KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600

K092167 · Kimberly-Clark Corp. · FRG · Nov 2, 2009 · General Hospital

Device Facts

• Record ID: K092167
• Device Name: KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600
• Applicant: Kimberly-Clark Corp.
• Product Code: FRG · General Hospital
• Decision Date: Nov 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

KIMGUARD ONE-STEP* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider in the Amsco V-PRO 1 Low Temperature Sterilization System's Cycle or the Amsco V-PRO 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PRO 1 Cycle) and Non Lumen Cycles. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened. The wrap was validated to be effectively aerated during the pre-programmed V-PRO 1 and V-PRO 1 Plus Sterilization Cycles.

Device Story

KIMGUARD ONE-STEP* Sterilization Wrap consists of two sheets of polypropylene SMS (spunbond-meltblown-spunbond) fabric ultrasonically seamed on two sides; designed for simultaneous two-sheet wrapping. Used by healthcare providers in clinical settings to enclose medical instruments prior to sterilization in Amsco V-PRO 1 or V-PRO 1 Plus Low Temperature Sterilization Systems. Wrap allows sterilant penetration and aeration during cycles; maintains sterility of contents post-sterilization. Healthcare providers select appropriate wrap model (KC100-KC600) based on instrument weight and configuration. Benefits include protection of sterile integrity of instruments until point of use.

Clinical Evidence

No clinical data. Bench testing performed in accordance with FDA guidance for medical sterilization packaging systems. Testing included biocompatibility (ISO 10993), sterilant penetration, and physical integrity. Sterility maintenance validated for up to 30 days post-sterilization. All results met acceptance criteria.

Technological Characteristics

Material: Polypropylene three-layer SMS (spunbond-meltblown-spunbond) fabric. Construction: Two sheets ultrasonically seamed on two sides. Form factor: Square or rectangular sheets. Models KC100-KC600 vary by weight capacity. Sterilization compatibility: Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems.

Indications for Use

Indicated for healthcare providers to enclose medical devices for sterilization in Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems and to maintain sterility until opened.

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 (K082177)

Submission Summary (Full Text)

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

# NOV - 2 2009

2092167

# 510(k) Summary for the Kimberly-Clark* Corporation KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600) for the Additional Indication for Use with the Amsco® V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems

Date Summary was Prepared: 510(k) Submitter and Primary Contact:

October 23, 2009

Sterilization Wrap

FRG

Thomas Kozma, PhD Director, Regulatory Affairs Kimberly-Clark Health Care 1400 Holcomb Bridge Road Roswell, GA 30076 Ph: 770.587.8393 FAX: [phone] Email: [e-mail]

Device Common Name: Classification Name:

Sterilization Wrap (21 CFR 880.6850)

Product Code:

Additional Intended Use Subject of this 510(k) Submission: KIMGUARD ONE-STEP* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider in the Amsco V-PRO 1 Low Temperature Sterilization System's Cycle or the Amsco V-PRO 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PRO 1 Cycle) and Non Lumen Cycles. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened. The wrap was validated to be effectively aerated during the pre-programmed V-PRO 1 and V-PRO 1 Plus Sterilization Cycles.

See Wrap Model Recommendations on Page 2 of this Summary.

The KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600) for the additional indication for use with the Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems is substantially equivalent to the predicate KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100,

KC200, KC300, KC400, KC500, and KC600) (K082177).

Predicate Devices:

Substantial Equivalence: The KIMGUARD ONE-STEP* Sterilization Wrap is identical to the predicate in intended use, design, materials, and performance. The 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 polypropylene three-layer SMS (spunbondmeltblown-spunbond) process.

Page 1 of 2 - 510(k) Summary

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

K092167
page 2 of 2

### Summary of Testina:

KIMGUARD ONE-STEP* Sterilization Wrap performance has been tested in accordance with the applicable requirements recommended in Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002). Testing included biocompatibility in compliance with the methods of ISO 10993, sterilant penetration, and physical integrity. The Wrap has also been tested for the ability to maintain sterility of pack contents after sterilization for up to 30 days under standard conditions. All results of testing met acceptance criteria.

## Wrap Model Recommendations for Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization1

| KIMGUARD<br>ONE-STEP*<br>Sterilization<br>Wrap Models | Intended Loads | Maximum<br>Wrapped<br>Package<br>Content<br>Weights Used in<br>Sterility<br>Maintenance<br>Validation<br>Study2 | Descriptions of Loads Used in Sterility<br>Maintenance Validation Study2 |
|-------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| KC100 | Very Light Weight<br>Package (for example<br>batteries) | 3 lbs | • 3 lbs metal mass<br>• 6 forceps |
| KC200 | Light Weight Package<br>(for example telescope<br>with light cord) | 6.5 lbs | • 2.5 lbs metal mass<br>• 6 forceps<br>• V-PRO tray (17" x 10" x 3½") at 4 lbs |
| KC300 | Light to Moderate<br>Weight Package (for<br>example: general use<br>medical instruments) | 9 lbs | • 5 lbs metal mass<br>• 6 forceps<br>• V-PRO tray (17" x 10" x 3½") at 4 lbs |
| KC400 | Moderate to Heavy<br>Weight Package (for<br>example: general use<br>medical instruments) | 10 lbs | • 6 lbs metal mass<br>• 6 forceps<br>• V-PRO tray (17" x 10" x 3½") at 4 lbs |
| KC500 | Heavyweight Package<br>(for example: general<br>use medical<br>instruments) | 10 lbs | • 5 lbs metal mass<br>• 6 forceps<br>• V-PRO tray (21" x 10" x 3½") at 5 lbs |
| KC600 | Very Heavy Weight<br>Package (for example:<br>general use medical<br>instruments) | 10 lbs | • 5 lbs metal mass<br>• 6 forceps<br>• V-PRO tray (21" x 10" x 3½") at 5 lbs |

Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding methods. Results may also differ due to the use of irregularly shaped contents, which may put added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use. 1 t is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model.

Furthermore, it is recommended to not exceed the number, weight, and size of individual content types that were validated for the KIMGUARD Sterilization Wraps (i.e.; the weight of the metal mass).

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

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the bird-like figure. The text is in all capital letters and is evenly spaced around the circle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Dr. Thomas Kozma Director of Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076

# NOV - 2 2009

Re: K092167

Trade/Device Name: KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500 and KC600) for the Use With the Lumen Cycle of the Amsco V-PRO 1 Low Temperature Sterilization System and With the Lumen and Non Lumen Cycles of the Amsco V-PRO 1 Plus Low Temperature Sterilization System

Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II · Product Code: FRG Dated: October 5, 2009 Received: October 7, 2009

Dear Dr. Kozma:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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.

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

## Page 2- Dr. Kozma

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH Offices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Anthony D. Roberts Jr.

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

Enclosure

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

#### Indications for Use

#### 510(k) Number (if known): K092167

Device Name: _ KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600) for the Additional Indication for Use with the Amsco® V-PRO™ 1 and V-PRO 1 Plus Low Temperature Sterilization Systems

#### Indications for Use:

KIMGUARD ONE-STEP* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider in the Amsco V-PRO 1 Low Temperature Sterilization System's Cycle or the Amsco V-PRO 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PRO 1 Cycle) and Non Lumen Cycles. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened. The wrap was validated to be effectively aerated during the pre-programmed V-PRO 1 and V-PRO 1 Plus Sterilization Cycles.

KIMGUARD ONE-STEP* Sterilization Wrap Recommendations for use with the Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems are provided on Page 2.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

<PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

| | Eli sheth P. Clavene-Wilde |
|--------------------------------------------------------|----------------------------|
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K092167 |

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

#### Indications for Use

# Wrap Model Recommendations for Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization'

| KIMGUARD<br>ONE-STEP*<br>Sterilization<br>Wrap Models | Intended Loads | Maximum<br>Wrapped<br>Package<br>Content<br>Weights Used<br>in Sterility<br>Maintenance<br>Validation<br>Study2 | Descriptions of Loads Used in<br>Sterility Maintenance Validation<br>Study2 |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| KC100 | Very Light Weight<br>Package (for<br>example batteries) | 3 lbs | 3 lbs metal mass 6 forceps |
| KC200 | Light Weight<br>Package (for<br>example telescope<br>with light cord) | 6.5 lbs | 2.5 lbs metal mass 6 forceps V-PRO tray (17" x 10" x 3½") at 4 lbs |
| KC300 | Light to Moderate<br>Weight Package<br>(for example:<br>general use<br>medical<br>instruments) | 9 lbs | 5 lbs metal mass 6 forceps V-PRO tray (17" x 10" x 3½") at 4 lbs |
| KC400 | Moderate to Heavy<br>Weight Package<br>(for example:<br>general use<br>medical<br>instruments) | 10 lbs | 6 lbs metal mass 6 forceps V-PRO tray (17" x 10" x 3½") at 4 lbs |
| KC500 | Heavyweight<br>Package (for<br>example: general<br>use medical<br>instruments) | 10 lbs | 5 lbs metal mass 6 forceps V-PRO tray (21" x 10" x 3½") at 5 lbs |
| KC600 | Very Heavy Weight<br>Package (for<br>example: general<br>use medical<br>instruments) | 10 lbs | 5 lbs metal mass 6 forceps V-PRO tray (21" x 10" x 3½") at 5 lbs |

Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding methods. Results may also differ due to the use of iregularly shaped contents, which may put added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use. 2 It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. Furthernore, it is recommended to not exceed the number, weight, and size of individual content types that were validated for the KIMGUARD Sterilization Wraps (i.e .: the weight of the metal mass).