TSO3 OZONE STERILIZER, MODEL 125L

K051595 · Tso3, Inc. · FLF · Jul 26, 2006 · General Hospital

Device Facts

• Record ID: K051595
• Device Name: TSO3 OZONE STERILIZER, MODEL 125L
• Applicant: Tso3, Inc.
• Product Code: FLF · General Hospital
• Decision Date: Jul 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6860
• Device Class: Class 2

Indications for Use

The TSO3 Model 125L is an Ozone Sterilizer intended for use in the sterilization processing of reusable medical devices in health care facilities. The TSO3 Ozone Sterilizer, Movol 1252. is designed for sterilization of both metal and non-metal medical devices at low temperatires. The sterilization cycle operates at very low pressure and low temperature, consequently it is suitable for processing medical devices sensitive to heat and moisture. The TSO3 Ozone Sterilizer, Model 125L, is designed to sterilize instruments and devices with diffusion-restricted spaces, such as the hinged portion of forceps and sciators.

Device Story

TSO3 Ozone Sterilizer Model 125L is a low-temperature, low-pressure sterilization system for pre-cleaned reusable medical devices. Device requires USP grade oxygen, water, and electricity; operates as a standalone or recessed unit. Sterilization process uses ozone; by-products are oxygen and low-humidity water vapor. No aeration required post-cycle; items are cool to touch and ready for immediate use or storage. Compatible with non-woven wraps, pouches, and anodized aluminum containers. Factory-programmed control system manages cycle. Healthcare providers use OZO-TEST biological indicators and chemical indicators to verify performance. Benefits include safe processing of heat/moisture-sensitive instruments and diffusion-restricted spaces like hinges.

Clinical Evidence

Bench testing only. Validation performed using the 'overkill' approach to demonstrate effectiveness for extended lumen claims. Testing conducted using half-cycles to achieve a sterility assurance level (SAL) of 10^-6 for stainless steel lumens ranging from 0.9mm to 4mm internal diameter and 485mm to 700mm in length.

Technological Characteristics

125-liter sterilization chamber; ozone-based sterilization; low-temperature/low-pressure process. Compatible with non-woven wraps, pouches, and anodized aluminum containers. Requires USP grade oxygen, water, and electricity. Factory-programmed control system. No exhaust gas ventilation required if room is adequately ventilated.

Indications for Use

Indicated for sterilization of reusable metal and non-metal medical devices, including those with diffusion-restricted spaces (e.g., hinged forceps, scissors) and heat/moisture-sensitive instruments, in healthcare facilities.

Regulatory Classification

Identification

An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.

Predicate Devices

• TSO3 Ozone Sterilizer, model 125L (K020875)

Submission Summary (Full Text)

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K051595

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#### EXTENDED LUMEN CLAIMS FO TSO3 OZONE STERILIZER, MODEL 125L

510(k) Summary

JUL 26 2006

#### Applicant's Name and Address

TSO3 Inc. 2505, Dalton Avenue Ste-Foy, Quebec, Canada G1P 3S5

Contact Person, Telephone, FAX

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

# U.S. Agent

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

Submission Date June 14, 2005

## Trade Name

TSO3 Ozone Sterilizer, model 125L

# Common Name

TSO3 125L Ozone Sterilizer

# Classification Name

Sterilizer, Chemical Class II (as per 21CFR, part 880.6860 equivalent device)

# Legally Marketed Equivalent Device Name(s) TSO3 Ozone Sterilizer, model 125L (K020875)

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#### EXTENDED LUMEN CLAIMS FOR TSO3 OZONE STERILIZER, MODEL 125L

## Description of Device

TSO3 Ozone Sterilizer, model 125L is intended to sterilize medical devices that has been previously cleaned.

The sterilization chamber has a capacity of 125 liters (4.3 cu. ft.).

It requires USP grade oxygen, water and electricity. Model 125L could be installed as a free standing unit or recessed behind the wall. No exhaust gas ventilation duct is required as long as the room is adequately ventilated. By-products are oxygen and low humidity water vapor.

Model 125L is equipped with a unique factory-programmed control system.

Non-woven wrapping material or pouches and anodized aluminum containers are used as packaging for medical devices to be sterilized.

OZO-TEST® self-contained Biological Indicators (B. stearothermophilus) are recommended for use in evaluating cycle performance.

TSO3 Chemical Indicators are available for this process.

No aeration is needed following the sterilization cycle. The sterilized items are cool to the touch and can be removed immediately and used, or stored for future use.

# Effectiveness

Model 125L validation testing for extended lumen claims was performed using the « overkill » approach to demonstrate the effectiveness of the process.

## Safety

Safety of the TSO3 Ozone Sterilizer, model 125L was demonstrated into the original 510(k) submission (K020875). The content of the actual submittal does not compromise the safety of the device.

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TSO3 Ozone Sterilizer, Model 1251, bas the ability to sterilize successfully medical devices having a single stainless steel humen which falls into the following length and internal diameters *:

| Internal diameter (mm) | Internal diameter (French)<br>(Approximative correspondence) | Length (mm) |
|------------------------|--------------------------------------------------------------|-------------|
| 0.9 | 2.7 | 485 |
| 1 | 3 | 500 |
| 2 | 6 | 575 |
| 3 | 9 | 650 |
| 4 | 12 | 700 |

*Note: Testing on lumens were conducted employing half cycle to demonstrate achievement of a sterility assurance level (SAL) of 10°.

The types of packaging compatible with the TSO; Model 1231 Ozone Sterilizer are the TSO3 sterifization pouch and rigid anodized aluminum containers using disposable cellulose filiter paper.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the circle's perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 6 2006

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

Re: K051595

Trade/Device Name: TSO3 Ozone Sterilizer, Model 125L Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: FLF Dated: July 10, 2006 Received: July 10, 2006

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.

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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 (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.

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 vours.

Chiu 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

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# Indications for Use

510(k) Number (if known): K051595

Device Name: TSO3 Ozone Sterilizer, Model 125L

Indications For Use:

The TSO3 Model 125L is an Ozone Sterilizer intended for use in the sterilization processing of reusable medical devices in health care facilities. The TSO3 Ozone Sterilizer, Movol 1252. is designed for sterilization of both metal and non-metal medical devices at low temperatires. The sterilization cycle operates at very low pressure and low temperature, consequently it is suitable for processing medical devices sensitive to heat and moisture.

The TSO3 Ozone Sterilizer, Model 125L, is designed to sterilize instruments and devices with diffusion-restricted spaces, such as the hinged portion of forceps and sciators.

Prescription Use (Part 21 CFR 801 Subpan D)

AND/OR

X Over-The-Counter Use (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)

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