(31 days)
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 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SafeAir Smoke Pencil:
The document provided is a 510(k) summary for a medical device, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This type of submission typically focuses on demonstrating "substantial equivalence" rather than presenting a full clinical trial with acceptance criteria for new device performance. Therefore, the information provided isn't structured to detail specific acceptance criteria for diagnostic performance or a study proving those criteria in the way one might expect for a diagnostic AI device.
Instead, the document focuses on non-clinical performance testing to demonstrate the safety and effectiveness of the modified device in comparison to a predicate device. The "acceptance criteria" can be inferred from the types of tests performed and the statement that "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."
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the document (a 510(k) summary for a modified electrosurgical pencil), explicit numerical acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity) are not provided, as this is not a diagnostic device. The "acceptance criteria" here relate to engineering performance, biocompatibility, and sterility.
| Acceptance Criteria (Inferred from tests) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Device validated as biocompatible in accordance with ANSI/AAMI/ISO 10993-1:2009. |
| Sterility | Sterility validated to a Sterility Assurance Level (SAL) of 10⁻⁶ in accordance with ANSI/AAMI/ISO 11135-1:2007. |
| Electrical Safety | Device meets ISO 60601-1 and ISO 60601-2-2 standards (implied by "Same" in predicate comparison). |
| Integrity and Functionality after Aging | Testing performed and results supported substantial equivalence (specific outcomes not detailed). |
| Thermal Spread | Testing performed and results supported substantial equivalence (specific outcomes not detailed). |
| Functionality (Electrosurgical - cutting/coagulation) | Device enables remote conduction of electrosurgical current for desired surgical effect (implied to be consistent with predicate). |
| Smoke Evacuation Functionality | Device removes smoke when used with an effective smoke evacuation system (implied to be consistent with predicate). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of diagnostic AI (i.e., a dataset of cases used to evaluate an algorithm's classification performance). The testing described is non-clinical performance testing of the device itself.
- Sample Size: Not specified for individual non-clinical tests (e.g., how many pencils were tested for electrical safety, or how many materials for biocompatibility). The focus is on demonstrating compliance with standards and equivalence.
- Data Provenance: Not applicable in the context of clinical data provenance. The testing was performed on samples of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This device is not an AI diagnostic device that requires expert-established ground truth for a test set. The validation pertains to physical and electrical properties, and biological safety.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" of clinical cases requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is designed for evaluating diagnostic devices, typically AI, and their impact on human reader performance. This device is an electrosurgical tool, not a diagnostic one.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This is not an AI algorithm. The device itself is a standalone medical instrument.
7. The Type of Ground Truth Used
The concept of "ground truth" as used in diagnostic AI is not applicable here. The "truth" for the non-clinical tests refers to compliance with established engineering standards (e.g., ISO 60601-1 for electrical safety, ISO 11135-1 for sterilization) and biocompatibility standards (ISO 10993-1).
8. The Sample Size for the Training Set
Not applicable. This is not an AI device, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for an AI algorithm.
Summary of the Document's Focus:
This 510(k) submission is for a modification and line extension of an existing electrosurgical device (the SafeAir Smoke Pencil). The goal is to demonstrate "substantial equivalence" to a predicate device (K142538) by showing that the changes (electrode connector material, added accessories, pre-mounted components, and a new coated blade electrode) do not alter the intended use, indications for use, or fundamental scientific technology, and do not raise new questions of safety or effectiveness.
The "study that proves the device meets the acceptance criteria" refers to a battery of non-clinical performance tests covering:
- Biocompatibility (meeting ISO 10993-1)
- Sterilization validation (meeting ISO 11135-1 with a SAL of 10⁻⁶)
- Electrical safety (meeting ISO 60601-1 and 60601-2-2)
- Integrity and functionality after aging
- Thermal spread testing
The acceptance criteria for these tests are implicitly the successful demonstration of compliance with the relevant standards and the assurance that the device's performance is equivalent to, or better than, the predicate device. Specific numerical results for each test are not detailed in this summary document, but the conclusion states that the "results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness... are sufficient for their intended use and support a determination of substantial equivalence."
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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 (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
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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 theSafeAir Smoke Pencil will be expanded to includethe following configuration: |
|---|---|
| • Blade electrode, coated, 70 mm length | |
| The line extension does not change the intendeduse, indications for use, or the fundamentalscientific 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 bladeelectrode | SHK-VS-C-TS |
| SafeAir Smoke Pencil with 70 mm coated bladeelectrode, 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 ofDifference | |
|---|---|---|---|---|
| 510(k)Number | Not yet assigned | K142538 | N/A | |
| Product Code | GEI | GEI | Same | |
| RegulationNumber | 21 CFR 878.4400 | 21 CFR 878.4400 | Same | |
| RegulationName | Electrosurgical cutting andcoagulation device andaccessories | Electrosurgical cutting andcoagulation device andaccessories | Same | |
| ProductClassification | Class II | Class II | Same | |
| Regulatory Information | Indicationsfor use | The SafeAir Smoke Pencilis designed for generalelectrosurgical applicationsincluding cutting andcoagulation and forremoving smoke generatedby electrosurgery when usedin conjunction with aneffective smoke evacuationsystem. The pencil enablesthe operator to remotelyconduct an electrosurgicalcurrent from the outputconnector of anelectrosurgical unit to theoperative site for the desiredsurgical effect. | The SafeAir Smoke Pencilis designed for generalelectrosurgical applicationsincluding cutting andcoagulation and forremoving smoke generatedby electrosurgery when usedin conjunction with aneffective smoke evacuationsystem. The pencil enablesthe operator to remotelyconduct an electrosurgicalcurrent from the outputconnector of anelectrosurgical unit to theoperative site for the desiredsurgical effect. | Same |
| Overall Design Concept | OverallDesign | Device designed to integratesmoke evacuation intoelectrosurgery by combiningboth features into a singlehandpiece | Device designed to integratesmoke evacuation intoelectrosurgery by combiningboth features into a singlehandpiece | |
| Power supply | Monopolar generatorsupplied by user | Monopolar generatorsupplied by user | Same | |
| MonopolarGeneratorSetting | Maximum 6 kV peak | Maximum 6 kV peak | Same | |
| ElectricalConnector | US-3-Pin | US-3-Pin | Same | |
| ElectricalSafety Testing | ISO 60601-1ISO 60601-2-2 | ISO 60601-1ISO 60601-2-2 | Same | |
| Description | SafeAir Smoke Pencil(Subject) | SafeAir Smoke Pencil,K120454(Predicate) | Explanation ofDifference | |
| Electrode Technology and Materials | Sterility | Sterile, single use onlySterilized by EthyleneOxide gasSterility Assurance level =$10^{-6}$ | Sterile, single use onlySterilized by EthyleneOxide gasSterility Assurance level =$10^{-6}$ | Same |
| Packaging | Single pencil unit withpreassembled blade andsuction sleeve, holster, andclip in an individual Tyveksealed pouch, sold 10 perbox. | Single pencil unit withblade, in an individualTyvek sealed pouch, sold 10per box. | Similar - Bladeand suctionsleeve arepreassembled,holster and clipincluded. | |
| Electrode rodmaterial | Stainless steel | Stainless steel | Same | |
| Electrode roddiameter | 2.4 mm (3/32 inches) | 2.4 mm (3/32 inches) | Same | |
| Electrodeconnectormaterial | Polypropylene | Polypropylene | Similar -polypropyleneconnector forcoated blade issupplied from adifferent sourcethan clearedconnectormaterial. | |
| Electrodecoupler shape(allelectrodes) | Pentagonal | Pentagonal | Same | |
| Electrode,bladematerial | Stainless steel | Stainless steel | Same | |
| Electrode,blade coating(if present) | Polytetrafluoroethylene(PTFE) | N/A | Coating is beingintroduced inthis submission. | |
| ElectrodeLength | 70 mm | 70 mm | Same |
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| Description | SafeAir Smoke Pencil(Subject) | SafeAir Smoke Pencil,K120454(Predicate) | Explanation ofDifference | |
|---|---|---|---|---|
| Smoke Evacuation Materialsand Technology | AdjustableSuctionSleeveMaterial | Styrene butadiene copolymer | Styrene butadienecopolymer | Same |
| SleeveMaterial | Acrylonitrile butadienestyrene with barium sulfate | Acrylonitrile butadienestyrene with barium sulfate | Same | |
| EvacuationTubingDimension | 10 mm diameter X 3 mlength | 10 mm diameter X 3 mlength | Same | |
| SmokeEvacuationSystemConnector | 8 mm, 22 mm | 8 mm, 22 mm | Same | |
| HandpieceHousingMaterial | Acrylonitrile ButadieneStyrene with ThermoplasticElastomer | Acrylonitrile ButadieneStyrene withThermoplastic Elastomer | Same | |
| Pencil Technology andMaterials | HandpieceDimension | 15 mm diameter X 190 mmlength | 15 mm diameter X 190mm length | Same |
| OperationFunctionSwitches | CUT button labeled yellowand proximal to electrode | CUT button labeled yellowand proximal to electrode | Same | |
| COAG button labeled blueand distal to electrode | COAG button labeled blueand 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.
§ 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.