≥ 0.48 mm ID and ≤ 100 mm in length
†† The validation studies were conducted with a flexible
endoscope in a tray with endoscope accessories,
silicone mat, light cord (if not integral to endoscope)
and 5 stainless steel lumens. Also included in the load
was a tray with additional instruments and silicone mat
for a total weight of 24 lbs (11 kg). |
| | The V-PRO 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 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 | The V-PRO maX Sterilizers' Lumen Cycle can
sterilize: † Medical devices with the following
configurations:
• Single, dual or triple channeled stainless steel lumen
that are:
• ≥ 0.77 mm ID and ≤ 527 mm in length
• ≥ 0.8 mm ID and ≤ 542 mm in length
• ≥ 0.48 mm ID and ≤ 100 mm in length
• Dead end lumen that is ≥ 1.3 mm ID and ≤ 73 mm in
length
• Rigid non-metallic lumen (such as those used in
endoscope sheaths, take-apart forceps and trocars)
that are:
■ ≥ 3 mm ID and ≤ 298 mm in length
■ ≥ 4 mm ID and ≤ 424 mm in length
† Validation testing for all lumen sizes was conducted
using a maximum of 20 lumens per load. Hospital
loads should not exceed the maximum number of
lumens validated by this testing. The validation studies
were performed using a validation load consisting of
two trays with silicone mats for a total weight of 19.65
lbs (8.9 kg). |
| Feature | V-PRO 1, V-PRO 1Plus, V-PRO maX Low
Temperature Sterilization System
(Predicate Device – K190103) | V-PRO maX Low Temperature Sterilization
System (Modified Device) K222093 |
| 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 | 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. | 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. |
| Total
Cycle
Time | The software allows user selection of either the Lumen,
Non Lumen or Flexible pre-programmed cycle.
Lumen Cycle - 55 minutes
Non Lumen Cycle - 28 minutes
Flexible Cycle - 35 minutes | The software allows user selection of either the Lumen,
Non Lumen or Flexible pre-programmed cycle.
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 | 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 |
6
7
Table 5-2. A comparison between the proposed V-PRO maX 2 Low Temperature Sterilization System to the predicate device
| Feature | V-PRO maX 2 Low Temperature Sterilization System (Predicate Device/K190103) | V-PRO maX 2 Low Temperature Sterilization System (Modified Device) K222093 |
|---|---|---|
| The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant are intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues. | The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues. | |
| Indications | ||
| for Use | Each Cycle can sterilize non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle and the Fast Non Lumen Cycle. | Each Cycle can sterilize non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. |
| The Non Lumen Cycle can sterilize: ‡ | ||
| Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. | The Non Lumen Cycle can sterilize: ‡ | |
| Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. | ||
| Feature | V-PRO maX 2 Low Temperature Sterilization | |
| System (Predicate Device/K190103) | V-PRO maX 2 Low Temperature Sterilization | |
| System (Modified Device) K222093 | ||
| † The validation studies were conducted using a | ||
| validation load consisting of two instrument trays for a | ||
| total weight of 50 lbs (22.7 kg). | † The validation studies were conducted using a | |
| validation load consisting of two instrument trays for a | ||
| total weight of 50 lbs (22.7 kg). | ||
| The 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:
- 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 | 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 single or
dual channel lumens that are ≥ 1 mm internal diameter
(ID) and ≤ 1050 mm in length.
- The validation studies were conducted with two
flexible endoscopes, each packaged into a tray with
silicone mat and light cord (if not integral to
endoscope). |
| | 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). | 2. One flexible endoscope with a light cord (if not
integral to endoscope), endoscope accessories, mat and
additional non-lumened instruments. †† The flexible
endoscope may contain single or dual channel lumens
that are ≥ 1 mm ID and ≤ 1050 mm in length
■ Additional instruments may include non-lumened
or lumened medical devices with the following
configurations:
■ Single, dual or triple channel stainless steel
lumen that is ≥ 0.48 mm ID and ≤ 100 mm in
length
†† The validation studies were conducted with a flexible
endoscope in a tray with endoscope accessories,
silicone mat, light cord (if not integral to endoscope)
and 5 stainless steel lumens. Also included in the load
was a tray with additional instruments, and silicone mat
for a total weight of 24 lbs (11 kg). |
| | The 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 | The Lumen Cycle can sterilize: †
Medical devices with the following configurations:
• Single, dual or triple channeled stainless steel lumen
that are:
• ≥ 0.77 mm ID and ≤ 527 mm in length
• ≥ 0.8 mm ID and ≤ 542 mm in length |
| Feature | V-PRO maX 2 Low Temperature Sterilization
System (Predicate Device/K190103) | V-PRO maX 2 Low Temperature Sterilization
System (Modified Device) K222093 |
| | • Single channeled devices with a stainless lumen that
is $\ge$ 1.8 mm ID and $\le$ 542 mm in length | • $\ge$ 0.48 mm ID and $\le$ 100 mm in length |
| | • Dual channeled devices with stainless lumens that
are $\ge$ 0.77 mm ID and $\le$ 527 mm in length | • Dead end lumen that is $\ge$ 1.3 mm ID and $\le$ 73 mm in
length |
| | • Triple channeled devices with stainless lumens that
are either: | • Rigid non-metallic lumen (such as those used in
endoscope sheaths, take-apart forceps and trocars)
that are: |
| | $\ge$ 1.2 mm ID and $\le$ 275 mm in length
$\ge$ 1.8 mm ID and $\le$ 310 mm in length
or
$\ge$ 2.8 mm ID and $\le$ 317 mm in length | • $\ge$ 3 mm ID and $\le$ 298 mm in length
• $\ge$ 4 mm ID and $\le$ 424 mm in length |
| | † Validation testing for all lumen sizes was conducted
using a maximum of 20 lumens per load. Hospital
loads should not exceed the maximum number of
lumens validated by this testing. The validation studies
were performed using a validation load consisting of
two 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
• Sterilant Injection Weight | The critical process parameters are:
• Time
• Chamber Temperature
• Vaporizer Temperature
• Chamber Pressure Prior to Injection
• Sterilant Injection Weight |
| 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 four cycles. | VAPROX HC Sterilant (59% Hydrogen Peroxide).
The same amount of sterilant is injected for each of the
sterilization pulses for all four cycles. |
| | Sterilant Cup is read by an RFID reader. | Sterilant Cup is read by an RFID reader. |
| 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 |
| | • Tape | • Tape |
| | | |
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The proposed and predicate device are identical in all ways except their indications for use and consequently their labeling (operator manual).
3. Description of Device
The V-PRO Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers.
The sterilizers have three 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.
The V-PRO Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The four preprogrammed cycles all use 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 / Indications for Use
The V-PRO 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 Indications for use are detailed in Tables 5.1 and 5.2 above. The differences between the proposed devices and predicate include:
- Simplification of claims description for the Flexible and Lumen Cycles on both sterilizers
- Addition of stainless steel lumen claims to Flexible Cycle on both sterilizers -
- Addition of non-metallic and stainless steel lumen claims to Lumen Cycle on both sterilizers
- Addition of diffusion restricted materials for Non Lumen and Fast Non Lumen -Cycles on both sterilizers
న్. Technological Characteristics
The proposed and predicate devices are identical in all technological characteristics including but not limited to: fundamental scientific technology, composition, mechanism of action, components and accessories. No physical changes were made to the devices for this modification other than labeling (operator manual).
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6. Summary of Testing to Support Substantial Equivalence
The proposed devices have the same intended use and the same technological characteristics as the predicate devices. Performance testing to assess and demonstrate substantial equivalence, based on risk assessment of the proposed change to the predicate is summarized below.
| Test | Result | Conclusion |
|---|---|---|
| ½ Cycle | ||
| Verification of | ||
| Mated Surfaces | Sterile efficacy was demonstrated for mated surfaces | |
| under worst case conditions in the V-PRO Sterilizer | ||
| cycles. | PASS | |
| ½ Cycle Efficacy | The standard injection weight resulted in all sterile results | |
| within the validation load used to qualify each sterilizer | ||
| cycle. | PASS | |
| Simulated Use | ||
| Test | Simulated use testing verified the ability of the sterilizer | |
| cycles to sterilize medical devices under worst-case | ||
| processing conditions. | PASS | |
| In Use Test | The in use investigation demonstrated the ability of the V- | |
| PRO Sterilizer cycles to sterilize patient-soiled, | ||
| clinically-cleaned, medical instruments. | PASS |
7. Conclusions
The V-PRO maX Low Temperature Sterilization System has met the established performance criteria. Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performed as well as the legally marketed predicate device K190103, Class II (21 CFR 880.6860), product code MLR.
The V-PRO maX 2 Low Temperature Sterilization System has met the established performance criteria. Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performed as well as the legally marketed predicate device K190103, Class II (21 CFR 880.6860), product code MLR.