Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a sterilization pouch, a passive containment product. The description focuses on its physical properties and compatibility with sterilization systems, with no mention of AI or ML.

Therapeutic

No
The device is a sterilization containment pouch used to maintain the sterility of medical devices, not to treat a disease or condition.

Diagnostic

No

Explanation: The device is a sterilization containment pouch for medical devices, used to maintain sterility until use. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device is a physical sterilization pouch/tubing made of Tyvek/plastic film, not software. The description focuses on its physical properties and performance in sterilization cycles.

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 for sterilization containment of medical devices and items before they are used on or in a patient. The purpose is to maintain sterility.
Device Description: The device is a sterilization containment pouch/tubing.
Function: Its function is to enclose items for sterilization and maintain sterility until use.
Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.

IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to provide diagnostic information. This device's function is entirely related to the preparation and storage of medical devices for use, not for diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose:

medical devices in a single or double pouch configuration
trays* containing medical devices in a single or double pouch configuration
small items requiring surface sterilization in a single pouch configuration within a tray*

to be sterilized in the Lumen, Non Lumen, Flexible and Fast Non Lumen Cycles of the V-PRO Low Temperature Sterilization Systems. The pouches are intended to maintain the sterility of the enclosed devices until used.

When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch.

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

FRG

Device Description

The proposed Vis-U-All Low Temperature Sterilization Pouches/Tubing is identical to the predicate and is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in V-PRO Low Temperature Sterilization Systems. As is the predicate device, the proposed device is available as a self seal pouch, a heat seal pouch, or heat seal tubing.

The purpose of K172749 is to add claims 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 Cycles 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 2-1).

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

health care providers

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)

Testing of the Vis-U-All Low Temperature Sterilization Pouches/Tubing as summarized in the table below demonstrated that the proposed pouch is qualified for use in the V-PRO maX 2 Fast Non Lumen Cycle and for sterilization of titanium mated surfaces (diffusion-restricted spaces) in the V-PRO 1 Plus, maX, and maX 2 Sterilizers Non Lumen Cycle and is as safe, as effective, and performs the same as the predicate device.

Test Results:

Effective Sterilant Penetration into Pouches (including pouched trays and, if applicable, pouches placed within a tray):
- V-PRO maX 2 Sterilizer Fast Non Lumen Cycle: Worst case test article shall be reproducibly sterilized under worst case abbreviated ½ cycle conditions for Fast Non Lumen Cycle. Conclusion: PASS
- V-PRO 1 Plus, maX, and maX 2 Sterilizer Non Lumen Cycle, diffusion restricted titanium claims: Diffusion-restricted spaces (composed of stainless steel and titanium, as well as contact points between medical devices and tray accessories) shall be reproducibly sterilized under worst case abbreviated ½ cycle conditions for Fast Non Lumen Cycle. Conclusion: PASS
- V-PRO 1 Plus, maX, and maX 2 Sterilizer Non Lumen Cycle, diffusion restricted titanium claims: Diffusion-restricted spaces (titanium) shall be reproducibly sterilized under worst case ½ cycle conditions for the Non Lumen Cycle. Conclusion: PASS
Pouch Integrity: Physical and Microbial Barrier Properties
- Tensile Strength: Pouch material tensile strength will show no statistical difference between processed and unprocessed samples. Conclusion: PASS
- Whole Package Integrity (Burst): Pouch burst strength will show no statistical difference between processed and unprocessed pouches. Conclusion: PASS
- Seal Strength: Pouch seal strength will show no statistical difference between processed and unprocessed pouches. Conclusion: PASS
- Microbial Retention: Tyvek microbial retention will show no statistical difference between processed and unprocessed pouches. Conclusion: PASS
Maintenance of Package Integrity: Packaged instruments shall remain sterile through event related and real time studies. Conclusion: PASS
Aeration: Hydrogen Peroxide Residuals: Hydrogen peroxide residuals on the pouch will be reduced to acceptable levels for dermal contact in Fast Non Lumen Cycle with 3 minute aeration. Conclusion: PASS
Cytotoxicity: Pouch materials shall be non-cytotoxic following worst case exposure in a V-PRO Sterilizer for Fast Non Lumen Cycle with 3 minute aeration. 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.

K160908

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.

K092745

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

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" underneath.

February 9, 2018

STERIS Corporation Bill Brodbeck, Ph.D. Director, Regulatory Affairs 5960 Heislev Road Mentor, Ohio 44060

Re: K172749

Trade/Device Name: Vis-U-All Low Temperature Sterilization Pouches/Tubing Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: January 9, 2018 Received: January 10, 2018

Dear Dr. Brodbeck:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

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 medical devices and radiation-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) K172749 Device Name Vis-U-All Low Temperature Sterilization Pouches/Tubing

Indications for Use (Describe)

Lumen Cycle

The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose:

o medical devices in a single or double pouch configuration
trays* containing medical devices in a single or double pouch configuration ●
small items requiring surface sterilization in a single pouch configuration within a tray*

to be sterilized in the Lumen. Flexible and Fast Non Lumen Cycles of the V-PRO Low Temperature Sterilization Systems. The pouches are intended to maintain the sterility of the enclosed devices until used.

When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch.

| Intended
Sterilization

Cycles	Intended Pouch Load when Medical Devices are:
	Directly Pouched or Placed Inside of a Tray* and the Tray*
Pouched
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 $( \ge )$ 0.77 mm ID and $( \le )$ 410 mm in length triple lumen devices $( \ge )$ 1.2 mm ID and $( \le )$ 275 mm in length $( \ge )$ 1.8 mm ID and $( \le )$ 310 mm in length or $( \ge )$ 2.8 mm ID and $( \le )$ 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: single or dual lumen device with lumens that are $( \ge )$ 1 mm ID and $( \lt )$ 990 mm in length
V-PRO 1, 1	Instruments with diffusion-restricted spaces such as the hinged
	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 $\leq$ 527 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 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
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 $\geq$ 1 mm ID and $\leq$ 1050 mm in length
	• or two lumens with:
	• one lumen that is $\geq$ 1 mm ID and $\leq$ 990 mm in length
	• and the other lumen that is $\geq$ 1 mm ID and $\leq$ 850 mm in
length
	Load 2: Non-lumened instruments including instruments with
diffusion-restricted areas such as the hinged portion of forceps or
scissors.
	• 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
V-PRO maX
2 Lumen
Cycle	configurations:
	o single or dual lumen devices
	■ $\geq$ 0.77 mm ID and $\leq$ 527 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 1
Plus & maX,
Non Lumen
Cycle	Non-lumened devices including non-lumened rigid, semi-rigid
and flexible endoscopes and non-lumened devices with titanium
diffusion-restricted spaces such as the hinged portion of forceps
and scissors.
V-PRO 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
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 $\geq$ 1 mm ID and $\leq$ 1050 mm in length
	• or two lumens with:
	• one lumen that is $\geq$ 1 mm ID and $\leq$ 990 mm in length
	• and the other lumen that is $\geq$ 1 mm ID and $\leq$ 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 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.
	* Trays must be legally marketed for use in the V-PRO Low Temperature Sterilization Sys
	a vent surface area to tray volume ratio $\geq$ 0.135 in-1 with the maximum number of instrument organizers

· Non-lumened devices including non-lumened rigid and semi-

Vis-U-All Pouch/Tubing Claims with V-PRO Sterilization Systems

3

4

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

installed.

_ Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

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510(k) Summary for K172749 Vis-U-All Low Temperature Sterilization Pouches/Tubing

STERIS Corporation 5960 Heisley Road Mentor, OH 44060

Contact:

Bill Brodbeck, Ph.D. Director, Regulatory Affairs Telephone: (440) 392-7690 Fax No: (440) 357-9198 E-mail: William_Brodbeck@steris.com

January 9, 2018 Date of Preparation:

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

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1. Device Name

| Trade Name: | Vis-U-All Low Temperature Sterilization
Pouches/Tubing |
|------------------------|-----------------------------------------------------------|
| Device Classification: | Class II |
| Common/Usual Name: | Sterilization pouch |
| Classification Name: | Sterilization wrap |
| Classification Number: | 21 CFR 880.6850 |
| Product Code: | FRG |

2. Predicate Device

Vis-U-All Low Temperature Sterilization Pouches/Tubing (K160908)

Reference Device - Vis-U-All Low Temperature Sterilization Pouch/Tubing (K092745)

3. Description of Device

The proposed Vis-U-All Low Temperature Sterilization Pouches/Tubing is identical to the predicate and is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in V-PRO Low Temperature Sterilization Systems. As is the predicate device, the proposed device is available as a self seal pouch, a heat seal pouch, or heat seal tubing.

The purpose of K172749 is to add claims 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 Cycles 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 2-1).

7

| 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 | Concurrent
Submission | | | | X |

Table 2-1: 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 Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose:

. medical devices in a single or double pouch configuration
trays* containing medical devices in a single or double pouch configuration
. small items requiring surface sterilization in a single pouch configuration within a tray*

to be sterilized in the Lumen, Non Lumen, Flexible and Fast Non Lumen Cycles of the V-PRO Low Temperature Sterilization Systems. The pouches are intended to maintain the sterility of the enclosed devices until used.

When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch.

| Intended
Sterilization
Cycles | Intended Pouch Load when Medical Devices are:
• Directly Pouched or
• Placed Inside of a Tray* and the Tray* Pouched |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
• ≥ 0.77 mm ID and ≤ 410 mm in length |
| Intended
Sterilization
Cycles | Intended Pouch Load when Medical Devices are:
Directly Pouched or Placed Inside of a Tray* and the Tray* Pouched 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:
single or dual lumen device with lumens that are $\geq$ 1 mm ID and $\leq$ 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 $\geq$ 0.77 mm ID and $\leq$ 527 mm in length 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 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
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 $\geq$ 1 mm ID and $\leq$ 1050 mm in length or two lumens with: one lumen that is $\geq$ 1 mm ID and $\leq$ 990 mm in length and the other lumen that is $\geq$ 1 mm ID and $\leq$ 850 mm in length |
| Intended
Sterilization
Cycles | Intended Pouch Load when Medical Devices are:
Directly Pouched or Placed Inside of a Tray* and the Tray* Pouched |
| | Load 2: Non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. |
| V-PRO 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 $\geq$ 0.77 mm ID and $\leq$ 527 mm in length 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 1 Plus
& maX, Non
Lumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors. |
| V-PROmaX 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 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 $\geq$ 1 mm ID and $\leq$ 1050 mm in length or two lumens with: one lumen that is $\geq$ 1 mm ID and $\leq$ 990 mm in length and the other lumen that is $\geq$ 1 mm ID and $\leq$ 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 rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless |
| Intended
Sterilization
Cycles | Intended Pouch Load when Medical Devices are: |
| | Directly Pouched or Placed Inside of a Tray* and the Tray* Pouched |
| | steel or titanium diffusion-restricted spaces such as the hinged
portion of forceps and scissors. |

Vis-U-All Pouch/Tubing Claims with V-PRO Sterilization Systems

8

9

10

Trays must be legally marketed for use in the V-PRO Low Temperature Sterilization Systems and contain a vent surface area to tray volume ratio ≥ 0.135 in-1 with the maximum number of instrument organizers installed.

5. Available Sizes / Configurations

| Type | Size
(inches unless specified) |
|-----------------|-----------------------------------|
| Heat Seal Pouch | 3 x 7 |
| | 4 x 9 |
| | 4 x 12 |
| | 4 x 22 |
| | 6 x 10 |
| | 8 x 12 |
| | 10 x 15 |
| | 12 x 18 |
| Self Seal Pouch | 3 x 7 |
| | 4 x 9 |
| | 4 x 12 |
| | 4 x 22 |
| | 6 x 10 |
| | 8 x 12 |
| | 10 x 15 |
| | 12 x 18 |
| Tubing | 3" x 100' |
| | 4" x 100' |
| | 6" x 100' |
| | 9" x 100' |
| | 14" x 100' |

6. Description of Safety and Substantial Equivalence

Testing of the Vis-U-All Low Temperature Sterilization Pouches/Tubing as summarized in the table below demonstrated that the proposed pouch is qualified for use in the V-PRO maX 2 Fast Non Lumen Cycle and for sterilization of titanium mated surfaces (diffusion-restricted spaces) in the V-PRO 1 Plus, maX, and maX 2 Sterilizers Non Lumen Cycle and is as safe, as effective, and performs the same as the predicate device.

11

Test	Acceptance Criteria	Conclusion
Effective
Sterilant
Penetration
into
Pouches
(including
pouched
trays and,
if
applicable,
pouches
placed
within a
tray):	V-PRO maX 2
Sterilizer Fast Non
Lumen Cycle	Worst case test article shall be
reproducibly sterilized under worst
case abbreviated ½ cycle conditions
for Fast Non Lumen Cycle.	PASS
	V-PRO 1 Plus,
maX, and maX 2
Sterilizer Non
Lumen Cycle,
diffusion restricted
titanium claims	Diffusion-restricted spaces
(composed of stainless steel and
titanium, as well as contact points
between medical devices and tray
accessories) shall be reproducibly
sterilized under worst case
abbreviated ½ cycle conditions for
Fast Non Lumen Cycle.	PASS
	V-PRO 1 Plus,
maX, and maX 2
Sterilizer Non
Lumen Cycle,
diffusion restricted
titanium claims	Diffusion-restricted spaces (titanium)
shall be reproducibly sterilized under
worst case ½ cycle conditions for the
Non Lumen Cycle.	PASS
Pouch
Integrity:
Physical
and
Microbial
Barrier
Properties	Tensile Strength	Pouch material tensile strength will
show no statistical difference between
processed and unprocessed samples.	PASS
	Whole Package
Integrity (Burst)	Pouch burst strength will show no
statistical difference between
processed and unprocessed pouches.	PASS
	Seal Strength	Pouch seal strength will show no
statistical difference between
processed and unprocessed pouches.	PASS
	Microbial
Retention	Tyvek microbial retention will show
no statistical difference between
processed and unprocessed pouches.	PASS
Maintenance of Package
Integrity	Packaged instruments shall remain
sterile through event related and real
time studies.	PASS
Aeration: Hydrogen Peroxide
Residuals	Hydrogen peroxide residuals on the
pouch will be reduced to acceptable
levels for dermal contact in Fast Non
Lumen Cycle with 3 minute aeration.	PASS
Cytotoxicity	Pouch materials shall be non-
cytotoxic following worst case
exposure in a V-PRO Sterilizer for
Fast Non Lumen Cycle with 3 minute
aeration.	PASS

12

Comparison of Technological Characteristics 7.

| Characteristic | Proposed
K172749 | Predicate
K160908 | Comparison |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Materials of
Construction | Tyvek and plastic | Tyvek and plastic | Same |
| Types | Self Seal, Heat Seal, Tubing | Self Seal, Heat Seal, Tubing | Same |
| Chemical
Indicator | Ethylene Oxide Process
Chemical Indicator Printed
on both sides of Tyvek | Ethylene Oxide Process
Chemical Indicator Printed on
both sides of Tyvek | Same |
| Intended Use | The Vis-U-All Low
Temperature Sterilization
Pouches/Tubing are
sterilization containment
pouches for use by health
care providers to enclose:
• medical devices in a single
or double pouch
configuration
• trays* containing medical
devices in a single or double
pouch configuration
• small items requiring
surface sterilization in a
single pouch configuration
within a tray*
to be sterilized in the Lumen,
Non Lumen, Flexible and
Fast Non Lumen Cycles of
the V-PRO Low
Temperature
Sterilization Systems. The
pouches maintain the sterility
of the enclosed devices until
used.

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. | The Vis-U-All Low
Temperature Sterilization
Pouches/Tubing are
sterilization containment
pouches for use by health care
providers to enclose:
• medical devices in a single
or double pouch configuration
• trays* containing medical
devices in a single or double
pouch configuration
• small items requiring
surface sterilization in a single
pouch configuration within a
tray*
to be sterilized in the Lumen,
Non Lumen and Flexible
Cycles of the V-PRO Low
Temperature Sterilization
Systems. The pouches
maintain the sterility of the
enclosed devices until used.

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. | Similar |
| | | | |
| Device Features | Chevron end of pouches for ease of opening Chemical process indicator for EO | Chevron end of pouches for ease of opening Chemical process indicator for EO | Same |
| Maintenance of
Sterility | 1 year | 1 year | Same |

13

8. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K160908.