The Sterilization Trays are used to contain medical devices for sterilization in the Lumen, Non Lumen and Flexible 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 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.

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

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

Device Description

The 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 and V-PRO 60 Low Temperature Sterilization Systems. The trays are available in various sizes, outlined in Table 10-1, to accommodate the loads to be processed. The proposed trays are similar in design to the predicate V-PRO Sterilization Tray (K140494) 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.

Optional instrument organizers are provided as accessories to the trays and allow stabilization of various cylindrical medical devices during processing. Table 10-2 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 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 as shown in Table 10-3 to fit the nine 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for "Sterilization Trays" by STERIS Corporation. It outlines the device's intended use and includes a summary of nonclinical tests performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

Test	Acceptance Criteria	Reported Device Performance
Demonstration of Effective Sterilant Penetration	Worst case test article packaged in the trays shall be reproducibly sterilized under worst case ½ cycle conditions.	PASS
Package Integrity Maintenance of Package Integrity	Not applicable, Trays to be used with legally marketed sterilization wrap or pouch.	N/A
Demonstration of Effective Drying and Aeration	Residual hydrogen peroxide levels shall be below acceptable levels after exposure to worst case Sterilizer Cycle conditions.	PASS
Demonstration of Effective Cleaning	Clean following automated and manual cleaning.	PASS
Demonstration of Material Compatibility	After processing through multiple worst case sterilization cycles, the trays and accessories shall retain functionality.	PASS
Demonstration of Biocompatibility	Component materials shall be non cytotoxic after exposure to worst case Sterilizer Cycle conditions.	PASS

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify the exact sample sizes (e.g., number of trays, number of sterilization cycles) used for each test. It also does not explicitly state the data provenance (country of origin, retrospective or prospective). However, given that this is a 510(k) submission to the FDA, it is prospective testing conducted by the manufacturer, STERIS Corporation, likely in the USA, to support the device's market clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document. The tests described are laboratory-based performance tests (e.g., sterilization effectiveness, material compatibility, cleaning efficacy), not diagnostic accuracy studies requiring expert interpretation of images or clinical outcomes. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense may not directly apply here. Instead, ground truth would be established by validated analytical methods and scientific standards within a laboratory setting.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers interpreting data (e.g., medical images). Since the tests described are laboratory performance tests for a sterilization tray, an adjudication method for interpretations is not applicable and therefore not mentioned. Results would be determined by objective measurements and passing/failing pre-defined technical criteria (e.g., presence/absence of microbial growth, chemical residue levels, visual assessment of functionality).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable as the device (sterilization tray) is not an AI-powered diagnostic tool involving human readers. The document details performance tests for physical sterilization equipment, not AI assistance for human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

A standalone algorithm performance study is not applicable as the device is a physical sterilization tray, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the performance tests would be established through scientific and objective measurements based on established standards and methods relevant to sterilization and material science. For example:

Effective Sterilant Penetration: Ground truth would be the absence of microbial growth on biological indicators or test articles after sterilization, as per established sterilization protocols (e.g., ISO standards, AAMI guidelines).
Effective Drying and Aeration: Ground truth would be hydrogen peroxide levels below a pre-determined safe threshold, measured using chemical analysis.
Effective Cleaning: Ground truth would involve visual inspection and potentially chemical analysis to confirm removal of soil and contaminants according to established cleaning validation protocols.
Material Compatibility: Ground truth would be the visual assessment or mechanical testing to confirm the trays and accessories retain their functionality and integrity after repeated sterilization cycles.
Biocompatibility: Ground truth would be the absence of cytotoxic effects, determined by standardized in vitro (e.g., cell culture) or in vivo biocompatibility tests.

8. The sample size for the training set:

A training set is relevant for machine learning or AI models. Since this device is a physical sterilization tray and not an AI system, the concept of a "training set" is not applicable.

9. How the ground truth for the training set was established:

As implied by point 8, a training set is not applicable for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 7, 2016

STERIS Corporation Mr. Tony Piotrkowski Senior Manager, Regulatory Affairs 5960 Heisley Road Mentor, OH 44060

Re: K160912

Trade/Device Name: Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: September 9, 2016 Received: September 12, 2016

Dear Mr. Tony Piotrkowski :

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 and Part 809); medical device reporting (reporting of

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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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name

Sterilization Trays

K160912

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.

Model Number (sizeLxWxH in inches)	IntendedSterilizationCycles	Intended Tray Load
VP0045 (13x4.5x2.25)VP0046 (19x4.5x2.25)VP0047 (25x4.5x2.25)VP0048 (13x7.75x2.25)VP0049 (19x7.75x2.25)VP0050 (27x7.75x4)	V-PRO 60Lumen 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 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 60Non LumenCycle	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 (13x4.5x2.25)VP0046 (19x4.5x2.25)VP0047 (25x4.5x2.25)VP0048 (13x7.75x2.25)VP0049 (19x7.75x2.25)VP0050 (27x7.75x4)	V-PRO 60FlexibleCycle	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
VP0051 (12x11.75x4)VP0052 (25x11,75x4.5)VP0053 (25x14x5)	V-PRO 1, 1Plus & maXLumen 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 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 1Plus & maXNon LumenCycle	Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel diffusion-restricted spaces such as the hinged portion of forceps and scissors.

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Model Number (sizeLxWxH in inches)	IntendedSterilizationCycles	Intended Tray Load
VP0045 (13x4.5x2.25)VP0046 (19x4.5x2.25)VP0047 (25x4.5x2.25)VP0048 (13x7.75x2.25)VP0049 (19x7.75x2.25)VP0050 (27x7.75x4)VP0051 (12x11.75x4)VP0052 (25x11.75x4.5)VP0053 (25x14x5)	V-PRO maXFlexibleCycle	Load 1: Single or dual lumen surgical flexible endoscopes (such as those used inENT, Urology and Surgical Care) and bronchoscopes with a light cord (if notintegral to endoscope) and mat with no additional 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 with diffusion-restrictedareas such as the hinged portion of forceps or scissors.

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

Model	Description	Model	Description
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.

Model	Description	Model	Description	Model	Description
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)

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

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STERIS®

510(k) Summary For Sterilization Trays

Sponsor Facility

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

Repackager/Relabeler Facility

STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: (440) 392-7800 Fax No: (440) 392-7896

Contact: Tony Piotrkowski Senior Manager, Regulatory Affairs

Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: tpiotrko@steris.com

Submission Date: September 9, 2016

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

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K160912/S001 STERIS Response to 5/31/16 Request for Additional Information Sterilization Travs

Device Name 1.

Trade Name:	Sterilization Trays
Common/usual Name:	Sterilization Trays, cassettes and other accessories
Classification Name:	Sterilization Wrap21 CFR 880.6850Class IIProduct Code KCT

Predicate Device 2.

V-PRO Sterilization Tray K140494

3. Description of Device

Model	Description	Model	Description
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 4.5
VP0048	13 x 7.75 x 2.25	VP0053	25 x 14 x 5
VP0049	19 x 7.75 x 2.25

Table 10-1. External Dimensions of Tray Line

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Model	Description	Model	Description
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

K160912/S001 STERIS Response to 5/31/16 Request for Additional Information Sterilization Travs

Table 10-3. Sterilization Tray Model Numbers

Model	Description	Model	Description
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

4. Intended Use/ Indications for Use

. 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.

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K160912/S001 STERIS Response to 5/31/16 Request for Additional Information Sterilization Trays

Model Number (sizeLxWxH in inches)	IntendedSterilizationCycles	Intended Tray Load
	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-rigid endoscopes• 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 ≤ 410 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
VP0045 (13x4.5x2.25)VP0046 (19x4.5x2.25)VP0047 (25x4.5x2.25)VP0048 (13x7.75x2.25)VP0049 (19x7.75x2.25)VP0050 (27x7.75x4)VP0051 (12x11.75x4)VP0052 (25x11,75x4.5)VP0053 (25x14x5)	V-PRO 60Non 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 60FlexibleCycle	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 withlumens that are > 1 mm ID and < 990 mm in length
	V-PRO 1, 1Plus & maXLumen Cycle	• Instruments with diffusion-restricted spaces such as the hingedportion of forceps and scissors• Non-lumened devices including non-lumened rigid and semi-rigid endoscopes• 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 1Plus & maXNon LumenCycle	Non-lumened devices including non-lumened rigid, semi-rigid andflexible endoscopes and non-lumened devices with stainless steeldiffusion-restricted spaces such as the hinged portion of forceps andscissors.
Model Number (sizeLxWxH in inches)	IntendedSterilizationCycles	Intended Tray Load
VP0045 (13x4.5x2.25)VP0046 (19x4.5x2.25)VP0047 (25x4.5x2.25)VP0048 (13x7.75x2.25)VP0049 (19x7.75x2.25)VP0050 (27x7.75x4)VP0051 (12x11.75x4)VP0052 (25x11.75x4.5)VP0053 (25x14x5)	V-PRO maXFlexibleCycle	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 length Load 2: Non-lumened instruments including instruments withdiffusion-restricted areas such as the hinged portion of forceps orscissors.

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K160912/S001 STERIS Response to 5/31/16 Request for Additional Information Sterilization Trays

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

Model	Description	Model	Description
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

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

Model	Description	Model	Description	Model	Description
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

ട്. Summary of Technical Characteristics

The sterilization trays, sterilization mats and instrument organizers are identical in composition to the claimed predicate devices. The technical characteristics are summarized in Table 10-4.

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Feature	Sterilization Tray (proposed)	V-PRO Sterilization Tray (K140494)	Comparison
Intended Use	The Sterilization Trays are used to contain medical devices for sterilization in the Lumen, Non Lumen and Flexible 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 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.Instrument organizers are optional accessories intended to stabilize cylindrical medical instruments within the Sterilization Trays. Sterilization mats are optional accessories intended to cushion and stabilize instruments within the Sterilization Trays.	The V-PRO Sterilization Tray is used to contain medical devices for sterilization in the Lumen, Non Lumen and Flexible Cycles of the V-PRO Low Temperature Sterilization Systems and to maintain sterility of properly processed medical devices during normal handling and storage until they are removed for use. The trays must be wrapped with a legally marketed sterilization wrap for use in the V-PRO Low Temperature Sterilization Systems prior to placing in the Sterilizer.Optional instrument organizers are accessories to the tray and are intended to allow stabilization of various cylindrical medical devices during processing. The instrument organizers attach to the V-PRO Sterilization Tray base and stabilize cylindrical medical instruments.	Adding ability to pouch trays for sterilization or to process pouched items in a wrapped or pouched tray - peroxide residual and sterilant penetration testing demonstrate safety and efficacy.Use of Vis-U-All pouches with the trays is part of separate, concurrent, submission.
Vent toVolumeRatio	All trays are the same:0.135 in-1	All trays are the same:0.137 in-1	Similar; peroxide residual and sterilant penetration testing demonstrate safety and efficacy
TrayComposition	Glass-filledpolypropylene, stainlesssteel	Polypropylene, Noryl andstainless steel	Similar, Compatibility testing demonstrates safety and efficacy
Feature	Sterilization Tray(proposed)	V-PRO SterilizationTray (K140494)	Comparison
OrganizerComposition	Medical Grade Silicone,USP grade VI	Polypropylene	Compatibility testingdemonstrates safety andefficacy
MatComposition	Medical Grade Silicone,USP grade VI	Medical Grade Silicone,USP grade VI	Same

Table 10-4 Summary of Tray Physical Description and Technological Properties

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K160912/S001 STERIS Response to 5/31/16 Request for Additional Information Sterilization Trays

Summary of Nonclinical Tests 6.

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 10-5 below.

Test	Acceptance Criteria	Conclusion
Demonstration ofEffective SterilantPenetration	Worst case test article packaged in the trays shallbe reproducibly sterilized under worst case ½cycle conditions.	PASS
Package IntegrityMaintenance ofPackage Integrity	Not applicable, Trays to be used with legally marketedsterilization wrap or pouch.
Demonstration ofEffective Drying andAeration	Residual hydrogen peroxide levels shall be belowacceptable levels after exposure to worst caseSterilizer Cycle conditions.	PASS
Demonstration ofEffective Cleaning	Clean following automated and manual cleaning.	PASS
Demonstration ofMaterialCompatibility	After processing through multiple worst casesterilization cycles, the trays and accessories shallretain functionality.	PASS
Demonstration ofBiocompatibility	Component materials shall be non cytotoxic afterexposure to worst case Sterilizer Cycleconditions.	PASS

Table 10-5. Summary of Non-clinical Testing

7. Conclusion

The Sterilization Trays have met the established performance criteria. The results of the studies demonstrate that the sterilization trays and accessories perform as intended, and based on the nonclinical tests performed, the subject device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate devices, 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).