(113 days)
Not Found
No
The summary describes a coated electrosurgical electrode with a non-stick coating, focusing on material properties and performance in cutting and coagulation. There is no mention of AI, ML, image processing, or data-driven algorithms.
No
The device is an accessory (surgical electrode) used in electrosurgical procedures for cutting and coagulation, not a therapeutic device itself that treats a disease or condition.
No
The device is an electrosurgical accessory used for cutting and coagulation, which are therapeutic procedures, not diagnostic ones. Its function is to perform surgical actions, not to detect or identify medical conditions.
No
The device description explicitly states it is a "standard stainless steel active electrode with a nonstick coating," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the E Surgical Coated Electrodes are used in monopolar electrosurgical accessories for cutting and coagulation of tissue. This is a surgical procedure performed directly on the patient's body, not a test performed on a sample outside the body.
The device is a surgical tool used during a procedure, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
E Surgical Coated Electrodes are intended as an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes for use in conventional monopolar electrosurgical accessories. The Coated Electrodes are intended for use in situations where monopolar electrosurgical cutting and coagulation are normally used.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The E Surgical coated electrodes are designed as a standard stainless steel active electrode with a nonstick coating to prevent tissue and char build-up on the electrode. Three models: ball, needle, and blade are included.
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)
a. Meets safety and performance requirements under ANSI/AAMI HF 18 Electrosurgical Devices.
b. Finished product non-stick coating was bent to 90 degrees ten times without visible cracking of the coating.
c. Cutting or coagulation is initiated immediately at both lower and higher power settings.
d. Easy to clean properties after use on tissue.
e. Materials used in the construction of the electrodes meet ISO 10993 Biocompatibility requirements.
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
510(k) Summary
$\qquad k\omega 6187\delta$
E Surgical, LLC 1990 N. California Blvd., Suite 1040 Walnut Creek, CA 94596 925-280-8388 Phone 925-280-1788 Fax Contact: Hans Richter
I. Trade Name: E Surgical Coated Electrode: Electrode, Coated Ball Electrode, Coated Blade Electrode, Coated Needle
OCT 2 4 2006
II. Common Name: Active Electrode
III. Classification: 21 CFR 878.4400, Class II, Electrosurgical Cutting and Coagulation Accessory
IV. Product Code: GEI
V. Indications for Use
E Surgical Coated Electrodes are intended as an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes for use in conventional monopolar electrosurgical accessories. The Coated Electrodes are intended for use in situations where monopolar electrosurgical cutting and coagulation are normally used.
VI. Predicate Devices
a. Valleylab Edge™ Coated Electrodes, K962044 b. New Deantronics, Ltd. Disposable Hand Switching Pencil, K982742
VII. Device Description
The E Surgical coated electrodes are designed as a standard stainless steel active electrode with a nonstick coating to prevent tissue and char build-up on the electrode. Three models: ball, needle, and blade are included.
VIII. Summary of Technological Characteristics
The active electrodes are substantially equivalent to the New Deantronic electrodes in the disposable hand switching pencil, K982742, and the Valleylab Edge™ Coated Electrodes, K962044. The electrodes are a modification to the single-use electrodes of various tip configurations. A proprietary coating provides a non-stick surface for easier cleaning of eschar during use.
The electrodes are intended for use during monopolar electrosurgery. The electrodes fit in currently marketed electrosurgical pencils offered by New Deantronics and other manufacturers.
IX. Safety and Performance Data
a. Meets safety and performance requirements under ANSI/AAMI HF 18 Electrosurgical Devices.
b. Finished product non-stick coating was bent to 90 degrees ten times without visible cracking of the coating.
c. Cutting or coagulation is initiated immediately at both lower and higher power settings.
- d. Easy to clean properties after use on tissue.
- e. Materials used in the construction of the electrodes meet ISO 10993 Biocompatibility requirements.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three abstract shapes resembling birds in flight. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2006
E. Surgical, LLC % L.W. Ward and Associates, Inc. Mr. Lewis Ward 4655 Kirkwood Court Boulder, Colorado 80301
Re: K061878
Trade/Device Name: E Surgical, Electrodes, Coated Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 4, 2006 Received: October 10, 2006
Dear Mr. Ward:
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.
2
Page 2 - Mr. Lewis Ward
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,
F. Pdplhn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Ko61878
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: E Surgical, Electrodes, Coated
Indications for Use:
E Surgical Coated Electrodes are intended as an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes for use in conventional monopolar electrosurgical accessories. The Coated Electrodes are intended for use in situations where monopolar electrosurgical cutting and coagulation are normally used.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | 4061878 |