(123 days)
No
The document describes a sterilization system with pre-programmed cycles based on physical parameters (pressure, temperature, time, sterilant concentration) and device characteristics (lumen size, length, material). 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 algorithmic performance or data-driven decision making.
No.
This device is a sterilizer, intended for use in the terminal sterilization of medical devices, not for therapeutic purposes on a patient.
No
The provided text clearly states that the device is a "Low Temperature Sterilization System" intended for "terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities." It outlines the types of instruments it can sterilize and the sterilization process (conditioning, sterilize, aeration phases). There is no mention of it being used for diagnosis or detecting diseases.
No
The device is a physical sterilization system (V-PRO s2 and V-PRO 60) that uses vaporized hydrogen peroxide to sterilize medical devices. While it likely contains software to control the sterilization cycles, it is fundamentally a hardware device with a physical mechanism for sterilization.
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 use on patients, not for performing diagnostic tests on biological samples.
- Device Description: The device is described as a "vaporized hydrogen peroxide sterilizer model." This is a piece of equipment used for sterilization, not for analyzing samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- 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 preventing the spread of infection in healthcare settings. This falls under the category of medical devices used for patient care, not for in vitro diagnostics.
N/A
Intended Use / Indications for Use
The V-PRO s2 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 low temperature, suitable for processing medical devices without leaving toxic residues.
Each Cycle can sterilize non-luments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
The V-PRO s2 Sterilizer Non Lumen Cycle can sterilize: t Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes.
The V-PRO s2 Sterilizer Fast Cycle can sterilize: t Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:
- · Single or dual channeled devices with stainless steel lumens that are
-
0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (~16-9/64") in length
- ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length
· Triple channeled devices with stainless steel lumens that are either: - ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") in length
- ≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length or
- ≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length
Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes.
The V-PRO s2 Sterilizer Flexible Cycle can sterilize: @ One surgical flexible endoscope (such as those used in ENT. Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.
- · The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm in length
- · Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions
- ≥ 0.76 mm (~1/32") ID and ≤ 233 mm (~9 11/64") in length
- ≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length
- ≥ 1.8 mm (~5/64") ID and ≤ 542 mm (~21-5/16") in length
The V-PRO s2 Sterilizer Lumen Cycle can sterilize: ^ Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:
- · Single or dual channeled devices with stainless steel lumens that are
- ≥ 0.77 mm (~1/32") ID and ≤ 410 mm (16-9/64") in length
- ≥ 1.8 mm (~5/64) ID x ≤ 542 mm (~21-5/16") in length
- · Triple channeled devices with stainless steel lumens that are either:
- ≥ 1.2 mm (~3/64") ID and
§ 878.5070 Air-handling apparatus for a surgical operating room.
(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
0
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May 9, 2019
STERIS Corporation Anthony Piotrkowski Director Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060
Re: K190917
Trade/Device Name: V-PRO 60 Low Temperature Sterilization Systems, V-PRO s2 Low Temperature Sterilization Systems Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: April 8, 2019 Received: April 9, 2019
Dear Anthony Piotrkowski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For David Krause, PhD Acting 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)
Device Name
V-PRO® s2 Low Temperature Sterilization System
Indications for Use (Describe)
The V-PRO s2 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 low temperature, suitable for processing medical devices without leaving toxic residues.
Each Cycle can sterilize non-luments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
The V-PRO s2 Sterilizer Non Lumen Cycle can sterilize: t
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 instrument tray for a total weight of 25 lbs (11.3 kg).
The V-PRO s2 Sterilizer Fast Cycle can sterilize: t
Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:
- · Single or dual channeled devices with stainless steel lumens that are
-
0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (~16-9/64") in length
- ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length
· Triple channeled devices with stainless steel lumens that are either:
- ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") in length
- ≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length
- or
- ≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length
Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes.
- Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing was conducted using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg).
The V-PRO s2 Sterilizer Flexible Cycle can sterilize: @
One surgical flexible endoscope (such as those used in ENT. Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.
- · The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm in length
- · Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions
- ≥ 0.76 mm (~1/32") ID and ≤ 233 mm (~9 11/64") in length
- ≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length
- ≥ 1.8 mm (~5/64") ID and ≤ 542 mm (~21-5/16") in length
@ The validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second
3
tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 1bs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing.
The V-PRO s2 Sterilizer Lumen Cycle can sterilize: ^
Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:
- · Single or dual channeled devices with stainless steel lumens that are
- ≥ 0.77 mm (~1/32") ID and ≤ 410 mm (16-9/64") in length
- ≥ 1.8 mm (~5/64) ID x ≤ 542 mm (~21-5/16") in length
- · Triple channeled devices with stainless steel lumens that are either:
- ≥ 1.2 mm (~3/64") 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
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4
Indications for Use
510(k) Number (if known)
Device Name
V-PRO® 60 Low Temperature Sterilization System
Indications for Use (Describe)
The V-PRO® 60 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 low temperature, suitable for processing medical devices without leaving toxic residues.
Each Cycle can sterilize non-luments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
The V-PRO 60 Sterilizer Non Lumen Cycle can sterilize: t
Non-lumened instruments including non-luments, non-luments, non-lumened rigid, sem-rigid and flexible endoscopes.
- The validation studies were conducted using a validation load consisting of one instrument tray for a total weight of 25 lbs (11.3 kg).
The V-PRO 60 Sterilizer Flexible Cycle can sterilize: @
One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.
- The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm (~3/64") internal diameter (ID) and ≤ 990 mm (38-63/64'') in length
- · Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions
- ≥ 0.76 mm (~1/32") ID and ≤ 233 mm (~9-11/64") in length
- ≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length
- ≥ 1.8mm (~5/64") ID and ≤ 542 mm (~21-5/16") in length
@ The validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel load weight of 11 1bs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing.
The V-PRO 60 Sterilizer Lumen Cycle can sterilize: ^
Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:
- · Single or dual channeled devices with stainless steel lumens that are
- ≥ 0.77 mm (~1/32") ID and ≤ 410 mm (16-9/64") in length
- ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") length
- · Triple channeled devices with stainless steel lumens that are either:
- ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") in length
- ≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length
- or
- ≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length
^ Validation testing for all lumen sizes was conducted using a maximum of twelve (12) stainless seel 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 one instrument tray and two pouches for a total weight of 11 Ibs (5.0 kg).
5
Prescription Use (Part 21 CFR 801 Subpart D)
- X Over-The-Counter Use (21 CFR 801 Subpart C)
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6
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510(k) Summary For
V-PRO® 60 Low Temperature Sterilization Systems and V-PRO®s2 Low Temperature Sterilization Systems
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Tony Piotrkowski Contact: Director, Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 357-9198
Summary Date: May 8, 2019
Premarket Notification Number: K190917
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
7
1. Device Name
| Trade Name: | V-PRO® 60 Low Temperature Sterilization
Systems and V-PRO® s2 Low Temperature
Sterilization Systems |
|----------------------------|-----------------------------------------------------------------------------------------------------------|
| 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 |
| Predicate Devices | |
| Primary Predicate: K182568 | V-PRO® s2 and V-PRO® 60 Low Temperature
Sterilization Systems |
| Reference Device: K190103 | V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX and V- |
Description of Devices 3.
The V-PRO s2 Sterilizer contains the same three sterilization cycles as V-PRO 60 Sterilizer (the Lumen. Non Lumen and Flexible Cycles) with one additional cycle (the Fast Cycle). The V-PRO s2 Sterilizer contains a cabinetry modification and is free-standing as opposed to the cart-mounted V-PRO 60 Sterilizer.
Systems
PRO® maX 2 Low Temperature Sterilization
The V-PRO 60 Low Temperature Sterilization System is a vaporized hydrogen peroxide sterilizer model that currently exists in the STERIS V-PRO family of sterilizers. The current proposed device claims are intended to modify the indications for use statement.
The V-PRO s2 and V-PRO 60 Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried and packaged surgical instruments used in healthcare facilities and utilizes VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The pre-programmed 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.
8
Intended Use / Indications for Use 4.
V-PRO s2 Low Temperature Sterilization System
The V-PRO® s2 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 low temperature, suitable for processing medical devices without leaving toxic residues.
Each Cycle can sterilize non-luments and instruments with diffusionrestricted spaces such as the hinged portion of forceps and scissors.
The V-PRO s2 Sterilizer Non Lumen Cycle can sterilize: t
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 instrument tray for a total weight of 25 lbs (11.3 kg).
The V-PRO s2 Sterilizer Fast Cycle can sterilize:*
Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:
- Single or dual channeled devices with stainless steel lumens that are ● > 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (~16-9/64") in length
- ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length.
- Triple channeled devices with stainless steel lumens that are either: ● ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") in length
-
1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length or
- ≥ 2.8 mm (~7/64") ID and ≤ 317 (12-31/64") mm in length
-
Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.
- Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. Validation testing was conducted using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg).
The V-PRO s2 Sterilizer Flexible Cycle can sterilize: ®
One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.
- The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm (~3/64") ID and ≤ 990 mm (38-63/64") in length.
- Additional load, up to 11 lb (5 kg) can include stainless steel lumens with ● the following dimensions
9
≥ 0.76 mm (~1/32") ID and ≤ 233 mm (~9 11/64") in length
- ≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length
- ≥ 1.8 mm (~5/64") ID and ≤ 542 mm (~21 5/16") in length
@ The validation studies were conducted using a validation load consisting of two instrument travs. One tray contained one flexible endoscope, with silicone mat. instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing.
The V-PRO s2 Sterilizer Lumen Cycle can sterilize: ^
Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:
- . Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm (~1/32") ID and ≤ 410 mm (16-9/64") in length and ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length.
- Triple channeled devices with stainless steel lumens that are either: . > 1.2 mm (~3/64") ID and 1.8 mm (~5/64") ID and 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length.
- Triple channeled devices with stainless steel lumens that are either: ● > 1.2 mm (~3/64") ID and 0.77 mm (~1/32") internal |
| Feature | V-PRO 60 Low Temperature
Sterilization System
(Proposed Device/K190917) | V-PRO 60 Low Temperature
Sterilization System
(Predicate Device/K182568) |
| | ≥ 0.77 mm (~1/32") internal
diameter (ID) and ≤ 410 mm (16-
9/64") in length
≥ 1.8 mm (~5/64") ID x ≤ 542
mm (21 5/16") in length
• Triple channeled devices with
stainless steel lumens that are
either:
≥ 1.2 mm (~3/64") ID and ≤ 275
mm (~10-53/64") in length
≥ 1.8 mm (~5/64") ID and ≤ 310
mm (~12-13/64") in length
or
≥ 2.8 mm (~7/64") ID and ≤ 317
mm (12-31/64") in length
^ Validation testing for all lumen sizes
was conducted using a maximum of
twelve (12) stainless steel 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 one instrument tray and two
pouches for a total weight of 11 lbs (5.0
kg). | diameter (ID) and ≤ 410 mm (16-
9/64") in length
• Triple channeled devices with
stainless steel lumens that are
either:
≥ 1.2 mm (~3/64") ID and ≤ 275
mm (~10-53/64") in length
≥ 1.8 mm (~5/64") ID and ≤ 310
mm (~12-13/64") in length
or
≥ 2.8 mm (~7/64") ID and ≤ 317
mm (12-31/64") in length
^ Validation testing for all lumen sizes was
conducted using a maximum of twelve (12)
stainless steel 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 one
instrument tray and two pouches for a total
weight of 11 lbs (5.0 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 microcomputer
control board and peripheral function circuit
boards, located within the control housing.
A memory backup system maintains cycle
settings and current cycle information
indefinitely.
The software allows user selection of either
the Lumen, Non Lumen, or Flexible pre-
programmed cycle. | Control system consists of a microcomputer
control board and peripheral function circuit
boards, located within the control housing.
A memory backup system maintains cycle
settings and current cycle information
indefinitely.
The software allows user selection of either
the Lumen, Non Lumen, or Flexible pre-
programmed cycle. |
| Total
Cycle Time | Lumen Cycle - 60 minutes
Non Lumen Cycle - 28 minutes
Flexible Cycle - 38 minutes | Lumen Cycle - 60 minutes
Non Lumen Cycle - 28 minutes
Flexible Cycle - 38 minutes |
| Sterilant | VAPROX HC Sterilant (59% Hydrogen
Peroxide).
1.1 g of sterilant is used for each sterilant
injection for all three cycles. | VAPROX HC Sterilant (59% Hydrogen
Peroxide).
1.1 g of sterilant is used for each sterilant
injection for all three cycles. |
| Feature | V-PRO 60 Low Temperature
Sterilization System
(Proposed Device/K190917) | V-PRO 60 Low Temperature
Sterilization System
(Predicate Device/K182568) |
| Accessories | Accessories include:
• Self-contained biological indicator
• Biological indicator challenge pack
• Fast Acting Biological Indicator
• Chemical indicator
• Trays & Tray Accessories
• Pouches
• Tape | Accessories include:
• Self-contained biological indicator
• Biological indicator challenge pack
• Fast Acting Biological Indicator
• Chemical indicator
• Trays & Tray Accessories
• Pouches
• Tape |
15
16
17
STERIS Corporation Special Premarket Notification [510(k)] Modifications to V-PRO® s2 and V-PRO® 60 Low Temperature Sterilization Systems
The proposed device is identical to the predicate except for modification to the indications for use to allow sterilization of single and dual lumen stainless steel lumened devices with the following dimensions: ≥ 1.8 mm ID x ≤ 542 mm length in the Lumen, flexible and fast cycles. Note that with the addition of the 1.8mm x 542 mm stainless steel lumen claim, the previous claim (2mm ID x 400mm length) that falls within the new claim has been removed from the Flexible Cycle.
The Reference Devices, V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX and V-PRO® maX 2 Low Temperature Sterilization Systems are 136 L chamber sterilizers. They have the same technological characteristics, mechanism of action and intended use as the proposed devices were cleared in K190103 for the same modification to the indications for use described in this submission.
6. Summary of Nonclinical Tests
The modified sterilizers have the same intended use and same technological characteristics as the predicate devices. Performance testing for the subject device were identical to the methods used to validate predicate device. Shown below is a summary of those methods below.
18
STERIS Corporation Special Premarket Notification [510(k)] Modifications to V-PRO® s2 and V-PRO® 60 Low Temperature Sterilization Systems
| Test | Result | Conclusion |
|---|---|---|
| 1/2 Cycle Modified | ||
| Total Kill Endpoint | ||
| Verification | ½ Cycle modified total kill end point analysis | |
| was demonstrated for the sterilizer cycles. The | ||
| standard injection weight of 1.1 g and at least one | ||
| lower injection weight resulted in all sterile | ||
| results within the validation load used to qualify | ||
| each sterilizer cycle. Partial positives or all | ||
| survive results were seen at lower injection | ||
| weights. | PASS | |
| Simulated Use Test | Simulated use testing verified the ability of the | |
| sterilizer cycles to sterilize medical devices under | ||
| worst-case processing conditions. | PASS |
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the V-PRO® 60 Low Temperature Sterilization System and V-PRO® s2 Low Temperature Sterilization System is as safe, as effective and performs as well as or better than the legally marketed predicate device K182568, Class II (21 CFR 880.6860), product code MLR.