(56 days)
Not Found
No
The summary describes a device that uses HEPA filtration and directed airflow to reduce airborne particles and microorganisms. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device provides a clean air environment for the surgical site and instruments to reduce microorganisms, but it does not directly treat a patient's disease or condition.
No
Explanation: The device, Operio, is designed to provide HEPA-filtered airflow to a surgical site to reduce particulate matter and microorganisms. Its function is to prevent contamination and create a cleaner environment for surgery, not to diagnose medical conditions or analyze biological samples for diagnostic purposes.
No
The device description clearly outlines 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 medical device, not a software-only one.
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, tissue) to provide information for diagnosis, monitoring, or screening.
- Operio's Function: Operio is a device that filters and directs air in a surgical environment. Its purpose is to reduce airborne particulate matter and microorganisms at the surgical site and on instruments. It does not analyze any biological specimens from the patient.
- Intended Use: The intended use clearly states it's for producing a directed airflow to the surgical site and instruments during surgery.
- Device Description: The description focuses on air filtration and circulation within the operating room.
- Performance Studies: The performance studies measure air quality (particulate counts, CFU levels in the air), not the analysis of patient samples.
Therefore, Operio falls under the category of a medical device used in a surgical setting to improve air quality and reduce contamination, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Operio is a portable device for use in a surgical operating environment that produces a directed, non-turbulent flow of air to the surgical site during ophthalmic, orthopedic and neuro 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 99.995% efficiency against 0.3 um particles.
In testing, the subject device has demonstrated a level of particulates by 1.1 particles of 0.5 um/f³.
The following non-clinical tests has been conducted: Simulated use test. Particulate counting test, Colony Forming Units counting test, Air velocity test, Air leakage test, Smoke test and Turbulence tests to demonstrate air flow patterns.
The following standards have been used for performance testing:
- IEC/EN 60601-1:2006 Medical electrical equipment Part 1: General requirements ● for basic safety and essential performance
- IEC/EN 60601-1-2:2007 Medical electrical equipment - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
Summary of clinical testing:
Clinical tests have been carried out for surgical procedures such as ophthalmology, orthopedics and neurosurgery. Measurements where made near the surgical site and over the instruments where the results demonstrated a statistically significant reduction in CFU levels. The clinical tests include 302 CFU measurements from 82 patients in Swedish Hospitals. For the predicate device Operio for ophthalmic surgery the mean CFU value is 0.4 CFU/m² and the subject device Operio with additional claims show for orthopaedic surgery a mean CFU value of 0.52 CFU/m3 and for neurosurgery a mean CFU value of 2 CFU/m².
Key Results: Since CFU level doesn't exceed the predicate device of 99.995% efficiency against 0.3 µm particles (HEPA filtration)
CFU Reduction:
§ 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2017
Toul Meditech AB Tomas Hansson CEO Tunbytorpsgatan 31 Vasteras, 72137 SE
Re: K173349
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: October 25, 2017 Received: October 25, 2017
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173349
Device Name Operio
Indications for Use (Describe)
Operio is a portable device for use in a surgical operating environment that produces a directed, non-turbulent flow of air to the surgical site during ophthalmic, orthopedic and neuro 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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Image /page/3/Picture/0 description: The image shows the logo for "toul meditech". The word "toul" is in a large, blue, sans-serif font, with the "o" being partially obscured by a blue square. Below "toul" is the word "meditech" in a smaller, light blue, sans-serif font. The logo is simple and modern, and the colors are calming and professional.
510(k) Summary
Submission information
| Submission date: | 12th of October 2017 |
|---|---|
| 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 | Toul Meditech AB | Operio | K153498 |
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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. Below "toul" is the word "meditech" in smaller, blue letters. The logo is simple and modern.
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 environment that produces a directed, non-turbulent flow of air to the surgical site during ophthalmic, orthopedic and neuro 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 99.995% efficiency against 0.3 um particles.
In testing, the subject device has demonstrated a level of particulates by 1.1 particles of 0.5 um/f³.
The following non-clinical tests has been conducted: Simulated use test. Particulate counting test, Colony Forming Units counting test, Air velocity test, Air leakage test, Smoke test and Turbulence tests to demonstrate air flow patterns.
The following standards have been used for performance testing:
- IEC/EN 60601-1:2006 Medical electrical equipment Part 1: General requirements ● for basic safety and essential performance
- . IEC/EN 60601-1-2:2007 Medical electrical equipment - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . IEC 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
Summary of clinical testing
Clinical tests have been carried out for surgical procedures such as ophthalmology, orthopedics and neurosurgery. Measurements where made near the surgical site and over the instruments where the results demonstrated a statistically significant reduction in CFU levels.
7
Image /page/7/Picture/0 description: The image shows the logo for "toul meditech". The word "toul" is in large, blue, sans-serif font, with the "o" inside a blue square. Below "toul" is the word "meditech" in a smaller, blue, sans-serif font.
The clinical tests include 302 CFU measurements from 82 patients in Swedish Hospitals. For the predicate device Operio for ophthalmic surgery the mean CFU value is 0.4 CFU/m² and the subject device Operio with additional claims show for orthopaedic surgery a mean CFU value of 0.52 CFU/m3 and for neurosurgery a mean CFU value of 2 CFU/m².
Since CFU level doesn't exceed the predicate device of