(238 days)
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
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.
Here's an analysis of the provided text regarding the XenX device, structured according to your request.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list quantitative acceptance criteria with specific thresholds for device performance. Instead, it states that "Testing showed that the XenX is as safe, effective and performs as well as, or better than the predicates." The performance data section describes a series of nonclinical tests conducted to demonstrate equivalence to predicate devices.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Tip flexibility | Tested; found to perform as well as, or better than predicates. |
| Deployment/retrieval force | Tested; found to perform as well as, or better than predicates. |
| Tensile strength | Tested; found to perform as well as, or better than predicates. |
| Pushability test | Tested; found to perform as well as, or better than predicates. |
| Radial expansion | Tested; found to perform as well as, or better than predicates. |
| Functional Performance | |
| Stenting compatibility | Tested; found to perform as well as, or better than predicates. |
| Particle sieving (stone entrapment) | Tested; found to perform as well as, or better than predicates (prevents retrograde migration of calculi, can disintegrate stone particles down to 1mm). |
| Radiopacity | Tested; found to perform as well as, or better than predicates. |
| Overall Safety & Effectiveness | "As safe, effective and performs as well as, or better than the predicates." |
2. Sample Size for Test Set and Data Provenance
The 510(k) summary does not provide information on the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are "nonclinical testing," implying bench testing or in-vitro studies, not human clinical trials with patient data.
3. Number of Experts and Qualifications for Ground Truth
This information is not provided as the studies are "nonclinical testing" and do not involve human expert assessment of a test set for ground truth establishment.
4. Adjudication Method
This information is not applicable/not provided as there is no mention of a clinical test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted (or at least not reported in this summary). The studies are nonclinical and do not involve human readers or AI assistance.
6. Standalone (Algorithm Only) Performance Study
This is not applicable as the XenX is a physical medical device (guidewire with a braided structure), not an AI algorithm. Hence, standalone performance for an algorithm is not relevant.
7. Type of Ground Truth Used
The ground truth for the nonclinical tests would have been established by physical measurements, engineering specifications, and established testing protocols for medical device performance. For example, a "Tensile strength" test would have a defined breaking point or force resistance that the device must meet, which serves as the "ground truth" for that particular performance metric. There is no mention of expert consensus, pathology, or outcomes data, as these are typically associated with clinical studies.
8. Sample Size for Training Set
There is no mention of a training set sample size, as this device does not involve machine learning or AI that would require a "training set."
9. How Ground Truth for Training Set Was Established
This is not applicable for the same reason as point 8.
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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: +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.
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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
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 tofacilitate theplacement ofendourologicalinstrumentsduringdiagnostic orinterventionalprocedures. | Used forureteral accessto establish atract, andassist in theplacement,replacementand exchangeof devicesduringurologicalproceduresincludes use ina torturous orkinked uretertraversing alarge stone inroute to thekidney or incasesdemandingenhancedcontrol andhighradiopacity. | Used as anendoscopicentrapment andextractiondevice forcalculi andother foreignbodies in theurinary tract,and to minimizestone migrationduring laser,electrohydraulicor pneumaticlithotripsy | Intended to beusedendoscopicallyto entrapand removecalculi andother foreignobjects fromthe urinarytract. | Intended to beusedendoscopicallyto entrap andremove calculiand otherforeign objectsfrom theUrinary tractand to guideinstrumentationwithin theureteral tract. | The XenXdevice isintended to beusedendoscopicallyto bypass andentrap calculifrom theurinary tract,to preventretrogrademigration ofcalculi duringlaserlithotripsy,andto facilitate theplacement ofendourologicalinstrumentsduringdiagnostic orinterventionalprocedures |
| Location ofuse | Urinary tract | Urinary tract | Urinary tract | Urinary tract | Urinary tract | Urinary tract |
| Technologicalcharacteristics | BostonScientificoffers theSensorguidewirewith PTFEcoatings;hydrophiliccoatings forreducedfriction;Nitinol corefor kinkreduction anda flexible tip tofacilitatenavigation. | Cook WireGuides consistof a Nitinolcore for kinkresistancecoated with apolymersleeve, andhydrophilicallycoated toreducefriction. | NiTi extractorretrieval basket,interlaced andinterweavedtogether wires,creating aspecial shapethat will notallow urinarytract stones orother objects tofall out at theextraction stageas well asensuring theireasy capture, itis manuallydeployed byretracting the | The StoneCone Nitinolurologicalretrieval coilconsists of anitinol corewire with aPTFE coating.The wireassembly ishoused in asheath. Thesheath isprovided tostraighten thedevice coilduringplacement andwithdrawal; | TheACCORDIONUrologicalOccludingGuidewireconsists of afilm membranepre-loadedwithin a two-part guidewireit is activated bya removablehandle. Thefoldedmembrane actsto entrap stonefragmentsduringlithotripsy. The | The XenXdeviceincorporates anitinol corewire, a floppy,polyurethane-coatedhydrophilic tipfor easy stonepassage andkink resistancewith a verythin andflexible nitinol-based self-expandablebraid/sievestructure as anintegral part ofthe 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 ofoperation | 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 stonefragments can | larger stone | film conforms | ureter to | |
| be swept into | fragments canbe swept into | to and fills the | prevent | |||
| the bladder | the bladder | ureter toprevent | retrogrademigration 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, | ||||||
| Polyimideouter sheath | ||||||
| Advancement | Advancement | Inserted past | Inserted past | Inserted past | Inserted while | |
| Principal ofoperation | 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 byconedeployment. | occluding film. | the stone untilthe desiredanatomicallocation isreached,followed bydeployment ofoccludingbraid. |
XenX™ - Page 5-4
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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.
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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
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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
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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
§ 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.