(290 days)
The device is used to conduct electrosurgical current from an electrosurgical generator to target tissue in electrosurgical procedures for monopolar cutting and coagulation, with the additional function of evacuation to facilitate the removal of surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
There are two main series of smoke evacuation pencil.
(1) Smoke Evacuation Fingerswitch (PS947): The device includes the active handle which connects with the active electrode. The diameter of the mating part is 2.36mm+/-0.02mm. The buttons on the active handle control cutting and coagulation, the yellow side activates the cutting function and the blue side activates the coagulation function. The active handle's end is connected to an insulation cord with an active connector. The EVA tubing at the rear of the active handle then leads to a filter and pump system that facilitates the removal of harmful "surgical smoke" from the site of operation. The switching controls are mounted onto an active handle that moves freely up and down the shaft of the device when the device is in vertical position (or moves freely forward and backward when the device is in horizontal position), when the switching control moves freely on the shaft, distance between the front end of the handle and the controls is reduced or increased that works like extending and retracting the suction tip on general smoke evacuation, allowing the surgeon a greater degree of control and removing the need for additional accessories to extend the length of the device when working in cavities and other areas with restrictive access. Furthermore, the electrode can be exchanged with 63.5mm, 69mm and 120mm long electrodes in diameter 2.36±0.2mm with corresponding nosecone for further extending the length of suction tip for smoke evacuation.
(2) Smoke evacuation system with electrosurgical pencil (CE809): The device includes electrosurgical pencil with electrode and smoke evacuation handle connected with EVA tubing with ID22mm tubing connector. Electrosurgical pencil (PD646 or PD631) with 69mm long electrodes in diameter 2.36±0.2mm, can be put into the handle that functions as smoke evacuation pencil.
This document is a 510(k) premarket notification for a medical device and therefore primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in a traditional clinical trial sense. The provided text describes non-clinical performance testing (bench testing) to support substantial equivalence.
Here's an analysis based on the information provided, specifically addressing the requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical quantitative AI/software sense (e.g., sensitivity, specificity, AUC thresholds). Instead, it compares the proposed device's characteristics and its tested performance against those of a predicate device to demonstrate substantial equivalence.
The "acceptance criteria" in this context are implicitly defined by the safety and performance standards met by the predicate device and the relevant international and national standards for electrosurgical devices and smoke evacuation systems. The "reported device performance" refers to the results of the bench testing that showed equivalence to the predicate device.
Here's a reinterpretation of the request based on the available information:
| Feature / Performance Aspect | Acceptance Criteria (Implicitly from standards/predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Intended Use | Same as predicate (electrosurgical cutting/coagulation with smoke evacuation) | Same as predicate: "The device is intended to be used as the active monopolar electrode in an electrosurgery generator system for cutting and coagulation, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system." |
| Indication for Use | Same as predicate: remove smoke plume, conduct electrosurgical current | Same as predicate: "To conduct electrosurgical current from an electrosurgical generator to target tissue in electrosurgical procedures for monopolar cutting and coagulation, with the additional function of evacuation to facilitate the removal of surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system." |
| Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Product Code | GEI | GEI |
| OTC or Prescription | For prescription use | For prescription use |
| Energy Delivery | High frequency electrical current/energy | High frequency electrical current/energy |
| Technology | Monopolar electrosurgery and use of vacuum for smoke capture | Monopolar electrosurgery and use of vacuum source to capture smoke |
| Device Mode | Cut and Coag. | Cut and Coag. |
| Electrical Safety | Comply with dielectric strength per AAMI HF-18 (predicate) | Comply with dielectric strength in accordance with ES60601-1, IEC60601-1-2 & IEC60601-2-2 (Similar kinds of safety requirements) |
| Biocompatibility | Comply with ISO10993 | Comply with ISO10993 |
| Sterility | EO sterile SAL 10-6 | EO sterile SAL 10-6 (Validated according to ISO 11135) |
| Shelf Life | 3 years | 3 years (Packaging integrity and accelerated aging test completed to support) |
| Performance (Thermal Effects) | Equivalent thermal effects and thermal zone sizes as predicate on porcine tissue | Bench testing using porcine tissue (kidney, liver, muscle) for Cut and Coagulation modes confirmed equivalent thermal effects and thermal zone sizes compared to the predicate device. |
| Rated Accessory Voltage | 5kVp (Predicate) | 4.5kVp (PS947) / 5kVp (CE809) - "Similar, does not affect performance" |
| Max. Operation Power | 300W | 300W |
2. Sample size used for the test set and the data provenance
- Test Set (for performance testing): The document mentions "bench testing on the subject device and predicate devices by using porcine tissue: kidney, liver, muscle for both Cut mode and Coagulation mode".
- Sample Size: Not explicitly stated (e.g., number of porcine tissue samples, number of tests performed). It only specifies the types of tissue.
- Data Provenance: Porcine tissue (an animal model). The country of origin is not specified, but the applicant is based in Hong Kong, China. It is a prospective bench test, not retrospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the study described is a non-clinical, bench testing study, not a study evaluating human performance or diagnostic accuracy that would require expert ground truth. The "ground truth" for the non-clinical performance evaluation was laboratory measurements and objective assessments (e.g., thermal zone size measurement, electrical safety compliance, sterilization validation).
4. Adjudication method for the test set
Not applicable. This was a non-clinical bench test. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for establishing expert consensus on patient data.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an electrosurgical pencil with smoke evacuation, not an AI or imaging device that would involve human readers or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an algorithm-only device. It's a physical medical device. The "performance" evaluated was its physical and electrical characteristics and its ability to perform cutting, coagulation, and smoke evacuation, as operated by a user in a simulated environment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench testing, the "ground truth" was established by:
- Laboratory measurements: Assessing thermal effects and thermal zone sizes on porcine tissue.
- Standard compliance: Verification against international and national standards (e.g., IEC, ISO, ASTM). This involves objective measurements and tests rather than expert consensus on subjective data.
8. The sample size for the training set
Not applicable. This is a hardware device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as it is not an AI/ML algorithm.
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November 30, 2020
Modern Medical Equipment Manufacturing, Ltd. Jerry Cheung Assistant Regulatory Manager Flat A, 11/F., Mai Wah Ind. Bldg., 1-7 Wah Sing Street Kwai Chung N.T. Hong Kong, China
Re: K200372
Trade/Device Name: Sterile and Non-sterile Single Use Smoke Evacuation Fingerswitch, Nosecone and Smoke Evacuation System with Electrosurgical Pencil Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 10, 2020 Received: February 14, 2020
Dear Jerry Cheung:
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.
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K2000372
Device Name
Sterile and Non-sterile Single Use Smoke Evacuation Fingerswitch, Nosecone and Smoke Evacuation System with Electrosurgical Pencil
Indications for Use (Describe)
The device is used to conduct electrosurgical current from an electrosurgical generator to target tissue in electrosurgical procedures for monopolar cutting and coagulation, with the additional function of evacuation to facilitate the removal of surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
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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| 1. 510(k) OwnerName: | Modern Medical Equipment Manufacturing Limited |
|---|---|
| Address: | Modern Medical Equipment Mfg., Ltd.Flat A, 11/F., Mai Wah Ind. Bldg.,1-7 Wah Sing Street,Kwai Chung, N.T., Hong Kong, China. |
| Telephone: | (852) 2420 9068 |
| Fax: | (852) 2481 1234 |
| Contact person: | Mr. Jerry Cheung |
| Date of preparation: | 26 Nov, 2020 |
| 2. DeviceName of Device: | Sterile and Non-sterile Single Use Smoke EvacuationFingerswitch, Nosecone and Smoke EvacuationSystem with Electrosurgical Pencil |
| Trade or proprietary name: | Sterile and Non-sterile Single Use Smoke EvacuationFingerswitch, Nosecone and Smoke EvacuationSystem with Electrosurgical Pencil |
| Common or usual name: | Sterile and Non-sterile Single Use SmokeEvacuation Pencil |
| Classification name: | Electrosurgical Cutting & CoagulationDevice & Accessories |
| Classification Panel: | General & Plastic Surgery |
| Product Code: | GEI |
| Class: | II |
3. Predicate device
MEDTEK PLUMEPEN Integrated Smoke Evacuation Pencil with 510(k) number K103375.
4. Device description
There are two main series of smoke evacuation pencil.
- (1) Smoke Evacuation Fingerswitch (PS947)
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The device includes the active handle which connects with the active electrode. The diameter of the mating part is 2.36mm+/-0.02mm. The buttons on the active handle control cutting and coagulation, the yellow side activates the cutting function and the blue side activates the coagulation function. The active handle's end is connected to an insulation cord with an active connector. The EVA tubing at the rear of the active handle then leads to a filter and pump system that facilitates the removal of harmful "surgical smoke" from the site of operation.
The device is compatible with the socket of generator accommodating the standard 3-pin active connector, the output voltage setting of generator not larger 4.5kVp, compatible cable connection of grounding pad to the generator and all smoke evacuators with an ID22mm EVA tubing connector.
In addition to these familiar features and functions, the switching controls are mounted onto an active handle that moves freely up and down the shaft of the device when the device is in vertical position (or moves freely forward and backward when the device is in horizontal position), when the switching control moves freely on the shaft, distance between the front end of the handle and the controls is reduced or increased that works like extending and retracting the suction tip on general smoke evacuation, allowing the surgeon a greater degree of control and removing the need for additional accessories to extend the length of the device when working in cavities and other areas with restrictive access. Furthermore, the electrode can be exchanged with 63.5mm, 69mm and 120mm long electrodes in diameter 2.36±0.2mm with corresponding nosecone for further extending the length of suction tip for smoke evacuation.
(2) Smoke evacuation system with electrosurgical pencil (CE809)
The device includes electrosurgical pencil with electrode and smoke evacuation handle connected with EVA tubing with ID22mm tubing connector. Electrosurgical pencil (PD646 or PD631) with 69mm long electrodes in diameter 2.36±0.2mm, can be put into the handle that functions as smoke evacuation pencil.
The device is compatible with the socket of generator accommodating the standard 3-pin active connector, the output voltage setting of generator not larger 5kVp, compatible cable connection of grounding pad to the generator and all smoke evacuators with an ID22mm EVA tubing connector.
The products, PS947 and CE809 do not have technology difference.
5. Indication for use
The device is used to conduct electrosurgical current from an electrosurgical generator to target tissue in electrosurgical procedures for monopolar cutting and coagulation, with the additional function of evacuation to facilitate the removal of surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
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6. Technological characteristics
Single Use Smoke Evacuation Fingerswitch and Smoke Evacuation System with Electrosurgical Pencil integrates two technologies of electrosurgery and smoke evacuation. These two devices have substantially equivalent construction and performance as the predicate devices.
7. Substantial Equivalence
The technological characteristics and performance testing of the subject and predicate devices are substantially equivalent. The following table shows the comparisons in more detail information among the subject devices and the predicate device.
| ComparedItems | Proposed Device | Proposed Device | Predicate Device(K103375) | Comments ondifference |
|---|---|---|---|---|
| Intended use | Single Use SmokeEvacuationFingerswitch(PS947)The device isintended to be usedas the activemonopolar electrodein an electrosurgerygenerator system forcutting andcoagulation, with theadditional function tofacilitate the removalof surgical smokegenerated byelectrosurgery whenused in conjunctionwith an effectivesmoke evacuationsystem | Single Use Smokeevacuation systemwith electrosurgicalpencil (CE809)The device isintended to be usedas the activemonopolar electrodein an electrosurgerygenerator system forcutting andcoagulation, with theadditional function tofacilitate the removalof surgical smokegenerated byelectrosurgery whenused in conjunctionwith an effectivesmoke evacuationsystem | MEDTEKPLUMEPENIntegrated SmokeEvacuation PencilThe PLUMEPEN isdesigned for generalelectrosurgicalapplications,including cutting andcoagulation, and forremoving smokegenerated byelectrosurgery whenused in conjunctionwith an effectivesmoke evacuationsystem. The pencilenables the operatorto remotely conductan electrosurgicalcurrent from theoutput connector ofan electrosurgicalunit to the operativesite for the desiredsurgical effect. | Same |
| Indication foruse | The device is usedto conductelectrosurgicalcurrent from anelectrosurgicalgenerator to targettissue inelectrosurgicalprocedures formonopolar cuttingand coagulation,with the additionalfunction ofevacuation tofacilitate the removalof surgical smokegenerated byelectrosurgery whenused in conjunctionwith an effectivesmoke evacuationsystem. | The device is usedto conductelectrosurgicalcurrent from anelectrosurgicalgenerator to targettissue inelectrosurgicalprocedures formonopolar cuttingand coagulation,with the additionalfunction ofevacuation tofacilitate the removalof surgical smokegenerated byelectrosurgery whenused in conjunctionwith an effectivesmoke evacuationsystem. | To remove smokeplume form thesurgical site andremotely conduct anelectrosurgicalcurrent from theoutput connector ofan electrosurgicalunit to the targettissue for thedesired surgicaleffect | Same |
| Regulationnumber | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | Same |
| Product code | GEI | GEI | GEI | Same |
| OTC orprescription | For prescription use | For prescription use | For prescription use | Same |
| Energydelivery | High frequencyelectricalcurrent/energy | High frequencyelectricalcurrent/energy | High frequencyelectricalcurrent/energy | Same |
| Technology | Monopolarelectrosurgery anduse of vacuumsource to capturesmoke | Monopolarelectrosurgery anduse of vacuumsource to capturesmoke | Monopolarelectrosurgery anduse of vacuumsource to capturesmoke | Same |
| Device mode | Cut and coag. | Cut and coag. | Cut and coag. | Same |
| Design | Smoke evacuation | Smoke evacuation | Electrosurgical | Similarconstruction andprovide the sametechnology toachieve targetfunction.Extending thesuction tip and |
| fingerswitch is | system with pencil | pencil is integrated | ||
| produced from that | includes pencil is | with smoke | ||
| electrosurgical | combined with the | evacuation with | ||
| pencil is integrated | specified suction | extendable suction | ||
| with smoke | handle that performs | tip A variety of | ||
| evacuation with | as those of suction | length of electrode | ||
| switching control | evacuation pencil. | be used with | ||
| moving on the shaftof device in order toperform asextending orretracting suctiontip. Nosecone canbe added to furtherextend the suctiontip. | extendable suctiontip. | electrode is onlyfor facilitatingoperation indeeper surgicalsite | ||
| Structure ofPencil- Housing- Cable | ||||
| - Housing- Cable | - ABS- PVC | - ABS- PVC | - ABS- PVC | The materialused andstructure among |
| -Nosecone /Suction tip | - K-resin | - K-resin | - K-resin | the purposedand predicatedevices are very |
| -Suctiontubing | - EVA | - EVA | - EVA and PVC | similar and donot raise safetyandeffectivenessissues becausethose weretested accordingto IEC test andbiocompatibilityrequirements |
| -Switching | - Push button, rocker | - Push button, rocker | - Push button | Same function |
| -Electrode tipstyle | -Blade | -Blade | -Blade | Same |
| -ElectrodeMaterial | -Stainless steel | -Stainless steel | - Stainless steel | Same |
| - Length | - 50mm, 63.5mm, 69mm, and 120mm. | - 69 mm | -69mm or longer | Similar, longerlengths do notaffect cut andcoag.performance butonly facilitatesthe electrode tipgo to deepersurgical site. |
| - Diameter | -2,36 mm | -2,36 mm | ~2.36mm | Same |
| - Conductiveend | -15.5mm | -15.5mm | -15.5mm | Same |
| - Tip width | - 2.3mm | - 2.3mm | - 2.3mm | Same |
| - Tip depth | ~0.5mm | ~0.5mm | ~0.5mm | Same |
| - Insulationmaterial | - PTFE Shrink Wrap | - HIPS | - HIPS | The proposedelectrode passesthe required testsaccording toISO10993,IEC60601-1 andIEC60601-2-2 sothere will not anyissue for safety. |
| - Electrodecoating | -Teflon one coat | -Teflon one coat | - Teflon one coat | Same |
| -Ratedaccessoryvoltage | - 4.5kVp | - 5kVp | - 5kVp | Similar, does notaffectperformance |
| Max.operationpower | -300W | -300W | -300W | Same |
| Sterile | EO sterile SAL 10-6 | EO sterile SAL 10-6 | EO sterile SAL 10-6 | Same purpose,EO sterilization isvalidatedaccording to ISO11135 |
| Shelf life | 3 years | 3 years | 3 years | Same |
| Electricalsafety | Comply withdielectric strength inwith accordanceES60601-1,IEC60601-1-2 &IEC60601-2-2 | Comply withdielectric strength inwith accordanceES60601-1,IEC60601-1-2 &IEC60601-2-2 | Comply withdielectric strength inwith accordanceAAMI HF-18 | Same kinds ofsafetyrequirements |
| Biocompatibility | Comply withISO10993 | Comply withISO10993 | Comply withISO10993 | Meet tobiocompatibilityrequirements soit does not raise |
| any safety issue for biocompatibility |
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8. The technology different raising safety or effectiveness of the devices.
Basically, the technologies used for the proposed device and predicate device are the same including electrosurgical monopolar cutting and coagulation, and smoke evacuation, only a little difference on suction tip mechanism that will not raise any additional safety issue.
9. Non-clinical Performance Testing Data
Validation and Verification testing was performed on device sterility in accordance with ISO 11135:2014.
Performance Testing included bench testing on the subject device and predicate devices by using porcine tissue: kidney, liver, muscle for both Cut mode and Coagulation mode in accordance with the Premarket Notification (510(k) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff, Document issued on August 15, 2016, the evaluation of the thermal effects on the tissues and measurement of the thermal zone sizes are proved that the subject device and the predicate device are equivalent in the performance.
The safety performance of the subject device passed all the testing according to internal requirements and international standards shown below to support the substantial equivalence of the subject device
- ANSI/AMMI ES60601-1:2005/(R)2012 + A1:2012, C1:2009/(R)2012 + A2:2010/(R)2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC60601-2-2: 2017 (Fifth Ed), Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.
- IEC60601-1-2:2014, Medical Electrical Equipment Part 1-2: General - Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
- ISO10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- -ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
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- -ISO 11607-1:2019 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
Furthermore, the packaging integrity and accelerated aging test were completed on the subject device to support the proposed shelf life.
10. Conclusion
Based on comparing technological characteristic and performance testing data, the subject device, Single Use Smoke Evacuation Fingerswitch and Single Use Smoke Evacuation System with Electrosurgical Pencil are substantially equivalent to predicate device (K103375).
§ 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.