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.

Device Description

The Versaport™ V2 Bladeless Optical Trocar 11mm and 12mm with a transparent cannula is available in standard (100mm), short (70mm) and long (150mm) cannula lengths. The Versaport™ V2 Bladeless Optical Trocar with transparent 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trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port.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 11mm and 12mm Versaport™ seal system accommodate instruments indicated as 5mm up to 11mm and 12mm respectively. These features are the same as the Versaport™ V2 Bladeless Optical Trocar (5mm) [K112349].

The proposed device (Versaport™ V2 Bladeless Optical Trocar, 11mm and 12mm) has similar design, lengths, and optical features as the predicate devices. The Versaport™ V2 Bladeless Optical Trocar, 11mm and 12mm, includes a transparent cannula, 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. There is a 3 way stopcock for insufflation and rapid desufflation. 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.

AI/ML Overview

The provided submission is a 510(k) Summary of Safety and Effectiveness for a medical device (Versaport™ V2 Bladeless Optical Trocar System). It describes the device, its intended use, and states that in-vitro and in-vivo tests were performed to verify performance and substantial equivalence to predicate devices. However, it does not provide specific acceptance criteria or detailed results of those studies.

Here's a breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in the provided document.	- In Vitro Leak Resistance (verified)
	- In Vitro Instrument Insertion and Removal Forces (verified)
	- In Vitro Snap Feature Retention Force (verified)
	- In Vitro Scope Insertion and Retention Forces (verified)
	- In Vitro and In Vivo Penetration Force (verified)
	- In Vitro and In Vivo Fixation Force (verified)
	- In Vivo Visualization of Tissue Layers (verified)

Note: The document only states that these performance aspects were "verified" and that the device performs "as intended" and is "substantially equivalent" to predicate devices. It does not provide the specific quantitative or qualitative acceptance criteria used for each test, nor the actual measured performance values that demonstrated compliance.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample sizes: Not specified in the provided document.
Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this type of device submission. This device is a surgical instrument (trocar), not an imaging or diagnostic device that requires expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as it pertains to methods for resolving discrepancies in expert interpretations, which is not relevant to testing a surgical instrument.

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

This information is not applicable. This device is not an AI-powered diagnostic tool, and therefore, MRMC studies involving human readers or AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This device is a physical surgical instrument and does not involve algorithms or AI.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the performance tests mentioned (e.g., leak resistance, forces, visualization), the "ground truth" would be established by objective measurements and functional requirements defined by engineering specifications and surgical practice standards, rather than expert consensus on diagnostic images or pathology. For example, "leak resistance" would be measured against a defined threshold of acceptable leakage. "Visualization of tissue layers" would be assessed through direct observation during in vivo testing.

8. The sample size for the training set

This information is not applicable. This device is not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable. As above, this device does not use a training set.

Summary of what the document does provide regarding the study:

The document (specifically "PERFORMANCE DATA" on Page 2) states that a study was performed, encompassing:

Study Type: A combination of in-vitro (laboratory) and in-vivo (live subject) tests.
Purpose: To verify that the performance of the Versaport™ V2 Bladeless Optical 11mm and 12mm trocars is substantially equivalent to the predicate devices and performs as intended.
Tests Performed:
- In Vitro Leak Resistance
- In Vitro Instrument Insertion and Removal Forces
- In Vitro Snap Feature Retention Force
- In Vitro Scope Insertion and Retention Forces
- In Vitro and In Vivo Penetration Force
- In Vitro and In Vivo Fixation Force
- In Vivo Visualization of Tissue Layers

Missing Information:

Crucially, this 510(k) summary provides a high-level overview of the tests conducted but lacks detailed quantitative results, specific acceptance criteria, and specific methodologies (e.g., sample sizes, experimental setup details) that would typically be found in a full study report. This level of detail is usually present in the full 510(k) submission, but not always in the publicly available summary.

Summary

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Page 1 of 2

AR 1 4 2013

Versaport™ V2 Bladeless Optical Trocar System

510(k) Summary of Safety and Effectiveness

Covidien SUBMITTER: 60 Middletown Avenue North Haven, CT 06473 USA CONTACT PERSON: Sarah Rizk Senior Product Specialist, Regulatory Affairs February 21, 2013 DATE PREPARED: Versaport™ V2 Bladeless Optical Trocar TRADE/PROPRIETARY NAME: Optical Trocar COMMON/USUAL NAME: Endoscope and Accessories CLASSIFICATION NAME: Versaport™ V2 Bladeless Optical Trocar [K112349] PREDICATE DEVICE(S): Versaport™ Bladeless Trocar [K081169] The Versaport™ V2 Bladeless Optical Trocar 11mm and 12mm with a DEVICE DESCRIPTION: transparent cannula is available in standard (100mm), short (70mm) and long (150mm) cannula lengths. The Versaport™ V2 Bladeless Optical Trocar with transparent 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 11mm and 12mm Versaport™ seal system accommodate instruments indicated as 5mm up to 11mm and 12mm respectively. These features are the same as the Versaport™ V2 Bladeless Optical Trocar (5mm) [K112349].

The proposed device (Versaport™ V2 Bladeless Optical Trocar, 11mm and 12mm) has similar design, lengths, and optical features as the predicate devices. The Versaport™ V2 Bladeless Optical Trocar, 11mm and 12mm, includes a transparent cannula, 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. There is a 3 way stopcock for insufflation and rapid desufflation. The external interlocking snaps secure the obturator The Versaport™ Bladeless V2 Optical trocar is to the cannula. equivalent to the predicate devices in terms of its intended use and fundamental technology.

All components of the Versaport™ Bladeless Optical Trocar 11mm and 12mm are comprised of materials which were tested in accordance with ISO Standard 10993-1.

Special 510(k)Premarket Notification February 2013

MATERIALS:

INTENDED USE:

TECHNICAL

CHARACTERISTICS:

Page 22 TMTrademark

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K 130 4.35

Page 2 of ②

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 11mm and 12mm trocars are substantially equivalent to the predicate devices. To validate that the proposed device performs as intended to facilitate endoscopic access into the body cavity, the following describes the testing performed.

In Vitro Leak Resistance .
In Vitro Instrument Insertion and Removal Forces .
In Vitro Snap Feature Retention Force ●
In Vitro Scope Insertion and Retention Forces .
In Vitro and In Vivo Penetration Force �
In Vitro and In Vivo Fixation Force .
In Vivo Visualization of Tissue Layers

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Image /page/2/Picture/0 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 an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 14, 2013

Covidien, Formerly US Surgical a Division of Tyco Healthcare % Ms. Sarah Rizk Senior Product Specialist, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

Re: K130435

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: February 21, 2013 Received: February 21, 2013

Dear Ms. Rizk:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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Page 2 - Ms. Sarah Rizk

marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours, FOR

Peter ₪mm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Versaport™ V2 Bladeless Optical Trocar System

Indications for Use

510(k) Number (if known): _K130435

Device Name:

Versaport™ V2 Bladeless Optical Trocar

Indications for Use:

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)

Long H. Chen
-A
Digitally signed by Long H. Chen-A
ON: o=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Long H. Chen-

0.9.2342.19200300.100.1.1=1300369056
Date: 2013.03.14 06:42:01 -04'00'
for

(Division Sign-Off)

Division of Surgical Devices

510(k) Number

Regulation Number and Section

§ 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.