KIMGUARD* Smart Fold* Sterilization Wrap (KC450 and KC650) is intended to enclose another medical device that is to be sterilized by a healthcare provider using:

Advanced Sterilization Products' STERRAD® Sterilization Systems that include:
- STERRAD® 100S o
- STERRAD® NX® [Standard Cycle, Advanced Cycle] O
- STERRAD® 100NX®). [Standard Cycle, Flex Cycle, EXPRESS cycle, DUO Cycle] C

KIMGUARD* Smart Fold* Sterilization Wraps (KC450 are intended to allow sterlization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

Device Description

KIMGUARD* Smart Fold* Sterilization Wrap is comprised of two pre-shaped sheets of KIMGUARD Sterilization Wrap (blue base sheet and white intermediate sheet), which include reinforcement strips, and adhesively seamed on three edges to allow convenient wrapping with two sheets (i.e., white and blue) simultaneously. The fabric is a nonwoven spunbondmeltblown-spunbond (SMS) composite sheet manufactured with polypropylene with less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of a potassium phosphate anti-static treatment. Two strips of blue SMS are adhesively bonded to the white SMS intermediate layer for added strength. These reinforcement strips also function as a "reference line" to indicate proper sterilization tray placement by the user. The Smart-Fold wrap also incorporates pull tabs comprised of blue SMS material for convenient aseptic opening of wrapped packages.

AI/ML Overview

The provided document is a 510(k) premarket notification for the KIMGUARD* Smart-Fold* Sterilization Wrap (Models KC450 and KC650). It describes the device's indications for use, comparison to predicate devices, and a summary of nonclinical tests performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it lists "Performance Requirements" and indicates "Passed" for each. The acceptance criterion implicitly seems to be "meeting the performance requirements" or demonstrating that the wrap "maintains sterility until used, after completion of the sterilization processes provided by the STERRAD® Sterilization Systems." The specific quantitative thresholds for these "passed" results are not detailed in this summary.

Acceptance Criteria (Performance Requirement)	Reported Device Performance
STERRAD Sterilant Penetration	Passed
Material Compatibility/Biocompatibility post-sterilization using maximum hydrogen peroxide concentration (Cytotoxicity, Dermal Irritation)	Passed
Material Usability post-sterilization	Passed
Maintenance of Package Integrity (180 Days)	Passed

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

The document does not specify the exact sample size for the test set used in the nonclinical tests. For example, it doesn't state how many wraps were tested for "STERRAD Sterilant Penetration" or "Maintenance of Package Integrity."

The data provenance is not explicitly stated. The tests were performed as part of a 510(k) submission to the FDA, suggesting they were conducted by the manufacturer (Kimberly-Clark Health Care, later Halyard Health) to demonstrate device performance. It is implied to be prospective testing specifically for this submission, rather than retrospective data analysis from external sources. No information about country of origin of the data beyond the manufacturer's location (Roswell, GA) is provided.

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

This type of information is generally not applicable to a device like a sterilization wrap. The "ground truth" for a sterilization wrap is typically established through objective laboratory testing according to established standards (e.g., ISO, ASTM, or specific sterilization system validation protocols) rather than expert interpretation of images or clinical assessment. Therefore, there's no mention of experts establishing ground truth in this context.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective human assessment, such as in clinical trials or image interpretation studies where multiple readers agree on a diagnosis. This is not relevant for the performance testing of a sterilization wrap, which relies on objective measurements and tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are used to evaluate the performance of diagnostic devices often involving human readers interpreting images or data, with or without AI assistance. This device is a physical medical device (sterilization wrap) rather than a diagnostic tool, so such a study is not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This question is not applicable to the device under review. The KIMGUARD* Smart-Fold* Sterilization Wrap is a physical product, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. Type of Ground Truth Used

The "ground truth" for the performance tests appears to be established through:

Objective laboratory testing and controlled experiments: For STERRAD Sterilant Penetration, this would involve measuring the presence or absence of sterilant penetration.
Adherence to relevant ISO standards for biocompatibility: For Material Compatibility/Biocompatibility, this refers to ISO 10993-5:2009 (Cytotoxicity) and ISO 10993-10:2010 (Dermal Irritation).
Functional testing: For Material Usability post-sterilization, this would likely involve evaluating the physical properties and integrity of the wrap after sterilization.
Time-based integrity testing: For Maintenance of Package Integrity (180 Days), this involves evaluating the barrier properties and physical integrity of the package over an extended period.

The ground truth is based on the outcomes of these standardized and objective tests, rather than expert consensus, pathology, or clinical outcomes data in the way these terms are typically used for diagnostic or therapeutic devices.

8. Sample Size for the Training Set

This information is not applicable. As stated previously, this device is a physical medical product, not an AI/ML algorithm that requires 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 a physical medical device like a sterilization wrap.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the organization's name and national affiliation.

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

November 10, 2014

Kimberly-Clark Health Care Dr. Thomas Kozma Director of Regulatory Affairs 1400 Holcomb Bridge Road Roswell, GA 30076

Re: K140963

Trade/Device Name: KIMGUARD* Smart-Fold* Sterilization Wrap (Models KC450 and KC650) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: September 25, 2014 Received: September 26, 2014

Dear Dr. Kozma:

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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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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

K140963 510(k) Number (if known)

Device Name

●

KIMGUARD* Smart Fold* Sterilization Wrap (Models KC450 and KC650)

Indications for Use (Describe)

KIMGUARD* Smart Fold* Sterilization Wrap (KC450 and KC650) is intended to enclose another medical device that is to be sterilized by a healthcare provider using:

Advanced Sterilization Products' STERRAD® Sterilization Systems that include:
- STERRAD® 100S o
- STERRAD® NX® [Standard Cycle, Advanced Cycle] O
- STERRAD® 100NX®). [Standard Cycle, Flex Cycle, EXPRESS cycle, DUO Cycle] C

KIMGUARD* Smart Fold* Sterilization Wraps (KC450 are intended to allow sterlization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

Test results validated that KIMGUARD* Smart Fold* Sterlization Wrap (KC450 and KC650) allowed sterilization of the enclosed devices by the Advanced Sterilization Products STERRAD® 100S, NX® [Standard Cycle and Advanced Cycle and Advanced Cycle], and 100NX . (Standard Cycle, Flex Cycle, DUO Cycle)), (Refer to the STERRAD Sterilization System User's Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions.)

The KC450 and KC650 models of the KIMGUARD* Smart Fold* Sterilization Wrap have been validated for use with the STERRAD® 100S, STERRAD® NX®, and STERRAD® 100 NX® cycles in Table 1.

KIMGUARD* Smart Fold* Sterilization Wrap Recommendations for Use with the Advanced Sterilization Systems are provided in Table 2.

(continued on next 3 pages)

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TABLE 1: Validated Advanced Sterilization Products (ASP) STERRAD® 100S, STERRAD® NX®, and STERRAD® 100NX® Cycles
ASPSTERRAD®System andCycle	Intended Load
STERRAD®100S	Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load:• An inside diameter of 1 mm or larger and a length of 125 mm or shorter of single-channel stainless steel lumens.• An inside diameter of 2 mm or larger and a length of 250 mm or shorter of single-channel stainless steel lumens.• An inside diameter of 3 mm or larger and a length of 400 mm or shorter of single-channel stainless steel lumens.• An inside diameter of 6 mm or larger and a length of 310 mm or shorter of single-channel Teflon/Polyethylene lumens.
STERRAD®NX®StandardCycle	Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load:• An inside diameter of 1 mm or larger and a length of 150 mm or shorter of single-channel stainless steel lumens.• An inside diameter of 2 mm or larger and a length of 400 mm or shorter of single-channel stainless steel lumens.
STERRAD®NX®AdvancedCycle	Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load:• An inside diameter of 1 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens.OROne single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain:• A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter.
STERRAD®100NX®StandardCycle	Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load:• An inside diameter of 0.7 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens. (A maximum of two flexible endoscopes, one per tray per sterilization cycle.)
STERRAD®100NX®Flex Cycle	One or two single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope maycontain:• A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter. (A maximum of two flexible endoscopes, one per tray per sterilization cycle).
STERRAD®100NX®EXPRESSCycle	Non-lumened reusable metal and non-metal devices requiring surface sterilization, and sterilization of diffusion-restricted spaces such asthe hinged portions of forceps and scissors, and rigid or semi-rigid endoscopes without lumens.
STERRAD®100NX®DUO Cycle	One or two single-channel Flexible Endoscope with accessory devices that are normally connected to it, with or without a silicone mat.The flexible endoscope may contain:• A single-channel Teflon®/Polyethylene lumen with an inside diameter of 2 mm or larger and a length of 250 mm or shorter.• Accessory devices that are normally connected to a flexible endoscope during use.• Flexible endoscopes without lumens

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TABLE 2: Recommended Loads for KIMGUARD* Smart-Fold* Sterilization Wrap for use with Advanced Sterilization Products
[Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle])

KIMGUARD* SmartFold* SterilizationWrap Models	Intended Loads1	Maximum Wrapped PackageContent Weights Used in SterilityMaintenance Validation Study	Description of Leads Used inSterility Maintenance ValidationStudy
KC450	Moderate to heavy weightpackage (e.g., general usemedical instruments	10.7 lbs.	•APTIMAX® Instrument Tray (23 in.x 11 in. x 4in.) with Tray Mat•Metal and non-metal instruments
KC650	Very heavy weight package (e.g.,general use medical instruments	10.7 lbs.	•APTIMAX® Instrument Tray (23 in.x 11 in. x 4in.) with Tray Mat•Metal and non-metal instruments

l htended loads include: Medical Instruments without lumens that include telescopes, cameras, light cords, and general use medical instruments

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Applicant's Name, Address, Telephone, FAX, Contact PersonHalyard Health (f/k/a Kimberly-Clark Health Care)1400 Holcomb Bridge Road Roswell, GA 30076-2190, USAEstablishment Registration Number: 1033422Contact Name: Thomas Kozma, PhD, Director of Regulatory AffairsE-mail: thomas.kozma@hyh.com(770) 587-8393 (Telephone)(920) 225-3408 (Fax)
DATE PREPARED:	November 07, 2014
TRADE NAME:	KIMGUARD* Smart-Fold* Sterilization Wrap (Models KC450 andKC650)
CLASSIFICATION NAME:	Sterilization Wrap
COMMON/USUAL NAME:	Sterilization Wrap
PRODUCT CODE:	FRG
DEVICE CLASSIFICATION:	Class II per 21 CFR §880.6850
PREDICATE DEVICES:	KimGuard* Smart-Fold* Sterilization Wrap (Models KC250,KC450, KC550, and KC650) cleared January 19, 2013(K112300).KimGuard* ONE-STEP Sterilization Wrap (Models KC100,KC200, KC300, KC400, KC500, and KC600 cleared August 20,2013 (K113806)

Indications for Use

KIMGUARD* Smart Fold* Sterilization Wrap (KC450 and KC650) is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:

Advanced Sterilization Products' STERRAD® Sterilization Systems that include: .
- o STERRAD® 100S
- STERRAD® NX® |Standard Cycle, Advanced Cycle]
- o STERRAD® 100NX®). [Standard Cycle, Flex Cycle, EXPRESS cycle, DUO Cycle]

KIMGUARD* Smart Fold* Sterilization Wraps (KC450 and KC650) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

Test results validated that KIMGUARD* Smart Fold* Sterilization Wrap (KC450 and KC650) allowed sterilization of the enclosed devices by the Advanced Sterilization Products STERRAD® Sterilization Systems (STERRAD® 100S, NX® [Standard Cycle and Advanced Cycle], and 100NX®. [Standard Cycle, Flex Cycle, EXPRESS cycle, DUO Cycle]). (Refer to the STERRAD®

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Sterilization System User's Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions.)

The KC450 and KC650 models of the KIMGUARD* Smart Fold* Sterilization Wrap have been validated for use with the STERRAD® 100S, STERRAD® NX®, and STERRAD® 100 NX® cycles in Table 1.

TABLE 1: Validated Advanced Sterilization Products (ASP) STERRAD® 100S, STERRAD® NX®, and STERRAD®100NX® Cycles
ASPSTERRAD®Systemand Cycle	Intended Load
STERRAD®100S	Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamberload:An inside diameter of 1 mm or larger and a length of 125 mm or shorter of single-channel stainless steel lumens. An inside diameter of 2 mm or larger and a length of 250 mm or shorter of single-channel stainless steel lumens. An inside diameter of 3 mm or larger and a length of 400 mm or shorter of single-channel stainless steel lumens. An inside diameter of 6 mm or larger and a length of 310 mm or shorter of single-channel Teflon/Polyethylene lumens.
STERRAD®NX®StandardCycle	Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamberload:An inside diameter of 1 mm or larger and a length of 150 mm or shorter of single-channel stainless steel lumens. An inside diameter of 2 mm or larger and a length of 400 mm or shorter of single-channel stainless steel lumens.
STERRAD®NX®AdvancedCycle	Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load:An inside diameter of 1 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens. OROne single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain:A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter.
STERRAD®100NX®StandardCycle	Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: An inside diameter of 0.7 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens. (A maximum of two flexible endoscopes, one per tray per sterilization cycle.)
STERRAD®100NX®Flex Cycle	One or two single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain: A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter. (A maximum of two flexible endoscopes, one per tray per sterilization cycle).
STERRAD®100NX®EXPRESSCycle	Non-lumened reusable metal and non-metal devices requiring surface sterilization, and sterilization of diffusion- restricted spaces such as the hinged portions of forceps and scissors, and rigid or semi-rigid endoscopes without lumens.
STERRAD®100NX®DUO Cycle	One or two single-channel Flexible Endoscope with accessory devices that are normally connected to it, with or without a silicone mat. The flexible endoscope may contain: A single-channel Teflon®/Polyethylene lumen with an inside diameter of 2 mm or larger and a length of 250 mm or shorter. Accessory devices that are normally connected to a flexible endoscope during use. Flexible endoscopes without lumens

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KIMGUARD* Smart Fold* Sterilization Wrap Recommendations for Use with the Advanced Sterilization Products STERRAD® Sterilization Systems are provided in Table 2.

TABLE 2: Recommended Loads for KIMGUARD* Smart-Fold* Sterilization Wrap for use with AdvancedSterilization Products (ASP) STERRAD® Sterilization Systems (STERRAD® 100S, NX® [StandardCycle, Advanced Cycle], and 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle])
KIMGUARDSmart FoldSterilization WrapModels	Intended Loads¹	Maximum WrappedPackage Content WeightsUsed in SterilityMaintenance ValidationStudy²	Description of Leads Usedin Sterility MaintenanceValidation Study
KC450	Moderate to heavy weightpackage (e.g., general usemedical instruments	10.7 lbs.	•APTIMAX® Instrument Tray(23 in. x 11 in. x 4in.) withTray Mat•Metal and non-metalinstruments
KC650	Very heavy weight package(e.g., general use medicalinstruments	10.7 lbs.	•APTIMAX® Instrument Tray(23 in. x 11 in. x 4in.) withTray Mat•Metal and non-metalinstruments

Intended loads include: Medical Instruments with and without lumens that include telescopes, cameras, light cords, and general use medical instruments

it is recommended to not exceed the maximum, wrapped package content weights indicated for each wrap model. Furthermore, it is recommended to not exceed the number, weight, and size of individual content types that were validated (i.e. the number and size of the fluid resistant linens or the weights of the metal mass)

DESCRIPTION OF DEVICE

The following table compares the subject KIMGUARD* Smart Fold* Sterilization to the predicate KIMGUARD Sterilization Wrap devices.

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General Comparison Matrix Overview: Subject and Predicate Device
	Subject Device	Predicate	Predicate
Characteristic	KIMGUARD* Smart-Fold*Sterilization Wrap (modelsKC450 and KC650)	KIMGUARD* Smart-Fold*Sterilization Wrap (modelsKC250, KC450, KC550, andKC650)	KIMGUARD* ONE-STEP*Sterilization Wrap (modelsKC100, KC200, KC300,KC400, KC500, KC600)
510(k) Number	TBD	K112300	K113806
Regulation/Product Code	Sterilization Wrap:21CFR880.6850FRG	[SAME]	[SAME]
Intended Use	Intended to allow sterilization ofthe enclosed medical device(s)and also maintain sterility of theenclosed device(s) until used.	[SAME]	[SAME]
SterilizationModality	STERRAD® (hydrogen peroxide)Sterilization Systems	Pre-Vacuum Steam andEthylene Oxide	[SAME]
Base MaterialsofConstruction	Three-layer SMS (spunbond-meltblown-spunbond) fabric	[SAME]	[SAME]
Packaging	Bulk and Non-sterile	[SAME]	[SAME]
Use	Over the Counter/Single Use	[SAME]	[SAME]

SUMMARY OF NONCLINICAL TESTS

Performance testing was conducted to show that the KIMGUARD* Smart Fold* Sterilization Wrap maintains sterility until used, after completion of the sterilization processes provided by the STERRAD® Sterilization Systems. The following Table summarizes performance evaluations performed.

Performance Requirement	Results
STERRAD Sterilant Penetration	Passed
Material Compatibility/Biocompatibility post-sterilizationusing maximum hydrogen peroxide concentration· Cytotoxicity per ISO 10993-5:2009 Elution Method usingMEM extraction· Dermal Irritation per ISO 10993-10:2010, Intracutaneousreactivity using two extracts (i.e., 0.9% Sodium Chloride,USP and Sesame Oil, NF)	Passed
Material Usability post-sterilization	Passed
Maintenance of Package Integrity (180 Days)	Passed

Overall Performance Conclusions

The nonclinical studies demonstrate that the KIMGUARD* Smart Fold* Sterilization Wrap performs as intended as a sterilization packaging system of medical devices when sterilized in the STERRAD® Sterilization Systems. These studies show that the KIMGUARD* Smart Fold* Sterilization Wrap (KC450 and KC650) met the same criteria as the predicate device and are substantially equivalent.

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).