(51 days)
The Smoke Evacuation Button Switch Pencil and Telescoping Smoke Evacuation 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.
The application devices, the Smoke Evacuation Button Switch Pencil and the Telescopic Smoke Evacuation Button Switch Pencil (referred to hereafter as the Smoke Evaluation Pencils), are a collection of electrosurgical electrodes with an integrated smoke collection tube. The flat blade electrode provided in each pencil can be removed and replaced with a compatible electrode.
New Deantronics is requesting clearance two series Smoke Evacuation Pencils.
The simplified series includes two different housing styles (round and oval) of pencil body design. Each housing style has two different lengths of attached tubing at the proximal end of the pencil body, 10ft and 15ft; thus, there are 4 models in this and the premium series. These 4 simplified series models share the same design elements (functional design, technology design, packaging, sterilization method and process, etc.)
The premium series embodies one of two extender mechanisms. There are 2 smoke nozzle extender/fixation mechanism designs in this series; with and without lock mechanism. Each design includes two lengths of spiral tube and cable, while all the other design elements, such as cosmetic appearance, grip characteristics, construction materials, packaging, sterilization method, etc., are identical in this premium series to the simplified series.
The Smoke Evacuation Pencils are designed to be used with a compatible electrosurgical generator and smoke evacuation system.
These devices are single use and are sold sterile.
The provided text is a 510(k) summary for a medical device (Smoke Evacuation Button Switch Pencil) seeking FDA clearance. It focuses on demonstrating substantial equivalence to a predicate device. This type of document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/algorithm-driven device.
The document describes the device as an electrosurgical accessory for cutting, coagulation, and smoke evacuation, and its performance is evaluated against engineering standards (e.g., IEC 60601 series, ISO 10993-1) and physical tests (e.g., button activation force, weld integrity). It does not mention any AI or algorithmic components, nor does it describe a study involving human readers or expert consensus for ground truth.
Therefore, I cannot fulfill the request using the provided text. The questions posed in the prompt (regarding acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance) are relevant to the evaluation of AI/ML-based medical devices, which this document is not about.
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November 20, 2020
New Deantronics Taiwan Ltd. % Mr. Craig Coombs President Coombs Medical Device Consulting, Inc. 1100 Pacific Marina, Suite 806 Alameda, California 94501
Re: K202962
Trade/Device Name: Smoke Evacuation Button Switch Pencil and Telescopic Smoke Evacuation Button 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 29, 2020 Received: September 30, 2020
Dear Mr. Coombs:
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202962
Device Name
Smoke Evacuation Button Switch Pencil and Telescopic Smoke Evacuation Button Switch Pencil
Indications for Use (Describe)
The Smoke Evacuation Button Switch Pencil and Telescoping Smoke Evacuation 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image contains the logo for "NEW DEANTRONICS". The word "NEW" is in black outlined in blue. To the right of the word "NEW" is a blue circle with a red dot in the center. The word "DEANTRONICS" is in blue and to the right of the circle.
K202962 510(k) Summary
A. Device Information:
| Category | Comments |
|---|---|
| Sponsor: | New Deantronics Taiwan Ltd. |
| 12F., No.51, Sec. 4, Zhongyang Rd., | |
| Tucheng District | |
| New Taipei City 236, | |
| Taiwan. | |
| Tel: (886) 2-2268-1726 | |
| Fax: (886) 2-2268-3800 | |
| Sponsor Contact: Ms. Jane Liu, President | |
| Email: jane@newdean.com.tw | |
| Correspondent ContactInformation: | |
| President | |
| Coombs Medical Device Consulting | |
| 1100 Pacific Marina, Suite 806 | |
| Alameda, CA 94501 | |
| Tel: 510-995-8499 | |
| Email: CraigJCoombs@gmail.com | |
| Device Common Name: | Electrosurgical Accessory - Electrode |
| Device Classification Number: | 21 CFR 878.4400 |
| Device Classification &Product Code: | Class II,GEI |
| Device Proprietary Name: | Smoke Evacuation Button Switch Pencil andTelescopic Smoke Evacuation Button Switch Pencil |
Predicate Device Information:
| Predicate Device: | Smoke Evacuation Rocker Switch PencilandTelescoping Smoke Evacuation RockerSwitch Pencil |
|---|---|
| Predicate Device Manufacturer: | Covidien (formerly Valleylab, Inc.) |
| Predicate Device Common Name: | Electrosurgical Accessory - Electrode |
| Predicate Device Premarket Notification # | K182772 |
| Predicate Device Classification: | 21 CFR 878.4400Electrosurgical, Cutting & CoagulationDevice and Accessories |
| Predicate Device Classification &Product Code: | Class 2,GEI |
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Image /page/4/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, and the word "DEANTRONICS" is in dark blue. There is a blue circle with a red dot in the middle between the two words. The logo is simple and clean.
B. Date Summary Prepared
16 November 2020
C. Description of Device
The application devices, the Smoke Evacuation Button Switch Pencil and the Telescopic Smoke Evacuation Button Switch Pencil (referred to hereafter as the Smoke Evaluation Pencils), are a collection of electrosurgical electrodes with an integrated smoke collection tube. The flat blade electrode provided in each pencil can be removed and replaced with a compatible electrode.
New Deantronics is requesting clearance two series Smoke Evacuation Pencils.
The simplified series includes two different housing styles (round and oval) of pencil body design. Each housing style has two different lengths of attached tubing at the proximal end of the pencil body, 10ft and 15ft; thus, there are 4 models in this and the premium series. These 4 simplified series models share the same design elements (functional design, technology design, packaging, sterilization method and process, etc.)
The premium series embodies one of two extender mechanisms. There are 2 smoke nozzle extender/fixation mechanism designs in this series; with and without lock mechanism. Each design includes two lengths of spiral tube and cable, while all the other design elements, such as cosmetic appearance, grip characteristics, construction materials, packaging, sterilization method, etc., are identical in this premium series to the simplified series.
The Smoke Evacuation Pencils are designed to be used with a compatible electrosurgical generator and smoke evacuation system.
These devices are single use and are sold sterile.
D. Indications for Use
The Smoke Evacuation Button Switch Pencil and Telescoping Smoke Evacuation Button 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.
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Image /page/5/Picture/1 description: The image shows the logo for New Deantronics. The word "NEW" is in black font on the left side of the logo. To the right of the word "NEW" is a blue circle with a red dot in the center. The word "DEANTRONICS" is in blue font on the right side of the logo.
E. Comparison to Predicate Device
The application Smoke Evacuation Pencils and the predicate devices
| Same | Indications for Use FDA Product Code Electrosurgical Monopolar Energy Operation Principle Compatible Device Maximum Allowable Voltage Replaceable Coated Electrode Ex-vivo Monopolar Thermal Effect Sterilization Method Single Use |
|---|---|
| Different | Physical Dimensions Construction Materials Activation Switch Type Electrode Coating Extendable Smoke Nozzle Fixation Mechanism |
None of the differences raised new questions of safety or effectiveness. New Deantronics concludes the devices are substantially equivalent.
F. Summary of Supporting Data
The application Smoke Evacuation Pencils were tested and found to be in compliance with the pertinent portions of the following standards:
| StandardsBody & # | Standard Name | StandardVersion |
|---|---|---|
| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for basicsafety and essential performance | 2005 + AMD1:2012 |
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements for basicsafety and essential performance – Collateral Standard:Electromagnetic disturbances – Requirements and tests | 2014 |
| IEC 60601-2-2 | Medical electrical equipment –Part 2-2: Particular requirements for thesafety of high frequency surgical equipment | 2017 |
| ISO 10993-1 | Biological Evaluation of Medical Devices – Part 1: Evaluation and testingwithin a risk management process. | 2018 |
| ISO 11607-1 | Packaging for terminally sterilized medical devices – Part 1:Requirements for materials, sterile barrier systems and packagingsystems; | 2019 |
| ASTM D4169 | Standard Practice for Performance Testing of Shipping Containers andSystems | 2016 |
The Smoke Evacuation Pencil was fully tested and in compliance with the FDA guideline Premarket Notification (510(k)) Submissions for Electrosurqical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff (9 March 2020).
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Image /page/6/Picture/1 description: The image shows the logo for New Deantronics. The word "NEW" is in a sans-serif font and is in a light blue color. To the right of the word "NEW" is a blue circle with a red dot in the center. To the right of the circle is the word "DEANTRONICS" in a bold, sans-serif font and is in a dark blue color.
Additional performance testing, outside of that described in the standards and guidelines described above, included:
| Additional Performance Test Item |
|---|
| Button Activation Force |
| Continuity & Activation switch resistance |
| Button activation over time |
| Continuity & Activation switch resistance |
| Activation over time |
| Electrode insertion/extraction force and electrode heat shrink inspection |
| Plug insertion/extraction force |
| Dynamic strain relief |
| Static strain relief |
| Adapter insertion/extraction force |
| Smoke tube-cable exit separation force |
| Smoke tube separation force |
| Nozzle extension/retraction force |
| Snap fit strength |
| Weld integrity test |
| Button retention force |
| Smoke tube linear force rupture |
| Smoke nozzle pull-out force |
| Electrode Wobble |
G. Conclusion
After comparing the Indications for Use, technology and design of the Smoke Evacuation Pencils, along with all electrical safety (including IEC 60601-1: 2005 + AM1:2012; IEC 60601-1-2: 2014; IEC 60601-2-2: 2017) and performance testing, in accordance with the FDA's guidelines and FDA-recognized consensus standards for electrical safety, New Deantronics concludes that the Smoke Evacuation Button Switch Pencil and Telescoping Smoke Evacuation Button Switch Pencil are substantially equivalent to the predicate Covidien (ValleyLab) Smoke Evacuation Rocker Switch Pencil and the Telescoping Smoke Evacuation Rocker Switch Pencil (K182772).
§ 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.