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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the VersaOne™ optical trocar with fixation balloon cannula. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove safety and effectiveness from scratch. Therefore, the information provided mainly focuses on non-clinical performance data (bench testing and animal testing) rather than a detailed human-in-the-loop study often seen with AI/software as a medical device.

Based on the provided document, here's a breakdown of the acceptance criteria and the "study" (non-clinical testing) that proves the device meets them:

The "acceptance criteria" for a 510(k) device like this are primarily demonstrated by showing that its performance characteristics are comparable to a predicate device, and that any new features (like the balloon fixation) do not raise new questions of safety or effectiveness. The "studies" here are the non-clinical tests.

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

The document doesn't present a formal table of "acceptance criteria" with quantitative targets and reported performance values in the way one might see for an AI algorithm's diagnostic accuracy. Instead, the acceptance is implicitly based on the device meeting design specifications and performing comparably to predicates in various non-clinical tests.

However, we can infer some key performance aspects tested and the general conclusion:

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Biocompatibility:	Tested and demonstrated according to: Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity.
Mechanical Performance (Bench Testing):
- Visual Inspection	Performed and presumably passed.
- Anchor Mechanism Force	Tested. (Implied to meet design specs.)
- Instrument Insertion/Removal Force	Tested. (Implied to meet design specs.)
- Cannula Leak Rate	Tested. (Implied to meet design specs.)
- Cannula Seal Anchoring	Tested. (Implied to meet design specs.)
- Fixation Mechanism Burst Force	Tested. (Implied to meet design specs.)
- Fixation Mechanism Inflation/Deflation Force	Tested. (Implied to meet design specs.)
- Anchor Mechanism Activation/Deactivation Force	Tested. (Implied to meet design specs.)
Functional Performance (Animal Testing):
- Fixation Force	Tested. (Implied to meet design specs.)
- Removal Force	Tested. (Implied to meet design specs.)
- Cavity Access	Demonstrated in side-by-side animal testing with predicate/reference devices.
- Tissue Visualization	Demonstrated in side-by-side animal testing with predicate/reference devices.
- Establish/Maintain Pneumoperitoneum	Demonstrated in side-by-side animal testing with predicate/reference devices.
- Instrument Manipulation	Demonstrated in side-by-side animal testing with predicate/reference devices.
Overall Safety & Effectiveness:	Concluded to be as safe and effective as the legally marketed predicate (K112349) and does not raise different questions of safety and effectiveness.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., number of devices tested for burst force, number of animals used). It simply states that "Testing... performed" or "Animal testing... performed." For a 510(k) of this nature, detailed sample sizes for specific engineering tests would be in the full submission, not typically summarized in the public 510(k) decision letter.
Data Provenance: The document does not explicitly state the country of origin for the data or if the tests were retrospective or prospective. Given that this is non-clinical testing (bench and animal), the terms "retrospective" or "prospective" don't apply in the same way they would for human clinical data. The tests were presumably conducted as part of the device development and submission process.

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 question is not applicable in the context of this device's 510(k) submission. "Ground truth" established by experts is typically for diagnostic imaging devices where human expert interpretation is the standard against which an algorithm or new diagnostic method is compared. For a surgical trocar, ground truth is established by physical measurement (e.g., force testing), engineering analysis, and direct observation during performance testing (e.g., in animal models). The document mentions "side-by-side" animal testing, which implies comparative observation by individuals conducting the tests, but not "expert consensus" on diagnostic findings.

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

Not applicable. Adjudication methods are relevant for human reader studies or clinical trials where discordant findings among human readers or clinical outcomes need to be resolved to establish a definitive "truth" for comparison. For bench and animal testing of a surgical instrument, results are typically objective measurements or direct observations without requiring such adjudication.

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:

Not applicable. An MRMC study is a type of clinical comparative effectiveness study, usually for diagnostic devices, particularly those involving human interpretation (e.g., radiologists reading images with or without AI assistance). This 510(k) is for a physical surgical instrument and explicitly states: "Clinical performance data - No clinical study has been performed."

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

Not applicable. This is not an AI/algorithm device. The performance tests ("bench testing" and "animal testing") are for the physical device itself.

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

The "ground truth" for this device's performance is established through:

Engineered Specifications and Physical Measurements: For bench testing (e.g., anchor mechanism force, leak rate, burst force). The device performs to its design specifications.
Direct Observation and Functional Assessment in Animal Models: For animal testing (e.g., cavity access, tissue visualization, ability to establish/maintain pneumoperitoneum, instrument manipulation). Performance is considered "successful" if it meets the functional needs for a surgical trocar.
Comparison to Predicate Devices: The ultimate "ground truth" for a 510(k) is demonstrating "substantial equivalence" to a legally marketed predicate device, meaning it performs similarly and does not raise new safety or effectiveness concerns.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a "training set."

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

Not applicable. (See #8)

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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DATE PREPARED:

June 15, 2022

SUBMITTER:

Covidien 60 Middletown Avenue North Haven, CT 06473 USA

CONTACT PERSON:

Michael Mach Senior Regulatory Affairs Specialist Telephone: (320) 493-1411 Fax: (203) 492-5029

IDENTIFICATION OF DEVICE:

Proprietary/Trade Name:

Classification Name:
Regulation Number:
Product Code:
Device Class:
Review Panel:
Common Name:

PREDICATE DEVICE:

Proprietary/Trade Name:

510(k) Number:
Manufacturer:
Classification Name:
Regulation Number:
Product Code:
Device Class:
Review Panel:
Common Name:

REFERENCE DEVICE:

Proprietary/Trade Name:
510(k) Number:
Manufacturer:
Classification Name:
Regulations Number:
Product Codes:
Device Class:
Review Panel:
Common Name:

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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DEVICE DESCRIPTION

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(Subject)	K112349(Predicate)	K924011(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: Ribbedcannula	Fixation: Balloon
	Anchoringmechanism: anti-	NA	Anchoringmechanism: 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(Subject)	K112349(Predicate)	K924011(Reference)
	migration disc		migration disc
Dimensions	Diameter: 5 mmLengths:70/100/150 mm	Diameter: 5 mmLengths:70/100/150 mm	Diameter: 10 mmLengths: 70/100mm
Compatibility withsurgical instruments	Usable with manualinstrumentation 5mm diameter dueto self-adjustingseal system	Usable with manualinstrumentation 5mm diameter dueto self-adjustingseal system	Usable withendoscopes andinstruments 10 mmin 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.

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.