PRO-LITE Sterilization Tray

The PRO-LITE Sterilization Trays are used to contain medical devices for sterilization in the following Cycles:

* Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast, and Specialty Cycles of the V-PRO Low Temperature Sterilization Systems

* Default Cycle of the STERRAD®* 100S Sterilizer

« Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers

» Standard, Flex Scope, Express and DUO Cycles of the STERRAD 100NX and 100NX with ALLClear Technology Sterilizers

*STERRAD and ALLClear are trademarks of Advanced Sterilization Products

Prior to placing in the Sterilizer, the trays must either be:

» wrapped with a legally marketed sterilization wrap for use in the Sterilizers listed above

or

» placed inside a legally marketed pouch for enclosing trays in the Sterilizers listed above

The PRO-LITE Sterilization Trays ate not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments.

Intended Sterilization Cycles and Intended Tray Loads for Tray Models: VP0045, VP0046, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052

V-PRO 60 and s2 Lumen Cycle:

* Non-lumened devices 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:

= Single or dual channeled devices with stainless steel lumens that are:

*>0.77 mm ID and <410 mm in length

*> 1.8 mm ID x < 542 mm in length

» Triple channeled devices with stainless steel lumens that are either:

*> 1.2 mm ID and <275 mm in length

*> 1.8 mm ID and <310 mm in length

or

*>2.8 mm ID and <317 mm in length

V-PRO 60 and s2 Non Lumen Cycle:

Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.

V-PRO 60 and s2 Flexible Cycle:

Load 1: One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a:

» Single or dual lumen device with lumens that are > 1 mm ID and < 990 mm in length

Toad 2- Non-Tumened devices including non-lumened rigid, semi-rigid, and flexible endoscopes and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps or scissors. Medical devices, including rigid and semi-rigid endoscopes with the following configurations:

+>0.76 mm ID and < 233 mm in length

+> 1.0 mm ID and <254 mm in length

+> 1.8 mm ID and < 542 mm in length

Intended Sterilization Cycles and Intended Tray Loads for Tray Models: VP0045, VP0046, VP0047, VP0048, VP0049

V-PRO s2 Fast Cycle:

« Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes, and non-lumened devices with diffusion-restricted areas 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 or dual channeled devices with stainless steel lumens

+>0.77 mm ID and < 410 mm in length

+>1.8 mm ID and < 542 mm in length

» Triple channeled devices with stainless steel lumens

+> 1.2 mm ID and <275 mm in length

+>1.8 mm ID and <310 mm in length

or

+>2.8mm ID and <317 mm in length

Intended Sterilization Cycles and Intended Tray Loads for Tray Models: VP0045, VP0046, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052, VP0053

V-PRO 1, 1 Plus, maX, and maX 2 Lumen Cycle:

« Non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors

« Medical devices, including single, dual or triple channeled stainless steel lumens 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

« Medical devices with dead end stainless steel lumens that are > 1.3 mm ID and < 73 mm in length

« Instruments with rigid non-metallic lumens (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

V-PRO 1 Plus, maX, and maX 2 Non Lumen Cycle:

Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors

V-PRO maX, and maX 2 Flexible Cycle:

Load 1: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes with a light cord (if not integral to endoscope) and mat with no additional load. The flexible endoscopes may contain either a single or dual lumen that is > 1 mm ID and < 1050 mm in length

Load 2:

« Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors

« Single, dual or triple channel stainless steel lumens that are > 0.48 mm ID and < 100 mm in length

Intended Sterilization Cycles and Intended Tray Loads for Tray Models: VP0045, VP0046, VP0047, VP0048, VP0049, VP0050

V-PRO maX 2 Fast Non Lumen Cycle:

Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.

V-PRO maX 2 Specialty Cycle:

Patient-specific surgical guides (eg. osteotomy, shoulder, hip, knee, spine) or anatomical models fabricated via additive manufacturing (3D printing) processes and intended for single-use during operative procedures.*

or

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 pouched guide(s)/model(s) (with or without tray) for a total weight of 5 Ibs (2.3 kg) 3D printed material.

**The validation studies were conducted using a validation load consisting of one pouched intrument try or one pouch with guide(s)/model(s) (with or without tray) for a total weight of 11 Ibs (5kg).

Material Manufacturer Specialty Cycle Lumens

Surgical Guide Resin Formlabs F >3mmIDand <30 mmL

Biomed Amber Resin Formlabs F >3 mmIDand <30 mmL

Dental LT Clear V2 Resin Formlabs D >3mmIDand <30 mmL

Biomed Clear Resin Formlabs D >3mmIDand <30 mmL

Biocompatible Clear MED610 Stratasys E >3mmIDand <20 mmL

Biocompatible Opaque Med615RGD Stratasys E >3 mm ID and <20 mm L

Veroglaze MED620 Stratasys E >3mmIDand <20 mmL

Intended Sterilization Cycles and Intended Tray Loads for Tray Models: VP0045, VP0046, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052

STERRAD 100S Default Cycle:

Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.

Metal and nonmetal lumened instruments with

»>6 mm ID and <310 mm in length

Medical devices with a single stainless steel lumen with:

*>1 mm ID and < 125 mm in length

»>2 mm ID and < 250 mm in length

+> 3 mm ID and < 400 mm in length

Intended Sterilization Cycles and Intended Tray Loads for Tray Models: VP0045, VP0046, VP0048, VP0049

STERRAD NX and NX with ALLClear Technology Standard Cycle:

Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.

Medical devices with a single stainless steel lumen with:

+> 1 mm ID and < 150 mm in length

»>2 mm ID and <400 mm in length

STERRAD NX and NX with ALLClear Technology Advanced Cycle:

Metal and non-metal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors

Medical devices with:

« a single stainless steel lumen with:

FORM FDA 3881 (6/20) Page 3 of 5

»>1 mm ID and < 500 mm in length

« single channel polyethylene and Teflon (polytetrafluoroethylene)

> lmm ID and < 850 mm in length

Intended Sterilization Cycles and Intended Tray Loads for Tray Models: VP0045, VP0046, VP0047, VP0048, VP0049, VP0051, VP0052, VP0053

STERRAD 100NX and 100NX with ALLClear Technology Standard Cycle:

Metal and nonmetal medical devices including instruments with have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.

Medical devices with a single stainless steel lumen with:

»> 0.7 mm ID and < 500 mm in length

STERRAD 100NX and 100NX with ALLClear Technology Flex Scope Cycle:

Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.

Medical devices, including most flexible endoscopes, with:

- Single channel polyethylene and Teflon (polytetrafluoroethylene)

« > 1mm ID and < 850 mm in length

STERRAD 100NX and 100NX with ALLClear Technology Express Cycle:

Metal and nonmetal devices surfaces and instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.

STERRAD 100NX and 100NX with ALLClear Technology Duo Cycle:

Medical devices including:

« most flexible endoscopes with a single channe! of polyethylene and Teflon (polytetrafluoroethylene) with > 1 mm ID and < 875 mm in length

« accessory devices that are normally connected to a flexible endoscope during use

» flexible endoscopes without lumens

Instrument organizers are optional accessories intended to stabilize cylindrical medical instruments within the Sterilization Trays.

Model Description

VP0054 Blank, Tall

VP0055 Blank, Short

VP0063 3 mm — 7 mm, Tall

VP0064 7 mm — 11 mm, Tall

VP0065 11 mm — 15 mm, Tall

VP0066 15 mm — 19 mm, Tall

VP0067 3 mm — 7 mm, Short

VP0068 7 mm — 11 mm, Short

VP0069 11 mm — 15 mm, Short

VP0070 15 mm — 19 mm, Short

Sterilization mats are optional accessories intended to cushion and stabilize instruments within the Sterilization Trays.

Model Description (to fit Length” x Width” Tray)

VP0071 13x4.5

VP0072 19x4.5

VP0073 25x 4.5

VP0074 13x7.75

VP0075 19x7.75

VP0076 27x7.75

VP0077 12x 11.75

VP0078 25x 11.75

VP0079 25x 14