KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION

K973827 · Kimberly-Clark Corp. · KCT · Feb 11, 1998 · General Hospital

Device Facts

• Record ID: K973827
• Device Name: KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION
• Applicant: Kimberly-Clark Corp.
• Product Code: KCT · General Hospital
• Decision Date: Feb 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Kimberly-Clark Self-Seal Pouch for Low Temperature Sterilization is intended to be used to enclose another medical device that is to be sterilized by a health care provider and to maintain sterility of the enclosed device until needed. The sterilization pouch is intended for use with low temperature sterilization processes (hydrogen peroxide gas plasma/STERRAD® sterilization system, peracetic acid gas plasma/Plazlyte™ sterlization process or ethylene oxide).

Device Story

Kimberly-Clark Self-Seal Pouch is a sterilization packaging system; consists of Tyvek backing and clear polyolefin/polyester film front. Used by healthcare providers to enclose medical devices prior to low-temperature sterilization (hydrogen peroxide gas plasma, peracetic acid gas plasma, or ethylene oxide). Pouch allows sterilant penetration while maintaining microbial barrier post-sterilization. Provides sterile storage until device is needed for clinical use. Available in multiple sizes.

Clinical Evidence

Bench testing only. Testing included sterilant penetration and microbial barrier efficiency for STERRAD, Plazlyte, and ethylene oxide processes, showing no growth of indicator organisms. Event-related sterility maintenance testing (EO only) demonstrated superiority to 140-count cloth packages.

Technological Characteristics

Materials: Tyvek backing, polyolefin/polyester film laminate front. Form factor: Pouch available in various dimensions (3.5" x 8.5" to 15.75" x 18"). Principle: Porous backing allows sterilant penetration; film allows visual inspection. Sterilization compatibility: Hydrogen peroxide gas plasma, peracetic acid gas plasma, ethylene oxide.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization and to maintain sterility until use. Compatible with low temperature sterilization processes including hydrogen peroxide gas plasma (STERRAD), peracetic acid gas plasma (Plazlyte), and ethylene oxide.

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

• Medi-Oxide Sterilization Pouch

Submission Summary (Full Text)

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

・

:

FEB | | 1998

| 510(k) Summary of Safety and Effectiveness | |
|--------------------------------------------|--|
| K973827 | |

| Manufacturer: | Kimberly-Clark Corporation<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs<br>Contact: | Larry R. Kludt<br>Department of Product Safety<br>Kimberly-Clark Corporation<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076<br>[phone] |
| Summary Date: | September 30, 1997 |
| Product Trade Name: | Kimberly-Clark™ Self-Seal Pouch for Low<br>Temperature Sterilization |
| Common Name: | Sterilization Pouch |
| Classification: | Pack, Sterilization Wrapper Bag & Accessories |
| Predicate Device: | Medi-Oxide Sterilization Pouch |
| Description: | The Kimberly-Clark Self-Seal Pouch is available in<br>sizes to suit the health care provider (3.5 " x 8.5",<br>5.25" x 10.25", 5" x 15", 7.5" x 13.5", 12" x 15",<br>12" x 18" & 15.75" x 18"). The pouch has a Tyvek<br>backing with a clear, polyolefin/polyester film<br>laminate material as a front. |
| Intended Use: | The Kimberly-Clark Self-Seal Pouch for Low<br>Temperature Sterilization is intended to be used to<br>enclose another medical device that is to be<br>sterilized by a health care provider and to maintain<br>sterility of the enclosed device until needed. The<br>sterilization pouch is intended for use with low<br>temperature sterilization processes (hydrogen<br>peroxide gas plasma/STERRAD® sterilization<br>system, peracetic acid gas plasma/Plazlyte™<br>sterlization process or ethylene oxide). |

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

Technological Characteristics

Both the Medi-Oxide pouch and the Kimberly-Clark Seal Pouch for Low Temperature Sterilization are composed of the same materials (a porous, Tyvek backing to allow the sterilant to penetrate into the package and a polyolefin/polyester film as a front to allow viewing of the pouch contents). Both products are intended for use with low temperature sterilization processes and are able to maintain the sterility of their contents once sterilized.

## Summary of Testing

## Test

## Result

Sterilant Penetration (STERRAD, Plazlyte and EO)

Microbial Barrier Efficiency (STERRAD, Plazlyte and EO)

Event Related Sterility Maintenance (EO only) No growth of indicator organism

No growth of indicator organism

Superior to 140 count cloth packages in maintaining sterility

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Larry R. Kludt Manager Requlatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076

## FEB 11 1998

Re : K973827 Kimberly-Clark™ Self-Seal Pouch for Low Trade Name: Temperature Sterilization Requlatory Class: II Product Code: KCT Dated: December 19, 1997 Received: December 22, 1997

Dear Mr. Kludt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A-- ---substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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

Page 2 - Mr. Kludt

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debtribut in your for equivalence of your device to a legally marketed predicate device results in a classification for your marice and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to one roganized notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fdaygov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

l'age of

510(k) Number (if known): ___ K973827

Device Name Kimberly-Clark™ Self Seal Pouch for Low Temperature Sterilli zation

Indications For Use:

The Kimberly-Clark Th Self-Seal Pouch for Low Temperature Sterilization is intended to be used to enclose another medical device that is to be sterilized by a health care provider and to maintain sterility of the enclosed device until needed. The sterilization pouch is intended for use with low temperature sterilization processes (hydrogen peroxide gas plasma/STERRAD Sterilization System, peracetic acid

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|----------------------------------------|---------|
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K973827 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use <u>X</u><br>(Optional Format 1-2-96) |
|------------------------------------------|----|-----------------------------------------------------------|
|------------------------------------------|----|-----------------------------------------------------------|