Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus solely on the physical properties and function of a sterilization tray for containing medical devices during sterilization cycles. There is no mention of any computational or analytical capabilities, let alone AI or ML.

Therapeutic

No
The device is a sterilization tray used to contain medical devices during sterilization, not to provide therapy.

Diagnostic

No

Explanation: The device, the PRO-LITE™ Sterilization Trays, is described as being used to "contain medical devices for sterilization." Its function is to hold medical instruments during the sterilization process, not to diagnose medical conditions or analyze body functions.

SaMD (Software as a Medical Device)

No

The device description clearly states the device is composed of a base and a lid made of mineral-filled polypropylene material, indicating it is a physical hardware device.

IVD (In Vitro Diagnostic)

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 containing medical devices for sterilization in specific sterilization systems. This is a function related to the processing and handling of medical devices, not the diagnosis of diseases or conditions using samples from the human body.
Device Description: The description details a physical tray with a base and lid designed for sterilant penetration and enclosure within a sterilization wrap or pouch. This aligns with a device used in the sterilization process, 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 substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases

The device's purpose is to facilitate the sterilization of other medical devices, which is a crucial step in preventing the spread of infection in healthcare settings. This falls under the category of medical device processing, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast 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 V-PRO or STERRAD Sterilization Systems. or
placed inside a legally marketed pouch for enclosing trays in the V-PRO or STERRAD Sterilization Systems.

The PRO-LITE Sterilization Trays are 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.

Product codes

FRG, KCT

Device Description

The PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems: V-PRO 1 Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO maX 2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System and V-PRO s2 Low Temperature Sterilization System and the following STERRAD Sterilizers and cycles: STERRAD 100S Sterilizer Default Cycle, STERRAD NX with and without ALLClear Technology Sterilizer Standard and Advanced Cycles, STERRAD 100NX with and without ALLClear Technology Sterilizer Standard, Flex Scope, Express and Duo Cycles. The trays are available in various sizes to accommodate the loads to be processed. The proposed trays are identical in design to the predicate Sterilization Tray (K172755) and are composed of a base and a lid. The lid includes clamping mechanisms designed to secure the lid onto the base. There are numerous holes in the base and lid for sterilant penetration. The tray is categorized as a cassette and requires complete enclosure in a legally-marketed sterilization wrap or pouch to maintain sterility of the enclosed devices. Both the base and the lid for the proposed tray are made of a mineral-filled polypropylene material. Optional instrument organizers are provided as accessories to the trays and allow stabilization of various cylindrical medical devices during processing. The organizers are either "blank" and are used to partition the tray or have a device holding portion into which the devices are inserted. At the organizer base is a flapped groove that is used to position the organizer within a PRO-LITE Sterilization Tray. Optional sterilization mats are provided as accessories to the trays. The mats, which are used to cushion and stabilize devices placed into the trays, are available in sizes to fit the nine PRO-LITE Sterilization Trays. The mats are a diamond grid design with "fingers" that extend from each corner of the diamond and at the midpoint of each diamond side. The fingers cushion and stabilize instruments, helping to prevent the instruments from freely moving in the tray during packaging, sterilization and storage. The cushioning and stabilization qualities help protect delicate instruments placed into the trays.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Non-clinical tests were conducted to demonstrate substantial equivalence to the predicate device.
Study Type: Performance Testing
Sample Size: Not specified
Key Results:

Demonstration of Effective Sterilant Penetration: PASS for STERRAD 100S Default Cycle, STERRAD NX Standard Cycle, STERRAD NX Advanced Cycle, STERRAD 100NX Standard Cycle, STERRAD 100NX Flex Scope Cycle, STERRAD 100NX Express Cycle, STERRAD 100NX Duo Cycle.
Package Integrity/Maintenance of Package Integrity: Not applicable as the tray meets the definition of a "tray" in ANSI/AAMI ST77:2013, which does not require this testing.
Demonstration of Effective Drying and Aeration: PASS, residual hydrogen peroxide levels below acceptable levels.
Demonstration of Material Compatibility: PASS, trays and accessories retained functionality after multiple worst-case sterilization cycles.
Demonstration of Biocompatibility: PASS, component materials non-cytotoxic after exposure to worst-case Sterilizer Conditions.
Demonstration of Effective Cleaning: PASS, Sterilization Trays and accessories were clean following automated and manual cleaning.

Key Metrics

Not Found

Predicate Device(s)

PRO-LITE Sterilization Tray, K172755

Reference Device(s)

PRO-LITE Sterilization Tray, K183301

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 25, 2019

STERIS Corporation Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Rd Mentor, Ohio 44060

Re: K183402

Trade/Device Name: PRO-LITE Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: FRG Dated: December 6, 2018 Received: December 7, 2018

Dear Jennifer Nalepka:

This letter corrects our substantially equivalent letter of March 1, 2019.

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

1

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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Clarence W. Murray lii III -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) K183402

Device Name PRO-LITE Sterilization Trays

Indications for Use (Describe)

The PRO-LITE™ Sterilization Trays are used to contain medical devices for sterilization in the following cycles: · Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast 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, DUO Cycles of the STERRAD 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 are 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 Load for Tray Models: VP0045, VP0047, VP0048, VP0049, VP0050, VP0050, VP0051, VP0052

V-PRO 60 & s2 Lumen Cycle

· 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 endoscopes, with the following configurations:
- · single or dual lumen devices
  - · ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm in length
- · triple lumen devices
  - ≥ 1.2 mm ID and ≤ 275 mm in length
  - ≥ 1.8 mm ID and ≤ 310 mm in length
≥ 2.8 mm ID and ≤ 317 mm in length

V-PRO 60 & 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 & s2 Flexible Cycle

Load 1: One flexible surgical endoscope 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

Load 2: Non-lumened devices including non-lumened rigid, semi-rigid, and flexible endoscopes and non-lumened devices

3

with diffusion-restricted areas such as the hinged portion of forceps or scissors. Medical devices, including rigid and semi-rigid endoscopes, with the following dimensions:

≥ 2 mm ID and ≤ 400 mm in length
≥ 0.76 mm ID and 0.77 mm ID and ≤ 410 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 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."

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Image /page/6/Picture/0 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in large, bold, black font. Below the word is a graphic of several horizontal, wavy blue lines, resembling water.

K183402 510(k) Summary For PRO-LITE™ Sterilization Tray

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Contact: Jennifer Nalepka Senior Regulatory Affairs Specialist

Telephone: (440) 392-7458 Fax No: (440) 357-9198 e-mail: jennifer_nalepka@steris.com

Submission Date: December 6, 2018

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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1. Device Name

Trade Name:	PRO-LITE Sterilization Tray
Common/usual Name:	Sterilization Trays, cassettes and other accessories
Classification Name:	Sterilization Wrap
Classification	21 CFR 880.6850
Class	II
Product Code	KCT

2. Predicate Device

PRO-LITE Sterilization Tray, K172755

Reference Device: PRO-LITE Sterilization Tray, K183301

3. Description of Device

The PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems:

V-PRO 1 Low Temperature Sterilization System, ●
V-PRO 1 Plus Low Temperature Sterilization System, ●
V-PRO maX Low Temperature Sterilization System, ●
V-PRO maX 2 Low Temperature Sterilization System, ●
V-PRO 60 Low Temperature Sterilization System and
V-PRO s2 Low Temperature Sterilization System (NOTE: the V-PRO s2 ● Low Temperature Sterilization System claims are under review in a concurrent premarket notification, K183301).

and the following STERRAD Sterilizers and cycles:

STERRAD 100S Sterilizer Default Cycle ●
STERRAD NX with and without ALLClear Technology Sterilizer Standard ● and Advanced Cycles
STERRAD 100NX with and without ALLClear Technology Sterilizer Standard, Flex Scope, Express and Duo Cycles

The trays are available in various sizes, outlined in Table 1, to accommodate the loads to be processed. The proposed trays are identical in design to the predicate Sterilization Trav (K172755) and are composed of a base and a lid. The lid includes clamping mechanisms designed to secure the lid onto the base. There are numerous holes in the base and lid for sterilant penetration. The trav is categorized as a cassette and requires complete enclosure in a legally-marketed sterilization wrap or

8

pouch to maintain sterility of the enclosed devices. Both the base and the lid for the proposed tray are made of a mineral-filled polypropylene material.

Model	Description (in)	Model	Description (in)
VP0045	13 x 4.5 x 2.25	VP0050	27 x 7.75 x 4
VP0046	19 x 4.5 x 2.25	VP0051	12 x 11.75 x 4
VP0047	25 x 4.5 x 2.25	VP0052	25 x 11.75 x 4
VP0048	13 x 7.75 x 2.25	VP0053	25 x 14 x 5
VP0049	19 x 7.75 x 2.25

Table 1. External Dimensions of Tray Line

Optional instrument organizers are provided as accessories to the trays and allow stabilization of various cylindrical medical devices during processing. Table 2 lists the organizer sizes. The organizers are either "blank" and are used to partition the tray or have a device holding portion into which the devices are inserted. At the organizer base is a flapped groove that is used to position the organizer within a PRO-LITE Sterilization Tray.

Table 2. Instrument Organizer Model Numbers

Model	Description	Model	Description
VP0054	Blank, Tall	VP0055	Blank, Short
VP0063	3 mm - 7mm, Tall	VP0067	3 mm - 7 mm, Short
VP0064	7 mm - 11mm, Tall	VP0068	7 mm -11 mm, Short
VP0065	11 mm - 15 mm, Tall	VP0069	11 mm - 15 mm, Short
VP0066	15 mm - 19mm, Tall	VP0070	15 mm - 19 mm, Short

Optional sterilization mats are provided as accessories to the trays. The mats, which are used to cushion and stabilize devices placed into the trays, are available in sizes as shown in Table 3 to fit the nine PRO-LITE Sterilization Trays. The mats are a diamond grid design with "fingers" that extend from each corner of the diamond and at the midpoint of each diamond side. The fingers cushion and stabilize instruments, helping to prevent the instruments from freely moving in the tray during packaging, sterilization and storage. The cushioning and stabilization qualities help protect delicate instruments placed into the trays.

Model	Description (in)	Model	Description (in)
VP0071	13 x 4.5	VP0076	27 x 7.75
VP0072	19 x 4.5	VP0077	12 x 11.75
VP0073	25 x 4.5	VP0078	25 x 11.75
VP0074	13 x 7.75	VP0079	25 x 14
VP0075	19 x 7.75

		Table 3. Silicone Mat Model Numbers

The purpose of this submission is to add claims for the use of these tray models in the following sterilizer cycles:

STERRAD 100S Sterilizer Default Cycle

9

. STERRAD NX with and without ALLClear Technology Sterilizer Standard and Advanced Cycles
STERRAD 100NX with and without ALLClear Technology Sterilizer Standard, Flex Scope, Express and Duo Cycles

4. Indications for Use

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

Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast 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 100 NX 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 V-PRO ● or STERRAD Sterilization Systems. or
. placed inside a legally marketed pouch for enclosing trays in the V-PRO or STERRAD Sterilization Systems.

The PRO-LITE Sterilization Trays are 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.

| Tray Models | Intended
Sterilization
Cycles | Intended Tray Load |
|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VP0045
VP0046
VP0047
VP0048
VP0049
VP0050
VP0051
VP0052 | V-PRO 60
and s2 Lumen
Cycle | · 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:
o single or dual lumen devices
· ≥ 0.77 mm ID and ≤ 410 mm in length
o triple lumen devices
· ≥ 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 |
| Tray Models | Intended
Sterilization
Cycles | Intended Tray Load |
| | 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:
o single or dual lumen device with lumens that are $≥$ 1 mm ID and $≤$ 990 mm in length
Load 2: 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 or scissors. Medical devices, including rigid and semi-rigid endoscopes, with the following configurations:
o $≥$ 2.0 mm ID and $≤$ 400 mm in length
o $≥$ 1.0 mm ID and $≤$ 254 mm in length
o $≥$ 0.76 mm ID and $≤$ 233 mm in length |
| VP0045
VP0046
VP0047
VP0048
VP0049 | V-PRO s2
Fast Cycle | • 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:
o single or dual lumen devices
▪ $≥$ 0.77 mm internal diameter (ID) and $≤$ 410 mm in length
o triple lumen devices
▪ $≥$ 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 |
| VP0045
VP0046
VP0047
VP0048
VP0049
VP0050
VP0051
VP0052
VP0053 | V-PRO 1, 1
Plus, maX &
maX 2
Lumen Cycle | • 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:
o single or dual lumen devices
▪ $≥$ 0.77 mm ID and $≤$ 527 mm in length
o triple lumen devices
▪ $≥$ 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 |
| Tray Models | Intended
Sterilization
Cycles | Intended Tray Load |
| | V-PRO 1
Plus, maX &
maX 2 Non
Lumen Cycle | Non-lumened devices including non-lumened rigid, semi-
rigid and flexible endoscopes and non-lumened devices
with stainless steel or titanium diffusion-restricted spaces
such as the hinged portion of forceps and scissors. |
| | V-PRO maX
& 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 lumen that is $\ge$ 1 mm ID and $\le$ 1050 mm in
length or two lumens with: one lumen that is $\ge$ 1 mm ID and $\le$ 990 mm in length and the other lumen that is $\ge$ 1 mm ID and $\le$ 850 mm in lengthLoad 2: Non-lumened instruments including instruments |
| | | with diffusion-restricted areas such as the hinged portion
of forceps or scissors. |
| | 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 stainless steel or titanium diffusion-restricted spaces
such as the hinged portion of forceps and scissors. |
| 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:
$\ge$ 6 mm ID and $\le$ 310 mm in lengthMedical devices with a single stainless steel lumen with: $\ge$ 1 mm ID and $\le$ 125 mm in length $\ge$ 2 mm ID and $\le$ 250 mm in length $\ge$ 3 mm ID and $\le$ 400 mm in length |
| 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: $\ge$ 1 mm ID and $\le$ 150 mm in length $\ge$ 2 mm ID and $\le$ 400 mm in length |
| VP0048
VP0049 | STERRAD
NX and NX
with
ALLClear
Technology | 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: |
| Tray Models | Intended
Sterilization
Cycles | Intended Tray Load |
| | Advanced
Cycle | $\geq$ 1 mm ID and $\leq$ 500 mm in length Single channel polyethylene and Teflon
(polytetrafluoroethylene) $\geq$ 1 mm ID and $\leq$ 850 mm in length |
| | STERRAD
100NX and
100NX 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: $\geq$ 0.7 mm ID and $\leq$ 500 mm in length |
| VP0045
VP0046
VP0047
VP0048
VP0049
VP0051
VP0052
VP0053 | 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) $\geq$ 1 mm ID and $\leq$ 850 mm in length |
| | STERRAD
100NX and
100NX with
ALLClear
Technology
Express
Cycle | Metal and nonmetal medical 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 channel of
polyethylene and Teflon (polytetrafluoroethylene)
with $\geq$ 1 mm ID and $\leq$ 875 mm in length accessory devices that are normally connected to a
flexible endoscope during use flexible endoscopes without lumens |

10

11

12

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

Model	Description	Model	Description
VP0054	Blank, Tall	VP0055	Blank, Short
VP0063	3 mm - 7 mm, Tall	VP0067	3 mm - 7 mm, Short
VP0064	7 mm - 11 mm, Tall	VP0068	7 mm - 11 mm, Short
VP0065	11 mm - 15 mm, Tall	VP0069	11 mm - 15 mm, Short
VP0066	15 mm - 19 mm, Tall	VP0070	15 mm - 19 mm, Short

13

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

Model	Description (in)	Model	Description (in)	Model	Description (in)
VP0071	13 x 4.5	VP0074	13 x 7.75	VP0077	12 x 11.75
VP0072	19 x 4.5	VP0075	19 x 7.75	VP0078	25 x 11.75
VP0073	25 x 4.5	VP0076	27 x 7.75	VP0079	25 x 14

ട. Technological Characteristics

The proposed PRO-LITE sterilization trays, sterilization mats and instrument organizers are identical in composition to the claimed predicate devices. The technical characteristics are summarized below in Table 5.

		Table 5. Technical Characteristic Comparison Table
--	--	----------------------------------------------------	--	--

| Feature | PRO-LITE Sterilization Tray
(K183402) | PRO-LITE Sterilization Tray
(K172755) |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The PRO-LITE Sterilization Trays are
used to contain medical devices for
sterilization in the following Cycles:
• Lumen, Non Lumen, Flexible, Fast
Non Lumen and Fast 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 V-
PRO or STERRAD Sterilization
Systems
• placed inside a legally marketed
pouch for enclosing trays in the V- | The PRO-LITE Sterilization Trays are
used to contain medical devices for
sterilization in the Lumen, Non Lumen,
Flexible and Fast Non Lumen Cycles
of the V-PRO Low Temperature
Sterilization Systems. Prior to placing
in the Sterilizer, the trays must either
be:
• wrapped with a legally marketed
sterilization wrap for use in the V-
PRO Low Temperature Sterilization
Systems or
• placed inside a legally marketed
pouch for enclosing trays in the V-
PRO Low Temperature Sterilization
Systems. |
| Feature | PRO-LITE Sterilization Tray
(K183402) | PRO-LITE Sterilization Tray
(K172755) |
| | PRO or STERRAD Sterilization
Systems. | |
| | The PRO-LITE Sterilization Trays are
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. | The PRO-LITE Sterilization Trays are
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 | Intended Sterilization Cycles and
Intended Tray Loads for Tray models:
VP0045, VP0046, VP0047, VP0048,
VP0049, VP0050, VP0051, VP0052 |
| | V-PRO 60 & s2 Lumen Cycle:
• 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 | V-PRO 60 Lumen Cycle
• 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:
o single or dual lumen devices
■ ≥ 0.77 mm internal diameter (ID)
and ≤ 410 mm in length
o triple lumen devices
■ ≥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 | • Medical devices, including single,
dual and triple channeled rigid and
semi-rigid endoscopes, with the
following configurations:

single or dual lumen devices
≥ 0.77 mm ID and less than or
equal to 410 mm in length
triple lumen devices
≥1.2 mm ID and less than or equal
to 275 mm in length
≥1.8 mm ID and less than or equal
to 310 mm in length
or
≥2.8 mm ID and less than or equal
to 317 mm in length |
| | length
V-PRO 60 & 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 & s2 Flexible Cycle: | to 317 mm in length
V-PRO 60 Non Lumen Cycle

Non-lumened devices including non-
lumened rigid, semi-rigid and flexible
endoscopes and non-lumened devices
with stainless steel or titanium
diffusion-restricted spaces such as the
hinged portion of forceps and scissors.
V-PRO 60 Flexible Cycle |
| Feature | PRO-LITE Sterilization Tray
(K183402) | PRO-LITE Sterilization Tray
(K172755) |
| | 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:
o single or dual lumen device with
lumens that are $\ge$ 1 mm ID and $\le$
990 mm in length | - 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 $\ge$ 1 mm ID and less than or equal
990 mm in length |
| | Load 2: 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 or scissors. Medical
devices, including rigid and semi-rigid
endoscopes, with the following
configurations:
o $\ge$ 2 mm ID and $\le$ 400 mm in length
o $\ge$ 0.76 mm ID and $\le$ 233 mm in
length
o $\ge$ 1.0 mm ID and $\le$ 254 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 endoscope, and non-lumened
devices with diffusion-restricted
areas such as the hinged portion of
forceps or scissors
• Medical devices, including single,
dual and triple channeled rigid and
semi-rigid endoscopes, with the
following configurations:
o single or dual lumen devices
■ $\ge$ 0.77 mm internal diameter (ID)
and $\le$ 410 mm in length
o triple lumen devices
■ $\ge$ 1.2 mm ID and $\le$ 275 mm in
length
■ $\ge$ 1.8 mm ID and $\le$ 310 mm in
length
or | |
| Feature | PRO-LITE Sterilization Tray
(K183402) | PRO-LITE Sterilization Tray
(K172755) |
| | ■ ≥2.8 mm 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 | 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 & maX 2
Lumen Cycle:
• 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:
o single or dual lumen devices
■ ≥ 0.77 mm ID and ≤ 527 mm in
length
o triple lumen devices
■ ≥ 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 1, 1 Plus, maX, & maX 2
Lumen Cycle
• 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:
➤ single or dual lumen devices
≥ 0.77 mm ID and less than or
equal to 527 mm in length
➤ triple lumen devices
≥1.2 mm ID and less than or equal
to 275 mm in length
≥1.8 mm ID and less than or equal
to 310 mm in length
or
≥2.8 mm ID and less than or equal
to 317 mm in length |
| | V-PRO 1, 1 Plus, maX & maX 2 Non
Lumen Cycle:
Non-lumened devices including non-
lumened rigid, semi-rigid and flexible
endoscopes and non-lumened devices
with stainless steel or titanium
diffusion-restricted spaces such as the
hinged portion of forceps and scissors. | V-PRO 1 Plus, maX, & maX 2 Non
Lumen Cycle
Non-lumened devices including non-
lumened rigid, semi-rigid and flexible
endoscopes and non-lumened devices
with stainless steel or titanium
diffusion-restricted spaces such as the
hinged portion of forceps and scissors. |
| | V-PRO 1, 1 Plus, maX & maX 2
Flexible Cycle:
Load 1: Single or dual lumen surgical
flexible endoscopes (such as those
used in ENT, Urology and Surgical | V-PRO maX & maX 2 Flexible Cycle
Load 1: Single or dual lumen surgical
flexible endoscopes (such as those
used in ENT, Urology and Surgical |
| Feature | PRO-LITE Sterilization Tray
(K183402) | PRO-LITE Sterilization Tray
(K172755) |
| | 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 lumen that is $\ge$ 1 mm ID and $\le$ 1050 mm in length
• or two lumens with:
■ one lumen that is $\ge$ 1 mm ID and $\le$ 990 mm in length
■ and the other lumen that is $\ge$ 1 mm ID and $\le$ 850 mm in length
Load 2: Non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. | bronchoscopes with a light cord (if not integral to endoscope) and mat with no additional load.
The flexible endoscopes may contain either:
a single lumen that is $\ge$ 1 mm ID and less than or equal 1050 mm in length
or two lumens with:
one lumen that is $\ge$ 1 mm ID and less than or equal 990 mm in length
and the other lumen that is $\ge$ 1 mm ID and less than or equal 850 mm in length
Load 2: Non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. |
| | 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 stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors. | V-PRO maX 2 Fast Non Lumen
Non-lumened devices including non-lumened rigids, semi-rigids and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors. |
| | Intended Sterilization Cycles and Intended Tray Loads for Tray models:
VP0045, VP0046, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052 | Instrument organizers are optional accessories intended to stabilize cylindrical medical instruments within the PRO-LITE Sterilization Trays. |
| | STERRAD 100S Default Cycle:
• Metal and nonmetal devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
• Metal and nonmetal lumened instruments with:
○ $\ge$ 6 mm ID and $\le$ 310 mm in | Sterilization mats are optional accessories intended to cushion and stabilize instruments within the PRO-LITE Sterilization Trays. |
| | length
• Medical devices with a single stainless steel lumen with:
○ $\ge$ 1 mm ID and $\le$ 125 mm in length
○ $\ge$ 2 mm ID and $\le$ 250 mm in length | |
| Feature | PRO-LITE Sterilization Tray
(K183402) | PRO-LITE Sterilization Tray
(K172755) |
| | $\geq$ 3 mm ID and $\leq$ 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:
$\circ$ $\geq$ 1 mm ID and $\leq$ 150 mm in
length
$\circ$ $\geq$ 2 mm ID and $\leq$ 400 mm in
length | |
| | STERRAD NX and NX with
ALLClear Technology Advanced
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:
• a single stainless steel lumen with:
$\circ$ $\geq$ 1 mm ID and $\leq$ 500 mm in
length
• Single channel polyethylene and
Teflon (polytetrafluoroethylene)
$\circ$ $\geq$ 1 mm ID and $\leq$ 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 : | |
| Feature | PRO-LITE Sterilization Tray
(K183402) | PRO-LITE Sterilization Tray
(K172755) |
| | 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:
$ ⌀ ≥ 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) $≥ 1 mm ID and