(226 days)
Not Found
No
The description focuses on air filtration and flow mechanics, with no mention of AI or ML terms or functionalities.
No.
The device is intended to reduce airborne particulate matter and microorganisms at the surgical site and on instruments, which is a supportive function for surgical procedures, not a direct therapeutic intervention on a patient.
No
Explanation: The device is designed to clean the air in a surgical setting by filtering out particulate matter and microorganisms, and to direct a flow of clean air to the surgical site and instruments. Its function is to reduce contamination, not to diagnose a medical condition.
No
The device description clearly details a physical, mobile unit with a control panel, castors, and an optional instrument tray, designed to filter and direct air. This indicates a hardware-based device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Operio device is designed to filter and direct air to reduce airborne particulate matter and microorganisms at a surgical site and over instruments. It does not analyze any biological specimens from a patient.
- Intended Use: The intended use is to create a clean air environment during surgery, not to diagnose or provide information about a patient's health status based on in vitro analysis.
The device is a medical device used in a surgical setting to improve air quality and reduce the risk of contamination, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Operio is a portable device for use in a surgical operating room that produces a directed, non-turbulent flow of air to the surgical site during ophthalmic surgery and to the sterile instruments used during surgery. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter to reduce the microorganisms to a level of
§ 878.5070 Air-handling apparatus for a surgical operating room.
(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
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Image /page/0/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 20, 2016
Toul Meditech AB Tomas Hansson CEO Tunbytorpsgatan 31 Västerås, 721 37 SE
Re: K153498
Trade/Device Name: Operio Regulation Number: 21 CFR 878.5070 Regulation Name: Air-Handling Apparatus For A Surgical Operating Room Regulatory Class: Class II Product Code: ORC Dated: January 7, 2016 Received: January 14, 2016
Dear Tomas Hansson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -S
for Erin I. Keith, M.S.
Director Division of Anesthesiology, General Hospital, Respiratory, 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) K153498
Device Name Operio
Indications for Use (Describe)
Operio is a portable device for use in a surgical operating room that produces a directed, non-turbulent flow of air to the surgical site during ophthalmic surgery and to the sterile instruments used during surgery. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter to reduce the microorganisms to a level of Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary
Submission information
| Submission date: | 4th of December 2015 |
|---|---|
| 510(k) submitter: | Tomas Hansson |
| Toul Meditech AB | |
| Tunbytorpsgatan 31 | |
| 721 37 Västerås, Sweden | |
| Phone: + 46 21 13 50 00 | |
| Fax: + 46 21 13 86 45 | |
| Email: tomas.hansson@toulmeditech.com) |
Device information
| Trade name: | Operio |
|---|---|
| Common name: | Air zone unit |
| Classification name: | Air-handling apparatus for a surgical operating room |
| Regulation number: | 21 CFR 878.5070 |
| Product code | ORC |
| Device class | II |
Legally marketed predicate device
Identification of the legally marketed predicate device to which Toul Meditech AB claims SE for.
| Code | Manufacturer | Device | 510(k) # |
|---|---|---|---|
| ORC | Nimbic, Inc | Air Barrier System | K123006 |
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Image /page/4/Picture/1 description: The image shows the logo for "toul meditech". The word "toul" is in large, bold, blue letters, with the "o" in a light blue square. Below "toul" is the word "meditech" in smaller, blue letters.
Device description
The air zone unit Operio is used in a surgical operating room for cleaning the air in a given area by re-circulating the ambient air and cleaning it from airborne particles. The air is filtered through a HEPA filter and the air is generated over the areas where the demands of clean air are especially high. The air zone unit Operio is equipped with a control panel for adjustments and for positioning of the unit.
The air zone unit Operio is a mobile unit that with the help of castors easily can be moved around the patient to an optimal position or, when needed, transported inside the hospital between wards. It is also equipped with an optional instrument tray.
By using a unique sterile shield as a protective barrier the air zone unit can be placed close to the OR table and deliver HEPA filtered air to the surgical site and instruments to reduce the presence of airborne particulate and microorganisms.
Indications for use
Operio is a portable device for use in a surgical operating room that produces a directed, nonturbulent flow of air to the surgical site during ophthalmic surgery and to the sterile instruments used during surgery. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter to reduce the microorganisms to a level of