The Xtractor™ device is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects.

Device Description

The Xtractor™ device is a single use sterilized device designed to be advanced through the veins over a cardiac pacemaker/defibrillator lead. The device is a motor driven mechanical tool that is introduced over the lead and follows its path, using a flexible and steerable shaft connected to a control handle. The proximal section of the shaft maintains pushability while the distal section is very flexible, to facilitate easy passage through vein curves and junctions. The device' distal tip is designed to facilitate dilation of fibrous binding tissue and passage through calcified binding sites along the implanted lead (for example by use of combined rotational and impact movements). The device' control handle, which is connected to the shaft, contains a steering mechanism for assisting the device maneuverability, and a motorized power transmission mechanism to activate the device tip. The Xtractor™ device is visible under fluoroscopy during the procedure.

AI/ML Overview

The provided document does not contain information about the acceptance criteria and study that proves the device meets them as typically presented for AI/ML-driven medical devices.

The document is a 510(k) premarket notification for the Xtractor™ device, which is a mechanical device for lead extraction, not an AI/ML diagnostic or prognostic tool. Therefore, it does not include details such as:

A table of acceptance criteria and reported device performance related to diagnostic accuracy (e.g., sensitivity, specificity, AUC).
Sample sizes for test sets used for diagnostic accuracy, data provenance, or the number/qualifications of experts for ground truth.
Adjudication methods for ground truth.
Results from multi-reader, multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.
Type of ground truth (pathology, outcomes data, etc.) for diagnostic accuracy.
Training set sample size or ground truth establishment for a machine learning model.

Instead, the performance data section focuses on standard medical device testing for a physical device, including:

Biocompatibility: Tests like cytotoxicity, irritation, sensitization, systemic toxicity, complement activation, hemolysis, and pyrogenicity per ISO 10993-1.
Sterilization, Packaging, and Shelf Life Testing: Validation per ISO 11135-1, transportation simulation, and environmental tests.
Performance Testing (Mechanical/Physical):
- Bending Test
- Corrosion Resistance (ASTM A967/A967M)
- Device Radiopacity
- Dimensional Verification
- Tensile Strength
- Extended Use
- Torque Test
- Simulated Use (in an anatomical model simulator at T0 and Tx shelf life)
- Hydrophilic Coating Testing (particles, visual, pinch test)
- Xtractor™ vs. Predicate comparison test
Software Validation: Conducted as per FDA guidance for contained software, with a moderate level of concern.
Electrical Safety and EMC: Per IEC 60601-1 and IEC 60601-1-2.

The document states that "All tests passed and met the predefined acceptance criteria," but it does not explicitly list these criteria in a table alongside reported performance for each test. The predefined acceptance criteria would be specific thresholds or results required for each of the performance tests listed above (e.g., "no signs of defects, wear or deformations" for extended use, or specific values for tensile strength, etc.). An "Xtractor™ vs. Predicate comparison test" is mentioned, indicating a direct comparison was likely part of the performance evaluation.

In summary, the provided text details the type of non-clinical performance studies conducted for a mechanical medical device to demonstrate safety and effectiveness for 510(k) clearance, rather than the kind of AI/ML evaluation typically requested in the prompt.

Summary

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February 17, 2022

Xcardia Innovation Ltd. % Orly Maor Regulatory Consultant 25 Sirkin Street Kfar Saba, 4442156 Israel

Re: K211679

Trade/Device Name: Xtractor device Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator For Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: January 17, 2022 Received: January 21, 2022

Dear Orly Maor:

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,

for

Hetal Odobasic Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

K211679

Device Name Xtractor™ device

Indications for Use (Describe)

The Xtractor™ device is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects.

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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Traditional Premarket Notification Submission - 510(k) Xtractor™ device 510(k) Number K211679

Date Prepared: February 15, 2022

I. SUBMITTER

Xcardia Innovation Ltd. 1 Hamada St. Rehovot 7670301, Israel E-mail: info@xcardia.com Tel: +97286321175

Contact Person

Orly Maor 25 Sirkin Street Kfar Saba 44421 Israel Tel: +972-9-7453607 oram.ma@gmail.com

II. DEVICE

Name of Device: Xtractor™ device Common or Usual Name: Xtractor™ device Classification Name: 21 CFR 870.1310; Vessel dilator for percutaneous catheterization Regulatory Class: II Product Code: DRE.

III. PREDICATE DEVICE

Xcardia Innovation Ltd. believes that the Xtractor™ device is substantially equivalent to the following predicate device:

Spectranetics TightRail™ Mechanical Dilator Sheath Set cleared under K140047 . (product code DRE Regulation No. 21 CFR 870.1310) and in subsequent submission under K142546 TightRail and TightRail Mini Rotating Dilator Sheaths.

DEVICE DESCRIPTION IV.

The Xtractor™ device is a single use sterilized device designed to be advanced through the veins over a cardiac pacemaker/defibrillator lead.

The device is a motor driven mechanical tool that is introduced over the lead and follows its path, using a flexible and steerable shaft connected to a control handle.

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The proximal section of the shaft maintains pushability while the distal section is very flexible, to facilitate easy passage through vein curves and junctions. The device' distal tip is designed to facilitate dilation of fibrous binding tissue and passage through calcified binding sites along the implanted lead (for example by use of combined rotational and impact movements).

The device' control handle, which is connected to the shaft, contains a steering mechanism for assisting the device maneuverability, and a motorized power transmission mechanism to activate the device tip.

The Xtractor™ device is visible under fluoroscopy during the procedure.

V. INDICATIONS FOR USE

The Xtractor™ device is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Xtractor™ device has the same intended use as the predicate device. Its indications for use are identical to that of the predicate device.

	Xtractor™	TightRail™	SE JUSTIFICATION
510(k) Number	K211679	K140047	—
Manufacturer	Xcardia Innovation Ltd.	Spectranetics, Inc.	—
Product Code	DRE	DRE	Same
CFR	21 CFR 870.1310	21 CFR 870.1310	Same
Intended Use	The Xtractor™ device isintended for use in patientsrequiring the percutaneousdilation of tissue tofacilitate removal ofcardiac leads, indwellingcatheters, and foreignobjects.	The TightRail™ RotatingDilator Sheaths areintended for use inpatients requiring thepercutaneous dilation oftissue to facilitateremoval of cardiac leads,indwelling catheters, andforeign objects.	Same
Nominal OuterDiameter	7.75mm	6.6mm without sheathand is designed to be usedwith a 8.1mm sheath	SimilarThe nominal outerdiameter is similar.
	Xtractor™	TightRail™	SE JUSTIFICATION
Nominal InnerDiameter	13Fr	9,11,13 Fr	SimilarThe nominal innerdiameter is similar.
Nominaleffective length	540mm	475mm	SimilarThe nominal effectivelength is similar.
RadiopacityMarkers	Device: Radio-detectablematerials source is the denselayers of stainless steel coilsSheath: Radio-detectablematerials source is Tefloncompounded with 10-12%bismuth	Device: Radio-detectablematerials source is the denselayers of stainless steel coilsSheath: Radio-detectablematerials source is Tefloncompounded with bismuthtrioxide	SimilarThe radiopacity markersare similar.
Blade design	Two circular rings: a rotatingblade for dilation, and a bluntimpact ring for axialdilatation	Serrated / InterruptedBeveled EdgeBlade includes an axialtranslation during rotation.	SimilarBoth designs are suitablefor dilation ofsurrounding tissue.
Blade feature	ShieldedBlade is covered by the bluntring.	ShieldedBlade is retracted into theshaft.	Similar.Achieved by different butsubstantially equivalentmechanism.
Materials	Stainless Steel, Pebax JacketPTFE Teflon with bismuth forradiopacityHydrophilic coating	Stainless Steel, Pebax JacketPTFE Teflon with bismuthtrioxide for radiopacity	Similar
Shaft Design	Shaft is designed to providea flexible means of aligningthe shaft and tip assemblyparallel tothe vessel wall in theexpected curvature ofthe anatomy.	Shaft is designed toprovide a flexible meansof aligning the shaft andtip assembly parallel to thevessel wall in the expectedcurvature of the anatomy.	Same
	Xtractor™	TightRail™	SE JUSTIFICATION
Outer Sheath /External Sheathdesign	Outer Sheath / Teflon (radio-detectable)Beveled distal end (tonavigate the expectedcurvature of the anatomy)The Xtractor™ externalsheath has flare proximal endfor convenient grip.The Xtractor™ device (notthe sheath) already has ablunt proximal end, thussupports counter traction torelease of the lead from themyocardium	Outer Sheath / Teflon(radio-detectable)Beveled distal (tonavigate the expectedcurvature of the anatomy)Blunt straight proximalend when flipped around(to provide a blunt surfacefor counter-traction at therelease of the lead from themyocardium)	Both devices have samepurpose and similarperformance forsupporting the procedureand entry into the vessel.
Anatomical Siteused	From pacemaker pocket,through the veins, along thepath towards the heart	From pacemaker pocket,through the veins, along thepath towards the heart	Same
Environments ofUse	Physicians knowledge in thetechniques and devices forlead or catheter removal	Physicians knowledge in thetechniques and devices forlead or catheter removal	Same
Sterilization	Sterile for single use (EtO)	Sterile for single use (EtO)	Same
Device Life	Disposable	Disposable	Same
Prescription Use	The device should be used bya physician who is familiarwith the intended procedures.	The device should be usedby a physician who isfamiliar with the intendedprocedures.	Same
Operation	Battery operated	Mechanical	Testing demonstratedsubstantial equivalencewith respect to safeoperation
Haptic feel	The user advances the deviceand pulls the lead manually.The user activates themotorized rotation of the shaftusing the handle's button orpedal.	The user advances the deviceand pulls the lead manually.The user rotates the shaft bymanual squeezing of the	The user advances thedevice and pulls the leadin exact same way.Rotation is achieved bydifferent but substantiallyequivalent mechanisms.
	Xtractor™	TightRail™	SE JUSTIFICATION
Mechanisms ofaction/tissueinteraction	The Xtractor™ has a rotatingdilation blade that rotates toassists the user in separatingthe tissue that is bound aroundthe lead. The blade has sharpteeth that when pushedagainst the fibrotic tissue areused to assist in separating it.The Xtractor™ has a"combined" mode	The TightRail™ device has arotating dilation blade thatrotates to assist the user inseparating the tissue that isbound around the lead. Theblade has sharp teeth thatwhen pushed against thefibrotic tissue are used toassist in separating it.The TightRail™ device isactually working in a similar"combined" mode.	The mechanism of action,tissue interaction, and fullcontrol by the user issimilar for both devices.For the Extractor™, thetotal amount of rotarydilation is controlled bythe duration of buttonpress and in the predicatedevice by number ofsqueezes.The Xtractor™ enablesthe user to select modesin which only sub-set ofthe actions would beperformed.The activation is fullycontrolled by the user inboth devices.The user can start andstop the shaft rotation atany time and changemode as desired in theXtractor™.
Pedal	The Xtractor has a pedal thatincludes the battery andelectrical circuitry to drive thehandle's motor, LED displayand buttons.The pedal can be used toselect modes and for deviceactivation.	NA	The Xtractor™ pedalprovides battery power,mode selection and forconvenient use by user.The Xtractor™ can beused to release the handof the user from manuallysqueezing the trigger asin the predicate device.The activation is fullycontrolled by the user inboth devices.The user can start andstop the shaft rotation atany time and changemode as desired inXtractor™.Electrical safety, EMCand software testing were

The Xtractor™ device has similar technological characteristics as the predicate device as demonstrated in the table below:

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

Biocompatibility -

Biocompatibility evaluation in compliance with ISO 10993-1 was performed. The following tests were conducted: Cytotoxicity Study Xtractor™ -Device Cytotoxicity Study- Handle Cytotoxicity- pooling rod ISO Intracutaneous /irritation Study Sensitization Test Acute Systemic toxicity SC5b-9 Complement Activation Assay ASTM Hemolysis Pyrogen Study - Material Mediated ASTM Partial Thromboplastin Time with Sponsor Provided Control NAVI The device was found biocompatible.

Sterilization, Packaging and Shelf Life Testing -

Sterilization validation was performed to demonstrate compliance with ISO 11135-1. In addition, transportation simulation and environmental tests prior shelf life and packaging testing were performed to support the labeled shelf life. All tests were successfully completed.

Performance Testing -

Performance testing included the following:

Name of test	Test description
Bending Test	The test was done to verify that the XtractorTM deviceis functional after working in an extreme bendingradius.
Corrosion Resistance	Corrosion resistance was tested per ASTMA967/A967M
Device radiopacity	The test was done to verify that the XtractorTM deviceis visible under fluoroscopy.
Dimensional Verification	Measurements following sterilization of theXtractorTM device critical dimensions were taken.
Tensile strength	The test was done to define the tensile strength of theXtractorTM device and the External Sheath.
Extended use	Test was done to verify that the XtractorTM device isnot damaged by the procedure and remains without

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Name of test	Test description
	signs of defects, wear or deformations in substantiallyextended and/or extreme use
	Torque test	Torque transmission from the handle to the distal tipboth inner and outer shaft was tested.
	Simulated use	Simulated use of the device in anatomical modelsimulator was done in time T0 and time Tx (shelflife)
Hydrophilic coating testing		3 tests (particles, visual, and pinch test) thatdemonstrated that the device coating performs asintended.
		Xtractor™ vs. Predicate comparisontest

All tests passed and met the predefined acceptance criteria.

Software Validation -

The Xtractor™ device level of concern is moderate. Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

-Electrical Safety and EMC

Electrical Safety per IEC 60601-1 and Electromagnetic compatibility (EMC) per IEC 60601-1-2 were conducted on the Xtractor™ Lead Extraction device.

VIII. CONCLUSION

The Xtractor™ device was determined to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).