K Number

Device Name

Bladeless Trocar Artemis Lap Cannula

Manufacturer

T.A.G. Medical Products Corporation, Ltd

Date Cleared

2023-04-28

(109 days)

Product Code

GCJ

Regulation Number

876.1500

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K032676

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and biocompatibility aspects of a laparoscopic trocar, with no mention of AI or ML capabilities.

Therapeutic

No
This device is a surgical instrument (trocar/cannula) used to create a path for other instruments. It is not designed to treat a condition or disease directly, which is the primary function of a therapeutic device.

Diagnostic

The device description indicates it is a laparoscopic trocar used to establish a path of entry for instruments during surgical procedures, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components (cannula, obturator, depth limiter, seal pack) and mentions nonclinical testing related to physical properties (biocompatibility, reprocessing, leak testing), indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Artemis Lap Cannula is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is to "establish a path of entry for minimally invasive instruments" during surgical procedures. This is a surgical tool used on the body, not a device used to examine specimens from the body to diagnose or monitor a condition.
Device Description: The description details a surgical instrument (cannula, obturator, depth limiter, seal pack) used for creating access during surgery.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Artemis Lap Cannula does not fit this description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

GCJ

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

abdominal, thoracic, and gynecologic

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Biocompatibility evaluation was conducted on the proposed device. It was found biocompatible for intended use.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K032676

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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

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

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 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.

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. |

| 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.

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.

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.