Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical and structural features of the device for stone management and instrument placement, with no mention of AI or ML capabilities. The performance studies are based on physical testing, not algorithmic performance.

Therapeutic

No.
Explanation: The device is primarily designed for mechanical intervention (bypassing and entrapping calculi, preventing migration, facilitating instrument placement) during urological procedures. It does not appear to treat or cure a disease itself, but rather assists in procedures to address a condition.

Diagnostic

No

The device is intended for interventional purposes such as bypassing and entrapping calculi, preventing retrograde migration, and facilitating instrument placement during procedures, not for identifying the nature or cause of a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical device with a braided structure, guidewire-like features, and mechanical actions (deployment, retrieval, stenting compatibility), indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly describes a device used within the body (endoscopically) to manipulate and manage calculi in the urinary tract. This is an in vivo procedure.
Device Description: The description details a physical device that is inserted into the body and performs mechanical functions (blocking, facilitating placement).
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro) to provide information about a physiological state, health, or disease. It doesn't analyze biological samples like blood, urine, or tissue.

IVD devices are used to perform tests on samples taken from the body, not to directly interact with structures within the body in the way the XenX device does.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The XenX device is intended to be used endoscopically to bypass and entrap calculi from the urinary tract, to prevent retrograde migration of calculi during laser lithotripsy,and to facilitate the placement of endourological instruments during diagnostic or interventional procedures.

Product codes (comma separated list FDA assigned to the subject device)

OCY, FFL

Device Description

The XenX device combines several features in one device which facilitate an endoscopic procedure. The XenX easily tracks past ureteral kidney stone and is navigated under fluoroscopy like a urologic guidewire. Once in place, a self expandable braided structure is deployed to block the ureteral lumen and prevent stone particle migration towards the kidney. The braided structure enables a constant irrigation flow for clear uretroscopic vision during the procedure. Following stone fragmentation and if required the physician can choose to propagate a urinary stent over the device for ureteral placement.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Urinary tract

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)

The following nonclinical testing were performed to demonstrate the performance and safety of XenX as compared to its predicate devices

Tip flexibility test
Deployment/retrieval force
Stenting compatibility
Tensile strength
Pushability test
Radial expansion
Particle sieving
Radiopacity test
Testing showed that the XenX is as safe, effective and performs as well as, or better than the predicates.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K082536, K970121, K052048, K863081

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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page 1 of 5

510(K) SUMMARY (06/11/12) [As required by 21 CFR §§ 807.87 and 807.92] XenXTM

510(k) Number K113692

AUG 9 2012

Applicant's Name:

Xenolith Medical Ltd. 1 Leshem Street, PO Box 720 Kiryat-Gat, 82000 Israel Phone: +972-8-6811761 Fax: +972-8-6811763

Contact Person:

Mr. Ofer Zigman Head of Research and Development Xenolith Medical 1 Leshem Street, PO Box 720 Kiryat Gat, 82000 Israel Phone: +972-8-6811761 Cell: +972-52-6447263 Email: ozigman@xenolithmedical.com

US Agent

Shoshana (Shosh) Friedman, RAC Push-Med LLC 1914 JN Pease Place Charlotte, NC 28269 Phone: 704-899-0092 704-430-8695 Cell: Email: shosh@pushmed.com

Trade Name:

ХепХтм

Classification Name:

Endoscopic guidewire, gastroenterology-urology AND dislodger, stone, basket, ureteral, metal

Classification:

FDA has classified these types of devices as class II devices (product codes OCY and FFL) and they are reviewed by the Gastroenterology/Urology panel.

1

Basis for Submission:

New device

Predicate Devices:

Sensor Nitinol Guidewire, Boston Scientific Corp, 510(k) Exempt .
Roadrunner PC Wire Guide, Cook Urological Inc, K082536 .
. Stone Cone Nitinol Urological retrieval coil, Boston Scientific Corp. K970121
Accordion urological occluding guidewire, Percsys, K052048 .
. NTrap stone entrapment and extraction device, Cook Urological Inc, K863081

Device Description:

The XenX device combines several features in one device which facilitate an endoscopic procedure. The XenX easily tracks past ureteral kidney stone and is navigated under fluoroscopy like a urologic guidewire. Once in place, a self expandable braided structure is deployed to block the ureteral lumen and prevent stone particle migration towards the kidney. The braided structure enables a constant irrigation flow for clear uretroscopic vision during the procedure. Following stone fragmentation and if required the physician can choose to propagate a urinary stent over the device for ureteral placement.

Intended Use:

The XenX device is intended to be used endoscopically to bypass and entrap calculi from the urinary tract, to prevent retrograde migration of calculi during laser lithotripsy,and to facilitate the placement of endourological instruments during diagnostic or interventional procedures.

Technological Characteristics:

The XenX consist of a braided tubular mesh compacted into a guidewireshaped device.

Performance Data

The following nonclinical testing were performed to demonstrate the performance and safety of XenX as compared to its predicate devices

Tip flexibility test .
Deployment/retrieval force ●
Stenting compatibility .
Tensile strength .
Pushability test .
Radial expansion .
Particle sieving .
Radiopacity test ●

2

K 113692
page 3 of 5

Testing showed that the XenX is as safe, effective and performs as well as, or better than the predicates.

Substantial Equivalence

Characteristic	Sensor	Roadrunner	NTrap	Stone cone	Accordion	XenX
Intended use	Intended to
facilitate the
placement of
endourological
instruments
during
diagnostic or
interventional
procedures.	Used for
ureteral access
to establish a
tract, and
assist in the
placement,
replacement
and exchange
of devices
during
urological
procedures
includes use in
a torturous or
kinked ureter
traversing a
large stone in
route to the
kidney or in
cases
demanding
enhanced
control and
high
radiopacity.	Used as an
endoscopic
entrapment and
extraction
device for
calculi and
other foreign
bodies in the
urinary tract,
and to minimize
stone migration
during laser,
electrohydraulic
or pneumatic
lithotripsy	Intended to be
used
endoscopically
to entrap
and remove
calculi and
other foreign
objects from
the urinary
tract.	Intended to be
used
endoscopically
to entrap and
remove calculi
and other
foreign objects
from the
Urinary tract
and to guide
instrumentation
within the
ureteral tract.	The XenX
device is
intended to be
used
endoscopically
to bypass and
entrap calculi
from the
urinary tract,
to prevent
retrograde
migration of
calculi during
laser
lithotripsy,and
to facilitate the
placement of
endourological
instruments
during
diagnostic or
interventional
procedures
Location of
use	Urinary tract	Urinary tract	Urinary tract	Urinary tract	Urinary tract	Urinary tract
Technological
characteristics	Boston
Scientific
offers the
Sensor
guidewire
with PTFE
coatings;
hydrophilic
coatings for
reduced
friction;
Nitinol core
for kink
reduction and
a flexible tip to
facilitate
navigation.	Cook Wire
Guides consist
of a Nitinol
core for kink
resistance
coated with a
polymer
sleeve, and
hydrophilically
coated to
reduce
friction.	NiTi extractor
retrieval basket,
interlaced and
interweaved
together wires,
creating a
special shape
that will not
allow urinary
tract stones or
other objects to
fall out at the
extraction stage
as well as
ensuring their
easy capture, it
is manually
deployed by
retracting the	The Stone
Cone Nitinol
urological
retrieval coil
consists of a
nitinol core
wire with a
PTFE coating.
The wire
assembly is
housed in a
sheath. The
sheath is
provided to
straighten the
device coil
during
placement and
withdrawal;	The
ACCORDION
Urological
Occluding
Guidewire
consists of a
film membrane
pre-loaded
within a two-
part guidewire
it is activated by
a removable
handle. The
folded
membrane acts
to entrap stone
fragments
during
lithotripsy. The	The XenX
device
incorporates a
nitinol core
wire, a floppy,
polyurethane-
coated
hydrophilic tip
for easy stone
passage and
kink resistance
with a very
thin and
flexible nitinol-
based self-
expandable
braid/sieve
structure as an
integral part of
the guide wire.
Characteristic	Sensor	Roadrunner	NTrap	Stone cone	Accordion	XenX
			sheath.	manually	coated Nitinol	The braid is
				deployed by	tip is offered to	housed in a
				retracting the	enable easy	sheath and is
				cone out of	stone passage	manually
				sheath.		deployed out
						of the sheath.
Mode of
operation	Inserted into	Inserted into	Inserted into	Inserted in the	Inserted into	Inserted in the
	the ureter past	the ureter past	the ureter in its	ureter in its	the ureter in its	ureter in its
	the stone to	the stone to	closed	closed	straightened	un-deployed
	establish a	establish a	configuration;	configuration,	un-deployed	guidewire
	tract and	tract and assist	once past the	once past the	film	mode, once
	assist in the	in the	stone the	stone the	configuration	past the stone
	placement,	placement	retention basket	retention cone	similar to a	the self
	replacement	replacement	is deployed to	is deployed to	guidewire, once	expandable
	and exchange	and exchange	prevent stone	prevent stone	past the stone	braid is
	of devices	of devices	migration	migration	the multi fold	deployed,
	during	during	during	during	film is formed.	braid conforms
	urological	urological	lithotripsy;	lithotripsy;	The device's	to and fills the
	procedures	procedures.	larger stone
fragments can	larger stone	film conforms	ureter to
			be swept into	fragments can
be swept into	to and fills the	prevent
			the bladder	the bladder	ureter to
prevent	retrograde
migration of
			following	following	retrograde	stone
			treatment.	treatment.	migration of	fragments.
					stone
					fragments.
					Following
					fragmentation;
					The device can
					sweep larger
					stone fragments
					into the bladder
Material made	Nitinol core	Nitinol core,	Nitinol core	Nitinol core	Nitinol core	Nitinol core
	wire PTFE	Platinum coil,	wire,	wire PTFE	wire, PTFE	wire
	coat,	Hydrophilic	Nitinol woven	coated,	coated,	Nitinol braid
	Polyurethane	coat,	mesh basket,	Polymeric	Hydrophilic tip,	mesh,
	coat,	Polyurethane	Polyimide outer	sheath	Polymeric	Polyurethane
	Hydrophilic	jacket	sheath		occlusion film	coat, Tungsten
	coating,					filled
	Tungsten filled					radiopaque tip,
	radiopaque tip					Hydrophilic
						Nitinol braided
						mesh coating,
						Polyimide
outer sheath
	Advancement	Advancement	Inserted past	Inserted past	Inserted past	Inserted while
Principal of
operation	of the flexible	of the flexible	occluding stone	occluding	stone while	braid is
	tip past the	tip past the	while basket is	stone while	occluding film is	retracted
	stone until	stone until	retracted within	cone is	in its straight	within outer
	located at the	located at the	outer sheath,	retracted	configuration,	sheath, the
	desired	desired	followed by	within outer	followed by	flexible tip is
			basket	sheath,	folding the	advanced past
	anatomical	anatomical
Characteristic	Sensor	Roadrunner	NTrap	Stone cone	Accordion	XenX
	location	location	deployment	followed by
cone
deployment.	occluding film.	the stone until
the desired
anatomical
location is
reached,
followed by
deployment of
occluding
braid.

XenX™ - Page 5-4

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4

K113692
page 5 of 5

The XenX combines guide-wire and stone retention functionalities in one device. In its guidewire configuration it is substantially equivalent in its introduction, function, intended use and technology to the Sensor and Roadrunner guidewires and to the Accordion device. Once the self-expanding braid is deployed the XenX acts as a retention device and is substantially equivalent to the Stone-cone, Ntrap and Accordion devices in all characteristics excluding stone particle retrieval (sweeping functionality) which is not claimed as one of XenX features. This makes the XenX safer and less invasive in comparison with its predicate retention devices. Using the XenX, stone particles can be disintegrated by lithotripsy down to 1mm size, allowing them to easily pass through the urine system, hence the sweeping function becomes irrelevant.

Conclusion:

Xenolith Medical Ltd. believes that, based on the information provided in this submission, XenX™ is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness issue.

5

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Ofer Zigman Head of Research and Development Xenolith Medical 1 Leshem, P.O Box 720 KIRYAT GAT 82000 ISRAEL

AUG 9 2012

Re: K113692

Trade/Device Name: XenXTM Regulation Number: 21 CFR8 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY, FFL Dated: July 24, 2012 Received: July 30, 2012

Dear Mr. Zigman:

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. 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 (reporting of medical

6

Page 2 -

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K-tinka

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

7

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K113692

Device Name: ХепХтм

Indications for Use:

The XenX device is intended to be used endoscopically to bypass and entrap calculi from the urinary tract, to prevent retrograde migration of calculi during laser lithotripsy,and to facilitate the placement of endourological instruments during diagnostic or interventional procedures

Prescription Use _X (Per 21 CFR 801 Subpart D) AND/OR

Over the Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRHAffice of Device Evaluation (ODE)

Helent Leeman

ivision Sign-10(k) Num

XenX™ - Page 4:2