(262 days)
Not Found
No
The document describes a standard sterilization system with pre-programmed cycles and does not mention any AI or ML capabilities.
No.
This device is a sterilizer intended for the terminal sterilization of medical devices in healthcare facilities, not for direct therapeutic use on patients.
No
This device is a sterilization system intended for the terminal sterilization of medical devices in healthcare facilities, not for diagnostic purposes.
No
The device description clearly states it is a "vaporized hydrogen peroxide sterilizer" and describes physical components and processes (conditioning, sterilize, aeration phases) that are indicative of a hardware-based system, 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 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 tests on biological samples to diagnose conditions.
- Device Description: The device is described as a "vaporized hydrogen peroxide sterilizer." This is a piece of equipment used for sterilization, not for in vitro diagnostic testing.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
- Reagents or test kits
The device's purpose is to sterilize medical instruments, which is a crucial step in healthcare but falls outside the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues.
Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
The Non Lumen Cycle can sterilize: †
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 two instrument trays for a total weight of 50 lbs (22.7 kg).
The Fast Non Lumen Cycle can sterilize: *
Non-lumened instruments including non-luments. non-luments. non-lumened rigid, semi-rigid and flexible endoscopes.
- The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).
The Flexible Cycle can sterilize:
Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations:
-
Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain 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) and 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 with the following configurations:
· Single, dual or triple channeled stainless steel lumen that are:
-
0.77 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
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August 7, 2023
STERIS Corporation Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060
Re: K223476
Trade/Device Name: V-PRO maX 2 Low Temperature Sterilization System Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: July 12, 2023 Received: July 12, 2023
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,
Christopher K. Dugard -S
for Clarence W. Murray, III, Ph.D. 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) K223476
Device Name
V-PRO maX 2 Low Temperature Sterilization System
Indications for Use (Describe)
The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues.
Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
The Non Lumen Cycle can sterilize: †
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 two instrument trays for a total weight of 50 lbs (22.7 kg).
The Fast Non Lumen Cycle can sterilize: *
Non-lumened instruments including non-luments. non-luments. non-lumened rigid, semi-rigid and flexible endoscopes.
- The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).
The Flexible Cycle can sterilize:
Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations:
-
Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain 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) and 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 with the following configurations:
· Single, dual or triple channeled stainless steel lumen that are:
-
0.77 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
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510(k) Summary For K223476
V-PRO® maX 2 Low Temperature Sterilization System
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: August 1, 2023
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
5
1. Device Name
| Trade Name: | V-PRO® maX 2 Low Temperature Sterilization
System |
|------------------------|------------------------------------------------------|
| Device Class: | Class II |
| Common/usual Name: | Vapor Phase Hydrogen Peroxide Sterilizer |
| Classification Name: | Sterilizer, Ethylene Oxide Gas |
| Classification Number: | 21 CFR 880.6860 |
| Product Code: | MLR |
Predicate Device 2.
The claimed primary predicate device is the V-PRO maX 2 Low Temperature Sterilization Systems, cleared most recently under K222093.
Table 5-1. A comparison between the proposed V-PRO maX 2 Low Temperature Sterilization System to the predicate device
| Feature | V-PRO maX 2 Low Temperature Sterlization
System (Predicate Device/K222093) | V-PRO maX 2 Low Temperature Sterlization
System (Proposed Device/ K223476) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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. |
| | Each Cycle can sterilize non-lumened instruments
with diffusion-restricted spaces such as the hinged
portion of forceps and scissors. | Each Cycle can sterilize non-lumened instruments
with diffusion-restricted spaces such as the hinged
portion of forceps and scissors. |
| Indications
for Use | The Non Lumen Cycle can sterilize: ‡
Non-lumened instruments including non-lumened
general medical instruments, non-lumened rigid, semi-
rigid and flexible endoscopes.
‡ The validation studies were conducted using a
validation load consisting of two instrument trays for a
total weight of 50 lbs (22.7 kg). | The Non Lumen Cycle can sterilize: ‡
Non-lumened instruments including non-lumened
general medical instruments, non-lumened rigid, semi-
rigid and flexible endoscopes.
‡ The validation studies were conducted using a
validation load consisting of two instrument trays for a
total weight of 50 lbs (22.7 kg). |
| | The Fast Non Lumen Cycle can sterilize:*
Non-lumened instruments including non-lumened
general medical instruments, non-lumened rigid, semi-
rigid and flexible endoscopes.
- The validation studies were conducted using a
validation load consisting of one pouched instrument
tray for a total weight of 11 lbs (5 kg). | The 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). |
| Feature | V-PRO maX 2 Low Temperature Sterlization
System (Predicate Device/K222093) | V-PRO maX 2 Low Temperature Sterlization
System (Proposed Device/ K223476) |
| | The Flexible Cycle can sterilize: | 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: | 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: |
| | 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). | 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 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). | 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 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 ma
for a total weight of 24 lbs (11 kg). |
| | The Lumen Cycle can sterilize: † | 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
• ≥ 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 instrument trays and two pouches for a total weight
of 19.65 lbs (8.9 kg). | 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 studie-
were performed using a validation load consisting of
two instrument trays and two pouches for a total weigh
of 19.65 lbs (8.9 kg). |
6
7
| Feature | V-PRO maX 2 Low Temperature Sterlization
System (Predicate Device/K222093) | V-PRO maX 2 Low Temperature Sterlization
System (Proposed Device/ K223476) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| | | The Specialty 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 or one pouch with guide(s)/model(s) (with or
without tray) for a total weight of 11 lbs (5 kg).
or
Patient-specific surgical guides (e.g. osteotomy,
shoulder, hip, knee, spine) or anatomical models
fabricated via additive manufacturing (3D printing)
processes and intended for single-use during operative
procedures.**
** The validation studies were conducted using a
validation load consisting of pouched
guide(s)/model(s) (with or without tray) for a total
weight of 5 lbs (2.3 kg) 3D printed material. Devices
used in validation studies were prepared in accordance
with printer manufacturers' instructions for use, to
include printing, curing, removal of support material
and cleaning. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | Material Manufacturer Specialty
Cycle Lumens Surgical Guide
Resin Formlabs F ≥3 mm ID x