The KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened. The KC300 Model ONE-STEP* wrap was validated for dry times for pre-vacuum steam sterilization of 30 minutes.

KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization.

The KC 300 Model KIMGUARD ONE-STEP* Sterilization Wrap was previously cleared for use in K082177 for use with an ethylene oxide sterilization method of 100% ethylene oxide (EtO) with a concentration of 725-735 mg/L at 131°F/ 55°C and 40% - 80% relative humidity for 60 minutes.

Device Description

The KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap is identical to the predicate KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap in K082177 in design, materials, and intended use (the intended use is being expanded in this 510(k) notification to include pre-vacuum steam sterilization in addition to the previously cleared indication for use with ethylene oxide sterilization). The KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap ultrasonically seamed on two sides. This allows for convenient wrapping with two sheets simultaneously. The sheets of sterilization wrap are square or rectangular fabric produced using a polypropylene three-layer SMS (spunbondmeltblown-spunbond) process.

AI/ML Overview

The KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap was tested for biocompatibility (irritation and sensitization), sterilant penetration, dry time, and physical integrity based on the applicable requirements recommended in the Draft Guidance for Industry and FDA titled "Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities" (March 7, 2002).

All reported results met the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Biocompatibility (Irritation)	Compliant with ISO 10993 methods	Met acceptance criteria
Biocompatibility (Sensitization)	Compliant with ISO 10993 methods	Met acceptance criteria
Sterilant Penetration	Not explicitly stated, but implies effective penetration for sterilization	Met acceptance criteria
Dry Time (Pre-Vacuum Steam)	Validated for 30 minutes	Met acceptance criteria (validated for 30 minutes)
Physical Integrity	Ability to maintain sterility of pack contents for up to 30 days under standard conditions	Met acceptance criteria

2. Sample Size and Data Provenance for Test Set:

The specific sample sizes for each test mentioned (biocompatibility, sterilant penetration, dry time, physical integrity) are not detailed in the provided text. The data provenance is also not explicitly stated, but it can be inferred that these studies were conducted internally or by a contracted laboratory by Kimberly-Clark Health Care as part of their 510(k) submission to the FDA in the USA. The studies are retrospective as they were conducted to support a premarket notification.

3. Number of Experts and Qualifications for Ground Truth:

This section is not applicable as the described tests for a sterilization wrap do not typically involve human expert interpretation of results to establish ground truth in the same way as, for example, image analysis or disease diagnosis. The evaluation of test results (e.g., bacterial growth, physical integrity, moisture levels) is based on objective measurements against established scientific and regulatory standards.

4. Adjudication Method for Test Set:

Not applicable for this type of device and testing. The tests are laboratory-based and assessed against pre-defined scientific criteria rather than requiring adjudication of subjective interpretations.

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

Not applicable. This type of study involves human readers interpreting cases, often with AI assistance, and is relevant for diagnostic or interpretive medical devices. The Kimberly-Clark ONE-STEP* Sterilization Wrap is a sterile barrier system and its performance is evaluated through laboratory and physical tests, not through human reader interpretation.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This device is a physical product (sterilization wrap), not an algorithm or software. Its performance is inherent in its material properties and design, tested through physical and biological challenges.

7. Type of Ground Truth Used:

The ground truth for the performance of the sterilization wrap is established through objective laboratory measurements and scientific standards as outlined in the "Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002)" and ISO 10993 for biocompatibility.

Biocompatibility: Absence of irritation and sensitization as per ISO 10993 standards.
Sterilant Penetration: Successful sterilization of enclosed devices, typically evidenced by biological indicator (e.g., spore strip) conversion or chemical indicator changes.
Dry Time: Achievement of specified dry times without residual moisture.
Physical Integrity/Sterility Maintenance: Absence of microbial ingress into the wrapped package for a specified duration (e.g., 30 days), determined through microbial challenge tests and physical assessments of the barrier properties.

8. Sample Size for the Training Set:

Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.

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

Not applicable as there is no training set for this device.

Summary

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K09/685

3 2009

SFP

510(k) Summary for the Kimberly-Clark* Corporation KC300 Model KIMGUARD ONE-STEP* Sterilir ation Wrap for the Additional Indication for Use with Pre-Vacuum Steam

June 5, 2009 Date Summary was Prepared:

510(k) Submitter:

Thomas Kozma Director, Regulatory Affairs Kimberly-Clark Health Care 1400 Holcomb Bridge Road Roswell, GA 30076 Ph: 770.587.8393 FAX: 920.225.3408 Email: thomas.kozma@kcc.com

Sterilization Wrap (21 CFR 880.6850)

Primary Contact for this 510(k) Submission:

Lisa Peacock, Consultant to Kimberly-Clark Health Care SciMed. Inc. Ph: 706.216.3413 FAX: 800.713.7754 Email: lisa.peacock@kcc.com

Device Common Name:

Sterilization Wrap

FRG

Classification Name:

Product Code:

Intended Use:

KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization.

See KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap recommendations for pre-vacuum steam on Page 2.

Page 1 of 2 - 510(k) Summary

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Predicate Devices:

Substantial Equivalence: The KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap for pre-vacuum steam sterilization is substantially equivalent to the predicate KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100 KC200, KC300, KC400, KC500, and KC600) (K082177).

Summary of Testing:

The KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap performance has been tested in accordance with the applicable requirements recommended in Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002). Testing included biocompatibility (i.e., irritation and sensitization) in compliance with the methods of ISO 10993, sterilant penetration, dry time, and physical integrity. The Wrap has also been tested for the ability to maintain sterility of pack contents after sterilization for up to 30days under standard conditions All results of testing met acceptance criteria.

KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap Recommendations for Pre-Vacuum Steam Sterilization

KIMGUARDONE-STEP*SterilizationWrap Models	Intended Loads	MaximumWrappedPackageContentWeights Used inSterilityMaintenanceValidationStudy2	Descriptions of Loads Used in SterilityMaintenance Validation Study2
KC300	Light to ModerateWeight Package (forexample: general usemedical instruments)	9 lbs	15 huck towels (17"x 29")1 small fluid resistant drape (60"x 76")5 lbs of metal mass

Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding to methods. Results may also differ due to the use of irregularly shaped contents, which may put added stress on the wrap Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use, 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 for the KIMGUARD Sterilization Wraps (i.e.: the number and size of the fluid resistant linens or the weight of the metal mass).

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's emblem in the center. The emblem features a stylized caduceus, a symbol often associated with medicine and healthcare, with three snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

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

Mr. Thomas Kozma Director of Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076

SEP - 3 2009

Re: K091685

Trade/Device Name: KC300.Model KIMGUARD ONE-STEP* Sterilization Wrap for the Additional Indication for Use with Pre-Vacuum Steam

Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: June 5, 2009 Received: June 12, 2009

Dear Mr. 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.

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- Mr. Kozma

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH Offices/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,

Anthony D. Watson for

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, 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):

Device Name: KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap for the Additional Indication for Use with Pre-Vacuum Steam

Indications for Use:

The KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by prevacuum steam at 270ºF/132ºC for 4 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened. The KC300 Model ONE-STEP * wrap was validated for dry times for prevacuum steam sterilization of 30 minutes.

KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization.

See KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap Recommendations for pre-vacuum steam on Page 2.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule R. Murphy 10

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

510(k) Number: K091185

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Indications for Use

KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap Recommendations for Pre-Vacuum Steam Sterilization1

KIMGUARDONE-STEP*SterilizationWrap Models	Intended Loads	MaximumWrappedPackageContentWeights Used inSterilityMaintenanceValidationStudy2	Descriptions of Loads Used in SterilityMaintenance Validation Study2
KC300	Light to ModerateWeight Package (forexample: general usemedical instruments)	9 lbs	15 huck towels (17"x 29")1 small fluid resistant drape (60"x 76")5 lbs of metal mass

I Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding methods. Results may also differ due to the use of iregularly shaped contents, which may put added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use. 2 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 for the KIMGUARD Sterilization Wraps (i.e.: the number and size of the fluid resistant linens or the weight of the metal mass).

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

510(k) Number:

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).