(89 days)
Encision's Suction Irrigation Electrodes and Adapters are intended for evacuation of body fluids and to cut and coagulate tissue through a trocar cannula for various general surgical laparoscopic procedures.
The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the ENCISION AEM Monitor. The AEM Monitoring System, with compatible electrosurgical instruments, is designed to minimize the likelihood of stray energy injuries caused by active insulation failure or capacitive coupling. The monitor does this by shutting down the ESU when excessive current is returned via the shield circuit which extends to near the tip of the electrode. The electrode has a stainless electrode tip welded onto the distal ID of the active tube. The active tube acts as the suction and irrigation path. The tube assembly has primary and secondary insulation layers which separate the inner active tube from the outer shield tube. The device has a molded body that interfaces with the 30 party trumpet valves or luer valves via the appropriate adapter. The Adapters (sold separately) are attached to the body of the electrode to make a compatible connection with selected suppliers of trumpet valve/tube sets. There is an electrical connector on the body capable of accepting Encision AEM cords, which carry the active and AEM shield conductors. The electrode has various fixed tips at the distal end for surgical manipulation and delivery of electrosurgical energy to the patient. All tip styles are insulated from the end of the active tube to the working portion of the tip. There is a sliding sheath outside of the tube assembly. The sheath in the extended position minimizes risk of injury to tissue from tips when the electrode is inserted into a trocar cannula or reoriented. Holes in the distal end of the tube facilitate suction when the sheath is extended. When the sheath is retracted the electrode tip is exposed for delivery of electrosurgical energy. The sheath can be locked into place in the extended position, and has tactile stops in both the extended and retracted positions. The sheath is required for full protection from stray energy.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Suction Irrigation Electrodes, structured according to your request:
Acceptance Criteria and Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Continuity | * Active circuit: Continuity between active connector and tip of electrode is to be ≤ 4 Ohms. * Shield circuit: Continuity between shield connector and distal end of shield tube is to be ≤ 2 Ohms. | * Active circuit: The device was found to have an active circuit resistance ≤ 1.618 ohms using a 95% confidence interval with 99% reliability. Pass * Shield circuit: The device was found to have a shield circuit resistance ≤ 0.830 ohms for a 95% confidence interval with 99% reliability. Pass |
| Capacitance | Capacitance between active connector and shield connector is ≤ 130 pF @ 100 kHz. | The device was found to have a capacitance ≤ 121.49 pF @ 100 kHz using a 95% confidence interval with 95% reliability. Pass |
| Energy Transmission | The device must transmit the full range of HF energy, from 30 to 60 watts of power in all modes from any approved ESU with less than 10% change in voltage. | The device was subjected to all 7 modes on the Conmed System 5000 ESU (4 cut modes, 3 coag modes). For every mode, at each of the 3 different power settings, the device transmitted the full range of high frequency energy with less than 10% change in voltage. Pass |
| Flow | Flow rate from the proximal to distal end of the lumen must be a minimum of 580 mL/min when tested with a fluid head height of 57". | The flow rate was found to be greater than 689.7 mL/min using a 95% confidence interval with 95% reliability. Pass |
| Safety (Standards) | Satisfactory results for all applicable clauses of: * IEC 60601-2-2:2006 (Medical electrical equipment – Part 2-2: Particular requirements for the safety of high frequency surgical equipment.) * IEC 60601-1:1988 with amendments (Medical Electrical Equipment - Part 1: General Requirements for Safety.) * AAMI ANSI/ISO 10993-1:2003 (Biological evaluation of medical devices - Part 1: Evaluation and testing). | Satisfactory results for all applicable clauses. |
| Biocompatibility | Non-cytotoxic (AAMI/ANSI/ISO 10993-5:1999) Non-irritating, non-sensitizing (AAMI/ANSI/ISO 10993-10:2002) Non-toxic (AAMI/ANSI/ISO 10993-11:2006) | * Tests selected for limited contact external communicating device to tissue. * Non-cytotoxic. * Non-irritating, non-sensitizing. * Non-toxic. |
| Sterilization | Recommended Cleaning Method and Moist Heat Sterilization for 10⁻⁶ SAL (AAMI/ANSI/ISO 17665-1:2006) was validated. | Recommended Cleaning Method and Moist Heat Sterilization for 10⁻⁶ SAL was validated. |
Study Information
-
Sample Size used for the test set and the data provenance:
- The document does not explicitly state a sample size ("n") for the device performance tests (continuity, capacitance, energy transmission, flow). It describes the results in terms of confidence intervals (e.g., "using a 95% confidence interval with 99% reliability"), which implies statistical analysis from a sample, but the size of that sample is not provided.
- Data Provenance: The tests are described as bench testing, meaning they were performed in a laboratory setting. There is no information regarding country of origin for the data or whether it was retrospective or prospective, as it's not clinical data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This section is not applicable to the provided document. The study described is non-clinical bench testing for device performance characteristics (electrical, fluid flow, and compliance with general standards) rather than clinical performance requiring expert ground truth.
-
Adjudication method for the test set:
- This section is not applicable for the same reason as above. Bench testing results are typically evaluated against pre-defined engineering criteria, not through expert adjudication.
-
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, an MRMC comparative effectiveness study was not done. The device is a surgical instrument (Suction Irrigation Electrode), not an AI-assisted diagnostic or therapeutic tool for which human reader performance with/without AI would be relevant.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is an electrosurgical instrument for direct surgical use, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.
-
The type of ground truth used:
- For the non-clinical performance tests, the "ground truth" implicitly refers to the pre-defined engineering test criteria and established industry/international standards (e.g., 4 Ohms max for continuity, 580 mL/min min for flow, specific levels for biocompatibility). The results were compared directly to these objective, quantitative criteria.
-
The sample size for the training set:
- This section is not applicable as there is no "training set" to speak of. The device is not an AI/ML model requiring a training set. The performance tests are conducted on the final device design.
-
How the ground truth for the training set was established:
- This section is not applicable for the same reason as above. There is no training set mentioned in the document.
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510(k) Summary - Suction Irrigation Electrodes
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510(k) Summary
DATE: 3/10/2010
JUN - 9 2010
510(k) Submitter: ENCISION INC. 6797 Winchester Circle Boulder, CO 80301 USA Establishment Registration: 1722040
Contact Person: Judith V. King, VP Regulatory Affairs and Quality Assurance Phone: 303-339-6917 Fax: 303-444-2693 e-mail: iking@encision.com
Device Name: Suction Irrigation Electrodes and Adapters
Common name: Device, Electrosurgical, Cutting and Coagulation and Accessories
Classification: CFR Section: 878.4400
Class: II
Product Code: GEI
Predicate Devices:
| Trade, Proprietary or Model Name | Manufacturer | 510(k) |
|---|---|---|
| Model ES1000 series Monopolar LaparoscopicElectrodes with Electroshield | Electroscope, Inc. (nowEncision Inc.) | K912780 |
| Nezhat-Dorsey™ Reusable ElectrosurgicalAttachments | Davol Inc. | K003674 |
| StrykeFlow Electrocautery Probes | Stryker Endoscopy | K963765 |
| Opti4 Laparoscopic Handset and HollowElectrodes | Covidien (was ValleylabInc.) | K964175 |
| Universal Plus Multifunction InstrumentControl Handles and Laparoscopic Electrodeswith Suction Irrigation Lumen | ConMed Corp. | K973890 |
Reason for_510(k) Submission:
Accumulated changes in design and materials of the Suction Electrodes and Adapters raised new issues of safety and efficacy that required testing to confirm the devices were substantially equivalent to the original Encision device and/or predicate devices in commercial distribution. The original 510(k) submission did not have an explicit indications for use statement. Wording based on the original submission and predicate devices is provided.
Description of Device:
The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the ENCISION AEM Monitor.
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The AEM Monitoring System, with compatible electrosurgical instruments, is designed to minimize the likelihood of stray energy injuries caused by active insulation failure or capacitive coupling. The monitor does this by shutting down the ESU when excessive current is returned via the shield circuit which extends to near the tip of the electrode.
The electrode has a stainless electrode tip welded onto the distal ID of the active tube. The active tube acts as the suction and irrigation path. The tube assembly has primary and secondary insulation layers which separate the inner active tube from the outer shield tube.
The device has a molded body that interfaces with the 30 party trumpet valves or luer valves via the appropriate adapter. The Adapters (sold separately) are attached to the body of the electrode to make a compatible connection with selected suppliers of trumpet valve/tube sets. There is an electrical connector on the body capable of accepting Encision AEM cords, which carry the active and AEM shield conductors.
The electrode has various fixed tips at the distal end for surgical manipulation and delivery of electrosurgical energy to the patient. All tip styles are insulated from the end of the active tube to the working portion of the tip.
There is a sliding sheath outside of the tube assembly. The sheath in the extended position minimizes risk of injury to tissue from tips when the electrode is inserted into a trocar cannula or reoriented. Holes in the distal end of the tube facilitate suction when the sheath is extended. When the sheath is retracted the electrode tip is exposed for delivery of electrosurgical energy. The sheath can be locked into place in the extended position, and has tactile stops in both the extended and retracted positions. The sheath is required for full protection from stray energy.
Indications for Use:
Encision's Suction Irrigation Electrodes and Adapters are intended for evacuation of body fluids and to cut and coagulate tissue through a trocar cannula for various general surgical laparoscopic procedures.
Contraindications:
These instruments are not intended for use when laparoscopic electrosurgical techniques are contraindicated.
These instruments have not been shown to be effective for tubal sterilization procedures, and should not be used for these procedures.
Technological Characteristics:
The Encision Suction Irrigation Electrodes and Adapters incorporate the same technological characteristics as the predicate devices for delivery of the ESU high frequency current, consisting of insulated conductors and shafts with appropriately shaped tips for electrosurgery.
Like the Encision predicate device, the electrodes include an additional AEM shielding function which diverts stray energy from the shaft of the instrument and is monitored by the Encision AEM Monitor.
Non-clinical Performance Testing:
Performance of the devices' AEM technology, delivery of electrosurgical energy, and suction/irrigation flow has been verified by bench testing.
| PerformanceCharacteristic | Test Description andCriteria | Suction Irrigation Electrode Results |
|---|---|---|
| Continuity | Continuity between activeconnector and tip of electrodeis to be 4 Ohms maximum. | The device was found to have an active circuitresistance ≤ 1.618 ohms using a 95%confidence interval with 99% reliability. Pass |
| Continuity between shield | The device was found to have a shield circuit |
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| PerformanceCharacteristic | Test Description andCriteria | Suction Irrigation Electrode Results |
|---|---|---|
| connector and distal end ofshield tube is to be 2 Ohmsmaximum. | resistance ≤ 0.830 ohms for a 95% confidenceinterval with 99% reliability. Pass | |
| Capacitance | Capacitance between activeconnector and shieldconnector is 130 pFmaximum @ 100 kHz. | The device was found to have a capacitance ≤121.49 pF @ 100 kHz using a 95% confidenceinterval with 95% reliability. Pass |
| EnergyTransmission | The device must transmit thefull range of HF energy, from30 to 60 watts of power in allmodes from any approvedESU with less than 10%change in voltage. | The device was subjected to all 7 modes on theConmed System 5000 ESU (4 cut modes, 3coag modes). For every mode, at each of the 3different power settings, the device transmittedthe full range of high frequency energy withless than 10% change in voltage. Pass |
| Flow | Flow rate from the proximalto distal end of the lumenmust be a minimum of 580ml/min when tested with afluid head height of 57". | The flow rate was found to be greater than689.7 mL/min using a 95% confidence intervalwith 95% reliability. Pass |
The device meets applicable industry and international standards for electrosurgical accessories.
| Standard | Purpose | Summary of Results |
|---|---|---|
| IEC 60601-2-2:2006, Medical electricalequipment – Part 2-2: Particular requirementsfor the safety of high frequency surgicalequipment. (This standard is primarilyapplicable to electrosurgical generators, butthere are clauses applicable to accessories.) | Safety | Satisfactory results for allapplicable clauses |
| IEC 60601-1:1988, with amendments,Medical Electrical Equipment - Part 1: GeneralRequirements for Safety. (Applicable asreferenced by the high frequency surgicalequipment standard.) | Safety | Satisfactory results for allapplicable clauses |
| AAMI ANSI/ISO 10993-1:2003, Biologicalevaluation of medical devices - Part 1:Evaluation and testing. | Biocompatibility | Tests selected for limitedcontact externalcommunicating device totissue |
| AAMI/ANSI/ISO 10993-5:1999, Biologicalevaluation of medical devices - Part 5:Tests for In Vitro cytotoxicity. | Biocompatibility | Non-cytotoxic |
| AAMI/ANSI/ISO 10993-10:2002, Biologicalevaluation of medical devices - Part 10:Tests for irritation and sensitization. | Biocompatibility | Non-irritating, non-sensitizing |
| AAMI/ANSI/ISO 10993-11:2006, Biologicalevaluation of medical devices -Part 11:Tests for systemic toxicity. | Biocompatibility | Non-toxic |
| AAMI/ANSI/ISO 17665-1:2006, Sterilizationof healthcare products - Moist heat - Part 1:Requirements for development, validation and | Sterilization | Recommended CleaningMethod and Moist HeatSterilization for 106 SAL |
,:"
.
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510(k) Summary - Suction Irrigation Electrodes
| routine control of a sterilization process formedical devices. | was validated |
|---|---|
| -------------------------------------------------------------------- | --------------- |
Conclusions:
The performance data for continuity, capacitance, and energy transmission is equivalent to the electrosurgical performance and AEM technology of the Encision predicate device. The performance data for flow rate is within the range of flow rates for the other predicate suction irrigation devices. This demonstrates that the Encision Reusable Suction Irrigation Electrodes and Adapters substantially equivalent to the predicate devices.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Encision, Inc. % Intertek Testing Services NA, Inc. Mr. Jason M. Goss 2307 E. Aurora Road Unit B7 Twinsburg, OH 44087
JUN - 9 2010
Re: K100711
Trade/Device Name: Suction Irrigation Electrodes and Adapters Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 11, 2010 Received: March 12, 2010
Dear Mr. Goss:
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
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Page 2 - Mr. Jason M. Goss
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/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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Names: Suction Irrigation Electrodes and Adapters
Indications for Use:
ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ
Encision's Suction Irrigation Electrodes and Adapters are intended for evacuation of body fluids and to cut and coagulate tissue through a trocar cannula for various general surgical laparoscopic procedures.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(DW (DWision of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number
§ 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.