Advanced Sterilization Products STERRAD® Sterilization Systems that include: STERRAD® 50, 100S, and 200 STERRAD® NX® [Standard Cvcle. Advanced Cvcle] STERRAD® 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle]

KIMGUARD* ONE-STEP* Sterilization Wraps 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* ONE-STEP* Sterilization Wraps (KC300, KC400, KC500, and KC600) allowed sterilization of the enclosed devices by the Advanced Sterilization Products STERRAD® Sterilization Systems (STERRAD® 50, 100S, 200, NX® [Standard Cycle and Advanced Cycle] and 100NX® [Standard Cycle, EXPRESS Cycle, DUO Cycle]).

The KIMGUARD* ONE-STEP* Sterilization Wrap (Models KC300, KC400, K500, KC600) have been validated for use with the STERRAD® 50, STERRAD® 100S, STERRAD® 200, STERRAD® NX® and STERRAD® 100NX® cycles in Table 1.

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

Device Description

KIMGUARD® ONE-STEP® Sterilization Wrap is comprised of two sheets of KIMGUARD® Sterilization Wrap ultrasonically seamed on two edges. This allows for convenient wrapping with two sheets simultaneously.

The sheets of sterilization wrap are square or rectangular fabric produced using a threelayer SMS (spunbond-meltblown-spunbond) process. The wrap fabric is composed of polypropylene with the addition of 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. The wrap allows a sterilized package to be opened aseptically.

AI/ML Overview

The acceptance criteria are that the KIMGUARD® ONE-STEP® Sterilization Wrap maintains sterility until used, after being sterilized by the referenced STERRAD® Sterilization Systems.

Here's the summary of the study:

1. Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Maintenance of 180-Day Package Integrity	Passed
Allow sterilization of enclosed devices	Passed with all specified STERRAD® systems and cycles
Maintain sterility of enclosed devices until used	Passed

2. Sample Size and Data Provenance for Test Set:
The document does not explicitly state the specific sample sizes for each test in the test set. It mentions "Test results validated" and "Performance testing was conducted," implying a test set was used. The data provenance is not specified (e.g., country of origin). It's a nonclinical study, so it wouldn't be retrospective or prospective in the human study sense.

3. Number of Experts and Qualifications for Ground Truth of Test Set:
This information is not provided in the document. As this is a non-clinical device (sterilization wrap), it's unlikely that "experts" in the medical sense (like radiologists) were used to establish ground truth for performance tests like package integrity or sterilization efficacy. Ground truth would be based on validated scientific and engineering testing protocols.

4. Adjudication Method for the Test Set:
The document does not mention an adjudication method. For non-clinical performance tests, adjudication (e.g., 2+1, 3+1 for human readers) is typically not applicable. The results are usually objectively measured against predefined pass/fail criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or evaluative devices where human interpretation is involved. This device is a sterilization wrap, and its effectiveness is determined by objective physical and biological tests.

6. Standalone Performance:
Yes, a standalone (algorithm only without human-in-the-loop performance) study was done, as this is a physical product being tested for its intrinsic performance (package integrity, ability to allow sterilization). The study involved "Performance testing" and "nonclinical tests" as described.

7. Type of Ground Truth Used:
The ground truth used for these tests would be based on:

Standardized microbiological testing (to confirm sterilization efficacy and sterility maintenance).
Physical integrity testing methods (to assess package integrity).
Chemical indicators or biological indicators (for sterilization effectiveness).
The tests adhere to established standards and protocols for sterilization validation and sterile barrier system performance.

8. Sample Size for the Training Set:
The concept of a "training set" is not applicable here as this is a physical device being evaluated for its performance through testing, not an AI/algorithm being trained on data.

9. How the Ground Truth for the Training Set Was Established:
As mentioned in point 8, the concept of a "training set" is not applicable to this type of device and study.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three faces in profile, stacked on top of each other. The faces are black and are oriented to the right. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in black.

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

August 7, 2014

Kimberly-Clark Health Care Marsha Johnson, RAC, CBA Associate Director, Regulatory Affairs 1400 Holcomb Bridge Road Roswell, GA 30076

Re: K141612

Trade/Device Name: KIMGUARD® ONE-STEP® Sterilization Wrap (Models: KC300, KC400, KC500, and KC600) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: July 11, 2014 Received: July 14, 2014

Dear Mrs. Johnson:

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 - Mrs. Johnson

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 (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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Appendix B - Revised Indications For Use

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below

510(k) Number (if known)

K141612

Device Name

KIMGUARD* ONE-STEP* Sterilization Wrap (Models KC300, KC400, KC500, and KC600)

Indications for Use (Describe)

KIMGUARD* ONE-STEP* Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using:

KIMGUARD* ONE-STEP* Sterilization Wraps are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

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

PSC Publishing Services (301) 443-6740 EP

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TABLE 1: Validated Advanced Sterilization Products (ASP) STERRAD 50, STERRAD 100S, STERRAD®200, STERRAD® NX®, and STERRAD® 100NX® Cycles

ASP STERRAD®System andCycle	Intended Load
STERRAD®50	Reusable metal and non-metal medical devices, including up to 10 lumens of the followingdimensions 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®100S	Reusable metal and non-metal medical devices, including up to 10 lumens of the followingdimensions 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®200	Reusable metal and non-metal medical devices, including up to 12 lumens of the followingdimensions 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 followingdimensions 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 followingdimensions 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. Theflexible 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.
TABLE 1: Validated Advanced Sterilization Products (ASP) STERRAD® 50, STERRAD® 100S,STERRAD® 200, STERRAD® NX®, and STERRAD® 100NX® Cycles (Cont.)
STERRAD®100NX®StandardCycle	Reusable metal and non-metal medical devices, including up to 10 lumens of the followingdimensions per chamber load:• An inside diameter of 0.7 mm or larger and a length of 500 mm or shorter of single-channelstainless steel lumens. (A maximum of two flexible endoscopes, ONE per tray per sterilizationcycle.)
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 alength of 850 mm or shorter. (A maximum of two flexible endoscopes, ONE per tray persterilization cycle).
STERRAD®100NX®EXPRESSCycle	Non-lumened reusable metal and non-metal devices requiring surface sterilization, and sterilizationof 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 connectedto it, with or without a silicone mat. The flexible endoscope may contain:• A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and alength of 875 mm or shorter.• Flexible endoscopes without lumens

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TABLE 2: Recommended Loads for KIMGUARD* ONE-STEP* Sterilization Wrap for use with Advanced Sterilization Products (ASP) STERRAD Sterilization Systems (STERRAD" 50, 100S, 200, NX [Standard Cycle, Advanced Cycle], and 100NX [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle])

KIMGUARD ® ONE-STEP® SterilizationWrap Models	Intended Load1	Weights of Wrapped PackageContent Used in Validation Study(Total weight including tray)	Descriptions of Loads Used in SterilityMaintenance Validation Study
KC300	Light to moderate weightpackage (e.g., general usemedical instruments)	10.7 lbs	APTIMAX® Instrument Tray(23 in. x 11 in. x 4 in.) with Tray Mat Metal and non-metal instruments
KC400	Moderate to heavy weightpackage (e.g., general usemedical instruments)	10.7 lbs	APTIMAX® Instrument Tray(23 in. x 11 in. x 4 in.) with Tray Mat Metal and non-metal instruments
KC500	Heavy weight package (e.g.,general use medicalinstruments)	10.7 lbs	APTIMAX® Instrument Tray(23 in. x 11 in. x 4 in.) with Tray Mat Metal and non-metal instruments
KC600	Very heavy weight package(e.g., general use medicalinstruments)	10.7 lbs	APTIMAX® Instrument Tray(23 in. x 11 in. x 4 in.) with Tray Mat Metal and non-metal instruments

11ntended loads include: Medical Instruments with and without lumens that include telescopes, endoscopes, 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

Elizabeth Concurrence of പ്ലെട്ടു.ട്രൈപ്പോട്ടെ.and Radiological Health (CDRH) (Signature)
Press (F.

Claverie -S

ople, 0.9.2342.19200300.100.1.1=1300055864 : 2014.08.07 14:42:52 -04'00

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Appendix A - 510(K) SUMMARY (REVISED)

Applicant's Name, Address, Telephone, FAX, Contact Person

Kimberly-Clark Health Care 1400 Holcomb Bridge Road Roswell, GA 30076-2190, USA Contact Name: Marcia Johnson, RAC, CBA Associate Director, Regulatory Affairs Tel: 770.587.8566 Fax: 920.380.6351 email: marcia.johnson@kcc.com

Establishment Registration Number: 1033422

Date: July 11, 2014

1. CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification:	Class II per 21 CFR 880.6850
Classification Name:	Sterilization Wrap
Common/Usual Name:	Sterilization Wrap
Product Code:	FRG
Proprietary Name:	KIMGUARD® ONE-STEP® Sterilization Wrap (Models: KC300, KC400, KC500, and KC600)

2. PREDICATE DEVICES

KIMGUARD® ONE-STEP® Sterilization Wrap, which is currently manufactured and distributed by Kimberly-Clark Corporation [510(k) Notification K113806, cleared August 20, 2013]

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3. INDICATIONS FOR USE

KIMGUARD* ONE-STEP* Sterilization Wraps are intended 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® 50, 100S, and 200
- o STERRAD® NX® [Standard Cycle, Advanced Cycle, Advanced Cycle]
  o STERRAD® 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle]

KIMGUARD* ONE-STEP* Sterilization Wraps are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

These models of the KIMGUARD* ONE-STEP* Sterilization Wrap have been validated for use with the STERRAD® 50, STERRAD® 100S, STERRAD® 200, STERRAD® NX® and STERRAD® 100NX® cycles in Table 1 below.

ASP STERRAD®System and Cycle	STERRAD® 200, STERRAD® NX®, and STERRAD® 100NX® CyclesIntended Load
STERRAD®50	Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions perchamber 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®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.
ASP STERRAD®System and Cycle	Intended Load
STERRAD®200	Reusable metal and non-metal medical devices, including up to 12 lumens of the following dimensions perchamber load:• An inside diameter of 1 mm or larger and a length of 125 mm or shorter of single-channel stainlesssteel lumens.• An inside diameter of 2 mm or larger and a length of 250 mm or shorter of single-channel stainlesssteel lumens.• An inside diameter of 3 mm or larger and a length of 400 mm or shorter of single-channel stainlesssteel lumens.• An inside diameter of 6 mm or larger and a length of 310 mm or shorter of single-channelTeflon/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 stainlesssteel lumens.• An inside diameter of 2 mm or larger and a length of 400 mm or shorter of single-channel stainlesssteel lumens.
STERRAD®NX®AdvancedCycle	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 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®Standard Cycle	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 1 mm or larger and a length of 875 mm or shorter.• Accessory devices that are normally connected to a flexible endoscope during use.• Flexible endoscopes without lumens

TABLE 1: Validated Advanced Sterilization Products (ASP) STERRAD® 50, STERRAD® 100S, ଜ

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KIMGUARD* ONE-STEP* Sterilization Wrap Recommendations for Use with the Advanced Sterilization Products STERRAD® Sterilization Systems are provided in TABLE 2.

TABLE 2: Recommended Loads for KIMGUARD* ONE-STEP* Sterilization Wrap for use with Advanced Sterilization Products (ASP) STERRAD® Sterilization Systems (STERRAD® 50, 100S, 200, NX® [Standard Cycle, Advanced Cycle], and 100NX® [Standard Cycle, EXPRESS Cycle, DUO Cycle])

KIMGUARD®ONE-STEP®Sterilization WrapModels	Intended Load1	Weights of Wrapped PackageContent Used in Validation Study(Total weight including tray)	Descriptions of Loads Used in SterilityMaintenance Validation Study
KC300	Light to moderate weightpackage (e.g., general usemedical instruments)	10.7 lbs	®APTIMAX Instrument Tray•(23 in. x 11 in. x 4 in.) with Tray Mat• Metal and non-metal instruments
KC400	Moderate to heavy weightpackage (e.g., general usemedical instruments)	10.7 lbs	®APTIMAX Instrument Tray•(23 in. x 11 in. x 4 in.) with Tray Mat• Metal and non-metal instruments
KC500	Heavy weight package (e.g.,general use medical instruments)	10.7 lbs	®APTIMAX Instrument Tray•(23 in. x 11 in. x 4 in.) with Tray Mat• Metal and non-metal instruments
KC600	Very heavy weight package(e.g., general use medicalinstruments )	10.7 lbs	®APTIMAX Instrument Tray•(23 in. x 11 in. x 4 in.) with Tray Mat• Metal and non-metal instruments

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

4. DESCRIPTION OF DEVICE

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TechnologicalCharacteristics	Proposed:KIMGUARD® ONE-STEP® SterilizationWrap	Predicate Device:KIMGUARD® ONE-STEP® SterilizationWrap (K113806)
Manufacturer	Kimberly-Clark Corporation	Kimberly Clark Corporation
Regulation/ProductCode	Sterilization Wrap: 880.6850 / FRG	Sterilization Wrap: 880.6850 / FRG
Device Design	Two sheets of medium blue nonwovenpolypropylene fabric. Each sheet offabric is composed of three thermally-bonded layers consisting of aMeltblown polypropylene layersurrounded by Spunbondpolypropylene layers (SMS)	Two sheets of medium blue nonwovenpolypropylene fabric. Each sheet offabric is composed of three thermally-bonded layers consisting of aMeltblown polypropylene layersurrounded by Spunbondpolypropylene layers (SMS)
Method for bondingSMS layers	Thermal bonding with round pin,hexagonal, triangle bond pattern("daisy" pattern)	Thermal bonding with round pin,hexagonal, triangle bond pattern("daisy" pattern)
Materials	Polypropylene with blue and whitepigments	Polypropylene with blue and whitepigments
Over the CounterUse Device	Yes	Yes
Single Use Device	Yes	Yes
(Continued on next page)
TechnologicalCharacteristics	Proposed:KIMGUARD® ONE-STEP® SterilizationWrap	Predicate Device:KIMGUARD® ONE-STEP® SterilizationWrap (K113806)
Indications for Use	KIMGUARD* ONE-STEP* SterilizationWraps are intended to enclose anothermedical device that is to be sterilized bya healthcare provider using:Advanced Sterilization ProductsSTERRAD® Sterilization Systems thatinclude:STERRAD® 50, 100S, and 200STERRAD® NX® [Standard Cycle,Advanced Cycle]STERRAD® 100NX® [Standard Cycle,Flex Cycle, EXPRESS Cycle, DUOCycle]KIMGUARD* ONE-STEP* SterilizationWraps are intended to allow sterilizationof the enclosed medical device(s) andalso maintain sterility of the encloseddevice(s) until used.Test results validated that KIMGUARDONE-STEP Sterilization Wraps(KC300, KC400, KC500, and KC600)allowed sterilization of the encloseddevices by the Advanced SterilizationProducts STERRAD® SterilizationSystems (STERRAD® 50, 100S, 200,NX® [Standard Cycle and AdvancedCycle] and 100NX® [Standard Cycle,Flex Cycle, EXPRESS Cycle, DUOCycle]).	KIMGUARD* ONE-STEP* SterilizationWraps are intended to enclose anothermedical device that is to be sterilized by ahealthcare provider using:Advanced Sterilization ProductsSTERRAD® Sterilization Systems thatinclude:STERRAD® 50, 100S, and 200STERRAD® NX® [Standard Cycle,Advanced Cycle]STERRAD® 100NX® [Standard Cycle,Flex Cycle, EXPRESS Cycle, DUOCycle]KIMGUARD* ONE-STEP* SterilizationWraps are intended to allow sterilization ofthe enclosed medical device(s) and alsomaintain sterility of the enclosed device(s)until used.Test results validated that KIMGUARDONE-STEP Sterilization Wraps (KC100,KC200, KC300, KC400, KC500, andKC600) allowed sterilization of theenclosed devices by the AdvancedSterilization Products STERRAD®Sterilization Systems (STERRAD® 50,100S, 200, NX® [Standard Cycle andAdvanced Cycle] and 100NX® [StandardCycle, Flex Cycle, EXPRESS Cycle, DUOCycle]).
Maintenance ofPackage Sterility	Passed 180-Day Maintenance of Package Passed 30-Day Maintenance of PackageIntegrity	Integrity

Table 3: Device Comparison Table - Technological Characteristics

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5. SUMMARY OF NONCLINICAL TESTS

Performance testing was conducted to show that the KIMGUARD®
ONE-STEP® Sterilization Wrap maintains sterility umil used, afterilization Systems.

Table 4: Sterilization Wrap Performance Tests

Study	Results
Maintenance of 180-Day Package Integrity	Passed

6. OVERALL PERFORMANCE CONCLUSIONS

The nonclinical studies demonstrate that the KIMGUARD® ONE-STEP® Sterilization Wrap performs as intended as a sterilization packaging system of medical devices when terminally sterilized in the STERRAD® Sterilization Systems. These studies show that the KIMGUARD® ONE-STEP® Sterilization Wrap met the same criteria the predicate device and are substantially equivalent. as

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).