ArtiSential Trocar

K212500 · Livsmed, Inc. · GCJ · Dec 3, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K212500
• Device Name: ArtiSential Trocar
• Applicant: Livsmed, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Dec 3, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

ArtiSential Trocar has an application in general, abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.

Device Story

ArtiSential Trocar is a sterile, single-use surgical instrument used in minimally invasive procedures (general, abdominal, thoracic, gynecologic) to create access for endoscopic instruments. The device consists of a main body, cannula, and obturator. An optical element in the obturator allows visualization of tissue layers during insertion when used with an endoscope. A funnel serves as an insertion guide for passive multi-joint surgical instruments. Used by surgeons in clinical settings to establish pneumoperitoneum and provide a conduit for instruments. The device facilitates surgical access and instrument manipulation, potentially reducing trauma and improving procedural efficiency compared to manual entry methods.

Clinical Evidence

Bench testing and animal studies (micro pig) were conducted. Bench tests compared appearance, dimensions, leak testing, tensile strength, pneumoperitoneum maintenance, and instrument manipulation against the predicate. Animal testing evaluated tissue insertion/retention forces, intra-abdominal pressure, and obturator integrity. All tests passed, demonstrating performance equivalent to the predicate.

Technological Characteristics

Materials: Polycarbonate (PC) cannula and obturator. Dimensions: 8mm diameter, 100mm length. Sterilization: Ethylene Oxide (EO) per ISO 11135. Biocompatibility: Tested per ISO 10993-1. Packaging/Shelf-life: Tested per ASTM F88/F88M-15, ASTM F1929, and ISO 11737-2.

Indications for Use

Indicated for patients undergoing general, abdominal, thoracic, or gynecologic minimally invasive procedures requiring a path of entry for endoscopic instruments.

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

• Modular Trocar System (K060096)

Submission Summary (Full Text)

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December 3, 2021

LivsMed Inc. Dong Wook Lee Quality Management Representative #304, D-dong, 700, Pangyo-ro, Bundang-gu, 13516 Seongnam-si, Gyeonggi-do Republic of Korea

Re: K212500

Trade/Device Name: ArtiSential Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: October 18, 2021 Received: October 19,2021

Dear Dong Wook Lee:

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/cfpm/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.

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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 and Part 809); medical device reporting (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 (QS) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 [phone] or 301-796-7100).

Sincerely,

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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K212500

Device Name ArtiSential Trocar

Indications for Use (Describe)

ArtiSential Trocar has an application in general, abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| X | Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

# 1. General Information

| Applicant/Submitter: | LivsMed Inc. |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | #304, D-dong, 700, Pangyo-ro, Bundang-gu, 13516<br>Seongnam-si, Gyeonggi-do, Republic of Korea<br>Tel) [phone]<br>Fax) [phone] |
| Contact Person: | Dong Wook Lee / QMR<br>(Quality Management Representative) |
| Address: | #304, D-dong, 700, Pangyo-ro, Bundang-gu, 13516<br>Seongnam-si, Gyeonggi-do, Republic of Korea<br>Tel) [phone]<br>Fax) [phone]<br>Email) [e-mail] |
| Preparation Date: | 11-19-2021 |

# 2. Device Name and Code

| Device Trade Name | ArtiSential Trocar |
|---------------------|----------------------------------------|
| Common Name | Sterile Trocars for Endoscopic surgery |
| Classification Name | Endoscope and accessories |
| Product Code | GCJ |
| Regulation Number | 21 CFR 876.1500 |
| Classification | Class II |
| Review Panel | General & Plastic Surgery |

# 3. Predicate Devices

ArtiSential Trocar is the same or similar to the device in Table 3.1.

- 3.1 Subject Device Description
ArtiSential Trocar is for use during endoscopic minimally invasive procedures or to gain access potential spaces for endoscopic instruments. This device is a sterile, single-use instruments consisting of a main body, cannula, obturator. An optical element, which when used with an endoscope, provides visibility of individual tissue layers during insertion. And a funnel serves as an instrument insertion guide and aids in the insertion of a passive multijoint surgical instrument into the cannula.

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The device falls within Section 876.1500 Endoscope and accessories and is a prescription use only.

Table 3.1 Predicate device

| Applicant | Device Name | 510(k) Number |
|------------------------------------|-----------------------|---------------|
| Applied Medical Resources<br>Corp. | Modular Trocar System | K060096 |

# 4. Indications for Use

- 4.1 Indications for use
ArtiSential Trocar has an application in general, abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.

# 5. Technical Characteristics in Comparison to Predicate Devices

Table 5.1 Comparison of Proposed device and predicate device

| | Proposed<br>device | Predicate<br>device | Substantial<br>Equivalence<br>Assessment |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K212500 | K060096 | N/A |
| Manufacture | LivsMed, Inc. | Applied Medical<br>Resources Corp. | N/A |
| Device Name | ArtiSential Trocar | Modular Trocar System | N/A |
| Clearance Date | N/A | 01-24-2006 | N/A |
| Classification /<br>Regulation | Class 2 / 876.1500 | Class 2 / 876.1500 | Same |
| Product Code | GCJ | GCJ | Same |
| Intended for | Prescription Use | Prescription Use | Same |
| Indications for<br>Use | ArtiSential Trocar has an<br>application in general,<br>abdominal, thoracic, and<br>gynecologic minimally<br>invasive procedures to<br>establish a path of entry for<br>endoscopic instruments. | The Applied Medical<br>Modular Trocar System<br>is a sterile single use<br>device, or may be used<br>with a reusable stainless<br>steel or reusable<br>DuraGold® cannula and<br>is intended for use in<br>conjunction with<br>Applied's currently<br>marketed trocar<br>products to establish a<br>path of entry for<br>endoscopic instruments<br>for use during general,<br>abdominal, | Same |
| | | | |
| | | thoracic minimally<br>invasive procedures or<br>to gain access through<br>tissue planes and/or<br>potential spaces for<br>endoscopic instruments.<br>If utilizing the Applied<br>Medical Optical<br>Separator Obturator<br>with the Modular Trocar<br>System it may be used<br>with or without<br>visualization for primary<br>and secondary<br>insertions. | |
| Description | ArtiSential Trocar is for<br>use during endoscopic<br>minimally invasive<br>procedures or to gain<br>access potential spaces for<br>endoscopic instruments.<br>This device is a sterile,<br>single-use instruments<br>consisting of a main body,<br>cannula, obturator. An<br>optical element, which<br>when used with an<br>endoscope, provides<br>visibility of individual<br>tissue layers during<br>insertion.<br>And a funnel serves as an<br>instrument insertion guide<br>and aids in the insertion of<br>a passive multi-joint<br>surgical instrument into the<br>cannula. | The Modular Trocar<br>System is a sterile single<br>use device, intended for<br>use in conjunction with<br>Applied's currently<br>marketed Trocar products.<br>A standard trocar assembly<br>consists of an obturator, a<br>seal and a cannula system.<br>The Modular Trocar<br>System will be available<br>in sizes of 5mm, 8mm,<br>11mm, 12mm and<br>15mm diameter in<br>lengths ranging from<br>55mm to 150mm. | Similar: The<br>description of<br>the proposed<br>ArtiSential<br>Trocar is as<br>same as the<br>predicate<br>devices except<br>for the function<br>of the funnel<br>part, which is an<br>optional feature<br>that the user<br>selects. Also,<br>given the<br>technological<br>characteristics<br>of the proposed<br>ArtiSential<br>Trocar are<br>identical to the<br>predicate<br>products.<br>Design<br>verification and<br>validation<br>testing of the<br>proposed Trocar<br>have provided<br>reasonable<br>assurance that<br>the proposed<br>ArtiSential<br>Trocar are<br>appropriate for<br>the proposed<br>indications for<br>use and can be<br>as safely and<br>effectively used |
| | | | as predicate<br>devices. |
| Principles of<br>operation | This product is a sterile,<br>single-use product<br>which is composed of<br>main body, cannula,<br>obturator that is<br>generally used in<br>invasive surgery to<br>create passageways for<br>surgery in the abdomen,<br>gynecology, chest,<br>access through tissues,<br>or to make space for<br>endoscopic instruments.<br>The obturator has an<br>optical element applied<br>to visualize the tissue<br>layer during insertion<br>into the body, and a<br>funnel serves as an<br>instrument insertion<br>guide and aids in the<br>insertion of a passive<br>multi-joint surgical<br>instrument into the<br>cannula. | This product consists of<br>a sleeve and an<br>obturator that are<br>generally used in<br>minimally invasive<br>surgery to create a<br>passageway for surgery<br>in the abdomen,<br>gynecology, chest,<br>access through tissue, or<br>to make space for<br>endoscopic instruments.<br>It is a sterile disposable<br>product.<br>The optical type uses a<br>separate obturator with<br>optical elements applied to<br>visualize the tissue layer<br>during insertion, and the<br>shielded bladed type<br>includes a blade. | Similar: The<br>operation<br>principle of the<br>proposed<br>ArtiSential<br>Trocar is as<br>same as the<br>predicate<br>devices except<br>for the function<br>of the funnel<br>part, which is an<br>optional feature<br>that the user<br>selects. Also,<br>given the<br>technological<br>characteristics<br>of the proposed<br>ArtiSential<br>Trocar are<br>identical to the<br>predicate<br>products.<br>Design<br>verification and<br>validation<br>testing of the<br>proposed Trocar<br>have provided<br>reasonable<br>assurance that<br>the proposed<br>ArtiSential<br>Trocar are<br>appropriate for<br>the proposed<br>indications for<br>use and can be<br>as safely and<br>effectively used<br>as predicate<br>devices. |
| Physical<br>dimensions and<br>design<br>(diameter, length<br>of Cannula) | -Diameter: 8mm<br>-Length: 100mm | -Diameter: 8mm<br>-Length: 100mm | Same |
| Raw Materials | | | Similar |
| | -Cannula: Polycarbonate (PC) | -Cannula: Copolyester | : Raw materials |
| | -Obturator: Polycarbonate (PC) | -Obturator: Polycarbonate (PC) | of the proposed |
| | | | ArtiSential |
| | | | Trocar are same |
| | | | as the predicate |
| | | | device(K060096 |
| | | | ), except |
| | | | Copolyester of |
| | | | the predicate |
| | | | device's raw |
| | | | material. All |
| | | | patient |
| | | | contacting |
| | | | materials of |
| | | | proposed |
| | | | ArtiSential |
| | | | Trocar have |
| | | | been tested per |
| | | | the same |
| | | | standards of |
|…