. 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.

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).

AI/ML Overview

The provided document describes the acceptance criteria and study results for STERIS Vis-U-All Low Temperature Sterilization Pouches/Tubing (K172749).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Effective Sterilant Penetration into Pouches:
- 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 (first entry)	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 (second entry)	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

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the specific sample sizes used for each test. It refers to "worst case test article" and "processed and unprocessed samples/pouches" without providing numerical details for the test sets.

The data provenance is not specified in terms of country of origin or whether it's retrospective or prospective. Given the nature of a 510(k) submission, these are likely laboratory-based studies conducted by the manufacturer to demonstrate product performance for regulatory approval.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable and not provided in the document. The tests performed are objective physical, chemical, and microbiological evaluations of the sterilization pouches, not interpretations of medical images or patient data that would require medical experts to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of data by multiple human readers, not for objective laboratory testing of device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document focuses on the performance of the sterilization pouches themselves through laboratory tests, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not applicable. The device is a physical sterilization pouch, not an algorithm or AI system. The tests are focused on its physical and functional capabilities.

7. The Type of Ground Truth Used

The "ground truth" for these tests is based on established scientific principles and regulatory standards for sterilization and material performance. For example:

Sterilant Penetration: Ground truth is complete sterilization, typically demonstrated by the absence of microbial growth in biological indicators after exposure to the sterilization process. The ½ cycle conditions are a recognized method to challenge sterilization efficacy.
Pouch Integrity (Tensile, Burst, Seal Strength): Ground truth is maintaining pre-determined physical properties within acceptable ranges after processing, ensuring the pouch remains intact.
Microbial Retention: Ground truth is the ability of the material to prevent microbial ingress.
Hydrogen Peroxide Residuals: Ground truth is residuals falling below acceptable safety limits.
Cytotoxicity: Ground truth is the material being non-toxic to cells.

These are objective, empirical measures determined by laboratory testing, not by expert consensus, pathology, or outcomes data in a medical context.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product and does not involve AI or machine learning, which would require a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for this device.

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.

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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

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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.

IntendedSterilizationCycles	Intended Pouch Load when Medical Devices are:
	Directly Pouched or Placed Inside of a Tray* and the Tray*Pouched
V-PRO 60Lumen 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 60Non LumenCycle	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 60FlexibleCycle	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 1Plus & maXNon LumenCycle	Non-lumened devices including non-lumened rigid, semi-rigidand flexible endoscopes and non-lumened devices with stainlesssteel diffusion-restricted spaces such as the hinged portion offorceps and scissors.
V-PRO maXFlexibleCycle	Load 1: Single or dual lumen surgical flexible endoscopes (suchas those used in ENT, Urology and Surgical Care) andbronchoscopes with a light cord (if not integral to endoscope) andmat 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 inlength
	Load 2: Non-lumened instruments including instruments withdiffusion-restricted areas such as the hinged portion of forceps orscissors.
	• Instruments with diffusion-restricted spaces such as the hingedportion of forceps and scissors
	• Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
	• Medical devices, including single, dual and triple channeledrigid and semi-rigid endoscopes, with the following
V-PRO maX2 LumenCycle	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 1Plus & maX,Non LumenCycle	Non-lumened devices including non-lumened rigid, semi-rigidand flexible endoscopes and non-lumened devices with titaniumdiffusion-restricted spaces such as the hinged portion of forcepsand scissors.
V-PRO maX2 NonLumen Cycle	Non-lumened devices including non-lumened rigid, semi-rigidand flexible endoscopes and non-lumened devices with stainlesssteel or titanium diffusion-restricted spaces such as the hingedportion of forceps and scissors.
V-PRO maX2 FlexibleCycle	Load 1: Single or dual lumen surgical flexible endoscopes (suchas those used in ENT, Urology and Surgical Care) and
	bronchoscopes with a light cord (if not integral to endoscope) andmat 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 inlength
	Load 2: Non-lumened instruments including instruments withdiffusion-restricted areas such as the hinged portion of forceps orscissors.
V-PRO maX2 Fast NonLumen	Non-lumened devices including non-lumened rigid, semi-rigidand flexible endoscopes and non-lumened devices with stainlesssteel or titanium diffusion-restricted spaces such as the hingedportion 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

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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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Image /page/5/Picture/1 description: The image shows the STERIS logo. The word "STERIS" is in all caps and is in a serif font. Below the word is an image of several horizontal wavy lines that are blue.

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 SterilizationPouches/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 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).

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Cycle	Most RecentPremarketNotificationClearance	V-PRO1	V-PRO1 Plus	V-PROmaX	V-PROmaX 2
Lumen Cycle	K131120	X	X	X	X
Non Lumen Cycle	K160433	*	X	X	X
Flexible Cycle	K102330			X	X
Fast Non Lumen Cycle	ConcurrentSubmission				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.

IntendedSterilizationCycles	Intended Pouch Load when Medical Devices are:• Directly Pouched or• Placed Inside of a Tray* and the Tray* Pouched
V-PRO 60Lumen Cycle	• Instruments with diffusion-restricted spaces such as the hingedportion of forceps and scissors• Non-lumened devices including non-lumened rigid and semi-rigid endoscopes• Medical devices, including single, dual and triple channeledrigid and semi-rigid endoscopes, with the followingconfigurations:o single or dual lumen devices• ≥ 0.77 mm ID and ≤ 410 mm in length
IntendedSterilizationCycles	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 60Non LumenCycle	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 60Flexible 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, 1Plus & maXLumen 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 NonLumen 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 maXFlexible 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
IntendedSterilizationCycles	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 2Lumen 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, NonLumen 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 2Non LumenCycle	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 2Flexible 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 2Fast NonLumen	Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless
IntendedSterilizationCycles	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 hingedportion of forceps and scissors.

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

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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.

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Test	Acceptance Criteria	Conclusion
EffectiveSterilantPenetrationintoPouches(includingpouchedtrays and,ifapplicable,pouchesplacedwithin atray):	V-PRO maX 2Sterilizer Fast NonLumen Cycle	Worst case test article shall bereproducibly sterilized under worstcase abbreviated ½ cycle conditionsfor Fast Non Lumen Cycle.	PASS
	V-PRO 1 Plus,maX, and maX 2Sterilizer NonLumen Cycle,diffusion restrictedtitanium claims	Diffusion-restricted spaces(composed of stainless steel andtitanium, as well as contact pointsbetween medical devices and trayaccessories) shall be reproduciblysterilized under worst caseabbreviated ½ cycle conditions forFast Non Lumen Cycle.	PASS
	V-PRO 1 Plus,maX, and maX 2Sterilizer NonLumen Cycle,diffusion restrictedtitanium claims	Diffusion-restricted spaces (titanium)shall be reproducibly sterilized underworst case ½ cycle conditions for theNon Lumen Cycle.	PASS
PouchIntegrity:PhysicalandMicrobialBarrierProperties	Tensile Strength	Pouch material tensile strength willshow no statistical difference betweenprocessed and unprocessed samples.	PASS
	Whole PackageIntegrity (Burst)	Pouch burst strength will show nostatistical difference betweenprocessed and unprocessed pouches.	PASS
	Seal Strength	Pouch seal strength will show nostatistical difference betweenprocessed and unprocessed pouches.	PASS
	MicrobialRetention	Tyvek microbial retention will showno statistical difference betweenprocessed and unprocessed pouches.	PASS
Maintenance of PackageIntegrity	Packaged instruments shall remainsterile through event related and realtime studies.	PASS
Aeration: Hydrogen PeroxideResiduals	Hydrogen peroxide residuals on thepouch will be reduced to acceptablelevels for dermal contact in Fast NonLumen Cycle with 3 minute aeration.	PASS
Cytotoxicity	Pouch materials shall be non-cytotoxic following worst caseexposure in a V-PRO Sterilizer forFast Non Lumen Cycle with 3 minuteaeration.	PASS

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Comparison of Technological Characteristics 7.

Characteristic	ProposedK172749	PredicateK160908	Comparison
Materials ofConstruction	Tyvek and plastic	Tyvek and plastic	Same
Types	Self Seal, Heat Seal, Tubing	Self Seal, Heat Seal, Tubing	Same
ChemicalIndicator	Ethylene Oxide ProcessChemical Indicator Printedon both sides of Tyvek	Ethylene Oxide ProcessChemical Indicator Printed onboth sides of Tyvek	Same
Intended Use	The Vis-U-All LowTemperature SterilizationPouches/Tubing aresterilization containmentpouches for use by healthcare providers to enclose:• medical devices in a singleor double pouchconfiguration• trays* containing medicaldevices in a single or doublepouch configuration• small items requiringsurface sterilization in asingle pouch configurationwithin a tray*to be sterilized in the Lumen,Non Lumen, Flexible andFast Non Lumen Cycles ofthe V-PRO LowTemperatureSterilization Systems. Thepouches maintain the sterilityof the enclosed devices untilused.V-PRO 1 Plus, maX, & maX2 Non Lumen Cycle- Non-lumened devicesincluding non-lumened rigid,semi-rigid and flexibleendoscopes and non-lumeneddevices with stainless steel ortitanium diffusion-restrictedspaces such as the hingedportion of forceps andscissors.	The Vis-U-All LowTemperature SterilizationPouches/Tubing aresterilization containmentpouches for use by health careproviders to enclose:• medical devices in a singleor double pouch configuration• trays* containing medicaldevices in a single or doublepouch configuration• small items requiringsurface sterilization in a singlepouch configuration within atray*to be sterilized in the Lumen,Non Lumen and FlexibleCycles of the V-PRO LowTemperature SterilizationSystems. The pouchesmaintain the sterility of theenclosed devices until used.V-PRO 1 Plus & maX NonLumen Cycle- Non-lumened devicesincluding non-lumened rigid,semi-rigid and flexibleendoscopes and non-lumeneddevices with stainless steeldiffusion-restricted spacessuch as the hinged portion offorceps 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 ofSterility	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.

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).