(58 days)
No
The document describes electrosurgical pads, which are passive electrodes used to complete an electrical circuit during electrosurgery. There is no mention of any computational processing, learning, or AI-related terms.
No.
The device is a neutral electrode used to complete an electrical circuit during electrosurgery, which is a surgical procedure. It does not directly treat a disease or condition, but rather facilitates a surgical technique.
No
The device, Electrosurgical Pads, is a return electrode used to complete an electrical circuit during electrosurgical procedures. Its function is to facilitate the flow of electrical current back to the generator, not to diagnose a condition or disease.
No
The device is an electrosurgical pad, which is a physical hardware component used in electrosurgery to complete an electrical circuit. The description explicitly states it is a "single-use, non-sterile dispersive electrode" and discusses physical attributes like adherence to the patient and providing a low-impedance path. The performance studies and predicate devices also relate to physical electrosurgical pads. There is no mention of software being the primary medical device.
No.
The device is a non-sterile dispersive electrode used in electrosurgery to complete an electrical circuit, not to provide information from in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
Electrosurgical Pads are Neutral Electrode which is also known as plate, plate electrode, passive, return, or dispersive electrode. They are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient.
Solid Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical Pads are for use with generators that have a CQMS (i.e. REM, ARM, NESSY, etc.).
Product codes
GEI
Device Description
Electrosurgical Pads are single-use, non-sterile dispersive electrode with or without a pre-attached cord. This devices are used in monopolar surgery to complete the electrical circuit with the generator. Providing a low-impedance path back to the generator through the return electrode helps to prevent unintended RF burns. The Electrosurgical Pads are designed to be compatible with the return electrode monitoring function of compatible OBS generators.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
15kg
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
CLINICAL TESTING
The performance of Electrosurgical Pads in the clinical environment has been well established. No clinical data is included in this submission.
NON-CLINICAL PERFORMANCE TESTING
Performance test, Electrical safety test, Electromagnetic compatibility(EMC) test and biocompatibility test have been done to demonstrate the safety and performance of subject device. The test details as follows:
-
Performance test was performed according to:
- 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, and, Final Products Inspection Protocol.
-
Electrical safety test, Electromagnetic compatibility(EMC) test Compliance with
- IEC 60601-1-2: 2014/ AMD1: 2020 Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests, and,
- IEC 60601-1: 2005+A1: 2012+A2: 2020 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
-
A biological evaluation was performed on the Subject device according to ISO 10993-1:2018 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
-
Biocompatibility test was performed according to:
- ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, and,
- ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin sensitization, and,
- ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation.
Non-clinical performance testing of the Subject device met the acceptance criteria for each validation and test described above. This non-clinical performance testing demonstrates that the Subject device is suitable for intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
FDA 510(k) Clearance Letter - Electrosurgical Pads
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 19, 2025
Baisheng Medical Co., Ltd.
Haley Lin
Registration Specialist
No.11 Fusheng Road, Xinhui District 529100
Jiangmen, Guangdong 529100
China
Re: K251235
Trade/Device Name: Electrosurgical Pads
Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories
Regulatory Class: Class II
Product Code: GEI
Dated: April 22, 2025
Received: April 22, 2025
Dear Haley Lin:
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 (the 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 available 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.
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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K251235 - Haley Lin
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K251235 - Haley Lin
Page 3
Sincerely,
James H. Jang -S
Digitally signed by James H. Jang -S
Date: 2025.06.19 16:01:45 -04'00'
James Jang, Ph.D.
Acting Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
Indications for Use
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K251235 |
|---|---|
| Please provide the device trade name(s). | |
| Electrosurgical Pads | |
| Please provide your Indications for Use below. |
Electrosurgical Pads are Neutral Electrode which is also known as plate, plate electrode, passive, return, or dispersive electrode. They are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient.
Solid Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical Pads are for use with generators that have a CQMS (i.e. REM, ARM, NESSY, etc.).
| Please select the types of uses (select one or both, as applicable). | ☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
Electrosurgical Pads
Page 8 of 37
Page 5
Traditional 510(k) Submission - Electrosurgical Pads
510(k) Summary
Electrosurgical Pads
Baisheng Medical Co., Ltd.
Date prepared: Apr. 22, 2025
510(k) submitter ADMINISTRATIVE INFORMATION
Manufacturer Name: Baisheng Medical Co., Ltd.
Address: No.11 Fusheng Road, Xinhui District 529100 Jiangmen City, Guangdong, PEOPLE'S REPUBLIC OF CHINA
General Manager: Mr. Chen Xi
E-mail: renzhen@bs0750.com
Official Contact Person: Haley Lin-Registration Specialist
E-mail: haley@bs0750.com
SUBJECT DEVICE NAME AND CLASSIFICATION
Trade/Device Name: Electrosurgical Pads
Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories
Regulation Number: 21 CFR 878.4400
Regulation Class: Class II
Product Code: GEI
Review Panel: General & Plastic Surgery
PREDICATE DEVICE INFORMATION
The Subject device in this submission is substantially equivalent in indications for use and design principles to the following predicate device
| 510(k) Number | Predicate Device | Company Name |
|---|---|---|
| K233615 | Electrosurgical Pads | Baisheng Medical Co., Ltd. |
REFERENCE DEVICES INFORMATION
| 510(k) Number | Predicate Device | Company Name |
|---|---|---|
| K160290 | Valleylab REM Polyhesive Infant Patient Return Electrode | Covidien LLC |
| K822572 | Valleylab REM Polyhesive Adult Patient Return Electrode | Covidien LLC |
| K861036 | Valleylab REM Polyhesive Adult Cordless Patient Return Electrode | Valleylab, INC. |
1 / 12
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Traditional 510(k) Submission - Electrosurgical Pads
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DEVICE DESCRIPTION
Electrosurgical Pads are single-use, non-sterile dispersive electrode with or without a pre-attached cord. This devices are used in monopolar surgery to complete the electrical circuit with the generator. Providing a low-impedance path back to the generator through the return electrode helps to prevent unintended RF burns. The Electrosurgical Pads are designed to be compatible with the return electrode monitoring function of compatible OBS generators.
INDICATIONS FOR USE
Electrosurgical Pads are Neutral Electrode which is also known as plate, plate electrode, passive, return, or dispersive electrode. They are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient.
Solid Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical Pads are for use with generators that have a CQMS (i.e. REM, ARM, NESSY, etc.).
EQUIVALENCE TO MARKETED DEVICE
The subject device is highly similar to the predicate device with respect to Indications for Use, and technological principles. The comparison tables at below comparing the indications for Use and technological characteristics of the subject and predicate/reference devices.
Indications for Use Between the Subject Device and Predicate Device
| Device | Subject Device | Predicate Device | Discussion |
|---|---|---|---|
| Indications for use statement | Electrosurgical Pads are Neutral Electrode which is also known as plate, plate electrode, passive, return, or dispersive electrode. They are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit | Electrosurgical Pads are Neutral Electrode which is also known as plate, plate electrode, passive, return, or dispersive electrode. They are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit | The subject device and predicate device's indications for use are the same. |
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Traditional 510(k) Submission - Electrosurgical Pads
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| | during electrosurgery between the electrosurgical generator, the active electrode and the patient. Solid Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical Pads are for use with generators that have a CQMS (i.e. REM, ARM, NESSY, etc.). | during electrosurgery between the electrosurgical generator, the active electrode and the patient. Solid Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical Pads are for use with generators that have a CQMS (i.e. REM, ARM, NESSY, etc.). | |
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Traditional 510(k) Submission - Electrosurgical Pads
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Indications for Use Between the Subject Device and Reference Devices
| Device | Subject Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | Discussion |
|---|---|---|---|---|---|
| Indications for use statement | Electrosurgical Pads are Neutral Electrode which is also known as plate, plate electrode, passive, return, or dispersive electrode. They are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient. Solid Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical Pads are for | The REM Polyhesive Infant Patient Return Electrode is a single use, non-sterile dispersive electrode with a preattached cord. The electrode adheres to the patient over its entire surface. Its purpose is to complete the electrosurgical circuit between the generator, the active electrode, and the patient. The product is used for general monopoloar electrosurgery on newborns, infants, and children weighing between approximately 6 and 30 lb. | The E7507 and E7507DB patient return electrodes are single use, non-sterile dispersive electrodes with a preattached cord. The electrode adheres to the patient over its entire surface. lts purpose is to complete the electrosurgical circuit between the generator,the active electrode, and the patient. These products are used for general monopolar electrosurgery on patients of approximately 30 pounds or greater. | The E7508, E7509, and E7509B patient return electrodes are single use, non-sterile dispersive electrodes intended to be used with the E0560 or E0560E patient return electrode reusable cord/clamp assemblies. The electrode adheres to the patient over its entire surface. The cord connects and clamps onto the electrode in order to complete the electrosurgical circuit between the generator, the active electrode, and the patient. These products are used for | 1. The subject device and reference device's indications for use are highly similar. All are intended to complete the electrosurgical circuit between the generator, the active electrode, and the patient. 2. Only differ with the weight range and the pre-attached cord. The subject device intended for three weight range patients, with no upper body weight limit. The reference device 2 &3 are for patients weighing over 30 pounds, while reference |
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Traditional 510(k) Submission - Electrosurgical Pads
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| | use with generators that have a CQMS (i.e. REM, ARM, NESSY, etc.). | | general monopolar electrosurgery on patients of approximately 30 pounds or greater. | | device 1 is for patients weighing between approximately 6 and 30 lb (6 and 30pounds). 3. The reference device 1 &2 both are with a pre-attached cord, while the reference device 3 is cordless, and it need to be combination used with reusable cord/clamp. |
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Traditional 510(k) Submission - Electrosurgical Pads
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Technological Characteristics
| Parameter | Subject Device | Predicate Device (K233615) | Reference Device 1 (K160290) | Reference Device 2 (K822572) | Reference Device 3 (K861036) | Differences | Discussion |
|---|---|---|---|---|---|---|---|
| Device Name | Electrosurgical Pads | Electrosurgical Pads | Valleylab REM Polyhesive Infant Patient Return Electrode | Valleylab REM Polyhesive Adult Patient Return Electrode | Valleylab REM Polyhesive Adult Cordless Patient Return Electrode | / | |
| Product Code | GEI | GEI | GEI | GEI | GEI | Same | |
| Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | Same | |
| Regulation Name | Electrosurgical cutting and coagulation device and accessories | Electrosurgical cutting and coagulation device and accessories | Electrosurgical cutting and coagulation device and accessories | Electrosurgical cutting and coagulation device and accessories | Electrosurgical cutting and coagulation device and accessories | Same | |
| Regulatory Class | Class II | Class II | Class II | Class II | Class II | Same | |
| Technology | Conductive resin that adheres to the patient's skin and conducts electrical current away from the patient's body | Same | |||||
| Model | GBS-Db4030, GBS-Db4030c, GBS-Db4030c-45 GBS-Db4030bc, GBS-Db4030nc, See below table 6 | E7510-25, E7510-25DB | E7507, E7507-DB | E7508, E7509, E7509B | / |
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Traditional 510(k) Submission - Electrosurgical Pads
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| Parameter | Subject Device | Predicate Device (K233615) | Reference Device 1 (K160290) | Reference Device 2 (K822572) | Reference Device 3 (K861036) | Differences | Discussion |
|---|---|---|---|---|---|---|---|
| GBS-Dm4020, GBS-Dm4020c | |||||||
| Corded or Non-corded | Corded and Non-corded | Corded and Non-corded | Corded | Corded | Non-corded | Same. The subject device include corded and non-corded, is the same as the predicate device, and the reference device 1 & 2 have cord, while the reference device 3 is cordless. | |
| Applicable Patient Weight | 15kg: GBS-Db4030, GBS-Db4030c, GBS-Db4030c-45, GBS-Dm4020, GBS-Dm4020c: Neonates:5kg Children and Adult:>5kg, 13.6kg) | 30lb or greater (>13.6kg) | Same. The subject device and predicate device both are intended for three weight range patients. But is different with the reference devices, reference devices only for single weight range patients. | ||||
| Overall Dimensions | 15kg: 18.4*11.5=211.6cm2 | have fifteen sizes applicable. The reference devices only have single size respectively. Highly similar to the subject device. The pads are intended to carry current in application, the Electrical Safety & EMC tests have been conducted and conformed to standards. So the size has no influence on safety and performance. | |||||
| Conductive Surface Area | 15kg:141.3cm2 | Neonates:43cm2 Children:87cm2 Children and Adult:135-307cm2 Adult:100-144cm2 See below table 6 | 75cm2 From brochure | 137cm2 From brochure | 1373cm2 From brochure | Highly similar. Some model of the predicate device have larger surface area, but the subject device are the same as the reference devices. Comply with clauses 201.15.101.4 of IEC 60601-2-2. Test results verified the differences do not raise additional safety or effectiveness concerns. | |
| Frame Width | 15kg:1.2cm±2cm | / | 0.95cm From brochure | 1.11cm From brochure | 1.11cm From brochure | Different. The subject device has a frame while the predicate device has no frame. But it is the same as |
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Traditional 510(k) Submission - Electrosurgical Pads
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| | | | | | | | reference devices, only differ with the dimension. A frame is adhered around the border to secure the gel to prevent them from unraveling, rotting, or falling off the patient's skin during operation. The difference have been evaluated through appropriate biocompatibility and performance testing and met the standards. |
| Patient Contact Materials | Conductive gel (Sodium Polyacrylate, Propanetriol (Glycerin), Water, Potassium Chloride) | Conductive gel (Sodium Polyacrylate, Propanetriol (Glycerin), Water, Potassium Chloride) | Conductive gel (adhesive polymer matrix, water, electrolytes, blue colorant, and preservative) Pressure-sensitive adhesive border Silicone-coated paper | Unknown | Unknown | | Same as predicate device. Similar to reference devices. The difference have been evaluated through biocompatibility testing and met the standards. |
| Biocompatibility Properties | Comply with the standards of ISO 10993 | Comply with the following standards: ISO 10993-5, | Be tested and conform to ISO 10993. | Be subjected to | Unknown | | Same. All products had met the requirements. |
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Traditional 510(k) Submission - Electrosurgical Pads
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| | | ISO 10993-10, ISO 10993-23 | cytotoxicity, sensitization, and primary skin irritation tests. | | | | |
| Safety and Performance Properties | Comply with relevant clauses of IEC 60601-2-2, IEC 60601-1, IEC 60601-1-2 | Comply with the following standards: IEC 60601-1:2005, IEC 60601-2-2:2017, IEC 60601-1-2:2014 | Conform to IEC 60601-1:2005, IEC 60601-2-2:2009, IEC 60601-1-2:2007 and 2014 | Unknown | Unknown | | Same. All the testing were conducted in accordance with latest version standards. |
| Shelf life | 3 years | 3 years | Two years | Two years | Two years | | Same. But different with reference devices. The real time aging verification for subject device has been conducted and conformed to three years shelf life criteria. |
| Single use | Yes | Yes | Yes | Yes | Yes | | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile | | Same |
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Traditional 510(k) Submission - Electrosurgical Pads
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CLINICAL TESTING
The performance of Electrosurgical Pads in the clinical environment has been well established. No clinical data is included in this submission.
NON-CLINICAL PERFORMANCE TESTING
Performance test, Electrical safety test, Electromagnetic compatibility(EMC) test and biocompatibility test have been done to demonstrate the safety and performance of subject device. The test details as follows:
-
Performance test was performed according to:
- 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, and, Final Products Inspection Protocol.
-
Electrical safety test, Electromagnetic compatibility(EMC) test Compliance with
- IEC 60601-1-2: 2014/ AMD1: 2020 Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests, and,
- IEC 60601-1: 2005+A1: 2012+A2: 2020 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
-
A biological evaluation was performed on the Subject device according to ISO 10993-1:2018 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
-
Biocompatibility test was performed according to:
- ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, and,
- ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin sensitization, and,
- ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation.
Non-clinical performance testing of the Subject device met the acceptance criteria for each validation and test described above. This non-clinical performance testing demonstrates that the Subject device is suitable for intended use.
CONCLUSION
Since the Indications for Use statements for the subject and predicate/reference devices are highly similar, differing slightly only in structure comparing to predicate device but same as reference devices. Additionally the technological characteristics of
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Traditional 510(k) Submission - Electrosurgical Pads
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the subject device are the same or highly similar to the predicate device with any differences mitigated through non-clinical performance testing.
Overall, these similarities between the subject and predicate devices, support a determination of substantial equivalence.