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 < 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 an analysis of the acceptance criteria and study details for the Operio device, based on the provided document:

Acceptance Criteria and Device Performance for Operio

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Device Performance (Operio)
Microorganisms at Surgical Site & Instruments: < 5 CFU per m³	0.4 CFU/m³ (clinical environment, mean value)
Particulate Matter (0.5 µm/f³): Reduction in comparison to predicate device	1.1 particles of 0.5 µm/f³ (compared to 68,122 particles of 0.5 µm/f³ for predicate)
HEPA Filtration Efficiency: At least 99.97% against 0.3 µm particles	At least 99.995% against 0.3 µm particles
Airflow Coverage (Width): 20" (50 cm)	Not explicitly stated if tested independently, but the indication mentions this as the intended directed flow area.
Airflow Coverage (Length): 47" (120 cm)	Not explicitly stated if tested independently, but the indication mentions this as the intended directed flow area, with effectiveness depreciating beyond.
Airflow Coverage (Height): 15" (40 cm)	Not explicitly stated if tested independently, but the indication mentions this as the intended directed flow area.

2. Sample Sizes and Data Provenance

Test Set (Clinical): 31 samples from 23 patients.
Data Provenance: Clinical tests were carried out in a Swedish University Hospital. The data is prospective as it's stated "measurements were made near the surgical site and over the instruments."

3. Number of Experts and their Qualifications for Ground Truth

The document does not explicitly state the number of experts used to establish ground truth or their qualifications. The clinical tests were performed in a "Swedish University Hospital," suggesting medical professionals were involved in the procedures and data collection, but their specific roles in ground truth establishment for the microbial and particulate counts are not detailed.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for the clinical test set (e.g., 2+1, 3+1, none). The CFU and particulate counting results are presented as measured values.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on the device's performance in reducing airborne contamination, not on evaluating human reader improvement with or without AI assistance. This device is an air-handling apparatus, not an AI diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done for the device itself. The clinical and non-clinical tests evaluate the device's capability to clean the air and reduce microorganisms and particulates without human intervention in the purification process itself. The "algorithm" here refers to the device's mechanical and filtration processes.

7. Type of Ground Truth Used

The ground truth used was based on direct measurements of:

Colony Forming Units (CFU): Indicative of microbial load.
Particulate counts: Indicative of particulate matter.
These are direct, empirical measurements taken from the environment.

8. Sample Size for the Training Set

The document does not mention a training set as this is a physical device, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" of the device is inherent in its engineering and design, validated by the tests described.

9. How Ground Truth for the Training Set was Established

Not applicable, as this device does not utilize a training set in the context of machine learning. The "ground truth" for the device's design and operational parameters would be based on engineering specifications, regulatory standards for air quality, and previous research on surgical site infection prevention.

Summary

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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)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

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:	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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Device description

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

Difference from predicate device:

The air zone unit Operio is suitable for ophthalmic surgery and sterile instruments used during surgery. It is possible to deliver the clean air without coming into contact with the patient or compromising the work space required by surgical staff. The clean air flow can also be used over instruments and the area of the air flow is bigger compared to the predicate device.

The difference in indications for use compared to the predicate device does not introduce any new hazards and test results can confirm that the subject device is as safe and as effective for use.

Summary of technological characteristics compared to predicate devices

The subject device Operio differs from the predicate device in that it doesn't use a sterile nozzle and device does not depend on attachment to the patient. The subject device requires a single use sterile shield which functions as an equipment cover as well as to direct the non-turbulent flow to the surgical site. The sterile shield is attached to the unit and is not in contact with the patient.

To eliminate contaminated particles entering the surgical site, HEPA filtration is used by both the predicate device and the subject device. The efficiency of HEPA filtration of the subject

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device has a higher precision than the predicate device (subject device guarantees 99.995 % compared to 99.97 % for the predicate device).

Comparison table:
-------------------	--

Characteristic	Subject device	Predicate device
Review Panel	General Hospital	General Hospital
Indications for use	Operio is a portable device foruse in a surgical operating roomthat produces a directed, non-turbulent flow of air to thesurgical site during ophthalmicsurgery and to the sterileinstruments used during surgery.The air flow from the device isHEPA-filtered to reduce thepresence of particulate matter toreduce the microorganisms to alevel of < 5 CFU per m3 at thesurgical site and instruments.The air flow is intended to bedirected parallel to the surgicalsite and/or instruments within:20" (50 cm) in width, 47" (120cm) in length and 15" (40 cm) inheight. Device effectiveness maynot be reliably detectable at adistance of 47 inches (120 cm)from the air flow outlet, andeffectiveness depreciates beyondthis specified area.	The Air Barriers system is aportable device for use in asurgical operating room thatproduces a directed, non-turbulentflow of air to the surgical site. Theair flow from the device is HEPA-filtered to reduce the presence ofparticulate matter andmicroorganisms at the surgicalsite during hip arthroplasty andposterior vertebral fusion andlaminoplasty.The ABS Nozzle is intended to beused only where: (1) it can beplaced on an anatomical surfacewith no gap between the bottomof the nozzle and the surface, (2)the incision plane is parallel withthe direction of air flow, and (3)the Incision dimensions arewithin: 6' (15.2 cm) in width and20b (50.8 cm) in length. Deviceeffectiveness may not be reliablydetectable at a distance of 20inches from the Nozzle, andeffectiveness depreciates beyondthis specified area.
PhysicalDimension	24 x 18 x 47-67 inches	11 x 11 x 25 inches
Weight	92 lb	48 lb
Material	Aluminium, powder coatedsteel, ABS plastic, stainless steel	Stainless steel
ElectricalSpecifications	1. Mains power input: 120 V(AC), 60 Hz2. Power consumption: 290 VA	1. Mains power input: 120 V (AC),60 Hz2. Unknown
Type of device	Prescription use	Prescription use
Movability	Operio is a portable unit.	The Air Barrier System is aportable unit.

Air filtration	HEPA filtered air with at least99.995% efficiency against 0.3 µm particles	HEPA filtered air with at least99.97% efficiency against 0.3 µm particles
HEPA filtermedia	Nelior membrane media.Folded sheets of nelior.	Continuous pleated glassmicrofiber
Air inlet Pre-filterMedia	Polyamide mesh	Polyurethane Foam
Regularmaintenance	HEPA filter to be replaced after2000 hours/yearly.	Annual
Airflow capacity	Airflow is 235 CFM (400 m3/h)	Airflow 150 CFM
Efficiency	Bacteria carrying particles at thesurgical site is 0.4 CFU/m3.	Bacteria carrying particles in thesurgical incision is 1.57 CFU/m3
Air volumedelivered toincision in CFM	Airflow over surgical site is 235CFM (400 m3/h)	41
Measuredaverageparticulatedensity atsurgical incision	1.1 particulate of 0.5 µm/f³	68,122 particulate of 0.5 µm/f³
Air flow position	Air flow is provided over thesurgical site and instruments. Noattachment to the patient isnecessary.	Air flow is provided to anattachment, nozzle, attached on thepatient near the surgical site.
Sterilization	Single-use sterile shield.	Sterile single use.
SterilityAssurance (SAL)	10-6 SAL	10-6 SAL
SterilizationMethod	Gamma irradiation	ETO

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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 better than the predicate device.

In testing, the predicate demonstrated a level of particulate presence by 68,122 particles of 0.5 um/f³, while the subject device had a level of particulates by 1.1 particles of 0.5 µm/f3.

The predicate device demonstrated a reduction from 10.73 to 1.60 CFU's whereas the subject device demonstrated a reduction from 48.2 to 0.4 CFU in a clinical environment.

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.

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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

Summary of clinical testing

Clinical tests have been carried out in surgical procedures such as Ophthalmology. Measurements where made near the surgical site and over the instruments where the results demonstrated a statistically significant reduction in CFU levels as well as particulates. The CFU value is based on 31 samples from 23 patients. The clinical tests have been carried out in a Swedish University Hospital. As a mean value, the subject device had a CFU counting of 0.4. For particulate counting, the subject device had a mean value of 1.1 particles of 0.5 um/f3.

Since both particulate counts and CFU level doesn't exceed the predicate device in a clinical environment it is concluded that substantial equivalence is achieved as clinical validation.

Conclusion

Based on a comparison of the performance characteristics, the tests performed, clinical and nonclinical, it is concluded that the subject device Operio is substantially equivalent to the predicate device and therefore is as safe and as effective.

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.