Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a sterilization pouch, a passive containment product. The description focuses on material properties and sterilization compatibility, with no mention of AI/ML capabilities.

Therapeutic

No
This device is a sterilization containment pouch used to maintain the sterility of medical devices, not to provide therapy itself.

Diagnostic

No

The device is a sterilization containment pouch, not a diagnostic tool. Its purpose is to maintain the sterility of medical devices after they are sterilized.

SaMD (Software as a Medical Device)

No

The device is a physical sterilization pouch made of Tyvek and plastic film, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, 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 trays. This is a process related to preparing medical devices for use, not for diagnosing a condition or obtaining information about a patient's health from a sample.
Device Description: The device is described as a sterilization containment pouch. This aligns with its function in the sterilization process.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body, provide information for diagnosis, monitoring, or treatment, or any other activity typically associated with IVD devices.

Therefore, the Vis-U-All Low Temperature Sterilization Pouches/Tubing are classified as a medical device used in the sterilization process, not an In Vitro Diagnostic device.

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, Fast Non Lumen and Fast Cycles of the V-PRO® Low Temperature Sterilization Systems. The pouches 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. Available sizes and configurations are shown in Table 5-1.

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)

Performance Test Summary (Table 5-4)
Test: Effective Sterilant Penetration into Pouches (including pouched trays and, if applicable, pouches placed within a tray):

V-PRO s2 Sterilizer Fast Cycle:
- Acceptance Criteria: Worst case stainless steel lumen test articles shall be reproducibly sterilized under worst case 1½ cycle conditions for the Fast Cycle.
- Conclusion: PASS
- Acceptance Criteria: Diffusion-restricted spaces shall be reproducibly sterilized under worst case 1½ cycle conditions for Fast Cycle.
- Conclusion: PASS
- Acceptance Criteria: Contact points between medical devices and tray accessories shall be reproducibly sterilized under worst case 1½ cycle conditions for the Fast Cycle.
- Conclusion: PASS
- Acceptance Criteria: Worst case surface sterilization test articles shall be reproducibly sterilized under worst case 1½ cycle conditions for the Fast Cycle.
- Conclusion: PASS
V-PRO 60 & s2 Sterilizer Non Lumen Cycle, diffusion-restricted spaces claims:
- Acceptance Criteria: Diffusion-restricted spaces shall be reproducibly sterilized under worst case 1½ cycle conditions for the Non Lumen Cycle.
- Conclusion: PASS
V-PRO 60 & s2 Sterilizer Flexible Cycle, diffusion-restricted spaces claims:
- Acceptance Criteria: Diffusion-restricted spaces shall be reproducibly sterilized under worst case 1½ cycle conditions for the Flexible Cycle
- Conclusion: PASS
V-PRO 60 & s2 Sterilizer Flexible Cycle extended claims:
- Acceptance Criteria: Stainless steel test articles shall be reproducibly sterilized under worst case 1½ cycle conditions for the Flexible Cycle.
- Conclusion: PASS

Test: Pouch Integrity: Physical and Microbial Barrier Properties

Tensile Strength:
- Acceptance Criteria: Pouch material tensile strength will show no statistical difference between processed and unprocessed samples.
- Conclusion: PASS
Whole Package Integrity (Burst):
- Acceptance Criteria: Pouch burst strength will show no statistical difference between processed and unprocessed pouches.
- Conclusion: PASS
Seal Strength:
- Acceptance Criteria: Pouch seal strength will show no statistical difference between processed and unprocessed pouches.
- Conclusion: PASS
Microbial Retention:
- Acceptance Criteria: Tyvek microbial retention will show no statistical difference between processed and unprocessed pouches.
- Conclusion: PASS
Maintenance of Package Integrity:
- Acceptance Criteria: Packaged instruments shall remain sterile through event related and real time studies.
- Conclusion: PASS
Aeration: Hydrogen Peroxide Residuals:
- Acceptance Criteria: 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

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.

K172749

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

Not Found

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

Not Found

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).

Summary

0

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

January 3, 2018

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

Re: K183297

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: 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

1

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 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.

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

2

Indications for Use

510(k) Number (if known) K183297

Device Name

Vis-U-All Low Temperature Sterilization Pouches/Tubing

Indications for Use (Describe)

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 Fast Cycles of the V-PRO® Low Temperature Sterilization Systems. The pouches 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 and Intended Pouch Loads when Medical Devices are:

· Directly pouched
· Placed inside of a tray* and the tray pouched*

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, 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 1.2 mm ID and Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

5

Image /page/5/Picture/1 description: The image shows the STERIS logo. The word "STERIS" is written in a bold, serif font. A registered trademark symbol is present to the right of the word. Below the word is a graphic of three blue horizontal wavy lines.

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

Sponsor Facility

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

Contact: Jennifer Nalepka Senior Regulatory Affairs Specialist

Telephone: (440) 392-7458 Fax No: (440) 357-9198 e-mail: jennifer_nalepka@steris.com

Submission Date: December 30, 2018

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

6

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 |

Predicate Device 2.

Vis-U-All Low Temperature Sterilization Pouches/Tubing (K172749)

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. Available sizes and configurations are shown in Table 5-1.

Table 5-1. Sizes and Configurations of Vis-U-All Low Temperature Sterilization Pouches/Tubing

| 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 |

7

	10 x 15
	12 x 18
	8 x 21*
	8 x 27*
	9 x 27*
	11 x 22*
	12 x 27*
	3" x 100'
	4" x 100'
Tubing	6" x 100'
	9" x 100'
	14" x 100'

Additional pouch sizes

The purpose of this submission is to add claims for:

Use with devices having stainless steel lumens of the following . configurations:
- o > 2.0 mm internal diameter (ID) and ≤ 400 mm in length
- o ≥ 1.0 mm ID and ≤ 254 in length
- o ≥ 0.76 mm ID and ≤ 233 mm in length

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

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 and Flexible Cycles.
Use in the V-PRO s2 Sterilizer Fast Lumen Cycle ●
. Addition of the V-PRO s2 Sterilizer to the indications for use in the Lumen Cycle of the V-PRO 60 Sterilizer. The V-PRO s2 Sterilizer Lumen Cycle is performed identically to the previously cleared cycle listed in Table 5-2. The updated claims being sought for the V-PRO 60/s2 Sterilizer Non Lumen and Flexible Cycles as well as the V-PRO s2 Sterilizer Fast Cycle are the subject of a concurrent submission (K182528).
Notify FDA of an extension of the self seal pouch line to include five additional pouch models whose sizes were optimized to contain the smaller PRO-LITE Sterilization Trays that has recently been implemented.

8

| Cycle | Most Recent
Premarket
Notification Clearance | V-PRO 60 | V-PRO s2 |
|-----------------|----------------------------------------------------|----------|----------|
| Lumen Cycle | K172319 | X | X |
| Non Lumen Cycle | K172319 and | X | X |
| Flexible Cycle | Concurrent submission
(K182827) | X | X |
| Fast Cycle | Concurrent Submission
(K182827) | | X |

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, Fast Non Lumen and Fast Cycles of the V-PRO® Low Temperature Sterilization Systems. The pouches 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 &
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 and semi-
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 | |
| 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 &
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 or bronchoscope with a light cord (if
not integral to endoscope) and mat without any additional load. The flexible
endoscope may be a:
single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm
in length 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 | |
| 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 and semi-
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 Instruments with diffusion-restricted spaces such as the hinged portion of
forceps and scissors | |
| V-PRO 1, 1
Plus, maX &
maX 2 Lumen
Cycle | Non-lumened devices including non-lumened rigid and semi-rigid endoscopes Medical devices, including single, dual and triple channeled rigid and semi-
rigid endoscopes, with the following configurations: single or dual lumen devices ≥ 0.77 mm ID and ≤ 527 mm in length triple lumen devices > 1.2 mm ID and ≤ 275 mm in length ≥ 1.8 mm ID and ≤ 310 mm in length
or ≥ 2.8 mm ID and ≤ 317 mm in length | |
| V-PRO 1
Plus, maX &
maX 2 Non
Lumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible
endoscopes and non-lumened devices with stainless steel or titanium diffusion-
restricted spaces such as the hinged portion of forceps and scissors. | |
| V-PRO maX
& maX 2
Flexible Cycle | Load 1: Single or dual lumen surgical flexible endoscopes (such as those used
in ENT, Urology and Surgical Care) and bronchoscopes with a light cord (if not
integral to endoscope) and mat with no additional load.
The flexible endoscopes may contain either: | |
| Intended
Sterilization
Cycles | Intended Pouch Load when Medical Devices are:
• Directly Pouched or
• Placed Inside of a Tray* and the Tray* Pouched | |
| | • 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 Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors. | |

9

STERIS Traditional 510(k) PREMARKET NOTIFICATION Vis-U-All Low Temperature Sterilization Pouches/Tubing

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.

Description of Safety and Substantial Equivalence 5.

The proposed and predicate devices are single use sterilization pouches for use in V-PRO Sterilizers. Table 5-3 summarizes the difference between the proposed device and predicate device cleared under K172749.

| Characteristic | Proposed | Predicate
K172749 | Comparison |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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, Fast Non Lumen
and Fast Cycles of the V-
PRO® Low Temperature
Sterilization Systems | 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. | Similar
Data is
presented in
this submission
to support safe
and effective
use of the
pouches in the
additional
cycles and load
configurations.
Combined V-
PRO 1, 1 Plus
and maX
Sterilizer
Lumen, Non
Lumen and
Flexible Cycle
claims with the
V-PRO maX 2
Lumen, Non
Lumen and |
| The pouches maintain the | The pouches maintain the | Flexible Cycle | |
| sterility of the enclosed | sterility of the enclosed | claims. | |
| devices until used. | 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. | 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. | | |
| 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 and semi-
rigid endoscopes, with the
following configurations:
o single or dual lumen
devices
■ ≥ 0.77 mm internal
diameter (ID) and ≤
410 mm in length
o triple lumen devices
■ ≥1.2 mm ID and ≤
275 mm in length
■ ≥1.8 mm ID and ≤
310 mm in length
or
■ ≥ 2.8 mm ID and ≤
317 mm in length | V-PRO 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
o triple lumen devices
■ ≥1.2 mm ID and ≤
275 mm in length
■ ≥1.8 mm ID and ≤
310 mm in length
or
■ ≥2.8 mm ID and ≤
317 mm in length | | |
| V-PRO 60 & s2 Non Lumen
Cycle
Non-lumened devices
including non-lumened rigid,
semi-rigid and flexible
endoscopes and non-lumened
devices with diffusion- | 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 | | |
| restricted spaces such as the
hinged portion of forceps and
scissors. | spaces such as the hinged
portion of forceps and
scissors. | | |
| V-PRO 60 & s2 Flexible
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:
single or dual lumen device
with lumens that are $\ge$ 1
mm ID and $\le$ 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:
$\ge$ 2 mm ID and $\le$ 400 mm
in length $\ge$ 0.76 mm ID and $\le$ 233
mm in length $\ge$ 1.0 mm ID and $\le$ 254 mm
in length 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 and semi-
rigid endoscopes) with the
following configurations: | 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 $\le$ 990
mm in length | | |
| | | | |
| • 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

V-PRO 1, 1 Plus, maX &
maX 2 Lumen Cycle
• Instruments with diffusion-
restricted spaces such as the
hinged portion of forceps
and scissors
• Non-lumened devices
including non-lumened
rigid and semi-rigid
endoscopes
• Medical devices, including
single, dual and triple
channeled rigid and semi-
rigid endoscopes, with the
following configurations:
o single or dual lumen
devices
≥ $0.77 mm$ ID and ≤
$527 mm$ in length o triple lumen devices ≥ $1.2 mm$ ID and ≤
$275 mm$ in length ≥ $1.8 mm$ ID and ≤
$310 mm$ in length
or ≥ $2.8 mm$ ID and ≤
$317 mm$ in length V-PRO 1, 1 Plus, maX &
maX2 Non Lumen Cycle
Non-lumened devices
including non-lumened rigid,
semi-rigid and flexible
endoscopes and non-lumened | 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:
o single or dual lumen
devices
≥ $0.77 mm$ ID and ≤
$527 mm$ in length o triple lumen devices ≥ $1.2 mm$ ID and ≤
$275 mm$ in length ≥ $1.8 mm$ ID and ≤
$310 mm$ in length
or ≥ $2.8 mm$ ID and ≤
$317 mm$ in length V-PRO 1 Plus & maX Non
Lumen Cycle
Non-lumened devices
including non-lumened rigid,
semi-rigid and flexible
endoscopes and non-lumened | | |

Table 5-3. Technical Comparison to the Predicate.

11

12

13

14

| devices with stainless steel or
titanium diffusion-restricted
spaces such as the hinged
portion of forceps and
scissors. | devices with stainless steel
diffusion-restricted spaces
such as the hinged portion of
forceps and scissors. |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| V-PRO maX and maX 2
Flexible Cycle
Load 1: Single or dual lumen
surgical flexible endoscopes
(such as those used in ENT,
Urology and Surgical Care)
and bronchoscopes with a
light cord (if not integral to
endoscope) and mat with no
additional load.
The flexible endoscopes may
contain either:
• a single lumen that is ≥ 1
mm ID and ≤ 1050 mm
in length
• or two lumens with:
• one lumen that is ≥ 1
mm ID and ≤ 990
mm in length
• and the other lumen
that is ≥ 1 mm ID and
≤ 850 mm in length
Load 2: Non-lumened
instruments including
instruments with diffusion-
restricted areas such as the
hinged portion of forceps or
scissors. | V-PRO maX Flexible Cycle
Load 1: Single or dual lumen
surgical flexible endoscopes
(such as those used in ENT,
Urology and Surgical Care)
and bronchoscopes with a
light cord (if not integral to
endoscope) and mat with no
additional load.
The flexible endoscopes may
contain either:
• a single lumen that is ≥ 1
mm ID and ≤ 1050 mm
in length
or two lumens with:
• one lumen that is ≥ 1
mm ID and ≤ 990
mm in length
• and the other lumen
that is ≥ 1 mm ID and
≤ 850 mm in length
Load 2: Non-lumened
instruments including
instruments with diffusion-
restricted areas such as the
hinged portion of forceps or
scissors. |
| V-PRO maX 2 Fast Non
Lumen Cycle
Non-lumened devices
including non-lumened rigid,
semi-rigid and flexible
endoscopes and non-lumened
devices with stainless steel or
titanium diffusion-restricted
spaces such as the hinged
portion of forceps and
scissors.
*Trays must be legally
marketed for use in the V-
PRO Low Temperature | 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: |
| Sterilization Systems and | |
| contain a vent surface area to tray volume ratio $\ge$ 0.135 in -1 with the maximum number of instrument organizers installed. | single or dual lumen devices $\ge$ 0.77 mm ID and $\le$ 527 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 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 $\ge$ 1 mm ID and $\le$ 1050 mm in 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 length Load 2: Non-lumened instruments including instruments with diffusion- |

15

16

| | | 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.

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. | |
|------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| 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 |
| 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 |

Table 5-4 summarizes the testing of the Vis-U-All Low Temperature Sterilization Pouches/Tubing to demonstrate that the proposed pouch is qualified for use in the V-PRO s2 Fast Cycle and for extended sterilization claims in the V-PRO 60 and s2 Sterilizers Non Lumen and Flexible Cycles and is as safe, as effective, and performs the same as the predicate device.

17

Table 5-4. Performance Test Summary
	Test	Acceptance Criteria	Conclusion
Effective
Sterilant
Penetration
into
Pouches
(including
pouched
trays and,
if
applicable,
pouches
placed
within a
tray):	V-PRO s2 Sterilizer
Fast Cycle	Worst case stainless steel lumen test
articles shall be reproducibly sterilized
under worst case 1 $ 1 2 $ cycle conditions for
the Fast Cycle.	PASS
		Diffusion-restricted spaces shall be
reproducibly sterilized under worst case 1 $ 1 2 $ cycle conditions for Fast Cycle.	PASS
		Contact points between medical devices
and tray accessories shall be reproducibly
sterilized under worst case 1 $ 1 2 $ cycle
conditions for the Fast Cycle.	PASS
		Worst case surface sterilization test
articles shall be reproducibly sterilized
under worst case 1 $ 1 2 $ cycle conditions for
the Fast Cycle.	PASS
	V-PRO 60 & s2
Sterilizer Non
Lumen Cycle,
diffusion-restricted
spaces claims	Diffusion-restricted spaces shall be
reproducibly sterilized under worst case 1 $ 1 2 $ cycle conditions for the Non Lumen
Cycle.	PASS
	V-PRO 60 & s2
Sterilizer Flexible
Cycle, diffusion-
restricted spaces
claims	Diffusion-restricted spaces shall be
reproducibly sterilized under worst case 1 $ 1 2 $ cycle conditions for the Flexible Cycle	PASS
	V-PRO 60 & s2
Sterilizer Flexible
Cycle extended
claims	Stainless steel test articles shall be
reproducibly sterilized under worst case 1 $ 1 2 $ cycle conditions for the Flexible 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

Table 5-4. Performance Test Summary
-------------------------------------	--	--	--

18

8. Conclusion

Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as well as the legally marketed predicate device (K172749), Class II (21 CFR 880.6850), product code FRG.