(126 days)
No
The 510(k) summary describes a physical sterilization wrap and its intended use in a specific sterilization process. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
No
The device is a sterilization wrap used to maintain sterility of other medical devices, not to treat a medical condition or perform a therapeutic function on a patient.
No
The device is a sterilization wrap, designed to enclose and maintain the sterility of other medical devices, not to diagnose a condition.
No
The device description explicitly states it is a physical wrap made of a 2-layer laminate, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The TSO3 Ozone Sterilization Wrap is used to enclose medical devices for sterilization and maintain their sterility. It does not interact with or analyze samples from the human body.
- Intended Use: The intended use clearly states it's for enclosing another medical device for sterilization and maintaining sterility.
- Device Description: The description details the materials and function related to sterilization and maintaining sterility, not diagnostic testing.
Therefore, based on the provided information, the TSO3 Ozone Sterilization Wrap falls under the category of a medical device used in the sterilization process, not an in vitro diagnostic device.
N/A
Intended Use / 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 in the TSO3 Ozone Sterilization process.
Product codes
FRG
Device Description
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.
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
healthcare provider
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)
Sterilization performance studies and shelf-life sterility tests were conducted and all acceptance criteria were met.
A skin irritation test was performed by an independent laboratory to demonstrate that the final product does not induce any biocompatibility hazard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6850 Sterilization wrap.
(a)
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.(b)
Classification. Class II (performance standards).
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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 : (418) 651-0003 ext.242 FAX : (418) 653-5726 E-mail: mchaunet@tso3.com
U.S. Agent
Charles O. Hancock Associates, Inc. Contact person: Charles O. Hancock, RAC Tel : (585) 223-1850 FAX : (585) 223-6855 E-mail : chancock@rochester.rr.com
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
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K080198
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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
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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.
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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 (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 (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 (301) 443-6597 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
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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:
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