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.
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trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port.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.
Here's an analysis of the provided text regarding the Versaport™ V2 Bladeless Optical Trocar System, focusing on acceptance criteria and supporting studies:
Assessment of the Provided Information:
The provided document is a 510(k) Summary of Safety and Effectiveness, which is a premarket notification to the FDA. As such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting full, detailed study reports with specific acceptance criteria and detailed quantitative results for each test. The document states that tests were performed and what types of tests were performed to establish substantial equivalence for various performance aspects, but it does not explicitly list quantitative acceptance criteria for each test nor specific numerical results demonstrating how the device met those criteria.
Therefore, for many of the requested points, the answer will be that the information is not provided in this summary.
Acceptance Criteria and Study Details for Versaport™ V2 Bladeless Optical Trocar System
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, the document does not explicitly state quantitative acceptance criteria for the enumerated performance tests. It states that "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]". This implies that the acceptance criteria were likely based on matching or being within a permissible range of the predicate device's performance, but the specific numerical targets are not disclosed.
Therefore, the table below reflects the types of tests performed and the general conclusion drawn from the summary, rather than specific acceptance criteria and performance values.
| Test Category | Specific Test Description | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance (In-Vitro) | Leak Resistance | Likely: Equivalent to or better than predicate device (Endopath® Xcel trocar [K011257]) for preventing leakage during use. | Verified to perform as intended and is substantially equivalent to predicate device. |
| Penetration and Fixation Forces | Likely: Within acceptable range for safe and effective tissue penetration and secure fixation, comparable to predicate. | Verified to perform as intended and is substantially equivalent to predicate device. | |
| Snap Feature Retention Force | Likely: Sufficient force to maintain obturator-cannula connection during use, comparable to predicate. | Verified to perform as intended and is substantially equivalent to predicate device. | |
| One-Handed Use | Likely: Demonstrates feasibility and ease of single-handed operation, comparable to predicate. | Verified to perform as intended and is substantially equivalent to predicate device. | |
| Scope Insertion and Retention Forces | Likely: Appropriate force for scope insertion and secure retention during use, comparable to predicate. | Verified to perform as intended and is substantially equivalent to predicate device. | |
| Mechanical Performance (In-Vivo) | Penetration and Fixation Forces | Likely: Within acceptable range for safe and effective tissue penetration and secure fixation in biological systems, comparable to predicate. | Verified to perform as intended and is substantially equivalent to predicate device. |
| Insertion and Removal Forces | Likely: Appropriate forces for smooth insertion and removal without excessive trauma, comparable to predicate. | Verified to perform as intended and is substantially equivalent to predicate device. | |
| Multiple Penetration Forces | Likely: Maintains performance consistency over multiple uses/insertions, comparable to predicate. | Verified to perform as intended and is substantially equivalent to predicate device. | |
| Functional Performance (In-Vivo) | Visualization of Tissue Layers | Likely: Clear and adequate visualization of tissue layers during insertion, comparable to predicate's optical capabilities. | Verified to perform as intended and is substantially equivalent to predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample sizes used for any of the in-vitro or in-vivo tests.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission, the studies would typically be prospective for performance validation, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. These types of studies for a surgical trocar would typically involve engineers and potentially medical professionals (e.g., surgeons) for aspects like "Visualization of Tissue Layers" or "In Vivo" tests, but their number and qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of these engineering and in-vivo performance tests, typical adjudication methods (like 2+1 or 3+1 consensus commonly seen in imaging studies) are unlikely to be directly applicable. The "ground truth" would be established through direct measurement, observation, or expert assessment against predefined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was NOT done. This type of study is relevant for AI-powered diagnostic tools or imaging analysis where human readers interpret results. The Versaport™ V2 is a surgical trocar (medical device for creating a port of entry), not an AI diagnostic system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. The Versaport™ V2 is a mechanical surgical device and does not involve algorithms or AI. It is inherently a human-in-the-loop device (used by a surgeon).
7. The Type of Ground Truth Used
Based on the types of tests mentioned ("In Vitro Leak Resistance," "In Vivo Penetration and Fixation Forces," "In Vivo Visualization of Tissue Layers"), the ground truth would be established through:
- Direct Measurement: For forces, leak rates, resistance.
- Observational Assessment by Qualified Personnel: For aspects like "visualization of tissue layers" (likely by surgeons or trained medical personnel in an in-vivo setting) and qualitative aspects of one-handed use or ease of insertion/removal.
- Comparison to Predicate Device Performance: The overarching ground truth is framed as "substantial equivalence" to the Endopath® Xcel trocar [K011257].
8. The Sample Size for the Training Set
- Not applicable / Not provided. This device is not an AI/machine learning product, so there is no "training set" in that context. If referring to a design validation or development phase, the sample sizes for such iterations are not disclosed.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not provided. As mentioned above, there is no "training set" in the context of an AI device for this product. The ground truth for its performance validation (as discussed in point 7) was established through direct measurement, observation, and comparison to a predicate device.
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.112349
Versaport™ V2 Bladeless Optical Trocar System
SEP - 1 2011
510(k) Summary of Safety and Effectiveness
| SUBMITTER: | Covidien60 Middletown AvenueNorth Haven, CT 06473 USA |
|---|---|
| CONTACT PERSON: | Angela Van ArsdaleProduct Specialist, Regulatory Affairs |
| DATE PREPARED: | August 10, 2011 |
| TRADE/PROPRIETARY NAME: | Versaport™ V2 Bladeless Optical Trocar or Versaport™ BladelessOptical |
| 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 designand transparent fixation cannula is available in 5 mm standard(100mm), 5 mm short (70mm) and 5mm long (150mm) cannulalengths. The Versaport™ V2 bladeless optical 5mm trocar withtransparent fixation cannula and obturator allows optical entry forvisualization of tissue layers during insertion. The obturator housingcontains a scope retention mechanism. The trocar housing containsinternal seals to prevent loss of pneumoperitoneum when instrumentsare inserted into a port or withdrawn completely from a port. The 5 mmVersaport™ seal system accommodates 5mm instrumentsrespectively. There is a luer lock with cap for insufflation and rapiddesufflation. |
| INTENDED USE: | The Versaport™ Bladeless Optical Trocar is intended for use in avariety of gynecologic, general, thoracic and urologic endoscopicprocedures to create and maintain-a-port-of entry. The trocar may beused with or without visualization for primary and secondary insertions. |
| TECHNICALCHARACTERISTICS: | The subject device (Versaport™ V2 Bladeless Optical Trocar) hassimilar design, lengths, and optical features as the predicate devices.The design modifications includes a cannula material change, abladeless obturator with a transparent optical window at the distal end,an obturator housing scope retention mechanism and externalinterlocking snaps. The scope retention mechanism is located withinthe obturator housing allowing for secured insertion and retention of anappropriately sized 0° laparoscope for visualization of tissue layersduring insertion into the body cavity. The external interlocking snapssecure the obturator to the cannula. The Versaport™ Bladeless V2Optical trocar is equivalent to the predicate devices in terms of itsintended use and fundamental technology. |
| MATERIALS: | All components of the Versaport™ Bladeless Optical Trocar arecomprised of materials which were tested in accordance with ISO10993-1 |
Special 510(k)Premarket Notification August 2011
Page 22
™Trademark
P 1/2
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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
$\frac{P4}{2}$
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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
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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
§ 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.