TSO3 OZONE STERILIZATION WRAP

K080198 · Tso3, Inc. · FRG · May 30, 2008 · General Hospital

Device Facts

• Record ID: K080198
• Device Name: TSO3 OZONE STERILIZATION WRAP
• Applicant: Tso3, Inc.
• Product Code: FRG · General Hospital
• Decision Date: May 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The TSO3 Ozone Sterilization Wrap is a single-use, non-sterile device. It is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device, and also to maintain sterility of the enclosed device until used. This wrap is intended for use with TSO3 Ozone Sterilization process.

Device Story

Single-use, non-sterile sterilization wrap; designed to enclose medical devices during ozone sterilization process; maintains sterility of enclosed items until point of use. Composed of 2-layer laminate (ePTFE membrane and PE/PET nonwoven backer). Used by healthcare providers in clinical settings. Provides barrier protection for sterilized instruments.

Clinical Evidence

Bench testing only. Sterilization performance studies and shelf-life sterility tests conducted; all acceptance criteria met. Biocompatibility testing (skin irritation, cytotoxicity, sensitization) performed per ISO 10993-1; results previously submitted under K020875.

Technological Characteristics

2-layer laminate: ePTFE membrane and 100% Polyethylene/Polyester (PE/PET) bi-component nonwoven backer. Single-use, non-sterile. Designed for ozone sterilization compatibility. Biocompatibility tested per ISO 10993-1.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization and to maintain sterility of the enclosed devices until use, specifically within the TSO3 Ozone Sterilization process.

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

• Suprashield Express® Sterilization Wrap (K990300)

Reference Devices

• TSO3 125L Ozone Sterilizer (K020875)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the letters "TSO" in a simple, sans-serif font. The letters are arranged horizontally, with "TS" appearing to be connected. There is a faint, dotted line that forms a partial circle above and to the right of the "O", suggesting a possible incomplete or erased element in the image.

# 510(k) Summary of Safety and Effectiveness

#### Applicant's Name and Address

TSO3 Inc. 2505, avenue Dalton Québec (Quebec) Canada G1P 3S5

# Contact Person, Telephone, FAX

Marc Chaunet, Quality Assurance and Regulatory Affairs Tel : [phone] ext.242 FAX : [phone] E-mail: [e-mail]

# U.S. Agent

Charles O. Hancock Associates, Inc. Contact person: Charles O. Hancock, RAC Tel : [phone] FAX : [phone] E-mail : [e-mail]

# Submission Date

January 23, 2008

Trade Namc TSO3 Ozone Sterilization Wrap

Common Name CSR Wrap or Sterilization Wrap

Classification Name Wrap, Sterilization Class II (as per 21CFR, part 880.6850 cquivalent device)

Legally Marketed Equivalent Device Name(s) Suprashield Express® Sterilization Wrap (K990300) MAY 3 0 2008

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

Image /page/1/Picture/0 description: The image shows the letters "TS" followed by a set of parentheses. The letters are in a simple, sans-serif font and appear to be bolded. The parentheses are slightly smaller in size compared to the letters. The image has a grainy texture, particularly around the edges of the letters and parentheses.

K080198
p2of2

# Description of Device

The TSO3 Ozone Sterilization Wrap is a single-use, non-sterile device. It is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device, and also to maintain sterility of the enclosed device until used. This wrap is intended for use in the TSO3 Ozone Sterilization process.

The TSO3 Ozone Sterilization Wrap is a 2 layer laminate consisting of an ePTFE membrane and a 100% Polyethylene/Polyester (PE/PET) bi-component nonwoven backer.

# Effectiveness

Sterilization performance studies and shelf-life sterility tests were conducted and all acceptance criteria were met.

# Safety

The material used in the composition of the TSO3 Ozone Sterilization Wrap (ePTFF/PE/PET) was evaluated and tested as required in ISO 10993 standard, part 1. These materials were evaluated for skin irritation, cytotoxicity testing, and sensitization. Results were submitted as part of the 510(k) submission for the TSO3 125L Ozone Sterilizer (K020875). All acceptance criteria established in the applicable portions of the standards were met.

A skin irritation test was performed by an independent laboratory to demonstrate that the final product does not induce any biocompatibility hazard. Refer to Annex V for test protocol and results (test report).

# Substantial Equivalence

The TSO3 Sterilization Wrap is substantially equivalent to the Suprashield Express® Sterilization Wrap (K990300) in that the:

- Intended use is the same
- Performance attributes are the same

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a high-resolution image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 3 0 2008

TSO3 Incorporated C/O Mr. Charles O. Hancock Regulatory Affairs Consultant Charles O. Hancock Associates, Incorporated 33 Black Watch Trail Fairport, New York 14450

Re: K080198

Trade/Device Name: TSO3 Ozone Sterilization Wrap Regulation Number: 880,6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: May 13, 2008 Received: May 13, 2008

Dear Mr. Hancock:

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 - Mr. Hancock

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic 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), please 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/cdrh/industry/support/index.html.

Sincerely yours.

Ching-Lin, Ph.D.

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

Enclosure

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

# Indications for Use

510(k) Number (if known): K080198

Device Name: TSO3 Ozone Sterilization Wrap

Indications For Use:

The TSO3 Ozone Sterilization Wrap is a single-use, non-sterile device. It is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device, and also to maintain sterility of the enclosed device until used. This wrap is intended for use with TSO3 Ozone Sterilization process.

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 IF NEEDED)

> Office of Device Evaluation (ODE) Concurrence of CDRH.

Shala A. Murphy, MD

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Page 1 of *_*_