(18 days)
Not Found
Not Found
No
The description focuses on the electrosurgical function, safety features (shielding and monitoring), and mechanical aspects of the electrodes and handpieces. There is no mention of AI, ML, image processing, or data-driven decision making.
No.
The device is used in surgical procedures for ablation, removal, resection, and coagulation of soft tissue, which are actions that carry out a therapy rather than being a therapeutic device itself.
No
The device is an electrosurgical accessory used for ablation, removal, resection, and coagulation of soft tissue, not for diagnosis. While it has a monitoring system to prevent stray energy injuries, this is a safety feature during active electrosurgery, not a diagnostic function.
No
The device description clearly details physical components like electrodes, handpieces, and cords, which are hardware. The system also includes an AEM Monitor, which is also a 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 states that the devices are for "ablation, removal, resection and coagulation of soft tissue" using electrical current. This is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The description details electrosurgical accessories that connect to a generator to deliver electrical energy for surgical purposes. This aligns with surgical tools, not diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to perform surgical procedures directly on the patient's tissue.
N/A
Intended Use / Indications for Use
The AEM Disposable Electrodes and AEM Disposable Handpieces are electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
The devices are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
AEM instruments incorporate the use of AEM technology and are intended for use with the Encision AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The AEM Disposable Electrode and the AEM Disposable Handpiece connect to a compatible electrosurgical generator via an adapter on the ENCISION AEM Monitor. The handpiece has foot switching and hand switching versions. The electrodes and handpieces are single use products, which are provided sterile. They are designed not to be re-sterilized.
The AEM Monitoring System, including the electrodes and handpieces, are designed to minimize the likelihood of stray energy injuries caused by active insulation failure or capacitive coupling. The monitor does this by shutting down the ESU when excessive current is returned via the shield circuit which extends to near the tip of the electrode.
The electrodes, which consist of an insulated tip, shaft with locking knob, and AEM shield assembly, are available in various tip styles. The electrode has an inner insulation between the active conductor and shield tube, as well as a secondary outer insulation on the outside of the clectrode shaft. The electrodes snap into the handpiece.
One version of the handpiece provides switching for the Cut and Coag functions of the ESU. This version has an integral cord. The other version uses foot-switching provided with the electrosurgical generator. The foot-switching handpiece connects to either the existing reusable or disposable AEM Cord from Encision. The electrodes may be removed from the handpiece and replaced with another electrode within the sterile field.
The electrode can rotate freely or be locked in one of multiple orientations relative to the handpiece, as preferred by the surgeon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel trained in the use of electrosurgical equipment
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)
Performance of the devices' AFM technology and delivery of electrosurgical energy has heen verified by bench testing consisting of continuity and capacitance measurements, and compatibility testing with a worst case representative electrosurgical generator and the AEM Monitor.
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.
Model ES1000 series Monopolar Laparoscopic Electrodes with Electroshield, Model 30-6000 series Reusable Monopolar Electrodes, Model 8380 series Unipolar Electrodes, Models SW11100, SW11200, SW11202, SW11300 (Reusable) and SW1220, SW12202, SW12300 (Disposable) Electrosurgical Pencils, Model ES4000 AEM Cord (AEM Monitor accessory), Model E2508 Disposable Pencil
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
ENCISIGN
K 072-789
510(k) Summary
DATE: 5/19/07
510(k) Submitter: ENCISION INC. 6797 Winchester Circle Boulder, CO 80301 USA Establishment Registration: 1722040 JU7 1 § 2007
Contact Person.
Judith V. King, VP Regulatory Affairs and Quality Assurance Phone: 303-339-6917 Fax: 303-444-2693 e-mail: jking(a encision.com
Device Name: AEM Disposable Electrodes and AEM Disposable Handpieces
Common name: Device, Electrosurgical, Cutting and Coagulation and Accessories
Classification: CFR Section: 878.4400
Class: II
Product Code: GEI
Predicate Devices:
Electrodes
Trade, Proprietary or Model Name | Manufacturer |
---|---|
Model ES1000 series Monopolar Laparoscopic Electrodes with | |
Electroshield | ENCISION INC. |
Model 30-6000 series Reusable Monopolar Electrodes | Kirwin Surgical Products |
Model 8380 series Unipolar Electrodes | Richard Wolf Medical |
Instruments Corp. | |
Models SW11100, SW11200, SW11202, SW11300 (Reusable) | |
and SW1220, SW12202, SW12300 (Disposable) Electrosurgical | |
Pencils | Shining World Healthcare |
Co., Ltd. |
Handpieces
Trade, Proprietary or Model Name | Manufacturer |
---|---|
Model ES1000 series Monopolar Laparoscopic Electrodes with | |
Electroshield | ENCISION INC. |
Model ES4000 AEM Cord (AEM Monitor accessory) | ENCISION INC. |
Model E2508 Disposable Pencil | Valleylab, Inc. |
Models SW11100, SW11200, SW11202, SW11300 (Reusable) | |
and SW1220, SW12202, SW12300 (Disposable) Electrosurgical | |
Pencils | Shining World Healthcare |
Co., Ltd. |
ENCISION 510(k) Notification Summary AEM® Disposable Electrodes and AEM Disposable Handpieces
1
ENCISIGN
Description of Devices:
The AEM Disposable Electrode and the AEM Disposable Handpiece connect to a compatible electrosurgical generator via an adapter on the ENCISION AEM Monitor. The handpiece has foot switching and hand switching versions. The electrodes and handpieces are single use products, which are provided sterile. They are designed not to be re-sterilized.
The AEM Monitoring System, including the electrodes and handpieces, are designed to minimize the likelihood of stray energy injuries caused by active insulation failure or capacitive coupling. The monitor does this by shutting down the ESU when excessive current is returned via the shield circuit which extends to near the tip of the electrode.
The electrodes, which consist of an insulated tip, shaft with locking knob, and AEM shield assembly, are available in various tip styles. The electrode has an inner insulation between the active conductor and shield tube, as well as a secondary outer insulation on the outside of the clectrode shaft. The electrodes snap into the handpiece.
One version of the handpiece provides switching for the Cut and Coag functions of the ESU. This version has an integral cord. The other version uses foot-switching provided with the electrosurgical generator. The foot-switching handpiece connects to either the existing reusable or disposable AEM Cord from Encision. The electrodes may be removed from the handpiece and replaced with another electrode within the sterile field.
The electrode can rotate freely or be locked in one of multiple orientations relative to the handpiece, as preferred by the surgeon.
Intended 【Jse:
AEM Disposable Electrodes and AEM Disposable Handpieces are electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
The devices are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
AEM instruments incorporate the use of AEM technology and are intended for use with the Encision AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor.
Technological Characteristics:
The Encision AEM Disposable Electrodes and AEM Disposable Handpieces incorporate the same technological characteristics as the predicate devices for delivery of the ESU high frequency current, consisting of insulated conductors and shafts with appropriately shaped tips for electrosurgery. The control for ESU Cut and Coag modes on the handswitching handpiece is a switch similar in design and function to the predicate handpiece.
Like the Encision predicate devices, the AFM Disposable Electrodes and AEM Disposable Handpieces include an additional AEM shielding function which diverts stray energy from the shaft of the instrument and is monitored by the Encision AEM Monitor.
Non-clinical Performance Testing:
Performance of the devices' AFM technology and delivery of electrosurgical energy has heen verified by bench testing consisting of continuity and capacitance measurements, and
2
ENCISIGN
compatibility testing with a worst case representative electrosurgical generator and the AEM Monitor.
Conclusions:
The AEM Disposable Electrodes and AEM Disposable Handpieces are safe and effective and are substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping human profiles facing to the right, creating a sense of depth and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2007
Encision, Inc. % Intertek Testing Services Mr. Daniel W. Lehtonen 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087
Re: K072789
Trade/Device Name: AEM Disposable Electrodes and AEM Disposable Handpieces Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 28, 2007 Received: October 1, 2007
Dear Mr. Lehtonen:
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.
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Page 2 - Mr. Daniel W. Lehtonen
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the word "ENCISION" in all caps. The letters are in a bold, sans-serif font and are black. The "O" in "ENCISION" is replaced by a circular logo with a white curved line running through it. There is a registered trademark symbol to the upper right of the last letter N.
Indications for Use
510(k) Number (if known):
K 072789
Device Name:
AEM Disposable Electrodes and AEM Disposable Handpieces
Indications For Use:
The AEM Disposable Electrodes and AEM Disposable Handpieces are electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
The devices are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
X Prescription Use (Part 21 CFR 801 Subpart D)
OR
Over-The-Counter Use (Part 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 462289