Sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site. These accessories have applications in general endoscopy and laparoscopy procedures.

AEM instruments incorporate the use of AEM technology and are intended for use with the AEM monitoring system and electrosurgical generators compatible with the AEM system.

Device Description

Single-Use Hand-Control AEM Suction Irrigation Electrodes (DSIE) are electrosurgical accessories that

. Conduct high-frequency monopolar electrosurgical energy from compatible electrosurgical generators (ESU)
. Provide suction or irrigation

to a surgical site during laparoscopic and endoscopic procedures.

They combine the classic active electrode functions of cutting and coagulation by monopolar energy with the convenience of being able to provide suction and irrigation without having to swap instruments in and out of trocar, port, or cannula.

They are used during open, endoscopic, and laparoscopic surgical procedures to ablate, remove, resect, and coagulate soft tissue where associated hemostasis is required.

AI/ML Overview

{
  "acceptance_criteria_and_study": {
    "1. A table of acceptance criteria and the reported device performance": null,
    "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": null,
    "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": null,
    "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": null,
    "5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": null,
    "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": null,
    "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": null,
    "8. The sample size for the training set": null,
    "9. How the ground truth for the training set was established": null,
    "Study Summary": "The provided document is a 510(k) summary for a medical device (Single-Use Hand-Control AEM Suction Irrigation Electrodes). This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies typical for new algorithms or AI. \n\nThe conclusion states that the DSIE is 'substantially equivalent to its predicate devices in design and intended use'. It explicitly mentions that 'There are no significant differences between DSIE and the ConMed predicate in electrosurgery or suction/irrigation performance which would raise new issues of safety and effectiveness, performance, function or intended use of the device.' and 'There are no significant differences between DSIE and the Encision predicate in electrosurgery or AEM Monitoring performance which would raise new issues of safety and effectiveness, performance, function or intended use of the device.'\n\n**Based on the available information, the submission does not contain the details typically found in a study designed to prove device performance against a set of acceptance criteria, especially for AI/algorithm-driven devices.** Instead, it relies on demonstrating equivalence to existing, legally marketed predicate devices. Therefore, direct answers to the specific points about acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance are not present in this document."
  }
}

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a handwritten string of characters, "K122580". The characters are written in a simple, somewhat cursive style, with varying stroke thicknesses. The "K" is capitalized and slightly larger than the other characters. The numbers are all similar in size and spacing, with the "5" and "8" being slightly more rounded.

510(k) Summary

Device	Single-Use Hand-Control AEM® Suction Irrigation Electrodes
Owner	• Encision, Inc.6797 Winchester CircleBoulder, CO 80301Phone: (303) 444-2600Fax: (303) 444-2693
Contact	James W. LewisVice President, Regulatory Affairs and Quality Assurance
Date ofSummary	7 November 2012
DeviceClassification	Trade name	AEM Disposable Suction Irrigation Electrodes
	Common name	Active Electrosurgical Electrode with AEM
	Classification name	21 CFR 878.4400 Electrosurgical, Cutting &Coagulation & Accessories (Class 2, ProductCode GEI, General and Plastic Surgery Panel)
FirstPredicate	Trade Name	ConMed Universal Plus Electrosurgical ·Suction/Irrigation Electrodes
	Manufacturer	ConMed
	Market Clearance	510(k): K973890
SecondPredicate	Trade Name	Encision AEM Disposable Electrodes andHandpieces
	Manufacturer	Encision Inc.
	Market Clearance	510(k): K091074

Device Description

Single-Use Hand-Control AEM Suction Irrigation Electrodes (DSIE) are electrosurgical accessories that

. Conduct high-frequency monopolar electrosurgical energy from compatible electrosurgical generators (ESU)
. Provide suction or irrigation

to a surgical site during laparoscopic and endoscopic procedures.

They are used during open, endoscopic, and laparoscopic surgical procedures to ablate, remove, resect, and coagulate soft tissue where associated hemostasis is required.

{1}------------------------------------------------

510(k) Summary: Single-Use Hand-Control AEM Suction Irrigation Electrodes

data from aging tests demonstrate greater longevity on the shelf.

Conclusion

DSIE is substantially equivalent to its predicate devices in design and intended use. There are no significant differences between DSIE and the ConMed predicate in electrosurgery or suction/irrigation performance which would raise new issues of safety and effectiveness, performance, function or intended use of the device. There are no significant differences between DSIE and the Encision predicate in electrosurgery or AEM Monitoring performance which would raise new issues of safety and effectiveness, performance, function or intended use of the device. Technological similarities between the predicate devices and the proposed device also demonstrate equivalence.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. 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 symbol that resembles an abstract caduceus, with three angled lines above a wavy line.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter Dated: November 9, 2012

Encision, Inc. % Mr. James W. Lewis VP. Regulatory Affairs and Quality Assurance 6797 Winchester Circle Boulder, Colorado 80301

Re: K122580

Trade/Device Name: AEM Disposable Suction Irrigation Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 18, 2012 Received: October 19, 2012

Dear Mr. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your booken of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreativent of the enactment date of the Medical Device Amendments, or to commerce provision of this 20, 1978, the excordance with the provisions of the Federal Food, Drug, de rices that have been roomson of a premarket 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 I ho general ochilels proving 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 I lease oc acrised that I Drive issue that your device complies with other requirements of the Act that I DA has made a actoring administered by other Federal agencies. You must of any I each statutes and regaranents, including, but not limited to: registration and listing (21

{3}------------------------------------------------

Page 2 -- Mr. James W. Lewis

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CFK Fall 607), labeling (21 CFR 803); good manufacturing practice requirements as set device in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire speerile dayse to your centers offices/CDRH/CDRHOffices/ucm115809.html for go to mqp//www.lda.gov/rtoour.brills.com/s/ SelHoss/Office of Compliance. Also, please, please, posts (2010) Post the Center for Devices and Radionograph g by reference to premarket notification" (21CFR Part note the regulation onlined, "Informations of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the I ou may obtain other general meethers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Single-Use Hand-Control AEM® Suction Irrigation Electrodes Premarket Notification

Section 4 INDICATIONS FOR USE

510(k) Number (if known): 122580

Device Name: Single-Use Hand-Control AEM Electrosurgical Suction Irrigation Electrodes

Indications for Use:

AEM instruments incorporate the use of AEM technology and are intended for use with the AEM monitoring system and electrosurgical generators compatible with the AEM system.

Prescription Use (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)

Neil R.P. Ogden for mixer

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K122580

4.1

Regulation Number and Section

§ 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.