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 < 5 CFU per m3 at the surgical site and instruments.

The air flow is intended to be directed parallel to the surgical site and/or instruments within: 20" (50 cm) in width, 47" (120 cm) in length and 15" (40 cm) in height. Device effectiveness may not be reliably detectable at a distance of 47 inches (120 cm) from the air flow outlet, and effectiveness depreciates beyond this specified area.

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.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Operio device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Criteria (from Indications for Use)	Reported Device Performance (Operational, from Summary of Testing)
Microorganism Reduction	Reduce microorganisms to a level of < 5 CFU per m³ at the surgical site and instruments.	Ophthalmic Surgery (Predicate Device K153498): Mean CFU value is 0.4 CFU/m².Orthopedic Surgery (Subject Device): Mean CFU value is 0.52 CFU/m³.Neurosurgery (Subject Device): Mean CFU value is 2 CFU/m³.All reported CFU levels are < 5 CFU, meeting the criteria.
Particulate Matter Reduction (HEPA Filter)	HEPA-filtered to reduce the presence of particulate matter. (Implicitly, the stated efficiency below covers this.)	HEPA filtration efficiency > 99.995% against 0.3 µm particles.
Particulate Density at Surgical Incision	Not explicitly stated as a numerical acceptance criterion, but the predicate device has a measured average particulate density of 1.1 particulate of 0.5 µm/f³. The subject device has the same reported value.	1.1 particulate of 0.5 µm/f³ (This matches the predicate device and implies equivalence).
Directed Airflow Coverage	Air flow intended to be directed parallel to the surgical site and/or instruments within: 20" (50 cm) in width, 47" (120 cm) in length and 15" (40 cm) in height. Device effectiveness may not be reliably detectable at a distance of 47 inches (120 cm) from the air flow outlet, and effectiveness depreciates beyond this specified area.	Smoke test and turbulence tests were conducted to demonstrate airflow patterns, but specific numerical data on coverage within the specified dimensions is not explicitly detailed in the provided text. However, the CFU reduction results within the clinical tests imply effective coverage.

Note: The primary acceptance criterion highlighted in the document for the expanded indications (Orthopedic and Neurosurgery) is the microorganism reduction to < 5 CFU/m³.

2. Sample Size and Data Provenance

Test Set Sample Size:
- Clinical tests (CFU measurements): 302 CFU measurements.
- Patients: 82 patients.
Data Provenance: The clinical tests were conducted in "Swedish Hospitals." The text does not specify if the data was retrospective or prospective, but clinical measurements for the purpose of regulatory submission are typically prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish ground truth or their qualifications for the clinical studies. Instead, the ground truth for microorganism levels (CFU) and particulate levels appears to be established through direct laboratory and clinical measurements conducted by the manufacturer.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method for the test set. The reported CFU values appear to be direct measurements rather than interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done using human readers with and without AI assistance. The device is an air-handling unit, not an imaging or diagnostic AI device that would typically involve human reader performance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done in a functional sense, as the device's performance was evaluated based on its ability to reduce particulate matter and microorganisms independently. The "Summary of testing" details non-clinical tests (particulate counting, CFU counting, air velocity, air leakage, smoke, turbulence tests) and clinical tests where the device's effect on CFU levels was measured. The device functions as an algorithm/machine for air purification.

7. Type of Ground Truth Used

Microorganism levels: Direct microbiological measurements (Colony Forming Units - CFU) at the surgical site and over instruments.
Particulate matter levels: Direct particulate counting measurements.
Airflow characteristics: Measured through air velocity tests, smoke tests, and turbulence tests.

8. Sample Size for the Training Set

The document does not mention a training set in the context of an AI/machine learning model. The Operio device is an air-handling apparatus, not a software algorithm that undergoes a "training" phase. Its design and performance are based on engineering principles and physical testing.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a "training set" for an AI/ML model, this question is not applicable to the Operio device. The device's performance is driven by its physical design, HEPA filtration, and airflow mechanics, validated through physical and microbiological measurements.

Summary

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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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Page 2 - Tomas Hansson

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

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Indications for Use

510(k) Number (if known) K173349

Device Name Operio

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submission information

Submission date:	12th of October 2017
510(k) submitter:	Tomas Hansson
	Toul Meditech ABTunbytorpsgatan 31721 37 Västerås, SwedenPhone: + 46 21 13 50 00Fax: + 46 21 13 86 45Email: 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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Device description

Indications for use

Summary of technological characteristics compared to predicate devices

The difference for the subject device compared to the predicate device is additional and extended claims in the indications. to include neurosurgery and orthopedic surgery. The subject device and predicate device is the same model and identical in technology and characteristics. The use with additional claims do not introduce any new hazards and test results can confirm that the subject device is safe and effective for use.

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Comparison table:

Characteristic	Subject device	Predicate device
	Operio	Operio K153498
Review Panel	General Hospital	General Hospital
Indications foruse	Operio is a portable device for use in asurgical operating environment thatproduces a directed, non-turbulentflow of air to the surgical site duringophthalmic, orthopedic and neurosurgery and to the sterile instrumentsused during surgery. The air flow fromthe device is HEPA-filtered to reducethe presence of particulate matter toreduce the microorganisms to a levelof < 5 CFU per m³ at the surgical siteand instruments.The air flow is intended to be directedparallel to the surgical site and/orinstruments within: 20" (50 cm) inwidth, 47" (120 cm) in length and 15"(40 cm) in height. Device effectivenessmay not be reliably detectable at adistance of 47 inches (120 cm) fromthe air flow outlet, and effectivenessdepreciates beyond this specified area.	Operio is a portable device for use in asurgical operating room that producesa directed, non-turbulent flow of air tothe surgical site during ophthalmicsurgery and to the sterile instrumentsused during surgery. The air flowfrom the device is HEPA-filtered toreduce the presence of particulatematter to reduce the microorganismsto a level of < 5 CFU per m³ at thesurgical site and instruments.The air flow is intended to be directedparallel to the surgical site and/orinstruments within: 20" (50 cm) inwidth, 47" (120 cm) in length and 15"(40 cm) in height. Deviceeffectiveness may not be reliablydetectable at a distance of 47 inches(120 cm) from the air flow outlet, andeffectiveness depreciates beyond thisspecified area.
PhysicalDimension	24 x 18 x 47-67 inches	24 x 18 x 47-67 inches
Weight	92 lb	92 lb
Material	Aluminium, powder coated steel, ABSplastic, stainless steel	Aluminium, powder coated steel,ABS plastic, stainless steel
ElectricalSpecifications	1. Mains power input: 120 V (AC), 60Hz2. Power consumption: 290 VA	1. Mains power input: 120 V (AC), 60Hz2. Power consumption: 290 VA
Type of device	Prescription use	Prescription use
Movability	Operio is a portable device	Operio is a portable device
Air filtration	HEPA filtered air with at least99.995% efficiency against 0.3 µmparticles	HEPA filtered air with at least99.995% efficiency against 0.3 µmparticles
HEPA filtermedia	Nelior membrane media.Folded sheets of nelior.	Nelior membrane media.Folded sheets of nelior.
Air inlet Pre-filter Media	Polyamide mesh	Polyamide mesh
Regularmaintenance	HEPA filter to be replaced after 2000hours/yearly.	HEPA filter to be replaced after 2000hours/yearly.
Airflow capacity	Airflow is 235 CFM	Airflow is 235 CFM
Efficiency	Bacteria carrying particles at thesurgical sites are 0.4, 2 and 0.52	Bacteria carrying particles at thesurgical site is 0.4 CFU/m3.
Airflow speed	0.4 m/s	0.4 m/s
Air volumedelivered toincision in CFM	Airflow over surgical site is 235 CFM	Airflow over surgical site is 235 CFM
Measuredaverageparticulatedensity atsurgical incision	1.1 particulate of 0.5 $ \mu $ m/f3	1.1 particulate of 0.5 $ \mu $ m/f3
Air flow position	Air flow is provided over the surgicalsite and instruments.	Air flow is provided over the surgicalsite and instruments.
Sterile accessory	Single-use sterile shield from ToulMeditech.	Single-use sterile shield from ToulMeditech.
SterilityAssurance (SAL)	10-6 SAL	10-6 SAL
SterilizationMethod	Gamma irradiation	Gamma irradiation

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Summary of testing

The performance characteristics of the air zone unit Operio have been obtained through both a series of tests, clinical and non-clinical, and performance specifications. Particulate test and CFU test results clearly meet the criteria for achieving reduction of airborne contamination at the intended surgical site and over instruments. The efficiency of HEPA filtration has been tested and is found to have an efficiency > 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.

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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 < 5 CFU it is concluded that substantial equivalence is achieved as clinical validation.

Conclusion

The conclusions drawn from the nonclinical and clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device (K153498).

Regulation Number and Section

§ 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.