Vis-U-All Low Temperature Sterilization Pouch/Tubing

• K Number: K183401
• Device Name: Vis-U-All Low Temperature Sterilization Pouch/Tubing
• Manufacturer: STERIS Corporation
• Date Cleared: 2019-03-01 ( 84 days)
• Product Code: FRG
• Regulation Number: 880.6850

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 NOTE: Trays must be legally marketed for use in the V-PRO Low Temperature or STERRAD Sterilization Systems and contain a vent surface area to tray volume ratio ≥ 0.135 in-1 with the maximum number of instrument organizers installed. and to be sterilized in the: - 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 - Express, Standard, Flex Scope, and DUO Cycles of the STERRAD 100NX with ALLClear Technology Sterilizers 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.

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.

Predicate Devices

K172749

Reference Devices

K183297, K092745

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical sterilization pouch and the description focuses on its material properties and compatibility with sterilization systems, with no mention of AI/ML.

Therapeutic

No
The device is a sterilization containment pouch used to enclose medical devices for sterilization, not to treat a medical condition.

Diagnostic

No

Explanation: The device is a sterilization containment pouch used to maintain the sterility of medical devices. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device is a physical sterilization pouch made of Tyvek/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 clearly states that the pouches are for sterilization containment of medical devices and trays. This is a process related to preparing medical devices for use, not for performing diagnostic tests on biological samples.
• Device Description: The description reinforces that it's a "sterilization containment pouch."
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.

The device's function is to maintain the sterility of medical devices after they have been sterilized, which is a crucial step in infection control within a healthcare setting. This falls under the category of medical device accessories or components used in the sterilization process, not in vitro diagnostics.

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

and to be sterilized in the:

• 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
• Express, Standard, Flex Scope, and DUO Cycles of the STERRAD 100NX with ALLClear Technology Sterilizers

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.

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)

Non-Clinical Testing:

• Effective Sterilant Penetration into Pouches: Worst case test articles shall be reproducibly sterilized under worst case ½ cycle conditions for the STERRAD 100S Default Cycle, STERRAD NX Standard Cycle, STERRAD NX Advanced Cycle, STERRAD 100NX Standard Cycle, STERRAD 100NX Flex Scope Cycle, STERRAD 100NX Express Cycle, STERRAD 100NX Duo 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.
  • 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.

K183297, 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 two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

March 25, 2019

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

Re: K183401

Trade/Device Name: Vis-U-All Low Temperature Sterilization Pouch/Tubing 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) K183401

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

and to be sterilized in the:

• · 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
• · Express, Standard, Flex Scope, and DUO Cycles of the STERRAD 100NX with ALLClear Technology Sterilizers

*STERRAD and ALLClear are trademarks of Advanced Sterilization Products

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 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 Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"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."

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Image /page/6/Picture/1 description: The image shows the STERIS logo. The logo consists of the word "STERIS" in a bold, sans-serif font, with a registered trademark symbol to the right of the "S". Below the word "STERIS" is an image of several horizontal, wavy lines in blue.

K183401 510(k) Summary for Vis-U-All Low Temperature Sterilization Pouches/Tubing

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: | 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, K172749

Reference Device: Vis-U-All Low Temperature Sterilization Pouch/Tubing K183297

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. Available sizes and configurations are shown in Table 1.

Table 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 |

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

The purpose of this submission is to allow for use of the products in the following sterilizer 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

4. 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 trav

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

and to be sterilized in the:

• 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
• Express, Standard, Flex Scope, and DUO Cycles of the STERRAD 100NX . and 100NX with ALLClear Technology Sterilizers

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*STERRAD and ALLClear are trademarks of Advanced Sterilization Products

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:
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 & 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:
o single or dual lumen device with lumens that are ≥ 1 mm ID and
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. | 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
■ ≥ 0.77 mm ID and ≤ 527 mm
in length
○ triple lumen devices |
| STERRAD 100S Default Cycle
Metal and nonmetal medical devices
including instruments which have
diffusion-restricted spaces, such as
the hinged portion of forceps and
scissors. | |
| Metal and nonmetal 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 | ≥ 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 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. |
| 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 | 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 ≥ 1 mm ID and ≤ 1050 mm in length or two lumens with: one lumen that is ≥ 1 mm ID and