XENX

K113692 · Xenolith Medical · OCY · Aug 9, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K113692
• Device Name: XENX
• Applicant: Xenolith Medical
• Product Code: OCY · Gastroenterology, Urology
• Decision Date: Aug 9, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

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

Device Story

XenX is a combined guidewire and stone retention device used in urological procedures. It consists of a nitinol core wire with a hydrophilic, polyurethane-coated tip for navigation and a self-expandable braided nitinol mesh. The device is navigated under fluoroscopy past a ureteral stone; once positioned, the braided structure is manually deployed from its sheath to occlude the ureteral lumen. This prevents retrograde migration of stone fragments during laser lithotripsy while allowing irrigation flow. The device facilitates endourological instrument placement and can serve as a guidewire for urinary stent placement. It is intended for use by physicians in clinical settings. By preventing stone migration, it reduces the need for stone sweeping/retrieval, potentially simplifying procedures and improving patient safety.

Clinical Evidence

Bench testing only. Performance evaluated via tip flexibility, deployment/retrieval force, stenting compatibility, tensile strength, pushability, radial expansion, particle sieving, and radiopacity tests. No clinical data provided.

Technological Characteristics

Nitinol core wire; braided tubular nitinol mesh; polyurethane-coated hydrophilic tip; tungsten-filled radiopaque tip; polyimide outer sheath. Self-expandable braid mechanism. Manual deployment via sheath retraction. Standalone device.

Indications for Use

Indicated for endoscopic bypass and entrapment of urinary tract calculi, prevention of retrograde stone migration during laser lithotripsy, and facilitation of endourological instrument placement during diagnostic or interventional procedures.

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

• Sensor Nitinol Guidewire (510(k) Exempt)
• Roadrunner PC Wire Guide (K082536)
• Stone Cone Nitinol Urological retrieval coil (K970121)
• Accordion urological occluding guidewire (K052048)
• NTrap stone entrapment and extraction device (K863081)

Submission Summary (Full Text)

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#### 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: [phone] Fax: [phone]

#### Contact Person:

Mr. Ofer Zigman Head of Research and Development Xenolith Medical 1 Leshem Street, PO Box 720 Kiryat Gat, 82000 Israel Phone: [phone] Cell: [phone] Email: [e-mail]

#### US Agent

Shoshana (Shosh) Friedman, RAC Push-Med LLC 1914 JN Pease Place Charlotte, NC 28269 Phone: [phone] Cell: Email: [e-mail]

#### 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.

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#### 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 ●

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K 113692
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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<br>facilitate the<br>placement of<br>endourological<br>instruments<br>during<br>diagnostic or<br>interventional<br>procedures. | Used for<br>ureteral access<br>to establish a<br>tract, and<br>assist in the<br>placement,<br>replacement<br>and exchange<br>of devices<br>during<br>urological<br>procedures<br>includes use in<br>a torturous or<br>kinked ureter<br>traversing a<br>large stone in<br>route to the<br>kidney or in<br>cases<br>demanding<br>enhanced<br>control and<br>high<br>radiopacity. | Used as an<br>endoscopic<br>entrapment and<br>extraction<br>device for<br>calculi and<br>other foreign<br>bodies in the<br>urinary tract,<br>and to minimize<br>stone migration<br>during laser,<br>electrohydraulic<br>or pneumatic<br>lithotripsy | Intended to be<br>used<br>endoscopically<br>to entrap<br>and remove<br>calculi and<br>other foreign<br>objects from<br>the urinary<br>tract. | Intended to be<br>used<br>endoscopically<br>to entrap and<br>remove calculi<br>and other<br>foreign objects<br>from the<br>Urinary tract<br>and to guide<br>instrumentation<br>within the<br>ureteral tract. | The XenX<br>device is<br>intended to be<br>used<br>endoscopically<br>to bypass and<br>entrap calculi<br>from the<br>urinary tract,<br>to prevent<br>retrograde<br>migration of<br>calculi during<br>laser<br>lithotripsy,and<br>to facilitate the<br>placement of<br>endourological<br>instruments<br>during<br>diagnostic or<br>interventional<br>procedures |
| Location of<br>use | Urinary tract | Urinary tract | Urinary tract | Urinary tract | Urinary tract | Urinary tract |
| Technological<br>characteristics | Boston<br>Scientific<br>offers the<br>Sensor<br>guidewire<br>with PTFE<br>coatings;<br>hydrophilic<br>coatings for<br>reduced<br>friction;<br>Nitinol core<br>for kink<br>reduction and<br>a flexible tip to<br>facilitate<br>navigation. | Cook Wire<br>Guides consist<br>of a Nitinol<br>core for kink<br>resistance<br>coated with a<br>polymer<br>sleeve, and<br>hydrophilically<br>coated to<br>reduce<br>friction. | NiTi extractor<br>retrieval basket,<br>interlaced and<br>interweaved<br>together wires,<br>creating a<br>special shape<br>that will not<br>allow urinary<br>tract stones or<br>other objects to<br>fall out at the<br>extraction stage<br>as well as<br>ensuring their<br>easy capture, it<br>is manually<br>deployed by<br>retracting the | The Stone<br>Cone Nitinol<br>urological<br>retrieval coil<br>consists of a<br>nitinol core<br>wire with a<br>PTFE coating.<br>The wire<br>assembly is<br>housed in a<br>sheath. The<br>sheath is<br>provided to<br>straighten the<br>device coil<br>during<br>placement and<br>withdrawal; | The<br>ACCORDION<br>Urological<br>Occluding<br>Guidewire<br>consists of a<br>film membrane<br>pre-loaded<br>within a two-<br>part guidewire<br>it is activated by<br>a removable<br>handle. The<br>folded<br>membrane acts<br>to entrap stone<br>fragments<br>during<br>lithotripsy. The | The XenX<br>device<br>incorporates a<br>nitinol core<br>wire, a floppy,<br>polyurethane-<br>coated<br>hydrophilic tip<br>for easy stone<br>passage and<br>kink resistance<br>with a very<br>thin and<br>flexible nitinol-<br>based self-<br>expandable<br>braid/sieve<br>structure as an<br>integral part of<br>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<br>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<br>fragments can | larger stone | film conforms | ureter to |
| | | | be swept into | fragments can<br>be swept into | to and fills the | prevent |
| | | | the bladder | the bladder | ureter to<br>prevent | retrograde<br>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…