The FMX314 Introducer is intended to establish a path of entry for laparoscopic instruments for use during minimally invasive abdominal laparoscopic surgery in combination with the FMX314 Instruments.
The FMX314 Instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, cutting, cauterizing, ligating, and suction irrigation of tissues and vessels during laparoscopic procedures.

Device Description

The FMX314 Surgical Platform is a single-port laparoscopic surgery platform, featuring single-use, disposable articulating surgical instruments for the purpose of doing minimally invasive abdominal laparoscopic surgery by closely mimicking multi-port laparoscopic surgery. The FMX314 Surgical Platform is composed of the reusable FMX314 Introducer, the single-use FMX314 Hub Cap & Sealing Unit, and the single-use FMX314 Instruments that are used as part of laparoscopic surgery according to the intended use. The FMX314 Surgical Platform does not require a larger diameter incision than standard laparoscopic surgery (compatible with a single, standard 15mm trocar) and will utilize currently marketed conventional 15mm laparoscopic access devices (trocars), rigid 5mm laparoscopes, and instrument compatible handles for instrument manipulation and monopolar cutting and cauterizing.

The FMX314 Introducer is a reusable, single port access device for abdominal laparoscopic surgical procedures to be used in combination with a standard 15 mm trocar, FMX314 Hub Cap & Sealing Unit assembly (accessory), and the FMX314 Introducer is designed for introducer is designed for introducing, holding, supporting and guiding the FMX314 Instruments and a standard, rigid 5 mm laparoscope. The cavity at the top of the FMX314 Introducer (hub) is designed to place the single-use FMX314 Hub Cap & Sealing Unit. The FMX314 Hub Cap & Sealing Unit is designed to maintain pneumoperitoneum in the abdomen during the surgical procedure, whether or not one or more FMX314 Instruments are inserted in the instrument lumen(s) of the Introducer. Locking recesses in the hub guide the correct placement of the FMX314 Sealing Unit. The bayonet fitting at the hub is designed to properly position the single-use FMX314 Hub Cap & Sealing Unit on the FMX314 Introducer and to lock the FMX314 Sealing Unit in the hub. By turning the FMX314 Hub Cap clockwise a "click" is heard indicating that the FMX314 Hub Cap & Sealing Unit is locked into position. Prior to its reuse after completion of a procedure the FMX314 Introducer has to be disassembled and sterilized per Instructions For Use.

The FMX314 Surgical Platform comprises six (6) disposable articulating laparoscopic surgical instruments (i.e. FMX314 Grasper, Maryland, Clip Applier, Scissors, Hook-knife, and Suction/Irrigation Instrument). The FMX314 Instruments are locked into position in the instrument clamps of the FMX314 Introducer to activate a triangulated approach within the surgical field and facilitate independent anterior/posterior mobility. Each instrument is capable of 360 degree axial rotation of the end-effector as well as multidirectional lateral and superior/inferior mobility.

The FMX314 Instruments and FMX314 Hub Cap & Sealing Unit are provided sterile and are single-use, disposable. When the surgical procedure is completed, the single-use FMX314 Instruments as well as the FMX314 Hub Cap & Sealing Unit are removed from the Introducer and discarded according to standard hospital protocol.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the FMX314 Surgical Platform. It outlines the device's indications for use, its comparison to predicate devices, and the non-clinical performance data used to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests and states that the device "PASSED all testing" or "PASSED required testing." Specific quantitative acceptance criteria are generally not provided in this summary, only the qualitative outcome.

Test Category	Acceptance Criteria (Implicit from "PASSED")	Reported Device Performance
Biocompatibility	All testing related to cytotoxicity, sensitization, intracutaneous reactivity, and systemic toxicity per ISO 10993-1 should be passed.	PASSED all testing
Electrical Safety (AAMI/ANSI ES60601-1)	Applicable sections of AAMI/ANSI ES60601-1 should be passed.	PASSED required testing
Electrical Safety (IEC 60601-2-2)	Applicable sections of IEC 60601-2-2 should be passed.	PASSED required testing
Electrical Safety (IEC 60601-2-18)	Applicable sections of IEC 60601-2-18 should be passed.	PASSED required testing
Axial Guidance Verification & Durability (FMX314 Introducer)	Complies with requirements for friction and dynamic-static friction through a number of cycles.	PASSED required testing
Triangulation & Range of Motion (FMX314 Instruments)	Lateral, superior/inferior, and anterior/posterior mobility is maintained.	PASSED required testing
Instrument Stiffness	Maximal axial load forces, minimum torqued, and minimum distal articulation stiffness meet specifications.	PASSED required testing
Cleaning & Reprocessing (FMX314 Introducer)	Meets all requirements for reprocessing.	PASSED required testing
Sterilization Testing (FMX314 Instruments & Hub Cap & Sealing Unit)	Meets ISO 11137 standard for radiation sterilization with an SAL of 10^-6.	PASSED required testing
Shelf Life Testing	Functionality testing for a period of two (2) years for sterilized product.	PASSED all testing
Animal Model Study (Performance - Acute & Chronic)	Endpoints of the study relating to cut accuracy, coagulation depth, thermal spread and damage, tissue adherence, and compatibility across energy settings should pass defined criteria.	PASSED defined criteria
Human Cadaver Study	Relevant human landmarks in the abdominal cavity were reachable with no incidents; no negative feedback regarding landmark access, instrument manipulation, articulation, and overall surgical procedure.	Supports claims; no negative feedback
Usability Study	Positive feedback on the unpacking, installation, surgical procedure, and reprocessing; completion of all task selections.	Feedback obtained and assessed

2. Sample Size Used for the Test Set and Data Provenance

Non-Clinical Performance Tests: Sample sizes are not explicitly mentioned for the various bench tests. They are generally reported as "PASSED required testing" or "PASSED all testing."
Animal Model Studies (in vivo): The document states "The animals were each processed through a surgical procedure..." but does not specify the number of animals used for either the acute or chronic studies. The data provenance is stated as "animal model in vivo study."
Human Cadaver Study (ex vivo): The document mentions "A human cadaver study was performed..." but does not specify the number of cadavers used. The data provenance is "ex vivo cadaver studies."
Usability Study: This was conducted during the animal and cadaver studies, implying the sample size would correlate to the users performing those studies, but no specific number is provided for users or cases.

The document does not explicitly state the country of origin for the data from these studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts or their qualifications for establishing ground truth in any of the studies (bench, animal, cadaver, or usability). It mentions "negative feedback was given by the user" for the cadaver study and "feedback that was obtained from each of the users" for the usability study, implying at least one user/expert per study.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1, none) for any of the studies. The results are reported as "PASSED" or "no negative feedback," suggesting a direct verification against predefined criteria rather than a multi-expert consensus adjudication process for discrepancies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done comparing human readers with AI assistance versus without AI assistance. The device is a surgical platform, not an AI-powered diagnostic tool, so this type of study would not be applicable.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. The FMX314 Surgical Platform is a physical surgical device designed for human use, not a standalone algorithm.

7. Type of Ground Truth Used

Non-Clinical Performance Tests: The "ground truth" for these tests would be the established engineering specifications, national/international standards (e.g., ISO 10993-1, AAMI/ANSI ES60601-1, IEC 60601-2-2, IEC 60601-2-18, ISO 11137), and internal requirements for factors like friction, mobility, stiffness, sterilization, and shelf life.
Animal Model Studies: The ground truth involved "defined criteria" for tissue testing (cut accuracy, coagulation depth, thermal spread and damage, tissue adherence, compatibility) evaluated both grossly and histopathologically. This suggests a combination of quantitative measurements and expert pathological assessment.
Human Cadaver Study: "Relevant human landmarks" and "dimensional and functional adequacy" were assessed, implying a physical verification against anatomical expectations and user experience.
Usability Study: The ground truth was based on "feedback" from intended users regarding the unpacking, installation, surgical procedure, and reprocessing steps.

8. Sample Size for the Training Set

Not applicable. The FMX314 Surgical Platform is a physical medical device. It does not utilize machine learning or AI algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 26, 2016

Fortimedix Surgical B.V. % Mr. Richard Vincins Vice President, QA/RA Emergo Global Consulting, LLC 816 Congress Avenue Suite 1400 Austin, Texas 78701

Re: K160797

Trade/Device Name: FMX314 Surgical Platform Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OTJ, GCJ Dated: August 3, 2016 Received: August 9, 2016

Dear Mr. Vincins:

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. Ilsting 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 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

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Christopher J. Ronk -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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Indications for Use

510(k) Number (if known) K160797

Device Name FMX314 Surgical Platform

Indications for Use (Describe)

The FMX314 Surgical Platform is composed of FMX314 Instruments that are used in minimally invasive abdominal laparoscopic surgery:

The FMX314 Introducer is intended to establish a path of entry for laparoscopic instruments for use during minimally invasive abdominal laparoscopic surgery in combination with the FMX314 Instruments.
The FMX314 Instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, cutting, cauterizing, ligating, and suction irrigation of tissues and vessels during laparoscopic procedures.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

FMX314 Surgical Platform

K160797

1. Submission Sponsor

Fortimedix Surgical B.V. Daelderweg 20 Nuth 6361 HK The NETHERLANDS Office phone number: +31 (0) 45 544 95 20 Contact: Dirkjan Bakker Title: Quality Assurance and Regulatory Affairs Manager

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road, Bldg. 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327.9997 Contact: Richard A. VINCINS, Vice President, QA/RA Email: project.management@emergogroup.com

3. Date Prepared

24 August 2016

4. Device Identification

Trade/Proprietary Name:	FMX314 Surgical Platform
Common/Usual Name:	General and Plastic Surgery Laparoscope
Classification Name:	Endoscope and Accessories
Regulation Number:	876.1500
Product Code:	GCJ, OTJ
Device Class:	Class II

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Classification Panel: General & Plastic Surgery

5. Legally Marketed Predicate Device(s)

K090902, SPIDER™ Single Port Surgical Device, TransEnterix, Inc.

K091697, SPIDER™ Surgical Instruments, TransEnterix, Inc.

6. Device Description

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7. Indication for Use Statement

The FMX314 Surgical Platform is composed of FMX314 Introducer and FMX314 Instruments that are used in minimally invasive abdominal laparoscopic surgery:

The FMX314 Introducer is intended to establish a path of entry for laparoscopic instruments for use during minimally invasive abdominal laparoscopic surgery in combination with the FMX314 Instruments.
The FMX314 Instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, cutting, cauterizing, ligating and suction-irrigation of tissues and vessels during laparoscopic procedures.

8. Substantial Equivalence Discussion

The following table compares the FMX314 Surgical Platform (FMX314 Introducer and FMX314 Instruments) to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

Manufacturer	Fortimedix Surgical B.V.	TransEnterix, Inc.	Significant Differences
Trade Name	FMX314 Surgical Platform(FMX314 Introducer)	SPIDER™ Single PortSurgical Device
510(k) Number	K160797	K090902	N/A
Product Code	OTJ	GCJ	Different; the FDA advisedthat Product Code OTJ isused for the FMX314Introducer
RegulationNumber	876.1500	876.1500	Same
Regulation Name	Laparoscopic Single PortAccess Device	General and Plastic SurgeryLaparoscope	N/A
Indications for Use	The FMX314 Introducer isintended to establish a pathof entry for laparoscopicinstruments for use duringminimally invasiveabdominal laparoscopicsurgery in combination withthe FMX314 Instruments.	The SPIDER™ (Single PortInstrument DeliveryExtended Reach) is intendedto establish a path of entryfor laparoscopic instrumentsfor use during minimallyinvasive abdominallaparoscopic surgery.	Same
Manufacturer	Fortimedix Surgical B.V.	TransEnterix, Inc.	Significant Differences
Trade Name	FMX314 Surgical Platform(FMX314 Introducer)	SPIDER™ Single PortSurgical Device
Overview ofDesign, Principlesof Operation	The FMX314 SurgicalPlatform consists of:- the FMX314 Introducer,- the FMX314 Hub Cap &- Sealing Unit- five (5) semi-flexible,- double-articulatingFMX314 Instruments(Grasper, Scissors,Maryland, Clip-Applierand Hook-knife) and- one (1) semi-flexible,single-articulatingFMX314Suction/IrrigationInstrumentThe FMX314 Introducer is arigid, reusable single portdelivery system with four (4)lumens to facilitate multi-instrument access. Thesuperior lumen is designatedfor a 5mm rigid laparoscope;the two lateral ports aredesignated for theinstruments and the inferiorlumen for thesuction/irrigation.The FMX314 Introducer isinserted into a standard 15mm Trocar after insufflationof the abdomen. It includes afume release port for smokeevacuation.The FMX314 Instruments getsteered and activated withhandles with a rotating knob.The FMX314 SurgicalPlatform allows for x, y, and zas well as rotational motionfor a multidirectionalapproach of the surgicalfield	The single use SPIDER™device consists of:- the SPIDER™ SinglePort Surgical Device- the SPIDER™ SurgicalInstruments (flexibleand rigid)The SPIDER™ Single PortSurgical Device is a rigid, pre-sterilized introducer withfour channels. Two of thechannels known as IDTs(Instrument Delivery Tubes)are positioned left and rightand include extended lumensto facilitate manipulation offlexible surgical instruments,enabling control of theinstruments over extendeddistances. These 2 IDTs areflexible and allow for x, y,and z motion for amultidirectional approach ofthe surgical field, mimickingthe approach of standardlaparoscopic surgery usingpistol grip handles with arotating knob on the flexiblesurgical instruments.Two (2) rigid channels, northto south, can accommodatean endoscope or a rigidsurgical instrument. TheSPIDER™ Single Port SurgicalDevice includes ports forinsufflation or smokeevacuation.	Similar; both platforms aresingle access platforms, andallow for motion oflaparoscopic Instrumentsfor a multidirectionalapproach of the surgicalfield. Both platforms have aport for smoke evacuation.The SPIDER™ Single PortSurgical Device is for single-use only and requires abigger incision because ofits larger outer diametercompared to the reusableFMX314 Introducer.Furthermore, the flexibleSPIDER™ SurgicalInstruments do not haveinherent stiffness and getsteered and activated viathe Instrument DeliveryTubes, while the FMX314Instruments are semi-flexible and activated andarticulated via theinstrument handle.The differences in theoverall design and theprinciple of operation anduse of the FMX314 SurgicalPlatform are minor and donot raise any additionalquestions of safety orefficacy as the generalprinciple for use of thedevice is the same and isused in the same surgicalprocedures.
Manufacturer	Fortimedix Surgical B.V.	TransEnterix, Inc.	Significant Differences
Trade Name	FMX314 Surgical Platform(FMX314 Introducer)	SPIDER™ Single PortSurgical Device
	approach of standardlaparoscopic surgery.
Materials –Introducer	Introducer body:Stainless steel 316L and PEEKInstrument Clamps &Axial Guiding:Aluminum AL 6082Bearings:PTFE Rulon 641Spring:Stainless steel 301	Stainless steel andPlastic materials	Similar; the materialscomposing the introducercomponent are commonmaterials that are used inother medical devices. Thematerials do not introduceany concerns for safety andefficacy as the performancetesting of the FMX314Surgical Platform assuresproper functioning.
Materials — HubCap & Sealing Unit	FMX314 Hub Cap:PEEKFMX314 Sealing Unit:Silicone rubber, PBT	Plastic materials	Similar; the materialscomposing the FMX314 HubCap & Sealing Unit arecommon materials that areused in other medicaldevices. These materials donot introduce any concernsfor safety and efficacy asthe performance testing ofthe FMX314 Sealing Unitassures proper functioning.
Number of Lumens	4	4	Same
Stationary Lumens	4	2	Similar; the FMX314Introducer providesstationary lumens only, thisdoes not introduce any newsafety or efficacy concernsas compared to thepredicate device.
Flexible Lumens	0	2	Different; the FMX314Introducer providesstationary lumens only forrobust lumen pathway thatdoes not introduce any newsafety or efficacy concernsas compared to thepredicate device.
Manufacturer	Fortimedix Surgical B.V.	TransEnterix, Inc.	Significant Differences
Trade Name	FMX314 Surgical Platform(FMX314 Introducer)	SPIDER™ Single PortSurgical Device
Degrees ofRotation	360° of independentmovement of instruments atdistal end	360° of independentmovement of instruments atdistal end	Same
Lumen Diameter	3 x 6 mm (lateral, superior)1 x 3.6 mm (inferior)	2 x 7.2 mm (flexible)2 x 6 mm (stationary)	Similar; the semi-flexibleFMX314 Instruments have asmaller diameter; these donot introduce any newconcerns of safety andefficacy as the lumendiameter accommodatesthe instruments for eachplatform.
Overall Length	27.5 cm (with fully engagedaxial guidance; extremeposterior position)34.0 cm (with fully extendedaxial guidance; extremeanterior position)	72 cm	Different; the FMX314Instruments are semi-flexible and have aninherent stiffness throughthe material composition.Thus the instruments donot need full support alongthe length. The smallerlength of the introducerdoes not introduce anyadditional concerns forsafety or efficacy.
Outer Diameter(Shaft)	15.5 mm	18.9 mm (without plastictube)	Similar; the SPIDER™ SinglePort Surgical Device has a3.4 mm larger diameter; asthe path of entry is smallerthan the predicate device,this does not introduce anynew concerns for safety andefficacy.
Sterile	Introducer: Supplied non-sterile; user sterilizedHub Cap & Sealing Unit:Supplied sterile, single-useonly	Supplied sterile, single-useonly	Different; the entirepredicate device is single-use only compared toreusability of the FMX314Introducer. Reprocessingvalidation and lifecycleverification supports nonew concerns for safety orefficacy introduced.
Manufacturer	Fortimedix Surgical B.V.	TransEnterix, Inc.	Significant Differences
Trade Name	FMX314 Surgical Platform(FMX314 Introducer)	SPIDER™ Single PortSurgical Device
Single-Use	The Introducer isreprocessed according toinstructionsHub Cap & Sealing Unit:Single-use only, disposed ofafter use	Single-use only	Different; the entirepredicate device is single-use only compared toreusability of the FMX314Introducer. Reprocessingvalidation and lifecycleverification supports nonew concerns for safety orefficacy introduced.
Packaging	Holding tray in a carton box	Holding tray in a carton box	Same
Shelf Life	Introducer: 5 yearsHub Cap & Sealing Unit: 2years	Not known	N/A

Table 5A - Comparison of Characteristics - FMX314 Introducer

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Table 5B – Comparison of Characteristics – FMX314 Instruments

Manufacturer	Fortimedix Surgical B.V.	TransEnterix, Inc.	Significant Differences
Trade Name	FMX314 SurgicalPlatform(FMX314 Instruments)	SPIDER™ SurgicalInstruments
510(k) Number	K160797	K091697	N/A
Product Code	GCJ	GCJ	Same
RegulationNumber	876.1500	876.1500	Same
Regulation Name	General and Plastic SurgeryLaparoscope	General and Plastic SurgeryLaparoscope	Same
Indications for Use	The FMX314 Instrumentsare intended for use inminimally invasiveabdominal laparoscopicsurgical procedures forgrasping, mobilizing,dissecting, retracting,cutting, cauterizing, ligatingand suction irrigation oftissues and vessels duringlaparoscopic procedures.	The SPIDER SurgicalInstruments are intended foruse in minimally invasiveabdominal laparoscopicsurgical procedures forgrasping, mobilizing,dissecting, retracting,cutting, cauterizing, ligating,suction irrigation, and othermanipulation of tissues andvessels during laparoscopicprocedures.	Similar; the phrase 'andother manipulation' wasremoved from theindications as discussed withthe FDA during a Q-Submeeting.
Manufacturer	Fortimedix Surgical B.V.	TransEnterix, Inc.	Significant Differences
Trade Name	FMX314 SurgicalPlatform	SPIDER™ SurgicalInstruments
	(FMX314 Instruments)
Types ofInstruments	FMX314 GrasperFMX314 MarylandFMX314 ScissorsFMX314 Clip ApplierFMX314 Hook-KnifeFMX314 Suction-Irrigation	Fenestrated GrasperMaryland DissectorFlex ShearsClip ApplierMonopolar HookSuction Irrigator	Same
DesignConfiguration	Semi-flexible, articulatinglaparoscopic instrumentmade of telescoped tubes;pistol grip handle withrotating knob (except forthe Hook-Knife and theSuction/Irrigationinstruments)	Flexible laparoscopicinstrument; pistol griphandle with rotating knob(except for the Hook-Knifeand the Suction/Irrigationinstruments)	Similar; compared to theflexible SPIDER™ Instrumentswhich have no inherentstiffness and can only bemanipulated within theflexible lumens of theSPIDER™ Single Port SurgicalDevice, the FMX314Instruments are semi-flexiblewith an inherent stiffness.The use of the instrumentsare the same for theindications for use andsurgical application that issupported by performancetesting of the instrumentswhich does not raise anynew concerns for safety orefficacy.
Materials	Stainless steel tooltips;stainless steel tubing;polyolefin sheathing	Stainless steel tooltips;Sheathing material unknown	Similar; there is nodifference in the tool-tipmaterial as both are stainlesssteel. All patient contactingmaterials used with theFMX314 Instruments arebiocompatible and do notintroduce any new safety orefficacy concerns.
Length (Overall)	FMX314 Grasper: 63 cm(without handle) of whichup to 33 cm is inside theabdominal cavityFMX314 Maryland: 63 cm	Fenestrated Grasper: About84 cm (without handle) of whichup to 34 cm is insidethe abdominal cavityMaryland Dissector: About	Similar; the instruments ofthe predicate device need tofit through the SPIDER™Introducer which has anoverall length of 72cm;
Manufacturer	Fortimedix Surgical B.V.	TransEnterix, Inc.	Significant Differences
Trade Name	FMX314 SurgicalPlatform(FMX314 Instruments)	SPIDER™ SurgicalInstruments
	(without handle)FMX314 Scissors: 62 cm(without handle)FMX 314 Clip Applier: 63 cm(without handle)FMX314 Hook-knife: 59 cm(without handle); 73 cm	84 cm (without handle)Flex Shears: UnknownClip Applier: UnknownMonopolar Hook: Unknown	taking the bends of theflexible lumens of theSPIDER™ Single Port SurgicalDevice into account, theflexible SPIDER™Instruments need to belonger than 72 cm.
	(including handle)FMX314 Suction-Irrigation:68 cm (without connector)	Suction - Irrigator: About 80cm (without connector)	This does not introduce anysafety or efficacy concerns asthe manipulation of theinstrument is the same andthe operating principles isthe same.
Length (Tooltip)	FMX314 Grasper: 36 mmFMX314 Maryland: 33 mmFMX314 Scissors: 26 mmFMX314 Clip Applier: 34mmFMX314 Hook-knife: 14 mm	Fenestrated Grasper About26 mmMaryland Dissector: About25.5 mmFlex Shears: UnknownClip Applier: UnknownMonopolar Hook: Unknown	Similar; the slightly longertool-tip of the FMX314Instrument does notintroduce any new safetyand efficacy concerns as thisis only 1 cm which does nothave a significant impact onuse of the tool.
Shaft Diameter	5 mm	About 3.2 mm	Similar; the shaft diameter isslightly larger toaccommodate theconstruction of the flexibleinstruments. This does notraise any additional safety orefficacy concerns as theinstruments fit through theintroducer lumens.
Sterile	Yes by gamma sterilization	Yes by EtO sterilization	Similar; these are bothvalidated methods with theSterility Assurance Level(SAL) of 10 $^{-6}$ so this does notintroduce any new safety orefficacy concerns.
Electrical SafetyTesting	Yes	Yes	Same
Single-Use	Yes	Yes	Same
Manufacturer	Fortimedix Surgical B.V.	TransEnterix, Inc.	Significant Differences
Trade Name	FMX314 SurgicalPlatform(FMX314 Instruments)	SPIDER™ SurgicalInstruments
Maximum VoltageRating	< 3500 volts	< 3500 volts	Same
Shelf Life	2 years	Unknown	N/A

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9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of the FMX314 Surgical Platform and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Fortimedix Surgical completed a number of non-clinical performance tests. The FMX314 Surgical Platform meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety results confirming that the design output meets the design inputs and specifications for the device.

The FMX314 Surgical Platform passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

. Biocompatibility testing for the FMX314 Instruments including cytotoxicity, sensitization, intracutaneous reactivity, and systemic toxicity per ISO 10993-1: PASSED all testing
. Electrical safety testing according to applicable sections for the FMX314 Surgical Platform per AAMI/ANSI ES60601-1: PASSED required testing
. Electrical safety testing according to applicable sections for the FMX314 Surgical Platform per IEC 60601-2-2: PASSED required testing
Electrical safety testing according to applicable sections for the FMX314 Surgical Platform per IEC 60601-2-18: PASSED required testing
Axial Guidance Verification and Durability of the FMX314 Introducer complies with the requirements for friction and dynamic-static friction placed through a number of cycles: PASSED required testing
Triangulation and Range of Motion to verify that the FMX314 Instruments lateral, superior/inferior, and anterior/posterior mobility is maintained: PASSED required testing
. Instrument Stiffness is verified that the maximal axial load forces, minimum torqued, and the minimum distal articulation stiffness meet specifications: PASSED required testing
. Cleaning and Reprocessing for the FMX314 Introducer meet all requirements for reprocessing: PASSED required testing
Sterilization Testing of the FMX314 Instruments and FMX314 Hub Cap & Sealing Unit to ISO 11137 standard for radiation sterilization meeting an SAL of 10 °: PASSED required testing

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. Shelf Life Testing for a period of two (2) years for sterilized product including the FMX314 Instruments and FMX314 Hub Cap & Sealing Unit including functionality testing: PASSED all testing

10. Clinical Performance Data

There was no human clinical testing performed to support the medical device as the indications for use is equivalent to the predicate device. However, detailed thorough performance bench tests were completed including ex vivo cadaver studies and in vivo animal studies (minimally-invasive laparoscopic abdominal surgery in a animal model) that were performed using the subject device, FMX314 Surgical Platform.

. Performance of the FMX314 Surgical Platform in an animal model in vivo study confirmed the use, functionality, and operation of the device during single port laparoscopic surgery through cuts of defined length with different temperature/energy levels with subsequent analysis of the testing was performed grossly and histopathologically utilizing a representative instrument for testing. The tissue testing criteria for the study included cut accuracy, coagulation depth, thermal spread and damage, tissue adherence to instruments, and compatibility across representative energy settings. The animal study was completed according to Good Laboratory Practices (GLP) with proper handling of the study animals.
. An acute study was completed on animal models as described previously. The animals were each processed through a surgical procedure to have the liver accessed for the use of the FMX314 Surgical Platform according to the tissue/performance testing requirements. The endpoints of the study all passed defined criteria supporting performance testing through use of an in vivo animal model.
. A chronic study was completed in the same manner as the afore-mentioned acute study with the difference being that the animals were not immediately euthanized after the completion of the procedure. The endpoints of the study all passed defined criteria supporting performance testing through use of an in vivo animal model.
A human cadaver study was performed to evaluate real-life conditions for anatomical landmarks and dimensions that would be expected in a human patient. The goal was to evaluate the FMX314 Surgical Platform for dimensional and functional adequacy regarding triangulation, and length of instruments. The human cadaver study supports that relevant human landmarks in the abdominal cavity were reachable with no incidents. No negative feedback was given by the user for any aspect of landmark access, manipulation of the instruments, articulation of the instruments, and generally the overall laparoscopic surgical procedure.
Validation of the FMX314 Surgical Platform was performed by completing a usability study from the unpacking, installation, through the surgical procedure, and reprocessing of the finished device. The intended user was observed during use of the device including feedback that was obtained from each of the users for analysis. Usability assessment was made during the animal model in vivo study and ex vivo cadaver study to obtain feedback on completion of all task selections.

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The sponsor has provided each of the final testing reports that contain a description of the test objective, test article, test method, acceptance criteria, results, and conclusion such that these testing were performed to demonstrate the functionality and mechanical safety of the subject device, FMX314 Surgical Platform. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Conclusion

The results of the performance bench tests including ex vivo cadaver studies and in vivo animal studies demonstrated that the FMX314 Surgical Platform is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate devices.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.