(107 days)
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.
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.
The provided document is a 510(k) premarket notification for a medical device (SafeAir Telescopic Smoke Pencil). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial or algorithm validation.
Therefore, many of the requested pieces of information (acceptance criteria for a study, sample sizes for test/training sets, expert consensus for ground truth, MRMC studies, standalone performance of an algorithm) are not applicable to this type of regulatory submission, as it is primarily about demonstrating that a new device is as safe and effective as an already cleared device through non-clinical testing and comparison of characteristics.
The document emphasizes substantial equivalence to a predicate device (Stryker Neptune E-SEP Smoke Evacuation Pencil, K160693) through:
- Identical intended use.
- Similar technological characteristics.
- Non-clinical performance data (bench testing) to show it meets safety and performance standards.
Here's an attempt to address the points based on the provided document, noting where information is not available or not applicable:
Acceptance Criteria and Study for the SafeAir Telescopic Smoke Pencil
The provided document is a 510(k) Premarket Notification, which seeks to demonstrate "substantial equivalence" of a new device to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through clinical or algorithmic studies. Therefore, many of the requested details related to clinical trials, multi-reader studies, AI algorithm performance, and ground truth establishment (as typically seen in diagnostic device submissions) are not present or applicable in this context. The "acceptance criteria" here are primarily about meeting established safety and performance standards for electrosurgical devices and demonstrating equivalence to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are implied by the standards and characteristics that the SafeAir Telescopic Smoke Pencil must meet to be considered substantially equivalent and safe/effective. The "reported device performance" is the manufacturer's assertion and testing results confirming the device meets these standards and is comparable to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Same as predicate. | SafeAir Telescopic Smoke Pencil's intended use is identical to the predicate: "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." (Page 5, 6) |
| Technological Characteristics Equivalence: Similar to predicate. | Largely Same as Predicate: Product Code (GEI), Regulatory Class (II), Regulation Name & Number (21 CFR 878.4400), Prescription Use, Power Supply (Monopolar Generator), Voltage Rating (5.5 kV peak), Electrical Connector (US-3-Pin), Electrical Safety Testing (ISO 60601-1, -1-2, -2-2), Sterility (Sterile Single Use, EtO, SAL 10^-6), Packaging, Electrode Rod (303 SST), Electrode Rod Diameter (2.36mm), Electrode Tip Material (303 SST), Electrode Tip Coating (None), Electrode Tip Insulation (None), Evacuation Tubing Dimension, Smoke Evacuation System connector, Handpiece Housing Material, Tissue contacting Materials (ISO 10993-1 compliant), Range of Electrodes. |
| Minor Differences, Justified: | |
| * Overall Design: Includes a "telescoping feature allowing the length to be extended up to 120mm" (Subject Device) vs. "Designed to integrate smoke evacuation...into a single handpiece" (Predicate). (Page 5) - This is the primary difference and is argued not to affect substantial equivalence. | |
| * Electrode Connector Shape: Heat shrink sheath (Subject Device) vs. Pentagon (Predicate). (Page 5) | |
| * Electrode Connector Material: PTFE Heat shrink (Subject Device) vs. ABS Polylac PA-757 (Predicate). (Page 5) | |
| * Electrode shaft insulation (overmold): None (Subject Device) vs. ABS Polylac PA-757 (Predicate). (Page 5) | |
| * Electrode Tip Working Length: 70mm (Subject Device) vs. 70-165mm (Predicate). (Page 5) | |
| * Adjustable Suction Sleeve Material: Trianmx731 transparent (Subject Device) vs. Acrylonitrile Butadiene Styrene with barium sulfate (Predicate). (Page 5) | |
| * Handpiece Dimensions: 18 mm x 200 mm length (Subject Device) vs. 15mm dia x 190mm length (Predicate). (Page 5) | |
| * Operation Function Switches: Pushbutton configuration (Subject Device) vs. Rocker-switch and Pushbutton-switch (Predicate). (Page 5) | |
| * Accessories: None (Subject Device) vs. Holster-Clip provided (Predicate). (Page 5) | |
| Safety and Performance Testing Conformance: Meet relevant standards and prove safety. | Passed All Applicable Testing: (Page 8) |
| * Biocompatibility: ISO 10993-1, ISO 10993-10, ISO 10993-12. | |
| * Electrical Safety: AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-2. | |
| * Sterilization: ISO 11135, ISO 11737-2. | |
| * Packaging, Aging & Transport: ASTM F88-06, ASTM F1929-98, ASTM F1980-16, ASTM D4169-16. | |
| * Thermal Spread Testing: Passed. | |
| * Flammability Testing: Passed. | |
| * Smoke Evacuation Testing: Passed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of typical test sets for algorithmic or diagnostic performance. The "testing" refers to bench testing of the device itself (e.g., electrical safety, sterility), not a dataset of patients or images. The document does not specify the number of units tested for each non-clinical performance test.
- Data Provenance: The testing was conducted internally by the manufacturer (LiNA Medical ApS) based on internal requirements and international standards. (Page 8) The manufacturing facility is in Poland. (Page 5)
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This is not a study requiring human expert interpretation of data (e.g., images for a diagnostic AI). The ground truth for device performance is established by a combination of engineering specifications, international standards (e.g., ISO, IEC, ASTM), and the expected performance of an electrosurgical device for its intended use.
4. Adjudication Method for the Test Set
- Not applicable. There is no "test set" in the sense of data requiring human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This is explicitly stated: "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." (Page 8) This means no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This device is a manual medical instrument (an electrosurgical pencil), not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" for the device's acceptable performance is defined by adherence to recognized national and international consensus standards (e.g., ISO, IEC, AAMI/ANSI, ASTM for biocompatibility, electrical safety, sterilization, packaging, etc.), as well as its functional equivalence to a legally marketed predicate device. This is a demonstration of engineering validation and comparison, not clinical outcomes or expert consensus on clinical data.
8. The Sample Size for the Training Set
- Not applicable. There is no training set as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
- Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Long H. Chen -S, and the date of the signature is 2018.12.14. The time of the signature is 14:56:52 -05'00'. The signature is for something.
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 DeviceStryker Neptune E-SEP Smoke EvacuationPencil K160693 | Subject DeviceSafeAir Telescopic Smoke Pencil |
| Product Code | GEI | Same |
| Regulatory Class | II | Same |
| Regulation Name | Electrosurgical Cutting And Coagulation DeviceAnd Accessories | Same |
| Regulation Number | 21 CFR 878.4400 | Same |
| Prescription | Yes | Same |
| Intended Use | The Neptune E-SEP is an Integrated SmokeEvacuation Pencil (pencil) designed for general | SafeAir Telescopic Smoke Pencil isdesigned for general electrosurgical |
| Substantial Equivalence Table | ||
| Characteristic | Predicate DeviceStryker Neptune E-SEP Smoke EvacuationPencil K160693 | Subject DeviceSafeAir Telescopic Smoke Pencil |
| electrosurgical applications including cuttingand coagulation, and for removing smokegenerated by electrosurgery when used inconjunction with an effective smokeevacuation system. The pencil enables theoperator to remotely conduct anelectrosurgical current from the outputconnector of an electrosurgical unit (generator)to the operative site for the desired surgicaleffect | applications, including cutting andcoagulation, and for removing smokegenerated by electrosurgery whenused in conjunction with an effectivesmoke evacuation system. The pencilenables the operator to remotelyconduct an electrosurgical currentfrom the output connector of anelectrosurgical unit to the operativesite for the desired surgical effect. | |
| Overall Design | Designed to integrate smoke evacuation intoelectrosurgery by combining both features intoa single handpiece | Designed to integrate smokeevacuation into electrosurgery bycombining both features into a singlehandpiece. Incorporates atelescoping feature allowing thelength top extended up to 120mm |
| Power Supply | Monopolar Generator | Same |
| Voltage Rating | 5.5 kV peak | Same |
| Electrical Connector | US-3-Pin | Same |
| Electrical SafetyTesting | ISO 60601-1ISO 60601-1-2ISO 60601-2-2 | Same |
| Sterility | Sterile Single Use, EtO, SAL 10-6 | Same |
| Packaging | Individually packaged pencil and electrode inTyvek pouch, sold 10 per box | Same |
| Electrode Rod | 303 SST | Same |
| Electrode RodDiameter | 2.36mm | Same |
| Electrode ConnectorShape | Pentagon | Heat shrink sheath |
| Electrode ConnectorMaterial | ABS Polylac PA-757 | PTFE Heat shrink |
| Electrode shaftinsulation (overmold) | ABS Polylac PA-757 | None |
| Electrode TipMaterial | 303 SST | Same |
| Electrode Tip Coating | None | Same |
| Electrode TipWorking length | 70-165mm | 70mm |
| Electrode TipInsulation | None | None |
| Substantial Equivalence Table | ||
| Characteristic | Predicate DeviceStryker Neptune E-SEP Smoke EvacuationPencil K160693 | Subject DeviceSafeAir Telescopic Smoke Pencil |
| Adjustable SuctionSleeve Material | Acrylonitrile Butadiene Styrene with bariumsulfate | Trianmx731 transparent |
| Evacuation TubingDimension | 10 mm dia x 3 m length | Same |
| Smoke EvacuationSystem connector | 8mm, 22m | Same |
| Handpiece HousingMaterial | Acrylonitrile Butadiene Styrene withThermoplastic Elastomer | Same |
| HandpieceDimensions | 15mm dia x 190mm length | 18 mm x 200 mm length |
| Operation FunctionSwitches | CUT/COAG buttons available in both Rocker-switch and Pushbutton-switch configuration | CUT/COAG buttons available inPushbutton configuration |
| Accessories | Holster-Clip provided | None |
| Tissue contactingMaterials | Compliant with ISO 10993-1 | Same |
| Range of Electrodes | Neptune® E-SEP TM 165mm BladeElectrode, Coated and InsulatedNeptune® E-SEP TM 125mm BladeElectrode, Coated and InsulatedNeptune® E-SEP TM 70mm BladeElectrode, Coated and InsulatedNeptune E-SEP 165mm blade electrodeNeptune E-SEP loop t-bar electrode W20D15 L60Neptune E-SEP conization electrode W20D20 L120Neptune E-SEP 125mm blade electrodeNeptune E-SEP conization electrode W13D20 L120Neptune E-SEP 70mm Blade electrodeNeptune E-SEP 70mm needle electrodeNeptune E-SEP 5mm ball electrodeNeptune E-SEP loop t-bar electrode W20D20 L120Neptune E-SEP loop t-bar electrode W20 | Same |
| Substantial Equivalence Table | ||
| Characteristic | Predicate DeviceStryker Neptune E-SEP Smoke EvacuationPencil K160693 | Subject DeviceSafeAir Telescopic Smoke Pencil |
| Neptune E-SEP 165mm blade electrodecoated | ||
| Neptune E-SEP conization electrode W13D15 L120 | ||
| Neptune E-SEP loop u-bar electrode W20D20 L120 | ||
| Neptune E-SEP conization electrode W16D18 L 120 | ||
| Neptune E-SEP loop t-bar electrode W10D10 L120 | ||
| Neptune E-SEP 70mm blade electrodecoated | ||
| Neptune E-SEP loop t-bar electrode W20D15 L120 | ||
| Neptune E-SEP 3mm ball electrode | ||
| Neptune E-SEP conization electrode W16D8 L120 | ||
| Neptune E-SEP 125mm blade electrodecoated | ||
| Neptune E-SEP loop t-bar electrode W15D12 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.
§ 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.