(75 days)
No
The device description and performance studies focus on mechanical and functional aspects of a surgical trocar system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as creating and maintaining a port of entry for laparoscopic instruments, which are tools used in surgical procedures. It does not exert any therapeutic effect on the patient.
No.
The device is described as a "Fascial Closure System" used to "create and maintain a port of entry for laparoscopic instruments" during various surgical procedures. Its function is to facilitate access for surgical tools, not to diagnose a condition. While one version (Optical Trocar) allows for "visualization of tissue layers during insertion," this visualization is for surgical guidance and not diagnosis.
No
The device description clearly details physical components such as cannulas, obturators, blades, shields, seal systems, housings, sleeves, stopcocks, and suture passers. The performance studies also focus on physical characteristics and functionality of these hardware components.
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 creating and maintaining a port of entry for laparoscopic instruments during surgical procedures. This is a surgical tool used in vivo (within the body), not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Device Description: The description details the physical components and function of a surgical trocar and suture passer, all of which are used directly on the patient during surgery.
- Performance Studies: The performance studies mentioned are bench testing and in-vivo (live animal) testing, which are relevant to surgical devices, not IVDs.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics of an IVD.
Therefore, the VersaOne™ Fascial Closure System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The VersaOne™ Fascial Closure System Bladed Trocar with fixation cannula is intended for use in a variety of minimally invasive gynecologic, general, and urologic procedures to create and maintain a port of entry for laparoscopic instruments.
The VersaOne™ Fascial Closure System Bladeless Trocar with fixation cannula is intended for use in a variety of minimally invasive gynecologic, general, and urologic procedures to create and maintain a port of entry for laparoscopic instruments.
The VersaOne™ Fascial Closure System Optical Trocar with fixation cannula is intended for use in a variety of minimally invasive gynecologic, general, and urologic procedures to create and maintain a port of entry for laparoscopic instruments.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The VersaOne™ Fascial Closure System Bladed Trocar (12mm) is available in standard length (100mm) transparent cannula. The Bladed Trocar obturator has a dolphin nose (conical) shaped tip with a sharp linear blade and a spring-loaded locking shield. The blade is used to cut the tissues as the trocar is inserted into the body cavity. The shield advances to cover the blade upon entry into a free space. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, and a stopcock. The trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The cannula seal system accommodates instruments ranging 5mm up to 12mm. The distal end of the trocar cannula has two windows, 180 degrees apart, covered by a pierce-able membrane. A quide is provided which fits inside the trocar cannula to quide a suture passer through the wall of the cannula and soft tissue to be approximated. The stopcock valve is for insufflation and desufflation. A reusable suture passer is provided, which delivers suture through the trocar cannula to aid in port site closure.
The VersaOne™ Fascial Closure System Bladeless Trocar (12mm) is available in standard length (100mm) transparent cannula. Bladeless Trocar obturator has a dolphin nose (conical) shaped bladeless tip. The conical shape is for smooth insertion into the body cavity by spreading the tissue layers during insertion. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, and a stopcock. The trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The cannula seal system accommodates instruments ranging 5mm up to 12mm. The distal end of the trocar cannula has two windows, 180 degrees apart, covered by a pierce-able membrane. A quide is provided which fits inside the trocar cannula to quide a suture passer through the wall of the cannula and soft tissue to be approximated. The stopcock valve is for insufflation and desufflation. A reusable suture passer is provided, which delivers suture through the trocar cannula to aid in port site closure.
The VersaOne™ Fascial Closure System Optical Trocar (12mm) is available in standard length (100mm) transparent cannula. The Optical Trocar with transparent cannula and obturator allows for visualization of tissue layers during insertion. The obturator housing contains a scope retention mechanism. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, and a stopcock. The trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The cannula seal system accommodates instruments ranging 5mm up to 12mm. The distal end of the trocar cannula has two windows. 180 degrees apart, covered by a pierce-able membrane. A quide is provided which fits inside the trocar cannula to quide a suture passer through the wall of the cannula and soft tissue to be approximated. The stopcock valve is for insufflation and desufflation. A reusable suture passer is provided, which delivers suture through the trocar cannula to aid in port site closure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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, sample size, AUC, MRMC, standalone performance, key results)
Performance studies were conducted to demonstrate the proposed device(s), VersaOne™ Fascial Closure System trocars are substantially equivalent to the predicate devices. In-vitro (bench), in-vivo (live animal) and comparison testing to predicate support the intended use of this device and are as follows:
VersaOne™ Fascial Closure System In-Vitro (bench) Testing:
- Visual Examination
- Suture Passer Puncture Force
- Suture Passer handle open force
- Guide insertion force
- Guide torque to lock
- Suture Passer, suture Retention force
- Trocar Cannula Leak Test
- Cannula Leak test with quide
- Trocar Cannula Fixation Force
VersaOne™ Fascial Closure System In-Vivo (live animal) Testing:
- Trocar penetration force
- Trocar fixation force
- Functional Test
RELIABILITY TESTING:
Accelerated life cycle testing was performed for the proposed VersaOne™ Fascial Closure System Reusable Suture Passer.
HUMAN FACTORS:
Human Factors evaluations were completed using IEC 62366-1 Medical Devices - Part 1: Application of Usability Engineering to Medical Devices and FDA guidance Applying Human Factors and Usability Engineering to Medical Devices Dated February 3, 2016. While submission of Human Factors evaluation is not a requirement for premarket submission, a summative usability report is included as part of the objective evidence demonstrating safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 8, 2017
Covidien LLC Mr. Gary LeMere Sr. Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473
Re: K163654
Trade/Device Name: VersaOne Fascial Closure System Bladed Trocar. VersaOne Fascial Closure System Bladeless Trocar, VersaOne Fascial Closure System Optical Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: March 1, 2017 Received: March 3, 2017
Dear Mr. LeMere:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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,
Jennifer R. Stevenson -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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
VersaOne™ Fascial Closure System Bladed Trocar, VersaOne™ Fascial Closure System Bladeless Trocar, VersaOne™ Fascial Closure System Optical Trocar
Indications for Use (Describe)
The VersaOne™ Fascial Closure System Bladed Trocar with fixation cannula is intended for use in a variety of minimally invasive gynecologic, general, and urologic procedures to create and maintain a port of entry for laparoscopic instruments.
The VersaOne™ Fascial Closure System Bladeless Trocar with fixation cannula is intended for use in a variety of minimally invasive gynecologic, general, and urologic procedures to create and maintain a port of entry for laparoscopic instruments.
The VersaOne™ Fascial Closure System Optical Trocar with fixation cannula is intended for use in a variety of minimally invasive gynecologic, general, and urologic procedures to create and maintain a port of entry for laparoscopic instruments.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Traditional 510(k) Summary
| SUBMITTER: | Covidien Ilc
60 Middletown Avenue
North Haven, CT 06473 USA | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| CONTACT PERSON: | Gary LeMere
Sr. Regulatory Affairs Specialist
Covidien Ilc
Phone: (203) 492-5572
Fax: (203) 492-5029
e-mail: gary.f.lemere@medtronic.com | |
| DATE PREPARED: | December 20, 2016 | |
| PRODUCT CODE: | GCJ | |
| REGULATION NUMBER: | 21 CFR 876.1500 | |
| REVIEW PANEL: | Gastroenterology-urology devices | |
| TRADE/PROPRIETARY NAME: | VersaOne™ Fascial Closure System Bladed Trocar
VersaOne™ Fascial Closure System Bladeless Trocar
VersaOne™ Fascial Closure System Optical Trocar | |
| COMMON/USUAL NAME: | Surgical Trocar | |
| CLASSIFICATION NAME: | Endoscope and Accessories | |
| PREDICATE DEVICES: | (K151548) - VersaOne™ Bladed Trocar 12mm,
VersaOne™ Bladeless Trocar 12mm
(K130435) - Special 510(k) for Versaport™ V2
Bladeless Optical trocar | |
| REFERENCE DEVICE: | (K980123) - Carter-Thomason Needle-Point Suture
Passer Instrument Set [Carter-Thomason
CloseSure System] | |
DEVICE DESCRIPTION:
The VersaOne™ Fascial Closure System Bladed Trocar (12mm) is available in standard length (100mm) transparent cannula. The Bladed Trocar obturator has a dolphin nose (conical) shaped tip with a sharp linear blade and a spring-loaded locking shield. The blade is used to cut the tissues as the trocar is inserted into the body cavity. The shield advances to cover the blade upon entry into a free space. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, and a stopcock. The trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The cannula seal system accommodates instruments ranging 5mm up to 12mm. The distal end of the trocar cannula has two windows, 180 degrees apart, covered by a pierce-able
4
membrane. A quide is provided which fits inside the trocar cannula to quide a suture passer through the wall of the cannula and soft tissue to be approximated. The stopcock valve is for insufflation and desufflation. A reusable suture passer is provided, which delivers suture through the trocar cannula to aid in port site closure.
The VersaOne™ Fascial Closure System Bladeless Trocar (12mm) is available in standard length (100mm) transparent cannula. Bladeless Trocar obturator has a dolphin nose (conical) shaped bladeless tip. The conical shape is for smooth insertion into the body cavity by spreading the tissue layers during insertion. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, and a stopcock. The trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The cannula seal system accommodates instruments ranging 5mm up to 12mm. The distal end of the trocar cannula has two windows, 180 degrees apart, covered by a pierce-able membrane. A quide is provided which fits inside the trocar cannula to quide a suture passer through the wall of the cannula and soft tissue to be approximated. The stopcock valve is for insufflation and desufflation. A reusable suture passer is provided, which delivers suture through the trocar cannula to aid in port site closure.
The VersaOne™ Fascial Closure System Optical Trocar (12mm) is available in standard length (100mm) transparent cannula. The Optical Trocar with transparent cannula and obturator allows for visualization of tissue layers during insertion. The obturator housing contains a scope retention mechanism. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, and a stopcock. The trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The cannula seal system accommodates instruments ranging 5mm up to 12mm. The distal end of the trocar cannula has two windows. 180 degrees apart, covered by a pierce-able membrane. A quide is provided which fits inside the trocar cannula to quide a suture passer through the wall of the cannula and soft tissue to be approximated. The stopcock valve is for insufflation and desufflation. A reusable suture passer is provided, which delivers suture through the trocar cannula to aid in port site closure.
INTENDED USE:
The VersaOne™ Fascial Closure System Bladed Trocar with fixation cannula is intended for use in a variety of minimally invasive gynecologic, general, and urologic procedures to create and maintain a port of entry for laparoscopic instruments.
The VersaOne™ Fascial Closure System Bladeless trocar with fixation cannula is intended for use in a variety of minimally invasive gynecologic, general, and urologic procedures to create and maintain a port of entry for laparoscopic instruments.
The VersaOne™ Fascial Closure System Optical Trocar with fixation cannula is intended for use in a variety of minimally invasive gynecologic, general, and urologic procedures to create and maintain a port of entry for laparoscopic instruments.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
The VersaOne™ Fascial Closure System combines the existing technologies of the Covidien's VersaOne™ Bladed and Bladeless and Versaport Bladeless Optical Trocar systems with manual port site closure using a guide and suture passer. The VersaOne™
5
Fascial Closure System is available in three different models (reorder codes) each differing only by the obturator supplied; Bladed, Bladeless or Optical. The suture passer is a universal component to all three models. Below is a summary of characteristics for each of the three models.
| Proposed
Device | Predicate
Device | Similarities | Differences |
|---------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VersaOne™
Fascial
Closure
System
Bladed
Trocar | K151548
VersaOne™
Bladed
Trocar
12mm | Trocar Cannula
maintains a port of
entry for laparoscopic
instruments.
Both use the exact
same bladed obturator | The VersaOne™ Fascial Closure
System Bladed Trocar cannula has two
windows near the distal end to allow the
suture passer to exit. The predicate
VersaOne™ Bladed Trocar does not
have any openings along the trocar
cannula |
| | | Both use the same
self-adjusting seal
housing
Both are single use,
EtO sterilized | The VersaOne™ Fascial Closure
System Bladed Trocar cannula has a
line and arrow printed on the side of the
cannula for tissue alignment. The
predicate VersaOne™ Bladed Trocar
12mm has no printing on the trocar
cannula |
| | | Both have three main
components: trocar
cannula, seal housing
and a bladed obturator | The predicate VersaOne™ Bladed
Trocar 12mm has application in
gynecologic, general, thoracic and
urologic procedures. The VersaOne™
Fascial Closure System Bladed Trocar
has the same applications with the
exception of thoracic. |
| | | | With the addition of two new features,
the VersaOne™ Fascial Closure System
Bladed Trocar cannula also serves to
facilitate closure of the port site. A guide
that is inserted into the cannula provides
a pathway for the suture passer to
deliver suture into the body cavity. The
predicate trocar does not have this
feature. This feature is similar to the
Reference Device (K980123) |
6
| Proposed
Device | Predicate
Device | Similarities | Differences |
|------------------------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VersaOne™
Fascial
Closure
System
Bladeless
Trocar | K151548
VersaOne™
Bladeless
Trocar
12mm | Trocar Cannula
maintains a port of
entry for laparoscopic
instruments.
Both use the exact
same bladeless
obturator | The VersaOne™ Fascial Closure
System Bladeless Trocar cannula has
two windows near the distal end to allow
the suture passer to exit. The predicate
VersaOne™ Bladeless Trocar does not
have any openings along the trocar
cannula |
| | | Both use the same
self-adjusting seal
housing
Both are single use,
EtO sterilized | The VersaOne™ Fascial Closure
System Bladeless Trocar cannula has a
line and arrow printed on the side of the
cannula for tissue alignment. The
predicate VersaOne™ Bladed Trocar
12mm has no printing on the trocar
cannula |
| | | Both have three main
components: trocar
cannula, seal housing
and a bladeless
obturator | The predicate VersaOne™ Bladeless
Trocar 12mm has application in
gynecologic, general, thoracic and
urologic procedures. The VersaOne™
Fascial Closure System Bladeless
Trocar has the same applications with
the exception of thoracic. |
| | | | With the addition of two new features,
the VersaOne™ Fascial Closure System
Bladeless Trocar cannula also serves to
facilitate closure of the port site. A guide
that is inserted into the cannula provides
a pathway for the suture passer to
deliver suture into the body cavity. The
predicate trocar does not have this
feature. This feature is similar to the
Reference Device (K980123). |
7
| Proposed
Device | Predicate
Device | Similarities | Differences |
|----------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VersaOne™
Fascial
Closure
System
Optical
Trocar | K130435
Versaport™
V2 Bladeless
Optical
trocar | Trocar Cannula
maintains a port of
entry for laparoscopic
instruments.
Both use the exact
same (bladeless)
optical obturator | The VersaOne™ Fascial Closure
System Optical Trocar cannula has two
windows near the distal end to allow the
suture passer to exit. The predicate
Versaport V2 Bladeless Optical Trocar
does not have any openings along the
trocar cannula |
| | | Both use the same
self-adjusting seal
housing
Both are single use,
EtO sterilized | The VersaOne™ Fascial Closure
System Optical Trocar cannula has a
line and arrow printed on the side of the
cannula for tissue alignment. The
predicate Versaport™ V2 Bladeless
Optical Trocar 12mm has no printing on
the trocar cannula |
| | | Both have three main
components: trocar
cannula, seal housing
and an optical
obturator | The predicate VersaOne™ Bladeless
Optical Trocar 12mm has application in
gynecologic, general, thoracic and
urologic procedures. The VersaOne™
Fascial Closure System Optical Trocar
has the same applications with the
exception of thoracic. |
| | | | With the addition of two new features,
the VersaOne™ Fascial Closure System
Optical Trocar cannula also serves to
facilitate closure of the port site. A guide
that is inserted into the cannula provides
a pathway for the suture passer to
deliver suture into the body cavity. The
predicate trocar does not have this
feature. This feature is similar to the
Reference Device (K980123). |
COMPATIBILITY DATA:
Biocompatibility testing was completed in accordance International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation Dated June 6, 2016 and Testing within a Risk Management Process" as recognized by FDA and FDA Guidance for Industry: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process dated March 17, 2015.
8
The following tests were conducted. which are appropriate to the patient contact profile of the proposed devices:
- . Cytotoxicity
- Sensitization .
- . Intracutaneous irritation
- Pvrogenicitv ●
STERILIZATION:
Sterilization studies were completed for single use devices sterilized by ethylene oxide in accordance with ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals as recognized by FDA
CLEANING AND STERILIZATION:
Cleaning and sterilization studies were completed for the reusable suture passer in accordance with Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling dated March 17, 2015 and AAMI TIR30 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices and AAMI TIR12 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers as recognized by FDA
PERFORMANCE DATA:
Performance studies were conducted to demonstrate the proposed device(s), VersaOne™ Fascial Closure System trocars are substantially equivalent to the predicate devices. In-vitro (bench), in-vivo (live animal) and comparison testing to predicate support the intended use of this device and are as follows:
VersaOne™ Fascial Closure System In-Vitro (bench) Testing:
- Visual Examination .
- Suture Passer Puncture Force ●
- Suture Passer handle open force ●
- Guide insertion force ●
- Guide torque to lock ●
- . Suture Passer, suture Retention force
- Trocar Cannula Leak Test
- Cannula Leak test with quide ●
- o Trocar Cannula Fixation Force
VersaOne™ Fascial Closure System In-Vivo (live animal) Testing:
- Trocar penetration force ●
- Trocar fixation force
- Functional Test ●
RELIABILITY TESTING:
Accelerated life cycle testing was performed for the proposed VersaOne™ Fascial Closure System Reusable Suture Passer.
HUMAN FACTORS:
9
Human Factors evaluations were completed using
IEC 62366-1 Medical Devices - Part 1: Application of Usability Engineering to Medical Devices and FDA guidance Applying Human Factors and Usability Engineering to Medical Devices Dated February 3, 2016. While submission of Human Factors evaluation is not a requirement for premarket submission, a summative usability report is included as part of the objective evidence demonstrating safety and effectiveness.
CONCLUSION:
Supporting data enclosed in this submission demonstrates that the proposed VersaOne™ Fascial Closure System Bladed Trocar, VersaOne™ Fascial Closure System Bladeless Trocar and VersaOne™ Fascial Closure System Optical Trocar devices are as safe, as effective, and performs as well as, or better than their predicate devices and do not present any new issues of safety or effectiveness.