(107 days)
No
The document describes a low-temperature sterilization system with preprogrammed cycles and does not mention any AI or ML capabilities.
No.
This device is a sterilizer intended for reprocessing medical devices, not for therapeutic use on patients.
No
This device is a sterilizer intended for the "terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities." It is used to sterilize medical instruments, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a "vaporized hydrogen peroxide sterilizer model" and mentions "cabinetry modification," indicating it is a physical hardware device, not software only.
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 system is for the "terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities." This is a process for making medical devices safe for reuse, not for performing diagnostic tests on biological samples.
- Device Description: The description details a "vaporized hydrogen peroxide sterilizer" and its cycles for sterilizing surgical instruments and endoscopes. This aligns with sterilization equipment, not diagnostic equipment.
- 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 biological sample analysis
- Reagents, calibrators, or controls used in diagnostic testing
The device is a sterilizer, which is a type of medical device used to prepare other medical devices for use. It does not perform any diagnostic function.
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: † 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
§ 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).
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January 3, 2019
STERIS Corporation Bill Brodbeck Director, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060
Re: K182568
Trade/Device Name: V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene oxide gas sterilizer Regulatory Class: Class II Product Code: MLR Dated: November 26, 2018 Received: November 27, 2018
Dear Bill Brodbeck:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
1
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 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.html; 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, Elizabeth F. Claverie -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
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, 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
- · 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 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
"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
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, semi-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 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") 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
- $\≥$ 2 mm (~5/64") ID and $\le$ 400 mm (~15 3/4") in length
- $\ge$ 0.76 mm (~1/32") ID and $\le$ 233 mm (~9 11/64") in length
- $\ge$ 1.0 mm (~3/64") ID and $\le$ 254 mm (~10") 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 luad 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 $\ge$ 0.77 mm (~1/32") internal diameter (ID) and $\le$ 410 mm (16-9/64") in length
- · Triple channeled devices with stainless steel lumens that are either:
- $\ge$ 1.2 mm (~3/64") ID and $\le$ 275 mm (~10-53/64") in length
- $\ge$ 1.8 mm (~5/64") ID and $\le$ 310 mm (~12-13/64") in length or
$\ge$ 2.8 mm (~7/64") ID and $\le$ 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).
5
Prescription Use (Part 21 CFR 801 Subpart D)
- X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary For V-PRO® s2 and V-PRO 60 Low Temperature Sterilization Systems
K182568
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact: Bill Brodbeck Director, Regulatory Affairs
Telephone: (440) 392-7690 Fax No: (440) 357-9198
Summary Date: November 26, 2018
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
7
1. Device Name
| K#: | K182568 |
|---|---|
| Trade Name: | V-PRO® s2 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 Devices
V-PRO® 60 Low Temperature Sterilization System (originally cleared under K140498 with additional material compatibility claims cleared under K162413 and most recently, K172319)
| | V-PRO s2 Low Temperature
Sterlization System
(Proposed Device) | V-PRO 60 Low Temperature Sterlization
System
(Predicate Device/K172319) |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | | |
| 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 pre-
programmed sterilization cycles operate at
low pressure and low temperature, suitable
for processing medical devices without
leaving toxic residues.
Each Cycle can sterilize non-lumened
instruments 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:‡
Non-lumened instruments including non-
lumened general medical instruments, non-
lumened rigid, semi-rigid and flexible
endoscopes.
‡ The validation studies were conducted | 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 pre-programmed
sterilization cycles operate at low pressure
and low 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.
The V-PRO 60 Sterilizer's Non Lumen
Cycle can sterilize:‡
Non-lumened instruments including non-
lumened general medical instruments, non-
lumened rigid, semi-rigid and flexible |
| Feature | V-PRO s2 Low Temperature
Sterlization System
(Proposed Device) | V-PRO 60 Low Temperature Sterlization
System
(Predicate Device/K172319) |
| | using a validation load consisting of one
instrument tray for a total weight of 25 lbs
(11.3 kg). | endoscopes.
$\ddagger$ The validation studies were conducted using
a validation load consisting of one instrument
tray and one pouch for a total weight of 12 lbs
(5.4 kg). |
| | The V-PRO s2 Sterilizer Fast Cycle can
sterilize: $\ddagger$
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
• 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-
lumened general medical instruments, non-
lumened rigid, semi-rigid and flexible
endoscopes.
$\ddagger$ 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 60 Sterilizer's 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) and mat without
additional load. The flexible endoscope
may be a single or dual lumen device with
lumens that are > 1 mm (~3/64") ID and 1 mm (~3/64") ID and 2.8 mm (~7/64”) ID and 1.0 mm (~3/64”) ID and