VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula

K213818 · Covidien · GCJ · Jun 27, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K213818
• Device Name: VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula
• Applicant: Covidien
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jun 27, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The VersaOne™ optical trocar with fixation balloon cannula is indicated for use in general, gynecologic, thoracic and urologic minimally invasive surgical procedures. The intended purpose of the device is to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.

Device Story

Device is a 5mm diameter optical trocar used to create and maintain a surgical port of entry; consists of a bladeless obturator with optical tip, seal system, and cannula assembly. Obturator features a transparent 'dolphin nose' window for visualization. Cannula includes a thermoplastic elastomer balloon for fixation and an anti-migration disc for anchoring. Stopcock valve allows for insufflation/desufflation of the abdominal cavity. Used in OR by surgeons during minimally invasive procedures. Surgeon inserts trocar to establish access; balloon and disc secure cannula position to prevent inadvertent movement. Seal system maintains pneumoperitoneum while allowing instrument passage. Benefits include stable port access and visualization during insertion.

Clinical Evidence

No clinical data. Evidence consists of bench testing (visual inspection, anchor/fixation force, leak rate, seal performance) and animal testing (cavity access, tissue visualization, pneumoperitoneum maintenance, instrument manipulation) comparing subject device to predicate and reference devices.

Technological Characteristics

5mm diameter transparent cannula; materials include thermoplastic elastomer (not made with natural rubber latex). Features: bladeless optical obturator, seal system, balloon fixation, anti-migration disc, stopcock. Sterilization: Ethylene oxide. Standalone mechanical device.

Indications for Use

Indicated for patients undergoing general, gynecologic, thoracic, or urologic minimally invasive surgical procedures requiring a port of entry.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• VersaPort™ V2 Bladeless Optical Trocar and/or VersaPort™ Bladeless Optical Trocar (K112349)

Reference Devices

• Origin Blunt Tip Surgical Trocar (K924011)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Covidien Michael Mach Senior Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473

June 27, 2022

#### Re: K213818

Trade/Device Name: VersaOne Optical Trocar with Fixation Ballon Cannula, VersaOne Universal Fixation Balloon Cannula Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: April 29, 2022 Received: May 2, 2022

Dear Michael Mach:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K213818

#### Device Name

VersaOne™ optical trocar with fixation balloon cannula VersaOne™ universal fixation balloon cannula

#### Indications for Use (Describe)

The VersaOne™ optical trocar with fixation balloon cannula is indicated for use in general, gynecologic, thoracic and urologic minimally invasive surgical procedures.

The intended purpose of the device is to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/1 description: The image features the logo of Covidien. On the left side of the logo is a blue square with a white rectangle in the middle and a light blue vertical line. To the right of the square is the word "COVIDIEN" in blue font.

# DATE PREPARED:

June 15, 2022

# SUBMITTER:

Covidien 60 Middletown Avenue North Haven, CT 06473 USA

# CONTACT PERSON:

Michael Mach Senior Regulatory Affairs Specialist Telephone: [phone] Fax: [phone]

# IDENTIFICATION OF DEVICE:

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# PREDICATE DEVICE:

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# REFERENCE DEVICE:

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Origin Blunt Tip Surgical Trocar K924011 (S.E. July 9, 1993) Origin Medsystems, Inc. Endoscope and Accessories 21 CFR §876.1500 GCJ Class II General and Plastic Surgery Surgical Trocar

K213818 Traditional 510(k) 5 mm VersaOne™ optical trocar with fixation balloon cannula CONFIDENTIAL 1

VersaOne™ optical trocar with fixation ballooncannula/ VersaOne™ universal fixation balloon cannula Endoscope and Accessories 21 CFR §876.1500 GCJ Class II General and Plastic Surgery Surgical Trocar

VersaPort™ V2 Bladeless Optical Trocar and/or VersaPort™ Bladeless Optical Trocar K112349 (S.E. September 1, 2011) Covidien IIc Endoscope and Accessories 21 CFR §876.1500 GCJ Class II General and Plastic Surgery Surgical Trocar

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Image /page/4/Picture/1 description: The image shows the logo for Covidien. The logo consists of a blue square with a white square inside, and a light blue vertical line running through the center. To the right of the square is the word "COVIDIEN" in blue sans-serif font.

### DEVICE DESCRIPTION

VersaOne™ optical trocar with fixation balloon cannula with a low-profile design is a 5mm diameter transparent fixation cannula in various lengths and is comprised of three components: obturator with optical tip, seal system, and cannula assembly. The obturator is bladeless and has a transparent 'dolphin nose' window at distal end. The obturator housing contains a scope retention mechanism. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, thermoplastic elastomer (not made with natural rubber latex) balloon, anti-migration disc and a stopcock. The seal system prevents the loss of pneumoperitoneum and can accommodate instruments 5mm in diameter. The cannula sleeve is beveled and a thermoplastic elastomer (not made with natural rubber latex) balloon is attached at the distal end. The stopcock valve is for insufflation and desufflation of the abdominal cavity. The thermoplastic elastomer (not made with natural rubber latex) balloon provides fixation (defined as force that resists the cannula from being inadvertently removed out of the patient). The anti-migration disc is on the proximal end of the cannula body and provides anchoring (defined as the force that resist the cannula from being inadvertently pushed into the patient). The devices are supplied sterile f o r single use. VersaOne™ optical trocar with fixation balloon cannula is packaged with a 5 mL syringe for inflation/deflation of the thermoplastic elastomer (not made with natural rubber latex) balloon. The thermoplastic elastomer (not made with natural rubber latex) balloon is packaged with a protective cap which is removed and discarded before device use.

### INTENDED USE/INDICATIONS FOR USE:

The VersaOne™ optical trocar with fixation balloon cannula is indicated for use in general, gynecologic, thoracic and urologic minimally invasive surgical procedures.

The intended purpose of the device is to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.

| Devices | K213818<br>(Subject) | K112349<br>(Predicate) | K924011<br>(Reference) |
|---------------------|-------------------------------|-----------------------------|-------------------------------|
| Product Code | GCJ | GCJ | GCJ |
| Class | II | II | II |
| Components/Features | Cannula | Cannula | Cannula |
| | Optical Obturator | Optical Obturator | Blunt Obturator |
| | Stopcock | Stopcock | NA |
| | Fixation: Balloon | Fixation: Ribbed<br>cannula | Fixation: Balloon |
| | Anchoring<br>mechanism: anti- | NA | Anchoring<br>mechanism: anti- |

| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: | |
|----------------------------------------------|--|
|----------------------------------------------|--|

K213818 Traditional 510(k) 5 mm VersaOne™ optical trocar with fixation balloon cannula CONFIDENTIAL 2

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| Devices | K213818<br>(Subject) | K112349<br>(Predicate) | K924011<br>(Reference) |
|--------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| | migration disc | | migration disc |
| Dimensions | Diameter: 5 mm<br>Lengths:<br>70/100/150 mm | Diameter: 5 mm<br>Lengths:<br>70/100/150 mm | Diameter: 10 mm<br>Lengths: 70/100<br>mm |
| Compatibility with<br>surgical instruments | Usable with manual<br>instrumentation 5<br>mm diameter due<br>to self-adjusting<br>seal system | Usable with manual<br>instrumentation 5<br>mm diameter due<br>to self-adjusting<br>seal system | Usable with<br>endoscopes and<br>instruments 10 mm<br>in diameter. |
| Sterilization method | Ethylene oxide | Ethylene oxide | Ethylene oxide |

VersaOne™ optical trocar with fixation balloon cannula is similar to the legally marketed predicate device because the addition of balloon fixation and disc anchoring to the VersaOne™ trocar platform does not alter the intended use, indications, or user environments of the device. Applicable design control activities to ensure VersaOne™ optical trocar with fixation balloon cannula functions as intended have been completed without raising different types of questions in terms of safety and effectiveness when compared to the predicate and reference devices.

# PERFORMANCE DATA:

Non-clinical performance data, verification & validation and performance testing have been conducted, including

### BIOCOMPATIBILITY

Testing of the subject device performed to the following endpoints:

- Cytotoxicity o
- Sensitization .
- Intracutaneous Irritation .
- Acute Systemic Toxicity ●
- Material Mediated Pyrogenicity ●

### BENCH TESTING

Bench testing of the subject device performed:

- Visual Inspection .
- Anchor Mechanism Force ●
- Instrument Insertion/Removal Force ●
- Cannula Leak Rate ●
- Cannula Seal Anchoring
- Fixation Mechanism Burst Force ●
- Fixation Mechanism Inflation/Deflation Force ●
- Anchor Mechanism Activation/Deactivation Force ●

#### ANIMAL TESTING

Animal testing of the subject device performed:

- · Fixation Force
K213818 Traditional 510(k) 5 mm VersaOne™ optical trocar with fixation balloon cannula CONFIDENTIAL 3

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- . Removal Force
Side-by-side (subject, predicate, reference and informational devices) animal testing of the subject device performed:

- . Cavity Access
- Tissue Visualization ●
- Establish/Maintain Pneumoperitoneum ●
- Instrument Manipulation ●

Clinical performance data- No clinical study has been performed.

#### CONCLUSION:

Based upon the supporting data contained in this submission, we concluded that VersaOne™optical trocar with fixation balloon cannula is as safe and effective as the legally marketed predicate cleared in K112349 (S.E. September 1, 2011) and does not raise different questions of safety and effectiveness than the predicate device.