The GALAXY G3 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.

The GALAXY G3 XSFT Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

The GALAXY G3 Mini Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.

Device Description

The MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems consist of three components: a Microcoil System, a connecting cable, and a Detachment Control Box (DCB). Each component is sold separately.

The Microcoil System consists of a microcoil attached to a Device Positioning Unit (DPU). The Microcoil System is packaged in an introducer sheath designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the microcatheter. The microcoil is the implantable segment of the device and is detached from the Device Positioning Unit (DPU) using the Detachment Control System (Detachment Control Box and connecting cable).

For the MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, and GALAXY G3 XSFT microcoils: The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which may contain either a polypropylene suture (SR) or an absorbable polymer suture and then formed into a secondary shape. The secondary shape may be spherical, complex, or helical.

For the GALAXY G3 Mini microcoils: The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which contains a polypropylene suture (SR) and then formed into a secondary shape. The secondary shape is complex.

For all Microcoil Delivery Systems: The DPU is a variable stiffness wire and has a radiopaque marker band located three (3) cm from its distal end. The Device Positioning Unit includes five (5) fluoro saver markers on the proximal section of the shaft. The markers are intended to indicate when the tip of the microcoil is approaching the tip of the microcatheter. When the distal-most marker reaches the proximal end of the Rotating Hemostatic Valve (RHV) on the microcatheter, the tip of the coil is approaching the tip of the microcatheter and fluoroscopy should be used to guide further coil insertion.

The introducer sheath has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool.

The connecting cables may be one of two types: one with a remote detach button (the ENPOWER Control Cable) catalog no. ECB000182-00, or one without a detach button (standard connecting cable) catalog no. CCB00157-00. The ENPOWER Detachment Control Box, catalog no. DCB2000500, works with the ENPOWER Control Cable and with the standard connecting cable.

AI/ML Overview

The provided text describes a 510(k) premarket notification for microcoil delivery systems, which are medical devices, not an AI/ML powered device. Therefore, a study proving an AI/ML device meets acceptance criteria is not presented in this document.

The document discusses non-clinical performance data for the microcoil delivery systems, specifically focusing on verification and validation testing of minor design modifications related to the Device Positioning Unit's core wire.

Here's the information regarding the device's acceptance criteria and the study that proves it meets them, based on the provided text, adapted for the context of a medical device rather than an AI/ML system:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria Summary	Reported Device Performance
Tracking Force (delivery) - Verification	Not explicitly stated, but "established acceptance criteria" implies a threshold.	Pass
Simulated Use: Tracking Force (delivery) - Validation	Not explicitly stated, but "established acceptance criteria" implies a threshold.	Pass
Simulated Use: Microcatheter Stability - Validation	Not explicitly stated, but "established acceptance criteria" implies a threshold.	Pass

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document mentions "Samples" in the results, but doesn't quantify the number of units tested for each criterion.
Data Provenance: The tests were conducted internally as "bench testing." The country of origin is not specified, but the applicant, Medos International SARL, is located in Le Locle, Switzerland. The testing is retrospective, as it's part of a 510(k) submission for an already manufactured device with minor modifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable as the study involved non-clinical bench testing of a physical medical device, not a diagnostic or prognostic system requiring expert interpretation of data or images. The "ground truth" here is determined by the physical properties and performance measured during the tests.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements of physical performance and do not involve human adjudication in the typical sense of reviewing subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device, and no MRMC study was performed. The document explicitly states: "Clinical studies were not required as appropriate verification and validation of the minor design modifications was achieved based on the bench testing."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was defined by objective physical measurements and engineering specifications, which determine whether the device meets its design requirements. For example, "tracking force" would have a specified maximum force for successful delivery, and "microcatheter stability" would have an acceptable range of movement.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in the AI/ML context.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no AI/ML training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the words "U.S. Food & Drug Administration" on the right. The FDA part of the logo is in blue, with the acronym in a darker shade and the words in a lighter shade.

May 28, 2021

Medos International SARL % Ariell Joiner, Ph.D. Senior Regulatory Affairs Program Lead CERENOVUS 6303 Blue Lagoon Drive, Suite 315 Miami, Florida 33126

Re: K211344

Trade/Device Name: MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG. KRD Dated: April 30, 2021 Received: May 3, 2021

Dear Dr. Ariell Joiner:

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

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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,

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211344

Device Name

MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems

Indications for Use (Describe)

The GALAXY G3 XSFT Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

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 - K211344

I. Submitter Medos International SARL Chemin-Blanc 38 2400 Le Locle, Switzerland

Tel: +1 (908) 249-0182

Contact Person: Ariell Joiner Email: ajoiner@jts.jnj.com

Date Prepared: April 30, 2021

II. Devices

Table 1. Device
Device Proprietary Name	MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3,GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil DeliverySystems
Common or Usual Name	Device, Neurovascular Embolization & Vascular, for PromotingEmbolization
Classification Name	Class II 21 CFR 882.5950 – Device, Neurovascular EmbolizationClass II 21 CFR 870.3300 – Device, Vascular, For PromotingEmbolization
Regulatory Classification	II
Product Codes	HCG, KRD

III. Predicate

The predicate devices are listed below in Table 2.

Devices

Table 2: Predicate Devices
510(k) Number	Date Cleared	Name	Manufacturer
K171747	Jul 14, 2017	MICRUSFRAME, DELTAFILL,DELTAXSFT, GALAXY G3 FILL, andGALAXY G3 XSFT MicrocoilDelivery Systems	MedosInternationalSARL*
K171862	Sep 25, 2017	GALAXY G3 Mini Microcoil DeliverySystem
K150319	Jun 12, 2015	MICRUSFRAME, DELTAFILL,DELTAXSFT, GALAXY G3, andGALAXY G3 XSFT MicrocoilDelivery Systems	MedosInternationalSARL*

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The MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 IV. Device Description XSFT, and GALAXY G3 Mini Microcoil Delivery Systems consist of three components: a Microcoil System, a connecting cable, and a Detachment Control Box (DCB). Each component is sold separately.

As shown in Figure 1, the Microcoil System consists of a microcoil attached to a Device Positioning Unit (DPU).

Image /page/4/Figure/4 description: This image shows a microcoil system. The system includes a hub connector, a re-sheathing tool, an introducer sheath body, and an introducer sheath tip. The device positioning unit (DPU) is labeled, as well as the microcoil.

The Microcoil System is packaged in an introducer sheath designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the microcatheter. The microcoil is the implantable segment of the device and is detached from the Device Positioning Unit (DPU) using the Detachment Control System (Detachment Control Box and connecting cable).

For the MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, and GALAXY G3 XSFT microcoils:

. The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which may contain either a polypropylene suture (SR) or an absorbable polymer suture and then formed into a secondary shape. The secondary shape may be spherical, complex, or helical.

For the GALAXY G3 Mini microcoils:

. The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which contains a polypropylene suture (SR) and then formed into a secondary shape. The secondary shape is complex.

For all Microcoil Delivery Systems:

. The DPU is a variable stiffness wire and has a radiopaque marker band located three (3) cm from its distal end. The Device Positioning Unit includes five (5) fluoro saver markers on the proximal section of the shaft. The markers are intended to indicate when the tip of the microcoil is approaching the tip of the microcatheter. When the distal-most marker reaches the proximal end of the Rotating Hemostatic Valve (RHV) on the microcatheter, the tip of the coil is approaching the tip of the microcatheter and fluoroscopy should be used to guide further coil insertion.
. The introducer sheath has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool.

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IV. Device Description, continued	The ENPOWER Detachment Control Box (DCB) provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU. The connecting cable delivers the energy necessary to detach the embolic coil from the Microcoil System's detachment zone. The connecting cable is connected between the Microcoil System's hub connector on the DPU and the output connector on the DCB.The connecting cables may be one of two types: one with a remote detach button (the ENPOWER Control Cable) catalog no. ECB000182-00, or one without a detach button (standard connecting cable) catalog no. CCB00157-00. The ENPOWER Detachment Control Box, catalog no. DCB2000500, works with the ENPOWER Control Cable and with the standard connecting cable.
V. Indications for Use	MICRUSFRAME, DELTAFILL, and DELTAXSFT Microcoil Delivery Systems are intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.The GALAXY G3 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.The GALAXY G3 XSFT Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.The GALAXY G3 Mini Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.
VI. Comparison of Technological Characteristics with Predicate Device	The devices in this submission include minor design changes (reduced distal outer diameter and taper transition) only to the Core Wire of the Device Positioning Unit. There are no modifications to the material of the Core Wire, to other elements of the Device Positioning Unit, to the components or materials of the microcoil, to the introducer, or to the ENPOWER Detachment Control System.Endovascular coil embolization is the technological principle for both the subject and predicate devices. This technology is based on placing embolic coils in the neurovascular or peripheral vasculature to reduce or block blood flow. The subject devices and predicate devices are based on the same overall technological characteristics as shown in Table 3-1 and Table 3-2.

IV. Device Description, continued

The ENPOWER Detachment Control Box (DCB) provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU. The connecting cable delivers the energy necessary to detach the embolic coil from the Microcoil System's detachment zone. The connecting cable is connected between the Microcoil System's hub connector on the DPU and the output connector on the DCB.The connecting cables may be one of two types: one with a remote detach button (the ENPOWER Control Cable) catalog no. ECB000182-00, or one without a detach button (standard connecting cable) catalog no. CCB00157-00. The ENPOWER Detachment Control Box, catalog no. DCB2000500, works with the ENPOWER Control Cable and with the standard connecting cable.

V. Indications for Use

MICRUSFRAME, DELTAFILL, and DELTAXSFT Microcoil Delivery Systems are intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.The GALAXY G3 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.The GALAXY G3 XSFT Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.The GALAXY G3 Mini Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.

VI. Comparison of Technological Characteristics with Predicate Device

The devices in this submission include minor design changes (reduced distal outer diameter and taper transition) only to the Core Wire of the Device Positioning Unit. There are no modifications to the material of the Core Wire, to other elements of the Device Positioning Unit, to the components or materials of the microcoil, to the introducer, or to the ENPOWER Detachment Control System.Endovascular coil embolization is the technological principle for both the subject and predicate devices. This technology is based on placing embolic coils in the neurovascular or peripheral vasculature to reduce or block blood flow. The subject devices and predicate devices are based on the same overall technological characteristics as shown in Table 3-1 and Table 3-2.

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VI.	Table 3-1. Technological Characteristics of the Predicate and Subject Device
Comparison ofTechnologicalCharacteristicswith PredicateDevice,continued	Description	Predicate Devices:MICRUSFRAME, DELTAFILL,DELTAXSFT, GALAXY G3, GALAXYG3 XSFT Microcoil Delivery Systems(K150319, K171747)	This Submission:MICRUSFRAME,DELTAFILL,DELTAXSFT, GALAXYG3, GALAXY G3 XSFTMicrocoil DeliverySystems
	Indications for Use	MICRUSFRAME, DELTAFILL, andDELTAXSFT Microcoil Delivery Systemsare intended for endovascular embolization ofintracranial aneurysms, other neurovascularabnormalities such as arteriovenousmalformations and arteriovenous fistulae, andare also intended for arterial and venousembolizations in the peripheral vasculature.The GALAXY G3 Microcoil DeliverySystem is intended for endovascularembolization of intracranial aneurysms, otherneurovascular abnormalities such asarteriovenous malformations andarteriovenous fistulae, and is also intended forarterial and venous embolizations in theperipheral vasculature.The GALAXY G3 XSFT Microcoil DeliverySystem is intended for endovascularembolization of intracranial aneurysms.	Same as Predicate
		Microcoil
	Microcoil Material	Platinum/Tungsten	Same as Predicate
	Microcoil PrimaryWind	Triangular or Cylindrical	Same as Predicate
	Microcoil SecondaryShape	Complex, Helical, or Spherical	Same as Predicate
	Microcoil Stretch-Resistant	PGA= Polyglycolic Acid SuturePP= Polypropylene Suture	Same as Predicate
	Primary Coil WindOuter Diameter (OD)	0.009" - 0.015"	Same as Predicate
	Secondary Shape ODRanges	1.5mm - 24mm	Same as Predicate
	Microcoil LengthRanges	1cm - 60cm	Same as Predicate
	Delivery System Type	Wire Shaft with radiopaque marker	Same as Predicate
		Delivery System
	Delivery SystemIntroducer Sheath	HDPE Introducer	Same as Predicate
	Delivery SystemResheathing Tool	Nylon 12	Same as Predicate
	Introducer Tip WallThickness	0.0103"	Same as Predicate
	Introducer SheathLength	120cm and 81cm	Same as Predicate
Table 3-1. Technological Characteristics of the Predicate and Subject Device,continued
Description	Predicate Devices:MICRUSFRAME, DELTAFILL,DELTAXSFT, GALAXY G3, GALAXYG3 XSFT Microcoil Delivery Systems(K150319, K171747)	This Submission:MICRUSFRAME,DELTAFILL,DELTAXSFT, GALAXYG3, GALAXY G3 XSFTMicrocoil DeliverySystems
	Delivery System, continued
Device PositioningUnit (DPU) DeliverySystem Length	190cm ± 5cm	Same as Predicate
Device PositioningUnit Diameter	0.0159"	Same as Predicate
Fluoroscopy SaverMarkers	Five Markers Located on the ProximalSection of the Shaft	Same as Predicate
Fluoro Saver MarkerMicrocatheterCompatibility	150cm Length	Same as Predicate
Mechanism ofDetachment	Connection to Microcoil System: UsesConnecting Cable or ENPOWERControl CableDetachment: Thermo-Mechanical Systemuses the ENPOWER Detachment ControlBox (DCB) with ENPOWER Control Cableor Connecting Cable	Same as Predicate
Sterilization, Shelf Life, and Packaging
SterilizationMethod	Electron Beam Radiation	Same as Predicate
Shelf Life	3 years	Same as Predicate
Packaging	Packaged in a plastic hoop and enclosed in apouch	Same as Predicate

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VI.

Comparison of Technological Characteristics with Predicate Device, continued

Table 3-2. Technological Characteristics of the Predicate and Subject Device
Description	Predicate Device:GALAXY G3 Mini Microcoil DeliverySystem(K171862)	This Submission:GALAXY G3 MiniMicrocoil Delivery System
Indications forUse	The GALAXY G3 Mini Microcoil DeliverySystem is intended for endovascularembolization of intracranial aneurysms, otherneurovascular abnormalities such asarteriovenous malformations andarteriovenous fistulae, and is also intended forarterial and venous embolizations in theperipheral vasculature.	Same as Predicate
VI.Comparison ofTechnologicalCharacteristicswith PredicateDevice,continued		Table 3-2. Technological Characteristics of the Predicate and Subject Device,continued
	Description	Predicate Device:GALAXY G3 Mini Microcoil DeliverySystem(K171862)	This Submission:GALAXY G3 MiniMicrocoil Delivery System
		Microcoil
	Microcoil Material	Platinum/Tungsten	Same as Predicate
	Microcoil PrimaryWind	Cylindrical	Same as Predicate
	Microcoil SecondaryShape	Complex	Same as Predicate
	Microcoil Stretch-Resistant	PP= Polypropylene Suture	Same as Predicate
	Primary Coil WindOuter Diameter(OD)	0.009"	Same as Predicate
	Secondary ShapeOD Ranges	1.0mm – 3.0mm	Same as Predicate
	Microcoil LengthRanges	1cm – 8cm	Same as Predicate
		Delivery System
	Delivery System Type	Wire Shaft with radiopaque marker	Same as Predicate
	Delivery SystemIntroducer Sheath	HDPE Introducer	Same as Predicate
	Delivery SystemResheathing Tool	Nylon 12	Same as Predicate
	Introducer Tip WallThickness	0.0103"	Same as Predicate
	Introducer SheathLength	81cm and 120cm	Same as Predicate
	Device PositioningUnit (DPU) DeliverySystem Length	190cm ± 5cm	Same as Predicate
	Device PositioningUnit Diameter	0.0159"	Same as Predicate
	Fluoroscopy SaverMarkers	Five Markers Located on the ProximalSection of the Shaft	Same as Predicate
	Fluoro Saver MarkerMicrocatheterCompatibility	150cm Length	Same as Predicate
	Mechanism ofDetachment	Connection to Microcoil System: UsesConnecting Cable or ENPOWERControl CableDetachment: Thermo-Mechanical Systemuses the ENPOWER Detachment ControlBox (DCB) with ENPOWER Control Cableor Connecting Cable	Same as Predicate
		Sterilization, Shelf Life, and Packaging
	Sterilization Method	Ethylene Oxide (EtO)	Same as Predicate
	Shelf Life	3 years	Same as Predicate
	Packaging	Packaged in a plastic hoop and enclosed in apouch	Same as Predicate

Continued on next page

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VII. Non-	Table 4: Verification Testing
Clinical	Test	Test Method Summary	Results
Performance
Data	Tracking Force(delivery)	The purpose of the Track Force test was to evaluatethe force it takes to deliver the subject devicethrough a microcatheter; utilizing the systemCatheter Performance Simulation System (CPSS).	PassSamples passed theestablishedacceptance criteria

Table 5: Validation Testing
Test	Test Method Summary	Results
Simulated Use:Tracking Force(delivery)	The purpose of the Tracking Force test was toevaluate the ease of deliverability of the coilsthrough the microcatheter in a clinically relevantbench top model.	PassSamples passed theestablishedacceptance criteria
Simulated Use:MicrocatheterStability	The purpose of the Microcatheter Stability test wasto evaluate the amount of movement of themicrocatheter tip from its starting position in aclinically relevant bench top model.	PassSamples passed theestablishedacceptance criteria

Animal Testing

N/A – No animal studies were required as appropriate verification and validation of the modifications was achieved based on the bench testing.

Shelf Life Testing

N/A - Changes did not impact the shelf-life of the product.

Biocompatibility Testing

N/A - Changes did not impact biocompatibility.

Sterilization

N/A - Changes did not impact sterilization.

VIII. Clinical Clinical studies were not required as appropriate verification and validation of the Performance minor design modifications was achieved based on the bench testing. Data

IX. Conclusion The minor design modifications made to the Core Wire of the Device Positioning Unit do not alter the intended use or indications for use of the subject devices. The overall technological characteristics of the subject and predicate devices remain the same. The risk assessment and successful verification and validation testing raises no new questions regarding the safety and effectiveness of the devices. Therefore, the modified devices are substantially equivalent to their respective predicate devices.

End of 510(k) Summary

Regulation Number and Section

§ 882.5950 Neurovascular embolization device.

(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).