Ellusa Reusable Bipolar Cable

K222429 · Ellusa, LLC · GEI · Sep 9, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K222429
• Device Name: Ellusa Reusable Bipolar Cable
• Applicant: Ellusa, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 9, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

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

Device Story

Bipolar cable transfers RF electrosurgical power from high-frequency generator to bipolar electrodes; used in clinical settings; operated by healthcare professionals. Device features male connector for generator interface and female connector for bipolar instrument. Silicone and polypropylene construction allows for reuse and steam sterilization. Benefits include durable, autoclavable design for repeated surgical use.

Clinical Evidence

No clinical data provided. Substantial equivalence demonstrated via bench testing, including electrical safety (IEC 60601-2-2:2017) and sterilization validation (ISO 17665-1:2006).

Technological Characteristics

Bipolar electrosurgical accessory; 3-meter length; silicone and polypropylene H1500 construction; steam autoclavable. Complies with IEC 60601-2-2:2017 and ISO 17665-1:2006. Passive electrical conductor; no software or active circuitry.

Indications for Use

Indicated for use as a power transfer accessory between an RF generator and bipolar electrodes in electrosurgical 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

• Ellusa Bipolar Electrodes (K202558)

Submission Summary (Full Text)

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September 9, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Ellusa, LLC Ms. Suzanne Lucas Sr. Regulatory Affairs Specialist 2473 Grand Avenue Baldwin, New York 11510

Re: K222429

Trade/Device Name: Ellusa 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: July 25, 2022 Received: August 11, 2022

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 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

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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,

for

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) K222429

Device Name Ellusa Reusable Bipolar Cables

Indications for Use (Describe)

The Ellusa 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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Image /page/3/Picture/1 description: The image shows the word "ellusa" in a stylized, bold, sans-serif font. A swooping graphic element is on the left side of the word, adding a dynamic touch to the overall design. The letters are evenly spaced and have a uniform thickness, contributing to a clean and modern aesthetic. The image is in black and white.

K222429

# 510(k) SUMMARY

(As required by 21 CFR 807.92(a))

Date Prepared September 7, 2022

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

Company Name and Address:

Ellusa, LLC 2473 Grand Avenue Baldwin, NY 11510 Phone: [phone] Establishment Registration #: 3016087306

## Contact Information:

Ms. Suzanne Lucas, BS Sr. Regulatory Affairs Specialist Ellusa, LLC 2473 Grand Avenue Baldwin, NY 11510 Phone: [phone] Email: [e-mail]

Device Information (807.92(a)(2))

Trade Name: Ellusa Reusable Bipolar Cables

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

Classification Name and Requlation: Electrosurgical Cutting and Coaqulation 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

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

- Ellusa Bipolar Electrodes (K202558) ●
ellusa LLC. 2473 Grand Avenue, Baldwin, NY 11510 Main: [phone] • Fax: [phone] www.ellusa.com

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Image /page/4/Picture/1 description: The image shows the word "ellusa" in a stylized, sans-serif font. A curved, swooping line extends from the left, visually connecting to the "e" and adding a dynamic element to the logo. The letters are bold and evenly spaced, creating a clean and modern appearance. The overall design is simple yet distinctive, making it easily recognizable.

K222429

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

The subject device, Ellusa 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 Ellusa Reusable Bipolar Cable is intended to transfer power from an RF Generator to Bipolar Electrodes.

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

The Ellusa Reusable Bipolar Cables are substantially equivalent in intended use, technological characteristics, operating principle, and perf ormance characteristics to the predicate device by Ellusa (K202558).

| Predicate Information | Ellusa Reusable Bipolar Cable<br>(SUBJECT DEVICE) | Ellusa Disposable Bipolar Cables<br>(K202558)<br>PREDICATE |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Intended Use | The Ellusa Reusable Bipolar Cable is<br>intended to transfer power from an RF<br>Generator.to Bipolar Electrodes. | The Ellusa Bipolar Cables are intended to<br>transfer power from an RF Generator to<br>Bipolar Electrodes. |
| Product Code | GEI | GEI |
| Device Classification | Class II | Class II |
| Functions | Connect to High Frequency Generator to<br>provide power to Bipolar Electrodes. | Connect to Electrosurgical Generator to<br>provide power to Bipolar Electrodes. |
| Operating principle | Bipolar | Bipolar |
| Energy Source | RF Energy | RF Energy |
| Cable Length (m) | 3m | 3m |
| Activation Method | Footswtich | Footswtich |
| Materials | Silicon and Polypropylene H1500 | PVC |
| Testing standards used | IEC 60601-2-2:2017 | IEC 60601-2-2:2017 |
| Steam Sterilization<br>Validation | ISO 17665-1:2006 | Not applicable. Device is disposable |

ellusa LLC. 2473 Grand Avenue, Baldwin, NY 11510 Main: [phone] • Fax: [phone] www.ellusa.com

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Image /page/5/Picture/1 description: The image shows the word "ellusa" in a stylized, sans-serif font. To the left of the word, there is a curved, swooping design element that adds a dynamic and modern touch to the overall logo. The text and design are both in black, contrasting with the white background.

K222429

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

The Ellusa 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 surqical 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, Ellusa, LLC concludes that the subject device, Ellusa Reusable Bipolar Cables does not raise any issues of safety or effectiveness and are substantially equivalent to the predicate device as described above.

ellusa LLC. 2473 Grand Avenue, Baldwin, NY 11510 Main: [phone] • Fax: [phone] www.ellusa.com