KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:

· Pre-vacuum steam at 270°F / 132°C for 4 minutes. The wrap was validated for dry times of 20 minutes for models KC100 and KC200.

· 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F / 55°C and 40-80% relative humidity for 60 minutes. The wrap was validated for aeration times for EO sterilization of 8 hours at 43.3 °C for models KC100 and KC200.

KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) 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 (KC100, KC200) allowed sterilization of the enclosed devices by the ethylene oxide sterilization and by pre-vacuum cycles.

These models of the KIMGUARD* ONE-STED* Sterilization Wrap have been validated for use with the ethylene oxide and pre-vacuum cycles in Table 1 (see page 2 of 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 rectanqular fabric produced using a three-layer SMS (spunbond-meltblown-spunbond) process. The wrap fabric (white or blue color) is composed of polypropylene with the addition of less than 2% by weight of phthalocvanine blue pigment (blue fabric only), less than 1% by weight titanium dioxide pigment, and less than 0.009% by weight of a potassium phosphate anti-static treatment. The wrap allows a sterilized package to be opened aseptically.

AI/ML Overview

This FDA 510(k) summary describes KIMGUARD® ONE-STEP® Sterilization Wrap intended to enclose medical devices for sterilization and maintain sterility.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Acceptance Criteria (Measured Performance)	Reported Device Performance (Results)
Maintain Sterility (for Pre-vacuum steam sterilization at 270°F / 132°C for 4 minutes with 20 minutes dry time)	Passed
Maintain Sterility (for 100% ethylene oxide (EO) at 725-735 mg/L, 131°F / 55°C, 40-80% RH for 60 minutes with 8 hours aeration at 43.3°C or 12 hours at 55°C)	Passed
Maintenance of 365-Day Package Integrity (sterility maintenance)	Passed
Ethylene Oxide Sterilant Penetration	Passed
Pre-Vacuum Steam Sterilant Penetration	Passed
Post Sterilization Biocompatibility Testing (Cytotoxicity, ISO 10993-5: 2009; Irritation, ISO 10993-10:2010; Sensitization, ISO 10993-10: 2010)	Passed
Maximum Wrapped Package Content Weights for KC100 (Very Light Weight Package)	Up to 3 lbs. (Tested with 16 huck towels (17"x 29"))
Maximum Wrapped Package Content Weights for KC200 (Light Weight Package)	Up to 6 lbs. (Tested with 2 huck towels (17"x 29"), 2 fluid resistant U-drapes (68"x 109"), 1 fluid resistant universal bar drape (70" x 108"))

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

The document does not explicitly state the specific sample sizes used for the "Maintenance of 365-Day Package Integrity," "Sterilant Penetration," and "Biocompatibility" tests. For the KIMGUARD® ONE-STEP® Sterilization Wrap Recommendations for Use (Table 1), the "test set" can be considered the specific configurations of loads used to validate the maximum wrapped package content weights:

KC100: 16 huck towels (17"x 29") weighing 3 lbs.
KC200: 2 huck towels (17"x 29"), 2 fluid resistant U-drapes (68"x 109"), 1 fluid resistant universal bar drape (70" x 108") weighing 6 lbs.

The data provenance is not explicitly mentioned as country of origin, but the applicant is Halyard Health, located in Alpharetta, GA, USA. The studies appear to be prospective as they were conducted to validate the device's performance.

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)

This product is a sterilization wrap, not an AI/imaging device. Therefore, the concept of "experts" to establish ground truth in the context of diagnostic interpretation is not applicable here. The validation involves standardized performance tests for sterilization and material properties. Compliance with relevant standards (e.g., ISO 10993 for biocompatibility) would be performed by qualified personnel in testing laboratories.

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

Not applicable for this type of device and study. Adjudication methods are typically used in clinical studies involving interpretation by multiple readers.

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/imaging device.

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

Not applicable. This is not an AI software. The device itself (the sterilization wrap) has a standalone performance (its ability to maintain sterility and allow sterilant penetration). The nonclinical tests essentially evaluate this "standalone" performance.

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

The "ground truth" for this device's performance is established by:

Quantitative measurements and observations based on standardized test methods for:
- Sterilant penetration (ensuring the sterilant reaches the enclosed medical device).
- Microbiological challenge (implied by "maintenance of sterility" tests, indicating no microbial ingress).
- Physical integrity tests to confirm the wrap remains intact over time, preventing contamination.
- Biocompatibility tests according to ISO standards, which involve specific physiological responses.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device 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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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 the department's name in a circular arrangement around an emblem. The emblem consists of a stylized human figure with three faces, representing the department's focus on health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

April 3, 2015

Halyard Health Ms. Monica King Associate Director, Regulatory Affairs 5405 Windward Parkway Alpharetta, GA 30004

Re: K143053

Trade/Device Name: KIMGUARD® ONE-STEP® Sterilization Wrap (KC100, KC200) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: March 3, 2015 Received: March 4, 2015

Dear Ms. King:

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. King

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. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

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

510(k) Number (if known) K143053

Device Name

KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200)

Indications for Use (Describe)

KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:

· Pre-vacuum steam at 270°F / 132°C for 4 minutes. The wrap was validated for dry times of 20 minutes for models KC100 and KC200.

KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) 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 (KC100, KC200) allowed sterilization of the enclosed devices by the ethylene oxide sterilization and by pre-vacuum cycles.

These models of the KIMGUARD* ONE-STED* Sterilization Wrap have been validated for use with the ethylene oxide and pre-vacuum cycles in Table 1 (see page 2 of 2)

Page 1 of 2

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Continuation Page Indications for Use Statement K143053 KIMGUARD* ONE-STEP* Sterilization Wrap (KC100/KC200) Page 2 of 2

TABLE 1: KIMGUARD* ONE-STEP* Sterilization Wrap Recommendations for Use with the Pre-Vacuum Steam or Ethylene Oxide1

KIMGUARD*Sterilization WrapModels	Intended Loads	Maximum WrappedPackage ContentWeights Usedin SterilityMaintenanceValidation Study2	Descriptions ofLoads Used inSterilityMaintenanceValidation Study2
KC100	Very Light WeightPackage (forexample: batteries)	3 lbs.	16 huck towels (17"x29")
KC200	Light WeightPackage (forexample: telescopewith light cord)	6 lbs.	2 huck towels (17"x29")2 fluid resistant U-drapes (68"x 109")1 fluid resistantuniversal bar drape(70" x 108")

1Individual 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 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. 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).

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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 Person

Halyard Health 5405 Windward Parkway, Alpharetta, GA 30004, USA Establishment Registration Number: 1033422

Contact Name: Monica King, Associate Director of Regulatory Affairs E-mail: Monica.king@hyh.com (678) 477-4165 (Telephone) (678) 254-0347 (Fax)

DATE PREPARED:	April 2, 2015
TRADE NAME:	KIMGUARD* ONE-STEP* Sterilization Wrap (Models KC100 & KC200)
CLASSIFICATION NAME:	Sterilization Wrap
COMMON/USUAL NAME:	Sterilization Wrap
PRODUCT CODE:	FRG
DEVICE CLASSIFICATION:	Class II per 21 CFR §880.6850
PREDICATE DEVICES:	KIMGUARD* ONE-STEP* Sterilization Wrap, [510(k) Notification K082554 for ethylene oxide and K082177 for pre-vacuum steam, clearances on May 1, 2009 and March 27, 2009, respectively]

INDICATIONS FOR USE

KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:

Pre-vacuum steam at 270°F / 132°C for 4 minutes. The wrap was validated for dry times ● of 20 minutes.
. 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F / 55°C and 40-80% relative humidity for 60 minutes. The wrap was validated for aeration times for EO sterilization of 8 hours at 55°C or 12 hours at 43.3°C.

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KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) 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 (KC100, KC200) allowed sterilization of the enclosed devices by the ethylene oxide sterilization and by prevacuum cycles.

These models of the KIMGUARD* ONE-STEP* Sterilization Wrap have been validated for use with the ethylene oxide and pre-vacuum cycles in Table 1 below.

KIMGUARD*Sterilization WrapModels	Intended Loads	Maximum WrappedPackage ContentWeights Usedin SterilityMaintenanceValidation Study2	Descriptions ofLoads Used inSterilityMaintenanceValidation Study2
KC100	Very Light WeightPackage (forexample: batteries)	3 lbs.	16 huck towels (17"x29")
KC200	Light WeightPackage (forexample: telescopewith light cord)	6 lbs.	2 huck towels (17"x29")2 fluid resistant U-drapes (68"x 109")1 fluid resistantuniversal bar drape(70" x 108")

TABLE 1: KIMGUARD* ONE-STEP* Sterilization Wrap Recommendations for Use with the Pre-Vacuum Steam or Ethylene Oxide"

'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 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. 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).

DESCRIPTION OF DEVICE

K143053 KIMGUARD* ONE-STEP* Sterilization Wrap (KC100/KC200) Halvard Health

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TechnologicalCharacteristics	Proposed Device:KIMGUARD® ONE-STEP® SterilizationWrap K143053	Predicate Device: K3KIMGUARD® ONE-STEP® SterilizationWrap K082554, K082177
Manufacturer	Halyard Health	Halyard Health (formerly known asKimberly-Clark Health Care)
Regulation/ProductCode	Sterilization Wrap: 880.6850 / FRG	Sterilization Wrap: 880.6850 / FRG
Device Design	Two sheets of medium blue nonwovenPolypropylene fabric. Each sheet of fabricis composed of three thermally- bondedlayers consisting of a Meltblownpolypropylene layer surrounded bySpunbond polypropylene layers (SMS).	Two sheets of medium blue nonwovenPolypropylene fabric. Each sheet of fabricis composed of three thermally- bondedlayers consisting of a Meltblownpolypropylene layer surrounded bySpunbond polypropylene layers (SMS).
Method forbondingSMS 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
Biocompatibility	Applicable parts of ISO 10993 - Biologicalevaluation of medical devices (see Table 3)	Applicable parts of ISO 10993 - Biologicalevaluation of medical devices (see Table 3)
Maintenance ofPackage Sterility	Real-time testing following sterilization usingpre-vacuum steam or Ethylene Oxidesupports maintenance of package sterilityfor 365 days.	Real-time testing following sterilizationusing pre-vacuum steam or Ethylene Oxidesupports maintenance of package sterilityfor 30 days.

Table 2: Device Comparison Table - Technological Characteristics

SUMMARY OF NONCLINICAL TESTS

Performance testing was conducted to show that the KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) maintains sterility until used, after completion of the sterilization process in the pre-vacuum and ethylene oxide sterilization systems.

Table 3: Sterilization Wrap Performance Tests

Study	Results
Maintenance of 365-Day Package Integrity	Passed
Ethylene Oxide Sterilant Penetration	Passed
Pre-Vacuum Steam Sterilant Penetration	Passed
Post Sterilization Biocompatibility Testing (Cytotoxicity, ISO	Passed
10993-5: 2009; Irritation, ISO 10993-10:2010; Sensitization, ISO
10993-10: 2010.

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OVERALL PERFORMANCE CONCLUSIONS

The nonclinical studies demonstrate that the KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) performs as intended as a sterilization packaging system of medical devices when terminally sterilized in the pre-vacuum steam and ethylene oxide sterilization systems. These studies show that the KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) 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).