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.

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.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Bladeless Trocar - Artemis Lap Cannula." The submission seeks to prove substantial equivalence to a legally marketed predicate device (K032676, the ENDOPATH III Trocar System).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for performance metrics in a table format, nor does it provide detailed quantitative performance data for the Artemis Lap Cannula. Instead, the document focuses on demonstrating substantial equivalence through a comparison of technological characteristics and nonclinical testing.

Here's a summary of the stated performance and comparisons:

Acceptance Criteria (Implied)	Reported Device Performance (Artemis Lap Cannula)	Comparison to Predicate (ENDOPATH III Trocar System)
Biocompatibility	Found biocompatible for intended use.	Implied equivalent to predicate.
Reprocessing Effectiveness	Validated reprocessing instructions are sufficient to clean and sterilize it in healthcare settings.	Implied equivalent to predicate.
Small-Bore Connectors (ISO 80369-7)	Completed testing; data demonstrates success and met the criteria of ISO 80369-7.	Implied equivalent/compliant to standard.
Leak Testing	Data demonstrates the proposed devices perform statistically equivalent to the predicate device.	Statistically equivalent to predicate device for leak performance.
Intended Use	Applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry.	Identical to the relevant part of the predicate device.
Basic Design	Radiolucent, reusable, bladeless laparoscopic trocar, consisting of cannula, obturator, depth limiter, and disposable standalone seal pack. Two diameters (5mm, 12mm), 4 length variants, depth limiter.	Same basic design, but with differences in sleeve/obturator material, packaging, sleeve design, and inclusion of a depth limiter. These differences do not raise new questions of safety or effectiveness.
Sterilization	Cobalt, irradiation.	Equivalent (Cobalt, irradiation).
Seal Design (Outer & Inner)	Multi-piece (Pacman), overlapping outer seal; Duckbill inner seal.	Equivalent to predicate.
Obturator Tip Design	Bladeless.	Equivalent to predicate.
Sleeve Design	Low-profile design; release button for removal and locking of seal pack.	Equivalent to predicate for low-profile design; Difference: release button for seal pack vs. predicate's outer seal only.
Obturator Design	Low-profile design.	Equivalent to predicate.
Cannula Design	Low-profile design.	Equivalent to predicate.
Outer Seal Material	Polycarbonate and Polyisoprene.	Equivalent to predicate.
Inner Seal Material	Polyisoprene.	Equivalent to predicate.
Dimensions (Diameter)	5 mm & 12 mm.	Equivalent to predicate.
Dimensions (Length)	75 mm, 100 mm, 150 mm.	Equivalent to predicate.
Sleeve Material	Radel.	Difference: Radel vs. predicate's Polycarbonate.
Obturator Material	Radel.	Difference: Radel vs. predicate's Polycarbonate.
Packaging	Flexible Film Composite, with lidding film top stock (FMP-521®).	Difference: Flexible Film Composite vs. predicate's Copolyester rigid blister.
Depth Limiter	5 or 12 mm in diameter.	Difference: Included vs. predicate's "Not included with system."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state sample sizes for specific tests (e.g., biocompatibility testing might involve various samples for different analyses, and leak testing would have its own sample size).

Test Set Sample Size: Not explicitly stated for each test.
Data Provenance: Not explicitly stated whether retrospective or prospective. Given the nature of pre-market testing for medical devices (biocompatibility, reprocessing, performance testing), it is typically prospective testing conducted specifically for the submission. The country of origin of the data is not specified beyond the applicant's location (Israel).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The tests described (biocompatibility, reprocessing, ISO standard testing, leak testing) are primarily objective engineering/scientific tests, not typically reliant on expert interpretation for "ground truth" in the same way clinical imaging or diagnostic studies might be.

4. Adjudication Method for the Test Set

Not applicable for the types of nonclinical tests described. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices, which the "Bladeless Trocar - Artemis Lap Cannula" is not. It is a surgical instrument.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

A standalone performance study (algorithm only) was not done. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for the nonclinical tests (biocompatibility, reprocessing, ISO standards, leak testing) typically refers to established scientific methodologies, validated test methods, and pre-defined acceptance criteria based on industry standards and regulatory requirements. For example:

Biocompatibility: Established ISO standards (e.g., ISO 10993 series) define the ground truth for evaluating biological response.
Reprocessing: Ground truth is established by validated protocols demonstrating the device can be consistently cleaned and sterilized to meet sterility assurance levels.
ISO 80369-7: Ground truth is the successful meeting of the dimensional and performance requirements defined in the standard.
Leak Testing: Ground truth is the quantitative measurement of leakage and its statistical equivalence to the predicate, demonstrating it meets performance expectations for sealing.

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/machine learning device.

Summary

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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

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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,

MarkTrumbore -S		Digitally signed byMark Trumbore -S
		Date: 2023.04.2814:38:20 -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

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Indications for Use

510(k) Number (if known) K230058

Device Name Bladeless Trocar – Artemis Lap Cannula

Indications for Use (Describe)

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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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 2513000Israel972-4-9858400Gaaton 2513000, ISRAELwww.tag-med.com
	Applicant ContactTelephone:	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 MarketedPredicate 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, anobturator, a depth limiter, and a disposable standalone sealpack. The trocar is available in two diameters: Ø5mm andØ12mm, each consists of 4 different length variants. Depthlimiter component is available in two diameters and fitseither the Ø5mm or Ø12mm cannula regardless of thelength. Depth limiter can be used to prevent overpenetration during surgical procedures. Artemis LapCannula may be used in abdominal, thoracic, orgynecological procedures.

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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 DescriptionSummary	Artemis Lap Cannula system is aradiolucent, reusable, bladelesslaparoscopic trocar, consistingof a cannula, an obturator, adepth limiter, and a disposablestandalone seal pack. Thetrocar is available in twodiameters: Ø5mm and Ø12mm,each consists of 4 differentlength variants. Depth limitercomponent is available in twodiameters and fits either theØ5mm or Ø12mm cannularegardless of the length. Depthlimiter can be used to preventover penetration duringsurgical procedures. ArtemisLap Cannula may be used inabdominal, thoracic, orgynecological procedures.	The ENDOPATH III Trocarsare sterile single patient useinstruments consisting of aradiolucent sleeve andobturator in sizes rangingfrom 5-12 mm in diameter.There are three differentobturators Bladeless, BluntTip and Dilating Tip. TheBladeless obturator containsa clear, tapered opticalelement, which when usedwith an endoscope, providesvisibility of individual tissuelayers during insertion. TheBladeless obturatoraccommodates anappropriately sized zeroendoscope. The Blunt Tipobturator has a blunt plastictip, which gently moves asideany internal viscera that maybe adjacent to the abdominalor thoracic wall. The DilatingTip obturator has a sharpflat-bladed tip and a spring-loaded shield. The shield onthe Dilating Tip obturator isdesigned to cover the flat-bladed tip to protect internalstructures from puncture or	The proposed deviceand the predicatedevice have the samebasic design, intendeduse, and sterilization. Incomparison to thepredicate device, theproposed modificationsinclude differences inthe sleeve andobturator material,packagingconfiguration, sleevedesign, and theinclusion of a depthlimiter. Differencesbetween the proposedand predicate device donot raise new questionsof safety oreffectiveness.
Indications for Use:	The Artemis Lap Cannula hasapplications in abdominal,thoracic, and gynecologicminimally invasive surgicalprocedures to establish a pathof entry for minimally invasiveinstruments. Artemis LapCannula may be used forprimary and secondaryinsertions.	laceration once theabdominal or thoracic cavityhas been entered.The trocar sleeve containstwo seals, an outerintegrated removable self-adjusting seal toaccommodate instrumentsranging from 5mm to 12mmin diameter where indicatedand an internal seal.Together, these sealsminimize gas leakage wheninstruments are inserted orwithdrawn through thetrocar. The 5mm trocarsleeve does not contain anintegrated removable sealand accommodates only5mm instruments. Astopcock valve is compatiblewith standard luer lockfittings and providesattachment for gasinsufflation and desufflation.The stopcock is in closedposition when it is parallel tothe sleeve.The ENDOPATH III BladelessTrocar has applications inabdominal, thoracic, andgynecologic minimally invasiveprocedures to establish a pathof entry for endoscopicinstruments. The trocar may beused with or withoutvisualization for primary andsecondary insertions.The ENDOPATH III Dilating TipTrocar has applications inthoracic, gynecologiclaparoscopy and otherabdominal procedures toestablish a path of entry forendoscopic instruments.The ENDOPATH III Blunt TipTrocar has applications in	The indications for use areidentical to the relevantpart if the predicatedevice cleared underK032676.

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thoracic, gynecologic,laparoscopic and otherabdominal procedures toestablish a path of entry forminimally 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 andPolyisoprene	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, withlidding film top stock (FMP-521®)	Copolyester rigid blister, withheat-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.

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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.

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.