SafeAir Smoke Pencil. is designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

Device Description

The SafeAir Smoke Pencil is a sterile single use integrated electrosurgical pencil and smoke evacuation handpiece. The device is designed for general electrosurgical applications and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The integration of the electrosurgical pencil and smoke evacuation enables the operator to activate an electrosurgical current as well as capture the smoke plume simultaneously. The device is constructed of similar materials and design specifications as the predicate electrosurgical devices. The SafeAir Smoke Pencil combines the functions of electrosurgery and smoke evacuation into a single handpiece. The smoke evacuation orifice is located less than 1 cm from the electrosurgical blade to provide optimal smoke removal during cauterization. The smoke evacuation suction sleeve is adjustable to optimize the distance to the tip of the electrosurgical blade. As with the predicate GoldVac, the SafeAir Smoke Pencil is available in two (2) activation switch configurations, a rocker style and a push button style, which activate monopolar cut or coagulate functions. The device is connected to tubing using a dual connector to allow the user to connect to a variety of smoke evacuation systems including filtration or central vacuum systems, thus minimizing exposure of personnel to the surgical smoke plume. The device will be packaged singly for sterile distribution.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the SafeAir Smoke Pencil, an electrosurgical pencil with integrated smoke evacuation. The primary goal of this submission is to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SafeAir Smoke Pencil are implied by its claim of substantial equivalence to predicate devices. This means its performance characteristics (electrosurgical function and smoke evacuation capability) should be comparable to or not adversely different from the predicate devices.

Acceptance Criteria Category	Details (Implied from Substantial Equivalence Claims)	SafeAir Smoke Pencil Reported Performance
Electrosurgical Function (Cutting/Coagulation)	The device should effectively perform cutting and coagulation, similar to predicate electrosurgical pencils. This implies delivering appropriate electrical current to achieve the desired surgical effect without compromising safety.	"The LiNA SafeAir Smoke Pencil has been shown to perform as intended with the equivalent results as the predicate devices through simulated tissue cauterization and cutting functions.... The suction sleeve or intake portion of the device has been designed to not impede the electrosurgical function of the pencil...**" (Section 9)
Smoke Evacuation Effectiveness	The device should effectively remove surgical smoke generated during electrosurgery without impeding the electrosurgical function. The volume of air removed and the size of the smoke evacuation orifice should be similar to predicate devices. The smoke evacuation system should minimize exposure to the surgical team and patient.	"The SafeAir Smoke Pencil removes a similar volume of air and has a similar sized smoke evacuation orifice as the referenced predicate devices. The SafeAir Smoke Pencil smoke evacuation system is effective in removing smoke generated during the electrosurgery process." (Section 6) "No particular requirements specific to the smoke performance exist in the standards but tests conducted with the device have shown no effect or changes to function of the electrosurgical pencil. The suction sleeve or intake portion of the device has been designed to not impede the electrosurgical function of the pencil and provides intake of the surgical smoke for filtering." (Section 9)
Biocompatibility	Patient-contacting materials should be biocompatible, meeting ISO 10993 standards.	"Complies with ISO 10993 Yes." (Table in Section 8)
Electrical Safety and EMC	The device must meet electrical safety and electromagnetic compatibility (EMC) standards, specifically IEC 60601-1 and IEC 60601-2-2.	"Complies with IEC 60601-1 Yes." and "Complies with IEC 60601-2-2 Yes." (Table in Section 8) "The verification and validation testing of the device electrical safety and EMC testing of the device was found to acceptable and supports the claims of substantial equivalence." (Section 11)
Material Equivalence	Materials used for key components (handpiece housing, electrode, suction sleeve) should be the same or sufficiently similar to those used in predicate devices.	"The LiNA SafeAir Smoke Pencil and all predicate devices use polystyrene for the handpiece housing. The SafeAir Smoke Pencil and all the predicate devices use stainless steel for the electrode material. The predicate devices use either polycarbonate or polystyrene, as with the SafeAir Smoke Pencil, for the suction sleeve." (Section 10)
Sterilization	The device must be provided sterile and maintain sterility until use. The sterilization method should be validated.	"Sterile Processing: Ethylene Oxide" (Table in Section 8)

Study Information

Sample size used for the test set and the data provenance:
- The document describes non-clinical testing on Simulated Tissue. The specific sample size for this testing is not provided.
- The testing was performed by "LiNA Medical ApS" (the sponsor), which is a Danish company, suggesting the data provenance is likely European, possibly Danish, although no explicit country of origin is stated for the test data itself.
- The study is a prospective test in the sense that the testing was conducted specifically for this 510(k) submission to demonstrate performance of the new device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the testing was non-clinical and conducted on simulated tissue. There was no ground truth that needed to be established by human experts in the context of diagnostic interpretation. The ground truth was based on physical measurements of electrosurgical effect and smoke evacuation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable as the testing was non-clinical and did not involve human interpretation or adjudication of results in the traditional sense. Performance was evaluated based on objective measurements and compliance with engineering standards.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a surgical tool, not an AI-assisted diagnostic device, so such a study would not be relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, standalone performance testing was done. The document states: "The LiNA SafeAir Smoke Pencil has been shown to perform as intended with the equivalent results as the predicate devices through simulated tissue cauterization and cutting functions... The SafeAir Smoke Pencil passed all testing and results were consistent with the intended use of the device." (Section 9 & 10) This refers to the physical and functional performance of the device itself, without human-in-the-loop performance in the sense of a diagnostic interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the non-clinical performance testing was based on engineering and performance metrics for electrosurgical cutting and coagulation effectiveness, smoke evacuation capability (e.g., airflow, smoke capture), and compliance with international standards (ISO 10993, IEC 60601-1, IEC 60601-2-2). It's essentially "physical proof" that the device performs its intended functions and meets safety standards, rather than a diagnostic ground truth.
The sample size for the training set:
- Not applicable. This device does not involve AI or machine learning algorithms that would require a training set.
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an algorithm, there is no ground truth for a training set to be established.

Summary

{0}------------------------------------------------

K120454

Section 5 - 510(k) Summary for SafeAir Smoke Pencil

DEC

1. Submission Sponsor

LiNA Medical ApS Formervangen 5 2600 Glostrup Denmark Phone: +45 4329 6666 Fax: +45 4329 6699 Contact: Louisa Memborg, Regulatory Affairs Officer

Submission Correspondent

Emergo Group 611 West 5th Street, Third Floor Austin, TX 78701 Cell Phone: (406) 579.8124 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Rick Gillis, Ph.D., Senior Consultant Email: project.management@emergogroup.com

Date Prepared 10 February 2012
Device Name

Trade/Proprietary Name: SafeAir Smoke Pencil Common/Usual Name: Electrosurgical Pencil Accessory for Surgical Smoke Evacuation Classification Name: Electrosurgical Cutting and Coagulation Device and accessories Classification Regulation: 21 CFR 878.4400 Classification Panel: 878.4400 Product Code: GEI Device Class: Class II

5. Predicate Devices

Plumepen™ Smoke Evacuation Electrosurgical Pencil; K103375 GoldVac™ Smoke Evacuation Pencil; K961616 The PenEvac™ - Multifunctional ESU Pencil with telescopic Electrodes; K081634

{1}------------------------------------------------

ર. Device Description

The integration of the electrosurgical pencil and smoke evacuation enables the operator to activate an electrosurgical current as well as capture the smoke plume simultaneously. Surgical smoke produced from electrosurgery has been shown to contain viable viruses, bacteria, blood, blood fragment, carcinogens and ultra-fine particles. The amount, content and particulate size of smoke plume can vary depending on the type of procedure and surgical technique. The mutagen and carcinogen potential of smoke has been demonstrated on animal models. The effect on patients and operating room personnel can be extrapolated from the potentially harmful nature of these components. Depending on the type of tissue ablated, the inhalation hazard of electrosurgery smoke has been found to be similar to that of unfiltered cigarette smoke. Viral transmission through laser surgery smoke has been shown to occur in rare cases, and has thus changed standard practices to omit the use of these types of devices when excising viral lesions. Although this viral transmission was documented during laser surgery, surgical smoke generated from laser surgery and electrosurgery has been shown to be of similar composition and therefore could pose similar risk.

The Occupational Safety and Health Administration and the National Institute for Occupational Safety and Health have published evidence-based statements supporting the use of smoke evacuation practices. SafeAir Smoke Pencil is designed to evacuate surgical smoke at the source of emission to minimize exposure to the patient and surgical team. As with the predicate devices, the intent of the smoke evacuation system is to remove potentially harmful surgical smoke from the surgical site. The SafeAir Smoke Pencil removes a similar volume of air and has a similar sized smoke evacuation orifice as the referenced predicate devices. The SafeAir Smoke Pencil smoke evacuation system is effective in removing smoke generated during the electrosurgery process.

The device is constructed of similar materials and design specifications as the predicate electrosurgical devices. The SafeAir Smoke Pencil combines the functions of electrosurgery and smoke evacuation into a single handpiece. The smoke evacuation orifice is located less than 1 cm from the electrosurgical blade to provide optimal smoke removal during cauterization. Studies have shown that removal of surgical smoke is most effective within 2 cm from the generation point. The smoke evacuation suction sleeve is adjustable to optimize the distance to the tip of the electrosurgical blade. As with the predicate GoldVac, the SafeAir Smoke Pencil is available in two (2) activation switch configurations, a rocker style and a push button style, which activate monopolar cut or coagulate functions. The device is connected to tubing using a dual connector to allow the user to connect to a variety of smoke evacuation systems including filtration or central vacuum systems, thus minimizing exposure of personnel to the surgical smoke plume. The device will be packaged singly for sterile distribution.

7. Intended Use

SafeAir Smoke Pencil. is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with

{2}------------------------------------------------

LINA Medical

Traditional 510(k) Premarket Submission SafeAir Smoke Pencil

an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

8. Technological Characteristics and Substantial Equivalence

Substantial equivalence is based on three (3) predicate devices. The aforementioned referenced predicates are Electrosurgical Cutting and Coagulation Devices and Accessories; and Air-handling apparatus for a surgical operating room as defined in 21 CFR 878.4400 and 21 CFR 878.5070 respectively.

The LiNA SafeAir Smoke Pencil is an integration of two technologies, electrosurgery and smoke evacuation, previously cleared for use in predicate devices into a single device. The main difference from an independent electrosurgical handpiece is the incorporation of a smoke capture channel into the main body. The transparent suction sleeve is designed to be placed in a variety of positions, extended near the tip of the electrode for maximum smoke capture or retracted for maximum accessibility and visibility.

The tubing is highly flexible and houses device wiring within the smoke capture tubing for ease of use and decreased entanglement. The LiNA SafeAir Smoke Pencil is designed to be used in hospitals, operating room theaters and requires physician's prescription for use.

The LiNA SafeAir Smoke Pencil is equivalent in operational characteristics to the predicate devices; cut, coagulate, and smoke evacuation remain contained in one device. Like the predicate devices. the SafeAir Smoke Pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the target tissue for the desired surgical effect.

Manufacturer	LINA Medical ApS	Medtek Devices, Inc.	I.C. Medical, Inc.	ConMed Corporation
Trade Name	SafeAir Smoke Pencil	Predicate, PlumePen	Predicate, PenEvac	Predicate, GoldVac
510(k) Number	Not Assigned	K103375	K961616	K081634
Product Code	GEI	GEI	GEI	GEI
RegulationNumber	21 CFR 878.4400	21 CFR 878.4400	21 CFR 878.4400	21 CFR 878.4400
RegulationName	ElectrosurgicalCutting andCoagulationDevice andaccessories	ElectrosurgicalCutting andCoagulationDevice andaccessories	ElectrosurgicalCutting andCoagulationDevice andaccessories	ElectrosurgicalCutting andCoagulationDevice andaccessories
Indications foruse	The SafeAir SmokePencil is designed forgeneral electrosurgicalapplications and forremoving smokegenerated byelectrosurgery whenused in conjunction	The Plumepen isdesigned for generalelectrosurgicalapplications, includingcutting andcoagulation, and forremoving smokegenerated by	The TelescopingPenEvac is amultifunctionalheadpiece that ismeant to provide thefollowing optionalfunctions: monopolarelectrode handpiece in	The ConMed GoldVacpencils, when usedwith an effectivesmoke evacuationsystem, removessmoke plume from thesurgical site. The pencilenables the operator

	with an effectivesmoke evacuationsystem. The pencilenables the operatorto remotely conduct anelectrosurgical currentfrom the outputconnector of anelectrosurgical unit tothe operative site forthe desired surgicaleffect.	electrosurgery whenused in conjunctionwith an effectivesmoke evacuationsystem. The pencilenables the operator toremotely conduct anelectrosurgical currentfrom the outputconnector of anelectrosurgical unit tothe operative site forthe desired surgical	an electrosurgerygenerator system,suction, irrigation, andto facilitate theremoval of smokegenerated during theprocedure.	to remotely conduct anelectrosurgical currentfrom the outputconnector of anelectrosurgical unit tothe operative site forthe desired surgicaleffect
		effect.
OperationFunctionSwitches	button labelledyellow and proximal toelectrode; buttonlabelled blue and distalto electrode	button yellowand proximal toelectrode; button blueand distal to electrode	button yellowand proximal toelectrode; button blueand distal to electrode	button yellowand proximal toelectrode; button blueand distal to electrode
Function Switchconfigurationsavailable	Push ButtonRocker Switch	Push Button only	Push Button only	Push ButtonRocker SwitchFoot Switch
Power Supply	Monopolar generatorsupplied by user	Monopolar generatorsupplied by user	Monopolar generatorsupplied by user	Monopolar generatorsupplied by user
MonopolarGeneratorSetting	Max 6,0 kV	Not disclosed	Not disclosed	Max 5,5 kV
ElectricalConnector	US-3-Pin	US-3-Pin	US-3-Pin	US-3-Pin
SmokeEvacuationSystem	Yes	Yes	Yes	Yes
AdjustableSuction Sleeve	Yes	Yes	Yes	Yes
HandpieceDimensions(Dia x Length)	15 mm x 190 mm	25 mm x 190 mm	17 mm x 190 mm	25 mm x 190 mm
Suction SleeveMaterial*	Polystyrene	Polystyrene	Polycarbonate	Polycarbonate
HandpieceHousingMaterial*	Polystyrene	Polystyrene	Polystyrene	Polystyrene
Electrode Length	70 mm	70 mm	3.7-16.5 cm	70 mm
ElectrodeDimension	17 mm x 2.3 mm	18 mm x 2.5 mm	17mm x 2.3 mm	17 mm x 2.3 mm
AdjustableElectrode	No	No	Yes	No
ElectrodeMaterial*	Stainless steel	Stainless steel	Stainless steel	Not disclosed
Complies withISO 10993	Yes	Yes	Yes	Yes
Complies withIEC 60601-1	Yes	Yes	Yes	Yes
Complies withIEC 60601-2-2	Yes	Yes	Yes	Yes
Single Use	Yes	Yes	No	Yes
SterileProcessing	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide	Radiation

{3}------------------------------------------------

・

{4}------------------------------------------------

*Denotes patient contact material

9. Performance Testing

The LiNA SafeAir Smoke Pencil has been shown to perform as intended with the equivalent results as the predicate devices through simulated tissue cauterization and cutting functions. No particular requirements specific to the smoke performance exist in the standards but tests conducted with the device have shown no effect or changes to function of the electrosurgical pencil. The suction sleeve or intake portion of the device has been designed to not impede the electrosurgical function of the pencil and provides intake of the surgical smoke for filtering.

10. Non-Clinical Testing

The LiNA SafeAir Smoke Pencil and all predicate devices use polystyrene for the handpiece housing. The SafeAir Smoke Pencil and all the predicate devices use stainless steel for the electrode material. The predicate devices use either polycarbonate or polystyrene, as with the SafeAir Smoke Pencil, for the suction sleeve.

The following testing has been performed to support substantial equivalence:

Simulated Tissue Cauterization Smoke Evacuation Coagulation and Cutting

The SafeAir Smoke Pencil passed all testing and results were consistent with the intended use of the device.

11. Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate devices. The substantial equivalence of the device is supported by the non-clinical testing. The verification and validation testing of the device electrical safety and EMC testing of the device was found to acceptable and supports the claims of substantial equivalence.

12. Conclusion

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is substantially equivalent to the predicate device, and that the new

{5}------------------------------------------------

device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

The device has been designed to comply with the applicable sections of the standard for electrosurgical devices, IEC 60601-1 and IEC 60601-2-2 and Biocompatibility standard ISO 10993. It has been shown in this 510(k) submission that the differences between the SafeAir Smoke Pencil and the predicate devices do not raise any questions regarding its safety and effectiveness. The SafeAir Smoke Pencil as designed and manufactured therefore is determined to be substantially equivalent to the referenced predicate devices.

{6}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three heads, representing the department's focus on health, human services, and the well-being of the population. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA", which is arranged in a circular fashion around the figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter dated: December 7, 2012

LiNA Medical ApS % Emergo Group Rick Gillis, Ph.D. Senior Consultant 611 West 5th Street Austin, Texas 78701

Re: K120454

Trade/Device Name: SafeAir Smoke Pencil Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 15, 2012 Received: November 16, 2012

Dear Dr. Gillis:

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

{7}------------------------------------------------

Page 2 - Rick Gillis, Ph.D.

device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Mark N. Melkerson

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

Section 4 - Indications for Use statement

510(k) Number (if known): K120454

Device Name: SafeAir Smoke Pencil

Indications for Use:

(Part 21 CFR 801 Subpart D) Prescription Use X AND/OR Over-The-Counter Use __________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF
NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K 120.454.

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.