The smoke evacuation rocker switch pencil and telescoping smoker switch pencil are intended 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 Valleylab™ Smoke Evacuation Rocker Switch Pencil family consists of sterile, single-use, hand-held monopolar electrosurgical instruments designed for use with compatible Covidien generators that include monopolar capabilities to cut and coagulate through tissue. They have a standard three-prong monopolar plug. The devices have an integrated smoke capture capability and are included with a default adapter that can aid in the connection to a smoke evacuation system. The adapter can be removed or replaced as needed to fit a variety of smoke evacuation systems. The proposed device family will be provided gamma sterilized. The proposed devices do not contain software.

The pencil family consists of standard and telescoping pencil models and associated accessories. The standard model is designed with a fixed smoke nozzle and electrode length, with the option for use with extender accessories (Valleylab™ Smoke Evacuation Extension Tube) and longer electrodes to access deeper spaces while maintaining smoke evacuation capabilities. The telescoping model has an independently telescoping smoke nozzle and electrode, allowing for a customizable configuration.

AI/ML Overview

The provided text describes a 510(k) premarket notification for electrosurgical devices, not an AI/ML device. Therefore, the questions related to AI/ML specific acceptance criteria, study design, and performance metrics cannot be answered from the given document.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data, primarily related to safety and effectiveness of electrosurgical cutting, coagulation, and smoke evacuation.

However, I can extract information relevant to general device evaluation as presented:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence determination for a medical device (electrosurgical pencil) and not an AI/ML diagnostic tool, the acceptance criteria are not in terms of traditional metrics like sensitivity, specificity, or AUC. Instead, they relate to established medical device standards and functional performance in comparison to a predicate device.

Acceptance Criteria Category	Standard	Reported Device Performance
Biocompatibility	ISO 10993-1: "Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process"	Testing included Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, and Hemolysis. (Implied compliance with ISO 10993-1, though specific results/acceptance levels are not detailed). The direct patient-contacting materials are: stainless steel and polymers including polycarbonate and ABS.
Electrical Safety	IEC 60601-1 (general medical electrical equipment) and IEC 60601-2-2 (particular requirements for high-frequency surgical equipment)	The system complies with relevant portions of these standards.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2 (general requirements for basic safety and essential performance – electromagnetic disturbances – requirements and tests)	The system complies with relevant portions of this standard.
Mechanical/Functional Testing	Requirements defined in related design inputs and subsequent product specifications.	Carried out to verify that the proposed device family performs as expected and conforms to requirements. (No specific thresholds or results provided).
Ex-vivo Monopolar Thermal Effect	Comparison to predicate device across power settings and modes on various tissue types. (Implied acceptance is comparable thermal effect, ensuring safety and effectiveness are maintained).	Evaluated on three different tissue types with three power settings for all three energy modes using multiple compatible electrosurgical generators. (Results are not quantified, but the study implies equivalence to predicate).
Human Factors and Usability	IEC 62366 "Medical devices—Application of usability engineering to medical devices."	The usability engineering process complied with IEC 62366, including analysis of user needs, potential use errors, and testing to demonstrate safe and correct use by representative users.

The following questions are not applicable or cannot be answered from the provided text as it pertains to a traditional medical device submission, not an AI/ML device.

Sample size used for the test set and the data provenance: Not applicable for an AI/ML model. The "test set" here refers to physical testing of prototypes.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an AI/ML model. Ground truth in this context would be physical measurements or standardized test results.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for an AI/ML model.
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 tool, not an AI diagnostic assistant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device has no standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance data mentioned (biocompatibility, electrical safety, mechanical/functional, thermal effect), the "ground truth" would be objective measurements against established engineering standards and physical properties, not clinical diagnostic ground truth.
The sample size for the training set: Not applicable. There is no AI/ML model training set.
How the ground truth for the training set was established: Not applicable. There is no AI/ML model training set.

Summary of the study/performance evaluation presented:

The submission aimed to demonstrate substantial equivalence of the Valleylab™ Smoke Evacuation Rocker Switch Pencil family to its predicate device (Valleylab™ Smoke Evacuation Pencil, K103375). This was achieved through a series of non-clinical performance tests:

Biocompatibility testing according to ISO 10993-1.
Electrical safety and EMC testing complying with relevant IEC 60601 standards.
Mechanical and functional testing to confirm performance against design requirements.
Ex-vivo Monopolar Thermal Effect testing comparing the proposed device's thermal performance to the predicate device across various tissue types, power settings, and modes, using different electrosurgical generators.
Human Factors and Usability testing in compliance with IEC 62366 to ensure safe and correct use.

No pre-clinical or clinical studies relying on "assessment of performance data" for substantial equivalence were conducted, as stated in the document. The overall conclusion was that the device is as safe and effective as the predicate based on the non-clinical performance documentation.

Summary

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November 19, 2018

Covidien Ms. Jennie van Diemen Regulatory Affairs Specialist 5920 Longbow Drive Boulder, Colorado 80301

Re: K182772

Trade/Device Names: Valleylab™ Smoke Evacuation Rocker Switch Pencil and Accessories and ValleylabTM Telescoping Smoke Evacuation Rocker Switch Pencil

Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 28, 2018 Received: October 1, 2018

Dear Ms. van Diemen:

We have reviewed vour 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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,

Digitally signed by Long H. Chen Long H. Chen -S -s -5
Date: 2018.11.19 11:59:35 -05'00' Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182772

Device Name

Valleylab™ Smoke Evacuation Rocker Switch Pencil and Accessories and Valleylab™ Telescoping Smoke Evacuation Rocker Switch Pencil

Indications for Use (Describe)

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)

| X | Prescription Use (Part 21 CFR 801 Subpart D)

|__| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Date summary prepared: November 13, 2018

510(k) Submitter/Holder

Covidien 5920 Longbow Drive Boulder, CO 80301

Contact

Ms. Jennie van Diemen Regulatory Affairs Specialist Telephone: 303-581-7037 Fax: 303-530-6313 Email: jennie.vandiemen@medtronic.com

Name of Device

Recalls:

Trade Name:	Valleylab™ Smoke Evacuation Rocker Switch Pencil andAccessories and Valleylab™ Telescoping Smoke Evacuation RockerSwitch Pencil
Common Name:	Monopolar Electrosurgical Smoke Evacuation Instrument andAccessories
Classification Name:	Electrosurgical cutting and coagulation device and accessories(21 CFR § 878.4400, Class II, GEI)
Predicate Device
Trade Name:	Valleylab™ Smoke Evacuation Pencil
Common Name:	Monopolar Electrosurgical Smoke Evacuation Instrument
510(k) Number:	K103375 (cleared 03/16/2011) by MedTek, dba Buffalo Filter
Manufacturer:	Buffalo Filter

This device has not been subject to a design-related recall

No reference devices were used in this submission.

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Device Description

Indications for Use

The smoke evacuation rocker switch pencil and telescoping smoke evacuation rocker switch pencil are intended 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.

Technological Characteristics

The subject device and the predicate devices are based on the following same technological element:

Monopolar Energy
Monopolar electrode
. Sterilized, single use
Integrated smoke capture capability ●

The following technological differences exist between the subject and predicate devices:

Sterilization method ●
Shelf life
Physical features and dimensions
Maximum voltage ●
. Extended length configurations
. Electrode coating
. Smoke evacuation

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Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility

The biocompatibility evaluation for the Valleylab™ Smoke Evacuation Rocker Switch Pencil family was conducted in accordance with ISO 10993-1. "Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process." The testing included the following:

Cytotoxicity ●
Sensitization .
Irritation ●
. Systemic Toxicity
. Hemolysis

The direct patient-contacting materials are: stainless steel and polymers including polycarbonate and ABS.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety testing and EMC testing were conducted on the Valleylab™ Smoke Evacuation Rocker Switch Pencil family. The system complies with relevant portions of the IEC 60601-1 and IEC 60601-2-2 standards for electrical safety and IEC 60601-1-2 standard for EMC.

Mechanical / Functional Testing

Mechanical, electrical, and functional testing was carried out to verify that the proposed device family performs as expected and conforms to requirements defined in related design inputs and subsequent product specifications.

Ex-vivo Monopolar Thermal Effect

Monopolar ex vivo testing evaluated thermal effect resulting from monopolar energy application across the range of power setting and modes on the proposed devices in comparison to the predicate device. Testing utilized the Force FXTM Electrosurgical Generator Series (K944602), the ForceTriad™ Energy Platform (K051644), the Valley|ab™ FT10, FT Series Energy Platform (K151649), and the Valleylab™ FX8, FX Series Energy Platform (K172757). Monopolar thermal effects were evaluated on three different tissue types with three power settings for all three energy modes.

Pre-Clinical Studies

This premarket submission does not rely on the assessment of pre-clinical performance data to demonstrate substantial equivalence.

Clinical Studies

This premarket submission does not rely on the assessment of clinical performance data to demonstrate substantial equivalence.

Human Factors and Usability

The usability engineering process applied to the proposed devices was in compliance with the requirements of IEC 62366 "Medical devices—Application of usability engineering to medical devices." The process included analysis of user needs and potential use errors followed by testing to demonstrate that representative users can use the instruments safely and correctly.

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Summary

Based on the non-clinical performance as documented in the performance testing, the Valleylab™ Smoke Evacuation Rocker Switch Pencil family was found to be as safe and effective as the predicate device.

Conclusions

The comparison of device characteristics and the review of the performance data support the conclusion that the Valleylab™ Smoke Evacuation Rocker Switch Pencil family is substantially equivalent to the predicate device. The devices have intended use for their common fundamental technologies. The proposed devices have some design differences that enable them to better perform its indicated use. Testing has demonstrated that these differences do not raise any new questions of safety or effectiveness.

Regulation Number and Section

§ 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.