(78 days)
Not Found
No
The summary describes a standard electrosurgical accessory with suction and irrigation capabilities. There is no mention of AI, ML, image processing, or any data-driven algorithms. The "AEM technology" is mentioned but not described in a way that suggests AI/ML.
No
The device is described as an electrosurgical accessory intended to cut and coagulate tissue, and provide suction and irrigation, which are surgical functions, not therapeutic treatments.
No
The device is described as an electrosurgical accessory intended to cut, coagulate, ablate, remove, and resect tissue, as well as provide suction and irrigation. There is no mention of it being used for diagnosis or detection of any medical condition.
No
The device description clearly states it is a physical electrosurgical accessory (electrode) that conducts energy and provides suction/irrigation, indicating it is a hardware device.
Based on the provided text, 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, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device's function is to "conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site." This is a direct surgical intervention on the patient's tissue, not a test performed on a sample outside the body.
- Intended Use: The intended use is for "general endoscopy and laparoscopy procedures" to "ablate, remove, resect, and coagulate soft tissue." This further reinforces its role in surgical procedures.
The device is an electrosurgical accessory used during surgery, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
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.
Product codes
GEI
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.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
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 Circle | ||
| Boulder, CO 80301 | ||
| Phone: (303) 444-2600 | ||
| Fax: (303) 444-2693 | ||
| Contact | James W. Lewis | |
| Vice President, Regulatory Affairs and Quality Assurance | ||
| Date of | ||
| Summary | 7 November 2012 | |
| Device | ||
| Classification | 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, Product | ||
| Code GEI, General and Plastic Surgery Panel) | ||
| First | ||
| Predicate | Trade Name | ConMed Universal Plus Electrosurgical · |
| Suction/Irrigation Electrodes | ||
| Manufacturer | ConMed | |
| Market Clearance | 510(k): K973890 | |
| Second | ||
| Predicate | Trade Name | Encision AEM Disposable Electrodes and |
| Handpieces | ||
| 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 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.
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
4
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:
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.
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