(58 days)
Not Found
Not Found
No
The description focuses on the physical properties and electrical function of a dispersive electrode, with no mention of AI or ML.
No
Explanation: A therapeutic device is designed to treat a disease, injury, or medical condition. This device, a patient return electrode, is used to complete an electrosurgical circuit, facilitating a surgical procedure rather than directly providing therapy itself. Its function is to prevent patient burns by safely dispersing electrical current, which is a safety critical accessory to a therapeutic electrosurgical generator, not a therapeutic device in its own right.
No
The device is described as a dispersive electrode used to complete an electrosurgical circuit during surgery, not to diagnose a condition. Its function is to facilitate the electrosurgical procedure, not to identify or measure health conditions.
No
The device description clearly states it is a "single use, non-sterile disposable electrode with and without a pre-attached cord," indicating it is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used on the patient to complete an electrical circuit during surgery. This is a therapeutic/surgical device, not a diagnostic one.
- Device Description: The description reinforces its role in electrosurgery, which is a surgical procedure.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition. IVDs are designed to perform tests on these types of samples to aid in diagnosis.
Therefore, this device falls under the category of a surgical accessory or therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
A single use, non-sterile dispersive electrode with or without a pre-attached cord to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.
Product codes
GEI, JOS
Device Description
The E Surgical Patient Return Electrode Dual Plate is a single use, non-sterile disposable electrode with and without a pre-attached cord. The use is to complete an electrical circuit during electrosurgery between the generator, the active electrode, and an adult patient.
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
adult patient
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 E Surgical Pad complies with the ANSI/AAMI HF-18 standard Electrosurgical Devices for Dispersive Electrode Thermal Safety and Contact Impedance. The pad design is proven safe by compliance to biocompatibility standard ISO 10993.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Valleylab, Inc., VL 7600 REM Patient Return Electrode
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR 3 1 2006
510(k) Summary
E Surgical, LLC 1990 N. California Blvd., Suite 1040 Walnut Creek, CA 94596 925-280-8388 Phone 925-280-1788 Fax Contact: Hans Richter, RA/QA Director
K 060255
I. Trade Name: E Surgical
Electrosurgical Patient Return Electrode, Dual Plate with Cord Electrosurgical Patient Return Electrode, Dual Plate Cordless
II. Common Name: Electrosurgical Patient Return Electrode
III. Classification: 21 CFR 878.4400, Electrosurgical Cutting and Coagulation Devices and Accessories
IV. Product Code: GEI
V. Indications for Use:
A single use, non-sterile dispersive electrode with or without a pre-attached cord to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.
VI. Predicate Device: Valleylab, Inc., VL 7600 REM Patient Return Electrode
VII. Device Description: The E Surgical Patient Return Electrode Dual Plate is a single use, non-sterile disposable electrode with and without a pre-attached cord. The use is to complete an electrical circuit during electrosurgery between the generator, the active electrode, and an adult patient.
VIII. Summary of Technological Characteristics: The E Surgical Patient Return Dual Electrode is comparable to the Valleylab, Inc.'s VL 7600 Dual Pad, REM compatible electrode, a legally marketed device. The E Surgical pad is furnished with a 9' cord or without a cord attached for use with a clamp accessory. The pad has a hydrogel adhesive for conductivity with an acrylic border to prevent invasion of fluids. Both pad designs are compatible with return electrode monitoring generator systems.
IX. Performance Data: The E Surgical Pad complies with the ANSI/AAMI HF-18 standard Electrosurgical Devices for Dispersive Electrode Thermal Safety and Contact Impedance. The pad design is proven safe by compliance to biocompatibility standard ISO 10993.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (USA). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines curving upwards. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2006
E Surgical, LLC. c/o L.W. Ward and Associates, Inc. Mr. Lewis Ward 4655 Kirkwood Court Boulder, Colorado 80301
Re: K060255
Trade/Device Name: E Surgical Electrosurgical Patient Return Electrode, Dual Plate with Cord and Electrosurgical Patient Return Electrode, Dual Plate, Cordless
Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, JOS Dated: January 25, 2006 Received: February 1, 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 (sce 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
2
Page 2 - Mr. Lewis Ward
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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours
Sincerely yours,
Elmase
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: E Surgical Electrosurgical Patient Return Electrode, Dual Plate With Cord and Electrosurgical Patient Return Electrode, Dual Plate, Cordless
Indications for Use:
A single use, non-sterile dispersive electrode with or without a pre-attached cord used to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.
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
KOGOSZ Z 510(k) Number_