Electrosurgical disposable grounding pads are to conduct electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator.

Device Description

Electrosurgical disposable grounding pads construct of a layer of conductive aluminum foil with a foam as the supportive base of the pad. The aluminum foil is coated with adhesive hydro-gel layer. There is another film placed above the adhesive hydro-gel layer, which is used to protect the gel during the transportation and storage and will be removed prior to use.

They are available in different combinations of configurations, types, intended populations and conductive area.

They are not provided in sterile conditions and not required to be sterilized by the end user prior to operation. However, they are for single use only.

AI/ML Overview

The provided text is a 510(k) summary for Electrosurgical Disposable Grounding Pads. This document is a regulatory submission to the FDA for a medical device and not a study proving the device meets acceptance criteria for an AI/ML powered device.

Therefore, many of the requested criteria related to AI/ML model performance evaluation (e.g., sample size for test/training sets, expert ground truth, MRMC study, human reader improvement, standalone performance, etc.) are not applicable to this document as it describes a physical, non-software medical device.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing (bench testing) and biocompatibility, not through AI/ML performance metrics.

Here's a breakdown based on the provided document, addressing the applicable points and explaining why others are not applicable:

Acceptance Criteria and Study for Electrosurgical Disposable Grounding Pads

1. Table of Acceptance Criteria and Reported Device Performance

For this physical device, "acceptance criteria" are derived from compliance with recognized medical device standards and demonstrating substantial equivalence to a predicate device. The "reported device performance" is its successful compliance with these standards.

Acceptance Criteria Category	Specific Criteria (Standard/Test)	Reported Device Performance
Electrical Safety	IEC 60601-1:2005	Complies (results demonstrated device met design specifications and SE)
	IEC 60601-2-2:2009	Complies (results demonstrated device met design specifications and SE)
Electromagnetic Compatibility	IEC 60601-1-2:2007	Complies (results demonstrated device met design specifications and SE)
Biocompatibility	ISO 10993-5:2009/(R) 2014 (Cytotoxicity)	Complies (tested with ISO 10993 Series Standards)
	ISO 10993-10:2010 (Irritation & Sensitization)	Complies (tested with ISO 10993 Series Standards)
Functional/Design Equivalence	Conduct electrosurgical energy from target tissue to ESU/generator	Functionally equivalent to predicate device (K091672)
	Configuration: Single and Split aluminum film; Adult and pediatric; Single Use	Configurations are equivalent to predicate device
Material Equivalence	Adhesive hydro-gel, Aluminum foil, Polyester (PET), Foam (Polyester Fibre)	Materials are equivalent to predicate device

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the document. For non-clinical (bench) testing of physical devices, sample sizes are typically determined by engineering and statistical principles to ensure robust testing, but the explicit number of units tested is not provided in this regulatory summary.
Data Provenance: The tests were non-clinical tests conducted to verify compliance with international standards (IEC, ISO). The location of the testing is not explicitly stated, but the company is based in China. The data would be prospective, as it was generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is a physical electrosurgical device, not an AI/ML model for which "ground truth" would be established by experts reviewing data (e.g., medical images). Ground truth for this device is based on objective measurements and compliance with engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This concept is relevant to expert review of data (e.g., medical images) to establish ground truth for AI/ML validation, not for the non-clinical testing of a physical medical device.

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 device is a physical electrosurgical pad, not an AI/ML system, so no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not Applicable. This device is a physical electrosurgical pad, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this physical device, "ground truth" is established through objective measurements and compliance with recognized international standards (e.g., specified resistance limits, temperature rise limits, material compatibility, etc.) during non-clinical (bench) testing. There is no human interpretation of data for ground truth establishment as would be the case for an AI/ML diagnostic device.

8. The sample size for the training set

Not Applicable. This device is a physical medical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. As no AI/ML model was developed, there was no training set and thus no ground truth established for it.

Summary

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

August 19, 2016

TOP-RANK Health Care Co., Ltd % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China

Re: K160366

Trade/Device Name: Electrosurgical Disposable Grounding Pads Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: ODR Dated: August 10, 2016 Received: August 15, 2016

Dear Ms. Hong:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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,

Christopher J. Ronk -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K160366

Device Name

Electrosurgical disposable grounding pads

Indications for Use (Describe)

Electrosurgical disposable grounding pads are to conduct electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator.

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)

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Tab #7 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K160366

1. Date of Preparation: 01/30/2016
1. Sponsor Identification

TOP-RANK Health Care Co. Ltd.

Checun Village, Dongguan Street, Shangyu District Shaoxing, Zhejiang, 312352, China

Establishment Registration Number: 3006626283

Contact Person: Ms. Liubo Shen Position: Management Representative Tel: +86-575-82912999 Fax: +86-575-82670000 Email: liubo.shen@etop-rank.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

1. Identification of Proposed Device
  Trade Name: Electrosurgical disposable grounding pads Common Name: Electrosurgical Patient Return Electrode

Regulatory Information Classification Name: Electrosurgical Patient Return Electrode Classification: II

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Product Code: ODR Regulation Number: 21 CFR part 878.4400 Review Panel: General & Plastic Surgery

Intended Use Statement:

Electrosurgical disposable grounding pads are to conduct electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator.

Device Description

They are available in different combinations of configurations, types, intended populations and conductive area.

They are not provided in sterile conditions and not required to be sterilized by the end user prior to operation. However, they are for single use only.

ર. Identification of Predicate Device(s)
K091672 SHUYOU ELECTRIC MEDICAL SCIENCE CO., LTD. Disposable Grounding Pad Series
1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
V IEC 60601-1: 2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;
IEC 60601-2-2: 2009 Medical electrical equipment - Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical access;
イ IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
イ ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.

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く ISO 10993-10:2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
1. Clinical Test Conclusion

No clinical study is included in this submission.

1. Substantially Equivalent (SE) Comparison

Item	Proposed Device(s)	Predicate Device(s)
Code	ODR	ODR
Regulation #.	21 CFR 878.4400	21 CFR 878.4400
Intended Use	Electrosurgical disposable groundingpads are to conduct electrosurgicalenergy from target tissue of a patientback to an electrosurgical unit (ESU),or generator.	The Disposable Grounding Padseries devices are to conductelectrosurgical energy from targettissue of a patient back to anelectrosurgical unit (ESU), orgenerator.
Configuration	Single and Split aluminum filmAdult and pediatricSingle Use	Single and Split aluminum filmAdult and pediatricSingle Use
Biocompatibility	Adhesive hydro-gelAluminum foilPOLYESTER (PET)Foam (Polyster Fibre)Tested with ISO 10993 SeriesStandards	Adhesive hydro-gelAluminum foilPETFoamTested with ISO 10993 SeriesStandards
Electrical Safety	IEC 60601-1:2005IEC 60601-2-2: 2009	IEC 60601-1IEC 60601-2-2
EMC	IEC 60601-1-2: 2007	IEC 60601-1-2

Table 1 Comparison of Technology Characteristics (Scalpel System)

1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

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.