KIMGUARD ONE STEP STERILIZATION WRAP

• K Number: K113806
• Device Name: KIMGUARD ONE STEP STERILIZATION WRAP
• Manufacturer: KIMBERLY-CLARK HEALTH CARE
• Date Cleared: 2013-08-20 ( 606 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 o - STERRAD® NX® [Standard Cycle, Advanced Cycle] o - STERRAD® 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO o 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 Description

KIMGUARD® ONE-STEP® Sterilization Wrap is comprised of two sheets of KIMGUARD® Sterilization Wrap ultrasonically seamed on two sides. This allows for convenient wrapping with two sheets simultaneously. The sheets of sterilization wrap are square or rectangular fabric produced using a three-layer SMS (spunbound-meltblown-spunbound) 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

K092167

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and sterilization efficacy of the wrap, with no mention of AI or ML.

Therapeutic

No
The device is a sterilization wrap intended to maintain sterility of other medical devices, not to provide therapy itself.

Diagnostic

No
The device is a sterilization wrap used to enclose medical devices for sterilization and maintain their sterility, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

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

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use is to enclose other medical devices for sterilization and maintain their sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of diseases or conditions using samples from the human body.
• Device Description: The description details a sterilization wrap made of polypropylene fabric. This material and construction are consistent with packaging for medical devices, not components of an in vitro diagnostic test.
• Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.

Therefore, the KIMGUARD* ONE-STEP* Sterilization Wraps are a medical device used in the sterilization process, but they do not fit the definition of an In Vitro Diagnostic device.

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 o STERRAD® NX® [Standard Cycle, Advanced Cycle] o STERRAD® 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO o 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.

Product codes

FRG

Device Description

KIMGUARD® ONE-STEP® Sterilization Wrap is comprised of two sheets of KIMGUARD® Sterilization Wrap ultrasonically seamed on two sides. This allows for convenient wrapping with two sheets simultaneously.

The sheets of sterilization wrap are square or rectangular fabric produced using a three-layer SMS (spunbound-meltblown-spunbound) 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 type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing was conducted to show that the KIMGUARD® ONE-STEP® Sterilization Wrap maintains sterility until used, after completion of the sterilization process in the STERRAD® Sterilization Systems.
Study: Sterilant Penetration, Results: Passed
Study: Package Integrity, Results: Passed
Study: Maintenance of Package Integrity, Results: Passed
Study: Material Compatibility, Results: Passed
Study: Shelf Life, Results: Passed
Study: Biocompatibility, 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. These studies show that the KIMGUARD® ONE-STEP® Sterilization Wrap met the same criteria as the predicate device and are substantially equivalent.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K092167

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

K113806 510(k) Summary

Applicant's Name, Address, Telephone, FAX, Contact Person Kimberly-Clark Health Care 1400 Holcomb Bridge Road Roswell, GA 30076-2190, USA Contact Name: Thomas Kozma, Director of Regulatory Affairs E-mail: [e-mail] [phone] (Telephone) [phone] (Fax)

Establishment Registration Number: 1033422

AUG 20 2013

Contact Person Christopher B. Swanson

Regulatory Affairs Specialist Email: [e-mail] [phone] (Telephone) [phone] (Fax)

Date: August 8, 2013

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 KIMGUARD® ONE-STEP® Sterilization Proprietary Name Wrap (Models: KC100, KC200, 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 K092167, cleared November 2, 2009]

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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: STERRAD® 50, 100S, and 200 o
  • STERRAD® NX® [Standard Cycle, Advanced Cycle] o
  • STERRAD® 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO o 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)). (Refer to the STERRAD® Sterilizer System User's Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions.)

All 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.

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

Note: Refer to the User's Guide for complete instructions on load and cycle for each STERRAD® System. The instructions provided below are not intended to replace the detailed Instructions For Use provided with the STERRAD® Systems

| 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. Refer to the STERRAD® 50 Sterilizer User's Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e., 10 lumens per load).
	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. Refer to the STERRAD® 100S Sterilizer User's Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e., 10 lumens per load).
		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. Refer to the STERRAD® 200 Sterilizer User's Guide for complete instructions on load(s) and cycle(s),
including chamber loading instructions (i.e., 36.48 lbs per load).
		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. Refer to the STERRAD* NX* Sterilizer User's Guide for complete instructions on load(s) and cycle(s),
including chamber loading instructions (i.e., 10.7 lbs per load).
		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. Refer to the STERRAD® NX* Sterilizer User's Guide for complete instructions on load(s) and cycle(s),
including chamber loading instructions (i.e., 10.7 lbs per load).
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.) Refer to the STERRAD* 100NX* Sterilizer User's Guide for complete instructions on load(s) and cycle(s),
including chamber loading instructions (i.e., 21.4 lbs per load).
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). Refer to the STERRAD® 100NX* Sterilizer User's Guide for complete instructions on load(s) and cycle(s),
including chamber loading instructions (i.e., 12.2 lbs per load).
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.
Refer to the STERRAD* 100NX* User's Guide for complete instructions on load(s) and cycle(s), including
chamber loading instructions (i.e., 10.7 lbs per load).
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 Refer to the STERRAD* 100NX* Sterilizer User's Guide for complete instructions on load(s) and cycle(s),
including chamber loading instructions (i.e., 13.2 lbs per load).

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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, 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 |
|--------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| KC100 | Very light weight package
(e.g., batteries or towel packs) | 10.7 lbs | APTIMAX Instrument Tray
(23 in. x 11 in. x 4 in.) with Tray Mat
Metal and non-metal instruments |
| KC200 | Light weight package
(e.g., telescope with light cord) | 10.7 lbs | APTIMAX Instrument Tray
(23 in. x 11 in. x 4 in.) with Tray Mat
Metal and non-metal instruments |
| 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 |

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 sides. This allows for convenient wrapping with two sheets simultaneously.

The sheets of sterilization wrap are square or rectangular fabric produced using a three-layer SMS (spunbound-meltblown-spunbound) 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
Characteristics | Proposed:
KIMGUARD® ONE-STEP® Sterilization
Wrap | Predicate Device:
KIMGUARD® ONE-STEP® Sterilization
Wrap (K092167) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Spunbound
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 Spunbound
polypropylene layers (SMS) |
| Method for bonding
SMS layers | Thermal bonding with round pin,
hexagonal, triangle bond pattern
( | |

Table 3. Device Comparison Table - Technological Characteristics

5. SUMMARY OF NONCLINICAL TESTS

Performance testing was conducted to show that the KIMGUARD® ONE-STEP® Sterilization Wrap maintains sterility until used, after completion of the sterilization process in the STERRAD® Sterilization Systems.

	Table 4: Sterilization Wrap Performance Tests
--	-----------------------------------------------

Study	Results
Sterilant Penetration	Passed
Package Integrity	Passed
Maintenance of Package Integrity	Passed
Material Compatibility	Passed
Shelf Life	Passed
Biocompatibility	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 as the predicate device and are substantially equivalent.

5

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, composed of three curved lines.

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

August 20, 2013

Kimberly-Clark Health Care Christopher B. Swanson Regulatory Affairs Specialist Email 1400 Holcomb Bridge Road ROSWELL GA 30076-2190

Re: K113806

Trade/Device Name: KIMGUARD® ONE-STEP® Sterilization Wrap (Models KC100, KC200, KC 300, KC 400, KC500, and KC600) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatorv Class: II Product Code: FRG Dated: August 8, 2013 Received:

Dear Mr. Swanson:

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 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division 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): K113806

KIMGUARD® ONE-STEP® Sterilization Wrap (Models_KC100, Device Name: KC200, KC300, KC500, KC500, and KC600) Indications for Use with Advanced Sterilization Products STERRAD® Sterilization Systems

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 o
  • STERRAD® NX® [Standard Cycle, Advanced Cycle] o
  • STERRAD® 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO o 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]). (Refer to the STERRAD® Sterilizer System User's Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions.)

All 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.

KIMGUARD* ONE-STEP* Sterilization Wrap Recommendations for Use with the Advanced Sterilization Products STERRAD® Sterilization Systems are provided in Table 2.

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

	STERRAD® Systems
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. Refer to the STERRAD® 50 Sterilizer User's Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e., 10 lumens per load).
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. Refer to the STERRAD® 100S Sterilizer User's Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e., 10 lumens per 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. Refer to the STERRAD® 200 Sterilizer User's Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e., 36.48 lbs per tray load).
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. Refer to the STERRAD® NX® Sterilizer User's Guide for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e., 10.7 lbs per load).

Note: Refer to the User's Guide for complete instructions on load and cycle for each STERRAD® System. The instructions provided below are not intended to replace the detailed Instructions For Use provided with the

9

:

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

| ASP STERRAD®

System and Cycle	Intended Load
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.
Refer to the STERRAD® NX® Sterilizer User's Guide for complete instructions on load(s) and cycle(s),
including chamber loading instructions (i.e., 10.7 lbs per load).
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.)
Refer to the STERRAD® 100NX® Sterilizer User's Guide for complete instructions on load(s) and cycle(s),
including chamber loading instructions (i.e., 21.4 lbs per load).
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).
Refer to the STERRAD® 100NX® Sterilizer User's Guide for complete instructions on load(s) and cycle(s),
including chamber loading instructions (i.e., 12.2 lbs per load).
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.
Refer to the STERRAD® 100NX® User's Guide for complete instructions on load(s) and cycle(s), including
chamber loading instructions (i.e., 10.7 lbs per load).
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
Refer to the STERRAD® 100NX® Sterilizer User's Guide for complete instructions on load(s) and cycle(s),
including chamber loading instructions (i.e., 13.2 lbs per load).

10

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 |
|--------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| KC100 | Very light weight package
(e.g., batteries or towel packs) | 10.7 lbs | • APTIMAX® Instrument Tray
(23 in. x 11 in. x 4 in.) with Tray Mat
• Metal and non-metal instruments |
| KC200 | Light weight package
(e.g., telescope with light cord) | 10.7 lbs | • APTIMAX® Instrument Tray
(23 in. x 11 in. x 4 in.) with Tray Mat
• Metal and non-metal instruments |
| 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 |

Intended loads include: Medical Instruments with and without lumens that include telescopes, cameras, light cords, and general use medical instruments

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Sreekanth Gutala
2013.08.20 13:05:45-04'00'
Page 4 of 4
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Respiratory, Infection Control and
Dental Devices

510(k) Number:	K113806
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