PRO-LITE Sterilization Tray

K183402 · STERIS Corporation · KCT · Mar 1, 2019 · General Hospital

Device Facts

• Record ID: K183402
• Device Name: PRO-LITE Sterilization Tray
• Applicant: STERIS Corporation
• Product Code: KCT · General Hospital
• Decision Date: Mar 1, 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 · Default Cycle of the STERRAD 100S Sterilizer · Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers · Standard, Flex Scope, Express, DUO Cycles of the STERRAD 100NX with ALLClear Technology Sterilizers 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 rigid containers (base and lid) used to hold medical instruments during low-temperature sterilization cycles (V-PRO and STERRAD systems). Trays feature holes for sterilant penetration and clamping mechanisms to secure the lid. Optional accessories include silicone instrument organizers and diamond-grid sterilization mats to cushion and stabilize devices. The device is not a sterile barrier; it must be enclosed in an FDA-cleared sterilization wrap or pouch. Used in clinical settings by healthcare staff to organize and protect instruments during processing. The tray design facilitates sterilant exposure to the enclosed load, ensuring effective sterilization of lumened and non-lumened devices, including endoscopes and surgical instruments. Benefits include improved instrument organization, protection of delicate devices, and validated compatibility with specific low-temperature sterilization cycles.

Clinical Evidence

Bench testing only. Testing included demonstration of effective sterilant penetration, drying and aeration, material compatibility, biocompatibility, and cleaning efficacy across all claimed STERRAD and V-PRO sterilization cycles. All tests met predefined acceptance criteria.

Technological Characteristics

Materials: Mineral-filled polypropylene (tray base/lid), medical-grade silicone (mats/organizers, USP grade VI), stainless steel. Design: Cassette-style tray with lid clamping mechanism and ventilation holes. Vent-to-volume ratio: 0.135 in^-1. Connectivity: None. Sterilization: Compatible with V-PRO and STERRAD low-temperature systems. No software or electronics.

Indications for Use

Indicated for containing medical devices during sterilization in specific V-PRO and STERRAD low-temperature sterilization cycles. Patient population not specified; intended for use by healthcare professionals in clinical settings to process reusable medical instruments.

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)

Reference Devices

• PRO-LITE Sterilization Tray (K183301)

Submission Summary (Full Text)

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March 25, 2019

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

Re: K183402

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

Dear Jennifer Nalepka:

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

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely,

# Clarence W. Murray lii III -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K183402

### Device Name PRO-LITE Sterilization Trays

### Indications for Use (Describe)

- The PRO-LITE™ Sterilization Trays are used to contain medical devices for sterilization in the following cycles: · Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO® Low Temperature Sterilization Systems
- · Default Cycle of the STERRAD 100S Sterilizer
- Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers
- · Standard, Flex Scope, Express, DUO Cycles of the STERRAD 100NX with ALLClear Technology Sterilizers

*STERRAD and ALLClear are trademarks of Advanced Sterilization Products

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

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

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

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

### V-PRO 60 & s2 Lumen Cycle

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

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

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

### V-PRO 60 & s2 Flexible Cycle

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

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

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

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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

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

STERRAD 100S Default Cycle

- · Metal and non-metal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
- · Metal and non metal lumened instruments with:
- ≥ 6 mm ID and ≤ 310 mm in length
- · Medical devices with a single stainless steel lumen with:
- ≥ 1 mm ID and ≤ 125 mm in length
- · ≥ 2 mm ID and ≤ 250 mm in length
- ≥ 3 mm ID and ≤ 400 mm in length

Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0046, VP0049

STERRAD NX and NX with ALLClear Technology Standard Cycle

- · Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
- · Medical devices with a single stainless steel lumen with:
- ≥ 1 mm ID and ≤ 150 mm in length
- ≥ 2 mm ID and ≤ 400 mm in length

STERRAD NX and NX with ALLClear Technology Advanced Cycle

- · Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
- · Medical Devices, including most flexible endoscopes, with:
- · a single stainless steel lumen with:
- · ≥ 1 mm ID and < 500 mm in length
- · single channel polyethylene and Teflon (polytetrafluoroethylene):
- ≥ 1 mm ID and ≤ 850 mm in length

Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0047, VP0047, VP0048, VP0049, VP0051, VP0052, VP0053

STERRAD 100NX and 100NX with ALLClear Technology Standard Cycle

- · Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
- · Medical devices with a single stainless steel lumen with:
- · ≥ 0.7 mm ID and ≤ 500 mm in length

STERRAD 100NX and 100NX with ALLClear Technology Flex Scope Cycle

- · Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
- · Medical Devices, including most flexible endoscopes, with:
- · Single channel polyethylene and Teflon (polytetrafluoroethylene)
- ≥ 1 mm ID and ≤ 850 mm in length

STERRAD 100NX and 100NX with ALLClear Technology Express Cycle

- · Metal and nonmetal medical devices and instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
STERRAD 100NX and 100NX with ALLClear Technology Duo Cycle

- · Medical devices including:

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- most flexible endoscopes with a single channel of polyethylene and Teflon (polytetrafluoroethylene) with ≥ 1 mm ID and ≤ 875 mm in length
- · accessory devices that are normally connected to a flexible endoscope during use
- flexible endoscopes without lumens

Instrument organizers are optional accessories intended to stabilize cylindrical instruments within the Sterlization 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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# K183402 510(k) Summary For PRO-LITE™ Sterilization Tray

# Sponsor Facility

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

Contact: Jennifer Nalepka Senior Regulatory Affairs Specialist

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

Submission Date: December 6, 2018

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

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#### 1. Device Name

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

#### 2. Predicate Device

PRO-LITE Sterilization Tray, K172755

Reference Device: PRO-LITE Sterilization Tray, K183301

#### 3. Description of Device

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

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

and the following STERRAD Sterilizers and cycles:

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

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

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

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

Table 1. External Dimensions of Tray Line

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

Table 2. Instrument Organizer Model Numbers

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

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

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

| | | Table 3. Silicone Mat Model Numbers |
|--|--|-------------------------------------|
| | | |

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

- STERRAD 100S Sterilizer Default Cycle

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

#### 4. Indications for Use

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

- Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the ● V-PRO® Low Temperature Sterilization Systems
- Default Cycle of the STERRAD®* 100S Sterilizer
- Standard and Advanced Cycles of the STERRAD NX and NX with . ALLClear Technology Sterilizers
- Standard, Flex Scope, Express and DUO Cycles of the STERRAD 100NX . and 100 NX with ALLClear Technology Sterilizers

*STERRAD and ALLClear are trademarks of Advanced Sterilization Products

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

- wrapped with a legally marketed sterilization wrap for use in the V-PRO ● or STERRAD Sterilization Systems. or
- . placed inside a legally marketed pouch for enclosing trays in the V-PRO or STERRAD Sterilization Systems.

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

| Tray Models | Intended<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>and s2 Lumen<br>Cycle | · Instruments with diffusion-restricted spaces such as the<br>hinged portion of forceps and scissors<br>· Non-lumened devices including non-lumened rigid and<br>semi-rigid endoscopes<br>· Medical devices, including single, dual and triple<br>channeled rigid and semi-rigid endoscopes, with the<br>following configurations:<br>o single or dual lumen devices<br>· ≥ 0.77 mm ID and ≤ 410 mm in length<br>o triple lumen devices<br>· ≥ 1.2 mm ID and ≤ 275 mm in length<br>· ≥ 1.8 mm ID and ≤ 310 mm in length<br>or<br>· > 2.8 mm ID and ≤ 317 mm in length |
| Tray Models | Intended<br>Sterilization<br>Cycles | Intended Tray Load |
| | V-PRO 60<br>and s2 Non<br>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<br>and s2<br>Flexible<br>Cycle | Load 1: One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a:<br>o single or dual lumen device with lumens that are $≥$ 1 mm ID and $≤$ 990 mm in length<br>Load 2: Non-lumened devices including non-lumened rigid, semi-rigid, and flexible endoscopes and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps or scissors. Medical devices, including rigid and semi-rigid endoscopes, with the following configurations:<br>o $≥$ 2.0 mm ID and $≤$ 400 mm in length<br>o $≥$ 1.0 mm ID and $≤$ 254 mm in length<br>o $≥$ 0.76 mm ID and $≤$ 233 mm in length |
| VP0045<br>VP0046<br>VP0047<br>VP0048<br>VP0049 | V-PRO s2<br>Fast 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>o single or dual lumen devices<br>▪ $≥$ 0.77 mm internal diameter (ID) and $≤$ 410 mm in length<br>o triple lumen devices<br>▪ $≥$ 1.2 mm ID and $≤$ 275 mm in length<br>▪ $≥$ 1.8 mm ID and $≤$ 310 mm in length, or<br>▪ $≥$ 2.8 mm ID and $≤$ 317 mm in length |
| 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>o single or dual lumen devices<br>▪ $≥$ 0.77 mm ID and $≤$ 527 mm in length<br>o triple lumen devices<br>▪ $≥$ 1.2 mm ID and $≤$ 275 mm in length<br>▪ $≥$ 1.8 mm ID and $≤$ 310 mm in length<br>or<br>▪ $≥$ 2.8 mm ID and $≤$ 317 mm in length |
| Tray Models | Intended<br>Sterilization<br>Cycles | Intended Tray Load |
| | V-PRO 1<br>Plus, maX &<br>maX 2 Non<br>Lumen Cycle | Non-lumened devices including non-lumened rigid, semi-<br>rigid and flexible endoscopes and non-lumened devices<br>with stainless steel or titanium diffusion-restricted spaces<br>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<br>endoscopes (such as those used in ENT, Urology and<br>Surgical Care) and bronchoscopes with a light cord (if not<br>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<br>length or two lumens with: one lumen that is $\ge$ 1 mm ID and $\le$ 990 mm in length and the other lumen that is $\ge$ 1 mm ID and $\le$ 850 mm in lengthLoad 2: Non-lumened instruments including instruments |
| | | with diffusion-restricted areas such as the hinged portion<br>of forceps or scissors. |
| | V-PRO maX<br>2 Fast Non<br>Lumen Cycle | Non-lumened devices including non-lumened rigid, semi-<br>rigid and flexible endoscopes and non-lumened devices<br>with stainless steel or titanium diffusion-restricted spaces<br>such as the hinged portion of forceps and scissors. |
| VP0045<br>VP0046<br>VP0047<br>VP0048<br>VP0049<br>VP0050<br>VP0051<br>VP0052 | STERRAD<br>100S Default<br>Cycle | Metal and nonmetal medical devices including<br>instruments which have diffusion-restricted spaces, such<br>as the hinged portion of forceps and scissors.<br>Metal and nonmetal lumened instruments with:<br>$\ge$ 6 mm ID and $\le$ 310 mm in lengthMedical devices with a single stainless steel lumen with: $\ge$ 1 mm ID and $\le$ 125 mm in length $\ge$ 2 mm ID and $\le$ 250 mm in length $\ge$ 3 mm ID and $\le$ 400 mm in length |
| VP0045<br>VP0046<br>VP0048<br>VP0049 | STERRAD<br>NX and NX<br>with<br>ALLClear<br>Technology<br>Standard<br>Cycle | Metal and nonmetal medical devices including<br>instruments which have diffusion-restricted spaces, such<br>as the hinged portion of forceps and scissors.<br>Medical devices with a single stainless steel lumen with: $\ge$ 1 mm ID and $\le$ 150 mm in length $\ge$ 2 mm ID and $\le$ 400 mm in length |
| VP0048<br>VP0049 | STERRAD<br>NX and NX<br>with<br>ALLClear<br>Technology | Metal and nonmetal medical devices including<br>instruments which have diffusion-restricted spaces, such<br>as the hinged portion of forceps and scissors.<br>Medical Devices, including most flexible endoscopes,<br>with: |
| Tray Models | Intended<br>Sterilization<br>Cycles | Intended Tray Load |
| | Advanced<br>Cycle | $\geq$ 1 mm ID and $\leq$ 500 mm in length Single channel polyethylene and Teflon<br>(polytetrafluoroethylene) $\geq$ 1 mm ID and $\leq$ 850 mm in length |
| | STERRAD<br>100NX and<br>100NX with<br>ALLClear<br>Technology<br>Standard<br>Cycle | Metal and nonmetal medical devices including<br>instruments which have diffusion-restricted spaces, such<br>as the hinged portion of forceps and scissors.<br>Medical devices with a single stainless steel lumen with: $\geq$ 0.7 mm ID and $\leq$ 500 mm in length |
| VP0045<br>VP0046<br>VP0047<br>VP0048<br>VP0049<br>VP0051<br>VP0052<br>VP0053 | STERRAD<br>100NX and<br>100NX with<br>ALLClear<br>Technology<br>Flex Scope<br>Cycle | Metal and nonmetal medical devices including<br>instruments which have diffusion-restricted spaces, such<br>as the hinged portion of forceps and scissors.<br>Medical Devices, including most flexible endoscopes,<br>with: Single channel polyethylene and Teflon<br>(polytetrafluoroethylene) $\geq$ 1 mm ID and $\leq$ 850 mm in length |
| | STERRAD<br>100NX and<br>100NX with<br>ALLClear<br>Technology<br>Express<br>Cycle | Metal and nonmetal medical devices surfaces and<br>instruments which have diffusion-restricted spaces, such<br>as the hinged portion of forceps and scissors. |
| | STERRAD<br>100NX and<br>100NX with<br>ALLClear<br>Technology<br>Duo Cycle | Medical devices including: most flexible endoscopes with a single channel of<br>polyethylene and Teflon (polytetrafluoroethylene)<br>with $\geq$ 1 mm ID and $\leq$ 875 mm in length accessory devices that are normally connected to a<br>flexible endoscope during use flexible endoscopes without lumens |

{10}------------------------------------------------

{11}------------------------------------------------

{12}------------------------------------------------

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

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

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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 Characteristics

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

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

| Feature | PRO-LITE Sterilization Tray<br>(K183402) | PRO-LITE Sterilization Tray<br>(K172755) |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The PRO-LITE Sterilization Trays are<br>used to contain medical devices for<br>sterilization in the following Cycles:<br>• Lumen, Non Lumen, Flexible, Fast<br>Non Lumen and Fast Cycles of the<br>V-PRO® Low Temperature<br>Sterilization Systems<br>• Default Cycle of the STERRAD*<br>100S Sterilizer<br>• Standard and Advanced Cycles of<br>the STERRAD NX and NX with<br>ALLClear Technology Sterilizers<br>• Standard, Flex Scope, Express and<br>DUO Cycles of the STERRAD<br>100NX and 100NX with ALLClear<br>Technology Sterilizers<br>* STERRAD and ALLClear are<br>trademarks of Advanced Sterilization<br>Products<br>Prior to placing in the Sterilizer, the<br>trays must either be:<br>• wrapped with a legally marketed<br>sterilization wrap for use in the V-<br>PRO or STERRAD Sterilization<br>Systems<br>• placed inside a legally marketed<br>pouch for enclosing trays in the V- | The PRO-LITE Sterilization Trays are<br>used to contain medical devices for<br>sterilization in the Lumen, Non Lumen,<br>Flexible and Fast Non Lumen Cycles<br>of the V-PRO Low Temperature<br>Sterilization Systems. Prior to placing<br>in the Sterilizer, the trays must either<br>be:<br>• wrapped with a legally marketed<br>sterilization wrap for use in the V-<br>PRO Low Temperature Sterilization<br>Systems or<br>• placed inside a legally marketed<br>pouch for enclosing trays in the V-<br>PRO Low Temperature Sterilization<br>Systems. |
| Feature | PRO-LITE Sterilization Tray<br>(K183402) | PRO-LITE Sterilization Tray<br>(K172755) |
| | PRO or STERRAD Sterilization<br>Systems. | |
| | The PRO-LITE Sterilization Trays are<br>not intended to maintain sterility; they<br>are intended to be used in conjunction<br>with a validated, FDA-cleared<br>sterilization wrap or pouch in order to<br>maintain sterility of the enclosed<br>medical instruments. | The PRO-LITE Sterilization Trays are<br>not intended to maintain sterility; they<br>are intended to be used in conjunction<br>with a validated, FDA-cleared<br>sterilization wrap or pouch in order to<br>maintain sterility of the enclosed<br>medical instruments. |
| | Intended Sterilization Cycles and<br>Intended Tray Loads for Tray models:<br>VP0045, VP0046, VP0047, VP0048,<br>VP0049, VP0050, VP0051, VP0052 | Intended Sterilization Cycles and<br>Intended Tray Loads for Tray models:<br>VP0045, VP0046, VP0047, VP0048,<br>VP0049, VP0050, VP0051, VP0052 |
| | V-PRO 60 & s2 Lumen Cycle:<br>• Instruments with diffusion-restricted<br>spaces such as the hinged portion of<br>forceps and scissors<br>• Non-lumened devices including non-<br>lumened rigid and semi-rigid<br>endoscopes | V-PRO 60 Lumen Cycle<br>• Instruments with diffusion-restricted<br>spaces such as the hinged portion of<br>forceps and scissors<br>• Non-lumened devices including non-<br>lumened rigid and semi-rigid<br>endoscopes |
| | • Medical devices, including single,<br>dual and triple channeled rigid and<br>semi-rigid endoscopes, with the<br>following configurations:<br>o single or dual lumen devices<br>■ ≥ 0.77 mm internal diameter (ID)<br>and ≤ 410 mm in length<br>o triple lumen devices<br>■ ≥1.2 mm ID and ≤ 275 mm in<br>length<br>■ ≥1.8 mm ID and ≤ 310 mm in<br>length<br>or<br>■ ≥ 2.8 mm ID and ≤ 317 mm in<br>length | • Medical devices, including single,<br>dual and triple channeled rigid and<br>semi-rigid endoscopes, with the<br>following configurations:<br>> single or dual lumen devices<br>≥ 0.77 mm ID and less than or<br>equal to 410 mm in length<br>> triple lumen devices<br>≥1.2 mm ID and less than or equal<br>to 275 mm in length<br>≥1.8 mm ID and less than or equal<br>to 310 mm in length<br>or<br>≥2.8 mm ID and less than or equal<br>to 317 mm in length |
| | length<br>V-PRO 60 & s2 Non Lumen Cycle:<br>Non-lumened devices including non-<br>lumened rigid, semi-rigid and flexible<br>endoscopes and non-lumened devices<br>with diffusion-restricted spaces such as<br>the hinged portion of forceps and<br>scissors.<br>V-PRO 60 & s2 Flexible Cycle: | to 317 mm in length<br>V-PRO 60 Non Lumen Cycle<br>- Non-lumened devices including non-<br>lumened rigid, semi-rigid and flexible<br>endoscopes and non-lumened devices<br>with stainless steel or titanium<br>diffusion-restricted spaces such as the<br>hinged portion of forceps and scissors.<br>V-PRO 60 Flexible Cycle |
| Feature | PRO-LITE Sterilization Tray<br>(K183402) | PRO-LITE Sterilization Tray<br>(K172755) |
| | Load 1: One flexible surgical<br>endoscope or bronchoscope with a<br>light cord (if not integral to endoscope)<br>and mat without any additional load.<br>The flexible endoscope may be a:<br>o single or dual lumen device with<br>lumens that are $\ge$ 1 mm ID and $\le$<br>990 mm in length | - One flexible surgical endoscope or<br>bronchoscope with a light cord (if not<br>integral to endoscope) and mat<br>without any additional load. The<br>flexible endoscope may be a single or<br>dual lumen device with lumens that<br>are $\ge$ 1 mm ID and less than or equal<br>990 mm in length |
| | Load 2: Non-lumened devices<br>including non-lumened rigid, semi-<br>rigid, and flexible endoscopes and non-<br>lumened devices with diffusion-<br>restricted areas such as the hinged<br>portion of forceps or scissors. Medical<br>devices, including rigid and semi-rigid<br>endoscopes, with the following<br>configurations:<br>o $\ge$ 2 mm ID and $\le$ 400 mm in length<br>o $\ge$ 0.76 mm ID and $\le$ 233 mm in<br>length<br>o $\ge$ 1.0 mm ID and $\le$ 254 mm in<br>length | |
| | Intended Sterilization Cycles and<br>Intended Tray Loads for Tray models:<br>VP0045, VP0046, VP0047, VP0048,<br>VP0049 | |
| | V-PRO s2 Fast Cycle:<br>• Non-lumened devices including non-<br>lumened rigid, semi-rigid and<br>flexible endoscope, and non-lumened<br>devices with diffusion-restricted<br>areas such as the hinged portion of<br>forceps or scissors<br>• Medical devices, including single,<br>dual and triple channeled rigid and<br>semi-rigid endoscopes, with the<br>following configurations:<br>o single or dual lumen devices<br>■ $\ge$ 0.77 mm internal diameter (ID)<br>and $\le$ 410 mm in length<br>o triple lumen devices<br>■ $\ge$ 1.2 mm ID and $\le$ 275 mm in<br>length<br>■ $\ge$ 1.8 mm ID and $\le$ 310 mm in<br>length<br>or | |
| Feature | PRO-LITE Sterilization Tray<br>(K183402) | PRO-LITE Sterilization Tray<br>(K172755) |
| | ■ ≥2.8 mm ID and ≤ 317 mm in<br>length | |
| | Intended Sterilization Cycles and<br>Intended Tray Loads for Tray models:<br>VP0045, VP0046, VP0047, VP0048,<br>VP0049, VP0050, VP0051, VP0052,<br>VP0053 | Intended Sterilization Cycles and<br>Intended Tray Loads for Tray models:<br>VP0045, VP0046, VP0047, VP0048,<br>VP0049, VP0050, VP0051, VP0052,<br>VP0053 |
| | V-PRO 1, 1 Plus, maX & maX 2<br>Lumen Cycle:<br>• Instruments with diffusion-restricted<br>spaces such as the hinged portion of<br>forceps and scissors<br>• Non-lumened devices including non-<br>lumened rigid and semi-rigid<br>endoscopes<br>• Medical devices, including single,<br>dual and triple channeled rigid and<br>semi-rigid endoscopes, with the<br>following configurations:<br>o single or dual lumen devices<br>■ ≥ 0.77 mm ID and ≤ 527 mm in<br>length<br>o triple lumen devices<br>■ ≥ 1.2 mm ID and ≤ 275 mm in<br>length<br>■ ≥ 1.8 mm ID and ≤ 310 mm in<br>length<br>or<br>■ ≥2.8 mm ID and ≤ 317 mm in<br>length | V-PRO 1, 1 Plus, maX, & maX 2<br>Lumen Cycle<br>• Instruments with diffusion-restricted<br>spaces such as the<br>hinged portion of forceps and<br>scissors<br>• Non-lumened devices including non-<br>lumened rigid and semi-rigid<br>endoscopes<br>• Medical devices, including single,<br>dual and triple channeled rigid and<br>semi-<br>rigid endoscopes, with the following<br>configurations:<br>➤ single or dual lumen devices<br>≥ 0.77 mm ID and less than or<br>equal to 527 mm in length<br>➤ triple lumen devices<br>≥1.2 mm ID and less than or equal<br>to 275 mm in length<br>≥1.8 mm ID and less than or equal<br>to 310 mm in length<br>or<br>≥2.8 mm ID and less than or equal<br>to 317 mm in length |
| | V-PRO 1, 1 Plus, maX & maX 2 Non<br>Lumen Cycle:<br>Non-lumened devices including non-<br>lumened rigid, semi-rigid and flexible<br>endoscopes and non-lumened devices<br>with stainless steel or titanium<br>diffusion-restricted spaces such as the<br>hinged portion of forceps and scissors. | V-PRO 1 Plus, maX, & maX 2 Non<br>Lumen Cycle<br>Non-lumened devices including non-<br>lumened rigid, semi-rigid and flexible<br>endoscopes and non-lumened devices<br>with stainless steel or titanium<br>diffusion-restricted spaces such as the<br>hinged portion of forceps and scissors. |
| | V-PRO 1, 1 Plus, maX & maX 2<br>Flexible Cycle:<br>Load 1: Single or dual lumen surgical<br>flexible endoscopes (such as those<br>used in ENT, Urology and Surgical | V-PRO maX & maX 2 Flexible Cycle<br>Load 1: Single or dual lumen surgical<br>flexible endoscopes (such as those<br>used in ENT, Urology and Surgical |
| Feature | PRO-LITE Sterilization Tray<br>(K183402) | PRO-LITE Sterilization Tray<br>(K172755) |
| | 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…