KIMGUARD* ONE-STEP® Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

Device Description

KIMGUARD* ONE-STEP® Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap that is ultrasonically seamed on two edges. This seamed configuration allows for convenient wrapping of an article using two sheets simultaneously.

The blue or white sheets of sterilization wrap are square or rectangular fabric produced using a three-layer SMS (spunbound-meltblown-spunbound) process. The blue 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 anti-static treatment. The white sheet has the same material composition but contains no blue pigment. The wrap allows a sterilized package to be opened aseptically.

AI/ML Overview

I am sorry, but based on the provided document, the information required to compose the detailed response for "acceptance criteria and the study that proves the device meets the acceptance criteria" as requested is not available. The document is a 510(k) summary for a sterilization wrap, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics in the format requested for a device that typically involves AI or human interpretation.

Specifically, the document states:

"All results of testing met acceptance criteria demonstrating that the KIMGUARD* ONE-STEP® Sterilization Wrap allows sterilization of contents by the V-PRO® 60 Low Temperature Sterilization System (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) and maintains sterility of contents until used."
It lists a "Summary of Testing Performed" table with "Results" as "Passed" for "Sterilant Penetration", "Maintenance of Package Integrity (30 Days)", "Performance Testing", and "Material Biocompatibility."

However, it does not provide:

A table of specific acceptance criteria and reported device performance (e.g., quantifiable metrics like sensitivity, specificity, accuracy, or other performance thresholds with numerical results). The results are simply stated as "Passed."
Sample sizes used for the test set and data provenance.
Number of experts and their qualifications used to establish ground truth.
Adjudication method.
Multi-reader multi-case (MRMC) comparative effectiveness study details.
Standalone (algorithm only) performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document describes a medical device (sterilization wrap) which functions as a physical barrier and facilitator of sterilization, not an AI-powered diagnostic or interpretive device. Therefore, the types of studies and performance metrics typically associated with AI/software-as-a-medical-device (SaMD) are not applicable here.

Summary

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

March 9, 2015

Halyard Health (formerly known as Kimberly-Clark Health Care) Thomas Kozma, Ph.D. Director of Regulatory Affairs 5450 Windward Parkway Alpharetta, GA 30004

Re: K142782

Trade/Device Name: KIMGUARD* ONE-STEP® Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: February 12, 2015 Received: February 13, 2015

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (21 CFR 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 Post market Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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 vours.

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

510(k) Number (if known)

K142782

Device Name

KIMGUARD* ONE-STEP® Sterilization Wrap (Models KC100, KC200, KC300, 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:

V-PRO® 60 Low Temperature Sterilization System that include:
- o Lumen Cycle
- Non Lumen Cycle o
- Flexible Cycle O

KIMGUARD ONE-STEP® Sterilization Wrap (KC100, KC200, KC300 and KC600) 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, KC300, KC500, and KC600) allowed sterilization of the enclosed devices by the V-PRO® 60 Low Temperature Sterilization System (i.e., Lumen, Non Lumen, and Flexible Cycles). Additionally, the KIMGUARD ONE-STEP® Sterilization Wrap was validated to allow effective aeration under the pre-programmed sterilization cycles.

All models of the KIMGUARD ONE-STEP® Sterilization Wrap (KC100, KC300, KC300, KC500, and KC600) have been validated for use with the V-PRO® 60 Low Temperature Sterilization System cycles in Table 1.

KIMGUARD ONE-STEP® Sterilization Wraps (KC100, KC200, KC300, and KC600) Recommendations for Use with the V-PRO® 60 Low Temperature Sterilization System are provided in Table 2.

TABLE 1: Validated V-PRO® 60 Low Temperature Sterilizer System Cycles
V-PRO® 60 LowTemperatureSterilizerCycles	Intended Load
Lumen Cycle	Reusable metal and non-metal medical devices including instruments with diffusion-restricted spaces (such as the hingedportion of forceps or scissors) and single, dual or triple channeled rigid/semi-rigid endoscopes, with the followingconfigurations:Single or dual channeled devices with stainless steel lumens with An inside diameter of 0.77 mm or larger and a length of 410 mm or shorter Triple channeled devices with stainless steel lumens with An inside diameter of 1.2 mm or larger and a length of 257 mm or shorter. An inside diameter of 1.8 mm or larger and a length of 310 mm or shorter or An inside diameter of 2.8 mm or larger and a length of 317 mm or shorter
Non LumenCycle	Reusable metal and non-metal non-lumened medical devices including non-lumened rigid, semi-rigid and flexibleendoscopes and medical devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion offorceps or scissors.
Flexible Cycle	Single or dual channeled Flexible Surgical Endoscopes or Bronchoscopes with lumens that have:An inside diameter of 1 mm or larger and a length of 990 mm or shorter.

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TABLE 2: Recommended Loads for KIMGUARD ONE-STEP® Sterilization Wrap (KC100, KC200, KC300, KC400, KC500, & KC600) for use with V-PRO® 60 Low Temperature Sterilizer System
KIMGUARD ONE-STEP® Sterilization Wrap Models	Intended Loads1	Maximum Wrapped Package Content Weights Used in Sterility Maintenance Validation Study2	Description of Loads Used in Sterility Maintenance Validation Study2
KC100	Very Light Weight Package (for example batteries)	3 lbs.	3 lb of metal mass6 surgical forceps1 self-contained biological indicator (SCBI) (no tray was included)
KC200	Light Weight Package (for example telescope with light cord)	6.5 lbs.	• 2.5 lbs metal mass• 6 surgical forceps• 1 SCBI• V-PRO tray (17" x 10" x 3½") at 4 lbs
KC300	Light to Moderate Weight Package (for example: general use medical instruments)	9 lbs.	• 5 lbs metal mass• 6 surgical forceps• 1 SCBI• V-PRO tray (17" x 10" x 3½") at 4 lbs
KC400	Moderate to Heavy Weight Package (for example: general use medical instruments)	12 lbs.	• 8 lbs metal mass• 6 surgical forceps• 1 SCBI• V-PRO tray (17" x 10" x 3½") at 4 lbs
KC500	Heavyweight Package (for example: general use medical instruments)	12 lbs.	• 8 lbs metal mass• 6 surgical forceps• 1 SCBI• V-PRO tray (17" x 10" x 3½") at 4 lbs
KC600	Very Heavy Weight Package (for example: general use medical instruments)	12 lbs.	• 8 lbs metal mass• 6 surgical forceps• 1 SCBI• V-PRO tray (17" x 10" x 3½") at 4 lbs
1 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 KIMGUARD ONE-STEP® Sterilization Wraps.

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

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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 (formerly known as Kimberly-Clark Health Care) 5450 Windward Parkwav. Alpharetta. GA 30004. USA

Establishment Registration Number: 1033422

Contact Name:	Thomas Kozma, Director of Regulatory Affairs
E-mail:	thomas.kozma@hyh.com
Phone:	470.448.5681
FAX:	678.254.0099
DATE PREPARED:	March 6, 2015
TRADE NAME:	KIMGUARD* ONE-STEP® Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600)
CLASSIFICATION NAME:	Sterilization Wrap
COMMON/USUAL NAME:	Sterilization Wrap
PRODUCT CODE:	FRG
DEVICE CLASSIFICATION:	Class II per 21 CFR §880.6850
PREDICATE DEVICES:	K092167 and K112805 - KIMGUARD ONE-STEP® Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600).

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:

V-PRO® 60 Low Temperature Sterilization System that include: ●
- o Lumen Cycle
- Non Lumen Cycle o
- Flexible Cvcle O

Test results validated that KIMGUARD ONE-STEP® Sterilization Wraps (KC100, KC200, KC300, KC400, KC500, and KC600) allowed sterilization of the enclosed devices by the V-PRO® 60 Low Temperature Sterilization System (i.e., Lumen, Non Lumen, and Flexible Cycles). Additionally, the KIMGUARD ONE-STEP® Sterilization Wrap was validated to allow effective aeration under the pre-programmed sterilization cycles. All models of the KIMGUARD ONE-STEP® Sterilization Wrap (KC100, KC200, KC300, KC400, KC500, and KC600) have been validated for use with the V-PRO® 60 Low Temperature Sterilization System cycles in TABLE 1.

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TABLE 1: Validated V-PRO® 60 Low Temperature Sterilizer System Cycles
------------------------------------------------------------------------	--

Cycles	Intended Load
LumenCycle1	Reusable metal and non-metal medical devices including instruments with diffusion-restricted spaces(such as the hinged portion of forceps or scissors) and single, dual or triple channeled rigid/semi-rigidendoscopes, with the following configurations:Single or dual channeled devices with stainless steel lumens with An inside diameter of 0.77 mm or larger and a length of 410 mm or shorter Triple channeled devices with stainless steel lumens with An inside diameter of 1.2 mm or larger and a length of 257 mm or shorter. An inside diameter of 1.8 mm or larger and a length of 310 mm or shorter or An inside diameter of 2.8 mm or larger and a length of 317 mm or shorter
FlexibleCycle1	Single or dual channeled Flexible Surgical Endoscopes or Bronchoscopes with lumens that have:An inside diameter of 1 mm or larger and a length of 990 mm or shorter.
Non-LumenCycle1	Reusable metal and non-metal non-lumened medical devices including non-lumened rigid, semi-rigidand flexible endoscopes and medical devices with stainless steel or titanium diffusion-restrictedspaces such as the hinged portion of forceps or scissors.

KIMGUARD ONE-STEP® Sterilization Wraps (KC100, KC200, KC300, KC400, KC500, and KC600) Recommendations for Use with the V-PRO® 60 Low Temperature Sterilization System are provided in TABLE 2.

Wrap Models	Intended Loads1	Maximum WrappedPackage Content WeightsMPI Study2	Description of Loads Used in SterilityMaintenance Validation Study2
KC100	Very Light Weight Package(for example batteries)	3 lbs.	3 lb of metal mass6 surgical forceps1 self-contained biological indicator (SCBI)(no tray was included)
KC200	Light Weight Package (forexample telescope with lightcord)	6.5 lbs.	• 2.5 lbs metal mass• 6 surgical forceps• 1 SCBI• V-PRO® tray (17" x 10" x 3½") at 4
KC300	Light to Moderate WeightPackage (for example:general use medicalinstruments)	9 lbs.	• 5 lbs metal mass• 6 surgical forceps• 1 SCBI• V-PRO® tray (17" x 10" x 3½") at 4
KC400	Moderate to Heavy WeightPackage (for example:general use medicalinstruments)	12 lbs.	• 8 lbs metal mass• 6 surgical forceps• 1 SCBI• V-PRO® tray (17" x 10" x 3½") at 4
KC500	Heavyweight Package (forexample: general usemedical instruments)	12 lbs.	• 8 lbs metal mass• 6 surgical forceps• 1 SCBI• V-PRO® tray (17" x 10" x 3½") at 4
KC600	Very Heavy Weight Package(for example: general usemedical instruments)	12 lbs.	• 8 lbs metal mass• 6 surgical forceps• 1 SCBI• V-PRO® tray (17" x 10" x 3½") at 4

number, weight, and size of individual content types that were validated for KIMGUARD ONE-STEP® Sterilization Wraps.

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Description of Device

Substantial Equivalence to Predicate Device

KIMGUARD ONE-STEP® Sterilization Wrap (i.e., subject of this Premarket Notification) is substantially equivalent to the predicate Kimberly-Clark KIMGUARD* ONE-STEP® Sterilization Wraps (K092167 & K112805) in technology, design, and materials.

The following table compares the subject KIMGUARD* ONE-STEP® Sterilization Wrap to the predicate KIMGUARD* ONE-STEP® Sterilization Wrap.

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Device Comparison Table (Technological, Design, & Materials)

Characteristics	Predicate Devices:KIMGUARD* ONE-STEP® SterilizationWrap (KC100, KC200, KC300, KC400,KC500, & KC600) (K092167 & 112805)	Proposed Device:KIMGUARD* ONE-STEP® SterilizationWrap (KC100, KC200, KC300, KC400,KC500, & KC600)
Manufacturer	Kimberly-Clark Corporation	Kimberly Clark Corporation
Regulation/ProductCode	Sterilization Wrap: 880.6850 / FRG	Sterilization Wrap: 880.6850 / FRG
Indications for Use	The device is intended to be used to encloseanother medical device that is to be sterilized by ahealthcare provider by the Amsco® V-PRO™ 1Plus Low Temperature Sterilization System'sLumen (identical to the V-PRO™ 1 Cycle) andNon-Lumen Cycles, and the V-PRO™ LowTemperature Sterilization System's Flexible Cycle.The wrap is intended to allow sterilization of theenclosed medical device(s) and also to maintainsterility of the enclosed device(s) until openedwithin the period of time for which performancedata demonstrating maintenance of sterility hasbeen provided. The KIMIGUARD ONE-STEP*Sterilization Wrap was validated to be effectivelyaerated during the pre-programmed V-PRO™, V-PRO™ 1 Plus, and V-PRO™ Flexible Cycles.	KIMGUARD ONE-STEP® Sterilization Wraps areintended to enclose another medical device thatis to be sterilized by a healthcare provider using:· V-PRO® 60 Low Temperature SterilizationSystem that include:o Lumen Cycleo Non Lumen Cycleo Flexible CycleKIMGUARD* ONE-STEP® Sterilization Wrap(KC100, KC200, KC300, KC400, KC500 andKC600) are intended to allow sterilization of theenclosed medical device(s) and also maintainsterility of the enclosed device(s) until used.
Sterilization Cycles	Amsco® V-PRO™ 1 Plus Low TemperatureSterilization System's Lumen (identical to theV-PRO™ 1 Cycle) and Non-Lumen Cycles,and the V-PRO max Low TemperatureSterilization System's Flexible Cycle	V-PRO® 60 Low TemperatureSterilization System:o Lumen Cycleo Non Lumen Cycleo Flexible Cycle
Maintenance ofPackage Sterility	For models KC100, KC200, KC300, K400,KC500, and KC600 for at least 30 days.	Real-time testing following sterilization usingthe V-PRO® 60 Low TemperatureSterilization System supports maintenanceof package sterility for 180 days for allmodels of KIMGUARD* ONE-STEP® SterilizationWrap.
Technology	Tortuous sheet material used to enclosemedical devices that are to be sterilized by ahealthcare provider to allow sterilization ofthe enclosed medical device(s) and maintainsterility of the enclosed device(s) until used.	Tortuous sheet material used to enclosemedical devices that are to be sterilized by ahealthcare provider to allow sterilization ofthe enclosed medical device(s) and maintainsterility of the enclosed device(s) until used.
Device Design	Two sheets of nonwoven polypropylenefabric. Each sheet is composed of threethermally- bonded layers consisting of aMeltblown polypropylene layer surrounded bySpunbound polypropylene layers (SMS)	Two sheets of nonwoven polypropylenefabric. Each sheet is composed of threethermally- bonded layers consisting of aMeltblown polypropylene layer surroundedby Spunbound polypropylene 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
Distribution	Non-Sterile andOver-the-Counter	Non-Sterile andOver-the-Counter
Single Use Device	Yes	Yes

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SUMMARY OF NONCLINICAL TESTS

Performance of KIMGUARD* ONE-STEP® Sterilization Wrap (KC100, KC200, KC300, KC400, KC500, KC600) has been tested in accordance with the applicable requirements. All results of testing met acceptance criteria demonstrating that the KIMGUARD* ONE-STEP® Sterilization Wrap allows sterilization of contents by the V-PRO® 60 Low Temperature Sterilization System (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) and maintains sterility of contents until used.

Summary of Testing Performed	Results
V-PRO® 60 Low Temperature Sterilization SystemSterilant Penetration	Passed
Post V-PRO® 60 Low Temperature Sterilization SystemSterilization - Maintenance of Package Integrity (30 Days)	Passed
Post V-PRO® 60 Low Temperature Sterilization SystemSterilization - Performance Testing	Passed
Post V-PRO® 60 Low Temperature Sterilization SystemSterilization - Material Biocompatibility	Passed

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 V-PRO® 60 Low Temperature Sterilization System (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle). These studies demonstrate that the KIMGUARD* ONE-STEP® Sterilization Wrap met the same criteria as the predicate devices and are substantially equivalent.

BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

Based on the intended use, technological characteristics, performance data and nonclinical tests performed, the subject KIMGUARD* ONE-STEP® Sterilization Wrap is substantially equivalent and is as safe and as effective as the legally marketed predicate devices, K092167 and K112805.

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).