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 Description

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.

AI/ML Overview

This document is a 510(k) Pre-market Notification for Laparoscopic Hollow Electrodes. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "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." However, specific quantitative acceptance criteria or detailed reported performance values for each test are not explicitly provided in this document. The document broadly states that the device "passed all" relevant tests and "met the requirements."

Test Category	Acceptance Criteria (Not explicitly quantitative in this document)	Reported Device Performance
Bench Testing	Meet design specification, function as intended	"Meet the requirements of its pre-defined acceptance criteria and intended uses."
Suction & Aspiration testing	Adequate performance within a system	Adequate performance demonstrated
Thermal Effects on Tissue testing	Adequate performance within a system	Adequate performance demonstrated
Electrical Safety (IEC 60601-1, IEC 60601-2-2)	Compliance with standards	"Passed all electrical safety and EMC testing."
Electromagnetic Compatibility (EMC) (IEC 60601-1-2)	Compliance with standards	"Passed all electrical safety and EMC testing."
Shelf-Life Testing	Maintain functionality and sterility	"Established that the device and packaging remain functional and maintain sterility for 2 years."
Biocompatibility Testing (ISO 10993-1)	Not cause a biocompatibility reaction	"Demonstrates that the materials in the device will not cause a biocompatibility reaction when used as intended."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for any of the bench, electrical safety, EMC, shelf-life, or biocompatibility tests. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. These were all bench tests conducted by New Deantronics, presumably in their facilities in Taiwan, R.O.C., as per the sponsor information.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the evaluation involved physical, electrical, and material testing of a medical device, not a diagnostic or prognostic system requiring expert interpretation of results for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as above. The tests performed are objective measurements against predefined standards or specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device (electrosurgical electrodes). The device is a tool used by a surgeon, not a diagnostic aid that would improve human reader performance.

6. Standalone Performance (Algorithm Only without Human-in-the Loop Performance)

This is not applicable as the device is a physical electrosurgical electrode and does not involve any algorithms or AI for its function.

7. Type of Ground Truth Used

The "ground truth" for the tests performed was established through objective engineering and material science standards and specifications.

Bench Testing: Internal requirements, FDA guidance (Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery).
Electrical Safety & EMC: International standards (IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2).
Shelf-Life Testing: FDA guidance and internal requirements.
Biocompatibility Testing: ISO 10993-1 and FDA guidance.

8. Sample Size for the Training Set

This is not applicable as the device does not employ machine learning or AI, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for this device.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K183594

Device Name Laparoscopic Hollow Electrodes

Indications for Use (Describe)

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)

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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) 2-2268-1726Fax: (886) 2-2268-3800
Correspondent ContactInformation:	Craig CoombsCoombs Medical Device Consulting1193 Sherman StreetAlameda, CA 94501Tel: 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 878.4400Electrosurgical, Cutting & CoagulationDevice 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 878.4400Electrosurgical, Cutting & CoagulationDevice and Accessories
Reference Device Class & Product Code:	Class 2, GEI

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B. Date Summary Prepared

15 Feb 2019

C. Description of Device

D. Indications for Use

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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 DeantronicsLaparoscopic HollowElectrodes	Predicate Device:New DeantronicsDisposable LaparoscopicElectrodes, coated andnon-coated(K153265)	Reference Device:Valleylab LaparoscopicHandsets and LaparoscopicElectrodes(K964175)	Pertinence of Feature toConsideration of SubstantialEquivalence.
Indications for Use	These electrodes areintended for use inminimally invasivesurgical procedureswhere monopolarelectrosurgical cuttingand coagulation aredesired. Irrigation andsuction capabilities viathe same handset areavailable as well.	The disposablelaparoscopic electrodesare intended for use inminimally invasivesurgical procedureswhere monopolarelectrosurgical cuttingand coagulation aredesired.	The Valleylab LaparoscopicHandsets (models E2750,E2751, E2750T and E2751T)and the Electrodes (modelE2770 series, E2780 series,E2780R series and E2780R-ASP) are intended for use inthose laparoscopic orthoracoscopic surgicalprocedures where thedelivery of electrosurgicalcurrent, irrigation andsuction via a single handsetis desirable.The device is not intendedto be used in endoscopicsurgical procedures.	The Indications for Use of theapplication and predicate devicesare nearly the identical; all ofthese devices are for RF cuttingor coagulation in minimallyinvasive surgical procedures.The application device hasirrigation and suction capabilities,but as evidenced by thereference device, thesecapabilities have long beenapplied to such devices and raiseno new questions of safety orefficacy for these types ofdevices.
Product Code	GEI	GEI	GEI	Identical to both predicate andreference devices
Feature	Application Device:Laparoscopic HollowElectrodes	Predicate Device:New DeantronicsDisposable LaparoscopicElectrodes(K153265)	Reference Device:Valleylab LaparoscopicHandsets and LaparoscopicElectrodes (K964175)	Pertinence of Feature toConsideration of SubstantialEquivalence.
			Technology
Mechanism ofOperation	The New DeantronicsLaparoscopic HollowElectrodes combine RFtechnology with suctionand irrigation of fluidsduring electrosurgicalprocedures.	Same RF cutting andcoagulation capability	Same RF cutting andcoagulation capability andsame suction & irrigationcapabilities as applicationdevice	Identical to predicate for RFcutting and coagulation andidentical to reference for RFcapabilities and suction andirrigation of fluids.
Compatible w/ RFMonopolar or Bipolaradministration?	Monopolar only	Same	Same	Identical to both predicateand reference devices
Compatible Device	Valleylab™ E2750Laparoscopic handset	Monopolarelectrosurgical pencils w0.093" (2.36mm) nozzle &w 5mm cannula or larger	Valleylab™ E2750Laparoscopic handset	Identical to reference device;clinically equivalent topredicate device for insertioninto 3rd party hand pieces
	Design
Electrode length	Retractable: 28cmand 36 cmNon-Retractable:28cm	36cm and 45 cm	Same as application	Identical to reference device;Clinically equivalent topredicate. All sizes of alldevices intended forlaparoscopic applications
Electrode OuterDiameter	Retractable: 5.00mmNon-Retractable:4.75mm	2.36mm shaft OD	Same as application	Identical to reference device;Clinically equivalent topredicate. All sizes of alldevices intended forlaparoscopic applications
Feature	Application Device:Laparoscopic HollowElectrodes	Predicate Device:New DeantronicsDisposable LaparoscopicElectrodes(K153265)	Reference Device:Valleylab LaparoscopicHandsets and LaparoscopicElectrodes (K964175)	Pertinence of Feature toConsideration of SubstantialEquivalence.
Electrode InnerDiameter	Retractable: 4.10mmNon-Retractable:3.18mm	Not Applicable	Same as application	ldentical to reference device;Clinically equivalent topredicate.
Materials forElectrode Tip	SUS 304 Stainlesswithout coating	SUS 304 Stainless withPTFE coating orwithout coating	SUS 304 Stainless withoutcoating	Functional tip identical topredicate and referencedevices
Materials forElectrode Sheath	Retractable: PTFE, PCand POF (black)Non-Retractable: POF(black)	POF (blue)	Retractable: PTFE, PC andPOF (black)Non-Retractable: POF(black)	Nearly identical to predicateand reference devices
Materials forElectrode Hub(Retractable Only)	PC (Polycarbonate)	Not Applicable;No hub	PC (Polycarbonate)	ldentical to reference device
Materials for TipProtector	Distal: LDPEProximal: LDPE	Distal: LDPEProximal: LDPE	RetractableDistal: PVC,Proximal: LDPENon-RetractableDistal: LDPE, Proximal:LDPE	Nearly identical to predicateand reference devices
Feature	Application Device:Laparoscopic HollowElectrodes	Predicate Device:New DeantronicsDisposable LaparoscopicElectrodes(K153265)	Reference Device:Valleylab LaparoscopicHandsets and LaparoscopicElectrodes (K964175)	Pertinence of Feature toConsideration of SubstantialEquivalence.
Electrode Tip	Retractable:Curved Spatula,Wire J-Hook,Wire L-Hook,Flat L-HookNon-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-HookNon-Retractable:Straight Spatula,Curved Spatula,Wire J-Hook,Wire L-Hook,Cylindrical Tip,Flat L-Hook	Almost Identical, except forNon-Retractable Flat L-Hookexisting in reference but not inapplication. All styles inapplication device are found inpredicate device, except forcylindrical tip. Differencesraise no new questions ofsafety or efficacy
Maximum PeakVoltage	High Frequency:13.5 $kV_{p-p}$Main Frequency: 5400Vfor 60 seconds	6300V (60Hz) for 60seconds	5200V (60Hz) for 60 seconds	High withstand voltage is assafe as the predicate andreference devices.
Other Attributes
Single Use orReusable?	Single Use	Single Use	Single Use	Identical to predicate andreference devices
Provided Sterilized?	Yes	Yes	Yes	Identical to predicate andreference 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 60601-2-2IEC 60601-2-18	IEC 60601-2-2IEC 60601-2-18		application device inconformance with latest versionof the listed standards

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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

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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).

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.