(24 days)
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.
t 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 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 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 accessories, mat, and additional 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:
o 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 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 ≤ 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
The V-PRO Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers.
The V-PRO maX 2 sterilizer has the following pre-programmed cycles: the Lumen Cycle, the Non Lumen Cycle, the Flexible Cycle, the Fast Non Lumen Cycle, and the Specialty Cycle. The V-PRO Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried, and packaged surgical instruments used in healthcare facilities.
The five pre-programmed cycles all use 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.
VAPROX HC Sterilant is a 59% hydrogen peroxide sterilant used only the V-PRO Low Temperature Sterilization Systems (V-PRO). It was originally cleared for use in K062297 and the cup was modified in K112813. It has also been cleared as part of the various V-PRO Sterilizer models. The most recent Premarket Notifications for each model are identified in Table 1. This Premarket Notification is only for a proposed modification to VAPROX HC; there are no modifications to any of the V-PRO Low Temperature Sterilization Systems listed below:
- V-PRO 1
- V-PRO 1 Plus ●
- V-PRO maX ●
- V-PRO maX 2 ●
- V-PRO 60
- V-PRO s2 ●
The provided text does not describe a study involving an AI/ML device for medical image analysis. Instead, it describes a 510(k) premarket notification for a V-PRO maX 2 Low Temperature Sterilization System, a device used for sterilizing medical instruments. The "acceptance criteria" and "study" described in the document relate to the performance of this sterilization system and its associated sterilant, not to an AI system.
Therefore, I cannot fulfill your request to describe the acceptance criteria and study for an AI/ML medical device based on the provided text. The document is about a sterilization system, not an AI product.
§ 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).