Disposable Laparoscopic Electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip is either coated or non-coated and the conductive post is either 2.36mm or 4mm. The conductive post is inserted into the electrode entry of electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in laparoscopic procedure. During the operation, the electrode tip and the insulated shaft are to be inserted through a 5mm trocar. This device is used in conjunction with a compatible electrosurgical generator and patient grounding pad and complies with IEC60601-1 and IEC60601-2-2.

AI/ML Overview

This document describes a 510(k) premarket notification for a Disposable Laparoscopic Electrode. The submission aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove that the device meets specific acceptance criteria in the way a clinical study would for efficacy. Therefore, much of the requested information regarding clinical study parameters (sample size, ground truth, experts, MRMC studies, etc.) is not applicable to this type of submission.

However, based on the provided text, I can extract information related to performance testing to support the claim of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the format of a clinical study, but rather describes a comparative performance test to show equivalence. The "acceptance" is implied by demonstrating "no significant difference" to the predicate device.

Acceptance Criterion (Implied)	Reported Device Performance
Performance of device operation (Cutting & Coagulation modes)	"no significant difference between proposed device and predicate device" on porcine kidney, liver, and muscle at 30W, 50W, and 100W output power.
Result of eschar buildup on the tip of the electrode	"no significant difference between proposed device and predicate device" on porcine kidney, liver, and muscle at 30W, 50W, and 100W output power. The coated electrode eliminated the needs of using tip polisher to remove the eschar (This appears to be a design feature of some test articles being compared, not the outcome of the comparison).
Electrical Safety	Complies with IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) and IEC60601-2-2: 2009 (Fifth Ed).
Biocompatibility (Ethylene Oxide sterilization residuals)	EO and ECH residue test performed to ISO10993-7, demonstrating "no residue on the patient contact portion of device after aeration."
Biocompatibility (Biological evaluation)	Performed in accordance with ISO10993-1. Specific tests: Intracutaneous Reactivity, In vitro Cytotoxicity, Acute Systemic Toxicity, Skin Sensitization, In Vitro Hemolysis Study. (Results are not detailed but the performance of these tests implies they met the standards).

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

Sample Size: Not explicitly stated as a number of "samples" in the context of a clinical trial. The comparative testing was performed on "porcine kidney, liver, and muscle." The number of animal units or tests conducted on these tissues is not provided.
Data Provenance: Porcine (animal) tissue. The study is a prospective experimental study in a laboratory setting, not a retrospective or prospective human clinical data study.

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

This is not applicable to the type of performance testing described. The "ground truth" was established by direct observation and measurement of physical effects (cutting, coagulation, eschar buildup) in the laboratory setting. There were no human "experts" establishing a diagnostic ground truth.

4. Adjudication Method for the Test Set

Not applicable. This was a comparative experimental study, not a study requiring adjudication of expert interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device for surgical procedures, not an AI/imaging device requiring human reader assessment.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device for surgical procedures, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance testing was the direct physical effect observed on biological tissue (porcine kidney, liver, and muscle) during cutting and coagulation, and the qualitative assessment of eschar buildup. For safety and biocompatibility, the ground truth was meeting established international standards (IEC and ISO).

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable.

Summary of the Study:

The study was a comparative performance testing conducted in a laboratory setting using porcine tissues. The goal was to demonstrate that the Disposable Laparoscopic Electrode performed "no significant difference" compared to an existing predicate device (Megadyne E-Z Clean Disposable Laparoscopic Electrodes and Modern Medical Equipment Mfg. Ltd. - Laparoscopic Instrument, Electrode and Cable) in terms of cutting, coagulation, and eschar buildup across various power settings (30W, 50W, 100W). Additionally, the device underwent testing to ensure electrical safety (IEC standards) and biocompatibility (ISO standards), indicating compliance with these predefined safety "acceptance criteria." The specific quantitative results of the comparative tissue tests were not detailed, but the conclusion states "no significant difference."

Summary

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

November 21, 2014

Modern Medical Equipment Manufacturing Limited Mr. Thomas Chan Tsz Fung Regulatory Supervisor 35-41 Tai Lin Pai Road, Unit F 5th Floor, Gold King Ind. Building Kwai Chung, N.T. Hong Kong, China

Re: K134006

Trade/Device Name: Disposable Laparascopic Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 20, 2014

Received: October 27, 2014

Dear Mr. Chan:

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

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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 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" (21CFR 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,

David Krause -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) K134006

Device Name Disposable Laparoscopic Electrode

Indications for Use (Describe)

The electrode is used to cut and coagulate the selected tissue for laparoscopic procedures.

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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1. 510(k) Owner

Name:	Modern Medical Equipment Manufacturing Limited
Address:	Modern Medical Equipment Mfg., Ltd.
	35-41 Tai Lin Pai Rd., Unit F,
	4th Fl., Gold King Ind. Bldg
	Kwai Chung, N.T. Hong Kong, China
Telephone:	(852) 2420 9068
Fax:	(852) 2481 1234
Contact person:	Thomas, Chan Tsz Fung

Date of preparation: Oct 20 2014

2. Device

Name of Device:	Disposable Laparoscopic electrode
Trade or proprietary name:	Disposable Laparoscopic electrode
Common or usual name:	Disposable Laparoscopic electrode
Classification name:	Electrosurgical, Cutting & Coagulation & Accessories
Classification Panel:	General & Plastic Surgery
Product Code:	GEI
Class:	II

3. Device description

4. Intended use

The electrode is used to cut and coaqulate the selected tissue for laparoscopic procedures.

5. Predicate device

Megadyne E-Z Clean Disposable Laparoscopic Electrodes (K913281)

Modern Medical Equipment Mfg. Ltd. - Laparoscopic Instrument, Electrode and Cable (K032965)

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6. Technological characteristic

The proposed disposable laparoscopic electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip is either coated or coated or non-coated stainless steel. The coated electrode eliminated the needs of using tip polisher to remove the eschar. The diameter of the conductive post is available in 1.6mm or 2.36mm.The conductive electrode tip is the conductive portion of the electrode which has 11 tip styles, delivers high frequency current onto a target tissue for cutting and/or coagulation during an electro-surgery. The insulated shaft is the mid portion of the electrode. It is insulated with non-conductive material to prevent accidental conduction of the electrosurgical current from this point to the patient. The conductive post is used to plug the electrode into the nose of an electrosurgical pencil from which it receives the electrical current.

The construction of proposed electrode and the predicted device is identical although the only differences are the coating of electrode tip and the diameter of conductive post. The predicate device only is available one type of tip finishing: coated or non-coated stainless steel and its conductive post is only 2.36mm. However, these differences are not significantly to change mechanism of operation. There are no new questions raised regarding to effectiveness and safety.

7. Substantial Equivalence

The technological characteristic in both proposed device and predicate device is identical. Moreover, performance testing data show that operation result by using posed device and predicate device shall be the same.

8. Performance Testing Data

Validation and Verification testing was performed on the device and packaging.

Simulation Tests include comparative testing was performed on porcine kidney, liver, and muscle for both Cut and Coagulation modes at 30W, 50W, and 100W output power. It demonstrates that the performance of device operation and result of eschar buildup on the tip of electrode are no significant difference between proposed device and predicate device.

9. Safety and Biocompatibility testing data

Testing was performed to comply with IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC60601-2-2: 2009 (Fifth Ed)

EO and ECH residue test was performed in accordance to ISO10993-7 Biological

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evaluation of medical devices-Part 7: Ethylene oxide sterilization residualsafter ETO sterilization to demonstrate no residue on the patient contact portion of device after aeration.

The following Biocompatibility tests were performed in accordance to ISO10993-1 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process

Intracutaneous Reactivity Test
In vitro Cytotoxicity Test
· Acute Systemic Toxicity Test
Skin sensitization tests
In Vitro Hemolysis Study

10. Conclusion

Based on comparing technological characteristic and performance testing data, we believe the proposed device, disposable laparoscopic electrode is substantial equivalence to predicate device.

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.