(29 days)
Not Found
No
The device description and performance studies focus on the electrical and material properties of a cable, with no mention of AI/ML capabilities or data processing.
No
The device is a cable intended to transfer power to bipolar electrodes, not to directly treat a medical condition.
No
The device is described as a reusable bipolar cable intended to transfer power from an RF Generator to Bipolar Electrodes for electrosurgical purposes. It is an accessory for surgical equipment and does not perform any diagnostic function.
No
The device description clearly states it is a physical cable made of silicone and polypropylene, designed to transfer power, and mentions physical characteristics like length and material. It also includes performance studies related to electrical safety and sterilization, which are relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "transfer power from an RF Generator to Bipolar Electrodes." This describes a function related to surgical procedures, not diagnostic testing performed on samples from the human body.
- Device Description: The description details a cable used to connect a power source to a surgical instrument. This is consistent with a surgical accessory, not a device used for in vitro analysis.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely related to delivering power for a surgical procedure.
N/A
Intended Use / Indications for Use
The Ellusa Reusable Bipolar Cable is intended to transfer power from an RF Generator to Bipolar Electrodes.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
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
Not Found
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)
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
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.
Not Found
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.
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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.
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: (516) 634-1370 Establishment Registration #: 3016087306
Contact Information:
Ms. Suzanne Lucas, BS Sr. Regulatory Affairs Specialist Ellusa, LLC 2473 Grand Avenue Baldwin, NY 11510 Phone: (516) 634-1370 Email: slucas@ellusa.com
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: (516) 654-4000 • Fax: (516) 654-8000 www.ellusa.com
4
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.
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
(SUBJECT DEVICE) | Ellusa Disposable Bipolar Cables
(K202558)
PREDICATE |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Intended Use | The Ellusa Reusable Bipolar Cable is
intended to transfer power from an RF
Generator.to Bipolar Electrodes. | The Ellusa Bipolar Cables are intended to
transfer power from an RF Generator to
Bipolar Electrodes. |
| 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 | Footswtich | Footswtich |
| Materials | Silicon and Polypropylene H1500 | PVC |
| Testing standards used | IEC 60601-2-2:2017 | IEC 60601-2-2:2017 |
| Steam Sterilization
Validation | ISO 17665-1:2006 | Not applicable. Device is disposable |
ellusa LLC. 2473 Grand Avenue, Baldwin, NY 11510 Main: (516) 654-4000 • Fax: (516) 654-8000 www.ellusa.com
5
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.
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: (516) 654-4000 • Fax: (516) 654-8000 www.ellusa.com