The Vis-U-All Low Temperature Tyvek Sterilization Pouch for ethylene oxide has been qualified by STERIS Corporation as suitable for use by health care providers to enclose and seal other medical devices to be sterilized by ethylene oxide (ETO). The Vis-U-All Low Temperature Tyvek Sterilization Pouch for ethylene oxide is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

Device Description

The proposed Vis-U-All Low Temperature Tyvek Sterilization Pouch for Ethylene Oxide is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider using ethylene oxide (ETO). The proposed pouch is available as a self seal pouch, a heat seal pouch, or heat seal tubing. The material composition of the proposed and predicate device is identical with the exception of the addition of an ISO 11140 Class 1 compliant, ethylene oxide chemical indicator on the proposed device.

AI/ML Overview

The provided text describes performance testing for the Vis-U-All Low Temperature Tyvek Sterilization Pouch for Ethylene Oxide, but it does not describe an AI/algorithm-based device. Therefore, many of the requested fields (sample size for test/training set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth for training) are not applicable to this submission.

Here's the available information based on the provided document:

1. A table of acceptance criteria and the reported device performance

Testing	Acceptance Criteria (Implied by PASS)	Reported Device Performance
Sterilant Penetration	Effective penetration of ETO	PASS (ETO effectively penetrates pouches)
Event Related Sterility Maintenance	Maintained performance (strength, microbial resistance) after aging and handling	PASS (All packs maintained performance)
Microbial Barrier Properties	No microbial growth	PASS (No microbial growth on test articles/negative controls)
Tensile / Tear / Puncture Resistance / Seal Peel Strength	No statistically significant difference in tensile properties, clean peels, acceptable burst strength, no compromise to sealing	PASS (No statistically significant differences, clean peels, acceptable burst strength)
Cytotoxicity	Not cytotoxic	PASS (Not cytotoxic)
Sterilant Residues	Not retaining harmful levels of ETO or byproducts per ISO 10993-7:1995	PASS (Pouch materials confirmed not to retain harmful levels)
Chemical Indicator Class 1 Compliance	Compliant with ANSI/AAMI/ISO 11140-1:2005 requirements	PASS (Validated against requirements)
Chemical Indicator Toxicity	Not cytotoxic per ANSI/AAMI/ISO10993-5:1999 methodology and limits	PASS (Not cytotoxic)
Chemical Indicator Post-Processed Color Stability	Stable after ETO exposure for at least one year	PASS (Color is stable for at least one year)
Simulated Use	ETO can penetrate pouch to sterilize loads	PASS (All criteria met, ETO can penetrate)
Process Indicator End Point Stability - Aged Vis-U-All Tyvek pouches	Meet performance criteria after storage	PASS (Meet performance criteria)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the provided document.
Data Provenance: Not specified, but generally, such product testing for regulatory submission would be conducted by the manufacturer (STERIS Corporation, based in Mentor, OH, USA) or a contracted lab. This is product validation, not clinical data, so terms like "retrospective" or "prospective" are not directly applicable in the same way they would be for patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a product validation study involving physical, chemical, and microbiological performance, not expert-adjudicated diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a product validation study, not expert adjudication of diagnostic findings.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/algorithm-based device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device would be established through various standardized testing methods and international standards (e.g., ISO 10993, ANSI/AAMI/ISO 11140-1). For example:

Sterilant Penetration: Measured by biological indicator inactivation or gas concentration measurements within the pouch.
Microbial Barrier: Measured by bacterial challenge tests.
Material Properties (Tensile/Tear/Puncture/Seal Peel): Measured using standardized mechanical testing equipment and methods.
Cytotoxicity/Residues: Measured using in-vitro cell culture assays and analytical chemistry techniques following relevant standards.
Chemical Indicator Compliance: Assessed against the specified requirements of ANSI/AAMI/ISO 11140-1.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the text "K692745 p 1 of 5" at the top. Below that is the word "STERIS" with a registered trademark symbol. At the bottom of the image is a logo consisting of several horizontal lines.

NOV 1 9 2010

510(k) Summary For Vis-U-All Low Temperature Tyvek Sterilization Pouch for Ethylene Oxide Sterilization

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459

Contact:

Robert F. Sullivan Senior Director FDA Regulatory Affairs Telephone:(440) 392-7695 Fax No: (440) 357-9198

Summary Date:

November 19, 2010

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

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K092745/RC STERIS Response to 11/18/10 Request for Clarification Vis-U-All Low Temperature Tyvek Sterilization Pouch for Ethylene Oxide Sterilization

1. Device Name

Vis-U-All Low Temperature Tyvek Sterilization Trade Name: Pouch for Ethylene Oxide Sterilization Sterilization Pouch Common/usual Name: Classification Name: Sterilization Wrap (21 CFR 880.6850) . КСТ Product Code:

2. Predicate Device

' Vis-U-All Self Seal Pouch (K070765)
I Vis-U-All Heat Seal Pouch and Tubing (K071087)

3. Description of Device

4. Intended Use

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STERIS Part #	Type	Size (inches)
875037	Pouch, Heat Seal,	3 x 7
875049	Tyvek (low temp)	4 x 9
875412		4 x 12
875422		4 x 22
875610		6 x 10
875812		8 x 12
875115		10 x 15
875118		12 x 18
876037	Pouch, Self Seal,	3 x 7
876049	Tyvek (low temp)	4 x 9
876412		4 x 12
876422		4 x 22
876610		6 x 10
876812		8 x 12
876115		10 x 15
876118		12 x 18
872031	Tubing, Heat Seal,	3" x 100 ft
872041	Tyvek (low temp)	4" x 100 ft
872061		6" x 100 ft
872091		9" x 100 ft
872141		14" x 100 ft

Pouch and Tubing Sizes for STERIS Vis-U-All Low Temperature Products

The following are the validation test conditions:

1 hour exposure; at 130(±5) °F*, >30% RH using 100% ETO (750-790 mg/L);
· 4.5 hour exposure; at 100(±5) °F*, >30% RH using 100% ETO (750-790 mg/L);

±5 °F is during sterilization phase following an equilibration period of 10% of exposure time.

The ethylene oxide process indicator is intended to be used by a health care provider with the Vis-U-All Low Temperature Tyvek Sterilization Pouches to distinguish between processed and unprocessed units.

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K092745

p4 JR 5

Description of Safety and Substantial Equivalence 5.

The Vis-U-All Low Temperature Tyvek Sterilization Pouch models have been qualified by STERIS Corporation as suitable for use by health care providers to enclose and seal other medical devices to be sterilized using ethylene oxide. The predicates. Vis-U-All Self Seal Pouch (K070765) and Vis-U-All Heat Seal Pouch and Tubing (K071087) are also intended to enclose and seal medical devices to be sterilized. The proposed device's intended use is identical to the predicates, exceptingh thelow temperature sterilization modality to which the pouch is exposed: ethylene oxide (ETO) instead of hydrogen peroxide (VHP).

The proposed device is identical to the predicate devices in terms of physical and chemical properties, configurations and dimensions, air permeance and percent of surface perforations. The material composition of the proposed and predicate device is identical with the exception of the addition of an ISO 11140 Class 1 compliant, ethylene oxide chemical indicator on the proposed device.

As described in the next section, performance testing of the Vis-U-All Low Temperature Tyvek Sterilization Pouch for Ethylene Oxide demonstrated that the proposed product is qualified for use with ethylene oxide (ETO) sterilization and is as safe, as effective, and performs the same as the predicate devices.

6. Performance Testing

The following table summarizes the non-clinical testing performed for both indicated sterilization cycles to demonstrate that the Vis-U-All Low Temperature Tyvek Sterilization Pouch for Ethylene Oxide is safe and effective. The performance testing has demonstrated that the proposed device is substantially equivalent to its predicates and raises no new questions of safety or effectiveness.

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K092745

K092745/RC STERIS Response to 11/18/10 Request for Clarification Vis-U-All Low Temperature Tyvek Sterilization Pouch for Ethylene Oxide Sterilization

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Testing	Results
Sterilant Penetration	PASSTesting demonstrated that ethylene oxide can effectively penetrate thepouches to sterilize the load.
Event RelatedSterilityMaintenance	PASSAll packs processed in an ethylene oxide sterilizer and subjected toaccelerated aging and handling maintained their performance (strengthand microbial resistance).
Microbial BarrierProperties	PASSNo microbial growth occurred on test articles or negative controlpouches. Test articles from positive control pouches demonstratedmicrobial growth
Tensile / Tear /Puncture Resistance/ Seal Peel Strength	PASSThe differences in tensile properties (elongation, breaking force) ofprocessed and unprocessed Tyvek and plastic samples were notstatistically significant. All processed but un-aged pouches resulted inclean peels and all processed pouches had acceptable burst strength,indicating that ethylene oxide sterilization does not compromise pouchsealing.
Cytotoxicity	PASSFollowing ethylene oxide sterilization, the Vis-U-All LowTemperature Tyvek Pouch/Tubing plastic and Tyvek were notcytotoxic.
Sterilant Residues	PASSFollowing sterilization and aeration, pouch materials were confirmedto not retain harmful levels of ethylene oxide or its byproducts asoutlined in ISO 10993-7:1995.
Chemical IndicatorClass 1 Compliance	PASSChemical Indicators were validated against the ethylene oxide processindicator requirements of ANSI/AAMI/ISO 11140-1:2005
Chemical IndicatorToxicity	PASSThe indicator ink on its substrate- either exposed to ethylene oxide orunexposed - is not cytotoxic per the methodology and limits defined inANSI/AAMI/ISO10993-5:1999
Chemical IndicatorPost-ProcessedColor Stability	PASSThe post-processed chemical (process) indicator color is stable, afterexposure to ETO sterilization conditions, for at least one year ofstorage at ambient conditions.
Simulated Use	PASSAll criteria of the study were met, demonstrating that, ethylene oxidecan penetrate through the Vis-U-All Low Temperature Tyvek Pouchand Tubing to sterilize loads.
Process IndicatorEnd Point Stability -Aged Vis-U-AllTyvek pouches	PASSThe chemical indicator on Vis-U-All Low Temperature Tyvek Pouchesstored at warehouse conditions still meet performance criteria.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the caduceus. The caduceus is depicted as a stylized bird with three tail feathers.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Marcia Benedict Director, Regulatory Affairs Steris Corporation 5960 Heisley Road Mentor, Ohio 44060

NOV 1 9 2010

Re: K092745

Trade/Device Name: Vis-U-All Low Temperature Tyvek Sterilization Pouch with Ethylene Oxide Process Indicator Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: November 11, 2010 Received: November 12, 2010

Dear Ms. Benedict:

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.

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Page 2 - Ms. Benedict

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
fum I. Sated
for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology. General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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K092745/S001 STERIS Response to 11/10/09 Request for Additional Information Vis-U-All Low Temperature Tyvek Sterilization Pouch for Ethylene Oxide Sterilization

Indications for Use

NOV 1 9 2010

510(k) Number (if known): K092745

Device Name:

Vis-U-All Low Temperature Tyvek Sterilization Pouch with Ethylene Oxide Process Indicator

Indications For Use:

Pouch and Tubing Sizes for STERIS Vis-U-All Low Temperature Products

STERIS Part #	Type	Size (inches)
875037	Pouch, Heat Seal,	3 x 7
875049	Tyvek (low temp)	4 x 9
875412		4 x 12
875422		4 x 22
875610		6 x 10
875812		8 x 12
875115		10 x 15
875118		12 x 18
876037	Pouch, Self Seal,	3 x 7
876049	Tyvek (low temp)	4 x 9
876412		4 x 12
876422		4 x 22
876610		6 x 10
876812		8 x 12
876115		10 x 15
876118		12 x 18
872031	Tubing, Heat Seal,	3" x 100 ft
872041	Tyvek (low temp)	4" x 100 ft
872061		6" x 100 ft
872091		9" x 100 ft
872141		14" x 100 ft

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 2

510(k) Number:

May 05, 2010

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The following are the validation test conditions:

1 hour exposure; at 130(±5) °F*, >30% RH using 100% ETO (750-790 mg/L); .
4.5 hour exposure; at 100(±5) ºF*, >30% RH using 100% ETO (750-790 mg/L); .

±5 °F is during sterilization phase following an equilibration period of 10% of exposure time.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sted N. Murphey D. Matz J. Ellevan-Williams
(Division Sign Off)

Anesthesiology, General Hospital Control, Dental Devices

510(k) Number: K092245

Page 2 of 2

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).