KimGuard Smart-Fold* 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 270°F/132°C for 4 minutes or by 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 is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened. The wrap was validated for aeration times for EO sterilization of 8 hours at 131°F/ 55°C or 12 hours at 110°F/ 43.3°C. The KimGuard Smart-Fold* Sterilization Wrap was validated for dry times for prevacuum steam sterilization of 20 minutes for Model KC250 and for dry times of 30 minutes for Models KC450, KC550 and KC650.

Device Description

KimGuard Smart-Fold* Sterilization Wrap is comprised primarily of two pieces of KimGuard Sterilization Wrap fabric (the blue base layer and the white intermediate layer). The fabric is a nonwoven spunbondmeltblown-spunbond (SMS) fabric composed of a top (inner) layer of spunbond, a center laver of meltblown, and a bottom (outer) layer of spunbond. SMS nonwoven fabrics are composed of polypropylene and white titanium dioxide and phthalocyanine blue pigments. Two strips of blue SMS are adhesively bonded to the white SMS intermediate layer for added strength. The reinforcement strips also contain a "reference line" feature designed to indicate proper sterilization tray placement to the user. Adhesive tape strips with release liners are included to secure the inner layers of the package. Users remove the release liners and use these adhesive strips to secure the wrap prior to sterilization. The Smart-Fold product also incorporates handles and pulls tabs comprised of blue SMS material and adhesive branding labels for aseptic opening.

AI/ML Overview

Here's an analysis of the provided text regarding the KimGuard Smart-Fold Sterilization Wrap, broken down by your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria alongside reported numerical device performance results for direct comparison. Instead, it states that "All test results met acceptance criteria." The acceptance criteria mentioned are qualitative and relate to the successful fulfillment of certain functional and safety requirements.

Acceptance Criteria (Implied)	Reported (Met) Performance
Sterilant Penetration (Steam and EO)	Met
Maintain Sterility of Pack Contents (up to 30 days)	Met
Dry Time (Steam Sterilization - KC250: 20 min; KC450/KC550/KC650: 30 min)	Met
Aeration Time (EO Sterilization - 8 hours at 131°F/55°C or 12 hours at 110°F/43.3°C)	Met
Physical Integrity (post-sterilization)	Met
Biocompatibility (Irritation and Sensitization)	Met

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

Test Set Sample Size: The document does not specify an exact numerical sample size for each test conducted. It describes the "Maximum Wrapped Package Content Weights Used in Sterility Maintenance Validation Study" and "Descriptions of Loads Used in Sterility Maintenance Validation Study" for each wrap model, which indicate the types and maximum weights of items tested within the wraps.
- KC250: 6 lbs. (e.g., 2 huck towels, 2 fluid-resistant U-drapes, 1 fluid-resistant universal bar drape)
- KC450: 13 lbs. (e.g., 4 tray liners, 10x10x3.5 inch tray with 11 lbs. metal mass)
- KC550: 17 lbs. (e.g., 4 tray liners, 10x10x3.5 inch tray with 15 lbs. metal mass)
- KC650: 25 lbs. (e.g., 4 tray liners, 10x10x3.5 inch tray with 23 lbs. metal mass)
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to testing conducted "in compliance 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)," suggesting it was conducted specifically for this submission, implying a prospective study design for regulatory approval.

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

This information is not provided in the document. The testing described focuses on the physical and functional performance of the sterilization wrap itself, rather than diagnostic interpretation requiring expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided, as the tests described are objective measures of device performance (e.g., sterility maintenance, dry time, physical integrity) rather than subjective assessments that would require adjudication.

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

Not applicable. This device is a sterile barrier system, not a diagnostic imaging or screening tool that would involve human readers interpreting cases with and without AI assistance.

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

Not applicable. This device is a physical product (sterilization wrap) and does not involve an algorithm. The performance described is its standalone function in maintaining sterility and allowing sterilization.

7. The Type of Ground Truth Used

The ground truth used for this device's testing is based on:

Objective measurements of sterility: Demonstrated by the ability to prevent microbial ingress and maintain a sterile environment for a specified duration (up to 30 days).
Physical and material property evaluations: Ensuring the wrap retains its integrity, permits sterilant penetration, and has appropriate dry/aeration times.
Biocompatibility testing: Ensuring the materials are safe for patient contact.

These are established through standardized laboratory and performance testing methods relevant to sterilization wraps.

8. Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve machine learning or AI, and therefore no "training set" is used.

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

Not applicable, as no training set or machine learning algorithm is involved for this device.

Summary

{0}------------------------------------------------

K112300

JAN 1 9 2012

510(k) Summary for the Kimberly-Clark* Corporation KimGuard Smart-Fold* Sterilization Wrap (Models KC250, KC450, KC550 and KC650)

Device type:	Sterilization Wrap
Date ofSummary:	July 28, 2011
510(k) Submitter:	Brenda ShelkeyAssociate Director, Quality Assurance & RegulatoryAffairsKIMBERLY-CLARK CORPORATION1400 Holcomb Bridge RoadRoswell, GA 30076678-654-8021Brenda.Shelkey@kcc.comEstablishment Registration Number 1033422
Primary Contactfor this 510(k)Submission:	Same as above
ClassificationRegulation:	21 CFR 880.6850
Device Class:	Class II
Panel:	General Hospital
Product Code:	FRG

・・ー

{1}------------------------------------------------

Intended Use:

Wrap Model Recommendations for Pre-Vacuum Steam and for 100% Ethylene Oxide Sterilization'

KIMGUARDSMART-FOLD*SterilizationWrapModels	Intended Loads	Maximum WrappedPackage ContentWeights Used inSterilityMaintenanceValidation Study2	Descriptions of Loads Used in SterilityMaintenance Validation Study2
KC250	Light WeightPackage (forexample: standardlinen packs)	6 lbs.	2 huck towels (17 in. x 29 in.)2 fluid-resistant U-drapes (68 in. x 109 in.)1 fluid-resistant universal bar drape (70 in.x 108in.)
KC450	Moderate to HeavyWeight Package(for example:general use medicalinstruments)	13 lbs.	4 tray liners (20 in. x 25 in.) stacked10 in. x 10 in. x 3 ½ in. tray containing 11lbs. of metal mass
KC550	HeavyweightPackage (forexample: generaluse medicalinstruments)	17 lbs.	4 tray liners (20 in. x 25 in.) stacked10 in. x 10 in. x 3 ½ in. tray containing15 lbs. of metal mass
KC650	Very Heavy WeightPackage (forexample: generaluse medicalinstruments)	25 Ibs.	4 tray liners (20 in. x 25 in.) stacked10 in. x 10 in. x 3 ½ in. tray containing 23lbs. of metal mass

apping techniques, and tolding methods. Result's may a Individual results may differ due to factors such as var hich may pul action stress on the wap. Each health struit determine for itsell which wrap model is most apropriate for each intended use.

monded to not exceed be maximum wapped package content weble for each maps model. Furthermone, it is recomment its recomments and size of the history

{2}------------------------------------------------

Device Description: KimGuard Smart-Fold* Sterilization Wrap is comprised primarily of two pieces of KimGuard Sterilization Wrap fabric (the blue base layer and the white intermediate layer). The fabric is a nonwoven spunbondmeltblown-spunbond (SMS) fabric composed of a top (inner) layer of spunbond, a center laver of meltblown, and a bottom (outer) layer of spunbond. SMS nonwoven fabrics are composed of polypropylene and white titanium dioxide and phthalocyanine blue pigments. Two strips of blue SMS are adhesively bonded to the white SMS intermediate layer for added strength. The reinforcement strips also contain a "reference line" feature designed to indicate proper sterilization tray placement to the user. Adhesive tape strips with release liners are included to secure the inner layers of the package. Users remove the release liners and use these adhesive strips to secure the wrap prior to sterilization. The Smart-Fold product also incorporates handles and pulls tabs comprised of blue SMS material and adhesive branding labels for aseptic opening.

Predicate Device: The KimGuard Smart-Fold* Sterilization Wrap (Models KC250, KC450, KC550, and KC650) is substantially equivalent to the predicate KimGuard One-Step* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600) (K082177).

Substantial Equivalence: The modified design of KimGuard Smart-Fold* Sterilization Wrap is substantially equivalent to the predicate Kimberly-Clark KimGuard* One-Step* Sterilization Wrap (K082177) in intended use, design, and materials.

Summary of Testing: KimGuard Smart-Fold* Sterilization Wrap has been tested in compliance 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 irritation and sensitization biocompatibility 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 30 days under standard conditions. All test results met acceptance criteria.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

Ms. Brenda Shelkey Associate Director, Quality Assurance & Regulatory Affairs Kimbery- Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076

JAN 1 9 2012

Re: K112300

Trade/Device Name: KimGuard Smart-Fold* Sterilization Wrap (Models KC250, KC450, KC550, AND KC650) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: January 4, 2012 Received: January 5, 2012

Dear Ms. Shelkey:

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.

{4}------------------------------------------------

Page 2 - Ms. Shelkey

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/CDRHOffices /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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Mester

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number : K112300

Device Name: KimGuard Smart-Fold* Sterilization Wrap (Models KC250, KC450, KC550, and KC650)

Indications for Use:

KimGuard Smart-Fold* 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 270°F/132°C for 4 minutes or by 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 is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened. The wrap was validated for aeration times for EO aterilization of 8 hours at 131°F/ 55°C or 12 hours at 110°F/ 43.3°C. The KimGuard Smart-Fold* Sterilization Wrap was validated for dry times for prevacuum steam sterilization of 20 minutes for Model KC250 and for dry times of 30 minutes for Models KC450, KC550 and KC650.

See Wrap Model Recommendations on Page 2.

Prescription Use __ (Part 21 CFR 801 Subpart D)

AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth S. Clamie-Williams
(Printed Name)

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

510(k) Number:

{6}------------------------------------------------

Indications for Use

Wrap Model Recommendations for Pre-Vacuum Steam and for 100% Ethylene Oxide Sterilization1

KIMGUARDSMART-FOLD*SterilizationWrapModels	Intended Loads	Maximum WrappedPackage ContentWeights Used inSterilityMaintenanceValidation Study2	Descriptions of Loads Used in SterilityMaintenance Validation Study2
KC250	Light WeightPackage (forexample: standardlinen packs)	6 lbs.	2 huck towels (17 in. x 29 in.)2 fluid-resistant U-drapes (68 in. x 109 in.)1 fluid-resistant universal bar drape (70 in.x 108in.)
KC450	Moderate to HeavyWeight Package(for example:general use medicalinstruments)	13 lbs.	4 tray liners (20 in. x 25 in.) stacked10 in. x 10 in. x 3 ½ in. tray containing 11lbs. of metal mass
KC550	HeavyweightPackage (forexample: generaluse medicalinstruments)	17 lbs.	4 tray liners (20 in. x 25 in.) stacked10 in. x 10 in. x 3 ½ in. tray containing15 lbs. of metal mass
KC650	Very Heavy WeightPackage (forexample: generaluse medicalinstruments)	25 lbs.	4 tray liners (20 in. x 25 in.) stacked10 in. x 10 in. x 3 ½ in. tray containing 23lbs. of metal mass

'n chicular results may offer doe in handing pactios, wayping techriques, and lokling methods. Realls may also differ bell be use of ingularly shood onlarks

hich may put added stress on the wrap. Each healthcare facility should determine for each wrap 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

mich may not asked toes on the was and desemin of asseml of assemble by and transed to ear transed to next transed to next transed to ne creation on excession nor accoad to ght, and size ol
he metal mass).

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).