FMX314 Surgical Platform

K160797 · Fortimedix Surgical B.V. · OTJ · Aug 26, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K160797
• Device Name: FMX314 Surgical Platform
• Applicant: Fortimedix Surgical B.V.
• Product Code: OTJ · Gastroenterology, Urology
• Decision Date: Aug 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

FMX314 Surgical Platform is a single-port laparoscopic access system; enables multi-instrument access through a single 15mm trocar. Components: reusable FMX314 Introducer; single-use FMX314 Hub Cap & Sealing Unit; six disposable articulating instruments (grasper, Maryland, clip applier, scissors, hook-knife, suction/irrigation). Introducer provides four lumens: one for 5mm rigid laparoscope, two for instruments, one for suction/irrigation. Instruments feature 360-degree axial rotation and multidirectional lateral/superior/inferior mobility; semi-flexible design provides inherent stiffness. Used in OR by surgeons; instruments manipulated via pistol-grip handles. System maintains pneumoperitoneum via sealing unit. Benefits include triangulation and independent instrument mobility mimicking multi-port surgery through a single incision. Introducer is reprocessed; instruments/sealing unit are single-use.

Clinical Evidence

No human clinical trials performed. Evidence based on extensive non-clinical bench testing, ex vivo cadaver studies, and in vivo animal studies (acute and chronic). Animal studies confirmed functionality, cut accuracy, coagulation depth, and thermal spread. Cadaver study validated anatomical reach, triangulation, and instrument length. Usability study confirmed device handling from setup to reprocessing.

Technological Characteristics

Introducer: Stainless steel 316L, PEEK, Aluminum AL 6082, PTFE Rulon 641, Stainless steel 301. Instruments: Stainless steel tooltips/tubing, polyolefin sheathing. Energy: Monopolar cautery (<3500V). Connectivity: None. Sterilization: Gamma (instruments/sealing unit), user-reprocessed (introducer). Form factor: 15.5mm outer diameter, 4-lumen rigid introducer.

Indications for Use

Indicated for patients undergoing minimally invasive abdominal laparoscopic surgery requiring grasping, mobilizing, dissecting, cutting, cauterizing, ligating, and suction-irrigation of tissues and vessels.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• SPIDER™ Single Port Surgical Device (K090902)
• SPIDER™ Surgical Instruments (K091697)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] 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: [phone] Contact: Richard A. VINCINS, Vice President, QA/RA Email: [e-mail]

#### 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

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.

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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<br>(FMX314 Introducer) | SPIDER™ Single Port<br>Surgical Device | |
| 510(k) Number | K160797 | K090902 | N/A |
| Product Code | OTJ | GCJ | Different; the FDA advised<br>that Product Code OTJ is<br>used for the FMX314<br>Introducer |
| Regulation<br>Number | 876.1500 | 876.1500 | Same |
| Regulation Name | Laparoscopic Single Port<br>Access Device | General and Plastic Surgery<br>Laparoscope | N/A |
| Indications for Use | The FMX314 Introducer is<br>intended to establish a path<br>of entry for laparoscopic<br>instruments for use during<br>minimally invasive<br>abdominal laparoscopic<br>surgery in combination with<br>the FMX314 Instruments. | The SPIDER™ (Single Port<br>Instrument Delivery<br>Extended Reach) is intended<br>to establish a path of entry<br>for laparoscopic instruments<br>for use during minimally<br>invasive abdominal<br>laparoscopic surgery. | Same |
| Manufacturer | Fortimedix Surgical B.V. | TransEnterix, Inc. | Significant Differences |
| Trade Name | FMX314 Surgical Platform<br>(FMX314 Introducer) | SPIDER™ Single Port<br>Surgical Device | |
| Overview of<br>Design, Principles<br>of Operation | The FMX314 Surgical<br>Platform consists of:<br>- the FMX314 Introducer,<br>- the FMX314 Hub Cap &<br>- Sealing Unit<br>- five (5) semi-flexible,<br>- double-articulating<br>FMX314 Instruments<br>(Grasper, Scissors,<br>Maryland, Clip-Applier<br>and Hook-knife) and<br>- one (1) semi-flexible,<br>single-articulating<br>FMX314<br>Suction/Irrigation<br>Instrument<br>The FMX314 Introducer is a<br>rigid, reusable single port<br>delivery system with four (4)<br>lumens to facilitate multi-<br>instrument access. The<br>superior lumen is designated<br>for a 5mm rigid laparoscope;<br>the two lateral ports are<br>designated for the<br>instruments and the inferior<br>lumen for the<br>suction/irrigation.<br>The FMX314 Introducer is<br>inserted into a standard 15<br>mm Trocar after insufflation<br>of the abdomen. It includes a<br>fume release port for smoke<br>evacuation.<br>The FMX314 Instruments get<br>steered and activated with<br>handles with a rotating knob.<br>The FMX314 Surgical<br>Platform allows for x, y, and z<br>as well as rotational motion<br>for a multidirectional<br>approach of the surgical<br>field | The single use SPIDER™<br>device consists of:<br>- the SPIDER™ Single<br>Port Surgical Device<br>- the SPIDER™ Surgical<br>Instruments (flexible<br>and rigid)<br>The SPIDER™ Single Port<br>Surgical Device is a rigid, pre-<br>sterilized introducer with<br>four channels. Two of the<br>channels known as IDTs<br>(Instrument Delivery Tubes)<br>are positioned left and right<br>and include extended lumens<br>to facilitate manipulation of<br>flexible surgical instruments,<br>enabling control of the<br>instruments over extended<br>distances. These 2 IDTs are<br>flexible and allow for x, y,<br>and z motion for a<br>multidirectional approach of<br>the surgical field, mimicking<br>the approach of standard<br>laparoscopic surgery using<br>pistol grip handles with a<br>rotating knob on the flexible<br>surgical instruments.<br>Two (2) rigid channels, north<br>to south, can accommodate<br>an endoscope or a rigid<br>surgical instrument. The<br>SPIDER™ Single Port Surgical<br>Device includes ports for<br>insufflation or smoke<br>evacuation. | Similar; both platforms are<br>single access platforms, and<br>allow for motion of<br>laparoscopic Instruments<br>for a multidirectional<br>approach of the surgical<br>field. Both platforms have a<br>port for smoke evacuation.<br>The SPIDER™ Single Port<br>Surgical Device is for single-<br>use only and requires a<br>bigger incision because of<br>its larger outer diameter<br>compared to the reusable<br>FMX314 Introducer.<br>Furthermore, the flexible<br>SPIDER™ Surgical<br>Instruments do not have<br>inherent stiffness and get<br>steered and activated via<br>the Instrument Delivery<br>Tubes, while the FMX314<br>Instruments are semi-<br>flexible and activated and<br>articulated via the<br>instrument handle.<br>The differences in the<br>overall design and the<br>principle of operation and<br>use of the FMX314 Surgical<br>Platform are minor and do<br>not raise any additional<br>questions of safety or<br>efficacy as the general<br>principle for use of the<br>device is the same and is<br>used in the same surgical<br>procedures. |
| Manufacturer | Fortimedix Surgical B.V. | TransEnterix, Inc. | Significant Differences |
| Trade Name | FMX314 Surgical Platform<br>(FMX314 Introducer) | SPIDER™ Single Port<br>Surgical Device | |
| | approach of standard<br>laparoscopic surgery. | | |
| Materials –<br>Introducer | Introducer body:<br>Stainless steel 316L and PEEK<br>Instrument Clamps &<br>Axial Guiding:<br>Aluminum AL 6082<br>Bearings:<br>PTFE Rulon 641<br>Spring:<br>Stainless steel 301 | Stainless steel and<br>Plastic materials | Similar; the materials<br>composing the introducer<br>component are common<br>materials that are used in<br>other medical devices. The<br>materials do not introduce<br>any concerns for safety and<br>efficacy as the performance<br>testing of the FMX314<br>Surgical Platform assures<br>proper functioning. |
| Materials — Hub<br>Cap & Sealing Unit | FMX314 Hub Cap:<br>PEEK<br>FMX314 Sealing Unit:<br>Silicone rubber, PBT | Plastic materials | Similar; the materials<br>composing the FMX314 Hub<br>Cap & Sealing Unit are<br>common materials that are<br>used in other medical<br>devices. These materials do<br>not introduce any concerns<br>for safety and efficacy as<br>the performance testing of<br>the FMX314 Sealing Unit<br>assures proper functioning. |
| Number of Lumens | 4 | 4 | Same |
| Stationary Lumens | 4 | 2 | Similar; the FMX314<br>Introducer provides<br>stationary lumens only, this<br>does not introduce any new<br>safety or efficacy concerns<br>as compared to the<br>predicate device. |
| Flexible Lumens | 0 | 2 | Different; the FMX314<br>Introducer provides<br>stationary lumens only for<br>robust lumen pathway that<br>does not introduce any new<br>safety or efficacy concerns<br>as compared to the<br>predicate device. |
| Manufacturer | Fortimedix Surgical B.V. | TransEnterix, Inc. | Significant Differences |
| Trade Name | FMX314 Surgical Platform<br>(FMX314 Introducer) | SPIDER™ Single Port<br>Surgical Device |…