(277 days)
Not Found
No
The summary describes a device that monitors and manages "stray energy" using "AEM technology," but there is no mention of AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML models. The performance studies are limited to bench testing comparing the device to predicate devices.
No.
The device is described as electrosurgical instruments and accessories used to deliver monopolar electrosurgical energy and manage stray energy during laparoscopic procedures. It does not exert its effect through pharmacological, immunological or metabolic means, which are characteristics of a therapeutic device.
No
The device is described as delivering monopolar electrosurgical energy and primarily focuses on monitoring and managing "stray energy" during laparoscopic procedures. While it "monitors," this monitoring is for the device's function (insulation failure, capacitive coupling) to ensure safe energy delivery, not to diagnose a patient's medical condition. It's an energy delivery system with safety monitoring features.
No
The device description explicitly mentions reusable handles, reusable & disposable insert electrodes, and disposable sheaths, indicating it includes hardware components.
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 "delivering monopolar electrosurgical energy during laparoscopic procedures." This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the electrosurgical function and the monitoring of "stray energy" during surgery. It does not mention analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device is a surgical instrument used during a procedure, not a diagnostic tool used on samples.
N/A
Intended Use / Indications for Use
These AEM Instruments incorporate the use of AEM technology and are intended for use in delivering monopolar electrosurgical energy during laparoscopic procedures only. AEM Instruments are intended for use with the AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor. Scissors Inserts are intended for use on soft tissue only.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Encision AEM® Monopolar Laparoscopic Instruments and Accessories incorporate the use of AEM technology and are intended for use in delivering monopolar electrosurgical energy during laparoscopic procedures only. Encision AEM® Monopolar Laparoscopic Instruments and Accessories are intended for use with the AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor. These Encision AEM® Monopolar Laparoscopic Instruments and Accessories include reusable handles and reusable & disposable insert electrodes plus disposable sheath. Encision AEM® Monopolar Laparoscopic Instruments and Accessories, in conjunction with an AEM Monitor properly connected to the electrosurgical generator (ESU), continuously monitor and dynamically manage "stray energy" (insulation failure and capacitive coupling), which are likely out of the surgeon's field of view.
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)
All testing required per design control procedures was conducted using bench testing. Performance analysis has shown the Encision AEM® Monopolar Laparoscopic reusable handpieces and Encision AEM® Monopolar Laparoscopic reusable & disposable insert electrodes plus disposable sheath to perform as intended and as well as the predicate devices under the same and/or similar conditions. These devices have been tested with settings set equal to those seen in typical procedures where these devices would be indicated for use. The requirements for electrodes function in the AEM Monitoring System have not changed from the original 510(k) submissions. The tests conducted show that the changes since the original 510(k) submissions demonstrate conformity to the original internal and regulatory requirements. No differences have been observed between the performance of the predicate devices and the device subject of this 510(k) Notification submission. No animal or clinical testing is required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 20, 2020
Encision Incorporated % Charles Hart Principle Consultant HART Consulting LLC 615 Reid Place Castle Rock. Colorado 80108
Re: K191612
Trade/Device Name: Encision AEM Monopolar Laparoscopic Instruments and Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting & Coagulation Devices and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 18, 2020 Received: February 21, 2020
Dear Charles Hart:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191612
Device Name
Encision AEM® (Active Electrode Monitoring) Monopolar Laparoscopic Instruments and Accessories
Indications for Use (Describe)
These AEM Instruments incorporate the use of AEM technology and are intended for use in delivering monopolar electrosurgical energy during laparoscopic procedures only. AEM Instruments are intended for use with the AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor. Scissors Inserts are intended for use on soft tissue only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the text "K191612" in a simple, sans-serif font. The text is horizontally oriented and appears to be a code or identifier. The characters are uniformly sized and spaced, making the text easily readable.
Image /page/3/Picture/1 description: The image shows the logo for Encision. The logo features the word "ENCISION" in green, with a stylized orange circle to the right of the word. Below the word "ENCISION" is the phrase "DELIVERING ENERGY SAFELY" in a smaller font size.
K191612 510(k) Summary
Device: Encision AEM® (Active Electrode Monitoring) Monopolar Laparoscopic Instruments and Accessories
Owner: Encision Inc.
- Contact: Greg Trudel President & CEO 6797 Winchester Circle Boulder, CO, 80301, USA gtrudel@encision.com 303-444-2600
Date: 20 Mar 2020
Subject Device:
| Trade Name | See table below |
|---|---|
| Common Name | Monopolar laparoscopic accessory |
| Regulation Name | Electrosurgical, Cutting & Coagulation, |
| Accessories | |
| Regulation Number | 21 CFR 878.4400 |
| Product Code | GEI |
| Device Class | 2 |
| Review Panel | General and Plastic Surgery |
| Prior Submissions | No prior submissions for the subject device |
Primary Predicate Devices:
| Trade Name | See table below |
|---|---|
| Regulation Name | Electrosurgical, Cutting & Coagulation, |
| Accessories | |
| Manufacturer | Encision Inc. |
| 510(k) Number | K912780 |
Secondary Predicate Devices:
| Trade Name | ES03XX Series |
|---|---|
| Regulation Name | Electrosurgical, Cutting & Coagulation, |
| Accessories | |
| Manufacturer | Encision Inc. |
| 510(k) Number | K091074 |
4
ENCISIGN
Device Description:
Encision AEM® Monopolar Laparoscopic Instruments and Accessories incorporate the use of AEM technology and are intended for use in delivering monopolar electrosurgical energy during laparoscopic procedures only. Encision AEM® Monopolar Laparoscopic Instruments and Accessories are intended for use with the AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor. These Encision AEM® Monopolar Laparoscopic Instruments and Accessories include reusable handles and reusable & disposable insert electrodes plus disposable sheath. Encision AEM® Monopolar Laparoscopic Instruments and Accessories, in conjunction with an AEM Monitor properly connected to the electrosurgical generator (ESU), continuously monitor and dynamically manage "stray energy" (insulation failure and capacitive coupling), which are likely out of the surgeon's field of view.
Model Numbers and Trade Names:
| Model Number
(subject device) | Trade Name | Product Family | Predicate Device
(K912780) |
|----------------------------------|--------------------------------------------------------------|----------------------------|-------------------------------|
| ES0101 | AEM e·Edge® Curved
Scissors, 1/2"Insert | Disposable Scissors | ES0101 |
| ES0102 | AEM e·Edge® Curved
Scissors, 3/4" Insert | Disposable Scissors | ES0102 |
| ES0110 | AEM e-Edge® Hook Scissors
Insert | Disposable Scissors | ES0110 |
| ES0120 | AEM e·Edge® Scissors, 3/4",
Low Profile Insert | Disposable Scissors | ES0120 |
| ES8000 Series | AEM enTouch® Handles | AEM® Handles
(Reusable) | ES5700 |
| ES8200 Series | AEM enTouch® Handles with
Indexing and Locking | AEM® Handles
(Reusable) | ES5700 |
| ES0004 | AEM® Right Angle Dissector
Insert | Reusable Inserts | ES0004 |
| ES0008 | AEM® Tapered Right Angle
Dissector Insert | Reusable Inserts | ES0008 |
| ES0009 | AEM® Blunt Nose Grasper
Insert | Reusable Inserts | ES0009 |
| ES0011 | AEM® Short Right Angle
Dissector Insert | Reusable Inserts | ES0011 |
| ES0012 | AEM® Bottle Nose Grasper
Insert | Reusable Inserts | ES0012 |
| ES0013 | AEM® Bullet Nose Grasper
Insert | Reusable Inserts | ES0013 |
| ES0014 | AEM® Fine Tooth Fenestrated
Grasper Insert | Reusable Inserts | ES0014 |
| ES0501 | AEM® Curved Maryland
Dissector Insert | Reusable Inserts | ES0501 |
| ES0506 | AEM® 90° Grasper Insert | Reusable Inserts | ES0506 |
| ES0507 | AEM® Fenestrated Grasping
Forceps Insert | Reusable Inserts | ES0507 |
| ES0508 | AEM® Round Nose Grasper
Insert | Reusable Inserts | ES0508 |
| Model Number
(subject device) | Trade Name | Product Family | Predicate Device
(K912780) |
| ES0509 | AEM® Pointed Nose Grasper Insert | Reusable Inserts | ES0509 |
| ES0510 | AEM® Petelin Dissector Insert | Reusable Inserts | ES0510 |
| ES0511 | AEM® Dolphin Nose Grasper Insert | Reusable Inserts | ES0511 |
| ES0512 | AEM® Long Dolphin Nose Grasper Insert | Reusable Inserts | ES0512 |
| ES0513 | AEM® Straight Dissector Insert | Reusable Inserts | ES0513 |
| ES0514 | AEM® Standard Grasper Insert | Reusable Inserts | ES0514 |
| ES0521 | AEM® Bowel Grasper Insert | Reusable Inserts | ES0521 |
| ES0522 | AEM® Fenestrated Bowel Grasper Insert | Reusable Inserts | ES0522 |
| ES0526 | AEM® Tapered Maryland Dissector Insert | Reusable Inserts | ES0526 |
| ES0533 | AEM® Strong Curved Maryland, 7-8mm Insert | Reusable Inserts | ES0533 |
| ES0535 | AEM® Endo Cinch Extreme Atraumatic Serrated Insert | Reusable Inserts | ES0535 |
| ES0537 | AEM® Wave Grasper Insert | Reusable Inserts | ES0537 |
| ES0538 | AEM® Mixter Clamp, 90° Long Insert | Reusable Inserts | ES0538 |
| ES0541 | AEM® Kelly Forceps Insert | Reusable Inserts | ES0541 |
| ES0543 | AEM® Maxi Grasper Insert | Reusable Inserts | ES0543 |
| ES0547 | AEM® Maryland Dissector, Diamond Serrations Insert | Reusable Inserts | ES0547 |
| ES0548 | AEM® Dissecting Forceps, Right Angled Insert | Reusable Inserts | ES0548 |
| ES0549 | AEM® Maryland Dissector, Aggressive Insert | Reusable Inserts | ES0549 |
| ES0552 | AEM® Dissecting Forceps, Right Angled, Cross Serrated Insert | Reusable Inserts | ES0552 |
| ES0553 | AEM® Straight Micro-Grasper Insert | Reusable Inserts | ES0553 |
| ES0557 | AEM® Micro-Fenestrated Grasper Insert | Reusable Inserts | ES0557 |
| ES0558 | AEM® Tapered Micro-Fenestrated Grasper Insert | Reusable Inserts | ES0558 |
| ES0559 | AEM® Right Angle Dissector, 7mm, Diagonal Serrations Insert | Reusable Inserts | ES0559 |
| ES0565 | AEM® Maryland Dissector with 90° Tooth Insert | Reusable Inserts | ES0565 |
| ES0566 | AEM® Beveled Maryland Dissector, Tapered Insert | Reusable Inserts | ES0566 |
| ES0570 | AEM® Insert, Atraumatic Grasper (Single Action) | Reusable Inserts | ES0570 |
| Model Number
(subject device) | Trade Name | Product Family | Predicate Device
(K912780) |
| ES0571 | AEM® Insert, Traumatic Grasper | Reusable Inserts | ES0571 |
| ES0573 | AEM® Insert, Traumatic Grasper (Single Action) | Reusable Inserts | ES0573 |
| ES0574 | AEM® Insert, Fenestrated Bowel Grasper | Reusable Inserts | ES0574 |
| ES0001 | AEM® Curved Scissors, 1/2" Insert | Reusable Inserts | ES0001 |
| ES0002 | AEM® Curved Scissors, 3/4" Insert | Reusable Inserts | ES0002 |
| ES0010 | AEM® Hook Scissors Insert | Reusable Inserts | ES0010 |
| ES0150 Series | AEM® Disposable Sheath | Disposable Sheaths | ES0150 |
5
ENCISI&N
6
Indications for Use:
These AEM Instruments incorporate the use of AEM technology and are intended for use in delivering monopolar electrosurgical energy during laparoscopic procedures only.
AEM Instruments are intended for use with the AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor.
Scissors Inserts are intended for use on soft tissue only.
Sterility/Packaging:
The Disposable Scissors and Disposable Sheaths are supplied sterile per ANSVAAMI/ISO 11137-1:2006 and ANSI/AAMI/ISO 11607-1:2006. The products are sterilized using E-beam radiation sterilization to achieve 106 SAL. Product is packaged in a Tyvek mylar pouch (10 pouches in a box) with a 5 year shelf life in the sterile packaging.
The AEM® Handles and Reusable Inserts are reusable and steam sterilized for repeated use per ANSI/AAMI/ISO 17664:2017 and ANSI/AAMI/ISO 17665-1:2006. These instruments are cleaned using manual, automatic or combined manual/automatic cleaning methods. They are sterilized through Prevac steam sterilization using FDA-cleared sterile wraps to achieve 10th SAL. These products are shipped non-sterile and require sterilization before use.
Biocompatibility:
All patient contact materials are biocompatible. Material testing demonstrates conformance with ANSI/AAMI/ISO 10993-1:2009, 4th edition. Gap analysis 05927 demonstrates that testing to a previous revision of the standard is consistent with the current recognized revision of ISO 10993-1.
Standards:
The AEM® Monopolar Laparoscopic Instruments and Accessories have been tested to show conformity to the following FDA recognized standards:
7
ENCISI&N®
| Topic | Standard Used | Application |
|---|---|---|
| E-beam sterilization | ANSI/AAMI/ISO 11137-1:2006 | |
| Sterilization of Health Care Products – Radiation – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices | Disposable Scissors and Disposable Sheaths are sterilized to 10-6 SAL using E-beam sterilization in accordance with this standard. | |
| Sterile packaging | ANSI/AAMI/ISO 11607-1:2006 | |
| Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems | Disposable Scissors and Disposable Sheaths are packaged with a sterile barrier system in accordance with this standard. | |
| Reprocessing – cleaning and sterilization | ANSI/AAMI/ISO 17664:2017 | |
| Processing of Health Care Products – Information to be Provided by the Medical Device Manufacturer for the Processing of Medical Devices | AEM® Handles and Reusable Inserts are reprocessed for reuse in accordance with this standard | |
| Reprocessing – steam sterilization | ANSI/AAMI/ISO 17665-1:2006 | |
| Sterilization of Health Care Products – Moist Heat - Part 1: Requirements for the Development, Validation and Routing Control of a Sterilization Process for Medical Devices | AEM® Handles and Reusable Inserts are reprocessed to 10-6 SAL using steam sterilization in accordance with this standard. | |
| Biocompatibility | ANSI/AAMI/ISO 10993-1:2009 | |
| Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process | All patient-contact materials for the AEM® Monopolar Laparoscopic Instruments and Accessories have been tested for biocompatibility in accordance with this standard. | |
| Electromagnetic compatibility | ANSI/AAMI/IEC 60601-1-2:2014 | |
| Medical Electrical Equipment – Part 1-6: General Requirements for Basic Safety and Essential Performance. Collateral Standard. Electromagnetic Compatibility. Requirements and Tests | The AEM® Monitoring System in which these electrodes are an accessory has been tested for electromagnetic compatibility in accordance with this standard. | |
| Electrical safety | ANSI/AAMI/IEC 60601-2-2:2017 | |
| Medical Electrical Equipment – Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories | The AEM® Monitoring System in which these electrodes are an accessory has been tested for electrical safety in accordance with this standard. | |
| Labeling | ANSI/AAMI/ISO 15223-1:2016 | |
| Medical Devices – Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied – Part 1: General Requirements | The AEM® Monopolar Laparoscopic Instruments and Accessories have associated labeling in accordance with this standard. | |
| Topic | Standard Used | Application |
| Risk management | ANSI/AAMI/ISO 14971:2007 | |
| Medical Devices – Application of Risk | ||
| Management to Medical Devices | Risk management activities for the | |
| AEM® Monopolar Laparoscopic | ||
| Instruments and Accessories have | ||
| been conducted in accordance with | ||
| this standard. |
8
Technological Characteristics:
The technological characteristics of the subject device are identical to the predicate devices with regards to fundamental design, materials, operating principle, use, compatibility, packaging and sterilization. The accessories have both 35cm and 45cm configurations. The changes over time to the predicate devices do not introduce new concerns of safety or effectiveness. The differences between the subject and predicate device are:
- . Use of Metrilube Instrument Lubricant for Disposable and Reusable Scissors for effective cutting performance. The lubricant is a patient-contact material and is biocompatible.
- . Change from a removable trigger to a permanent trigger on the AEM® Handles for improved handle performance. The fundamental technology and operating principle is identical to the predicate devices.
- . Shelf life of Disposable Scissors and Disposable Sheaths has increased from 1 year to 5 years in the sterile packaging.
Substantial Equivalence:
The subject device is substantially equivalent to the predicate device, as there is no change to the Intended Use, Operating Principle, Patient Contact Materials, Fundamental Technology, Sterilization and Performance.
| Topic | Subject Device (this submission) compared to Predicate Devices | |
|---|---|---|
| (K912780) | ||
| Indications for Use | No change to Intended Use. | |
| Operating Principle | No change to Operating Principle. | |
| Materials | Substantially equivalent. Material changes are equivalent to predicate | |
| devices and do not add new biocompatibility concerns. | ||
| Use | No changes to Use. The AEM Instruments are prescription use only. | |
| Technology | Only minor changes to Technology. The design changes made to the | |
| products have not affected the fundamental technology of the AEM | ||
| Instruments. | ||
| Sterilization | No changes to Sterilization. Disposable Scissors and Disposable Sheaths are | |
| E-beam sterilized and supplied sterile. AEM Handles and Reusable Inserts | ||
| are reusable and supplied non-sterile. | ||
| Storage & | ||
| Transportation | No change to Storage and Transportation. | |
| Performance | No change to Performance. |
9
Image /page/9/Picture/0 description: The image shows the word "ENCISION" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. To the right of the letters is a stylized graphic that resembles a crescent shape with a curved line running through it.
Bench Testing:
All testing required per design control procedures was conducted using bench testing. Performance analysis has shown the Encision AEM® Monopolar Laparoscopic reusable handpieces and Encision AEM® Monopolar Laparoscopic reusable & disposable insert electrodes plus disposable sheath to perform as intended and as well as the predicate devices under the same and/or similar conditions. These devices have been tested with settings set equal to those seen in typical procedures where these devices would be indicated for use. The requirements for electrodes function in the AEM Monitoring System have not changed from the original 510(k) submissions. The tests conducted show that the changes since the original 510(k) submissions demonstrate conformity to the original internal and regulatory requirements. No differences have been observed between the performance of the predicate devices and the device subject of this 510(k) Notification submission. No animal or clinical testing is required.
Conclusion:
The AEM® Monopolar Laparoscopic Instruments and Accessories are substantially equivalent to the predicate devices. The design changes do not introduce new safety or effectiveness concerns and do not alter the fundamental technology or operating principle of the devices. The Intended Use is identical. Bench testing data has confirmed substantial equivalence to the predicate devices.