WINNER SELF SEAL STERILIZATION POUCH

K051242 · Winner Medical (Usa), Inc. · KCT · Dec 13, 2005 · General Hospital

Device Facts

• Record ID: K051242
• Device Name: WINNER SELF SEAL STERILIZATION POUCH
• Applicant: Winner Medical (Usa), Inc.
• Product Code: KCT · General Hospital
• Decision Date: Dec 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Winner® Self Seal Sterilization Pouches are intended to be used to enclose another medical device that is to be sterilized by a health provider by steam 121°C for 15 minutes or ethylene oxide (EtO). It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Device Story

Winner® Self Seal Sterilization Pouch consists of medical-grade paper and plastic film heat-sealed on three sides with an adhesive strip on the fourth side. Used by healthcare providers in clinical settings to enclose medical instruments prior to sterilization. Device allows penetration of steam or ethylene oxide gas to sterilize contents while maintaining a sterile barrier post-sterilization until the pouch is opened for use. Performance verified through testing of material properties and package integrity under sterilization conditions.

Clinical Evidence

No clinical data. Bench testing only. Testing included material property analysis (paper filtration/pressure drop; film tensile strength/elongation) and finished device performance (seal strength, package burst, dye migration, temperature distribution, and biological indicator sterilization efficacy) following steam and ethylene oxide sterilization.

Technological Characteristics

Materials: Medical-grade paper and plastic film. Construction: Heat-sealed on three sides with adhesive strip closure. Sterilization compatibility: Steam (121°C) and ethylene oxide. Characteristics: Permeable to sterilizing agents, impermeable to contaminants post-sterilization.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices requiring sterilization via steam (121°C for 15 minutes) or ethylene oxide (EtO) and to maintain sterility of the enclosed device until use.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

• Medipack® See-Through Self Seal Sterilization Pouch (K993764)
• Global Healthcare Self-Sealing Sterilization Pouch (K990567)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows a logo with the word "Winner" in a stylized font. Above the "i" in "Winner" is a small circle. Below the word "Winner" is the phrase "WIN-WIN PARTNER" in a smaller, sans-serif font. The text is slightly curved.

# WINNER MEDICAL (USA), II

### 1900-H PROFORMA AVE. ONTARIO, CA. 91761 TEL: [phone] FAX: [phone]

DEC 1 3 2005

### 510K SUMMARY

This summary of 510K safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510K number is: K051242

- 1. Submitter's Identification:
Winner Industries Co., LTD Winner Industrial Park,Bulong RD., Longhua, Shenzhen Shenzhen China 518109 Telephone: [phone] Facsimile: 86-755-28134588

U.S. Agent: Winner Medical USA, Inc. 1900-H Proforma Ave. Ontario, California 92861 Telephone: [phone] Facsimile: 909-947-9613

Contact Person: Ming Xie, Vice President

Date of Summary: 5-6-05

- 2. Device Name: Winner® Self Seal Sterilization Pouch
- 3. Classification Name: Pack, Sterilization Wrapper, Bag and Accessories (21 CFR 880.6850).
- 4. Predicate Device:
- a. K993764 Medipack® See-Through Self Seal Sterilization Pouch.
- b. K990567 Global Healthcare Self-Sealing Sterilization Pouch.

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

- 5. Intended Use: Winner® Self Seal Sterilization Pouches are intended to be used to enclose another medical device that is to be sterilized by a health provider by steam 121°C for 15 minutes or ethylene oxide (EtO). It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
- 6. Device Description/ Comparison: These pouches are manufactured from a medical grade paper and plastic film that are heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Winner® Self Seal Sterilization Pouch has the identical intended use and indication for use as the predicate devices, as well as, similar labeling. Substantial equivalent to the predicate device was established by testing the medical grade paper (pressure drop vs. flow and filtration efficiency) and film (thickness, tensile strength and elongation) from non-sterile, steam sterilized and ethylene oxide sterilized finished devices, as well as, performance of these finished devices (seal strength, package burst, dye migration, temperature distribution for steam and ethylene oxide sterilization, steam and ethylene oxide sterilization of biological indicators). This information has been included with this submission.

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

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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or abstract shapes, possibly representing health, people, and services.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC I 3 2005

Dr. Ming Xie Vice President Winner Medical USA, Incorporated 1900-H Proforma Avenue Ontario. California 91761

Re: K051242

Trade/Device Name: Winner® Self Seal Sterilization Pouch Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: October 24, 2005 Received: October 31, 2005

Dear Dr. Xie:

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 such 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. Xie

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. or the For of all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as bet formic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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), nlease contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/edrh/industry/support/index.html.

Sincerely vours,

Chiu Lin, Ph.D.

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

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

## Indications for Use

510(k) Number (if known): K051242

Device Name: Winner® Self Seal Sterilization Pouch

Indications For Use:

Winner® Self Seal Sterilization Pouch is intended to be used to enclose another medical device that is to be sterilized by a health provider by steam 121°C for 15 minutes or ethylene oxide (EtO). It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

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

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

Page 1 of of

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

Concurrence of CDRH, Office of Device Evaluation (ODE)