The SafeAir Combi is an electrosurgical generator containing an integrated surgical smoke evacuator. The unit is intended to deliver high frequency energy for cutting and/or coagulating tissues using monopolar and bipolar tools in surgical procedures. When used with an electrosurgical pencil capable of surgical smoke evacuation, the console is also intended to remove and filtrate smoke generated during electrosurgical procedures.

Device Description

SafeAir Combi (model: SFR-Combi-US) is an electrosurgical generator with the added functionality of smoke evacuation. This device is a non-sterile medical device, indicated to be used in operating theatres for use during general surgical procedures. SafeAir Combi uses 5 different output modes: 2 cut modes (Pure and Blend), 2 coagulation modes (Fulguration and Spray) and 1 mode for bipolar accessories. The device operates with a power range of 5-200 Watts for cut modes, 5-120 Watts for coagulation modes and 5-100 Watts for the bipolar mode. The device is intended to be used as a system together with monopolar or bipolar active accessories with a neutral electrode, however this submission is only intended to cover the electrosurgical generator and smoke evacuation feature and dedicated footswitch, without any active surgical accessories. Device is intended to be operated by healthcare professionals in hospitals and clinics where electrosurgical procedures are typically performed.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the SafeAir combi (SFR-combi-US) device based on the provided text, where available:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list a table of acceptance criteria with numerical targets. Instead, it refers to general performance testing and compliance with standards. However, it does provide a detailed comparison with predicate and reference devices, highlighting several operational characteristics and their similarity/difference. I'll construct a table based on the comparative performance characteristics mentioned and the implied "acceptance" of substantial equivalence.

Feature / Criteria (Implied)	Acceptance Criteria (Implied from Predicate/Reference)	Reported Device Performance (SafeAir combi)	Comparison
Electrosurgical Performance
Output Modes (MONOPOLAR Cut)	3 Different CUT modes, including Pure (300W max, 300 Ohm, CF 1.5, 390 kHz) and Blend (200W max, 300 Ohm, CF 2.5, 390 kHz) (Predicate)	2 Different CUT modes: Pure (200 W max, 400 Ω, CF 1.5, 472 kHz) Blend (200 W max, 400 Ω, CF 2.1, 472 kHz)	Different
Output Modes (MONOPOLAR Coag)	4 Different COAG Modes, including Fulgurate (120W max, 500 Ohm, CF 7.0, 470 kHz) and Spray (120W max, 500 Ohm, CF 8.0, 470 kHz) (Predicate)	2 Different COAG modes: Fulg (120 W max, 400 Ω, CF 6.6, 472 kHz) Spray (120 W max, 400 Ω, CF 7.5, 472 kHz)	Different
Output Modes (BIPOLAR)	3 Different BiPolar modes, including Standard (70W max, 100 Ohms, CF 1.5, 470 kHz) (Predicate)	BIPOLAR: 100 W max, 100 Ω, CF 1.6, 472 kHz	Different
CQM (Resist. Range)	5 to 135 Ohms, or up to 40% increase in initial contact resistance (Predicate)	10 to 130 Ohms, or up to 30% increase in initial contact resistance (whichever is less)	Different
Instant response technology	Automatically senses resistance and adjusts output voltage to maintain consistent effect (Predicate)	Automatically senses resistance and adjusts output voltage to maintain consistent effect	Similar
Power ON self diagnostics	Alarm sounds and number displayed on front panel if system alarm conditions (Predicate)	Self testing procedure on ON/OFF, alarms presented on screen if problems, generator cannot be activated	Similar
Smoke Evacuation Performance
Filtration rate	ULPA filter is 99.999% with efficiency at 0.1 microns (Reference)	ULPA filter is 99.999% with efficiency at 0.1 microns	Identical to reference device
Filter Life	5 hours (Reference)	5 hours	Identical to reference device
Levels of smoke evacuation	10 levels (Reference)	10 levels	Identical to reference device
Levels of smoke evacuation stop delay	10 levels (Reference)	10 levels	Identical to reference device
Maximum flow rate at filter (claimed in IFU)	110 l/min (Reference)	110 l/min	Identical to reference device
Maximum flow rate measured on pencil tip	97.8 l/min (Reference)	94.2 l/min	Similar to reference device
Electrical Safety/EMC	Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2	Device demonstrated appropriate electrical safety and electromagnetic compatibility profile	Met (Implied)
General Performance	Safety & Effectiveness comparable to predicate device	Design Verification and Validation confirmed device meets specifications and performs as intended	Met (Implied)

2. Sample size used for the test set and the data provenance

The document does not specify the precise sample sizes for each performance test. It mentions "Comparative performance testing" and "Design Verification and Validation activities".

The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective in terms of comparing the device against established predicate and reference device characteristics and regulatory standards. The testing itself would have been prospective (conducted specifically for this submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The testing described focuses on engineering and functional performance (e.g., electrical safety, thermal effects, smoke evacuation flow rates) rather than clinical diagnostic accuracy requiring ground truth established by medical experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable as the studies described are technical performance tests, not clinical studies requiring expert adjudication of outcomes.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not conducted. The device is an electrosurgical generator with smoke evacuation, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is hardware (electrosurgical generator and smoke evacuator), not a standalone algorithm. Its performance is inherent in its operation and is evaluated through bench testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the test set predominantly relies on:

Engineering specifications and regulatory standards: For electrical safety and EMC (IEC 60601 series).
Physical measurements: For factors like power output, flow rates, filtration efficiency.
Comparison to predicate/reference device characteristics: For functional aspects and parameter ranges.
FDA Guidance: "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" for specific tests like thermal effects on tissue and ESU performance.

8. The sample size for the training set

This is not applicable. The SafeAir combi is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set for this device.

Summary

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April 26, 2023

LiNA Medical ApS % Scott Blood Director of Regulatory Services MEDIcept. Inc. 200 Homer Ave Ashland, Massachusetts 01721

Re: K223932

Trade/Device Name: SafeAir combi (SFR-combi-US) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, FYD Dated: December 28, 2022 Received: March 30, 2022

Dear Scott Blood:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Mark Mark Trumbore -S Date: 2023.04.26 14:06:27 Trumbore -S -04'00 Mark Trumbore, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K223992

Device Name

SafeAir combi (SFR-combi-US)

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Date:

Company:

April 26, 2023

LiNA Medical ApS Formervangen 5 DK-2600 Glostrup, Denmark Jarosław Mrówczyński Regulatory Affairs Manager Email: imr@lina-medical.com Office number: +48 61 222 21 21

Official Contact:

Scott Blood Director of Regulatory Services MEDIcept Inc. 200 Homer Avenue Ashland, MA 01721 Email: SBlood@medicept.com Office number: +1 978-729-5978

Proprietary or Trade Name: SafeAir combi

Common/Usual Name:	Electrosurgical cutting and coagulation device and accessories
Classification Name:	Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number:	21 CFR 878.4400, Class IIClassification Product Code: GEI, FYD
Predicate Device:Reference Predicate:	K143161: Covidien Force FX GeneratorsK182224: LiNA Medical Smoke Evacuator compact

Device Description:

Formervangen 5

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Indications for Use:

The SafeAir Combi generator is an electrosurgical generator containing an integrated surgical smoke evacuator. The unit is intended to deliver high frequency energy for cutting and/or coagulating tissues using monopolar and bipolar tools in surgical procedures. When used with an electrosurgical pencil capable of surgical smoke evacuation, the console is also intended to remove and filtrate smoke generated during electrosurgical procedures.

Substantial Equivalence:

	Subject DeviceLiNA Medical	Predicate DeviceCovidien	Reference deviceLiNA Medical	Comparison
	SafeAir Combi	Force FX Generators	SafeAir SmokeEvacuator compact
	This Submission	K143161	K182224
Indications forUse	The SafeAir Combi generatoris an electrosurgical generatorcontaining an integratedsurgical smoke evacuator. Theunit is intended to deliver highfrequency energy for cuttingand/or coagulating tissuesusing monopolar and bipolartools in surgical procedures.When used with anelectrosurgical pencil capableof surgical smoke evacuation,the console is also intended toremove and filtrate smokegenerated duringelectrosurgical procedures	The Force FX™ElectrosurgicalGenerator is anelectrosurgicalgenerator containingmonopolar and bipolartechnology. It isintended for use withaccessories duringsurgical procedureswhere the surgeonrequires electrosurgicalcutting (resecting,dividing, or separating)and coagulating(hemostasis).	SafeAir Smoke Evacuatorcompact is designed toremove and filter smokegenerated duringelectrosurgical and laserprocedures.	Same withpredicate device,reference device
	Subject DeviceLiNA MedicalSafeAir CombiThis Submission	Predicate DeviceCovidienForce FX GeneratorsK143161	Reference deviceLiNA MedicalSafeAir SmokeEvacuator compactK182224	Comparison
Input power	110 - 230 V, 50-60 Hz	100 - 240 V, 50-60 Hz	100-120V/220-240V,50Hz/60Hz	Similar
Energy output	HF energy for electrosurgery	HF energy forelectrosurgery	Not applicable	Identical
Dimensions andweight	17 x 40 x 40 cm, 22 kg	11 x 35.6 x 35.6 cm, 8.2kg	14 x 30 x 38, 13.5 kg	Different
Workingconditions	Temperature: 10 to 35 °CRelative Humidity: 15-75%,non-condensingAtmospheric Pressure: 800 to1060 hPa	Temperature: 10 to 40°CRelative Humidity: 30-75%Atmospheric Pressure:700 to 1060 hPa	Temperature: 10 to 35 °CRelative Humidity: 30%-75%, non-condensingAtmospheric Pressure: n/a	Similar
Transport andstorage	Circumstance Temperature: -10°C to +60°CRelative Humidity: 10% to90%Atmospheric Pressure: 500 to1060 hPa	CircumstanceTemperature: -40 to +70°CRelative Humidity: 25-85 %Atmospheric Pressure:500 to 1060 hPa	CircumstanceTemperature: -10 to 60 oCRelative Humidity: 25-85% non-condensingAtmospheric Pressure: n/a	Similar
Display	One LCD touchscreen min. 7inch diagonal	No touchscreen, buttonsfor power settings	No touchscreen, buttonsfor power settings	Different
Electricalprotective class	Class I	Class I	Class I	Identical
Duty cycle	25% on max power (10sactivation and 30s off)	25% on max power (10sactivation and 30s off)	Not applicable	Identical
CQM	Acceptable resistance range(for monopolar activation):- 10 to 130 Ohms- or up to a 30% increase in theinitial measured contactresistance(whichever is less)	Acceptable resistancerange (for monopolaractivation):- 5 to 135 Ohms- or up to a 40%increase in the initialmeasured contactresistance(whichever is less)	Not applicable	Different
Monopolar	ESU generator connects itselectrosurgical accessories anda neutral ESU pad to form acyclic circuit, the HF currentgenerated from the generatorand through the accessory toachieve CUT or COAG, andthen return to generator by theneutral pad.	ESU generator connectsits electrosurgicalaccessories and aneutral ESU pad toform a cyclic circuit, theHF current generatedfrom the generator andthrough the accessory toachieve CUT or COAG,and then return togenerator by the neutralpad.	Not applicable	Identical
Bipolar	HF current generated from thegenerator and the cyclic circuitformed between the two tips ofthe bipolar forceps, the HFpower through the two tips towork on patient obtainingCOAG, no need extra ESUpad.	HF current generatedfrom the generator andthe cyclic circuit formedbetween the two tips ofthe bipolar forceps, theHF power through thetwo tips to work onpatient obtainingCOAG, no need extraESU pad.	Not applicable	Identical
Subject DeviceLiNA MedicalSafeAir CombiThis Submission	Predicate DeviceCovidienForce FX GeneratorsK143161	Reference deviceLiNA MedicalSafeAir SmokeEvacuator compactK182224	Comparison
Output modeMONOPOLAR	2 Different CUT modesCUT Pure:- Power: 200 W max,- Rated load (max): 400 Ω,- Crest factor: 1.5- Frequency: 472 kHzCUT Blend:- Power: 200 W max,- Rated load (max): 400 Ω,- Crest factor: 2.1- Frequency: 472 kHz	3 Different CUT modesincludingCUT Pure withfollowing parameters:- Power: 300W max- Rated load: 300 Ohm- Crest Factor: 1.5- Frequency: 390 kHzand CUT Blend withfollowing parameters:- Power: 200W max- Rated load: 300 Ohm- Crest Factor: 2.5- Frequency: 390 kHz	Not applicable	Different
	2 Different COAG modesCOAG Fulg:- Power: 120 W max,- Rated load (max): 400 Ω,- Crest factor: 6.6- Frequency: 472 kHzCOAG Spray:- Power: 120 W max,- Rated load (max): 400 Ω,- Crest factor: 7.5- Frequency: 472 kHz	4 Different COAGModes, includingCOAG Fulgurate withfollowing parameters:- Power: 120W max- Rated load: 500 Ohm- Crest Factor: 7.0- Frequency: 470 kHzCOAG Spray withfollowing parameters:- Power: 120W max- Rated load: 500 Ohm- Crest Factor: 8.0- Frequency: 470 kHz	Not applicable
Output mode –Bipolar	BIPOLAR:- Power: 100 W max,- Rated load (max): 100 Ω,- Crest factor: 1.6- Frequency: 472 kHz	3 Different BiPolarmodes, includingBIPOLAR Standardwith followingparameters:- Power: 70W max- Rated load: 100 Ohms- Crest factor: 1.5- Frequency: 470 kHz	Not applicable	Different
Instant responsetechnology	Automatically senses resistanceand adjusts the output voltageto maintain a consistent effectacross different tissue density	Automatically sensesresistance and adjuststhe output voltage tomaintain a consistenteffect across differenttissue density	Not applicable	Similar
Power ON selfdiagnostics	After pressing ON/OFF button,device initiates self testingprocedure, which verifiescorrect functioning of thedevice. If problems occur, thenalarm condition is highlightedon screen, and generator cannotbe activated.	When the generatorsenses a system alarmconditions, an alarmsounds and an alarmnumber is displayed onthe front panel. Asystem alarm conditiondeactivates the	Not applicable	Similar
	Subject DeviceLiNA MedicalSafeAir CombiThis Submission	Predicate DeviceCovidienForce FX GeneratorsK143161	Reference deviceLiNA MedicalSafeAir SmokeEvacuator compactK182224	Comparison
Filtration rate	The ULPA filter is 99.999%with efficiency at 0.1 micronsparticle size, SFR-FIL-C filter	Not applicable	The ULPA filter is99.999% with efficiencyat 0.1 microns particlesize, SFR-FIL-C filter	Identical toreference device
Filter Life	5 hours	Not applicable	5 hours	Identical toreference device
Levels of smokeevacuation	10 levels	Not applicable	10 levels	Identical toreference device
Levels of smokeevacuation stopdelay	10 levels	Not applicable	10 levels	Identical toreference device
Maximum flowrate at filter(claimed in IFU)	110 l/min	Not applicable	110 l/min	Identical toreference device
Maximum flowrate measured onpencil tip	94,2 l/min	Not applicable	97,8 l/min	Similar toreference device

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· www.lina-medical.com

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From the comparison above, the subject device and predicate device have similar intended use, are both prescription use, and have the same operating principle. The differences in the devices have been assessed and do not raise new questions of safety or effectiveness.

Non-clinical performance testing:

Electrical Safety:

Electrical safety and electromagnetic compatibility testing were conducted in accordance with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-2 to demonstrate the basic safety, essential performance and emissions and immunity characteristics of the device. The testing demonstrated the appropriate electrical safety and electromagnetic compatibility profile for the device.

Bench / Performance Testing:

Comparative performance testing included:

Human factors testing
Transportation simulation
Smoke evacuation functionality
Testing in accordance with FDA Guidance "Premarket Notification (510(k)) Submissions ● for Electrosurgical Devices for General Surgery"
- Thermal effects on tissue 0
- ESU performance O
- COM functionality ol
- Accessories compatibility O

The results demonstrated that the device performance was met and was substantially equivalent to the predicate device.

Substantial Equivalence Conclusion

LiNA Medical AnS

· Formervangen 5

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The subject device and predicate device are intended to deliver high frequency energy for cutting and/or coagulating tissues using monopolar and bipolar tools in surgical procedures. The smoke evacuation function is not a novel feature and there are several cleared devices already used in the US today. Smoke evacuation is recommended to be used in clinical procedures such as electrosurgery in which tissue smoke plume and aerosols can be generated due to concerns about potential carcinogenic effects.

The technological characteristics between the subject and predicate devices are in most cases identical, for those cases where they are similar or different, those differences have been properly tested and evaluated. Design Verification and Validation activities carried out on the SafeAir combi device confirms that device meets specification and performs as intended.

Based on above comparison and discussion, the SafeAir Combi is deemed as safe and effective as and substantially equivalent to the predicate device.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.