(117 days)
Not Found
No
The document describes a standard sterilization system with pre-programmed cycles and does not mention any AI or ML components.
No
This device is a sterilizer for medical instruments, not a therapeutic device used to treat patients or medical conditions.
No
Explanation: This device is a sterilizer, meaning it cleans and makes other medical devices free from bacteria or other living microorganisms. It is not used to diagnose any medical conditions.
No
The device is described as a "vaporized hydrogen peroxide sterilizer" and includes details about physical components, cycles, and sterilant. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used 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" that uses "VAPROX® HC Sterilant to sterilize the intended devices." This further reinforces its function as a sterilization system for medical instruments.
- 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.
The device's purpose is to sterilize medical instruments, which falls under the category of medical devices used in healthcare settings, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Amsco 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 reusable 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 Amsco V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle, the subject of this submission, can sterilize:
- Lumened and non-lumened instruments 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:
- single channeled devices with a stainless lumen that is ≥ 0.77 mm 0 internal diameter (ID) and ≤ 500 mm in length
- dual channeled devices with stainless steel lumens that are ≥ 0.77 0 mm ID and ≤ 527 mm in length
- triple channeled devices with stainless steel lumens that are either o
- ≥ 1.2 mm ID and ≤ 310 mm in length
or - ≥2.8 mm ID and ≤ 317 mm in length
- ≥ 1.2 mm ID and ≤ 310 mm in length
- a The validation studies were conducted using a maximum of twenty (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 Ibs.
The Amsco V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Non Lumen Cycle, cleared under K083097, K102394, and K111810, can sterilize:
Non-lumened instruments including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.
-
b The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.
The Amsco V-PRO maX Low Temperature Sterilization System's Flexible Cycle, cleared under K102330 and K112760, can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of two load 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:
- Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.
-
. 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 ≤ 998 mm in length
- and the other lumen that is > 1 mm ID and 1 mm ID and 1 mm 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
K120632/S001 STERIS Response to 5/10/12 Request for Additional Information Amsco® V-PRO 1 Plus and V-PRO max Low Temperature Sterilization Systems
Image /page/0/Picture/10 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in all capital letters, with a registered trademark symbol to the right of the S. Below the word STERIS is a graphic of several horizontal wavy lines stacked on top of each other.
JUN 2 6 2012
510(k) Summary For Amsco® V-PRO® 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact: Bill Brodbeck Senior Manager, Regulatory Affairs
Telephone: (440) 392-7690 Fax No: (440) 357-9198
Summary Date: June 5, 2012
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
1
1. Device Name
| Trade Name: | Amsco® V-PRO® 1, V-PRO 1 Plus and V-PRO
maX Low Temperature Sterilization Systems |
|----------------------|--------------------------------------------------------------------------------------|
| Common/usual Name: | Vapor Phase Hydrogen Peroxide Sterilizer |
| Classification Name: | Sterilizer, Ethylene Oxide Gas
21-CFR 880.6860
Product Code MLR |
2. Predicate Devices
Amsco® V-PRO® 1 Low Temperature Sterilization System (K062297, K102394, and K111810) Amsco V-PRO ®1 Plus Low Temperature Sterilization System (K083097, K102394, and K111810) Amsco® V-PRO® maX Low Temperature Sterilization System (K102330, K112760)
3. Description of Device
The Amsco V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers. The V-PRO Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The pre-programmed V-PRO cycles all utilize a conditioning phase, a sterilization 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.
. The three V-PRO Sterilizers share common cycles as outlined in Table 5-1.
| Cycle | V-PRO 1 | V-PRO 1 Plus | V-PRO maX |
|---|---|---|---|
| Lumen Cycle | X | X | X |
| Non Lumen Cycle | * | X | X |
| Flexible Cycle | X |
Table 5-1: V-PRO Cvcles Provided in the V-PRO Family of Sterilizers
- Shaded cell indicates that the V-PRO Sterilizer does not include the identified cycle.
All three sterilizers contain the Lumen Cycle. The purpose of this submission is to modify the V-PRO Lumen Cycle stainless steel lumen claims. No modifications were made to the Sterilizers' hardware or software for the proposed modification to the Lumen Cycle stainless steel lumen claims.
2
The accessories that have been validated for use in the three V-PRO Cvcles and the Premarket Notification submission references under which the accessories were cleared for the cycles are listed in Table 5-2.
| Accessory | Submission Reference | ||
|---|---|---|---|
| V-PRO Lumen Cycle | V-PRO Non Lumen Cycle | V-PRO Flexible Cycle | |
| Verify V24 SCBIs | K073244, | ||
| K090514 | K083097 | K102330 | |
| Verify Vaporized | |||
| VH2O2 Process | |||
| Indicators | K091174 | K091174 | K102330 |
| V-PRO | |||
| Sterilization Trays | K070769, | ||
| K103226 | K083097, | ||
| K103226 | K102330, | ||
| K103226 | |||
| Vis-U-All Tyvek | |||
| Pouches | K070765 | ||
| K071087 | |||
| K090371 | K083097 | ||
| K090371 | K102330 |
Table 5-2. Accessories Validated for Use in the V-PRO Sterilizers
4. Intended Use
The purpose of this submission is to modify the V-PRO Lumen Cycle stainless steel lumen claims. No modifications are being made to the V-PRO Sterilizers' intended use with respect to the Non Lumen and Flexible Cycles.
The Amsco 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 reusable 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 Amsco V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle, the subject of this submission, can sterilize:2
- Lumened and non-lumened instruments 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: 4
- o single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
- dual channeled devices with stainless steel lumens that are ≥ 0.77 O mm ID and ≤ 527 mm in length
3
K120632/S001 STERIS Response to 5/10/12 Request for Additional Information Amsco® V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems
- triple channeled devices with stainless steel lumens that are either o ■ > 1.2 mm ID and 1 mm ID and 1 mm ID and 1 mm and 1 mm ID and 1 mm ID and 1 mm and