(157 days)
Not Found
No
The description focuses on monitoring electrical signals and providing measurements, with no mention of AI/ML terms or capabilities.
No
The device is described as an "accessory for use with electrosurgical generators and electrodes" that monitors and aids in determining the endpoint of electrosurgical procedures. It prevents injury and assists the surgeon, but it does not directly treat a disease or condition.
No
The device is described as an accessory for electrosurgical generators designed to deliver energy safely and prevent injury, and to aid in determining the endpoint of bipolar electrosurgical desiccation. These functions are related to monitoring and controlling surgical energy, rather than diagnosing a medical condition.
No
The device description explicitly states the system comprises two components: the Monitor (electronic unit) and an ESU Adapter (accessory containing cords and connectors). This indicates the device includes hardware components beyond just software.
Based on the provided information, the EM3 AEM Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- EM3 AEM Monitor Function: The EM3 AEM Monitor is an accessory for electrosurgical generators. Its functions are related to monitoring and controlling electrosurgical energy delivery during surgical procedures performed on the patient's body (in vivo), not on specimens taken from the body (in vitro).
- Intended Use: The intended use clearly states it's for use with electrosurgical generators and electrodes to prevent injury and aid in determining the endpoint of bipolar desiccation during surgery.
- Device Description: The description reinforces its role as an interface and safety system for minimally-invasive electrosurgery, focusing on monitoring energy delivery and tissue response in vivo.
Therefore, the EM3 AEM Monitor falls under the category of surgical accessories or electrosurgical equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The EM3 AEM Monitor is an accessory for use with electrosurgical generators and electrodes that is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling.
The EM3 AEM Monitor performs two distinct functions:
- Active electrode monitoring is intended to control stray monopolar energy caused by insulation failure and capacitive coupling in surgical instruments on the shaft of the instrument.
- End point monitoring is intended to aid the surgeon in determining the end point of bipolar electrosurgical desiccation.
Product codes
GEI
Device Description
The EM3 AEM Monitor is the "nerve center" and interface to the electrosurgical generator and instruments for AEM monitoring, a safety system for minimally-invasive electrosurgery.
- For monopolar electrosurgery. AEM technology prevents unanticipated or undetected burns from stray energy along the instrument outside the surgeon's field of view
- In bipolar electrosurgery, the EM3 displays the measurement of high-frequency current flowing through the instrument and tissue as an aid in determining the endpoint of bipolar desiccation
The EM3 AEM Monitor system comprises two components
- The Monitor or electronic unit .
- A specific or standard ESU Adapter .
An ESU Adapter is an accessory to the Monitor containing cords and connectors, which connect the Monitor to the electrosurgical generator (ESU). Multiple models of ESU Adapters are required due to the wide variety of electrosurgical generators in the marketplace and in use in the hospitals.
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)
Bench Tests:
Complete verification and validation tests were performed in accordance with Design Control requirements per 21 CFR 820.30 for all essential specifications demonstrating substantial equivalence of the EM3 AEM Monitor to the predicate system.
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/1 description: The image shows the word "ENCISION" in bold, black letters. There is a logo to the right of the word that looks like a sphere with lines on it. Underneath the word is some smaller text that is difficult to read.
AECOM LANDMARK GRAPHIC INSTRUMENTS
510(k) Summary
JAN 1 0 2013
| Device | EM3 AEM® Monitor | ||
|---|---|---|---|
| Owner | Encision, Inc. | ||
| 6797 Winchester Circle | |||
| Boulder, CO 80301 | |||
| Phone: (303) 444-2600 | |||
| Fax: (303) 444-2693 | |||
| Contact | James W Lewis | ||
| VP RAQA | |||
| Date of Summary | 4 January 2013 | ||
| Subject Device | Trade name | EM3 AEM Monitor | |
| Common name | Electrosurgical, Cutting & Coagulation & | ||
| Accessories | |||
| Classification | (21 CFR 878.4400, Class II, | ||
| Product Code: GEI) | |||
| Predicate Device | Trade Names | EM2 AEM Monitor | |
| Market Clearance | 510(k): K093622 (2010) | ||
| Common name | Electrosurgical, Cutting & Coagulation & | ||
| Accessories | |||
| Classification | (21 CFR 878.4400, Class II, | ||
| Product Code: GEI) |
Device Description
The EM3 AEM Monitor is the "nerve center" and interface to the electrosurgical generator and instruments for AEM monitoring, a safety system for minimally-invasive electrosurgery.
- . For monopolar electrosurgery. AEM technology prevents unanticipated or undetected burns from stray energy along the instrument outside the surgeon's field of view
- In bipolar electrosurgery, the EM3 displays the measurement of high-frequency . current flowing through the instrument and tissue as an aid in determining the endpoint of bipolar desiccation
The EM3 AEM Monitor system comprises two components
- The Monitor or electronic unit .
- A specific or standard ESU Adapter .
An ESU Adapter is an accessory to the Monitor containing cords and connectors, which connect the Monitor to the electrosurgical generator (ESU). Multiple models of ESU Adapters are required due to the wide variety of electrosurgical generators in the marketplace and in use in the hospitals.
Page 1 of 4
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Technological Characteristics
The AEM monitor performs different functions for the two types of electrosurgery.
| Monopolar
electrosurgery | • Monitor connections shunt stray energy, attempting to pass through
the insulated shaft of an AEM instrument by insulation breakdown or
capacitive coupling, back to the ESU |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • Monitor shuts down the electrosurgical procedure if the level of stray
energy reaches dangerous levels |
| Bipolar
electrosurgery | • Monitor displays the level of flow of electrosurgical current in real-
time. (This information aids surgeons in determining the end point
of bipolar desiccation.) |
The EM3 AEM Monitor is the third generation of AEM monitor; updating, simplifying and improving the features of the second-generation monitor, the EM2, while serving identical indications and uses.
| Update | • Electronics/logic system modernized: circuits redesigned using identical analog elements/components while updating firmware to FPGA (field programmable gate array) logic |
|---|---|
| • Alarm visuals—Visual alarms amber in color, per international standard | |
| • ESU adapter designs—Redesigned monopolar and bipolar adapters | |
| • ESU compatibility—Designed to accommodate new-generation ESU | |
| Simplify | • Connections for hand-control instruments incorporated into monitor |
| • Monopolar ESU adapters with fewer connections and wires | |
| Improve | • Power-interruption response time by interrupting energy delivery directly rather than relying on ESU patient-electrode circuitry |
| • Power measurement accuracy across the spectrum of possible electrosurgical waveforms with increased logic capacity of FPGA | |
| • Logic maintenance and support flexibility | |
| • Alarm discernment by presenting active-electrode-related alarms (monitor alarms) independent of return-electrode alarms (ESU alarm) |
Intended Use
The EM3 AEM Monitor is an accessory for use with electrosurgical generators and electrodes that is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling.
The EM3 AEM Monitor performs two distinct functions:
2
- Active electrode monitoring is intended to control stray monopolar energy caused by . insulation failure and capacitive coupling in surgical instruments on the shaft of the instrument.
- End point monitoring is intended to aid the surgeon in determining the end point of . bipolar electrosurgical desiccation.
Equivalence:
Based on operating principle, intended use, technology, safety, and performance; the EM3 AEM Monitor is substantially equivalent to its predicate device, the EM2 AEM Monitor.
| EM3 AEM Monitor | EM2 AEM Monitor | |
|---|---|---|
| Intended Use | Identical to EM2 | Monopolar active-electrode stray-energy |
| shunting and monitoring and bipolar | ||
| desiccation end point monitoring | ||
| Operating | ||
| principle | • Monopolar high frequency current | |
| shunting, measuring, threshold detection, | ||
| and alarming | • Monopolar high frequency current | |
| shunting, measuring, threshold detection, | ||
| and alarming | ||
| • Bipolar high frequency ammeter | ||
| measuring and indicating current | • Bipolar high frequency ammeter | |
| measuring and indicating current | ||
| • Direct interruption of electrosurgical | ||
| current to active electrode under fault | ||
| condition | • Interruption of electrosurgical current | |
| under fault condition by tripping ESU | ||
| contact quality monitor alarm | ||
| Materials | Same as EM2 | Typical electronic wires, connectors, analog |
| and logic components, circuit boards, and | ||
| enclosures | ||
| Energy | ||
| source | Identical to EM2 | Mains power |
| Technology | • FPGA logic device | • Discrete logic components |
| • Analog electronics | • PAL logic device | |
| • HF power relays | • Analog electronics | |
| • Logic-level relay | ||
| Sterilization | None | None |
| Performance | • Shield circuit to ESU return potential | |
| impedance: 300 ms | ||
| (dependent on ESU circuit) | ||
| • Singular active fault indication from | ||
| monitor | • Simultaneous active and return faults | |
| alarmed: active on EM2, return on ESU | ||
| • Current graph granularity: ~ 120 mA | • Current graph granularity: ~30 mA |
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| EM3 AEM Monitor | EM2 AEM Monitor | |
|---|---|---|
| EMC and | ||
| Electrical | ||
| Safety | • Internal design control assurances | • Internal design control assurances |
| • IEC 60601-1 (3rd ed) compliant | • IEC 60601-1 (2nd ed) compliant | |
| • IEC 60601-1-2 compliance | • IEC 60601-1-2 compliance | |
| • IEC 60601-2-2 compliance | • IEC 60601-2-2 compliance |
Bench Tests:
Complete verification and validation tests were performed in accordance with Design Control requirements per 21 CFR 820.30 for all essential specifications demonstrating substantial equivalence of the EM3 AEM Monitor to the predicate system.
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Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font and is centered horizontally. The text is likely the heading of a document or website related to the Department of Health and Human Services.
Image /page/4/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The text is likely part of a document or sign, possibly indicating an affiliation with a public health organization.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: January 10, 2013
Encision, Inc. % Jim Lewis 6797 Winchester Cir. Boulder, CO 80301 US
Re: K122383
Trade Name: EM3 AEM Monitor AEM Connectors Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 14, 2012 Received: December 17, 2012
Dear Mr. Lewis:
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. 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
5
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting 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 Division of Small Manufacturers, 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/Resourcesfor You/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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510(k) Number (if known): K122383
Device Name: EM3 AEM Monitor
Indications for Use:
The EM3 AEM Monitor is an accessory for use with electrosurgical generators and electrodes that is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling.
The EM3 AEM Monitor performs two distinct functions:
- Active electrode monitoring is intended to control stray monopolar energy caused by . insulation failure and capacitive coupling in surgical instruments on the shaft of the instrument.
- · End point monitoring is intended to aid the surgeon in determining the end point of bipolar electrosurgical desiccation.
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)
Brian D. Pullin -S
Division of Surgical Devices 510(k) Number: K122383