(107 days)
Not Found
No
The provided text describes a standard electrosurgical pencil with a telescopic feature and smoke evacuation capabilities. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies listed are standard tests for electrosurgical devices, not AI/ML model validation.
Yes
The device is used for electrosurgical applications (cutting and coagulation) to achieve a surgical effect, which is a therapeutic intervention.
No
The device is described for electrosurgical applications (cutting and coagulation) and smoke evacuation, which are therapeutic and supportive functions, not diagnostic.
No
The device description clearly describes a physical electrosurgical pencil with a telescopic function, indicating it is a hardware device, not software only.
Based on the provided information, the SafeAir Telescopic Smoke Pencil is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The description clearly states its purpose is for "general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery." This involves direct surgical intervention on a patient's body.
- Device Description: The description reinforces its function as a tool to "remotely conduct an electrosurgical current... to the operative site for the desired surgical effect." This is a surgical instrument.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. The SafeAir Telescopic Smoke Pencil does not perform any such analysis of specimens.
Therefore, the SafeAir Telescopic Smoke Pencil is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SafeAir Telescopic 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
SafeAir Telescopic Smoke Pencil is designed for general electrosurgical applications 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.
SafeAir Telescopic Smoke Pencil has got telescopic function which allows to extend the length of pencil by up to 120 mm. Extension is possible after twisting the green lock-ring.
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)
Non-Clinical Performance Data: LiNA completed a number of non-clinical performance tests. The SafeAir Telescopic Smoke Pencil meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety results confirming that the design output meets the design inputs and specifications for the device. The SafeAir Telescopic Smoke Pencil passed all applicable testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- Biocompatibility testing per ISO 10993-1, ISO 10993-10, ISO 10993-10, ISO 10993-12.
- Electrical safety testing per AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-2.
- Sterilization per ISO 11135, ISO 11737-2.
- Packaging, Aging and Transport testing per ASTM F88-06, ASTM F1929-98, ASTM F1980-16, ASTM D4169-16.
- Thermal Spread Testing.
- Flammability Testing.
- Smoke Evacuation Testing.
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.
Stryker Neptune E-SEP Smoke Evacuation Pencil (K160693)
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
§ 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.
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December 14, 2018
LiNA Medical ApS % Kevin MacDonald Clinical/Regulatory Consultant MacDonald Regulatory Consulting 4297 D Street Sacramento, California 95819
Re: K182354
Trade/Device Name: SafeAir Telescopic 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 16, 2018 Received: November 19, 2018
Dear Kevin MacDonald:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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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
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Indications for Use
510(k) Number (if known) K182354
Device Name SafeAir Telescopic Smoke Pencil
Indications for Use (Describe)
SafeAir Telescopic 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.
| 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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K182354 510(k) Summary SafeAir Telescopic Smoke Pencil
1. Submission Sponsor:
LiNA Medical ApS Formervangen 5 DK-2600 Glostrup, Denmark Natalia Szychulska Regulatory Affairs Officer Email: nhe@lina-medical.com Office number: +48 61 222 21 43
2. Submission Correspondent:
Kevin MacDonald U.S. Regulatory Consultant Email: kma@lina-medical.com Office number: 1-415-609-9875
3. Date prepared:
December 11, 2018
4. Device Identification
| Type of 510(k) Submission: | Traditional |
|---|---|
| Trade or Proprietary Name: | SafeAir Telescopic Smoke Pencil |
| Regulation Number: | 21 CFR 878.4400 |
| Product Code: | GEI, Electrosurgical Cutting And Coagulation Device And Accessories |
| Class of Device: Class | II |
| Panel: | General and Plastic Surgery |
| Reason for Submission: | New device |
| Prior Related Submissions: | No prior submissions for the device |
| Multiple Devices: | n/a |
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K182354
5. Legally Marketed Predicate Device(s)
Stryker Neptune E-SEP Smoke Evacuation Pencil (K160693)
6. Indication for Use Statement
SafeAir Telescopic 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
7. Device Description
SafeAir Telescopic Smoke Pencil is designed for general electrosurgical applications 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.
SafeAir Telescopic Smoke Pencil has got telescopic function which allows to extend the length of pencil by up to 120 mm. Extension is possible after twisting the green lock-ring.
| Model number | |
|---|---|
| SHK-TSP-US | SafeAir Telescopic Smoke Pencil |
8. Substantial Equivalence Discussion
Both the SafeAir Telescopic Smoke Pencil and the Stryker Neptune E-SEP Smoke Evacuation Pencil (K160693) are manufactured by LiNA Medical in Poland. The subject and predicate devices are substantially equivalent in terms of technological characteristics and intended use. The primary difference is the telescopic feature present on the SafeAir Telescopic Smoke Pencil (Subject device).
| Substantial Equivalence Table | ||
|---|---|---|
| Characteristic | Predicate Device | |
| Stryker Neptune E-SEP Smoke Evacuation | ||
| Pencil K160693 | Subject Device | |
| SafeAir Telescopic Smoke Pencil | ||
| Product Code | GEI | Same |
| Regulatory Class | II | Same |
| Regulation Name | Electrosurgical Cutting And Coagulation Device | |
| And Accessories | Same | |
| Regulation Number | 21 CFR 878.4400 | Same |
| Prescription | Yes | Same |
| Intended Use | The Neptune E-SEP is an Integrated Smoke | |
| Evacuation Pencil (pencil) designed for general | SafeAir Telescopic Smoke Pencil is | |
| designed for general electrosurgical | ||
| Substantial Equivalence Table | ||
| Characteristic | Predicate Device | |
| Stryker Neptune E-SEP Smoke Evacuation | ||
| Pencil K160693 | Subject Device | |
| SafeAir Telescopic Smoke Pencil | ||
| 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 (generator) | ||
| to the operative site for the desired surgical | ||
| effect | 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. | ||
| Overall Design | Designed to integrate smoke evacuation into | |
| electrosurgery by combining both features into | ||
| a single handpiece | Designed to integrate smoke | |
| evacuation into electrosurgery by | ||
| combining both features into a single | ||
| handpiece. Incorporates a | ||
| telescoping feature allowing the | ||
| length top extended up to 120mm | ||
| Power Supply | Monopolar Generator | Same |
| Voltage Rating | 5.5 kV peak | Same |
| Electrical Connector | US-3-Pin | Same |
| Electrical Safety | ||
| Testing | ISO 60601-1 | |
| ISO 60601-1-2 | ||
| ISO 60601-2-2 | Same | |
| Sterility | Sterile Single Use, EtO, SAL 10-6 | Same |
| Packaging | Individually packaged pencil and electrode in | |
| Tyvek pouch, sold 10 per box | Same | |
| Electrode Rod | 303 SST | Same |
| Electrode Rod | ||
| Diameter | 2.36mm | Same |
| Electrode Connector | ||
| Shape | Pentagon | Heat shrink sheath |
| Electrode Connector | ||
| Material | ABS Polylac PA-757 | PTFE Heat shrink |
| Electrode shaft | ||
| insulation (overmold) | ABS Polylac PA-757 | None |
| Electrode Tip | ||
| Material | 303 SST | Same |
| Electrode Tip Coating | None | Same |
| Electrode Tip | ||
| Working length | 70-165mm | 70mm |
| Electrode Tip | ||
| Insulation | None | None |
| Substantial Equivalence Table | ||
| Characteristic | Predicate Device | |
| Stryker Neptune E-SEP Smoke Evacuation | ||
| Pencil K160693 | Subject Device | |
| SafeAir Telescopic Smoke Pencil | ||
| Adjustable Suction | ||
| Sleeve Material | Acrylonitrile Butadiene Styrene with barium | |
| sulfate | Trianmx731 transparent | |
| Evacuation Tubing | ||
| Dimension | 10 mm dia x 3 m length | Same |
| Smoke Evacuation | ||
| System connector | 8mm, 22m | Same |
| Handpiece Housing | ||
| Material | Acrylonitrile Butadiene Styrene with | |
| Thermoplastic Elastomer | Same | |
| Handpiece | ||
| Dimensions | 15mm dia x 190mm length | 18 mm x 200 mm length |
| Operation Function | ||
| Switches | CUT/COAG buttons available in both Rocker- | |
| switch and Pushbutton-switch configuration | CUT/COAG buttons available in | |
| Pushbutton configuration | ||
| Accessories | Holster-Clip provided | None |
| Tissue contacting | ||
| Materials | Compliant with ISO 10993-1 | Same |
| Range of Electrodes | Neptune® E-SEP TM 165mm Blade | |
| Electrode, Coated and Insulated | ||
| Neptune® E-SEP TM 125mm Blade | ||
| Electrode, Coated and Insulated | ||
| Neptune® E-SEP TM 70mm Blade | ||
| Electrode, Coated and Insulated | ||
| Neptune E-SEP 165mm blade electrode | ||
| Neptune E-SEP loop t-bar electrode W20 | ||
| D15 L60 | ||
| Neptune E-SEP conization electrode W20 | ||
| D20 L120 | ||
| Neptune E-SEP 125mm blade electrode | ||
| Neptune E-SEP conization electrode W13 | ||
| D20 L120 | ||
| Neptune E-SEP 70mm Blade electrode | ||
| Neptune E-SEP 70mm needle electrode | ||
| Neptune E-SEP 5mm ball electrode | ||
| Neptune E-SEP loop t-bar electrode W20 | ||
| D20 L120 | ||
| Neptune E-SEP loop t-bar electrode W20 | Same | |
| Substantial Equivalence Table | ||
| Characteristic | Predicate Device | |
| Stryker Neptune E-SEP Smoke Evacuation | ||
| Pencil K160693 | Subject Device | |
| SafeAir Telescopic Smoke Pencil | ||
| Neptune E-SEP 165mm blade electrode | ||
| coated | ||
| Neptune E-SEP conization electrode W13 | ||
| D15 L120 | ||
| Neptune E-SEP loop u-bar electrode W20 | ||
| D20 L120 | ||
| Neptune E-SEP conization electrode W16 | ||
| D18 L 120 | ||
| Neptune E-SEP loop t-bar electrode W10 | ||
| D10 L120 | ||
| Neptune E-SEP 70mm blade electrode | ||
| coated | ||
| Neptune E-SEP loop t-bar electrode W20 | ||
| D15 L120 | ||
| Neptune E-SEP 3mm ball electrode | ||
| Neptune E-SEP conization electrode W16 | ||
| D8 L120 | ||
| Neptune E-SEP 125mm blade electrode | ||
| coated | ||
| Neptune E-SEP loop t-bar electrode W15 | ||
| D12 L120 |
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The SafeAir Telescopic Smoke Pencil shares the same intended use, device operation, overall technical and functional capabilities as the predicate device. In addition, the SafeAir Telescopic Smoke Pencil is similar in design and function to the Stryker Neptune E-SEP Smoke Evacuation Pencil (K160693) in terms of mode of operation and use. In reference to manufacturing, the SafeAir Telescopic Smoke Pencil and the Stryker Neptune E-SEP Smoke Evacuator Pencil are manufactured in the LiNA Medical's Poland manufacturing facility under the same environmental conditions.
9. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of the SafeAir Telescopic Smoke Pencil and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, LiNA completed a number of non-clinical performance tests. The SafeAir Telescopic Smoke Pencil meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety results confirming that the design output meets the design inputs and specifications for the device.
The SafeAir Telescopic Smoke Pencil was subjected to safety performance testing in accordance with the FDA's Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery -Guidance for Industry and Food and Drug Administration Staff. Issued: August 15, 2016.
The SafeAir Telescopic Smoke Pencil passed all applicable testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
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- Biocompatibility testing per ISO 10993-1, ISO 10993-10, ISO 10993-10, ISO 10993-12
- . Electrical safety testing per AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-2
- . Sterilization per ISO 11135, ISO 11737-2
- Packaging, Aging and Transport testing per ASTM F88-06, ASTM F1929-98, ASTM F1980-16, ASTM D4169-16
- Thermal Spread Testing
- Flammability Testing
- Smoke Evacuation Testing
10. Clinical Performance Data
Based on the similarities in design, intended use and comparability in design verification results to the predicate device, human clinical testing was not required to establish substantial equivalence. These types of devices, including the predicate devices, have been a long market history with demonstrated safety and effectiveness for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence determination.
11. Statement of Substantial Equivalence
Based on the similarities in design, intended use statement and comparative verification test results, the SafeAir Telescopic Smoke Pencil raises no new issues of safety and effectiveness when compared to the predicate device, Stryker Neptune E-SEP Smoke Evacuation Pencil.
The SafeAir Telescopic Smoke Pencil function differs only in the telescopic feature which does not impact the intended use or significantly impact the technological features and therefore is determined to be substantially equivalent to the referenced predicate device.