Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a sterilization tray, a passive container for medical devices during sterilization. The description focuses on material composition, design for sterilant penetration, and compatibility with sterilization systems and wraps. There is no mention of any computational or analytical functions that would involve AI or ML.

Therapeutic

No.
The device is a sterilization tray used to contain medical devices during the sterilization process; it does not provide any therapeutic benefit or treatment to a patient.

Diagnostic

No

Explanation: The device, PRO-LITE™ Sterilization Trays, is described as being used to contain medical devices for sterilization. Its purpose is to facilitate the sterilization process and maintain sterility of enclosed instruments, not to diagnose medical conditions or provide diagnostic information.

SaMD (Software as a Medical Device)

No

The device description clearly states the device is a physical tray made of mineral-filled polypropylene material, designed to contain medical devices for sterilization. It is a hardware component.

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 to contain 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 focuses on the physical characteristics of the tray, its materials, and its function in the sterilization process. There is no mention of analyzing biological samples or providing diagnostic information.
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 analytes
- Providing diagnostic information
- Using reagents or assays

The device is clearly intended for use in the sterilization of medical instruments, which is a process related to infection control and device reprocessing, 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 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.

Product codes (comma separated list FDA assigned to the subject device)

KCT

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 are provided as accessories to the trays and allow stabilization of various cylindrical medical devices during processing.
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 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Test: Demonstration of Effective Sterilant Penetration in V-PRO maX 2 Sterilizer Fast Non Lumen Cycle
Acceptance Criteria: Worst case test article packaged in the trays shall be reproducibly sterilized under worst case 1/2 cycle conditions for Fast Non Lumen Cycle.
Conclusion: PASS

Test: Demonstration of Effective Sterilant Penetration in V-PRO maX 2 Sterilizer Fast Non Lumen Cycle
Acceptance Criteria: 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.
Conclusion: PASS

Test: Demonstration of Effective Sterilant Penetration in V-PRO 1 Plus, maX, and maX 2 Sterilizer Non Lumen Cycle, titanium surface claims
Acceptance Criteria: Diffusion-restricted spaces (titanium) shall be reproducibly sterilized under worst case 1/2 cycle conditions for the Non Lumen Cycle.
Conclusion: PASS

Test: Package Integrity
Acceptance Criteria: 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.
Conclusion: Not Applicable

Test: Demonstration of Effective Drying and Aeration
Acceptance Criteria: Residual hydrogen peroxide levels shall be below acceptable levels after exposure to worst case Sterilizer Cycle conditions.
Conclusion: PASS

Test: Demonstration of Material Compatibility
Acceptance Criteria: After processing through multiple worst case sterilization cycles, the trays and accessories shall retain functionality.
Conclusion: PASS

Test: Demonstration of Biocompatibility
Acceptance Criteria: Component materials shall be non-cytotoxic after exposure to worst case Sterilizer Cycle conditions.
Conclusion: PASS

Test: Demonstration of Effective Cleaning
Acceptance Criteria: Clean following automated and manual cleaning.
Conclusion: PASS

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K160912

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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 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);

1

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

2

Indications for Use

510(k) Number (if known) K172755

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 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.

| Tray
Models | Intended
Sterilization
Cycles | Intended Tray Load |
|----------------------------------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VP0045
VP0046
VP0047
VP0048
VP0049
VP0050
VP0051
VP0052 | 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
• $\geq$ 0.77 mm ID and $\leq$ 410 mm in length
o triple lumen devices
• $\geq$ 1.2 mm ID and $\leq$ 275 mm in length
• $\geq$ 1.8 mm ID and $\leq$ 310 mm in length
or
• $\geq$ 2.8 mm ID and $\leq$ 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 | 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 $\geq$ 1 mm ID and $\leq$
990 mm in length |
| Tray
Models | Intended
Sterilization
Cycles | Intended Tray Load |
| 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:
○ 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 length
or
• ≥ 2.8 mm ID and ≤ 317 mm in length |
| | 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 ≥ 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 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. |

3

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.

4

| 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

5

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

6

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

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.

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.

7

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.

8

| Cycle | Most Recent
Premarket
Notification
Clearance | V-PRO 1 | V-PRO
1 Plus | V-PRO
maX | V-PRO
maX 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

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
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 ≤ 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
or
• ≥2.8 mm ID and ≤ 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 |
| Tray Models | Intended
Sterilization
Cycles | Intended Tray Load |
| | | titanium diffusion-restricted spaces such as the hinged portion of
forceps and scissors. |
| | V-PRO 60
Flexible 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 ID
and ≤ 990 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 |
| | 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 ≥ 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 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. |

9

10

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 Sterilization
Tray (proposed) | Sterilization Tray
(K160912) | Comparison |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended 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 | 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 | Identical except for the
addition of the Fast
Non Lumen Cycle of
the V-PRO maX2
cycle. The Fast Non
Lumen Cycle is a new
cycle in the V-PRO
maX 2 Low
Temperature 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 Sterilization
Tray (proposed) | Sterilization Tray
(K160912) | Comparison |
| | or
$≥$ 2.8 mm ID and less than
or equal 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 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
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 less than or equal 990 mm
in length | |
| | V-PRO 60 Flexible 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 ID and less than or
equal 990 mm in length | V-PRO 1, 1 Plus & maX 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 | |
| | 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 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 | | |
| Feature | PRO-LITE Sterilization
Tray (proposed) | Sterilization Tray
(K160912) | Comparison |
| | ≥ 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 | or
≥2.8 mm ID and less than or
equal to 317 mm in length | |
| | 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 Plus & maX Non
Lumen Cycle
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. | |
| | 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 ≥ 1 mm
ID and less than or equal 1050
mm in length
or two lumens with:
one lumen that is ≥ 1 mm ID
and less than or equal 990 mm
in length | V-PRO maX 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 ≥ 1 mm ID
and less than or equal 1050 mm
in length
or two lumens with:
one lumen that is ≥ 1 mm ID and
less than or equal 990 mm in
length
and the other lumen that is ≥ 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. | |
| Feature | PRO-LITE Sterilization
Tray (proposed) | Sterilization Tray
(K160912) | Comparison |
| | 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
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.
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. | 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. | |
| Vent to
Volume
Ratio | All trays are the same:
$0.135 \text{ in}^{-1}$ | All trays are the same: $0.135 \text{ in}^{-1}$ | Identical. |
| Tray
Composition | Mineral-filled polypropylene,
stainless steel | Glass-filled polypropylene,
stainless steel | The materials of
construction are
similar. The
difference in
material has no
effect on
performance of the
tray. |
| Organizer
Composition | Medical Grade Silicone, USP
grade VI | Medical Grade Silicone, USP
grade VI | Identical. |
| Mat
Composition | Medical Grade Silicone, USP
grade VI | Medical Grade Silicone, USP
grade VI | Identical. |

11

12

13

14

15

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
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.	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.	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.	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.
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 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
Demonstration of Effective Cleaning		Clean following automated and
manual cleaning.	PASS

Table 5-5. Summary of Non-clinical Testing

16

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.