(60 days)
Not Found
No
The summary describes a standard electrosurgical accessory with suction and irrigation capabilities, focusing on its physical design, intended use, and basic performance testing. There is no mention of AI, ML, or any related concepts like image processing, training data, or performance metrics typically associated with AI/ML algorithms. The "AEM technology" appears to refer to the shielding and monitoring system for stray energy, not an AI/ML component.
Yes
The device is used for cutting and coagulation of tissue, which are therapeutic actions to treat a medical condition.
No
This device is an electrosurgical accessory used for cutting, coagulation, and providing suction/irrigation during surgical procedures. Its function is therapeutic and interventional, rather than diagnostic.
No
The device description clearly outlines physical components like electrosurgical accessories, instruments, cords, and channels, indicating it is a hardware device with electrosurgical functions, suction, and irrigation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site." This describes a surgical tool used on the patient's body during a procedure.
- Device Description: The description reinforces this, detailing its function as an "Electrosurgical accessory" used to "ablate, remove, resect, and coagulate soft tissue."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with tissue during surgery.
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
AEM Single-Use Suction Irrigation Instruments are
• Electrosurgical accessories, which combine
– Classic active electrode functions of cutting and coagulating tissue
with monopolar high-frequency electrical energy
– Shape, size and reach to work laparoscopically or endoscopically
– Elimination of stray-energy emission outside surgeon view
provided by AEM shielding and monitoring
– Convenience/peace-of-mind provided by product provided clean
and sterile from manufacturer to operating room
– Convenience of providing suction or irrigation to the surgical site
without having to swap instruments in and out of the cannula
• Used to ablate, remove, resect, and coagulate soft tissue where
associated hemostasis and visualization is required
• For use in open, endoscopic, and laparoscopic surgical procedures
The instruments of this submission are configured to support foot- controlled laparoscopic electrosurgery
• Direct connection from instrument tip to electrosurgical unit foot- switched power outlet via AEM Cord and Monitor
• Suction irrigation channel adapted directly to commercially available suction-irrigation valves
• Working length: 32 cm
• Fits within 5.5 mm diameter cannula
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
Bench testing included
- · Characterizing all essential specifications not covered by equivalent designs on productionequivalent units
- · Successfully demonstrating no significant effect on primary specifications of production units due to
- Aging (both with accelerated and real-time testing)
- Shipping drop/shock/vibration
All testing successfully completed prior to release of product for sale.
Key Metrics
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 "ENCISIGN" in a stylized, outlined font. The letters are bold and have a double-line effect, giving them a three-dimensional appearance. A horizontal line is present beneath the word, adding a subtle emphasis to the text.
510(k) Summary
| Device | AEM® Single-Use Suction Irrigation Instrument | |
|---|---|---|
| Owner | Encision, Inc. | |
| 6797 Winchester Circle | ||
| Boulder, CO 80301 | ||
| Phone: (303) 444-2600 | ||
| Fax: (303) 444-2693 | AUG 2 6 2013 | |
| Contact | James W. Lewis | |
| Vice President, Regulatory Affairs and Quality Assurance | ||
| Date of Summary | 26 June 2013 | |
| Device | ||
| Classification | Trade name | |
| Common name | ||
| Classification | AEM Disposable Suction Irrigation Electrode | |
| Active suction/irrigation laparoscopic monopolar | ||
| electrosurgical electrode with AEM technology | ||
| Classification name: Electrosurgical, Cutting & | ||
| Coagulation & Accessories | ||
| Classification number: 21 CFR 878.4400 | ||
| Product Code: GEI | ||
| Class: 2 | ||
| FDA Panel: General and Plastic Surgery | ||
| Primary | ||
| Predicate | Trade Name | |
| Manufacturer | ||
| Cleared by | AEM Suction Irrigation Electrode | |
| Encision Inc | ||
| 510(k): K100711 | ||
| Secondary | ||
| Predicate | Trade Name | |
| Manufacturer | ||
| Cleared by | AEM Disposable Suction Irrigation Electrode and | |
| Handset | ||
| Encision Inc | ||
| 510(k): K122580 |
Device Description
| General
description | AEM Single-Use Suction Irrigation Instruments are
• Electrosurgical accessories, which combine
– Classic active electrode functions of cutting and coagulating tissue
with monopolar high-frequency electrical energy
– Shape, size and reach to work laparoscopically or endoscopically
– Elimination of stray-energy emission outside surgeon view
provided by AEM shielding and monitoring
– Convenience/peace-of-mind provided by product provided clean
and sterile from manufacturer to operating room
– Convenience of providing suction or irrigation to the surgical site
without having to swap instruments in and out of the cannula |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Continued on next page |
1
510(k) Summary: AEM Single-Use Suction Irrigation Instrument
Device Description (continued)
| General
description
(continued) | • Used to ablate, remove, resect, and coagulate soft tissue where
associated hemostasis and visualization is required
• For use in open, endoscopic, and laparoscopic surgical procedures |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Specific
description | The instruments of this submission are configured to support foot-
controlled laparoscopic electrosurgery
• Direct connection from instrument tip to electrosurgical unit foot-
switched power outlet via AEM Cord and Monitor
• Suction irrigation channel adapted directly to commercially available
suction-irrigation valves
• Working length: 32 cm
• Fits within 5.5 mm diameter cannula |
| Intended Use | Sterile, single-patient-use electrosurgical accessories 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 |
Equivalence
Based on operating principles, intended use, technology, safety, and performance; these AEM Disposable Suction Irrigation Instruments are substantially equivalent to the combination of features and construction details of its predicate devices.
| Electrode shaft
and tip | Identical to electrode shaft and tip of AEM Disposable Suction
Irrigation Electrode in
• Design
• Construction
• Packaging
• Sterility
• Materials |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Hub and adapter | Identical to hub and adapter of AEM Suction Irrigation Electrode in
• Design
• Construction
• Material |
| | Substantially equivalent to hub of AEM Disposable SI Electrode in
sterility (slightly less packaged density for more effective sterilization) |
2
510(k) Summary: AEM Single-Use Suction Irrigation Instrument
Bench Testing
Verification and validation tests were performed in accordance with Design Control requirements per 21 CFR 820.30 and company quality system procedures.
Bench testing included
- · Characterizing all essential specifications not covered by equivalent designs on productionequivalent units
- · Successfully demonstrating no significant effect on primary specifications of production units due to
- Aging (both with accelerated and real-time testing)
- Shipping drop/shock/vibration
All testing successfully completed prior to release of product for sale.
Biocompatibility
Biocompatibility of all materials with direct or indirect contact with the patient verified through analogy with identical materials, processes, and uses from the predicate devices.
Sterility / Packaging / Shelf life
| Packaging | • Product individually packaged in Tyvek pouch
• Six individual pouches placed in cardboard shipping container |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization
method | • Sterilized in shipping boxes on pallets
• Electron-beam irradiation by qualified contract sterilizer |
| Sterilization
standard | Sterilized in accordance with ANSI-AAMI-ISO 11137-1:2006 guidelines |
| Aging validation | Shelf life of product and packaging validated for sterility and function
• For, at least, one year shelf life by accelerated aging
• Verified by real-time aging
• Extended as data from aging tests demonstrate greater longevity on
the shelf |
| Shelf-life
communication | A "use by" date on all boxes and pouches containing product will
indicate validated shelf life of the package |
Conclusion
ে
There are no significant differences between the subject instruments and their predicate devices which would raise new issues of safety and effectiveness, performance, function or intended use with respect to
- · Electrosurgical application or performance
- · Suction/irrigation performance
- · AEM shield and monitoring performance.
3
510(k) Summary: AEM Single-Use Suction Irrigation Instrument
Technological similarities between the predicate devices and the proposed device also demonstrate equivalence.
Product testing of subject instruments and direct analogy with predicate device design and materials demonstrates acceptable safety and performance outcomes and successful attainment of all essential specifications for the devices.
AEM Single-Use Suction Irrigation Instruments are substantially equivalent in design, use, construction, and safety and effectiveness to their predicate devices.
4
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
August 26, 2013
Encision, Inc. Mr. James W. Lewis Vice President, Regulatory Affairs and Quality Assurance 6797 Winchester Circle Boulder, Colorado 80301
Re: K131949
Trade/Device Name: AEM Disposable Suction Irrigation Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 26, 2013 Received: June 27, 2013
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
5
Page 2 - Mr. James W. Lewis
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.
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/Safetv/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -S FOR
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
AEM® Single-Use Suction Irrigation Instrument Premarket Notification
Section 4 INDICATIONS FOR USE
510(k) Number: K131949
Device Name: AEM Single-Use Suction Irrigation Instrument
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.
V 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)
Joshua C. Nipper -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number _ K131949