(405 days)
Not Found
No
The description focuses on the physical sterilization process and a "factory-programmed control system," with no mention of AI or ML capabilities.
No
This device is an ozone sterilizer used for processing reusable medical devices, not for therapeutic purposes on patients.
No.
The TSO3 Model 125L is an Ozone Sterilizer, described as a device intended for the sterilization processing of reusable medical devices, not for diagnosing medical conditions.
No
The device description clearly describes a physical sterilization chamber with a capacity of 125 liters, requiring oxygen, water, and electricity, and designed for installation as a free-standing or recessed unit. It also mentions hardware components like a factory-programmed control system. This indicates it is a hardware device with integrated software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in the sterilization processing of reusable medical devices in health care facilities." This describes a process for making medical devices safe for use on patients, not for performing tests on biological samples to diagnose conditions.
- Device Description: The description details a sterilizer that uses ozone, oxygen, water, and electricity to sterilize medical devices. It mentions packaging materials, biological indicators, and chemical indicators, all related to the sterilization process itself. There is no mention of analyzing biological samples or providing diagnostic information.
- No mention of biological samples: The text focuses entirely on the sterilization of medical devices. There is no indication that the device interacts with or analyzes biological samples from a patient.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is entirely separate from that.
N/A
Intended Use / 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, Model 125L, is designed for sterilization of both metal and non-metal medical devices at low temperatures. 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 scissors.
Product codes (comma separated list FDA assigned to the subject device)
FLF
Device Description
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.
TSO3 Ozone Sterilizer, Model 125L, has the ability to sterilize successfully medical devices having a single stainless steel lumen which falls into the following length and internal diameters *:
| Internal diameter (mm) | Internal diameter (French)(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 10-6.
The types of packaging compatible with the TSO3 Model 125L Ozone Sterilizer are the TSO3 sterilization pouch and rigid anodized aluminum containers using disposable cellulose filter paper.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Model 125L validation testing for extended lumen claims was performed using the « overkill » approach to demonstrate the effectiveness of the process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
sterility assurance level (SAL) of 10-6
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
TSO3 Ozone Sterilizer, model 125L (K020875)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6860 Ethylene oxide gas sterilizer.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows a chemical structure diagram. The diagram includes the letters 'TS' on the left side. To the right of the letters, there is a chemical symbol with a circle and lines, indicating a chemical bond or group. The overall image appears to represent a chemical compound or molecule, possibly an intermediate or reactant in a chemical reaction.
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 : (418) 651-0003 FAX : (418) 653-5726 E-mail : mchaunet@tso3.com
U.S. Agent
Charles O. Hancock Inc. Contact person: Charles O. Hancock, RAC Tel : (585) 223-1850 FAX : (585) 223-6855 E-mail : chancock@frontiernet.net
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)
1
Image /page/1/Picture/0 description: The image shows a chemical structure diagram. The diagram contains the letters 'TS' on the left side. To the right of the letters, there is a chemical structure with a central 'S' atom bonded to three 'O' atoms. The structure appears to represent a tosyl group, a common moiety in organic chemistry.
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.
2
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)
(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.
Page 2 of 2
3
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.
4
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
5
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)
Stil. Mighy, R
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an of Anesthesiology, General Hospital,
Control, Dental Devices
nn of Anesthestology
Control. Dental Devices
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ANNEX A19 - 0001