Who is the manufacturer of Bladeless Trocar Artemis Lap Cannula?

T.A.G. Medical Products Corporation, Ltd. filed the 510(k) submission for Bladeless Trocar Artemis Lap Cannula (K230058).

What is the FDA product code for Bladeless Trocar Artemis Lap Cannula?

GCJ. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for Bladeless Trocar Artemis Lap Cannula?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Bladeless Trocar Artemis Lap Cannula?

ENDOPATH III Trocar System (K032676).

Who can help prepare an FDA 510(k) submission like Bladeless Trocar Artemis Lap Cannula?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Bladeless Trocar Artemis Lap Cannula

K230058 · T.A.G. Medical Products Corporation, Ltd. · GCJ · Apr 28, 2023 · Gastroenterology, Urology

Device Facts

Record ID	K230058
Device Name	Bladeless Trocar Artemis Lap Cannula
Applicant	T.A.G. Medical Products Corporation, Ltd.
Product Code	GCJ · Gastroenterology, Urology
Decision Date	Apr 28, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended Use

The Artemis Lap Cannula has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments. Artemis Lap Cannula may be used for primary and secondary insertions.

Device Story

Artemis Lap Cannula is a reusable, radiolucent, bladeless laparoscopic trocar system. It consists of a cannula, obturator, depth limiter, and disposable standalone seal pack. Used in abdominal, thoracic, and gynecologic surgeries to establish instrument entry paths. The depth limiter prevents over-penetration. Operated by surgeons in clinical settings. The device facilitates minimally invasive access; the seal pack minimizes gas leakage during instrument insertion/withdrawal. The system is available in 5mm and 12mm diameters with various lengths.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility evaluation, reprocessing validation, ISO 80369-7 compliance testing, and leak testing demonstrating performance equivalent to the predicate.

Technological Characteristics

Reusable, radiolucent, bladeless trocar. Materials: Radel (sleeve/obturator), Polycarbonate/Polyisoprene (seals). Dimensions: 5mm and 12mm diameters; 75mm, 100mm, 150mm lengths. Features: Depth limiter, multi-piece (Pacman) outer seal, duckbill inner seal. Sterilization: Cobalt irradiation. Connectivity: None.

Indications for Use

Indicated for patients undergoing abdominal, thoracic, or gynecologic minimally invasive surgical procedures requiring a path of entry for instruments. Suitable for primary and secondary insertions.

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

ENDOPATH III Trocar System (K032676)

Related Devices

K231400 — Bladeless Trocar Artemis Lap Cannula · T.A.G. Medical Products Corporation, Ltd. · Aug 4, 2023
K060096 — MODULAR TROCAR SYSTEM · Applied Medical Resources Corp. · Jan 24, 2006
K172038 — Trocar · Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · Oct 27, 2017
K142547 — Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm · Covidien · Dec 9, 2014
K202931 — Disposable Trocar · Wuxi Shukang Medical Appliance Co., Ltd. · Nov 17, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 28, 2023 T.A.G. Medical Products Corporation, Ltd Shlomi Dines RA/OA Director T.A.G. Medical Products Corporation, Ltd Gaaton, 2513000 Israel Re: K230058 Trade/Device Name: Bladeless Trocar - Artemis Lap Cannula Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: March 29, 2023 Received: March 29, 2023 Dear Shlomi Dines: 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 {1}------------------------------------------------ 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); 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 (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 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, | Mark Trumbore -S | | Digitally signed by Mark Trumbore -S | |---------------------|--|-----------------------------------------| | | | Date: 2023.04.28 14:38:20 -04'00' | Mark Trumbore, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230058 Device Name Bladeless Trocar – Artemis Lap Cannula #### Indications for Use (Describe) The Artemis Lap Cannula has applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for minimally invasive instruments. Artemis Lap Cannula may be used 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) | |------------------------------------------------|-----------------------------------------------| |------------------------------------------------|-----------------------------------------------| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary Prepared on: 2023-04-27 Pursuant to CFR 807.92, the following 510(k) Summary is provided: | Contact Details | | | |---------------------------------------|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Applicant Name: Applicant Address: | T.A.G. Medical Products Corporation, Ltd. T.A.G. Medical Products Corporation, Ltd Gaaton 2513000 Israel 972-4-9858400 Gaaton 2513000, ISRAEL www.tag-med.com | | | Applicant Contact Telephone: | 972-4-9858400 | | Device Name | Applicant Contact: | Shlomi Dines | | | Applicant Contact Email: | sdines@tag-med.com | | | Device Trade Name: | Bladeless Trocar – Artemis Lap Cannula | | | Common Name: | Endoscope and accessories | | | Classification Name: | Endoscope and accessories | | | Regulation Number: | 876.1500 | | | Product Code: | GCJ | | Legally Marketed Predicate Devices | | | | | Predicate #: | K032676 | | | Predicate Trade Name: | ENDOPATH III Trocar System | | | Product Code: | GCJ | | Device Description | | Artemis Lap Cannula system is a radiolucent, reusable, bladeless laparoscopic trocar, consisting of a cannula, an obturator, a depth limiter, and a disposable standalone seal pack. The trocar is available in two diameters: Ø5mm and Ø12mm, each consists of 4 different length variants. Depth limiter component is available in two diameters and fits either the Ø5mm or Ø12mm cannula regardless of the length. Depth limiter can be used to prevent over penetration during surgical procedures. Artemis Lap Cannula may be used in abdominal, thoracic, or gynecological procedures. | {4}------------------------------------------------ Indications for Use Comparison of Technological Characteristics The Artemis Lap Cannula has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments. Artemis Lap Cannula may be used for primary and secondary insertions. The proposed device and the predicate device (K032676) have the same basic design, intended use, and sterilization. In comparison to the predicate device, the proposed modifications include differences in the sleeve and obturator material, packaging configuration, sleeve design, and the inclusion of a depth limiter. Differences between the proposed and predicate device do not raise new questions of safety or effectiveness. | Comparison to Predicate | | | | |-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | Subject Device | Predicate Device | Comparison | | Device Description Summary | Artemis Lap Cannula system is a radiolucent, reusable, bladeless laparoscopic trocar, consisting of a cannula, an obturator, a depth limiter, and a disposable standalone seal pack. The trocar is available in two diameters: Ø5mm and Ø12mm, each consists of 4 different length variants. Depth limiter component is available in two diameters and fits either the Ø5mm or Ø12mm cannula regardless of the length. Depth limiter can be used to prevent over penetration during surgical procedures. Artemis Lap Cannula may be used in abdominal, thoracic, or gynecological procedures. | The ENDOPATH III Trocars are sterile single patient use instruments consisting of a radiolucent sleeve and obturator in sizes ranging from 5-12 mm in diameter. There are three different obturators Bladeless, Blunt Tip and Dilating Tip. The Bladeless obturator contains a clear, tapered optical element, which when used with an endoscope, provides visibility of individual tissue layers during insertion. The Bladeless obturator accommodates an appropriately sized zero endoscope. The Blunt Tip obturator has a blunt plastic tip, which gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The Dilating Tip obturator has a sharp flat-bladed tip and a spring- loaded shield. The shield on the Dilating Tip obturator is designed to cover the flat- bladed tip to protect internal structures from puncture or | The proposed device and the predicate device have the same basic design, intended use, and sterilization. In comparison to the predicate device, the proposed modifications include differences in the sleeve and obturator material, packaging configuration, sleeve design, and the inclusion of a depth limiter. Differences between the proposed and predicate device do not raise new questions of safety or effectiveness. | | Indications for Use: | The Artemis Lap Cannula has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments. Artemis Lap Cannula may be used for primary and secondary insertions. | laceration once the abdominal or thoracic cavity has been entered. The trocar sleeve contains two seals, an outer integrated removable self- adjusting seal to accommodate instruments ranging from 5mm to 12mm in diameter where indicated and an internal seal. Together, these seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. The 5mm trocar sleeve does not contain an integrated removable seal and accommodates only 5mm instruments. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in closed position when it is parallel to the sleeve. The ENDOPATH III Bladeless Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions. The ENDOPATH III Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments. The ENDOPATH III Blunt Tip Trocar has applications in | The indications for use are identical to the relevant part if the predicate device cleared under K032676. | {5}------------------------------------------------ {6}------------------------------------------------ | thoracic, gynecologic, laparoscopic and other abdominal procedures to establish a path of entry for minimally invasive instruments. | | | | |-------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristics/Features: | | | | | Outer Seal Design | Multi-piece (Pacman), overlapping, | Multi-piece (Pacman), overlapping, | Multi-piece (Pacman), overlapping, | | Inner Seal Design | Duckbill design | Design Duckbill | Equivalent | | Obturator Tip Design | Bladeless | Bladeless | Equivalent | | Sleeve Design | Low-profile design | Low-profile design | Equivalent | | Obturator Design | Low-profile design | Low-profile design | Equivalent | | Cannula Design | Low-profile design | Low-profile design | Equivalent | | Outer Seal Material | Polycarbonate and Polyisoprene | Polycarbonate and Polyisoprene | Equivalent | | Inner Seal Material | Polyisoprene | Polyisoprene | Equivalent | | Dimensions (Diameter) | 5 mm & 12 mm | 5 mm & 12 mm | Equivalent | | Sterilization | Cobalt, irradiation | Cobalt, irradiation | Equivalent | | Dimensions (Length) | 75 mm, 100 mm, 150 mm | 75 mm, 100 mm, 150 mm | Equivalent | | Sleeve Material | Radel | Polycarbonate | The proposed device offers the sleeve material in Radel rather than polycarbonate. | | Obturator Material | Radel | Polycarbonate | The proposed device offers the obturator material in Radel rather than polycarbonate. | | Packaging | Flexible Film Composite, with lidding film top stock (FMP- 521®) | Copolyester rigid blister, with heat-sealed Tyvek lid | The proposed device incorporates a different packaging configuration compared to the predicate. | | Sleeve Design | Release button for removal and locking of seal pack (includes inner and outer seals) | Release button for removal and locking of outer seal | The proposed device offers a release button for the seal pack of the inner and outer seals whereas the predicate offers a release button for the outer seal only. | | Depth Limiter | 5 or 12 mm in diameter | Not included with system | The proposed device offers a depth limiter in either 5 or 12 mm in diameter whereas the predicate does not have a depth limiter included in the system. | ## Nonclinical Testing Discussion Biocompatibility evaluation was conducted on the proposed device. It was found biocompatible for intended use. {7}------------------------------------------------ Reprocessing evaluation was conducted on the proposed device. Validated reprocessing instructions are sufficient to clean and sterilize it in healthcare settings. Nonclinical testing in accordance with ISO 80639-7 was completed. The test data demonstrates success and met the criteria of ISO 80369-7. Leak testing was conducted on the proposed devices and submitted in this Traditional 510(k). The leak test data demonstrates the proposed devices preform statically equivalent to the predicate device. #### Conclusion Subject and predicate devices have same intended use. Differences in design between the subject and predicate device do not raise new questions of safety or effectiveness. Based on comparison of the technological characteristics, and performance test data, the subject devices is substantially equivalent to the predicate device for requested intended use.