KIMGUARD ONE-STEP STERILIZATION WRAP

K141612 · Kimberly-Clark Health Care · FRG · Aug 7, 2014 · General Hospital

Device Facts

• Record ID: K141612
• Device Name: KIMGUARD ONE-STEP STERILIZATION WRAP
• Applicant: Kimberly-Clark Health Care
• Product Code: FRG · General Hospital
• Decision Date: Aug 7, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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: STERRAD® 50, 100S, and 200 STERRAD® NX® [Standard Cycle, Advanced Cycle] 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.

Device Story

KIMGUARD® ONE-STEP® Sterilization Wrap consists of two sheets of polypropylene fabric ultrasonically seamed on two edges. Used by healthcare providers to wrap medical instruments (e.g., telescopes, endoscopes, cameras, light cords) prior to sterilization in STERRAD® systems. The wrap allows sterilant penetration while maintaining a sterile barrier post-sterilization until the package is opened aseptically. The device facilitates the sterilization process and protects the integrity of the enclosed instruments during storage.

Clinical Evidence

Bench testing only. Validation studies confirmed 180-day maintenance of package integrity and successful sterilization of various lumened and non-lumened medical devices using specified STERRAD® cycles.

Technological Characteristics

Two-sheet, ultrasonically seamed nonwoven fabric. Material: 3-layer SMS (spunbond-meltblown-spunbond) polypropylene with <2% phthalocyanine blue pigment, <1% titanium dioxide, and <0.008% potassium phosphate anti-static treatment. Thermal bonding with round pin, hexagonal, triangle 'daisy' pattern. Single-use.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices (metal and non-metal, including those with lumens) for sterilization via specific Advanced Sterilization Products STERRAD® systems and to maintain sterility of the enclosed devices until use.

Regulatory Classification

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.

Predicate Devices

• KIMGUARD® ONE-STEP® Sterilization Wrap (K113806)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

PSC Publishing Services [phone] 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®<br>System and<br>Cycle | Intended Load |
|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| STERRAD®<br>50 | Reusable metal and non-metal medical devices, including up to 10 lumens of the following<br>dimensions per chamber load:<br>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®<br>100S | Reusable metal and non-metal medical devices, including up to 10 lumens of the following<br>dimensions per chamber load:<br>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®<br>200 | Reusable metal and non-metal medical devices, including up to 12 lumens of the following<br>dimensions per chamber load:<br>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®<br>NX®<br>Standard<br>Cycle | Reusable metal and non-metal medical devices, including up to 10 lumens of the following<br>dimensions per chamber load:<br>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®<br>NX®<br>Advanced<br>Cycle | Reusable metal and non-metal medical devices, including up to 10 lumens of the following<br>dimensions per chamber load:<br>An inside diameter of 1 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens. OR<br>ONE single-channel Flexible Endoscope with or without a silicone mat and no additional load. The<br>flexible endoscope may contain:<br>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,<br>STERRAD® 200, STERRAD® NX®, and STERRAD® 100NX® Cycles (Cont.) | |
| STERRAD®<br>100NX®<br>Standard<br>Cycle | Reusable metal and non-metal medical devices, including up to 10 lumens of the following<br>dimensions per chamber load:<br>• An inside diameter of 0.7 mm or larger and a length of 500 mm or shorter of single-channel<br>stainless steel lumens. (A maximum of two flexible endoscopes, ONE per tray per sterilization<br>cycle.) |
| STERRAD®<br>100NX®<br>Flex Cycle | ONE or two single-channel Flexible Endoscope with or without a silicone mat and no additional load.<br>The flexible endoscope may contain:<br>• A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a<br>length of 850 mm or shorter. (A maximum of two flexible endoscopes, ONE per tray per<br>sterilization cycle). |
| STERRAD®<br>100NX®<br>EXPRESS<br>Cycle | Non-lumened reusable metal and non-metal devices requiring surface sterilization, and sterilization<br>of diffusion-restricted spaces such as the hinged portions of forceps and scissors, and rigid or semi-<br>rigid endoscopes without lumens. |
| STERRAD®<br>100NX®<br>DUO Cycle | ONE or two single-channel Flexible Endoscope with accessory devices that are normally connected<br>to it, with or without a silicone mat. The flexible endoscope may contain:<br>• A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a<br>length of 875 mm or shorter.<br>• 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-<br>STEP® Sterilization<br>Wrap Models | Intended Load1 | Weights of Wrapped Package<br>Content Used in Validation Study<br>(Total weight including tray) | Descriptions of Loads Used in Sterility<br>Maintenance Validation Study |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| KC300 | Light to moderate weight<br>package (e.g., general use<br>medical instruments) | 10.7 lbs | APTIMAX® Instrument Tray<br>(23 in. x 11 in. x 4 in.) with Tray Mat Metal and non-metal instruments |
| KC400 | Moderate to heavy weight<br>package (e.g., general use<br>medical instruments) | 10.7 lbs | APTIMAX® Instrument Tray<br>(23 in. x 11 in. x 4 in.) with Tray Mat Metal and non-metal instruments |
| KC500 | Heavy weight package (e.g.,<br>general use medical<br>instruments) | 10.7 lbs | APTIMAX® Instrument Tray<br>(23 in. x 11 in. x 4 in.) with Tray Mat Metal and non-metal instruments |
| KC600 | Very heavy weight package<br>(e.g., general use medical<br>instruments) | 10.7 lbs | APTIMAX® Instrument Tray<br>(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)

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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: [phone] Fax: [phone] email: [e-mail]

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.

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 Cvclel).

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®<br>System and Cycle | STERRAD® 200, STERRAD® NX®, and STERRAD® 100NX® Cycles<br>Intended Load |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| STERRAD®<br>50 | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per<br>chamber load:<br>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®<br>100S | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber<br>load:<br>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®<br>System and Cycle | Intended Load |
| STERRAD®<br>200 | Reusable metal and non-metal medical devices, including up to 12 lumens of the following dimensions per<br>chamber load:<br>• An inside diameter of 1 mm or larger and a length of 125 mm or shorter of single-channel stainless<br>steel lumens.<br>• An inside diameter of 2 mm or larger and a length of 250 mm or shorter of single-channel stainless<br>steel lumens.<br>• An inside diameter of 3 mm or larger and a length of 400 mm or shorter of single-channel stainless<br>steel lumens.<br>• An inside diameter of 6 mm or larger and a length of 310 mm or shorter of single-channel<br>Teflon/Polyethylene lumens. |
| STERRAD®<br>NX® Standard<br>Cycle | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber<br>load:<br>• An inside diameter of 1 mm or larger and a length of 150 mm or shorter of single-channel stainless<br>steel lumens.<br>• An inside diameter of 2 mm or larger and a length of 400 mm or shorter of single-channel stainless<br>steel lumens. |
| STERRAD®<br>NX®<br>Advanced<br>Cycle | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber<br>load:<br>• An inside diameter of 1 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens.<br>OR<br>ONE single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain:<br>• A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter. |
| STERRAD®<br>100NX®<br>Standard Cycle | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load:<br>• 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®<br>100NX®<br>Flex Cycle | ONE or two single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain:<br>• 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®<br>100NX®<br>EXPRESS<br>Cycle | 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®<br>100NX®<br>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:<br>• A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 875 mm or shorter.<br>• Accessory devices that are normally connected to a flexible endoscope during use.<br>• 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®<br>ONE-STEP®<br>Sterilization Wrap<br>Models | Intended Load1 | Weights of Wrapped Package<br>Content Used in Validation Study<br>(Total weight including tray) | Descriptions of Loads Used in Sterility<br>Maintenance Validation Study |
|--------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| KC300 | Light to moderate weight<br>package (e.g., general use<br>medical instruments) | 10.7 lbs | ®APTIMAX Instrument Tray<br>•<br>(23 in. x 11 in. x 4 in.) with Tray Mat<br>• Metal and non-metal instruments |
| KC400 | Moderate to heavy weight<br>package (e.g., general use<br>medical instruments) | 10.7 lbs | ®APTIMAX Instrument Tray<br>•<br>(23 in. x 11 in. x 4 in.) with Tray Mat<br>• Metal and non-metal instruments |
| KC500 | Heavy weight package (e.g.,<br>general use medical instruments) | 10.7 lbs | ®APTIMAX Instrument Tray<br>•<br>(23 in. x 11 in. x 4 in.) with Tray Mat<br>• Metal and non-metal instruments |
| KC600 | Very heavy weight package<br>(e.g., general use medical<br>instruments ) | 10.7 lbs | ®APTIMAX Instrument Tray<br>•<br>(23 in. x 11 in. x 4 in.) with Tray Mat<br>• 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

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.

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| Technological<br>Characteristics | Proposed:<br>KIMGUARD® ONE-STEP® Sterilization<br>Wrap | Predicate Device:<br>KIMGUARD® ONE-STEP® Sterilization<br>Wrap (K113806) |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Kimberly-Clark Corporation | Kimberly Clark Corporation |
| Regulation/Product<br>Code | Sterilization Wrap: 880.6850 / FRG | Sterilization Wrap: 880.6850 / FRG |
| Device Design | Two sheets of medium blue nonwoven<br>polypropylene fabric. Each sheet of<br>fabric is composed of three thermally-<br>bonded layers consisting of a<br>Meltblown polypropylene layer<br>surrounded by Spunbond<br>polypropylene layers (SMS) | Two sheets of medium blue nonwoven<br>polypropylene fabric. Each sheet of<br>fabric is composed of three thermally-<br>bonded layers consisting of a<br>Meltblown polypropylene layer<br>surrounded by Spunbond<br>polypropylene layers (SMS) |
| Method for bonding<br>SMS layers | Thermal bonding with round pin,<br>hexagonal, triangle bond pattern<br>("daisy" pattern) | Thermal bonding with round pin,<br>hexagonal, triangle bond pattern<br>("daisy" pattern) |
| Materials | Polypropylene with blue and white<br>pigments | Polypropylene with blue and white<br>pigments |
| Over the Counter<br>Use Device | Yes | Yes |
| Single Use Device | Yes | Yes |
| (Continued on next page) | | |
| Technological<br>Characteristics | Proposed:<br>KIMGUARD® ONE-STEP® Sterilization<br>Wrap | Predicate Device:<br>KIMGUARD® ONE-STEP® Sterilization<br>Wrap (K113806) |
| Indications for Use | KIMGUARD* ONE-STEP* Sterilization<br>Wraps are intended to enclose another<br>medical device that is to be sterilized by<br>a healthcare provider using:<br>Advanced Sterilization Products<br>STERRAD® Sterilization Systems that<br>include:<br>STERRAD® 50, 100S, and 200<br>STERRAD® NX® [Standard Cycle,<br>Advanced Cycle]<br>STERRAD® 100NX® [Standard Cycle,<br>Flex Cycle, EXPRESS Cycle, DUO<br>Cycle]<br>KIMGUARD* ONE-STEP* Sterilization<br>Wraps are intended to allow sterilization<br>of the enclosed medical device(s) and<br>also maintain sterility of the enclosed<br>device(s) until used.<br>Test results validated that KIMGUARD*<br>ONE-STEP* Sterilization Wraps<br>(KC300, KC400, KC500, and KC600)<br>allowed sterilization of the enclosed<br>devices by the Advanced Sterilization<br>Products STERRAD® Sterilization<br>Systems (STERRAD® 50, 100S, 200,<br>NX® [Standard Cycle and Advanced<br>Cycle] and 100NX® [Standard Cycle,<br>Flex Cycle, EXPRESS Cycle, DUO<br>Cycle]). | KIMGUARD* ONE-STEP* Sterilization<br>Wraps are intended to enclose another<br>medical device that is to be sterilized by a<br>healthcare provider using:<br>Advanced Sterilization Products<br>STERRAD® Sterilization Systems that<br>include:<br>STERRAD® 50, 100S, and 200<br>STERRAD® NX® [Standard Cycle,<br>Advanced Cycle]<br>STERRAD® 100NX® [Standard Cycle,<br>Flex Cycle, EXPRESS Cycle, DUO<br>Cycle]<br>KIMGUARD* ONE-STEP* Sterilization<br>Wraps are intended to allow sterilization of<br>the enclosed medical device(s) and also<br>maintain sterility of the enclosed device(s)<br>until used.<br>Test results validated that KIMGUARD*<br>ONE-STEP* Sterilization Wraps (KC100,<br>KC200, KC300, KC400, KC500, and<br>KC600) allowed sterilization of the<br>enclosed devices by the Advanced<br>Sterilization Products STERRAD®<br>Sterilization Systems (STERRAD® 50,<br>100S, 200, NX® [Standard Cycle and<br>Advanced Cycle] and 100NX® [Standard<br>Cycle, Flex Cycle, EXPRESS Cycle, DUO<br>Cycle]). |
| Maintenance of<br>Package Sterility | Passed 180-Day Maintenance of Package Passed 30-Day Maintenance of Package<br>Integrity | 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