(16 days)
No
The description focuses on the mechanical and optical features of a surgical trocar and does not mention any AI or ML components or functionalities.
No.
The device is a surgical access tool used to create and maintain a port of entry for endoscopic procedures, not to treat a disease or condition.
No
The device description indicates it is a surgical tool (trocar) used to create and maintain a port of entry for endoscopic procedures, not to diagnose a condition. While it allows for visualization during insertion, this is for guiding the surgical tool, not for diagnostic interpretation of tissue.
No
The device description clearly details physical components like cannulas, obturators, housings, seals, and a luer lock, indicating it is a hardware device. The performance studies also focus on physical properties and forces.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "create and maintain a port of entry" for endoscopic procedures. This is a surgical access device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the physical components and function of a surgical trocar, focusing on its mechanical properties and ability to facilitate instrument insertion and maintain pneumoperitoneum.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
The device is clearly intended for direct surgical use within the body, which is outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Versaport™ Bladeless Optical Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.
Product codes
GCJ
Device Description
The Versaport™ V2 bladeless optical trocar with a low profile design and transparent fixation cannula is available in 5 mm standard (100mm), 5 mm short (70mm) and 5mm long (150mm) cannula lengths. The Versaport™ V2 bladeless optical 5mm trocar with transparent fixation cannula and obturator allows optical entry for visualization of tissue layers during insertion. The obturator housing contains a scope retention mechanism. 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 5 mm Versaport™ seal system accommodates 5mm instruments respectively. There is a luer lock with cap for insufflation and rapid desufflation.
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)
In-vitro and in-vivo tests were performed to verify that the performance of the Versaport™ V2 Bladeless Optical 5mm trocar is substantially equivalent to the predicate device, Endopath® Xcel trocar [K011257], To validate that the subject device performs as intended to facilitate endoscopic access into the body cavity, the following describes the testing performed: . . . . .
- In Vitro Leak Resistance .
- In Vitro and In Vivo Penetration and Fixation Forces .
- In Vitro and In Vivo Fixation Force
- In Vitro and In Vivo Insertion and Removal Forces .
- In Vitro Snap Feature Retention Force ●
- In Vitro One-Handed Use ●
- In Vitro Scope Insertion and Retention Forces
- In Vivo Multiple Penetration Forces
- In Vivo Visualization of Tissue Layers
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Versaport™ Bladeless Low ProfileTrocar [K100548], Endopath® Xcel™ Trocar [K011257]
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
.112349
Versaport™ V2 Bladeless Optical Trocar System
SEP - 1 2011
510(k) Summary of Safety and Effectiveness
| SUBMITTER: | Covidien
60 Middletown Avenue
North Haven, CT 06473 USA |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Angela Van Arsdale
Product Specialist, Regulatory Affairs |
| DATE PREPARED: | August 10, 2011 |
| TRADE/PROPRIETARY NAME: | Versaport™ V2 Bladeless Optical Trocar or Versaport™ Bladeless
Optical |
| COMMON/USUAL NAME: | Surgical Trocar |
| CLASSIFICATION NAME: | Endoscope and Accessories |
| PREDICATE DEVICE(S): | Versaport™ Bladeless Low ProfileTrocar [K100548] |
| | Endopath® Xcel™ Trocar [K011257] |
| DEVICE DESCRIPTION: | The Versaport™ V2 bladeless optical trocar with a low profile design
and transparent fixation cannula is available in 5 mm standard
(100mm), 5 mm short (70mm) and 5mm long (150mm) cannula
lengths. The Versaport™ V2 bladeless optical 5mm trocar with
transparent fixation cannula and obturator allows optical entry for
visualization of tissue layers during insertion. The obturator housing
contains a scope retention mechanism. 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 5 mm
Versaport™ seal system accommodates 5mm instruments
respectively. There is a luer lock with cap for insufflation and rapid
desufflation. |
| INTENDED USE: | The Versaport™ Bladeless Optical Trocar is intended for use in a
variety of gynecologic, general, thoracic and urologic endoscopic
procedures to create and maintain-a-port-of entry. The trocar may be
used with or without visualization for primary and secondary insertions. |
| TECHNICAL
CHARACTERISTICS: | The subject device (Versaport™ V2 Bladeless Optical Trocar) has
similar design, lengths, and optical features as the predicate devices.
The design modifications includes a cannula material change, a
bladeless obturator with a transparent optical window at the distal end,
an obturator housing scope retention mechanism and external
interlocking snaps. The scope retention mechanism is located within
the obturator housing allowing for secured insertion and retention of an
appropriately sized 0° laparoscope for visualization of tissue layers
during insertion into the body cavity. The external interlocking snaps
secure the obturator to the cannula. The Versaport™ Bladeless V2
Optical trocar is equivalent to the predicate devices in terms of its
intended use and fundamental technology. |
| MATERIALS: | All components of the Versaport™ Bladeless Optical Trocar are
comprised of materials which were tested in accordance with ISO
10993-1 |
Special 510(k)Premarket Notification August 2011
Page 22
™Trademark
P 1/2
1
Versaport™ V2 Bladeless Optical Trocar System
PERFORMANCE DATA:
In-vitro and in-vivo tests were performed to verify that the performance of the Versaport™ V2 Bladeless Optical 5mm trocar is substantially equivalent to the predicate device, Endopath® Xcel trocar [K011257], To validate that the subject device performs as intended to facilitate endoscopic access into the body cavity, the following describes the testing performed: . . . . .
- In Vitro Leak Resistance .
- In Vitro and In Vivo Penetration and Fixation Forces .
- In Vitro and In Vivo Fixation Force
- In Vitro and In Vivo Insertion and Removal Forces .
- In Vitro Snap Feature Retention Force ●
- In Vitro One-Handed Use ●
- In Vitro Scope Insertion and Retention Forces
- In Vivo Multiple Penetration Forces
- In Vivo Visualization of Tissue Layers
$\frac{P4}{2}$
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a sans-serif font. The text is arranged around the circumference of the circle, framing the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Covidien % Ms. Angela Van Arsdale Regulatory Affairs Product Specialist 60 Middletown Avenue North Haven, Connecticut 06473
SEP - 1 2011
Re: K112349
Trade/Device Name: Versaport™ V2 Bladeless Optical Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: August 15, 2011 Received: August 16, 2011
Dear Ms. Arsdale:
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
3
Page 2 - Ms. Angela Van Arsdale
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For Peter
m.ait
DEN CLP
D/N
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
-11234 510(k) Number (if known):
Device Name:
Versaport™ V2 Bladeless Optical Trocar
Indications for Use:
The Versaport™ Bladeless Optical Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.
Prescription Use X (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Ogden for MSR
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112349
Special 510(k)Premarket Notification August 2011
Page 20 ™ Trademark