(290 days)
Ellman Electrodes Preamendment
No
The summary describes electrosurgical electrodes and their use with electrosurgical generators, focusing on material composition and function (cutting/coagulation). There is no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device, electrodes, is used to deliver high-frequency electrical current from an electrosurgical generator to tissue for cutting and coagulation, which are direct therapeutic effects on the human body.
No
The device, described as electrodes for electrosurgical generators, is used for cutting and coagulation of tissue by transferring high-frequency electrical current. This is a therapeutic function, not a diagnostic one.
No
The device description explicitly states the device is composed of electrodes, which are hardware components used with an electrosurgical generator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting of tissue and coagulation by use of high frequency electrical current." This is a surgical procedure performed directly on a patient's tissue.
- Device Description: The device is an accessory to electrosurgical generators and is used to transfer electrical power to tissue at a surgical site. This is an in-vivo application.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples. This device is used inside or on the body during surgery.
N/A
Intended Use / Indications for Use
The electrodes are accessories to the Ellman electrosurgical generators for cutting of tissue and coagulation by use of high frequency electrical current.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Ellman has been manufacturing and distributing electrodes for many years. The Ellman electrodes are used with an electrosurgical generator (such as Ellman Surgi Max K061174, Ellman Surgitron K052241). The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. The time-varying voltage produced by the RF electrical power source vields a predetermined electrosurgical effect, such as tissue cutting or coagulation.
The Ellman family of electrodes are available in various shapes and sizes depending on the need of the surgeon.
The Ace-Tip electrodes are composed of the new noble alloy. Several of the classical Ellman electrodes are now available in the new noble alloy including:
- Loop Electrode 3mm and 5mm
- Micro Incision Needle Electrode
- Ball Electrode 2mm
- O Tapered Ball Electrode 3mm
- o Fine Wire Electrode
- VariTip Electrode
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 subject device is composed of biocompatible materials, has passed dielectric testing, and performs similarly to the predicate device.
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.
Ellman Electrodes Preamendment
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.
Ellman Surgi Max K061174, Ellman Surgitron K052241
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
510 (k) S
28 11
Date Prepared [21 CFR 807.92(a)(1)] [Revised] August 28, 2007
Submitter's Information [21 CFR 807.92(a)(1)]
This 510(k) is being submitted by Joseph Azary on behalf of Ellman International Inc.
Contact Information / Regulatory Consultant: Joseph Azary Azary Technologies LLC 543 Long Hill Avenue Shelton, CT 06484 Tel: (203) 944-9320 Fax: (203) 944-9317 Email: info@azarytech.com
Manufacturer / Sponsor: Ellman International Inc. 3333 Royal Avenue Oceanside, NY 11572.
Establishment Registration for Ellman International Inc. is 2428235
Trade Name [21 CFR 807.92(a)(2)] Device trade name is Ace-Tip Electrodes
Device Common, Usual, or Classification Names
Electrodes, Electrosurgical Unit Accessories, Electrosurgical Cutting and Coagulation and Accessories
1
K 0 7 1 3 4 3
Page 2 of 3
Classification Panel
Classification of this device would fall under the responsibility of the Division of General, Restorative, and Neurological Devices.
Class
Classification: Class 2 Product Code: GEI, 21 CFR 878.4400
Predicate Device |21 CFR 807.92(a)(3)]
The predicate devices are listed as follows:
- Ellman Electrodes Preamendment .
Description of the Device [21 CFR 807.92(a)(4)]
Ellman has been manufacturing and distributing electrodes for many years. The Ellman electrodes are used with an electrosurgical generator (such as Ellman Surgi Max K061174, Ellman Surgitron K052241). The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. The time-varying voltage produced by the RF electrical power source vields a predetermined electrosurgical effect, such as tissue cutting or coagulation.
The Ellman family of electrodes are available in various shapes and sizes depending on the need of the surgeon.
The Ace-Tip electrodes are composed of the new noble alloy. Several of the classical Ellman electrodes are now available in the new noble alloy including:
- Loop Electrode 3mm and 5mm 0
- Micro Incision Needle Electrode 0
- Ball Electrode 2mm 0
- O Tapered Ball Electrode 3mm
- o Fine Wire Electrode
- VariTip Electrode o
2
Page 3 of (3)
Intended Use [21 CFR 807.92(a)(5)]
The electrodes are accessories to the Ellman electrosurgical generators for cutting of tissue and coagulation by use of high frequency electrical current.
Technological Characteristics [21 CFR 807.92(a)(6)]
The device is substantially equivalent to the predicate device based on a comparison on physical and performance characteristics.
Performance Data [21 CFR 807.92(b)(1)]
The subject device is composed of biocompatible materials, has passed dielectric testing, and performs similarly to the predicate device.
Conclusion [21 CFR 807.92(b)(3)]
We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
FEB 2 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ellman International, Inc. % Azary Technologies, LLC Mr. Joseph M. Azary 543 Long Hill Avenue Shelton, Connecticut 06484
Re: K071343
Trade/Device Name: Ellman Ace Tip Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 25, 2008 Received: February 6, 2008
Dear Mr. Azary:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 – Mr. Joseph M. Azary
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N Millerson
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
5 10(k) Number (if known):
Device Name: Ellman Ace Tip Electrodes
The electrodes are accessories to the Eliman electrosurgical generators for cutting of tissue and coagulation by use of high frequency electrical current.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Mark A. Milken
(Division Sig . Il) Division of General. Restorative, and Neurolog al Devices
510(k) Number K071343