PRO-LITE Sterilization Tray

K183301 · STERIS Corporation · KCT · Jan 3, 2019 · General Hospital

Device Facts

• Record ID: K183301
• Device Name: PRO-LITE Sterilization Tray
• Applicant: STERIS Corporation
• Product Code: KCT · General Hospital
• Decision Date: Jan 3, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The PRO-LITE™ Sterilization Trays are used to contain medical devices for sterilization in the following cycles: Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO® Low Temperature Sterilization Systems. Prior to placing in the Sterilizer, the trays must either be: wrapped with a legally marketed sterilization wrap for use in the Sterilizers listed above or placed inside a legally marketed pouch for enclosing trays in the Sterilizers listed above. The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments.

Device Story

PRO-LITE Sterilization Trays are mineral-filled polypropylene containers with lids and clamping mechanisms; used to hold medical instruments during low-temperature hydrogen peroxide sterilization in V-PRO systems. Trays feature holes for sterilant penetration; require external FDA-cleared sterilization wrap or pouch for sterility maintenance. Optional silicone mats and organizers stabilize instruments and protect delicate devices. Used in clinical settings by healthcare staff; trays are loaded with instruments, wrapped/pouched, and processed in V-PRO sterilizers. Output is a sterilized instrument set ready for clinical use. Benefits include organized, protected, and effective sterilization of complex surgical instruments, including endoscopes and diffusion-restricted devices.

Clinical Evidence

Bench testing only. Testing confirmed effective sterilant penetration, drying, aeration, material compatibility, and biocompatibility. Studies verified sterilization of worst-case stainless steel lumens and diffusion-restricted spaces under 1/2 cycle conditions for V-PRO 60 and s2 cycles.

Technological Characteristics

Materials: Mineral-filled polypropylene (tray), medical-grade silicone USP VI (mats/organizers), stainless steel. Design: Cassette-style with lid/base clamping and vent holes. Vent-to-volume ratio: 0.135 in^-1. Sterilization: Low-temperature hydrogen peroxide (V-PRO systems). Connectivity: None. Software: None.

Indications for Use

Indicated for containing medical devices during sterilization in V-PRO Low Temperature Sterilization Systems (Lumen, Non Lumen, Flexible, Fast Non Lumen, and Fast cycles). Patient population includes those requiring surgical procedures involving rigid, semi-rigid, and flexible endoscopes, and instruments with diffusion-restricted spaces (e.g., hinged forceps/scissors).

Regulatory Classification

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.

Predicate Devices

• PRO-LITE Sterilization Tray (K172755)

Submission Summary (Full Text)

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January 3, 2019

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

Re: K183301

Trade/Device Name: PRO-LITE Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: November 26, 2018 Received: November 27, 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Elizabeth F. Claverie -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) K183301

Device Name PRO-LITE Sterilization Trays

## Indications for Use (Describe)

The PRO-LITE™ Sterilization Trays are used to contain medical devices for sterilization in the following cycles: Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO® Low Temperature Sterilization Systems

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

- · wrapped with a legally marketed sterilization wrap for use in the Sterilizers listed above or
- · placed inside a legally marketed pouch for enclosing trays in the Sterilizers listed above

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

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

# V-PRO 60 & s2 Lumen Cycle

- · Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- · Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
- · Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations:
- · single or dual lumen devices
- · ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm in length
- · triple lumen devices
- ≥ 1.2 mm ID and ≤ 275 mm in length
- · > 1.8 mm ID and < 310 mm in length

or

- ≥ 2.8 mm ID and ≤ 317 mm in length
# V-PRO 60 & s2 Non Lumen Cycle

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

# V-PRO 60 & s2 Flexible Cycle

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

· single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm in length

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

- · > 2 mm ID and < 400 mm in length
- ≥ 0.76 mm ID and ≤ 233 mm in length
- ≥ 1.0 mm ID and ≤ 254 mm in length

Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0046, VP0047, VP0049, VP0049, VP0049

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# V-PRO s2 Fast Cycle

- · Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes, and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps or scissors.
- · Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:
- · Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm ID and ≤ 410 mm in length
- · Triple channeled devices with stainless steel lumens that are either:
- · > 1.2 mm ID and < 275 mm in length
- ≥ 1.8 mm ID and ≤ 310 mm in length
- or
- ≥ 2.8 mm ID and ≤ 317 mm in length

Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0047, VP0048, VP0049, VP0050, 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 endoscopes, with the following configurations:
- · single or dual lumen devices
- · ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm in length
- · triple lumen devices
- ≥ 1.2 mm ID and ≤ 275 mm in length
- ≥ 1.8 mm ID and ≤ 310 mm in length
- Or
- ≥ 2.8 mm ID and ≤ 317 mm in length

# V-PRO 1, 1 Plus, maX & maX 2 Non Lumen Cycle

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

V-PRO 1, 1 Plus, maX & maX 2 Flexible Cycle

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

The flexible endoscopes may contain either:
- 1-lumen with 1 > ID > 1050

- 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.

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

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

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

| Model | Description (to fit Length" x Width" Tray) |
|--------|--------------------------------------------|
| VP0071 | 13 x 4.5 |
| VP0072 | 19 x 4.5 |
| VP0073 | 25 x 4.5 |
| VP0074 | 13 x 7.75 |
| VP0075 | 19 x 7.75 |
| VP0076 | 27 x 7.75 |
| VP0077 | 12 x 11.75 |
| VP0078 | 25 x 11.75 |
| 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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# STE

# 510(k) Summary For K183301 PRO-LITE™ Sterilization Tray

# Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Jennifer Nalepka Contact: Senior Regulatory Affairs Specialist

Telephone: [phone] Fax No: [phone] e-mail: [e-mail]

Submission Date: November 26, 2018

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

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### 1. Device Name

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

### 2. Predicate Device

PRO-LITE Sterilization Tray, K172755

### 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 maX 2, V-PRO 60 and V-PRO s2 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 identical in design to the predicate Sterilization Trav (K172755) and are composed of a base and a lid. The lid includes clamping mechanisms designed to secure the lid onto the base. There are numerous holes in the base and lid for sterilant penetration. The 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.

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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 |

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 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.

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 for the use of tray models in the V-PRO Sterilizers for:

- Qualification for use with devices having stainless steel lumens of the following configurations:
- o > 2.0 mm ID and ≤ 400 mm in length
- o ≥1.0 mm ID and ≤ 254 mm in length
- o > 0.76 mm ID and ≤ 233 mm in length

in the V-PRO 60 and V-PRO s2 Sterilizer Flexible Cycle

- Qualification of use with diffusion-restricted spaces in addition to stainless ● steel and titanium when used in the V-PRO 60 and V-PRO s2 Sterilizer Non Lumen Cycle and Flexible Cycle.
- Oualification of use in the V-PRO s2 Sterilizer Fast Cycle
- Addition of the V-PRO s2 Sterilizer to the indications for use in the Lumen ● Cycle

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| Cycle | Most Recent<br>Premarket<br>Notification<br>Clearance | V-PRO 60 | V-PRO s2 |
|-----------------|-------------------------------------------------------|----------|----------|
| Lumen Cycle | | X | X |
| Non Lumen Cycle | K172319 | X | X |
| Flexible Cycle | | X | X |
| Fast Cycle | Concurrent<br>Submission<br>(K182528) | | X |

| Table 5-4: V-PRO Cycles Provided V-PRO 60 and s2 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. Indications for Use

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

- Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO® ● Low Temperature Sterilization Systems
Prior to placing in the Sterilizer, the trays must either be:

- wrapped with a legally marketed sterilization wrap for use in the Sterilizers listed . above.
or

- placed inside a legally marketed pouch for enclosing trays in the Sterilizers listed ● above.
The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated. FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments.

| Tray<br>Models | Intended<br>Sterilization<br>Cycles | Intended Tray Load |
|----------------------------------------------------------------------------------------|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VP0045<br>VP0046<br>VP0047<br>VP0048<br>VP0049<br>VP0050<br>VP0051<br>VP0052 | V-PRO 60 &<br>s2 Lumen<br>Cycle | • Instruments with diffusion-restricted spaces such as the hinged<br>portion of forceps and scissors<br>• Non-lumened devices including non-lumened rigid and semi-<br>rigid endoscopes<br>• Medical devices, including single, dual and triple channeled<br>rigid and semi-rigid endoscopes, with the following<br>configurations:<br>o single or dual lumen devices<br>• ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm in length<br>o triple lumen devices |
| Tray<br>Models | Intended<br>Sterilization<br>Cycles | Intended Tray Load |
| | | ≥1.2 mm ID and ≤ 275 mm in length ≥1.8 mm ID and ≤ 310 mm in length or<br>≥2.8 mm ID and ≤ 317 mm in length |
| | V-PRO 60 &<br>s2 Non<br>Lumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and<br>flexible endoscopes and non-lumened devices with diffusion-<br>restricted spaces such as the hinged portion of forceps and<br>scissors. |
| | V-PRO 60 &<br>s2 Flexible<br>Cycle | Load 1: One flexible surgical endoscope or bronchoscope with a<br>light cord (if not integral to endoscope) and mat without any<br>additional load. The flexible endoscope may be a:<br>○ single or dual lumen device with lumens that are ≥ 1 mm ID<br>and ≤ 990 mm in length<br>Load 2: Non-lumened devices including non-lumened rigid, semi-<br>rigid, and flexible endoscopes and non-lumened devices with<br>diffusion-restricted areas such as the hinged portion of forceps or<br>scissors. Medical devices, including rigid and semi-rigid<br>endoscopes, with the following configurations:<br>○ ≥ 2 mm ID and ≤ 400 mm in length<br>○ ≥ 0.76 mm ID and ≤ 233 mm in length<br>○ ≥1.0 mm ID and ≤ 254 mm in length |
| VP0045<br>VP0046<br>VP0047<br>VP0048<br>VP0049 | V-PRO s2<br>Fast Cycle | Non-lumened devices including non-lumened rigid, semi-rigid<br>and flexible endoscope, and non-lumened devices with<br>diffusion-restricted areas such as the hinged portion of forceps or<br>scissors Medical devices, including single, dual and triple channeled<br>rigid and semi-rigid endoscopes, with the following<br>configurations: single or dual lumen devices ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm in length triple lumen devices ≥1.2 mm ID and ≤ 275 mm in length ≥1.8 mm ID and ≤ 310 mm in length or<br>≥2.8 mm ID and ≤ 317 mm in length |
| Tray<br>Models | Intended<br>Sterilization<br>Cycles | Intended Tray Load |
| VP0045<br>VP0046<br>VP0047<br>VP0048<br>VP0049<br>VP0050<br>VP0051<br>VP0052<br>VP0053 | V-PRO 1, 1<br>Plus, maX &<br>maX 2<br>Lumen Cycle | • Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors<br>• Non-lumened devices including non-lumened rigid and semi-rigid endoscopes<br>• Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations:<br>○ single or dual lumen devices<br>■ $\ge$ 0.77 mm ID and $\le$ 527 mm in length<br>○ triple lumen devices<br>■ $\ge$ 1.2 mm ID and $\le$ 275 mm in length<br>■ $\ge$ 1.8 mm ID and $\le$ 310 mm in length<br>or<br>■ $\ge$ 2.8 mm ID and $\le$ 317 mm in length |
| | V-PRO 1<br>Plus, maX &<br>maX 2 Non<br>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<br>& maX 2<br>Flexible<br>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.<br>The flexible endoscopes may contain either:<br>• a single lumen that is $\ge$ 1 mm ID and $\le$ 1050 mm in length<br>• or two lumens with:<br>■ one lumen that is $\ge$ 1 mm ID and $\le$ 990 mm in length<br>■ and the other lumen that is $\ge$ 1 mm ID and $\le$ 850 mm in length<br>Load 2: Non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. |
| | V-PRO maX<br>2 Fast Non<br>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. |

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

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

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

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

### ട. Technological Characteristic Comparison Table

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

| Feature | PRO-LITE Sterilization<br>Tray (proposed) | PRO-LITE Sterilization<br>Tray (K172755) | Comparison |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | The PRO-LITE Sterilization<br>Trays are used to contain<br>medical devices for<br>sterilization in the following<br>Cycles:<br>Lumen, Non Lumen, Flexible, Fast Non Lumen<br>and Fast Cycles of the V-<br>PRO® Low Temperature<br>Sterilization Systems Prior to placing in the<br>Sterilizer, the trays must<br>either be:<br>wrapped with a legally<br>marketed sterilization<br>wrap for use in the<br>Sterilizers listed above. or placed inside a legally<br>marketed pouch for<br>enclosing trays in the<br>Sterilizers listed above. The PRO-LITE Sterilization<br>Trays are not intended to<br>maintain sterility; they are<br>intended to be used in<br>conjunction with a validated, | The PRO-LITE Sterilization<br>Trays are used to contain<br>medical devices for<br>sterilization in the Lumen, Non<br>Lumen, Flexible and Fast Non<br>Lumen Cycles of the V-PRO<br>Low Temperature Sterilization<br>Systems. Prior to placing in the<br>Sterilizer, the trays must either<br>be:<br>wrapped with a legally<br>marketed sterilization wrap<br>for use in the V-PRO Low<br>Temperature Sterilization<br>Systems or placed inside a legally<br>marketed pouch for<br>enclosing trays in the V-PRO<br>Low Temperature<br>Sterilization Systems. The PRO-LITE Sterilization<br>Trays are not intended to<br>maintain sterility; they are<br>intended to be used in<br>conjunction with a validated, | Identical except<br>for:<br>The addition<br>of the Fast<br>Cycle of the<br>V-PRO s2<br>Sterilizer.<br>The Fast<br>Cycle is a<br>new cycle in<br>the V-PRO s2<br>Low<br>Temperature<br>Sterilizer,<br>subject of a<br>concurrent<br>submission<br>(K182568). The extension<br>of claims in<br>the V-PRO<br>60 & s2<br>Sterilizers<br>Flexible<br>Cycle. |
| Feature | PRO-LITE Sterilization<br>Tray (proposed) | PRO-LITE Sterilization<br>Tray (K172755) | Comparison |
| | wrap or pouch in order to<br>maintain sterility of the<br>enclosed medical<br>instruments. | or pouch in order to maintain<br>sterility of the enclosed<br>medical instruments. | |
| | Intended Sterilization Cycles<br>and Intended Tray Loads for<br>Tray models: VP0045,<br>VP0046, VP0047, VP0048,<br>VP0049, VP0050, VP0051,<br>VP0052 | Intended Sterilization Cycles<br>and Intended Tray Loads for<br>Tray models: VP0045,<br>VP0046, VP0047, VP0048,<br>VP0049, VP0050, VP0051,<br>VP0052 | |
| | V-PRO 60 & s2 Lumen<br>Cycle:<br>• Instruments with diffusion-<br>restricted spaces such as<br>the hinged portion of<br>forceps and scissors<br>• Non-lumened devices<br>including non-lumened<br>rigid and semi-rigid<br>endoscopes<br>• Medical devices, including<br>single, dual and triple<br>channeled rigid and semi-<br>rigid endoscopes, with the<br>following configurations:<br>o single or dual lumen<br>devices<br>■ ≥ 0.77 mm internal<br>diameter (ID) and ≤<br>410 mm in length<br>o triple lumen devices<br>■ ≥1.2 mm ID and ≤ 275<br>mm in length<br>■ ≥1.8 mm ID and ≤ 310<br>mm in length<br>or<br>■ ≥ 2.8 mm ID and ≤<br>317 mm in length | V-PRO 60 Lumen Cycle<br>• Instruments with diffusion-<br>restricted spaces such as the<br>hinged portion of forceps<br>and scissors<br>• Non-lumened devices<br>including non-lumened rigid<br>and semi-rigid endoscopes<br>• Medical devices, including<br>single, dual and triple<br>channeled rigid and semi-<br>rigid endoscopes, with the<br>following configurations:<br>► single or dual lumen<br>devices<br>≥ 0.77 mm ID and less<br>than or equal to 410 mm in<br>length<br>► triple lumen devices<br>≥1.2 mm ID and less than<br>or equal to 275 mm in<br>length<br>≥1.8 mm ID and less than<br>or equal to 310 mm in<br>length<br>or<br>≥2.8 mm ID and less than<br>or equal to 317 mm in<br>length | |
| Feature | PRO-LITE Sterilization<br>Tray (proposed) | PRO-LITE Sterilization<br>Tray (K172755) | Comparison |
| | V-PRO 60 & s2 Non Lumen<br>Cycle:<br>Non-lumened devices<br>including non-lumened rigid,<br>semi-rigid and flexible<br>endoscopes and non-<br>lumened devices with<br>diffusion-restricted spaces<br>such as the hinged portion of<br>forceps and scissors. | V-PRO 60 Non Lumen Cycle<br>- Non-lumened devices<br>including non-lumened rigid,<br>semi-rigid and flexible<br>endoscopes and non-lumened<br>devices with stainless steel or<br>titanium diffusion-restricted<br>spaces such as the hinged<br>portion of forceps and scissors. | |
| | V-PRO 60 & s2 Flexible<br>Cycle:<br>Load 1: One flexible<br>surgical endoscope or<br>bronchoscope with a light<br>cord (if not integral to<br>endoscope) and mat without<br>any additional load. The<br>flexible endoscope may be a:<br>• single or dual lumen<br>device with lumens that<br>are ≥ 1 mm ID and ≤<br>990 mm in length<br>Load 2: Non-lumened<br>devices including non-<br>lumened rigid, semi-rigid,<br>and flexible endoscopes and<br>non-lumened devices with<br>diffusion-restricted areas<br>such as the hinged portion of<br>forceps or scissors. Medical<br>devices, including rigid and<br>semi-rigid endoscopes, with<br>the following configurations:<br>• ≥ 2 mm ID and ≤ 400<br>mm in length<br>• ≥ 0.76 mm ID and ≤ 233<br>mm in length<br>• ≥ 1.0 mm ID and ≤ 254<br>mm in length | V-PRO 60 Flexible Cycle<br>- One flexible surgical<br>endoscope or bronchoscope<br>with a light cord (if not<br>integral to endoscope) and<br>mat without any additional<br>load. The flexible endoscope<br>may be a single or dual lumen<br>device with lumens that are ≥<br>1 mm ID and less than or<br>equal 990 mm in length | |
| Feature | PRO-LITE Sterilization<br>Tray (proposed) | PRO-LITE Sterilization<br>Tray (K172755) | Comparison |
| | Intended Sterilization Cycles<br>and Intended Tray Loads for<br>Tray models: VP0045,<br>VP0046, VP0047, VP0048,<br>VP0049 | | |
| | V-PRO s2 Fast Cycle:<br>• Non-lumened devices<br>including non-lumened<br>rigid, semi-rigid and<br>flexible endoscope, and<br>non-lumened devices with<br>diffusion-restricted areas<br>such as the hinged portion<br>of forceps or scissors<br>• Medical devices,<br>including single, dual and<br>triple channeled rigid and<br>semi-rigid endoscopes,<br>with the following<br>configurations:<br>o single or dual lumen<br>devices<br>■ ≥ 0.77 mm internal<br>diameter (ID) and ≤<br>410 mm in length<br>o triple lumen devices<br>■ ≥1.2 mm ID and ≤ 275<br>mm in length<br>■ ≥1.8 mm ID and ≤ 310<br>mm in length<br>or | | |
| | ■ ≥2.8 mm ID and ≤ 317<br>mm in length | | |
| | Intended Sterilization Cycles<br>and Intended Tray Loads for<br>Tray models: VP0045,<br>VP0046, VP0047, VP0048,<br>VP0049, VP0050, VP0051,<br>VP0052, VP0053 | Intended Sterilization Cycles<br>and Intended Tray Loads for<br>Tray models: VP0045,<br>VP0046, VP0047, VP0048,<br>VP0049, VP0050, VP0051,<br>VP0052, VP0053 | |
| | V-PRO 1, 1 Plus, maX &<br>maX 2 Lumen Cycle:<br>• Instruments with diffusion-<br>restricted spaces such as<br>the hinged portion of<br>forceps and scissors | V-PRO 1, 1 Plus, maX, &<br>maX 2 Lumen Cycle<br>• Instruments with diffusion-<br>restricted spaces such as the<br>the hinged portion of forceps<br>and scissors | |
| Feature | PRO-LITE Sterilization | PRO-LITE Sterilization | Comparison |
| | Tray (proposed) | Tray (K172755) | |
| | • Non-lumened devices<br>including non-lumened<br>rigid and semi-rigid<br>endoscopes<br>• Medical devices, including<br>single, dual and triple<br>channeled rigid and semi-<br>rigid endoscopes, with the<br>following configurations:<br>o single or dual lumen<br>devices<br>■ ≥ 0.77 mm ID and ≤<br>527 mm in length<br>o triple lumen devices<br>■ ≥ 1.2 mm ID and ≤<br>275 mm in length<br>■ ≥ 1.8 mm ID and ≤<br>310 mm in length<br>or<br>■ ≥2.8 mm ID and ≤ 317<br>mm in length | • Non-lumened devices<br>including non-lumened rigid<br>and semi-rigid endoscopes<br>· Medical devices, including<br>single, dual and triple<br>channeled rigid and semi-<br>rigid endoscopes, with the<br>following configurations:<br>> single or dual lumen<br>devices<br>≥ 0.77 mm ID and less<br>than or equal to 527 mm in<br>length<br>> triple lumen devices<br>≥1.2 mm ID and less than<br>or equal to 275 mm in<br>length<br>≥1.8 mm ID and less than<br>or equal to 310 mm in<br>length<br>or<br>≥2.8 mm ID and less than<br>or equal to 317 mm in<br>length | |
| | V-PRO 1, 1 Plus, maX &<br>maX 2 Non Lumen Cycle:<br>Non-lumened devices<br>including non-lumened rigid,<br>semi-rigid and flexible<br>endoscopes and non-<br>lumened devices with<br>stainless steel or titanium<br>diffusion-restricted spaces<br>such as the hinged portion of<br>forceps and scissors. | V-PRO 1 Plus, maX, & maX 2<br>Non Lumen Cycle<br>- Non-lumened devices<br>including non-lumened rigid,<br>semi-rigid and flexible<br>endoscopes and non-lumened<br>devices with stainless steel or<br>titanium diffusion-restricted<br>spaces such as the hinged<br>portion of forceps and scissors. | |
| | V-PRO 1, 1 Plus, maX &<br>maX 2 Flexible Cycle:<br>Load 1: Single or dual<br>lumen surgical flexible<br>endoscopes (such as those<br>used in ENT, Urology and<br>Surgical Care) and<br>bronchoscopes with a light<br>cord (if not integral to<br>endoscope) and mat with no<br>additional load. | V-PRO maX & maX 2<br>Flexible Cycle<br>Load 1: Single or dual lumen<br>surgical flexible endoscopes<br>(such as those used in ENT.<br>Urology and Surgical Care)<br>and<br>bronchoscopes with a light<br>cord (if not integral to<br>endoscope) and mat with no<br>additional load. | |
| Feature | PRO-LITE Sterilization<br>Tray (proposed) | PRO-LITE Sterilization<br>Tray (K172755) | Comparison |
| | The flexible endoscopes may<br>contain either:<br>• a single lumen that is ≥ 1<br>mm ID and ≤ 1050 mm in<br>length<br>• or two lumens with:<br>■ one lumen that is ≥ 1<br>mm ID and ≤ 990 mm in<br>length<br>■ and the other lumen that<br>is ≥ 1 mm ID and ≤ 850<br>mm in length<br>Load 2: Non-lumened<br>instruments including<br>instruments with diffusion-<br>restricted areas such as the<br>hinged portion of forceps or<br>scissors. | The flexible endoscopes may<br>contain either:<br>a single lumen that is ≥ 1 mm<br>ID and less than or equal 1050<br>mm in length<br>or two lumens with:<br>one lumen that is ≥ 1 mm ID<br>and less than or equal 990 mm<br>in length<br>and the other lumen that is ≥ 1<br>mm ID and less than or equal<br>850 mm in length<br>Load 2: Non-lumened<br>instruments including<br>instruments with diffusion-<br>restricted areas such as the<br>hinged portion of forceps or<br>scissors. | |
| | V-PRO maX 2 Fast Non<br>Lumen Cycle:<br>Non-lumened devices<br>including non-lumened rigid,<br>semi-rigid and flexible<br>endoscopes and non-<br>lumened devices with<br>stainless steel or titanium<br>diffusion-restricted spaces<br>such as the hinged portion of<br>forceps and scissors. | V-PRO maX 2 Fast Non<br>Lumen<br>Non-lumened devices<br>including non-lumened rigids,<br>semi-rigids and flexible<br>endoscopes and non-lumened<br>devices with stainless steel or<br>titanium diffusion-restricted<br>spaces such as the hinged<br>portion of forceps and scissors. | |
| | Instrument organizers are<br>optional accessories<br>intended to stabilize<br>cylindrical medical<br>instruments with in the<br>Sterilization Trays. | Instrument organizers are<br>optional accessories intended<br>to stabilize cylindrical medical<br>instruments within the PRO-<br>LITE Sterilization Trays. | |
| | Sterilization mats are<br>optional accessories<br>intended to cushion and<br>stabilize instruments within<br>the Sterilization Trays. | Sterilization mats are optional<br>accessories intended to cushion<br>and stabilize instruments…