(27 days)
Not Found
No
The 510(k) summary describes a standard electrosurgical pencil with integrated smoke evacuation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The modification is limited to labeling changes for electrode compatibility.
No.
This device is used for surgical cutting and coagulation, and for smoke evacuation, which are procedural tools rather than devices intended to treat or cure a disease or condition.
No
The device is described as an electrosurgical tool for cutting and coagulation, and for smoke evacuation during surgery, not for diagnosing conditions.
No
The device description clearly states it is a "sterile single use integrated electrosurgical pencil and smoke evacuation hand piece that is packaged with an electrode blade," indicating it is a physical hardware device.
Based on the provided information, the LiNA SafeAir Smoke Pencil 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 tool used directly on a patient during a procedure.
- Device Description: The description reinforces this by calling it an "integrated electrosurgical pencil and smoke evacuation hand piece" used at the "operative site".
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information. IVDs are designed for testing samples in vitro (in glass or in a lab setting).
The device is a surgical instrument used in vivo (within the living body) during a procedure, not a diagnostic tool used in vitro.
N/A
Intended Use / Indications for Use
The LiNA 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
GEI
Device Description
The SafeAir Smoke Pencil is a sterile single use integrated electrosurgical pencil and smoke evacuation hand piece that is packaged with an electrode blade. The device is designed for general electrosurgical applications including cutting and coagulating 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 proposed device is the same as the predicate SafeAir Smoke Pencil. The only modification is a change to the labeling to allow the use of the Stryker® Colorado MicroDissection Needle electrodes in addition to the electrode that is packaged with the hand piece.
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
Non-Clinical Performance Data: Testing was performed to verify the compatibility of the Stryker Colorado MicroDissection Needle with the LiNA SafeAir Smoke Pencil hand piece. The testing demonstrated the proposed device met AAMI / ANSI / IEC 60601-2-2:2009, 201.15.4.1.102 for Compatibility of Third Party Electrodes, and demonstrated the hand piece delivers the electrosurgical current to the electrode for the desired surgical effect.
Clinical Testing: There was no clinical testing required to support the medical device as the indications for use is the same as to the predicate device LiNA SafeAir Smoke Pencil. The descriptive information detailed in this submission supports the substantial equivalence of the device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three faces overlapping to symbolize the department's focus on health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2014
LINA Medical ApS c/o Ms. Christine E. Nichols, RAC Regulatory Affairs Manager Boston Biomedical Associates 100 Crowley Drive, Suite 216 Marlborough, Massachusetts 01752
Re: K142538
Trade/Device Name: LINA SafeAir Smoke Pencil Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Device, Cutting & Coagulation & Accessories Product Code: GEI Dated: September 8, 2014 Received: September 9, 2014
Dear Ms. Nichols:
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
1
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/Resourcesfor You/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, Binita S. Ashar -S
2014.10.06 15:49:16 -04'00'
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
Enclosure
2
4 Indications for Use Statement
510(k) Number (if known): K142538
Device Name: LiNA SafeAir Smoke Pencil
Indications for Use:
The LiNA 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.
Prescription Use_X
AND/OR
Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)
(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)
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5 510(k) Summary (K142538)
Submission Sponsor 1.
LINA Medical ApS Formervangen 5 2600 Glostrup Denmark Phone: +45 43 29 66 66 Fax: -45 43 29 66 99 Contact: Louisa Memborg, Regulatory Affairs Officer
Submission Correspondent
Christine E. Nichols RAC Boston Biomedical Associates 100 Crowley Dr., Suite 216 Marlborough, MA 01752 Phone: 508-691-7046 Email: cnichols@boston-biomedical.com
Date Prepared
September 8, 2013
2. Device Identification
| Trade/Proprietary Name: | LiNA SafeAir Smoke Pencil |
|---|---|
| Common/Usual Name: | electrosurgical, cutting & coagulation & accessories |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification Regulation: | 21 CFR 878.4400 |
| Product Code: | GEI |
| Device Class: | Class II |
| Classification Panel: | General & Plastic Surgery |
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3. Predicate Device
LiNA SafeAir Smoke Pencil K120454
4. Device Description
The SafeAir Smoke Pencil is a sterile single use integrated electrosurgical pencil and smoke evacuation hand piece that is packaged with an electrode blade. The device is designed for general electrosurgical applications including cutting and coagulating 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 proposed device is the same as the predicate SafeAir Smoke Pencil. The only modification is a change to the labeling to allow the use of the Stryker® Colorado MicroDissection Needle electrodes in addition to the electrode that is packaged with the hand piece.
5. Indications for Use
The LiNA 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.
Comparison of Technological Characteristics with the Predicate Device 6.
This special 510(k) is a modification to the labelling for the LiNA SafeAir Smoke Pencil previously cleared by the FDA with the 510(k) number (K120454). No changes were made to the intended use, indications for use, energy type, performance specifications, materials, sterilization method or fundamental scientific technology.
Performance Data 7.
Non-Clinical Performance Data
Testing was performed to verify the compatibility of the Stryker Colorado MicroDissection Needle with the LiNA SafeAir Smoke Pencil hand piece. The testing demonstrated the proposed device met AAMI / ANSI / IEC 60601-2-2:2009, 201.15.4.1.102 for Compatibility of Third Party Electrodes, and demonstrated the hand piece delivers the electrosurgical current to the electrode for the desired surgical effect.
5
Clinical Testing
There was no clinical testing required to support the medical device as the indications for use is the same as to the predicate device LiNA SafeAir Smoke Pencil. The descriptive information detailed in this submission supports the substantial equivalence of the device.
8. Conclusion Statement of Substantial Equivalence
The differences between the Modified LiNA SafeAir Smoke Pencil and the predicate LiNA SafeAir Smoke Pencil do not raise any new questions regarding its safety and effectiveness. Testing was performed including compatibility with third party electrodes and functional testing to demonstrate that the Colorado MicroDissection Needles can be used with the LiNA SafeAir Smoke Pencil. The Modified LiNA SafeAir Smoke Pencil is the same in terms of design, components, principal of operation, sterilization, biocompatibility, performance characteristics, and intended use as the predicate. The proposed Modified LiNA SafeAir Smoke Pencil, as designed, is determined to be at least as safe and effective as the referenced predicate device, which supports a determination of substantial equivalence.