The disposable laparoscopic electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired.

Device Description

The disposable laparoscopic electrodes are classified by FDA as an "Electrosurgical, Cutting & Coagulation Device and Accessories", under the General & Plastic Surgery Panel, Product Code GEI, Regulation number 878.4400, Class II, panel 79. The devices are provided to healthcare professional only.

The New Deantronics disposable laparoscopic electrodes are used in conjunction with monopolar electrosurgical pencils that accept 2.36 mm connectors, trocars or cannulas with appropriate 5 mm adapters, electrosurgical generator, and patient return electrode. During the operation, the electrode and the insulated shaft are to be inserted through a trocar and the conductive shaft end is inserted into the nose of the electrosurgical pencil from which it receives the high frequency current while contacting target tissue for cutting and coagulation in laparoscopic procedure. The New Deantronics laparoscopic electrodes are single use.

The New Deantronics laparoscopic electrodes consists of four distinct sections, including a conduction insulated shaft, a conductive shaft end, and an electrode tip and a shaft end protector.

There are two groups of laparoscopic electrodes, including non-coated and coated laparoscopic electrodes. The coated laparoscopic electrodes have the same configuration but the electrode tips are coated with non-sticking coating material. The devices are available in five electrode tip configurations and two different shaft lengths.

There are sixteen models of New Deantronics laparoscopic electrodes available.

AI/ML Overview

The provided text describes the New Deantronics Disposable Laparoscopic Electrodes, non-coated and coated, and refers to non-clinical testing to demonstrate its performance and substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria and reported device performance in the format of a table, nor does it detail a study that proves the device meets specific acceptance criteria as you've requested.

The document primarily focuses on establishing substantial equivalence through comparison of technological characteristics, intended use, and adherence to various recognized standards. It states that "All the test results demonstrate the performance of monopolar laparoscopic accessories meet the requirements of its pre-defined acceptance criteria and intended uses." and "A side by side study comparing the ND electrode to the predicate devices demonstrates substantial equivalence. A thermal Effect Study productions the New Deantronics electrode performs equivalent or better than the predicates. The device is safe and effective based on the non-clinical studies."

However, it does not explicitly list the "pre-defined acceptance criteria" or specific performance metrics in a structured table. Additionally, information regarding sample size, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance data, or training set details is not present within this document.

The document mentions that the device "Passes test of 6.3 kV, according to IEC 60601-2-2, 201.8.8.3.104 Capacitive coupled HF current not exceed 50 mA" for electrical safety and "Wire electrode can survive 4 bends with no crack or failure" for mechanical safety. These could be considered acceptance criteria, but they are not presented in a comprehensive table with reported performance.

Therefore, I cannot fulfill your request for the comprehensive table and study details as the information is not provided in the input text.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked slightly offset from each other. Above the profiles is a design element resembling a wing or feather. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

New Deantronics Taiwan, Ltd. % Mr. Lewis Ward L.W. Ward and Associates Incorporated 4655 Kirkwood Court Boulder, Colorado 80301

January 5, 2016

Re: K153265

Trade/Device Name: New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 13, 2015 Received: November 12, 2015

Dear Mr. Ward:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153265

Device Name

Device Name
New Deantronics Disposable Laparoscopic Electrodes, non-coated and coated

Indications for Use (Describe)

Indications for Use (Describe)
The disposable laparoscopic electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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 I he burden time for this collection of information is connulatin the data needed and complete time to review instruction. Send comments regarding this burden estimate or any other aspect and review the collection of internations 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."

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

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K153265

Image /page/3/Picture/1 description: The image contains the logo for Deantronics. The logo features a blue circle with a red dot inside, followed by the word "DEANTRONICS" in blue, block letters. Below the company name, the words "New Deantronics Group" are written in a smaller, blue font.

Submitter New Deantronics Taiwan Ltd. 12F., No.51, Sec. 4, Chong Yang Rd., Tu Cheng Dist, New Taipei City 23675, Taiwan R.O.C. (886) (0) 2-2268-1726 Phone (886) (0) 2-2268-3800 Fax

Taiwan

大瑞企業股份有限公司

Contact Person: Lewis Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 USA 303-530-3279 lwward@gwest.net

Date Prepared: November 13, 2015

Trade Name: New Deantronics Disposable, laparoscopic electrodes, non-coated I. and coated
Common Name: Electrosurgical accessory, laparoscopic electrode II.
Classification: 21 CFR 878.4400, Electrosurgical cutting and coagulation III. device and accessories.
IV. Product Code: GEI
V. Indications For Use: The New Deantronics single use, laparoscopic electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired.
VI. Predicate Device Non-coated laparoscopic electrode Valleylab, Inc. 510(k) K904560 Cleared for marketing on December 31, 1990.

Coated laparoscopic electrode Megadyne Medical Products, Inc. E-Z Clean Laparoscopic Electrode 510(k) K913281 Cleared for marketing on Aug. 16, 1991.

Device Description and Technological Characteristics VII. The disposable laparoscopic electrodes are classified by FDA as an "Electrosurgical, Cutting & Coagulation Device and Accessories", under the General & Plastic Surgery Panel, Product Code GEI, Regulation number 878.4400, Class II, panel 79. The devices are provided to healthcare professional only.

USA

New Deantronics Ltd.

1990 North Califomia Blvd.

Suite 1040

Walnut Creek, CA. 94596

Tel: +1 (925) 280-8388

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Image /page/4/Picture/0 description: The image shows the logo for Deantronics. The logo consists of a blue circle with a red dot in the center, followed by the word "DEANTRONICS" in blue, bold letters. Below the word "DEANTRONICS" is the phrase "New Deantronics Group" in a smaller, lighter blue font.

The New Deantronics disposable laparoscopic electrodes are used in The New Dealitronics disposure rejurgical pencils that accept 2.36 mm conjuriction with monopolar elocal Jour er cannulas with appropriate 5 mm adapters, electrosurgical generator, and patient return electrode. During adapters, electrosulgiour general the insulated shaft are to be inserted the operation, the clootrode the conductive shaft end is inserted into the nose of through a trocal and the ownich it receives the high frequency current electrosurgical pericin on whiletarget tissue for cutting and coagulation in laparoscopic procedure. The New Deantronics laparoscopic electrodes are single use.

The New Deantronics laparoscopic electrodes consists of four distinct The New Deamlionio luparoose electrode tip with part of the tip covered sections, incruding a conduction insulated shaft, a conductive shaft end, and an electrode tip and a shaft end protector.

There are two groups of laparoscopic electrodes, including non-coated There are two groups of lapartrodes. The coated laparoscopic electrodes have the same configuration but the electrode tips are coated with nonsticking coating material. The devices are available in five electrode tip configurations and two different shaft lengths.

There are sixteen models of New Deantronics laparoscopic electrodes available.

Table 1. Non-coated laparoscopic electrodes

Catalog No.	Length (cm)	Coating	Electrode Tip Type
AP300-36	36	No	Straight Spatula
AP301-36	36	No	Curved Spatula
AP301-45	45	No	Curved Spatula
AP302-36	36	No	Wire J
AP303-36	36	No	Wire L
AP304-36	36	No	Flat L
AP303-45	45	No	Wire L
AP304-45	45	No	Flat L

Table 2. Coated laparoscopic electrodes

Catalog No.	Length (cm)	Coating	Electrode Tip Type
AP300-36C	36	Coated	Straight Spatula, Coated
AP301-36C	36	Coated	Curved Spatula, Coated
AP301-45C	45	Coated	Curved Spatula, Coated
AP302-36C	36	Coated	Wire J, Coated
AP303-36C	36	Coated	Wire L, Coated
AP304-36C	36	Coated	Flat L, Coated
AP303-45C	45	Coated	Wire L, Coated
AP304-45C	45	Coated	Flat L, Coated

Taiwan

大瑞企業股份有限公司 Deantmonics Taiwan. Ltd 域區中央路 1段 51 號 12 1 12F No 51 Sec Chong Yang Rd., Tu Chen Tel: +8862 2268-172

USA

New Deantronics Ltd 1990 North California Blvd

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Image /page/5/Picture/0 description: The image shows the logo for Deantronics. The logo features a blue circle with a red dot inside, followed by the word "DEANTRONICS" in blue, bold letters. Below the word, it says "New Deantronics Group" in a smaller, lighter blue font.

Non-clinical testing VIII.

Non-cillical testing New Deantionies mac ochauspecification, functions as intended and subject devices mot acong rolly recognized standards, including the following items:

(1) ISO 14971:2007, Medical devices Application of risk management to medical devices
(2) IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
(3) IEC 60601-1-2:2014, Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral requirements for basio salesy and the mances - Requirements and tests.
(4) IEC 60601-2-2: 2009 + C1:2014, Medical electrical equipment Part 2-2: Particular requirements for the safety of high frequency surgical equipment.
(5) ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process.
(6) ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
(7) ISO 11135:2014, Sterillization of Healthcare Products- Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices.
(8) IEC 62366-1:2015, Medical devices Part 1: Application of usability engineering to medical devices

Non-clinical testing conclusion:

All the test results demonstrate the performance of monopolar laparoscopic accessories meet the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the monopolar laparoscopic electrodes is as safe and effective as the predicate devices.

IX. Substantial equivalence

The proposed devices share the same technological characteristics, technology & operating principles, performance characteristics, and configuration found in the predicate devices. There are no new technologies incorporated into the device.

The laparoscopic electrodes meet the functional claims and intended use as described in the product labeling. The safety and effectiveness are equivalent to the predicate devices identified. The claim for substantial equivalence is supported by the information provided in this submission.

Therefore, the device of this submission is substantially equivalent to the predicate devices of Valleylab, Inc. non-coated laparoscopic electrodes (K904560) and Magadyne Medical Products, Inc. coated laparoscopic electrodes (K913281).

Taiwan

大蕴企業股份有限公司

New Deantronics Ltd.

1990 North California Blvd.

Suite 1040

Walnut Creek, CA 94596

Tel: +1 (925) 280-8388

Fax: +1 (925) 280-1788

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Image /page/6/Picture/0 description: The image shows the logo for Deantronics. The logo consists of a blue circle with a red dot inside, followed by the word "DEANTRONICS" in blue, and the words "New Deantronics Group" in a smaller font below. The logo is simple and modern, and the colors are eye-catching.

Table 3. Key Features Comparison to Predicates
------------------------------------------------	--	--	--	--

		This Submission	Predicate Device	Predicate Device
	Product name	New Deantronics Non-coated and Coated Laparoscopic Electrodes	Covidien Non-coated Laparoscopic Electrodes	Megadyne Coated Laparoscopic Electrodes
	Manufacturer	New Deantronics	Covidien (formerly Valleylab)K#904560	MegadyneK#913281
Taiwan	510(k) #Product Code	Subject of this submissionGEI	GEI	GEI
				The E-Z Clean laparoscopic electrode is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.
	Intended use	These electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired.	The intended use of the laparoscopic electrodes are for use in laparoscopic and thoracoscopic surgical procedures where monopolar electrosurgical cutting and coagulation are desired.
	Target Population	General patients that require laparoscopic electrosurgery	General patients that require laparoscopic electrosurgery	General patients that require laparoscopic electrosurgery
	Where used	Hospital	Hospital	Hospital
	Energy Used	High Radiofrequency	High Radiofrequency	High Radiofrequency
	Physical Dimensions and Design	Size:OD of shaft: 2.36 mmLength: 36 cm or 45 cm	Size:OD of shaft: 2.36 mmLength: 36 cm or 45 cm	Size:OD of shaft: 2.59 mmLength: 33 cm or 45 cm
	Operation Principle	Monopolar electrosurgery	Monopolar electrosurgery	Monopolar electrosurgery
	Shaft and shaft insulation Materials	Stainless steel shaft, polyolefin shaft insulation,	Stainless steel shaft, polyolefin shaft insulation	Stainless steel shaft, polyolefin shaft insulation
	Total electrode Resistance	Less than 100 mΩ	Less than 100 mΩ	Less than 100 mΩ
	Electrode tip insulation	PTFE electrode tip insulation, non-coated electrode and PTFE coated electrode	PTFE electrode tip insulation, non-coated electrode	Polyolefin electrode tip insulation, coated electrode
	Tip design	Options:Straight spatula, curved spatula, J-wire, L-wire, L-flat	Options:Straight spatula, curved spatula, J-wire, L-wire, L-flat	Options: Standard blade, spatula, curved spatula, curved, L-hook, J-hook, needle, ball, O-wire,
	Electrode tip coating	Non-coated and PTFE coated	Non-coated	PTFE Coated
	Performance	Performs cut and coagulation, in electrosurgical procedure	Performs cut and coagulation in electrosurgical procedure	Performs cut and coagulation in electrosurgical procedure
	Sterile	EO sterilization	EO sterilization	EO sterilization
	Single use	Single use	Single use	Single use
	Compatibility with other devices	Compatible with electrosurgical with 0.093" nozzle and with 5 mm cannula or larger	Compatible with electrosurgical with 0.093" nozzle and with 5 mm cannula or larger	Compatible with electrosurgical pencil with 0.093" nozzle and with 5 mm cannula or larger

	Electricalsafety	Passes test of 6.3 kV,according to IEC 60601-2-2, 201.8.8.3.104Capacitive coupled HFcurrent not exceed 50 mA	Passes test of 6.3 kV,according to IEC 60601-2-2, 201.8.8.3.104Capacitive coupled HFcurrent not exceed 50 mA	Passes test of 6.3 kV,according to IEC 60601-2-2, 201.8.8.3.104Capacitive coupled HFcurrent not exceed 50 mA
Taiwan	Mechanicalsafety	Wire electrode cansurvive 4 bends with nocrack or failure.	J-Hook electrode cansurvive 4 bends with nocrack or failure.	J-Hook electrode cansurvive 4 bends with nocrack or failure.
Deantronics Taiwan, Ltd. 12F., No.51, Sec. 4, Rd., Tu Cheng Dist., New Taipei City 23675, Taiwan R.O.C. tel: +886 2 2268-1726 fax: +886 2 2268-3800	Standardsmet	ISO 10993-1:2009IEC 60601-2-2:2009ISO 11135:2014IEC 60601-1:2005+Amendment 1: 2012IEC 60601-1-2:2014ISO 14971IEC 62366-1:2015IEC 60601-2-18:2009ISO 11607-1:2006+Amendment 1:2014	ISO 10993-1IEC 60601-2-2ISO 11135	ISO 10993-1IEC 60601-2-2ISO 11135

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Image /page/7/Picture/0 description: The image shows the logo for Deantronics. The logo consists of a blue circle with a red dot in the center, followed by the word "DEANTRONICS" in blue, block letters. Below the company name is the phrase "New Deantronics Group" in a smaller font.

Page 5 of 5 K153265

USA

New Deantronics Ltd 1990 North California Bivd lainut Creek, CA 94598

Tel

X. Conclusion:

The New Deantronics Disposable Laparoscopic Electrode, non-coated and coated i ne few Dealitromes Diperforms as well as or better than the legally marketed is sale and effective and p demonstrated safe and effective and meets the predicates. The dovice to act Electrical Safety, IEC 60601-1-2 EMC and IAO 10993 Biocompatibility. A side by side study comparing the ND electrode to the predicate devices demonstrates substantial equivalence. A thermal Effect Study productions the New Deantronics electrode performs equivalent or better than the predicates. The device is safe and effective based on the non-clinical studies.

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.