Soniquence Reusable Bipolar Cable

K211946 · Soniquence, LLC · GEI · Jul 16, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K211946
• Device Name: Soniquence Reusable Bipolar Cable
• Applicant: Soniquence, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 16, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Soniquence Reusable Bipolar Cable is intended to transfer power from an RF Generator to Bipolar Electrodes.

Device Story

The Soniquence Reusable Bipolar Cable is a 3-meter accessory designed to connect a high-frequency RF generator to bipolar electrosurgical electrodes. It functions as a conduit for RF energy, enabling the transfer of power required for cutting and coagulation. The device is operated by a clinician in a clinical setting, typically activated via a footswitch. It is constructed from silicone and polypropylene, designed to be flexible and autoclavable for reuse. By facilitating the connection between the generator and the electrode, the cable allows the surgeon to perform precise electrosurgical procedures, benefiting the patient through controlled tissue cutting and hemostasis.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including electrical safety and performance testing per IEC 60601-2-2:2017 and steam sterilization validation per ISO 17665-1:2006.

Technological Characteristics

Materials: Silicone and Polypropylene H1500. Energy: RF energy. Form factor: 3-meter cable. Connectivity: Male/female connectors for generator-to-electrode interface. Sterilization: Autoclavable (steam), validated per ISO 17665-1:2006. Safety standards: IEC 60601-2-2:2017.

Indications for Use

Indicated for use as an accessory to transfer electrosurgical RF power from a generator to bipolar electrodes for cutting and coagulation procedures.

Regulatory Classification

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.

Predicate Devices

• Soniquence Bipolar Electrodes (K190336)
• Tecno Instruments (K042608)

Submission Summary (Full Text)

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July 16, 2021

Soniquence, LLC Ms. Suzanne Lucas, BA Sr. Regulatory Affairs Specialist 2477 Grand Avenue Baldwin, New York 11510

Re: K211946

Trade/Device Name: Soniquence Reusable Bipolar Cable Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: June 16, 2021 Received: June 23, 2021

Dear Ms. Lucas:

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 inf ormation 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.

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Long Chen, Ph.D. 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

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#### Indications for Use

510(k) Number (if known) K211946

#### Device Name

Soniquence Reusable Bipolar Cables

#### Indications for Use (Describe)

The Soniquence Reusable Bipolar Cable is intended to transfer power from an RF Generator to Bipolar Electrodes.

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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K211946

Image /page/3/Picture/1 description: The image is a logo with a white, stylized letter "S" on a purple square background with rounded corners. The "S" appears to be made of a ribbon-like material with subtle shading to give it a three-dimensional effect. The purple square provides a clean and modern backdrop for the white letter, making it stand out.

Image /page/3/Picture/2 description: The image shows the word "Soniquence" in a stylized purple font. The "S" in "Soniquence" is stylized with a ribbon-like shape that curves around the letter. The rest of the letters are in a simple, sans-serif font. There is a registered trademark symbol to the right of the word.

510(k) SUMMARY (As required by 21 CFR 807.92(a))

Date Prepared July 15, 2021

Submitter's Information (807.92(a)(1))

Company Name and Address:

Soniquence, LLC 2477 Grand Avenue Baldwin, NY 11510 Phone: [phone] www.soniquence.com

Establishment Reqistration #: 3014982808

# Contact Information:

Ms. Suzanne Lucas, BA Sr. Regulatory Affairs Specialist Soniquence, LLC 2477 Grand Avenue Baldwin, NY 11510 Phone: [phone] Fax: [phone] Email: [e-mail]

# Device Information (807.92(a)(2))

Trade Name: Soniquence Reusable Bipolar Cables

Common/Usual Name: Electrosurgical, Cutting & Coagulation Device & Accessories

Classification Name and Regulation: Electrosurgical Cutting and Coagulation Device and Accessories, 21 CFR 878.4400

Classification Panel: General and Plastic Surgery

## Device Class/Product Code

FDA Classification: Class 2 FDA Product Code: GEI

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Image /page/4/Picture/0 description: The image is a logo with a purple square background and rounded corners. Inside the square is a stylized white letter "S" that appears to be made of a ribbon or folded paper. The "S" shape is curved and flowing, giving it a dynamic and elegant appearance. The overall design is simple, modern, and visually appealing.

K211946

Image /page/4/Picture/2 description: The image shows the word "Soniquence" in a stylized purple font. The "S" is elongated and curved, resembling a ribbon or wave. The rest of the letters are in a sans-serif font, and there is a small circle with an "R" inside it to the right of the word, indicating a registered trademark.

## Predicate Devices (807.92(a)(3))

- Soniquence Bipolar Electrodes (K190336) ●
- Tecno Instruments (K042608) ●

# Device Description (807.92(a)(4))

The subject device, Soniquence Reusable Bipolar Cable is a bipolar accessory designed to transfer the electrosurgical power to the Bipolar electrode. It is connected to a High Frequency Generator via the male end and the female end termination connects to the standard Bipolar instrument. The cable is made of Silicone material and Polypropylene H1500 which is flexible and autoclavable. The length of the cable is 3 meters, and it is provided non-sterile.

### Intended Use:

The Soniquence Reusable Bipolar Cable is intended to transfer power from an RF Generator to Bipolar Electrodes.

## Substantial Equivalence Comparison (807.92(a)(6))

The Soniquence Reusable Bipolar Cables are substantially equivalent in intended use, technological characteristics, operating principle, and performance characteristics to the predicate device by Tecno (K042608).

| Predicate Information | Soniquence Reusable Bipolar Cable<br>(SUBJECT DEVICE) | Tecno Reusable Bipolar Cables<br>(K042608)<br>PREDICATE |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Soniquence Reusable Bipolar Cable is intended to transfer power from an RF Generator.to Bipolar Electrodes. | An electrosurgical cable is a device intended to connect Electrosurgical Generator with electrosurgical cutting and coagulation devices. |
| Product Code | GEI | GEI |
| Device Classification | Class II | Class II |
| Functions | Connect to High Frequency Generator to provide power to Bipolar Electrodes. | Connect to Electrosurgical Generator to provide power to Bipolar Electrodes. |
| Operating principle | Bipolar | Bipolar |
| Energy Source | RF Energy | RF Energy |
| Cable Length (m) | 3m | 3m |
| Activation Method | Footswitch | Footswitch |
| Materials | Silicon and Polypropylene H1500 | Silicon and Santoprene |
| Testing standards used | IEC 60601-2-2:2017 | IEC 60601-2-2:2017 |
| Steam Sterilization<br>Validation | ISO 17665-1:2006 | ISO 17665-1:2006 |

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Image /page/5/Picture/0 description: The image is a logo with a purple square background and rounded corners. Inside the square is a white, stylized "S" shape that appears to be a ribbon or a piece of paper curling. The "S" shape is three-dimensional, with shading that gives it depth and a sense of movement.

K211946

Image /page/5/Picture/2 description: The image shows the logo for Soniquence. The logo is purple and features a stylized "S" that looks like a ribbon. The rest of the word "oniquence" is written in a simple, sans-serif font. There is a registered trademark symbol to the right of the word.

## Non-Clinical Testing (807.92(b)(1))

The Soniquence Reusable Bipolar Cables will be manufactured in accordance with the design control requirements of 21 CFR 820.30. Appropriate non-clinical verification and validation activities were planned and conducted to address identified risks and ensure the safety and effectiveness of the device. The following tests were successfully performed:

- 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
- ISO 17665-5:2006 Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

### Technological Characteristics

The devices are substantially equivalent to the predicate devices based on a comparison of physical and performance characteristics.

### Clinical Testing (807.92(b)(2))

This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.

### Conclusion (807.92(b)(3))

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the similarity to the predicate devices in terms of technology, performance, and indications for use, Soniquence, LLC concludes that the subject device, Soniquence Reusable Bipolar Cables does not raise any issues of safety or effectiveness and are substantially equivalent to the predicate device as described above.