Who is the manufacturer of AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES?

Encision, Inc. filed the 510(k) submission for AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES (K131949).

What is the FDA product code for AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES?

510(k) clearance (submission type: Traditional).

What are the predicate devices for AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES?

AEM Suction Irrigation Electrode (K100711); AEM Disposable Suction Irrigation Electrode and Handset (K122580).

Who can help prepare an FDA 510(k) submission like AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES

K131949 · Encision, Inc. · GEI · Aug 26, 2013 · General, Plastic Surgery

Device Facts

Record ID	K131949
Device Name	AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES
Applicant	Encision, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Aug 26, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

AEM Single-Use Suction Irrigation Instrument is a sterile, single-patient-use electrosurgical accessory for laparoscopic or endoscopic procedures. Device connects to electrosurgical unit via AEM Cord and Monitor; integrates suction/irrigation channel for connection to standard valves. Operates by conducting high-frequency monopolar electrical energy to tip for tissue cutting/coagulation; AEM shielding/monitoring technology prevents stray-energy emission outside surgeon view. Used by surgeons in OR to ablate, resect, and coagulate soft tissue while providing visualization and hemostasis. Eliminates need to swap instruments for suction/irrigation. Benefits include reduced risk of stray-energy injury and improved procedural efficiency.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation performed per 21 CFR 820.30. Testing included characterization of essential specifications, aging (accelerated and real-time), and shipping drop/shock/vibration. Biocompatibility verified by analogy to predicate materials. Sterility validated per ANSI-AAMI-ISO 11137-1:2006.

Technological Characteristics

Electrosurgical accessory; monopolar energy; 32 cm working length; fits 5.5 mm cannula. Materials identical to predicate devices. AEM shielding/monitoring technology. Sterilization via electron-beam irradiation per ANSI-AAMI-ISO 11137-1:2006. Single-use, sterile, disposable.

Indications for Use

Indicated for patients undergoing general endoscopic and laparoscopic surgical procedures requiring soft tissue ablation, resection, coagulation, and hemostasis. Intended for use by clinicians in surgical settings.

Regulatory Classification

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.

Predicate Devices

AEM Suction Irrigation Electrode (K100711)
AEM Disposable Suction Irrigation Electrode and Handset (K122580)

Related Devices

K122580 — AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES · Encision, Inc. · Nov 9, 2012
K100711 — SUCTION IRRIGATION ELECTRODES AND ADAPTERS · Encision, Inc. · Jun 9, 2010
K994319 — MODULAP · Atc Technologies, Inc. · Mar 20, 2000
K091074 — AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES · Encision, Inc. · Aug 17, 2009
K183445 — Erbe APCapplicators · Erbe Elektromedizin GmbH · Apr 4, 2019

Submission Summary (Full Text)

{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