SafeAir Smoke Pencil

• K Number: K143145
• Device Name: SafeAir Smoke Pencil
• Manufacturer: LiNA Medical ApS
• Date Cleared: 2014-12-04 ( 31 days)
• Product Code: GEI
• Regulation Number: 878.4400

Intended Use

The 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 smoke plume simultaneously. The SafeAir Smoke Pencil is available in two activation switch configurations, a rocker style and push-button style, which activate monopolar cut or coagulate functions. The pencil is connected to smoke evacuation tubing which features a dual connector (8 and 22 mm) 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 surgical smoke plume. Electrodes are available in either 70 mm blade or 70 mm coated blade configurations.

Predicate Devices

K142538

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical and electrical functions of an electrosurgical pencil with integrated smoke evacuation. There is no mention of any computational analysis, learning, or adaptive capabilities.

Therapeutic

No.
The device is used for surgical applications (cutting and coagulation) and smoke removal, not for treating a disease or condition in a therapeutic manner.

Diagnostic

No

The device is an electrosurgical pencil designed for surgical applications (cutting and coagulation) and smoke evacuation, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a sterile, single-use, integrated electrosurgical pencil and smoke evacuation handpiece, which are physical hardware components.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device is for "general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery". This describes a surgical procedure performed directly on a patient, not a test performed on a sample taken from a patient.
• Device Description: The description details a surgical handpiece that delivers electrosurgical current and evacuates smoke. This is consistent with a surgical tool, not a diagnostic test.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.

IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on performing a surgical procedure and managing the byproducts of that procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The 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.

Product codes (comma separated list FDA assigned to the subject device)

GEI

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 smoke plume simultaneously.

The SafeAir Smoke Pencil is available in two activation switch configurations, a rocker style and push-button style, which activate monopolar cut or coagulate functions. The pencil is connected to smoke evacuation tubing which features a dual connector (8 and 22 mm) 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 surgical smoke plume. Electrodes are available in either 70 mm blade or 70 mm coated blade configurations.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing was conducted on the subject devices as determined by the risk analysis of the product. The following areas were evaluated:

• Electrical safety testing
• Integrity and functionality testing after aging
• Thermal spread testing
• Biocompatibility testing
• Sterilization and packaging testing

The results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the SafeAir Smoke Pencil and electrodes are sufficient for their intended use and support a determination of substantial equivalence.

Biocompatibility testing was performed on the subject device in accordance with ANSI/AAMI/ISO 10993-1:2009: Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing. Results of testing validate the subject device is biocompatible as intended for use.

The SafeAir Smoke Pencil is available only in sterile packaged form. The sterile product will be terminally sterilized using ethylene oxide (EO). The sterilization method was validated and performed in accordance with ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide. A sterility assurance level of 10⁻⁶ has been validated for this product.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K142538

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a design that resembles a bird in flight above them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 11, 2014

LiNA Medical ApS Anne Klitgard QA/RA Manager Formervangen 5 Glostrup, Demark, DK-2600

Re: K1413145 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: October 31, 2014 Received: November 3, 2014

Dear Ms. Klitgard,

This letter corrects our substantially equivalent letter of 12/4/2014.

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

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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 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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" (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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K143145

Device Name SafeAir Smoke Pencil

Indications for Use (Describe)

The SafeAir Smoke Pencil is designed for general electrosurgical applications including cutting 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.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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K143145 Page 1 of 6

510(k) Summary

• LiNA Medical ApS Applicant: Formervangen 5 2600 Glostrup Denmark
• Contact: Anne Klitgård QA/RA Manager Phone: [phone] Fax: [phone] Email: akl(@)lina-medical.com

Registration Number: 3002626775

Date Summary Prepared: 29 October 2014

Trade Name: SafeAir Smoke Pencil

Common Name: Electrosurgical cutting and coagulation device and accessories

• Classification Data: 21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories, Product Code GEI, Class II 510(k)
  Special 510(k) - device modifications and line Reason for 510(k) Submission: extension with no change to fundamental scientific technology or intended use. Device Modification: LiNA Medical ApS submits this Special 510(k) for the SafeAir Smoke Pencil. The modifications are as follows.

• Modification of electrode connector material for coated blade electrode

• Addition of clip and holster accessories to the package

• . The 70 mm blade electrodes (coated and uncoated) and suction sleeve will be provided pre-mounted onto the pencil

The modifications change neither the intended use, the indications for use, nor the fundamental scientific technology of the system.

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| Line Extension: | The line of electrodes offered for use with the
SafeAir Smoke Pencil will be expanded to include
the following configuration: |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | • Blade electrode, coated, 70 mm length |
| | The line extension does not change the intended
use, indications for use, or the fundamental
scientific technology of the system. |
| Predicate SE Device: | SafeAir Smoke Pencil, K142538 |

Indications for Use:

The 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 smoke plume simultaneously.

The SafeAir Smoke Pencil is available in two activation switch configurations, a rocker style and push-button style, which activate monopolar cut or coagulate functions. The pencil is connected to smoke evacuation tubing which features a dual connector (8 and 22 mm) 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 surgical smoke plume. Electrodes are available in either 70 mm blade or 70 mm coated blade configurations.

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Device Models:

Description	Part Numbers
SafeAir Smoke Pencil with 70 mm blade electrode	SHK-VS-TS
SafeAir Smoke Pencil with 70 mm blade electrode,
rocker button style	SHK-VS-RS-TS
SafeAir Smoke Pencil with 70 mm coated blade
electrode	SHK-VS-C-TS
SafeAir Smoke Pencil with 70 mm coated blade
electrode, rocker button style	SHK-VS-RS-C-TS

Performance Data (Non-Clinical Tests):

The results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the SafeAir Smoke Pencil and electrodes are sufficient for their intended use and support a determination of substantial equivalence.

Summary of Performance Testing:

Biocompatibility testing was performed on the subject device in accordance with ANSI/AAMI/ISO 10993-1:2009: Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing. Results of testing validate the subject device is biocompatible as intended for use.

The SafeAir Smoke Pencil is available only in sterile packaged form. The sterile product will be terminally sterilized using ethylene oxide (EO). The sterilization method was validated and performed in accordance with ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide. A sterility assurance level of 10° has been validated for this product.

Performance testing was conducted on the subject devices as determined by the risk analysis of the product. The following areas were evaluated:

• Electrical safety testing
• Integrity and functionality testing after aging
• Thermal spread testing
• Biocompatibility testing
• Sterilization and packaging testing

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Predicate Comparison:

| | Description | SafeAir Smoke Pencil
(Subject) | SafeAir Smoke Pencil,
K142538
(Predicate) | Explanation of
Difference |
|------------------------------------|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k)
Number | Not yet assigned | K142538 | N/A |
| | Product Code | GEI | GEI | Same |
| | Regulation
Number | 21 CFR 878.4400 | 21 CFR 878.4400 | Same |
| | Regulation
Name | Electrosurgical cutting and
coagulation device and
accessories | Electrosurgical cutting and
coagulation device and
accessories | Same |
| | Product
Classification | Class II | Class II | Same |
| Regulatory Information | Indications
for use | The 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. | The 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. | Same |
| | Overall Design Concept | Overall
Design | Device designed to integrate
smoke evacuation into
electrosurgery by combining
both features into a single
handpiece | Device designed to integrate
smoke evacuation into
electrosurgery by combining
both features into a single
handpiece |
| Power supply | | Monopolar generator
supplied by user | Monopolar generator
supplied by user | Same |
| Monopolar
Generator
Setting | | Maximum 6 kV peak | Maximum 6 kV peak | Same |
| Electrical
Connector | | US-3-Pin | US-3-Pin | Same |
| | Electrical
Safety Testing | ISO 60601-1
ISO 60601-2-2 | ISO 60601-1
ISO 60601-2-2 | Same |
| | Description | SafeAir Smoke Pencil
(Subject) | SafeAir Smoke Pencil,
K120454
(Predicate) | Explanation of
Difference |
| Electrode Technology and Materials | Sterility | Sterile, single use only
Sterilized by Ethylene
Oxide gas
Sterility Assurance level =
$10^{-6}$ | Sterile, single use only
Sterilized by Ethylene
Oxide gas
Sterility Assurance level =
$10^{-6}$ | Same |
| | Packaging | Single pencil unit with
preassembled blade and
suction sleeve, holster, and
clip in an individual Tyvek
sealed pouch, sold 10 per
box. | Single pencil unit with
blade, in an individual
Tyvek sealed pouch, sold 10
per box. | Similar - Blade
and suction
sleeve are
preassembled,
holster and clip
included. |
| | Electrode rod
material | Stainless steel | Stainless steel | Same |
| | Electrode rod
diameter | 2.4 mm (3/32 inches) | 2.4 mm (3/32 inches) | Same |
| | Electrode
connector
material | Polypropylene | Polypropylene | Similar -
polypropylene
connector for
coated blade is
supplied from a
different source
than cleared
connector
material. |
| | Electrode
coupler shape
(all
electrodes) | Pentagonal | Pentagonal | Same |
| | Electrode,
blade
material | Stainless steel | Stainless steel | Same |
| | Electrode,
blade coating
(if present) | Polytetrafluoroethylene
(PTFE) | N/A | Coating is being
introduced in
this submission. |
| | Electrode
Length | 70 mm | 70 mm | Same |

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| | Description | SafeAir Smoke Pencil
(Subject) | SafeAir Smoke Pencil,
K120454
(Predicate) | Explanation of
Difference |
|----------------------------------------------|---------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------|
| Smoke Evacuation Materials
and Technology | Adjustable
Suction
Sleeve
Material | Styrene butadiene copolymer | Styrene butadiene
copolymer | Same |
| | Sleeve
Material | Acrylonitrile butadiene
styrene with barium sulfate | Acrylonitrile butadiene
styrene with barium sulfate | Same |
| | Evacuation
Tubing
Dimension | 10 mm diameter X 3 m
length | 10 mm diameter X 3 m
length | Same |
| | Smoke
Evacuation
System
Connector | 8 mm, 22 mm | 8 mm, 22 mm | Same |
| | Handpiece
Housing
Material | Acrylonitrile Butadiene
Styrene with Thermoplastic
Elastomer | Acrylonitrile Butadiene
Styrene with
Thermoplastic Elastomer | Same |
| Pencil Technology and
Materials | Handpiece
Dimension | 15 mm diameter X 190 mm
length | 15 mm diameter X 190
mm length | Same |
| | Operation
Function
Switches | CUT button labeled yellow
and proximal to electrode | CUT button labeled yellow
and proximal to electrode | Same |
| | | COAG button labeled blue
and distal to electrode | COAG button labeled blue
and distal to electrode | Same |

Conclusion/Substantial Equivalence Rationale:

The SafeAir Smoke Pencil and Accessories are either identical or similar in intended use, indications for use, technological characteristics, safety, and effectiveness to the previously cleared SafeAir Smoke Pencil. The products have the same fundamental scientific technology, basic design, functional characteristics and applications. The modifications and line extension of a coated electrode introduced raise no new questions of safety and effectiveness. Therefore, the SafeAir Smoke Pencil is at least as safe and effective as the predicate, and evidence supports a determination of substantial equivalence.