(165 days)
The EndoShield Burn Protection System is an accessory for use with electrosurgical generators and is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling. EndoShield performs acive electrode monitoring intended to control stray monopolar energy, caused by insulation failure and capacitive coupling in surgical instruments, along the instrument.
EndoShield is a self-contained battery-powered electronic module (about the size of a cell phone) with integral instrument and HF power cords:
• Module plugs directly into return-electrode receptacle of ESU
- Integral cords connect module to
- AEM laparoscopic instrument
- Foot-control power output receptacle of ESU
The EndoShield Burn Protection System is an accessory for use with electrosurgical generators, designed to safely deliver electrosurgical energy and prevent injury caused by insulation failure and capacitive coupling by performing active electrode monitoring.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (EM3 AEM Monitor) rather than detailing specific numerical acceptance criteria. However, we can infer the performance standard from the claim of equivalence and the description of the device's functions.
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (EndoShield Burn Protection System) |
|---|---|
| Functional Equivalence: | |
| * Enables AEM Monitoring and protection during monopolar laparoscopy. | Yes, enables AEM Monitoring and protection during monopolar laparoscopy. |
| * Transfers HF energy from ESU to AEM laparoscopic instruments while monitoring HF current returning from the instrument's shield. | Yes, transfers high-frequency (HF) energy from monopolar electrosurgical unit (ESU) to AEM laparoscopic instruments while providing AEM Monitoring of HF current returning from the instrument's shield. |
| * Disables HF energy delivery and presents a visual alert whenever a setup or operational fault is detected (due to stray HF energy). | Yes, disables HF energy delivery and presents a visual alert whenever a set up or operational fault is detected (when energy in shield approaches excessive levels). Indicates fault by extinguishing green "✓" and lighting red "X". |
| * Assures proper connections before enabling and indicating "ready." | Yes, assures all connections are proper before enabling energy delivery and presenting a visual "ready" indication by lighting a green "✓" on the face of the electronic module. |
| * Shunts stray energy from instrument shaft back to ESU. | Yes, 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. |
| Safety and Compliance: | |
| * Compliance with IEC 60601-1 (3rd Ed.), IEC 60601-1-2, IEC 60601-2-2. | Identical standards and internal design control assurances, including recognized international standards: IEC 60601-1 (3rd Ed.) compliant, IEC 60601-1-2 compliance, IEC 60601-2-2 compliance. |
| * Compliance with IEC 60601-1-6, IEC 62366 (Human Factors/Usability). | Identical standards and internal design control assurances, including recognized international standards: IEC 60601-1-6 compliance, IEC 62366 compliance. |
| * Sterility Assurance Level of 10⁻⁶ or better. | Yes, Sterility Assurance Level: 10⁻⁶ or better, achieved via ethylene oxide gas sterilization (ANSI-AAMI-ISO 11135-1:2007) by a qualified contract sterilizer. |
| * One-year shelf life for sterility and function. | Yes, validated for sterility and function to one year shelf life through accelerated aging. |
| Electromagnetic Compatibility (EMC) and Electrical Safety: | Equivalent performance to monopolar function of EM3 AEM Monitor predicate system demonstrated through third-party testing and design-file review. |
| Biocompatibility: | None required due to no direct or indirect contact with patient. |
The study supporting these claims is described as Bench Testing.
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size for Test Set: "Essential performance tested in 10 units" of the EndoShield Burn Protection System.
- Data Provenance: The document does not specify the country of origin for the data, but it falls under the jurisdiction of the FDA (United States). The testing appears to be prospective as it involves new units of the EndoShield device undergoing performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The testing described is technical bench testing against design control requirements and predicate device performance, not clinical evaluation requiring expert interpretation of results for ground truth.
4. Adjudication Method for the Test Set:
This information is not provided. Given the nature of the bench testing, an adjudication method as typically understood in clinical studies (e.g., 2+1, 3+1 for discordant reads) is not applicable. The documentation suggests direct measurement and comparison against established performance metrics of the predicate device and relevant standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was done or reported. This device is a hardware accessory designed to prevent injury by monitoring stray energy and shutting down the ESU if necessary, not an AI-assisted diagnostic or interpretive tool that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device itself is a standalone electronic module that actively monitors and controls electrosurgical energy based on its internal logic and DSP (Digital Signal Processor) measurements. The "Bench Testing" section implicitly covers its standalone performance against design control requirements and the predicate device's monopolar function. There is no specific mention of an "algorithm only" standalone study in the context of an AI/ML algorithm. The "logic" described is battery-powered digital and analog electronic circuitry with DSP for HF current measurement.
7. The Type of Ground Truth Used:
The ground truth for the bench testing was the performance parameters and established functional behavior of the predicate device (monopolar function of the EM3 AEM Monitor) and compliance with recognized international standards (IEC 60601 series). It also includes internal design control requirements per 21 CFR 820.30.
8. The Sample Size for the Training Set:
This information is not applicable/not provided. The device is a hardware accessory with electronic logic, not an AI/ML system that utilizes a "training set" in the conventional sense. The development likely involved traditional engineering design, simulation, and hardware testing.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable/not provided for the reasons stated above (not an AI/ML system). The device's operational principles and intended effects are based on known physics of electrosurgery and established safety standards, not learned from a data training set.
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Image /page/0/Picture/1 description: The image shows the word "ENCISION" in bold, sans-serif font. Below the word is a thin line, and below that are some blurred words. The "O" in "ENCISION" has a graphic inside of it.
JUN 1 6 2014
510(k) Summary
| Device | EndoShield Burn Protection System | |
|---|---|---|
| Owner | Encision, Inc. | |
| Contact | Mike Biggs, Director Engineering and Interim Director RA/QA | |
| Date | 11 June 2014 | |
| Subject Device | Trade name | EndoShield Burn Protection System |
| Model number | EM100 | |
| Common name | Disposable AEM Monitor | |
| Device name | Electrosurgical, Cutting & Coagulation & Accessories | |
| Regulation number | 21 CFR 878.4400 | |
| Product code | GEI | |
| Device class | 2 | |
| Panel | General and Plastic Surgery | |
| Predicate Device | Trade name | EM3 AEM Monitor |
| Device name | Electrosurgical, Cutting & Coagulation & Accessories | |
| Manufacturer | Encision Inc. | |
| Market clearance | 510(k): K122383 (2013) |
Device Description
人
| Devicepurpose | • Enables AEM Monitoring and protection during monopolar laparoscopy• Transfers high-frequency (HF) energy from monopolar electrosurgical unit(ESU) to AEM laparoscopic instruments while providing AEM Monitoring ofHF current returning from the instrument's shield• Disables HF energy delivery and presents a visual alert whenever a set upor operational fault is detected |
|---|---|
| AEMtechnology | • Safety system for minimally-invasive monopolar electrosurgery• Prevents unanticipated or undetected burns from stray HF energy outsidethe surgeon's field of view• Works by shielding instrument's shaft from stray HF energy due to insulationbreakdown or capacitive coupling• Monitors level of energy picked up by shield; interrupting energy deliverywhen energy in shield approaches excessive levels |
| Continued on next page |
ENCISION INC. + 6797 WINCHESTER CIRCLE • BCULDER, CO BO3D1 • 303,444.2693 • WWENDSHON.COM
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Device Description (continued)
| Device | EndoShield is a self-contained battery-powered electronic module (about the |
|---|---|
| components | size of a cell phone) with integral instrument and HF power cords: |
| • Module plugs directly into return-electrode receptacle of ESU |
- · Integral cords connect module to
- AEM laparoscopic instrument
- Foot-control power output receptacle of ESU
Technological Characteristics
EndoShield miniaturizes and integrates the primary monopolar functions of the predicate device, , EM3 AEM monitor, into a single-use, self-contained system.
Technology
| Logic | • Battery-powered digital and analog electronic circuitry• 3V Lithium battery• Normally-open relay controlling primary HF energy path• DSP HF current measurement of shield-to-ground HF energy• Shield HF threshold detection results in opening of relay of primary HF pathand lighting of red visual indicator |
|---|---|
| Instrumentconnector | Dual, gold plated, spring loaded, connector allowing free rotation of connectoron instrument post at end of instrument cord |
| ESU returnconnector | Standard CQM-type return electrode three-pin plug on back of monitormodule |
| ESU HFoutputconnector | Standard ESU foot-control instrument plug on short cord from module |
| Visualindicator | • Green light-emitting diode lighting a ready light: a "✓" molded into theelectronic module housing• Red light-emitting diode lighting an alarm/not-ready light: an "X" molded intothe electronic module housing |
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510(k) Summary: EndoShield Burn Protection System
| Function | |
|---|---|
| Enablesenergydelivery | Assures all connections are proper before enabling energy delivery andpresenting a visual "ready" indication by lighting a green "✓" on face ofelectronic module |
| Shields fromstray energy | Monitor connections shunt stray energy, attempting to pass through theinsulated shaft of an AEM instrument by insulation breakdown or capacitivecoupling, back to the ESU |
| Disablesenergydelivery | Monitor shuts down the electrosurgical procedure if the level of stray energyreaches dangerous levels |
| Indicates fault | Visual alert—extinguishes green "✓" and lights red "X" on face of electronicmodule—indicates a fault is detected, either at set up (system not ready) orduring operation (excess stray energy) |
Intended Use
The EndoShield Burn Protection System 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.
EndoShield performs active electrode monitoring intended to control stray monopolar energy, caused by insulation failure and capacitive coupling in surgical instruments, along the shaft of the instrument.
Equivalence
Based on operating principle, intended use, technology, safety, and performance; the EndoShield Burn Protection System is substantially equivalent to its predicate device, the monopolar function of the EM3 AEM Monitor.
| EndoShield equivalence to EM3 (Monopolar function) | |
|---|---|
| Intended Use | Identical intended use as an accessory for use with electrosurgical generatorsand electrodes to safely deliver electrosurgical energy and to prevent injurycaused by insulation failure and capacitive coupling through active electrodemonitoring. |
| Operatingprinciple | Identical operating principle: shunting stray energy from the shield of an AEMInstrument to ESU return-electrode ground and disabling energy deliveryshould stray-energy current exceed a predetermined threshold. |
Continued on next page
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Equivalence (continued)
| EndoShield equivalence to EM3 (Monopolar function) | |
|---|---|
| Materials | Substantially equivalent materials: typical electrical wires, connectors, analogand logic components, and printed circuit boards; primary differences arebattery instead of mains power and plastic instead of metal enclosure. |
| Technology | Substantially equivalent circuitry: discrete digital logic, analog electronics,and HF power relays instead of FPGA logic device (with software), analogelectronics, and HF power relays |
| Performance | Substantially equivalent: specifications are equivalent, except for the alarmdisplay being visual only and not specific to the type of fault detected |
| EMC andElectricalSafety | Identical standards and internal design control assurances, includingrecognized international standards:• IEC 60601-1 (3rd Ed.) compliant• IEC 60601-1-2 compliance• IEC 60601-2-2 compliance |
| Humanfactors/usability | Identical standards and internal design control assurances, includingrecognized international standards:• IEC 60601-1-6 compliance• IEC 62366 compliance |
Bench Testing
| Essentialperformancetesting | In accordance with Design Control requirements per 21 CFR 820.30,essential performance tested in 10 units showed equivalent performance tomonopolar function of EM3 AEM Monitor predicate system. |
|---|---|
| EMC,electricalsafety,usability | Third-party testing and design-file review demonstrated equivalentperformance to monopolar function of EM3 AEM Monitor predicate system. |
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510(k) Summary: EndoShield Burn Protection System
Biocompatibility
| Patient Contact | No direct or indirect contact with patient |
|---|---|
| Biocompatibility Evaluation | None required |
Sterility / Packaging
| Sterility | • Method of sterilization: ethylene oxide gas• Methodology: ANSI-AAMI-ISO 11135-1:2007• Sterility assurance level: 10⁻⁶ or better• Sterilization performance: By a qualified contract sterilizer |
|---|---|
| SterilityMaintenance/Shelf Life | • Initially, product validated for sterility and function to one year shelf life• Assurance method: accelerated aging• Validated shelf life indication: "use by" date on all labels-boxes andpouches• Post-market extension of shelf life: life extended as data from acceleratedand real-time aging tests demonstrate greater longevity |
Conclusion
EndoShield Burn Protection System is substantially equivalent to the monopolar function of its predicate devices in performance and intended use. There are no significant differences between EndoShield Burn Protection System and the EM3 predicate in design which would raise new issues of safety and effectiveness, performance, function or intended use of the device. Technological similarities between the predicate device and the proposed device also demonstrate equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 16, 2014
Encision Incorporated Mr. Mike Biggs Vice President, Regulatory and Quality 6797 Winchester Circle Boulder, Colorado 80301
Re: K140006
Trade/Device Name: EndoShield Burn Protection System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical, Cutting & Coagulation & Accessories Regulatory Class: Class II Product Code: GEI Dated: May 14, 2014 Received: May 15, 2014
Dear Mr. Biggs:
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 subicct 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
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Page 2 - Mr. Mike Biggs
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140006
Device Name
EndoShield Burn Protection System
Indications for Use (Describe)
The EndoShield Burn Protection System is an accessory for use with electrosurgical generators and is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling. EndoShield performs acive electrode monitoring intended to control stray monopolar energy, caused by insulation failure and capacitive coupling in surgical instruments, along the instrument.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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§ 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.