(311 days)
Indications for Use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two models, one for ABF01-F and the other for lock functions, ABF01-L. The two models are same except for lock function. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.
The document describes the ArtiSential Bipolar Fenestrated Forceps, a single-use electrosurgical instrument used in laparoscopic surgery for coagulation, dissection, and grasping of tissue. The device underwent several performance tests to demonstrate its safety and effectiveness and establish substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Clause and Test Requirement | Acceptance Criteria (Test Specification) | Reported Device Performance (Results - Remarks) |
|---|---|---|
| 1. AppearanceNo defects in the appearance; no problem in use. | Visual observation | No crack, stain, or no substances on the surface of the product. |
| 2. DimensionWithin ± 5% of the indicated value. | Measure by Vernier calipers and dial gauge etc. | Pass (Refer to [Measurement data] on 65 page at attachment #3). |
| 3. Operational TestJaw smoothly opened/closed, free from jamming. Jaw and hub bend up, down, left, right ≥ ±80°, 360° rotation. | Adjusting open and close the jaw by manipulating the grip and control ring; measure angle at bending and turning. | The jaw and hub are bent up, down, left and right within above 80°, and can rotate 360°. |
| 4. Tensile StrengthJaw and shaft connections not damaged from 20 N pull. | Hold the jaw and shaft connections and apply a force of 20 N using a Push pull gauge. | No damage to the connection when applying a force of 20N. |
| 5. Feedthrough TestElectricity transmitted between electrode tip and connector. | Electrical conduction between electrode tip and connector tested using DMM. | The resistance value between the electrode tip and the connector is less than 1Ω. |
| Biocompatibility | According to ISO 10993-1, assessed for Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity. | All evaluated endpoints passed. |
| Electrical Safety | According to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18, and IEC 60601-2-2. | The device passed all performed tests (Active accessory insulation, hf leakage, hf dielectric strength, mains frequency dielectric strength, feedthrough test). |
| Sterilization | EO-Sterilization in accordance with ISO-11135. | The device is provided sterile via EO-Sterilization. |
| Shelf Life | Proposed expiration date is 2 years from manufacturing date (real-time testing for 3 years). | Proposed 2-year shelf life. (Real-time testing for 3 years to be performed). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance tests. The data provenance is also not specified; however, given the applicant's address (Republic of Korea) and the FDA submission, it is likely that the testing data was generated in support of regulatory approval in the US. The nature of the tests (physical, electrical, and biocompatibility) suggests that they are laboratory-based and generally not dependent on patient data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The performance tests described are objective, engineering-based evaluations of the device's physical and electrical characteristics, and biological safety. They do not involve expert interpretation or ground truth derived from a clinical dataset (e.g., medical images).
4. Adjudication Method for the Test Set
Not applicable, as the tests are objective and do not involve human interpretation requiring adjudication.
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
Not applicable. The ArtiSential Bipolar Fenestrated Forceps is a medical instrument, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is a medical instrument and not an algorithm. Performance tests mentioned are for the physical device itself.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed is based on objective, measurable engineering specifications, established international standards (e.g., ISO 10993-1, IEC 60601 series, ISO-11135), and visual inspection criteria. It is not dependent on expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device.
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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.
February 13, 2020
Livsmed Inc. % Do Hyun Kim CEO BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul, Korea 06210
Re: K190909
Trade/Device Name: ArtiSential Bipolar Fenestrated Forceps (Model ABF01-L, ABF01-F) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 21, 2020 Received: January 22, 2020
Dear Do Hyun Kim:
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.
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
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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 medical devices and radiation-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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K190909
Device Name
ArtiSential Bipolar Fenestrated Forceps (Model name: ABF01-L, ABF01-F)
Indications for Use (Describe)
Indications for Use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
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6. 510(k) Summary
1. General Information
| Applicant/Submitter: | Livsmed Inc. |
|---|---|
| Address: | #304, D-dong, 700, Pangyo-ro, Bundang-gu, 13516Seongnam-si, Gyeonggi-do, Republic of KoreaTel) +82-70-4282-7652Fax) +82-31-706-3211 |
| Contact Person: | Do Hyun Kim, BT Solutions, Inc. |
| Address: | Unit 904, Eonju-ro 86-gil 5, Gangnam-gu, 06210Seoul, Republic of KoreaTel) +82-2-538-9140Fax) +82-2-539-9140Email) smanager@btsolutions.co.kr |
| Preparation Date: | 01-02-2020 |
2. Device Name and Code
| Device Trade Name: | ArtiSential Bipolar Fenestrated Forceps(Model name: ABF01-L, ABF01-F) |
|---|---|
| Common Name: | Electrosurgical Instruments |
| Classification Name: | Electrosurgical, cutting & coagulation & accessories |
| Product Code: | GEI |
| Regulation Number: | 21 CFR 878.4400 |
| Classification: | Class II |
| Review Panel: | General & Plastic Surgery |
3. Predicate Devices
ArtiSential Bipolar Fenestrated Forceps is substantially equivalent to the following devices
| Table 3.1 Predicate device | ||
|---|---|---|
| Applicant | Device Name | 510(k) Number |
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ArtiSential Bipolar Fenestrated Forceps 510(k) Summary
| Gyrus Medical, Inc. | Everest Bipolar MACRO, | K031078 |
|---|---|---|
| MICRO&MOLLY Forceps Gyrus | ||
| Bipolar MACRO, MICRO&MOLLY | ||
| Forceps |
Table 3.2 Reference Predicate device
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| Ethicon Endo-Surgery, LLC | ENSEAL® G2 Articulating TissueSealers | K122797 |
| Intuitive Surgical, Inc. | Intuitive Surgical Da Vinci Surgical | K050369 |
| Intuitive Surgical, Inc. | da Vinci® SpTM Surgical System,Model SP999, EndoWrist® SpTMInstruments, and Accessories | K131962* |
- This reference device is referred, of which articulating parts are the same to those of the ArtiSential Bipolar Fenestrated Forceps. This device is used in robotic surgery, but articulating function is very similar.
4. Device Description
This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two models, one for ABF01-F and the other for lock functions, ABF01-L. The two models are same except for lock function. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.
5. Indications / Intended Use
5.1 Intended use
The ArtiSential Bipolar Fenestrated Forceps are invasive instruments which is used with electrosurgical generator. They are intended to be used during laparoscopic surgical procedures for incision/coagulation (to electrocauterize, grasp and dissect tissue) during surgery.
5.2 Indications for use
Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
6. Technical Characteristics in Comparison to Predicate and Reference Devices
ArtiSential Bipolar Fenestrated Forceps is substantially equivalent to the following legally marketed predicate device.
Table 6.1 Predicate Device
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ArtiSential Bipolar Fenestrated Forceps 510(k) Summary
| Proposed Device | Predicate Device | |
|---|---|---|
| 510(K) Number | Not Available | K031078 |
| Manufacturer | LivsMed, Inc. | Gyrus Medical, Inc. |
| Device Name | ArtiSential Bipolar Fenestrated Forceps | Everest Bipolar MACRO,MICRO&MOLLY Forceps Gyrus BipolarMACRO, MICRO&MOLLY Forceps |
| Clearance Date: | N/A | 05/16/2003 |
| Classification /Regulation | Class 2 / 878.4400 | Class 2 / 878.4400 |
| Product Code | GEI | GEI |
| Intended for | Prescription Use | Prescription Use |
| Indications forUse | Electrosurgical coagulation, dissection, andgrasping of tissue during the performance oflaparoscopic and general surgicalprocedures. | Electrosurgical coagulation, dissection, andgrasping of tissue during the performance oflaparoscopic and general surgicalprocedures. |
| Principles ofoperation | This product is a single-use instrument usedin electrosurgical units to hold soft tissues orcoagulate and make an incision (tissuedissection) during general laparoscopicsurgery, which uses the principle ofapplying high-frequency currents from theelectrode to the human body to generateheat by bioimpedance when radio frequency(RF) energy from the electrosurgical unitapplies an electric current to the electrodepart, and using the generated heat to incisecellular tissues and cause coagulation.It is composed of a jaw, Φ8 diameter shaft,grip (including a control ring), andelectrosurgical unit connection electrodeconnector.During a procedure with this product, thejaw opens if the control ring opens, and jawcloses if the control ring closes. In addition,the jaw is also bent up, down, left and rightwithin a range of ±80° or more by movingthe grip up, down, left and right, and the jawcan also turn 360° when rotating the grip. | Unknown |
| Energy Type | Radiofrequency | Radiofrequency |
| Electrode type(monopolar orbipolar) | Bipolar | Bipolar |
| Physicaldimensions anddesign (size,length,connector type) | Shaft diameter: 8mmLength: 411.4mmConnector type: Dual-pin connector type | Shaft diameter: 5mmLength: 450mmConnector type: Dual-pin connector type |
| Rated voltage | 200 Vp | Unknown |
| Materials(electrode) | Stainless steel | Unknown |
| Materials(insulation) | Polyetherimide | Unknown |
| Materials(Shaft) | Glass fiber | Unknown |
| Rotation | Pitch:±80° or more, Yaw:±80° or moreand Open-Close | Unknown |
| Sterilization | EO | EO |
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ArtiSential Bipolar Fenestrated Forceps 510(k) Summary
Table 6.2 Reference Predicate Device
| Proposed Device | Reference PredicateDevice 1 | Reference Predicate Device2 | |
|---|---|---|---|
| 510(K)Number | Not Available | K122797 | K050369 |
| Manufacturer | LivsMed, Inc. | Ethicon Endo-Surgery, LLC | Intuitive Surgical, Inc. |
| Device Name | ArtiSential BipolarFenestrated Forceps | ENSEAL® G2 ArticulatingTissue Sealers | Intuitive Surgical Da VinciSurgical System, ModelIS2000 |
| ClearanceDate: | N/A | 01/25/2013 | 04/29/2005 |
| Classification /Regulation | Class 2 / 878.4400 | Class 2 / 878.4400Class 2/ 884.4120 | Class 2/ 876.1500 |
| Product Code | GEI | GEI, HGI | NAY |
| Intended forIndications forUse | Prescription UseElectrosurgical coagulation,dissection, and grasping oftissue during theperformance of laparoscopicand general surgicalprocedures. | Prescription UseThe ENSEAL® G2Articulating Tissue Sealersare indicated for bipolarcoagulation and mechanicaltransection of tissue duringlaparoscopic and openprocedures. The devices arebipolar electrosurgicalinstruments for use with theGenerator GEN11(GEN11). They are intendedfor use during open orlaparoscopic, general andgynecological surgery to cutand sealvessels, and to cut, graspand dissecttissue during surgery.Indications for use includeopen and laparoscopic,general and gynecologicalsurgical procedures(including urologic,thoracic, plastic andreconstructive, bowelresections, hysterectomies,cholecystectomies, gallbladder procedures, Nissen | Prescription UseThe Intuitive Surgical' daVinci Surgical System isintended to assist in theaccurate control of IntuitiveSurgical EndoscopicInstruments including rigidendoscopes, blunt and sharpendoscopic dissectors,scissors, scalpels, ultrasonicshears, forceps/pick-ups,needle holders, endoscopicretractors, stabilizers,electrocautery andaccessories for endoscopicmanipulation of tissue,including grasping, cutting,blunt and sharp dissection,approximation, ligation,electrocautery, suturing, anddelivery and placement ofmicrowave ablation probesand accessories duringurologic surgical procedures,general laparoscopic surgicalprocedures, gynecologiclaparoscopic surgicalprocedures, general non-cardiovascular thoracoscopic |
| fundoplication, adhesiolysis,oophorectomies, etc.), orany procedure where vesselligation (cutting andsealing), tissue grasping,and dissection is performed.The devices can be used onvessels up to (and including)7mm and tissue and/orvascular bundles as large aswill fit in the jaws of theinstruments. | surgical procedures, andthoracoscopically assistedcardiotomy procedures. Thesystem can also beemployed, with adjunctivemediastinotomy to performcoronary anastomosis duringcardiac revascularization. Itis intended for use by trainedphysicians in an operatingroom environment inaccordance with therepresentative specificprocedures set forth in theProfessional Instructions forUse. | ||
| Principles ofoperation | This product is a single-useinstrument used inelectrosurgical units to holdsoft tissues or coagulate andmake an incision (tissuedissection) during generallaparoscopic surgery, whichuses the principle ofapplying high-frequencycurrents from the electrodeto the human body togenerate heat bybioimpedance when radiofrequency (RF) energy fromthe electrosurgical unitapplies an electric current tothe electrode part, and usingthe generated heat to incisecellular tissues and causecoagulation.It is composed of a jaw, Φ8diameter shaft, grip(including a control ring),and electrosurgical unitconnection electrodeconnector.During a procedure withthis product, the jaw opensif the control ring opens,and jaw closes if the controlring closes. In addition, thejaw is also bent up, down,left and right within a rangeof ±80° or more by movingthe grip up, down, left andright, and the jaw can also | The ENSEAL G2Articulating TissueSealers have a 5 mmdiameter shaftand are available in twoshaftslengths: 35 and 45cm; andtwo jaw types: 3mm curvedjaw and 5mm straight jaw.The jaws are normally in theopened position and can bepartially or fully closed bysqueezingthe closing handle. The jawshave atraumnatic teeth forgrasping and holdingtargeted tissue whenclamped. The handles of theSubject ENSEAL G2Articulating Tissue Sealershave an ergonomic interfacefor the user. Like thePredicate, the Subjectdevices include anintegrated energy activationbutton. The devices use acombination of theapplication of bipolarelectrosurgical energy inconjunction with the I-BLADE knife, to compress,coagulate, and transecttissue. | This product is a reusablefoot control electro-surgicalelectrode equipped with aproduct mounted on acleared product like da VinciS Surgical system or daVinci Si Surgical System andused by connecting it to anelectrosurgical machine witha cable. It consists of ahousing, which is attached tothe robotic arm of the davinci system, and shaftwhich the bipolar energy istransferred and an electrode(tip) that coagulates,removes, dissects, ordestroys tissues using theenergy. The principlesapplied to the developmentof this product are asfollows.When high-frequency energyfrom an electrosurgicalmachine is energized on theelectrodes through cables,housings, and shafts, high-frequency currents fromelectrodes are applied to thehuman body to generate heatdue to bio-resistance, and theheat generated is used togenerate incision andcoagulation of tissue. Thisproduct is a medical devicethat can be reused by |
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ArtiSential Bipolar Fenestrated Forceps 510(k) Summary
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| ArtiSential Bipolar Fenestrated Forceps |
|---|
| 510(k) Summary |
| turn 360° when rotating the grip. | cleaning and sterilizing after use. | ||
|---|---|---|---|
| Energy Type | Radiofrequency | Radiofrequency | Radiofrequency |
| Electrode type(monopolar orbipolar) | Bipolar | Bipolar | Bipolar |
| Physicaldimensions anddesign (size,length,connector type) | Shaft diameter: 8mmLength: 411.4mmConnector type: Dual-pinconnector type | Shaft diameter: 5mmLength: 350mm, 450mmConnector type: Unknown | Shaft diameter: 8mmTotal length: 511mmConnector type: Dual-pinconnector type |
| Rated voltage | 200 Vp | Unknown | 384 Vp |
| Materials(electrode) | Stainless steel | Stainless steel | Stainless steel |
| Materials(insulation) | Polyetherimide | Unknown | Polyetherimide / ETFE(Ethylenetetrafluoroethylene) |
| Materials(Shaft) | Glass fiber | Unknown | Glass fiber |
| Rotation | Pitch:±80° or more,Yaw:±80° or more andOpen-Close | Articulates approximately50~65° tothe left and the right ofcenter andOpen-Close | Pitch: ±70°Yaw: ±90° |
| Sterilization | EO | EO | Moist Heat or SteamSterilization |
7. Performance Data
7.1 Biocompatibility
The device has been evaluated for its biological safety according to ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process". Following endpoints have been assessed during the evaluation:
- Cytotoxicity
- . Sensitization
- Intracutaneous reactivity
- Acute systemic toxicity
7.2 Electrical Safety
The ArtiSential Bipolar Fenestrated Forceps has been tested according to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18 and IEC 60601-2-2. The test setup included:
- Active accessory insulation
- Active accessory hf leakage ●
- Active accessory hf dielectric strength ●
- Active accessory mains frequency dielectric strength ●
- Feedthrough test ●
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The device had passed all performed tests. 7.3 Sterilization
ArtiSential Bipolar Fenestrated Forceps is provided sterile, intended to be single-use. This product is EO-Sterilization in accordance with ISO-11135.
7.4 Shelf life
The proposed expiration date is 2 years from the manufacturing date. The real-time testing will be performed to confirm the shelf-life for 3 years.
7.5 Performance test
| Test clause and Test requirement | Test specification | Results- Remarks |
|---|---|---|
| 1. AppearanceThere should be no defects in theappearance of the product and thereshould be no problem in use. | Visual observation | No crack, stain orno substances onthe surface of theproduct |
| 2. DimensionIt should be within ± 5% of the indicatedvalue of the dimensional term. | Measure by Vernier calipersand dial gauge etc. | PassRefer to[Measurementdata] on 65 pageat attachment #3 |
| 3. Operational testThe jaw must be smoothly opened andclosed and free from jamming, the jawand hub can be bent up, down, left, andright a range of above ±80° and arecapable of 360° rotation. | Adjusting open and close thejaw by manipulating the gripand control ring, and measurethe angle at bending andturning. | The jaw and hubare bent up, down,left and rightwithin above 80°,and can rotate360°. |
| 4. Tensile strengthThe jaw and shaft connections shall notbe damaged from pulling of 20 N. | Hold the jaw and shaftconnections respectively andapply a force of 20 N usingPush pull gauge. | No damage to theconnection whenapplying a force of20N |
| 5. Feedthrough testElectricity should be transmittedbetween the electrode tip and theconnector. | Electrical conduction betweenthe electrode tip and theconnector is tested using a DMM(digital multi meter). | Theresistancevalue between theelectrode tip andthe connector isless than 1Ω |
The device had passed all performed tests.
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Based on these performance characteristics, the results demonstrate that the performance requirements were met, the device performs as intended and that the subject device has substantially equivalent performance characteristics to the predicate and reference predicate devices.
8. Substantial Equivalence
The ArtiSential Bipolar Fenestrated Forceps indication for use is similar to the predicate device (K031078). The energy type, electrode type, sterilization as well as similar physical characteristics are the same. Although there are some minor differences with each product, these differences between the ArtiSential Bipolar Fenestrated Forceps and the predicate device do not raise new or different questions of safety and efficacy. There is no new technology and no difference that would raise new or different questions of safety or efficacy.
9. Conclusions
In conclusion, the comparison carried out covers all products, sizes, and the entire intended purpose of the device under evaluation. The subject device which is the Disposable Laparoscopic Instruments - ArtiSential Bipolar Fenestrated Forceps - is considerably similar to the predicate and reference devices in principles of operation, technological characteristics, as well as performance characteristics. The testing was conducted to evaluate the performance of subject device in comparison to the predicate and reference devices. Results of validation and verification activities in design control that include testing/certification to designated standards and performance testing of the devices has demonstrated substantial equivalence of the subject device to the predicate in terms of safety and effectiveness for requested intended use.
§ 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.