(214 days)
No
The summary describes a sterilization system with pre-programmed cycles based on device type and dimensions, without mentioning any adaptive learning or data-driven decision-making processes characteristic of AI/ML.
No
The device is a sterilizer for medical devices, not a therapeutic device used for treating patients.
No
This device is a sterilizer, intended for the terminal sterilization of medical devices, not for diagnosing medical conditions.
No
The device is described as a "vaporized hydrogen peroxide sterilizer" and includes details about processing physical medical devices, indicating it is a hardware system with integrated software, not a software-only device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the V-PRO systems are "vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities."
- IVD Definition: An In Vitro Diagnostic device is used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of disease.
- Function: The V-PRO systems are used to sterilize medical devices after they have been used on patients, not to analyze patient specimens for diagnostic purposes.
The text describes a sterilization system for medical instruments, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and are thus suitable for processing medical devices sensitive to heat and moisture.
The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle can sterilize:(a)
- Lumened and non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- · Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: (a)
- o single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
- o dual channeled devices with stainless steel lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length
- o triple channeled devices with stainless steel lumens that are
- ≥ 1.2 mm ID and ≤ 275 mm in length
- ≥ 1.8 mm ID and ≤ 310 mm in length
- or
-
2.8 mm ID and 1 mm ID and 1 mm ID and 1 mm ID and 1 mm (~3/64") 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures in profile, arranged in a cascading manner. The figures are depicted in black and white. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2017
Steris Corporation Bill Brodbeck Director, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060
Re: K162413
Trade/Device Name: Amsco® V-PRO™ 1 Low Temperature Sterilization System Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System V-PRO™ Max 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: February 21, 2017 Received: February 22, 2017
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -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) K162413
Device Name
V-PRO® 1, V-PRO® 1 Plus and V-PRO® maX Low Temperature Sterilization Systems
Indications for Use (Describe)
The V-PRO 1, V-PRO 1 Plus and V-PRO max Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and are thus suitable for processing medical devices sensitive to heat and moisture.
The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle can sterilize:(a)
- Lumened and non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- · Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: (a)
- o single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
- o dual channeled devices with stainless steel lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length
- o triple channeled devices with stainless steel lumens that are
- ≥ 1.2 mm ID and ≤ 275 mm in length
- ≥ 1.8 mm ID and ≤ 310 mm in length
- or
-
2.8 mm ID and 1 mm ID and 1 mm ID and 1 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
Indications for Use
510(k) Number (if known) K162413
Device Name
V-PRO® 60 Low Temperature Sterilization System
Indications for Use (Describe)
The V-PRO 60 Low Temperature Sterilization System, with VAPROX® HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and nonmetal medical devices used in Healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, and Flexible Cycle) operate at low pressure and are thus suitable for processing medical devices sensitive to heat and moisture.
The V-PRO 60 Sterilizer's Lumen Cycle can sterilize: (a)
- · Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- · Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
- · Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: (a)
- single or dual lumen devices with stainless steel lumens that are ≥ 0.77 mm (~1/32") internal diameter (ID) and 1 mm (~3/64") ID and Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary For Amsco V-PRO 1 Low Temperature Sterilization System Amsco V-PRO 1 Plus Low Temperature Sterilization System V-PRO maX Low Temperature Sterilization System V-PRO 60 Low Temperature Sterilization System
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact:
Bill Brodbeck Director, Regulatory Affairs Tel: 440-392-7690 Fax: 440-357-9198
Summary Date: March 31, 2017
STERIS Corporation ■ 5960 Heisley Road ■ Mentor. OH 44060-1834 USA ■ 440-354-2600
7
-
- Device Name
Amsco® V-PRO™ 1 Low Temperature Sterilization System Trade Name: Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System V-PROTM maX Low Temperature Sterilization System V-PRO 60 Low Temperature Sterilization System
- Device Name
| 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 Low Temperature Sterilization System, cleared most recently under K160433.
Reference Devices are included in this submission as the V-PRO maX cleared indications for use includes claims for the following proposed reference devices:
- Amsco® V-PROTM 1 Low Temperature Sterilization System (K062297) ●
- Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System (K083097, ● K102394 and K111810)
The V-PRO™ maX Low Temperature Sterilization System prior clearances include Premarket Submissions K102330, K112760, K112813, K120632 and K131120.
V-PRO 60 Low Temperature Sterilization System, cleared most recently under K140498.
The purpose of this submission is to remove labeling restrictions of processing evecontacting devices which contain certain materials and to include polyurethane as a material compatible while being processed in the devices' Lumen Cycle.
3. Description of Device
The V-PRO 1, V-PRO 1 Plus, V-PRO maX and V-PRO 60 Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through
8
exposure to vaporized hydrogen peroxide (VHP). 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.
The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems are programmed to enact one (the Lumen Cycle), two (the Lumen Cycle and the Non Lumen Cycle) or three (the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycle) cycles, respectively.
The V-PRO 60 Low Temperature Sterilization System, with VAPROX® HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The three pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.
4. Intended Use
The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.
The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle can sterilize:(a)
· Lumened and non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
• Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: (a)
o single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and 1.8 mm ID and 0.77 mm (~1/32") internal diameter (ID) and
1.2 mm (~3/64") ID and ≤ 275 mm (~10-55/64") in length
• > 1.8 mm (~5/64") ID and 1 mm (~3/64") ID and