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

The provided text describes a 510(k) premarket notification for a medical device called the "Bladeless Trocar - Artemis Lap Cannula" (K231400) and references a previous clearance (K230058) as a primary predicate. This document is a regulatory submission, not a study report, and thus focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical or analytical performance study with acceptance criteria and detailed outcomes in the same way one might describe an AI/ML device study.

Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, particularly aspects like sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable or available in this type of regulatory document for this specific device.

This device (Bladeless Trocar - Artemis Lap Cannula) is a physical surgical instrument, not an AI/ML diagnostic or prognostic system. The performance claims for such devices typically revolve around mechanical properties, biocompatibility, and sterility, which are verified through non-clinical testing and comparison to legally marketed predicate devices.

However, I can extract information regarding the non-clinical testing performed and the conclusion drawn from it, which serves as a form of "proof" of meeting the regulatory requirements for substantial equivalence.

Non-Clinical Testing and Performance for Bladeless Trocar - Artemis Lap Cannula (K231400)

1. Table of Acceptance Criteria and Reported Device Performance (Derived from Regulatory Review)

Acceptance Criteria (Implied)	Reported Device Performance
Leak Testing: Demonstrate performance statistically equivalent to the predicate device.	"The leak test data demonstrates the proposed devices preform statically equivalent to the predicate device."
ISO 80639-7 Compliance: Meet criteria of the standard.	"Nonclinical testing in accordance with ISO 80639-7 was completed. The test data demonstrates success and met the criteria of ISO 80369-7." (Note: The provided text mistakenly refers to 80639-7 in the criterion and 80369-7 in the performance. Assuming 80369-7 is the correct standard, likely relating to small-bore connectors.)

Explanation of "Acceptance Criteria" for this type of device:
For a physical surgical instrument like a trocar, "acceptance criteria" are typically defined by recognized consensus standards (e.g., ISO standards for medical devices, biomechanical testing standards) and comparison to predicate devices. The primary goal is to demonstrate that the new device is as safe and effective as a legally marketed device.

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

Sample Size: Not specified in the provided text. Non-clinical testing typically involves a statistically relevant number of units for mechanical or material tests, but the exact count is not detailed here.
Data Provenance: The testing was "Nonclinical Testing" conducted to support the 510(k) submission. This is laboratory-based testing, not human or patient data. The country of origin of the data is implicitly the country where the manufacturer (T.A.G. Medical Products Corporation, Ltd, Israel) conducted or commissioned the tests.

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

Not applicable. This information pertains to studies involving expert review for setting ground truth (e.g., for AI/ML algorithms). This device and its associated testing do not involve establishing ground truth from expert clinical review. The "ground truth" for non-clinical testing is typically defined by the test protocol, measurement standards, and device specifications.

4. Adjudication Method for the Test Set:

Not applicable. This concept relates to reconciling disagreements among experts in setting ground truth for data. Non-clinical physical testing results are usually objective measurements, not subject to expert adjudication in the same manner.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study is relevant for comparing the performance of human readers, often with and without AI assistance, on diagnostic cases. This device is a surgical instrument, not a diagnostic tool requiring such a study.

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

Not applicable. This refers to the performance of an AI algorithm in isolation. This device is a physical instrument, not an algorithm.

7. The Type of Ground Truth Used:

For the non-clinical tests (leak testing, ISO 80369-7 compliance), the "ground truth" is defined by:
- Established Test Standards: Adherence to the specified mechanical and performance characteristics outlined in the relevant ISO standard (ISO 80369-7).
- Predicate Device Performance: Comparison to the performance characteristics of the legally marketed predicate device (K230058) for specific attributes like leak resistance.
- Device Specifications: Meeting the manufacturer's own design specifications for the device.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of a physical medical device like a trocar. This concept applies to AI/ML algorithms that learn from data.

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

Not applicable. As there is no training set, this question is not relevant.

Summary

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August 4, 2023

T.A.G. Medical Products Corporation, Ltd Shlomi Dines RA/OA Director T.A.G. Medical Products Corporation, Ltd Gaaton, 2513000 Israel

Re: K231400

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: July 3, 2023 Received: July 3, 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 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); 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,

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Mark Trumbore. The date of the signature is August 4th, 2023, and the time is 09:28:04 -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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231400

Device Name Bladeless Trocar – Artemis Lap Cannula

Indications for Use (Describe)

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

Prepared on: 2023-08-03

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 NameLegally MarketedPredicate Devices	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
	Primary Predicate:	K230058
	Predicate Trade Name:	Bladeless Trocar – Artemis Lap Cannula
	Product Code:	GCJ
	Additional Predicate:	K072674
	Predicate Trade Name:	KII TROCAR SYSTEM
	Product Code:	GCJ

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K231400

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. Comparison of The proposed device and the predicate device have the Technological same basic design, intended use, and sterilization. In Characteristics comparison to the predicate device, the proposed modifications include an additional length option for the trocar and cannula (60 mm). This length is within the range of the additional predicate. Differences between the proposed and predicate device do not raise new or questions of safety or effectiveness. More details could be found in the comparison table below. Nonclinical Testing Leak testing was conducted on the proposed devices and Discussion submitted in this Traditional 510(k). The leak test data demonstrates the proposed devices preform statically equivalent to the predicate device. Nonclinical testing in accordance with ISO 80639-7 was completed. The test data demonstrates success and met the criteria of ISO 80369-7. 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.

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Comparison to Predicates
Device	Subject DeviceK231400	Primary Predicate DeviceK230058	Additional PredicateK072674
Indications for Use:	The Artemis Lap Cannula hasapplications in abdominal,thoracic, and gynecologicminimally invasive surgicalprocedures to establish apath of entry for minimallyinvasive instruments. ArtemisLap Cannula may be used forprimary and secondaryinsertions.	The Artemis Lap Cannula hasapplications in abdominal,thoracic, and gynecologicminimally invasive surgicalprocedures to establish apath of entry for minimallyinvasive instruments. ArtemisLap Cannula may be used forprimary and secondaryinsertions.	The Applied Medical ModularTrocar System is a sterile, single-use device consisting of abladed, shielded obturator, acannula and seal. The obturatorand seal may also be used withreusable APPLIED cannulas thatmay be made of stainless steelor DuraGold® polymer. Theobturator is intended for use inconjunction with APPLIED'Scurrently marketed trocarproducts to establish a path ofentry for endoscopicinstruments for use duringgeneral, abdominal,gynecological and thoracicminimally invasive procedures oto gain access through tissueplanes and/or potential spacesfor endoscopic instruments.
Characteristics/Features:
Outer Seal Design	Multi-piece (Pacman),overlapping,	Multi-piece (Pacman),overlapping,	n/a
Inner Seal Design	Duckbill design	Duckbill design	n/a
Obturator Tip Design	Bladeless	Bladeless	Shielded Blade
Sleeve Design	Low-profile design	Low-profile design	Low-profile design
Obturator Design	Low-profile design	Low-profile design	Low-profile design
Cannula Design	Low-profile design	Low-profile design	Low-profile design
Outer Seal Material	Polycarbonate andPolyisoprene	Polycarbonate andPolyisoprene	n/a
Inner Seal Material	Polyisoprene	Polyisoprene	n/a
Dimensions(Diameter)	5 mm & 12 mm	5 mm & 12 mm	5 mm & 12 mm
Sterilization	Cobalt, irradiation	Cobalt, irradiation	n/a
Dimensions (Length)	60 mm, 75 mm, 100 mm, 150 mm	75 mm, 100 mm, 150 mm	55mm to 150mm
Sleeve Material	Radel	Radel	n/a
Obturator Material	Radel	Radel	n/a
Packaging	Flexible Film Composite, withlidding film top stock (FMP-521®)	Flexible Film Composite, withlidding film top stock (FMP-521®)	n/a
Sleeve Design	Release button for removaland locking of seal pack(includes inner and outerseals)	Release button for removaland locking of seal pack(includes inner and outerseals)	Release button for removal andlocking of seal pack

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.