Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J

Q: Who is the manufacturer of Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J?

New Deantronics Taiwan , Ltd. filed the 510(k) submission for Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J (K183594).

Q: What is the FDA product code for Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K183594 · New Deantronics Taiwan , Ltd. · GEI · Feb 19, 2019 · General, Plastic Surgery

Device Facts

Record ID	K183594
Device Name	Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J
Applicant	New Deantronics Taiwan , Ltd.
Product Code	GEI · General, Plastic Surgery
Decision Date	Feb 19, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

These electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. Irrigation and suction capabilities via the same handset are available as well.

Device Story

Laparoscopic hollow electrodes; monopolar electrosurgical accessories. Input: high-frequency current from electrosurgical generator via compatible handset (e.g., Valleylab E2750). Transformation: delivers RF current to target tissue for cutting/coagulation; provides integrated suction/irrigation channels. Output: electrosurgical effect on tissue; fluid aspiration/delivery. Used in hospital settings by trained professionals. Benefits: enables simultaneous cutting, coagulation, and fluid management in minimally invasive procedures, reducing instrument exchanges.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via suction/aspiration testing, thermal effects on tissue, electrical safety (IEC 60601-1, IEC 60601-2-2), EMC (IEC 60601-1-2), shelf-life/sterility validation, and biocompatibility (ISO 10993-1).

Technological Characteristics

Monopolar electrosurgical accessory. Materials: SUS 304 stainless steel (tip), PTFE/PC/POF (sheath), PC (hub), LDPE (protector). Dimensions: 28cm/36cm lengths; 4.75mm-5.00mm OD. Energy: RF current. Sterilization: EtO (retractable) or Gamma (non-retractable). Connectivity: compatible with standard electrosurgical pencils/generators.

Indications for Use

Indicated for use in minimally invasive surgical procedures requiring monopolar electrosurgical cutting and coagulation, with optional irrigation and suction, in patients undergoing laparoscopic surgery.

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

Disposable Laparoscopic Electrodes, Coated and Non-coated (K153265)

Reference Devices

Valleylab Laparoscopic Electrodes (K964175)

Related Devices

K153265 — New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated · New Deantronics Taiwan , Ltd. · Jan 5, 2016
K200639 — LAP-iX · Sejong Medical Co., Ltd. · Sep 29, 2021
K030831 — LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS · Modern Medical Equipment Mfg., Ltd. · Jun 15, 2004
K973341 — HOOK ELECTRODE, NEEDLE ELECTRODE, COAGULATION BUTTON ELECTRODE · Richard Wolf Medical Instruments Corp. · Nov 13, 1997
K220384 — ArtiSential Laparoscopic Instruments-Electrodes · Livsmed, Inc. · Feb 24, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 19, 2019 New Deantronics Taiwan Ltd. % Craig Coombs President Coombs Medical Device Consulting, Inc 1193 Sherman St Alameda, California 94501 #### Re: K183594 Trade/Device Name: Laparoscopic Hollow Electrodes: Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm : Laparoscopic Wire L-Hook Electrode. Retractable. Aspiration Hole. 28cm: Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J-Hook Electrode, Hollow, 28cm ; Laparoscopic Wire L-Hook Electrode, Hollow, 28cm ; Laparoscopic Cylindrical Tip Electrode, Hollow, 28cm Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 20, 2018 Received: December 21, 2018 Dear Craig 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. {1}------------------------------------------------ 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 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 medical devices and radiation-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, Image /page/1/Picture/6 description: The image shows a digitally signed document. The document indicates that it was signed by Long H. Chen -S on February 19, 2019, at 15:19:41 -05'00'. The document is for Binita S. Ashar, M.D., M.B.A., F.A.C.S., who is the Director of the Division of Surgical Devices, Office of Device Evaluation. Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K183594 Device Name Laparoscopic Hollow Electrodes Indications for Use (Describe) These electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. Irrigation and suction capabilities via the same handset are available as well. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | \u2611 Prescription Use (Part 21 CFR 801 Subpart D) | \u2610 Over-The-Counter Use (21 CFR 801 Subpart C) | #### 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." {3}------------------------------------------------ # 510(k) Summary ## A. Device Information: | Category | Comments | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | New Deantronics Taiwan Ltd. 12F., No.51, Sec. 4, Chong Yang Rd., Tu Cheng District, New Taipei City 23675, Taiwan R.O.C. Tel: (886) 2-2268-1726 Fax: (886) 2-2268-3800 | | Correspondent Contact Information: | Craig Coombs Coombs Medical Device Consulting 1193 Sherman Street Alameda, CA 94501 Tel: 510-337-0140 | | Device Common Name: | Electrosurgical accessory | | Device Classification Number: | 21 CFR 878.4400 | | Device Classification & Product Code: | Class 2, GEI | | Device Proprietary Name: | Laparoscopic Hollow Electrodes | #### Predicate Device Information: | Predicate Device: | Disposable Laparoscopic Electrodes, Coated and Non-coated | |-------------------------------------------|-------------------------------------------------------------------------------------| | Predicate Device Manufacturer: | New Deantronics | | Predicate Device Common Name: | Electrosurgical accessory | | Predicate Device Premarket Notification # | K153265 | | Predicate Device Classification: | 21 CFR 878.4400 Electrosurgical, Cutting & Coagulation Device and Accessories | | Predicate Device Class & Product Code: | Class 2, GEI | #### Reference Device Information: | Reference Device: | Valleylab Laparoscopic Electrodes | |-------------------------------------------|-------------------------------------------------------------------------------------| | Reference Device Manufacturer: | Valleylab, Inc. | | Reference Device Common Name: | Electrosurgical accessory | | Reference Device Premarket Notification # | K964175 | | Reference Device Classification: | 21 CFR 878.4400 Electrosurgical, Cutting & Coagulation Device and Accessories | | Reference Device Class & Product Code: | Class 2, GEI | {4}------------------------------------------------ #### B. Date Summary Prepared 15 Feb 2019 #### C. Description of Device The New Deantronics Laparoscopic Hollow Electrodes, sold as sterile packaged, and ready for use devices, are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. The laparoscopic electrodes are used in conjunction with a Valleylab™ E2750 Laparoscopic Handset and 5 mm (internal diameter) or larger trocar, electrosurgical generator, and patient return electrode. During the operation, the electrode tip and the insulated shaft are to be inserted through a trocar, then conductive shaft end is inserted into the nose of an electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in a laparoscopic procedure. These devices can be used in hospitals and are used by trained professionally only. #### D. Indications for Use These electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. Irrigation and suction capabilities via the same handset are available as well. {5}------------------------------------------------ #### E. Comparison to Predicate Device As described below, the application New Deantronic Hollow Electrodes is substantially equivalent in intended use, technology, design and physician use to the predicate New Deantronics Disposable Laparoscopic Electrodes, coated and non-coated (K153265). | Feature | Application Device: New Deantronics Laparoscopic Hollow Electrodes | Predicate Device: New Deantronics Disposable Laparoscopic Electrodes, coated and non-coated (K153265) | Reference Device: Valleylab Laparoscopic Handsets and Laparoscopic Electrodes (K964175) | Pertinence of Feature to Consideration of Substantial Equivalence. | |-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | These electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. Irrigation and suction capabilities via the same handset are available as well. | The disposable laparoscopic electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired. | The Valleylab Laparoscopic Handsets (models E2750, E2751, E2750T and E2751T) and the Electrodes (model E2770 series, E2780 series, E2780R series and E2780R- ASP) are intended for use in those laparoscopic or thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable. The device is not intended to be used in endoscopic surgical procedures. | The Indications for Use of the application and predicate devices are nearly the identical; all of these devices are for RF cutting or coagulation in minimally invasive surgical procedures. The application device has irrigation and suction capabilities, but as evidenced by the reference device, these capabilities have long been applied to such devices and raise no new questions of safety or efficacy for these types of devices. | | Product Code | GEI | GEI | GEI | Identical to both predicate and reference devices | | Feature | Application Device: Laparoscopic Hollow Electrodes | Predicate Device: New Deantronics Disposable Laparoscopic Electrodes (K153265) | Reference Device: Valleylab Laparoscopic Handsets and Laparoscopic Electrodes (K964175) | Pertinence of Feature to Consideration of Substantial Equivalence. | | | | | Technology | | | Mechanism of Operation | The New Deantronics Laparoscopic Hollow Electrodes combine RF technology with suction and irrigation of fluids during electrosurgical procedures. | Same RF cutting and coagulation capability | Same RF cutting and coagulation capability and same suction & irrigation capabilities as application device | Identical to predicate for RF cutting and coagulation and identical to reference for RF capabilities and suction and irrigation of fluids. | | Compatible w/ RF Monopolar or Bipolar administration? | Monopolar only | Same | Same | Identical to both predicate and reference devices | | Compatible Device | Valleylab™ E2750 Laparoscopic handset | Monopolar electrosurgical pencils w 0.093" (2.36mm) nozzle & w 5mm cannula or larger | Valleylab™ E2750 Laparoscopic handset | Identical to reference device; clinically equivalent to predicate device for insertion into 3rd party hand pieces | | | Design | | | | | Electrode length | Retractable: 28cm and 36 cm Non-Retractable: 28cm | 36cm and 45 cm | Same as application | Identical to reference device; Clinically equivalent to predicate. All sizes of all devices intended for laparoscopic applications | | Electrode Outer Diameter | Retractable: 5.00mm Non-Retractable: 4.75mm | 2.36mm shaft OD | Same as application | Identical to reference device; Clinically equivalent to predicate. All sizes of all devices intended for laparoscopic applications | | Feature | Application Device: Laparoscopic Hollow Electrodes | Predicate Device: New Deantronics Disposable Laparoscopic Electrodes (K153265) | Reference Device: Valleylab Laparoscopic Handsets and Laparoscopic Electrodes (K964175) | Pertinence of Feature to Consideration of Substantial Equivalence. | | Electrode Inner Diameter | Retractable: 4.10mm Non-Retractable: 3.18mm | Not Applicable | Same as application | ldentical to reference device; Clinically equivalent to predicate. | | Materials for Electrode Tip | SUS 304 Stainless without coating | SUS 304 Stainless with PTFE coating or without coating | SUS 304 Stainless without coating | Functional tip identical to predicate and reference devices | | Materials for Electrode Sheath | Retractable: PTFE, PC and POF (black) Non-Retractable: POF (black) | POF (blue) | Retractable: PTFE, PC and POF (black) Non-Retractable: POF (black) | Nearly identical to predicate and reference devices | | Materials for Electrode Hub (Retractable Only) | PC (Polycarbonate) | Not Applicable; No hub | PC (Polycarbonate) | ldentical to reference device | | Materials for Tip Protector | Distal: LDPE Proximal: LDPE | Distal: LDPE Proximal: LDPE | Retractable Distal: PVC, Proximal: LDPE Non-Retractable Distal: LDPE, Proximal: LDPE | Nearly identical to predicate and reference devices | | Feature | Application Device: Laparoscopic Hollow Electrodes | Predicate Device: New Deantronics Disposable Laparoscopic Electrodes (K153265) | Reference Device: Valleylab Laparoscopic Handsets and Laparoscopic Electrodes (K964175) | Pertinence of Feature to Consideration of Substantial Equivalence. | | Electrode Tip | Retractable: Curved Spatula, Wire J-Hook, Wire L-Hook, Flat L-Hook Non-Retractable: Straight Spatula, Curved Spatula, Wire J-Hook, Wire L-Hook, Cylindrical Tip | Straight Spatula, Curved Spatula, Wire J-Hook, Wire L-Hook, Flat L-Hook | Retractable: Curved Spatula, Wire J-Hook, Wire L-Hook, Flat L-Hook Non-Retractable: Straight Spatula, Curved Spatula, Wire J-Hook, Wire L-Hook, Cylindrical Tip, Flat L-Hook | Almost Identical, except for Non-Retractable Flat L-Hook existing in reference but not in application. All styles in application device are found in predicate device, except for cylindrical tip. Differences raise no new questions of safety or efficacy | | Maximum Peak Voltage | High Frequency: 13.5 $kV_{p-p}$ Main Frequency: 5400V for 60 seconds | 6300V (60Hz) for 60 seconds | 5200V (60Hz) for 60 seconds | High withstand voltage is as safe as the predicate and reference devices. | | Other Attributes | | | | | | Single Use or Reusable? | Single Use | Single Use | Single Use | Identical to predicate and reference devices | | Provided Sterilized? | Yes | Yes | Yes | Identical to predicate and reference devices | | Sterilization | Retractable: EtO | EtO | Retractable: EtO | Identical to predicate and | | Method | Non-Retractable: Gamma | | Non-Retractable: Gamma | reference devices | | Performance/ Safety Testing in | IEC 60601-1 | IEC 60601-1 | AAMI HF18-1986 | Fundamentally Identical to | | accordance with | IEC 60601-1-2 | IEC 60601-1-2 | IEC 601-2-2 | predicate and reference devices, | | | IEC 60601-2-2 IEC 60601-2-18 | IEC 60601-2-2 IEC 60601-2-18 | | application device in conformance with latest version of the listed standards | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ #### F. Summary of Supporting Data. New Deantronics has conducted extensive testing to ensure that the subject devices met design specification, function as intended and conform to the internationally recognized standards. #### Bench Testing All the test results demonstrate the performance of New Deantronics Laparoscopic Hollow Electrodes meet the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the Laparoscopic Hollow Electrodes are as safe and effective as the predicate devices. Performance bench testing was conducted in accordance with FDA's guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery issued August 15, 2016 and internal requirements. Suction & Aspiration testing and Thermal Effects on Tissue testing were conducted to demonstrate adequate performance within a system. #### Electrical Safety and Electromagnetic Compatibility Testing Electrical safety testing was conducted in accordance with: IEC 60601-1:2005+AM1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-2-2:2017 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. Electromagnetic Compatibility Testing (EMC) was conducted in accordance with: IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. The New Deantronics Laparoscopic Hollow Electrodes passed all electrical safety and EMC testing. ### Shelf-Life Testing Shelf-life testing was conducted in accordance with FDA's guidance document Premarket Notification (510(k)) Submissions for Electrosurqical Devices for General Surgery issued August 15, 2016 and internal requirements. The New Deantronics Laparoscopic Hollow Electrodes were subjected to accelerated aging. The aging studies established that the device and packaging remain functional and maintain sterility for 2 years. #### Biocompatibility Testing Biocompatibility testing was conducted in accordance with ISO 10993-1:2009/AC:2010, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and FDA's guidance documents, Use of International Standard ISO {10}------------------------------------------------ 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued June 16, 2016 and Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery issued August 15, 2016. This testing demonstrates that the materials in the device will not cause a biocompatibility reaction when used as intended. #### Animal Studies No animal studies were performed as appropriate verification of the device was achieved from the results of the bench performance testing, biocompatibility evaluation, and electrical/safety testing. #### Clinical Studies No clinical studies were performed as appropriate verification of the device was achieved from the results of the bench performance testing, biocompatibility evaluation, and electrical/safety testing. #### Conclusion It is concluded that the New Deantronics Laparoscopic Hollow Electrodes are substantially equivalent to the predicate New Deantronics Disposable Laparoscopic Electrodes, coated and non-coated (K153265).

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