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

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.

Device Description

The PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems: V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO 60 and V-PRO maX 2 Low Temperature Sterilization Systems. The trays are available in various sizes, outlined in Table 5-1, to accommodate the loads to be processed. The proposed trays are similar in design to the predicate Sterilization Trav (K160912) 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 and sterilization mats are also described as accessories.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a medical device (PRO-LITE™ Sterilization Trays). It describes the device's intended use, its technical characteristics, and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance	Conclusion
Demonstration of Effective Sterilant Penetration
V-PRO maX 2 Sterilizer Fast Non Lumen Cycle	Worst case test article packaged in the trays shall be reproducibly sterilized under worst case 1/2 cycle conditions for Fast Non Lumen Cycle.	N/A (implied by "PASS")	PASS
V-PRO maX 2 Sterilizer Fast Non Lumen Cycle	Diffusion-restricted spaces (stainless steel and titanium) and sterilization tray/medical device contact points shall be reproducibly sterilized under worst case 1/2 cycle conditions for Fast Non Lumen Cycle.	N/A (implied by "PASS")	PASS
V-PRO 1 Plus, maX, and maX 2 Sterilizer Non Lumen Cycle, titanium surface claims	Diffusion-restricted spaces (titanium) shall be reproducibly sterilized under worst case 1/2 cycle conditions for the Non Lumen Cycle.	N/A (implied by "PASS")	PASS
Package Integrity	Not applicable. The Sterilization tray meets the definition of a "tray" in ANSI/AAMI ST77:2013, Containment devices for reusable medical device sterilization, therefore package integrity and maintenance of package integrity testing are not applicable.	N/A	Not Applicable
Demonstration of Effective Drying and Aeration	Residual hydrogen peroxide levels shall be below acceptable levels after exposure to worst case Sterilizer Cycle conditions.	N/A (implied by "PASS")	PASS
Demonstration of Material Compatibility	After processing through multiple worst case sterilization cycles, the trays and accessories shall retain functionality.	N/A (implied by "PASS")	PASS
Demonstration of Biocompatibility	Component materials shall be non-cytotoxic after exposure to worst case Sterilizer Cycle conditions.	N/A (implied by "PASS")	PASS
Demonstration of Effective Cleaning	Clean following automated and manual cleaning.	N/A (implied by "PASS")	PASS

Note: The document only states "PASS" for the performance. It does not provide specific quantitative results (e.g., actual residual hydrogen peroxide levels or specific functionality test results after cycles).

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set. It mentions "worst case test article" and "multiple worst case sterilization cycles" but not the number of units or cycles.

The data provenance is not specified in terms of country of origin. The studies appear to be pre-market, non-clinical tests conducted by the manufacturer, STERIS Corporation, for regulatory submission to the FDA. The tests are designed to demonstrate the device's performance under simulated "worst-case" conditions for sterilization. It's not a retrospective or prospective study on patient data, but rather a laboratory-based performance validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The tests described are non-clinical, performance-based, not involving interpretation by human experts. The "ground truth" for these tests relates to defined sterilization efficacy (e.g., absence of viable microorganisms after sterilization) and material integrity standards.

4. Adjudication Method for the Test Set

This is not applicable as the tests are non-clinical and do not involve human interpretation or adjudication processes like those in clinical studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret images and their performance with and without AI assistance is evaluated. The PRO-LITE™ Sterilization Trays are a medical device accessory for sterilization, not a diagnostic or AI-powered device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study was not performed in the context of an algorithm. This device is not an algorithm or AI. The performance tests conducted are standalone in the sense that they evaluate the device's physical and functional properties without human intervention during the sterilization process itself.

7. Type of Ground Truth Used

The ground truth for these tests is based on defined standards for sterilization efficacy and material properties.

For sterilant penetration, the ground truth is the complete and reproducible sterilization of test articles, likely verified through biological indicators or other validated methods to confirm the absence of viable microorganisms.
For drying/aeration, the ground truth is the acceptable level of residual hydrogen peroxide, measured against predefined safety limits.
For material compatibility, the ground truth is the retention of functionality and structural integrity after multiple sterilization cycles, and for biocompatibility, it's the demonstration of non-cytotoxicity according to established standards.
For cleaning, the ground truth is the device being clean per established protocols.

8. Sample Size for the Training Set

This is not applicable. This is a physical medical device, not an AI/ML model that requires training data.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for this type of device.

Summary

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

February 9, 2018

Steris Corporation Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060

Re: K172755

Trade/Device Name: PRO-LITE™ Sterilization Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: January 9, 2018 Received: January 10, 2018

Dear Jennifer Nalepka:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

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

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Indications for Use

510(k) Number (if known) K172755

Device Name	PRO-LITE™ Sterilization Trays
-------------	-------------------------------

Indications for Use (Describe)

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

TrayModels	IntendedSterilizationCycles	Intended Tray Load
VP0045VP0046VP0047VP0048VP0049VP0050VP0051VP0052	V-PRO 60Lumen Cycle	• Instruments with diffusion-restricted spaces such as the hingedportion of forceps and scissors• Non-lumened devices including non-lumened rigid and semi-rigidendoscopes• Medical devices, including single, dual and triple channeled rigid andsemi-rigid endoscopes, with the following configurations:o single or dual lumen devices• $\geq$ 0.77 mm ID and $\leq$ 410 mm in lengtho triple lumen devices• $\geq$ 1.2 mm ID and $\leq$ 275 mm in length• $\geq$ 1.8 mm ID and $\leq$ 310 mm in lengthor• $\geq$ 2.8 mm ID and $\leq$ 317 mm in length
	V-PRO 60 NonLumen Cycle	Non-lumened devices including non-lumened rigid, semi-rigid andflexible endoscopes and non-lumened devices with stainless steel ortitanium diffusion-restricted spaces such as the hinged portion offorceps and scissors.
	V-PRO 60Flexible Cycle	One flexible surgical endoscope or bronchoscope with a light cord (ifnot integral to endoscope) and mat without any additional load. Theflexible endoscope may be a:o single or dual lumen device with lumens that are $\geq$ 1 mm ID and $\leq$990 mm in length
TrayModels	IntendedSterilizationCycles	Intended Tray Load
VP0045VP0046VP0047VP0048VP0049VP0050VP0051VP0052VP0053	V-PRO 1, 1 Plus,maX & maX 2Lumen Cycle	• Instruments with diffusion-restricted spaces such as the hingedportion of forceps and scissors• Non-lumened devices including non-lumened rigid and semi-rigidendoscopes• Medical devices, including single, dual and triple channeled rigid andsemi-rigid endoscopes, with the following configurations:○ single or dual lumen devices• ≥ 0.77 mm ID and ≤ 527 mm in length○ triple lumen devices• ≥ 1.2 mm ID and ≤ 275 mm in length• ≥ 1.8 mm ID and ≤ 310 mm in lengthor• ≥ 2.8 mm ID and ≤ 317 mm in length
	V-PRO 1 Plus,maX & maX 2Non LumenCycle	Non-lumened devices including non-lumened rigid, semi-rigid andflexible endoscopes and non-lumened devices with stainless steel ortitanium diffusion-restricted spaces such as the hinged portion offorceps and scissors.
	V-PRO maX &maX 2 FlexibleCycle	Load 1: Single or dual lumen surgical flexible endoscopes (such asthose used in ENT, Urology and Surgical Care) and bronchoscopeswith a light cord (if not integral to endoscope) and mat with noadditional load.The flexible endoscopes may contain either:• 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 ≤ 990 mm in length• and the other lumen that is ≥ 1 mm ID and ≤ 850 mm in lengthLoad 2: Non-lumened instruments including instruments withdiffusion-restricted areas such as the hinged portion of forceps orscissors.
	V-PRO maX 2Fast Non LumenCycle	Non-lumened devices including non-lumened rigid, semi-rigid andflexible endoscopes and non-lumened devices with stainless steel ortitanium diffusion-restricted spaces such as the hinged portion offorceps and scissors.

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

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

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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

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

2 Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (7/17)

Page 3 of 3

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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: January 24, 2018

Premarket Notification: K172755

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

Sterilization Tray K160912

3. Description of Device

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 5-1. 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 5-2 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.

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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

Table 5.2. Instrument Organizer Model Numbers

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 5-3 to fit the nine PRO-LITE Sterilization Travs. 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.

Table 5-3. Silicone Mat Model Numbers

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

The purpose of this submission is to add claims and clarify the use of tray models in the V-PRO Sterilizers for:

use in the V-PRO maX 2 Fast Non Lumen Cycle ●
. the sterilization of titanium mated surfaces (diffusion-restricted spaces) in the V-PRO 1 Plus, maX, and maX 2 Sterilizers Non Lumen Cycle
addition of the V-PRO maX 2 Sterilizer to the indications for use in the . Lumen. Non Lumen and Flexible Cvcles of the V-PRO 1. 1 Plus and maX Sterilizers (the V-PRO maX 2 Sterilizer Lumen, Non Lumen, and Flexible Cycles are identical, with the exception of the condition phase of the Lumen Cycle, to the previously cleared cycles listed in Table 5-4).
Clarification of which tray models are used in which sterilizers listed in the Indications for Use. Tray model VP0053 does not fit within the V-PRO 60 Sterilizer and therefore tray model VP0053 is being removed from the Indications for Use for the V-PRO 60 Sterilizer.

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Cycle	Most RecentPremarketNotificationClearance	V-PRO 1	V-PRO1 Plus	V-PROmaX	V-PROmaX 2
Lumen Cycle	K131120	X	X	X	X
Non Lumen Cycle	K160433	*	X	X	X
Flexible Cycle	K102330			X	X
Fast Non Lumen Cycle	K172754				X

	Table 5-4. V-PRO Cycles Provided in the Large Size (136 L Chamber) V-PRO Sterilizers

Shaded cell indicates that the V-PRO Sterilizer does not include the identified cycle.

NOTE: V-PRO Sterilizer cycles are pre-set and thus the name of the cycle describes the cycle conditions.

4. Intended Use/ Indications for Use

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

Tray Models	IntendedSterilizationCycles	Intended Tray Load
VP0045VP0046VP0047VP0048VP0049VP0050VP0051VP0052	V-PRO 60Lumen Cycle	• Instruments with diffusion-restricted spaces such as the hingedportion of forceps and scissors• Non-lumened devices including non-lumened rigid and semi-rigidendoscopes• Medical devices, including single, dual and triple channeled rigidand semi-rigid endoscopes, with the following configurations:◦ single or dual lumen devices• ≥ 0.77 mm 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 lengthor• ≥2.8 mm ID and ≤ 317 mm in length
	V-PRO 60 NonLumen Cycle	Non-lumened devices including non-lumened rigid, semi-rigid andflexible endoscopes and non-lumened devices with stainless steel or
Tray Models	IntendedSterilizationCycles	Intended Tray Load
		titanium diffusion-restricted spaces such as the hinged portion offorceps and scissors.
	V-PRO 60Flexible Cycle	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 IDand ≤ 990 mm in length
VP0045VP0046VP0047VP0048VP0049VP0050VP0051VP0052VP0053	V-PRO 1, 1Plus, maX &maX 2 LumenCycle	• Instruments with diffusion-restricted spaces such as the hingedportion of forceps and scissors• Non-lumened devices including non-lumened rigid and semi-rigidendoscopes• Medical devices, including single, dual and triple channeled rigidand semi-rigid endoscopes, with the following configurations:o single or dual lumen devices≥ 0.77 mm ID and ≤ 527 mm in lengtho triple lumen devices≥ 1.2 mm ID and ≤ 275 mm in length≥ 1.8 mm ID and ≤ 310 mm in lengthor≥ 2.8 mm ID and ≤ 317 mm in length
	V-PRO 1 Plus,maX & maX 2Non LumenCycle	Non-lumened devices including non-lumened rigid, semi-rigid andflexible endoscopes and non-lumened devices with stainless steel ortitanium diffusion-restricted spaces such as the hinged portion offorceps and scissors.
	V-PRO maX &maX 2 FlexibleCycle	Load 1: Single or dual lumen surgical flexible endoscopes (such asthose used in ENT, Urology and Surgical Care) and bronchoscopeswith a light cord (if not integral to endoscope) and mat with noadditional load.The flexible endoscopes may contain either:• 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 ≤ 990 mm in lengthand the other lumen that is ≥ 1 mm ID and ≤ 850 mm inlengthLoad 2: Non-lumened instruments including instruments withdiffusion-restricted areas such as the hinged portion of forceps orscissors.
	V-PRO maX 2Fast NonLumen Cycle	Non-lumened devices including non-lumened rigid, semi-rigid andflexible endoscopes and non-lumened devices with stainless steel ortitanium diffusion-restricted spaces such as the hinged portion offorceps and scissors.

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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

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

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

5. Summary of Technical Characteristics

The sterilization mats and instrument organizers are identical in composition to the claimed predicate devices. The proposed PRO-LITE sterilization trays are composed a material that is slightly different from the material of the predicate device. The proposed device is a mineral-filled polypropylene whereas the predicate device is a glass-filled polypropylene. The technical characteristics are summarized below in Table 5-5.

Table 5-5. Summary of Tray Physical Description and Technological Properties

Feature	PRO-LITE SterilizationTray (proposed)	Sterilization Tray(K160912)	Comparison
Intended Use	The PRO-LITE SterilizationTrays are used to containmedical devices forsterilization in the Lumen, NonLumen, Flexible and Fast NonLumen Cycles of the V-PROLow Temperature SterilizationSystems. Prior to placing in theSterilizer, the trays must eitherbe:• wrapped with a legallymarketed sterilization wrapfor use in the V-PRO Low	The Sterilization Trays are usedto contain medical devices forsterilization in the Lumen, NonLumen and Flexible Cycles ofthe V-PRO Low TemperatureSterilization Systems. Prior toplacing in the Sterilizer, the traysmust either be:• wrapped with a legallymarketed sterilization wrap foruse in the V-PRO LowTemperature SterilizationSystems or	Identical except for theaddition of the FastNon Lumen Cycle ofthe V-PRO maX2cycle. The Fast NonLumen Cycle is a newcycle in the V-PROmaX 2 LowTemperature Sterilizer,K172754.
Feature	PRO-LITE Sterilization Tray (proposed)	Sterilization Tray (K160912)	Comparison
	Temperature Sterilization Systems or• placed inside a legally marketed pouch for enclosing trays in the V-PRO Low Temperature 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: VP0045, VP0046, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052	• placed inside a legally marketed pouch for enclosing trays in the V-PRO Low Temperature Sterilization Systems.The 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: VP0045, VP0046, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052, VP0053
	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:➤ 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	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:➤ 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
Feature	PRO-LITE SterilizationTray (proposed)	Sterilization Tray(K160912)	Comparison
	or$≥$ 2.8 mm ID and less thanor equal to 317 mm inlength	V-PRO 60 Non Lumen Cycle- Non-lumened devicesincluding non-lumened rigid,semi-rigid and flexibleendoscopes and non-lumeneddevices with stainless steel ortitanium diffusion-restrictedspaces such as the hinged portionof forceps and scissors.
	V-PRO 60 Non Lumen Cycle- Non-lumened devicesincluding non-lumened rigid,semi-rigid and flexibleendoscopes and non-lumeneddevices with stainless steel ortitanium diffusion-restrictedspaces such as the hingedportion of forceps and scissors.	V-PRO 60 Flexible Cycle- One flexible surgicalendoscope or bronchoscopewith a light cord (if not integralto endoscope) and mat withoutany additional load. Theflexible endoscope may be asingle or dual lumen devicewith lumens that are $≥$ 1 mm IDand less than or equal 990 mmin length
	V-PRO 60 Flexible Cycle- One flexible surgicalendoscope or bronchoscopewith a light cord (if notintegral to endoscope) andmat without any additionalload. The flexible endoscopemay be a single or dual lumendevice with lumens that are $≥$1 mm ID and less than orequal 990 mm in length	V-PRO 1, 1 Plus & maX LumenCycle• Instruments with diffusion-restricted spaces such as thehinged portion of forceps andscissors• Non-lumened devices includingnon-lumened rigid and semi-rigid endoscopes• Medical devices, includingsingle, dual and triplechanneled rigid and semi-rigidendoscopes, with the followingconfigurations:$➤$ - single or dual lumendevices$≥$ 0.77 mm ID and less thanor equal to 527 mm in length$➤$ triple lumen devices$≥$ 1.2 mm ID and less than orequal to 275 mm in length$≥$ 1.8 mm ID and less than orequal to 310 mm in length
	Tray models: VP0045,VP0046, VP0047, VP0048,VP0049, VP0050, VP0051,VP0052
	V-PRO 1, 1 Plus, maX, &maX 2 Lumen Cycle• Instruments with diffusion-restricted spaces such as thehinged portion of forcepsand scissors• Non-lumened devicesincluding non-lumened rigidand semi-rigid endoscopes• Medical devices, includingsingle, dual and triplechanneled rigid and semi-rigid endoscopes, with thefollowing configurations:$➤$ - single or dual lumendevices
Feature	PRO-LITE SterilizationTray (proposed)	Sterilization Tray(K160912)	Comparison
	≥ 0.77 mm ID and lessthan or equal to 527 mm inlength➤ triple lumen devices≥1.2 mm ID and less thanor equal to 275 mm inlength≥1.8 mm ID and less thanor equal to 310 mm inlengthor≥2.8 mm ID and less thanor equal to 317 mm inlength	or≥2.8 mm ID and less than orequal to 317 mm in length
	V-PRO 1 Plus, maX, & maX 2Non Lumen Cycle- Non-lumened devicesincluding non-lumened rigid,semi-rigid and flexibleendoscopes and non-lumeneddevices with stainless steel ortitanium diffusion-restrictedspaces such as the hingedportion of forceps and scissors.	V-PRO 1 Plus & maX NonLumen Cycle- Non-lumened devices includingnon-lumened rigid, semi-rigidand flexible endoscopes and non-lumened devices with stainlesssteel diffusion-restricted spacessuch as the hinged portion offorceps and scissors.
	V-PRO maX & maX 2Flexible CycleLoad 1: Single or dual lumensurgical flexible endoscopes(such as those used in ENT,Urology and Surgical Care)andbronchoscopes with a lightcord (if not integral toendoscope) and mat with noadditional load.The flexible endoscopes maycontain either:a single lumen that is ≥ 1 mmID and less than or equal 1050mm in lengthor two lumens with:one lumen that is ≥ 1 mm IDand less than or equal 990 mmin length	V-PRO maX Flexible CycleLoad 1: Single or dual lumensurgical flexible endoscopes(such as those used in ENT,Urology and Surgical Care) andbronchoscopes with a light cord(if not integral to endoscope) andmat with no additional load.The flexible endoscopes maycontain either:a single lumen that is ≥ 1 mm IDand less than or equal 1050 mmin lengthor two lumens with:one lumen that is ≥ 1 mm ID andless than or equal 990 mm inlengthand the other lumen that is ≥ 1mm ID and less than or equal850 mm in lengthLoad 2: Non-lumenedinstruments includinginstruments with diffusion-restricted areas such as thehinged portion of forceps orscissors.
Feature	PRO-LITE SterilizationTray (proposed)	Sterilization Tray(K160912)	Comparison
	and the other lumen that is $\ge$ 1 mm ID and less than or equal850 mm in lengthLoad 2: Non-lumenedinstruments includinginstruments with diffusion-restricted areas such as thehinged portion of forceps orscissors.V-PRO maX 2 Fast NonLumenNon-lumened devicesincluding non-lumened rigids,semi-rigids and flexibleendoscopes and non-lumeneddevices with stainless steel ortitanium diffusion-restrictedspaces such as the hingedportion of forceps and scissors.Instrument organizers areoptional accessories intendedto stabilize cylindrical medicalinstruments within the PRO-LITE Sterilization Trays.Sterilization mats are optionalaccessories intended to cushionand stabilize instruments withinthe PRO-LITE SterilizationTrays.	Instrument organizers areoptional accessories intended tostabilize cylindrical medicalinstruments within theSterilization Trays.Sterilization mats are optionalaccessories intended to cushionand stabilize instruments withinthe Sterilization Trays.
Vent toVolumeRatio	All trays are the same:$0.135 \text{ in}^{-1}$	All trays are the same: $0.135 \text{ in}^{-1}$	Identical.
TrayComposition	Mineral-filled polypropylene,stainless steel	Glass-filled polypropylene,stainless steel	The materials ofconstruction aresimilar. Thedifference inmaterial has noeffect onperformance of thetray.
OrganizerComposition	Medical Grade Silicone, USPgrade VI	Medical Grade Silicone, USPgrade VI	Identical.
MatComposition	Medical Grade Silicone, USPgrade VI	Medical Grade Silicone, USPgrade VI	Identical.

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Summary of Non-clinical Tests 6.

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-5 below.

	Test	Acceptance Criteria	Conclusion
Demonstration ofEffective SterilantPenetration	V-PRO maX 2Sterilizer Fast NonLumen Cycle	Worst case test articlepackaged in the trays shall bereproducibly sterilized underworst case 1/2 cycle conditionsfor Fast Non Lumen Cycle.	PASS
	V-PRO maX 2Sterilizer Fast NonLumen Cycle	Diffusion-restricted spaces(stainless steel and titanium)and sterilization tray/medicaldevice contact points shall bereproducibly sterilized underworst case 1/2 cycle conditionsfor Fast Non Lumen Cycle.	PASS
	V-PRO 1 Plus, maX,and maX 2 SterilizerNon Lumen Cycle,titanium surface claims	Diffusion-restricted spaces(titanium) shall bereproducibly sterilized underworst case 1/2 cycle conditionsfor the Non Lumen Cycle.	PASS
Package Integrity		Not applicable. The Sterilization tray meetsthe definition of a "tray" in ANSI/AAMIST77:2013, Containment devices for reusablemedical device sterilization, therefore packageintegrity and maintenance of package integritytesting are not applicable.
Demonstration of Effective Drying andAeration		Residual hydrogen peroxidelevels shall be belowacceptable levels afterexposure to worst caseSterilizer Cycle conditions.	PASS
Demonstration of Material Compatibility		After processing throughmultiple worst casesterilization cycles, the traysand accessories shall retainfunctionality.	PASS
Demonstration of Biocompatibility		Component materials shall benon-cytotoxic after exposure toworst case Sterilizer Cycleconditions.	PASS
Demonstration of Effective Cleaning		Clean following automated andmanual cleaning.	PASS

Table 5-5. Summary of Non-clinical Testing

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7. Conclusion

Based on the intended us, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as well as the legally marketed predicate device (K160912), Class II (21 CFR 880.6850), product code KCT.

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).