KIMGUARD ONE-STEP STERILIZATION WRAP

• K Number: K141612
• Device Name: KIMGUARD ONE-STEP STERILIZATION WRAP
• Manufacturer: KIMBERLY-CLARK HEALTH CARE
• Date Cleared: 2014-08-07 ( 52 days)
• Product Code: FRG
• Regulation Number: 880.6850

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 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.

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 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.

Predicate Devices

K113806

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus on the physical properties and function of a sterilization wrap, with no mention of AI or ML technology.

Therapeutic

No

Explanation: The device is a sterilization wrap intended to maintain the sterility of other medical devices, not to provide therapy itself.

Diagnostic

No.
This device is a sterilization wrap intended to enclose other medical devices for sterilization and maintain their sterility, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical wrap made of fabric, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an In Vitro Diagnostic (IVD).

Here's why:

• Intended Use: The intended use clearly states that the wraps are "intended to enclose another medical device that is to be sterilized by a healthcare provider". This describes a physical barrier and a method for maintaining sterility of other medical devices.
• Device Description: The description details the material composition and construction of the wrap, focusing on its function as a barrier and its ability to be opened aseptically.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (blood, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. The device itself is not performing a diagnostic test.

The device's function is to facilitate the sterilization and maintenance of sterility of other medical devices, which falls under the category of sterilization accessories or packaging, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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: 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.

Product codes

FRG

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare provider

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Study: Maintenance of 180-Day Package Integrity
Results: Passed
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.

Key Metrics

Not Found

Predicate Device(s)

K113806

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three faces in profile, stacked on top of each other. The faces are black and are oriented to the right. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in black.

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.

1

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

2

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

3

TABLE 1: Validated Advanced Sterilization Products (ASP) STERRAD 50, STERRAD 100S, STERRAD®200, STERRAD® NX®, and STERRAD® 100NX® Cycles

| ASP STERRAD®
System and

Cycle	Intended Load
STERRAD®
50	Reusable metal and non-metal medical devices, including up to 10 lumens of the following
dimensions per chamber load:
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®
100S	Reusable metal and non-metal medical devices, including up to 10 lumens of the following
dimensions per chamber load:
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®
200	Reusable metal and non-metal medical devices, including up to 12 lumens of the following
dimensions per chamber load:
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®
NX®
Standard
Cycle	Reusable metal and non-metal medical devices, including up to 10 lumens of the following
dimensions per chamber load:
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®
NX®
Advanced
Cycle	Reusable metal and non-metal medical devices, including up to 10 lumens of the following
dimensions per chamber load:
An inside diameter of 1 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens. OR
ONE single-channel Flexible Endoscope with or without a silicone mat and no additional load. The
flexible endoscope may contain:
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,
STERRAD® 200, STERRAD® NX®, and STERRAD® 100NX® Cycles (Cont.)
STERRAD®
100NX®
Standard
Cycle	Reusable metal and non-metal medical devices, including up to 10 lumens of the following
dimensions per chamber load:
• 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®
100NX®
Flex Cycle	ONE or two single-channel Flexible Endoscope with or without a silicone mat and no additional load.
The flexible endoscope may contain:
• 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®
100NX®
EXPRESS
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®
100NX®
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:
• A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a
length of 875 mm or shorter.
• Flexible endoscopes without lumens

4

5

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-
STEP® Sterilization
Wrap Models | Intended Load1 | Weights of Wrapped Package
Content Used in Validation Study
(Total weight including tray) | Descriptions of Loads Used in Sterility
Maintenance Validation Study |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| KC300 | Light to moderate weight
package (e.g., general use
medical instruments) | 10.7 lbs | APTIMAX® Instrument Tray
(23 in. x 11 in. x 4 in.) with Tray Mat Metal and non-metal instruments |
| KC400 | Moderate to heavy weight
package (e.g., general use
medical instruments) | 10.7 lbs | APTIMAX® Instrument Tray
(23 in. x 11 in. x 4 in.) with Tray Mat Metal and non-metal instruments |
| KC500 | Heavy weight package (e.g.,
general use medical
instruments) | 10.7 lbs | APTIMAX® Instrument Tray
(23 in. x 11 in. x 4 in.) with Tray Mat Metal and non-metal instruments |
| KC600 | Very heavy weight package
(e.g., general use medical
instruments) | 10.7 lbs | APTIMAX® Instrument Tray
(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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Press (F.

Claverie -S

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6

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]

7

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®
System and Cycle | STERRAD® 200, STERRAD® NX®, and STERRAD® 100NX® Cycles
Intended Load |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| STERRAD®
50 | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per
chamber load:
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®
100S | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber
load:
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®
System and Cycle | Intended Load |
| STERRAD®
200 | Reusable metal and non-metal medical devices, including up to 12 lumens of the following dimensions per
chamber load:
• 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®
NX® Standard
Cycle | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber
load:
• 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®
NX®
Advanced
Cycle | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber
load:
• An inside diameter of 1 mm or larger and a length of 500 mm or shorter of single-channel stainless steel lumens.
OR
ONE single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain:
• A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter. |
| STERRAD®
100NX®
Standard Cycle | Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load:
• 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®
100NX®
Flex Cycle | ONE or two single-channel Flexible Endoscope with or without a silicone mat and no additional load. The flexible endoscope may contain:
• 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®
100NX®
EXPRESS
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®
100NX®
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:
• A single-channel Teflon®/Polyethylene lumen with an inside diameter of 1 mm or larger and a length of 875 mm or shorter.
• Accessory devices that are normally connected to a flexible endoscope during use.
• Flexible endoscopes without lumens |

TABLE 1: Validated Advanced Sterilization Products (ASP) STERRAD® 50, STERRAD® 100S, ଜ

8

9

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®
ONE-STEP®
Sterilization Wrap
Models | Intended Load1 | Weights of Wrapped Package
Content Used in Validation Study
(Total weight including tray) | Descriptions of Loads Used in Sterility
Maintenance Validation Study |
|--------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| KC300 | Light to moderate weight
package (e.g., general use
medical instruments) | 10.7 lbs | ®APTIMAX Instrument Tray
•
(23 in. x 11 in. x 4 in.) with Tray Mat
• Metal and non-metal instruments |
| KC400 | Moderate to heavy weight
package (e.g., general use
medical instruments) | 10.7 lbs | ®APTIMAX Instrument Tray
•
(23 in. x 11 in. x 4 in.) with Tray Mat
• Metal and non-metal instruments |
| KC500 | Heavy weight package (e.g.,
general use medical instruments) | 10.7 lbs | ®APTIMAX Instrument Tray
•
(23 in. x 11 in. x 4 in.) with Tray Mat
• Metal and non-metal instruments |
| KC600 | Very heavy weight package
(e.g., general use medical
instruments ) | 10.7 lbs | ®APTIMAX Instrument Tray
•
(23 in. x 11 in. x 4 in.) with Tray Mat
• 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.

10

| Technological
Characteristics | Proposed:
KIMGUARD® ONE-STEP® Sterilization
Wrap | Predicate Device:
KIMGUARD® ONE-STEP® Sterilization
Wrap (K113806) |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Kimberly-Clark Corporation | Kimberly Clark Corporation |
| Regulation/Product
Code | Sterilization Wrap: 880.6850 / FRG | Sterilization Wrap: 880.6850 / FRG |
| Device Design | Two sheets of medium blue nonwoven
polypropylene fabric. Each sheet of
fabric is composed of three thermally-
bonded layers consisting of a
Meltblown polypropylene layer
surrounded by Spunbond
polypropylene layers (SMS) | Two sheets of medium blue nonwoven
polypropylene fabric. Each sheet of
fabric is composed of three thermally-
bonded layers consisting of a
Meltblown polypropylene layer
surrounded by Spunbond
polypropylene layers (SMS) |
| Method for bonding
SMS 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 white
pigments | Polypropylene with blue and white
pigments |
| Over the Counter
Use Device | Yes | Yes |
| Single Use Device | Yes | Yes |
| (Continued on next page) | | |
| Technological
Characteristics | Proposed:
KIMGUARD® ONE-STEP® Sterilization
Wrap | Predicate Device:
KIMGUARD® ONE-STEP® Sterilization
Wrap (K113806) |
| 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:
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.
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,
Flex Cycle, EXPRESS Cycle, DUO
Cycle]). | 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.
Test results validated that KIMGUARD*
ONE-STEP* Sterilization Wraps (KC100,
KC200, 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, Flex Cycle, EXPRESS Cycle, DUO
Cycle]). |
| Maintenance of
Package Sterility | Passed 180-Day Maintenance of Package Passed 30-Day Maintenance of Package
Integrity | Integrity |

Table 3: Device Comparison Table - Technological Characteristics

11

12

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