PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter

K230547 · Conmed Corporation · GEI · Apr 27, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K230547
• Device Name: PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter
• Applicant: Conmed Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 27, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PlumePen® Elite, PlumePen® Ultra, and PlumePen® Pro 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. Indicated for use to remove smoke plume from the surgical site and to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the target tissue for the desired surgical effect. The SnapEvac and PenAdapt is an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or blade exposed. This device is considered an accessory to an electrosurgical unit (ESU). SnapEvac and PenAdapt removes surgical smoke during surgical procedures that use ESU for cutting and cauterizing. This device is used in conjunction with a suction (vacuum) source.

Device Story

Devices include sterile, single-use electrosurgical handpieces (PlumePen Elite, Pro, Ultra) and aspiration sheath adapters (PenAdapt, SnapEvac). Handpieces integrate smoke evacuation channels into electrosurgical pencils; adapters fit over standard pencils. All devices connect to an electrosurgical unit (ESU) for current delivery and a vacuum source for smoke removal. Operated by surgeons/clinicians in clinical settings. Devices conduct electrical current to target tissue while simultaneously capturing smoke plume at the surgical site. Benefits include reduced exposure to surgical smoke and efficient tissue cutting/coagulation. No AI/ML components.

Clinical Evidence

Bench testing only. Performance verified via functionality testing (90% smoke capture per ISO 16571), electrical safety (IEC 60601-1, IEC 60601-2-2), biocompatibility (ISO 10993-1), and sterilization validation (ISO 11135, ISO 11137-1).

Technological Characteristics

Monopolar electrosurgical handpieces and aspiration sheaths. Materials meet ISO 10993-1. Electrical safety per IEC 60601-1 and IEC 60601-2-2. Sterilization via Ethylene Oxide (SAL 10^-6) or Gamma radiation. Single-patient use. No software or algorithm.

Indications for Use

Indicated for general electrosurgical applications (cutting/coagulation) and surgical smoke removal during procedures requiring electrosurgery. Contraindicated for microsurgery.

Regulatory Classification

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.

Predicate Devices

• PlumePen Integrated Smoke Evacuation Pencil (K103375)
• PenAdapt10 (K000904)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 27, 2023

ConMed Corporation Ali Abusaleh Regulatory Affairs Specialist 525 French Road Utica, New York 13502

## Re: K230547

Trade/Device Name: PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, FYD Dated: February 27, 2023 Received: February 28, 2023

Dear Ali Abusaleh:

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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

| Mark | Digitally signed by |
|-------------|---------------------|
| Trumbore -S | Mark Trumbore -S |
| | Date: 2023.04.27 |
| | 12:40:56 -04'00' |

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K230547

Device Name

SnapEvac Electrosurgical Pencil Adapter and PenAdapt Electrosurgical Pencil Adapter

Indications for Use (Describe)

The SnapEvac and PenAdapt is an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or blade exposed. This device is considered an accessory to an electrosurgical unit (ESU). SnapEvac and PenAdapt removes surgical smoke during surgical procedures that use ESU for cutting and cauterizing. This device is used in conjunction with a suction (vacuum) source.

Contraindications: This device should not be used for microsurgery.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><div><span style="font-size:20px;">☑</span></div><div>Prescription Use (Part 21 CFR 801 Subpart D)</div></div> | <div style="display:flex; align-items:center;"><div><span style="font-size:20px;">☐</span></div><div>Over-The-Counter Use (21 CFR 801 Subpart C)</div></div> |

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# Indications for Use

510(k) Number (if known)

K230547

Device Name

PlumePen (Elite, Pro and Ultra) Surgical Smoke Evacuation Pencil

#### Indications for Use (Describe)

The PlumePen® Elite, PlumePen® Ultra, and PlumePen® Pro 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 perator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Indicated for use to remove smoke plume from the surgical site and to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the target tissue for the desired surgical effect.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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## Section 6 - 510(k) Summary of Safety and Effectiveness

#### CONMED Smoke Evacuation Devices: PlumePen, PenAdapt and SnapEvac

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21CFR 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness

#### A. Submitter

ConMed Corporation 525 French Road Utica, NY 13502

### B. Company Contact

Ali AbuSaleh Requlatory Affairs Specialist [phone] Aliabusaleh(@conmed.com Date prepared: 4/26/2023

### C. Device Name

Proprietary Name:

Common Name: Model Numbers: Classification Name: Regulation Number: Product Code: Regulatory Class: Panel:

Proprietary Name:

Common Name: Model Numbers: Classification Name: Requlation Number: Product Code: Regulatory Class: Panel:

## D. Predicate Device

Primary Predicate Device Name: Company Name: 510(k):

Additional Predicate Device Name: Company Name: 510(k):

PlumePen Surqical Smoke Evacuation Pencils (Elite, Pro and Ultra) Electrosurgical Smoke Evacuation Pencil Refer to Tables 6-1 and 6-2 in Section G Electrosurgical, Cutting & Coagulation & Accessories 878.4400 GEI = General and Plastic Surgery

PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter Electrosurqical Pencil Adapter Refer to Tables 6-1 and 6-2 in Section G Electrosurgical, Cutting & Coagulation & Accessories 878.5070 FYD ll General Hospital

PLUMEPEN Integrated Smoke Evacuation Pencil CONMED Corporation K103375

PenAdapt10 CONMED Corporation K000904

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## E. Device Description

The smoke evacuation devices that are the subject of this 510(k) are PlumePen Surgical Smoke Evacuation Pencils (Elite, Pro and Ultra), PenAdapt Electrosurgical Pencil Adapters and Electrosurgical Pencil Adapters. By interfacing with an effective smoke evacuation unit, these devices function as part of the system to remove smoke particles from the point of surgical activity during procedures that use an electrosurgical unit (ESU) for cutting and cauterizing.

#### PlumePen Smoke Evacuation Pencils

The PlumePen® Elite, Pro, and Ultra family of devices are sterile, single use electrosurgical hand pieces featuring an integrated smoke evacuation channel. The devices, when connected to an electrosurgical generator and smoke evacuation system are designed to remove smoke plume generated during the use of the pencil for electrosurgical procedures.

### PenAdapt and SnapEvac Electrosurgical Pencil Adapters

PenAdapt and SnapEvac are sterile, single use pencil adapters which fit over standard electrosurgical pencils while keeping the blade exposed. They enable the capture and removal of smoke generated during the use of the pencil, in procedures that require cutting and cauterization, when connected to an effective smoke evacuation system.

## F. Intended Use / Indications for Use

### PlumePen Electrosurgical Pencils (Elite, Ultra and Pro)

The PlumePen® Elite, PlumePen® Ultra, and PlumePen® Pro 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. Indicated for use to remove smoke plume from the surqical site and to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the target tissue for the desired surgical effect.

#### SnapEvac and PenAdapt Electrosurgical Pencil Adapters

The SnapEvac and PenAdapt is an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or blade exposed. This device is considered an accessory to an electrosurgical unit (ESU). SnapEvac and PenAdapt removes surgical smoke during surgical procedures that use ESU for cutting and cauterizing. This device is used in conjunction with a suction (vacuum) source.

Contraindications: This device should not be used for microsurgery.

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## G. Comparison of the Technological Characteristics with the Predicate Device

The PlumePen Electrosurgical pencils (Elite, Pro and Ultra) are similar to the predicate device in that they remain an integration of two technologies, electrosurgery and smoke evacuation in a single device. Both the predicate and subject devices enable the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site while removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The subject and predicate devices have similar design features integrating a smoke capture channel into the main body of what is otherwise a standard electrosurgical handpiece. All PlumePen devices, including the predicate, comprise of the same critical parts: 1. Housing and buttons 2. Transparent/ translucent plume/smoke capture channel 3. Plastic Swivel 4. Electrosurgical blade 5. Power cord and suction hose.

The main difference between subject and predicate devices are the dimensions of the pencil body and placement of the smoke capture channel. The PlumePen line (Elite, Pro and Ultra) is safe, effective, and substantially equivalent to the predicate as demonstrated by non-clinical performance testing.

| Features | Subject Device: PlumePen Electrosurgical<br>Pencil (Elite, Pro and Ultra) | Predicate Device: PlumePen Integrated Smoke<br>Evacuation Pencil |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model<br>Numbers | PLP1020-25, PLP2020-25, PLP2520-25,<br>PLPRO4020-25, PLPRO4520-25,<br>PLPUL2020-25, PLPUL2520-25, PLP1020,<br>PLP2020, PLP2520, PLPRO4020,<br>PLPRO4520, PLPUL2020 and<br>PLPUL2520-25 | PLP1000 and PLP2000 |
| 510(k) | K230547 | K103375 |
| Intended Use/<br>Indications for<br>Use | The PlumePen® Elite, PlumePen® Ultra, and<br>PlumePen® Pro is designed for general electrosurgical<br>applications, including cutting and coagulation, and for<br>removing smoke generated by electrosurgery when<br>used in conjunction with an effective smoke evacuation<br>system. The pencil enables the operator to remotely<br>conduct an electrosurgical current from the output<br>connector of an electrosurgical unit to the operative site<br>for the desired surgical effect. Indicated for use to<br>remove smoke plume from the surgical site and to<br>remotely conduct an electrosurgical current from the<br>output connector of an electrosurgical unit to the target<br>tissue for the desired surgical effect. | The PLUMEPEN is designed for general electrosurgical applications,<br>including cutting and<br>coagulation, and for removing smoke generated by electrosurgery<br>when used in conjunction with<br>an effective smoke evacuation system. The pencil enables the<br>operator to remotely conduct an<br>electrosurgical current from the output connector of an<br>electrosurgical unit to the operative site<br>for the desired surgical effect.<br>Indications for use for PLUMEPEN® Integrated Smoke Evacuation<br>Pencil include:<br>a. To remove smoke plume from the surgical site.<br>b. To remotely conduct an electrosurgical current from the output<br>connector of an<br>electrosurgical unit to the target tissue for the desired surgical effect<br>c. To remove tissues and control bleeding by means of high<br>frequency electrical.<br>current |
| Polarity | Monopolar | Monopolar |
| Rated Voltage | 5 kVpk | 10kV P-P |
| Shelf-life | 3 years | 3 years |
| Sterilization<br>Method | Ethylene oxide, SAL of 10-6 | Ethylene oxide, SAL of 10-6 |
| Single use /<br>reusable | Single patient use device | Single patient use device |
| Electrical<br>Safety | Fulfils Electrical Safety requirements per<br>IEC 60601-1<br>Fulfils Electrical Safety requirements per<br>IEC 60601-2-2 | Fulfils Electrical Safety requirements per IEC 60601-1<br>Fulfils Electrical Safety requirements per IEC 60601-2-2 |

#### Table 6-1 Feature comparison between subject and predicate electrosurgical pencils

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PenAdapt and SnapEvac electrosurgical pencil adapters are similar to the predicate device in that they remain a sheath that can accommodate a standard electrosurgical pencil and facilitate smoke evacuation at the site of electrosurgery. The subject devices and predicate device have similar design features integrating a smoke capture channel into an accommodating sheath allowing the pencil to be inserted electrode first through the sheath tip and be secured proximally before being connected to an effective smoke evacuation system through tubing. This main difference between subject and predicate is the use of ABS in the SnapEvac devices. PenAdapt and SnapEvac are safe, effective, and substantially equivalent to the predicate as demonstrated by non-clinical performance testing.

| Features | Subject Device: PenAdapt and SnapEvac | Predicate Device: PenAdapt10 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model Numbers | PA2010-25, PA2010B-25, SNAPEVAC20-25,<br>PA2010, PA2010B and SNAPEVAC20 | PENADAPT10 |
| 510(k) | TBD | K000904 |
| Intended Use/<br>Indications for Use | The SnapEvac and PenAdapt is an aspiration sheath that<br>fits over an electrosurgical pencil body and leaves the tip or<br>blade exposed. This device is considered an accessory to<br>an electrosurgical unit (ESU). SnapEvac and PenAdapt<br>removes surgical smoke during surgical procedures that use<br>ESU for cutting and cauterizing. This device is used in<br>conjunction with a suction (vacuum) source. | This device is an aspiration sheath that fits over an<br>electrosurgical pencil body and leaves the tip or blade<br>exposed. This device is an accessory to an<br>electrosurgical unit (ESU). The device is used to<br>remove smoke, particles and body and other casual<br>fluids from the point of surgical activity during surgical<br>procedures that use ESU for cutting and cauterizing.<br>This device is used in conjunction with a suction<br>(vacuum) source. |
| Contraindications | This device should not be used for<br>microsurgery. | This device should not be used for<br>microsurgery. |
| Shelf-life | 3 years | 1 year |
| Sterilization Method | PenAdapt; Gamma<br>SnapEvac; Ethylene oxide | Gamma |
| Single use / reusable | Single patient use device | Single patient use device |
| Biocompatibility | Materials shall meet the requirements of ISO<br>10993-1 (tissue/bone/dentin externally<br>communicating device of limited duration) | Materials shall meet the requirements of<br>ISO 10993-1 (tissue/bone/dentin externally<br>communicating device of limited duration) |

| Table 6-2 Feature comparison between subject and predicate electrosurgical Pencil Adapters | | |
|--------------------------------------------------------------------------------------------|--|--|

#### H. Non-clinical Testing

Non-clinical bench testing demonstrated that PlumePen (Elite, Pro and Ultra), SnapEvac and PenAdapt are safe and effective for their intended use and are substantially equivalent in design. intended use, principals of operation, and technical characteristics to the predicates, PlumePen integrated smoke evacuation pencil cleared under K103375 the PenAdapt 10 cleared under K000904. The following testing was performed:

- Functionality verification testing, including 90% smoke capture per ISO16571 ●
- Electrical Safety (PlumePen) per IEC 60601-1 and IEC 60601-2-2
- Biocompatibility per ISO 10993-1 ●
- Ethylene Oxide Sterilization Validation (PlumePen and SnapEvac) per ISO 11135 .
- E-beam Sterilization validation (PenAdapt) per ISO 11137-1 ●
- Packaging Validation per ISO 11607-1

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#### -Conclusion

The subject PlumePen Smoke Evacuation pencils (Elite, Pro and Ultra), are substantially equivalent in design, materials, indications for use, principles of operation, performance, and technological characteristics to the predicate PlumePen integrated smoke evacuation pencil cleared under K103375. Based upon the findings of non-clinical testing, the differences present no issues of safety and efficacy and the subject PlumePen family (Elite, Pro and Ultra) is substantially equivalent to the PlumePen integrated smoke evacuation pencil (K103375).

The subject PenAdapt and SnapEvac Electrosurgical Pencil Adapters, are substantially equivalent in design, materials, indications for use, principles of operation, performance, and technological characteristics to the predicate PenAdapt 10 cleared under K000904. Based upon the findings of non-clinical testing, the differences present no issues of safety and efficacy, and the subject Electrosurgical Pencil Adapters are substantially equivalent to the PenAdapt10 (K000904).