SafeAir Smoke Pencil
Device Facts
| Record ID | K143145 |
|---|---|
| Device Name | SafeAir Smoke Pencil |
| Applicant | Lina Medical Aps |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Dec 4, 2014 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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 Story
SafeAir Smoke Pencil is a sterile, single-use, integrated electrosurgical pencil and smoke evacuation handpiece. Device connects to a user-supplied monopolar electrosurgical generator and a smoke evacuation system (filtration or central vacuum). Operator uses rocker or push-button switches on the handpiece to activate monopolar cut or coagulate functions while simultaneously capturing surgical smoke plume via an integrated suction sleeve. Device features 70 mm stainless steel blade electrodes (coated or uncoated). Smoke evacuation tubing includes dual 8 mm and 22 mm connectors. Used in surgical environments to minimize personnel exposure to surgical smoke. Output is the delivery of electrosurgical current to the operative site for tissue cutting or coagulation, with concurrent smoke plume capture.
Clinical Evidence
Bench testing only. Testing included biocompatibility (ANSI/AAMI/ISO 10993-1), electrical safety (ISO 60601-1, ISO 60601-2-2), integrity and functionality after aging, thermal spread, and sterilization validation (ANSI/AAMI/ISO 11135-1) to a sterility assurance level of 10^-6.
Technological Characteristics
Sterile, single-use electrosurgical pencil with integrated smoke evacuation. Materials: stainless steel (electrodes), polypropylene (connector), styrene butadiene copolymer (suction sleeve), ABS with barium sulfate (sleeve), ABS with thermoplastic elastomer (housing). Dimensions: 15 mm x 190 mm handpiece; 70 mm electrodes. Monopolar energy source (max 6 kV peak). Sterilization: Ethylene Oxide (EO).
Indications for Use
Indicated for general electrosurgical applications, including cutting and coagulation, and for smoke removal during electrosurgery in conjunction with an evacuation system. Intended for use by clinicians in surgical settings.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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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 (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" (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 (800) 638-2041 or (301) 796-7100 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: +45 43 29 66 50 Fax: +45 43 29 66 99 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<br>SafeAir Smoke Pencil will be expanded to include<br>the following configuration: |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | • Blade electrode, coated, 70 mm length |
| | The line extension does not change the intended<br>use, indications for use, or the fundamental<br>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,<br>rocker button style | SHK-VS-RS-TS |
| SafeAir Smoke Pencil with 70 mm coated blade<br>electrode | SHK-VS-C-TS |
| SafeAir Smoke Pencil with 70 mm coated blade<br>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<br>(Subject) | SafeAir Smoke Pencil,<br>K142538<br>(Predicate) | Explanation of<br>Difference |
|------------------------------------|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k)<br>Number | Not yet assigned | K142538 | N/A |
| | Product Code | GEI | GEI | Same |
| | Regulation<br>Number | 21 CFR 878.4400 | 21 CFR 878.4400 | Same |
| | Regulation<br>Name | Electrosurgical cutting and<br>coagulation device and<br>accessories | Electrosurgical cutting and<br>coagulation device and<br>accessories | Same |
| | Product<br>Classification | Class II | Class II | Same |
| Regulatory Information | Indications<br>for use | The SafeAir Smoke Pencil<br>is designed for general<br>electrosurgical applications<br>including cutting and<br>coagulation and for<br>removing smoke generated<br>by electrosurgery when used<br>in conjunction with an<br>effective smoke evacuation<br>system. The pencil enables<br>the operator to remotely<br>conduct an electrosurgical<br>current from the output<br>connector of an<br>electrosurgical unit to the<br>operative site for the desired<br>surgical effect. | The SafeAir Smoke Pencil<br>is designed for general<br>electrosurgical applications<br>including cutting and<br>coagulation and for<br>removing smoke generated<br>by electrosurgery when used<br>in conjunction with an<br>effective smoke evacuation<br>system. The pencil enables<br>the operator to remotely<br>conduct an electrosurgical<br>current from the output<br>connector of an<br>electrosurgical unit to the<br>operative site for the desired<br>surgical effect. | Same |
| | Overall Design Concept | Overall<br>Design | Device designed to integrate<br>smoke evacuation into<br>electrosurgery by combining<br>both features into a single<br>handpiece | Device designed to integrate<br>smoke evacuation into<br>electrosurgery by combining<br>both features into a single<br>handpiece |
| Power supply | | Monopolar generator<br>supplied by user | Monopolar generator<br>supplied by user | Same |
| Monopolar<br>Generator<br>Setting | | Maximum 6 kV peak | Maximum 6 kV peak | Same |
| Electrical<br>Connector | | US-3-Pin | US-3-Pin | Same |
| | Electrical<br>Safety Testing | ISO 60601-1<br>ISO 60601-2-2 | ISO 60601-1<br>ISO 60601-2-2 | Same |
| | Description | SafeAir Smoke Pencil<br>(Subject) | SafeAir Smoke Pencil,<br>K120454<br>(Predicate) | Explanation of<br>Difference |
| Electrode Technology and Materials | Sterility | Sterile, single use only<br>Sterilized by Ethylene<br>Oxide gas<br>Sterility Assurance level =<br>$10^{-6}$ | Sterile, single use only<br>Sterilized by Ethylene<br>Oxide gas<br>Sterility Assurance level =<br>$10^{-6}$ | Same |
| | Packaging | Single pencil unit with<br>preassembled blade and<br>suction sleeve, holster, and<br>clip in an individual Tyvek<br>sealed pouch, sold 10 per<br>box. | Single pencil unit with<br>blade, in an individual<br>Tyvek sealed pouch, sold 10<br>per box. | Similar - Blade<br>and suction<br>sleeve are<br>preassembled,<br>holster and clip<br>included. |
| | Electrode rod<br>material | Stainless steel | Stainless steel | Same |
| | Electrode rod<br>diameter | 2.4 mm (3/32 inches) | 2.4 mm (3/32 inches) | Same |
| | Electrode<br>connector<br>material | Polypropylene | Polypropylene | Similar -<br>polypropylene<br>connector for<br>coated blade is<br>supplied from a<br>different source<br>than cleared<br>connector<br>material. |
| | Electrode<br>coupler shape<br>(all<br>electrodes) | Pentagonal | Pentagonal | Same |
| | Electrode,<br>blade<br>material | Stainless steel | Stainless steel | Same |
| | Electrode,<br>blade coating<br>(if present) | Polytetrafluoroethylene<br>(PTFE) | N/A | Coating is being<br>introduced in<br>this submission. |
| | Electrode<br>Length | 70 mm | 70 mm | Same |
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| | Description | SafeAir Smoke Pencil<br>(Subject) | SafeAir Smoke Pencil,<br>K120454<br>(Predicate) | Explanation of<br>Difference |
|----------------------------------------------|---------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------|
| Smoke Evacuation Materials<br>and Technology | Adjustable<br>Suction<br>Sleeve<br>Material | Styrene butadiene copolymer | Styrene butadiene<br>copolymer | Same |
| | Sleeve<br>Material | Acrylonitrile butadiene<br>styrene with barium sulfate | Acrylonitrile butadiene<br>styrene with barium sulfate | Same |
| | Evacuation<br>Tubing<br>Dimension | 10 mm diameter X 3 m<br>length | 10 mm diameter X 3 m<br>length | Same |
| | Smoke<br>Evacuation<br>System<br>Connector | 8 mm, 22 mm | 8 mm, 22 mm | Same |
| | Handpiece<br>Housing<br>Material | Acrylonitrile Butadiene<br>Styrene with Thermoplastic<br>Elastomer | Acrylonitrile Butadiene<br>Styrene with<br>Thermoplastic Elastomer | Same |
| Pencil Technology and<br>Materials | Handpiece<br>Dimension | 15 mm diameter X 190 mm<br>length | 15 mm diameter X 190<br>mm length | Same |
| | Operation<br>Function<br>Switches | CUT button labeled yellow<br>and proximal to electrode | CUT button labeled yellow<br>and proximal to electrode | Same |
| | | COAG button labeled blue<br>and distal to electrode | COAG button labeled blue<br>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.
