(156 days)
Not Found
No
The description focuses on the mechanical and physical aspects of the surgical platform and instruments, with no mention of data processing, algorithms, or intelligent features.
Yes
The device is described as "minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, cutting, cauterizing, ligating, and suction irrigation of tissues and vessels during laparoscopic procedures," which involves directly treating tissues and vessels.
No
The device is a surgical platform and instruments intended for use in minimally invasive abdominal laparoscopic surgery for performing procedures like grasping, dissecting, and cutting tissues, not for diagnosing conditions.
No
The device description explicitly details physical components like the Introducer, Hub Cap & Sealing Unit, and Instruments, and the performance studies involve physical interactions with tissue and cadavers.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "minimally invasive abdominal laparoscopic surgery" for actions like "grasping, mobilizing, dissecting, cutting, cauterizing, ligating, and suction irrigation of tissues and vessels." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a surgical platform with instruments designed for physical manipulation of tissues within the body. It talks about access devices, sealing units to maintain pneumoperitoneum, and articulating instruments for surgical tasks.
- Lack of IVD Characteristics: An IVD is a device used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The provided text makes no mention of analyzing specimens or providing diagnostic information based on such analysis.
The device is a surgical instrument used during a surgical procedure, not a device used to test samples outside the body for diagnostic purposes.
N/A
Intended Use / Indications for 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.
Product codes
OTJ, GCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
- Study Type: Non-clinical performance tests, Ex vivo cadaver studies, In vivo animal studies
- Sample Size: Not specified
- AUC: Not Found
- MRMC: Not Found
- Standalone Performance: Not Found
- Key Results: 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 device passed all biocompatibility testing per ISO 10993-1. It passed electrical safety testing per AAMI/ANSI ES60601-1, IEC 60601-2-2, and IEC 60601-2-18. Axial Guidance Verification and Durability, Triangulation and Range of Motion, and Instrument Stiffness tests were passed. Cleaning and Reprocessing for the FMX314 Introducer met all requirements. Sterilization Testing to ISO 11137 standard met an SAL of 10^-6. Shelf Life Testing for 2 years was passed.
The 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. Tissue testing criteria included cut accuracy, coagulation depth, thermal spread and damage, tissue adherence to instruments, and compatibility across representative energy settings. Acute and chronic animal studies passed defined criteria. A human cadaver study evaluated real-life conditions for anatomical landmarks and dimensions, supporting that relevant human landmarks in the abdominal cavity were reachable with no incidents. A usability study was performed to validate the FMX314 Surgical Platform.
Key Metrics
- Sterility Assurance Level (SAL): 10^-6 for radiation sterilization.
Predicate Device(s)
K090902, SPIDER Single Port Surgical Device, K091697, SPIDER Surgical Instruments
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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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3
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 |
4
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.
5
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 Port | ||
| Surgical Device | |||
| 510(k) Number | K160797 | K090902 | N/A |
| Product Code | OTJ | GCJ | Different; the FDA advised |
| that Product Code OTJ is | |||
| used for the FMX314 | |||
| Introducer | |||
| Regulation | |||
| Number | 876.1500 | 876.1500 | Same |
| Regulation Name | Laparoscopic Single Port | ||
| Access Device | General and Plastic Surgery | ||
| Laparoscope | N/A | ||
| Indications for Use | 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 SPIDER™ (Single Port | ||
| Instrument Delivery | |||
| Extended Reach) is intended | |||
| to establish a path of entry | |||
| for laparoscopic instruments | |||
| for use during minimally | |||
| invasive abdominal | |||
| laparoscopic surgery. | Same | ||
| Manufacturer | Fortimedix Surgical B.V. | TransEnterix, Inc. | Significant Differences |
| Trade Name | FMX314 Surgical Platform | ||
| (FMX314 Introducer) | SPIDER™ Single Port | ||
| Surgical Device | |||
| Overview of | |||
| Design, Principles | |||
| of Operation | The FMX314 Surgical | ||
| Platform consists of: |
- the FMX314 Introducer,
- the FMX314 Hub Cap &
- Sealing Unit
- five (5) semi-flexible,
- double-articulating
FMX314 Instruments
(Grasper, Scissors,
Maryland, Clip-Applier
and Hook-knife) and - one (1) semi-flexible,
single-articulating
FMX314
Suction/Irrigation
Instrument
The FMX314 Introducer is a
rigid, reusable single port
delivery system with four (4)
lumens to facilitate multi-
instrument access. The
superior lumen is designated
for a 5mm rigid laparoscope;
the two lateral ports are
designated for the
instruments and the inferior
lumen for the
suction/irrigation.
The FMX314 Introducer is
inserted into a standard 15
mm Trocar after insufflation
of the abdomen. It includes a
fume release port for smoke
evacuation.
The FMX314 Instruments get
steered and activated with
handles with a rotating knob.
The FMX314 Surgical
Platform allows for x, y, and z
as well as rotational motion
for a multidirectional
approach of the surgical
field | The single use SPIDER™
device consists of: - the SPIDER™ Single
Port Surgical Device - the SPIDER™ Surgical
Instruments (flexible
and rigid)
The SPIDER™ Single Port
Surgical Device is a rigid, pre-
sterilized introducer with
four channels. Two of the
channels known as IDTs
(Instrument Delivery Tubes)
are positioned left and right
and include extended lumens
to facilitate manipulation of
flexible surgical instruments,
enabling control of the
instruments over extended
distances. These 2 IDTs are
flexible and allow for x, y,
and z motion for a
multidirectional approach of
the surgical field, mimicking
the approach of standard
laparoscopic surgery using
pistol grip handles with a
rotating knob on the flexible
surgical instruments.
Two (2) rigid channels, north
to south, can accommodate
an endoscope or a rigid
surgical instrument. The
SPIDER™ Single Port Surgical
Device includes ports for
insufflation or smoke
evacuation. | Similar; both platforms are
single access platforms, and
allow for motion of
laparoscopic Instruments
for a multidirectional
approach of the surgical
field. Both platforms have a
port for smoke evacuation.
The SPIDER™ Single Port
Surgical Device is for single-
use only and requires a
bigger incision because of
its larger outer diameter
compared to the reusable
FMX314 Introducer.
Furthermore, the flexible
SPIDER™ Surgical
Instruments do not have
inherent stiffness and get
steered and activated via
the Instrument Delivery
Tubes, while the FMX314
Instruments are semi-
flexible and activated and
articulated via the
instrument handle.
The differences in the
overall design and the
principle of operation and
use of the FMX314 Surgical
Platform are minor and do
not raise any additional
questions of safety or
efficacy as the general
principle for use of the
device is the same and is
used in the same surgical
procedures. |
| Manufacturer | Fortimedix Surgical B.V. | TransEnterix, Inc. | Significant Differences |
| Trade Name | FMX314 Surgical Platform
(FMX314 Introducer) | SPIDER™ Single Port
Surgical Device | |
| | approach of standard
laparoscopic surgery. | | |
| Materials –
Introducer | Introducer body:
Stainless steel 316L and PEEK
Instrument Clamps &
Axial Guiding:
Aluminum AL 6082
Bearings:
PTFE Rulon 641
Spring:
Stainless steel 301 | Stainless steel and
Plastic materials | Similar; the materials
composing the introducer
component are common
materials that are used in
other medical devices. The
materials do not introduce
any concerns for safety and
efficacy as the performance
testing of the FMX314
Surgical Platform assures
proper functioning. |
| Materials — Hub
Cap & Sealing Unit | FMX314 Hub Cap:
PEEK
FMX314 Sealing Unit:
Silicone rubber, PBT | Plastic materials | Similar; the materials
composing the FMX314 Hub
Cap & Sealing Unit are
common materials that are
used in other medical
devices. These materials do
not introduce any concerns
for safety and efficacy as
the performance testing of
the FMX314 Sealing Unit
assures proper functioning. |
| Number of Lumens | 4 | 4 | Same |
| Stationary Lumens | 4 | 2 | Similar; the FMX314
Introducer provides
stationary lumens only, this
does not introduce any new
safety or efficacy concerns
as compared to the
predicate device. |
| Flexible Lumens | 0 | 2 | Different; the FMX314
Introducer provides
stationary lumens only for
robust lumen pathway that
does not introduce any new
safety or efficacy concerns
as compared to the
predicate device. |
| Manufacturer | Fortimedix Surgical B.V. | TransEnterix, Inc. | Significant Differences |
| Trade Name | FMX314 Surgical Platform
(FMX314 Introducer) | SPIDER™ Single Port
Surgical Device | |
| Degrees of
Rotation | 360° of independent
movement of instruments at
distal end | 360° of independent
movement of instruments at
distal 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-flexible
FMX314 Instruments have a
smaller diameter; these do
not introduce any new
concerns of safety and
efficacy as the lumen
diameter accommodates
the instruments for each
platform. |
| Overall Length | 27.5 cm (with fully engaged
axial guidance; extreme
posterior position)
34.0 cm (with fully extended
axial guidance; extreme
anterior position) | 72 cm | Different; the FMX314
Instruments are semi-
flexible and have an
inherent stiffness through
the material composition.
Thus the instruments do
not need full support along
the length. The smaller
length of the introducer
does not introduce any
additional concerns for
safety or efficacy. |
| Outer Diameter
(Shaft) | 15.5 mm | 18.9 mm (without plastic
tube) | Similar; the SPIDER™ Single
Port Surgical Device has a
3.4 mm larger diameter; as
the path of entry is smaller
than the predicate device,
this does not introduce any
new concerns for safety and
efficacy. |
| Sterile | Introducer: Supplied non-
sterile; user sterilized
Hub Cap & Sealing Unit:
Supplied sterile, single-use
only | Supplied sterile, single-use
only | Different; the entire
predicate device is single-
use only compared to
reusability of the FMX314
Introducer. Reprocessing
validation and lifecycle
verification supports no
new concerns for safety or
efficacy introduced. |
| Manufacturer | Fortimedix Surgical B.V. | TransEnterix, Inc. | Significant Differences |
| Trade Name | FMX314 Surgical Platform
(FMX314 Introducer) | SPIDER™ Single Port
Surgical Device | |
| Single-Use | The Introducer is
reprocessed according to
instructions
Hub Cap & Sealing Unit:
Single-use only, disposed of
after use | Single-use only | Different; the entire
predicate device is single-
use only compared to
reusability of the FMX314
Introducer. Reprocessing
validation and lifecycle
verification supports no
new concerns for safety or
efficacy introduced. |
| Packaging | Holding tray in a carton box | Holding tray in a carton box | Same |
| Shelf Life | Introducer: 5 years
Hub Cap & Sealing Unit: 2
years | Not known | N/A |
Table 5A - Comparison of Characteristics - FMX314 Introducer
6
7
8
9
Table 5B – Comparison of Characteristics – FMX314 Instruments
| Manufacturer | Fortimedix Surgical B.V. | TransEnterix, Inc. | Significant Differences |
|---|---|---|---|
| Trade Name | FMX314 Surgical | ||
| Platform | |||
| (FMX314 Instruments) | SPIDER™ Surgical | ||
| Instruments | |||
| 510(k) Number | K160797 | K091697 | N/A |
| Product Code | GCJ | GCJ | Same |
| Regulation | |||
| Number | 876.1500 | 876.1500 | Same |
| Regulation Name | General and Plastic Surgery | ||
| Laparoscope | General and Plastic Surgery | ||
| Laparoscope | Same | ||
| Indications for Use | The FMX314 Instruments | ||
| are intended for use in | |||
| minimally invasive | |||
| abdominal laparoscopic | |||
| surgical procedures for | |||
| grasping, mobilizing, | |||
| dissecting, retracting, | |||
| cutting, cauterizing, ligating | |||
| and suction irrigation of | |||
| tissues and vessels during | |||
| laparoscopic procedures. | The SPIDER Surgical | ||
| Instruments are intended for | |||
| use in minimally invasive | |||
| abdominal laparoscopic | |||
| surgical procedures for | |||
| grasping, mobilizing, | |||
| dissecting, retracting, | |||
| cutting, cauterizing, ligating, | |||
| suction irrigation, and other | |||
| manipulation of tissues and | |||
| vessels during laparoscopic | |||
| procedures. | Similar; the phrase 'and | ||
| other manipulation' was | |||
| removed from the | |||
| indications as discussed with | |||
| the FDA during a Q-Sub | |||
| meeting. | |||
| Manufacturer | Fortimedix Surgical B.V. | TransEnterix, Inc. | Significant Differences |
| Trade Name | FMX314 Surgical | ||
| Platform | SPIDER™ Surgical | ||
| Instruments | |||
| (FMX314 Instruments) | |||
| Types of | |||
| Instruments | FMX314 Grasper | ||
| FMX314 Maryland | |||
| FMX314 Scissors | |||
| FMX314 Clip Applier | |||
| FMX314 Hook-Knife | |||
| FMX314 Suction-Irrigation | Fenestrated Grasper | ||
| Maryland Dissector | |||
| Flex Shears | |||
| Clip Applier | |||
| Monopolar Hook | |||
| Suction Irrigator | Same | ||
| Design | |||
| Configuration | Semi-flexible, articulating | ||
| laparoscopic instrument | |||
| made of telescoped tubes; | |||
| pistol grip handle with | |||
| rotating knob (except for | |||
| the Hook-Knife and the | |||
| Suction/Irrigation | |||
| instruments) | Flexible laparoscopic | ||
| instrument; pistol grip | |||
| handle with rotating knob | |||
| (except for the Hook-Knife | |||
| and the Suction/Irrigation | |||
| instruments) | Similar; compared to the | ||
| flexible SPIDER™ Instruments | |||
| which have no inherent | |||
| stiffness and can only be | |||
| manipulated within the | |||
| flexible lumens of the | |||
| SPIDER™ Single Port Surgical | |||
| Device, the FMX314 | |||
| Instruments are semi-flexible | |||
| with an inherent stiffness. | |||
| The use of the instruments | |||
| are the same for the | |||
| indications for use and | |||
| surgical application that is | |||
| supported by performance | |||
| testing of the instruments | |||
| which does not raise any | |||
| new concerns for safety or | |||
| efficacy. | |||
| Materials | Stainless steel tooltips; | ||
| stainless steel tubing; | |||
| polyolefin sheathing | Stainless steel tooltips; | ||
| Sheathing material unknown | Similar; there is no | ||
| difference in the tool-tip | |||
| material as both are stainless | |||
| steel. All patient contacting | |||
| materials used with the | |||
| FMX314 Instruments are | |||
| biocompatible and do not | |||
| introduce any new safety or | |||
| efficacy concerns. | |||
| Length (Overall) | FMX314 Grasper: 63 cm | ||
| (without handle) of which | |||
| up to 33 cm is inside the | |||
| abdominal cavity | |||
| FMX314 Maryland: 63 cm | Fenestrated Grasper: About | ||
| 84 cm (without handle) of which | |||
| up to 34 cm is inside | |||
| the abdominal cavity | |||
| Maryland Dissector: About | Similar; the instruments of | ||
| the predicate device need to | |||
| fit through the SPIDER™ | |||
| Introducer which has an | |||
| overall length of 72cm; | |||
| Manufacturer | Fortimedix Surgical B.V. | TransEnterix, Inc. | Significant Differences |
| Trade Name | FMX314 Surgical | ||
| Platform | |||
| (FMX314 Instruments) | SPIDER™ Surgical | ||
| Instruments | |||
| (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: Unknown | |||
| Clip Applier: Unknown | |||
| Monopolar Hook: Unknown | taking the bends of the | ||
| flexible lumens of the | |||
| SPIDER™ Single Port Surgical | |||
| Device into account, the | |||
| flexible SPIDER™ | |||
| Instruments need to be | |||
| longer than 72 cm. | |||
| (including handle) | |||
| FMX314 Suction-Irrigation: | |||
| 68 cm (without connector) | Suction - Irrigator: About 80 | ||
| cm (without connector) | This does not introduce any | ||
| safety or efficacy concerns as | |||
| the manipulation of the | |||
| instrument is the same and | |||
| the operating principles is | |||
| the same. | |||
| Length (Tooltip) | FMX314 Grasper: 36 mm | ||
| FMX314 Maryland: 33 mm | |||
| FMX314 Scissors: 26 mm | |||
| FMX314 Clip Applier: 34 | |||
| mm | |||
| FMX314 Hook-knife: 14 mm | Fenestrated Grasper About | ||
| 26 mm | |||
| Maryland Dissector: About | |||
| 25.5 mm | |||
| Flex Shears: Unknown | |||
| Clip Applier: Unknown | |||
| Monopolar Hook: Unknown | Similar; the slightly longer | ||
| tool-tip of the FMX314 | |||
| Instrument does not | |||
| introduce any new safety | |||
| and efficacy concerns as this | |||
| is only 1 cm which does not | |||
| have a significant impact on | |||
| use of the tool. | |||
| Shaft Diameter | 5 mm | About 3.2 mm | Similar; the shaft diameter is |
| slightly larger to | |||
| accommodate the | |||
| construction of the flexible | |||
| instruments. This does not | |||
| raise any additional safety or | |||
| efficacy concerns as the | |||
| instruments fit through the | |||
| introducer lumens. | |||
| Sterile | Yes by gamma sterilization | Yes by EtO sterilization | Similar; these are both |
| validated methods with the | |||
| Sterility Assurance Level | |||
| (SAL) of 10 $^{-6}$ so this does not | |||
| introduce any new safety or | |||
| efficacy concerns. | |||
| Electrical Safety | |||
| Testing | Yes | Yes | Same |
| Single-Use | Yes | Yes | Same |
| Manufacturer | Fortimedix Surgical B.V. | TransEnterix, Inc. | Significant Differences |
| Trade Name | FMX314 Surgical | ||
| Platform | |||
| (FMX314 Instruments) | SPIDER™ Surgical | ||
| Instruments | |||
| Maximum Voltage | |||
| Rating |