(25 days)
Not Found
No
The device description and performance studies focus on the mechanical and electrical components of the microcoil delivery system, with no mention of AI or ML for image analysis, decision support, or any other function.
Yes
The device is intended for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, which are medical treatments.
No
This device is an embolization coil delivery system used for treatment (endovascular embolization), not for diagnosis.
No
The device description clearly outlines physical components including microcoils, a connecting cable, and a Detachment Control Box (DCB), indicating it is a hardware device with potential software control for the detachment mechanism.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for endovascular embolization of various vascular abnormalities within the body. This is a therapeutic procedure performed in vivo (within a living organism).
- Device Description: The device description details a system for delivering microcoils into blood vessels. This is consistent with an interventional medical device used for treatment, not for analyzing samples in vitro (outside of a living organism).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
In summary, the device is an interventional medical device used for therapeutic purposes within the body, which is distinct from an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indications for Use (Describe)
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 fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
HCG, KRD
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, peripheral vasculature
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)
Non-Clinical Performance Data
| Test | Test Method Summary | Results |
|---|---|---|
| Tracking Force (delivery) | The purpose of the Track Force test was to evaluate the force it takes to deliver the subject device through a microcatheter; utilizing the system Catheter Performance Simulation System (CPSS). | Pass Samples passed the established acceptance criteria |
| Test | Test Method Summary | Results |
|---|---|---|
| Simulated Use: Tracking Force (delivery) | The purpose of the Tracking Force test was to evaluate the ease of deliverability of the coils through the microcatheter in a clinically relevant bench top model. | Pass Samples passed the established acceptance criteria |
| Simulated Use: Microcatheter Stability | The purpose of the Microcatheter Stability test was to evaluate the amount of movement of the microcatheter tip from its starting position in a clinically relevant bench top model. | Pass Samples passed the established acceptance 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.
Clinical Performance Data: Clinical studies were not required as appropriate verification and validation of the minor design modifications was achieved based on the bench testing.
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.
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
§ 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).
0
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
1
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
2
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)
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 fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.
| 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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3
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 Delivery | |
| Systems | |
| Common or Usual Name | Device, Neurovascular Embolization & Vascular, for Promoting |
| Embolization | |
| Classification Name | Class II 21 CFR 882.5950 – Device, Neurovascular Embolization |
| Class II 21 CFR 870.3300 – Device, Vascular, For Promoting | |
| Embolization | |
| 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, and | |||
| GALAXY G3 XSFT Microcoil | |||
| Delivery Systems | Medos | ||
| International | |||
| SARL* | |||
| K171862 | Sep 25, 2017 | GALAXY G3 Mini Microcoil Delivery | |
| System | |||
| K150319 | Jun 12, 2015 | MICRUSFRAME, DELTAFILL, | |
| DELTAXSFT, GALAXY G3, and | |||
| GALAXY G3 XSFT Microcoil | |||
| Delivery Systems | Medos | ||
| International | |||
| SARL* |
Continued on next page
4
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.
5
| 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. |
6
| VI. | Table 3-1. Technological Characteristics of the Predicate and Subject Device | ||
|---|---|---|---|
| Comparison of | |||
| Technological | |||
| Characteristics | |||
| with Predicate | |||
| Device, | |||
| continued | Description | Predicate Devices: | |
| MICRUSFRAME, DELTAFILL, | |||
| DELTAXSFT, GALAXY G3, GALAXY | |||
| G3 XSFT Microcoil Delivery Systems | |||
| (K150319, K171747) | This Submission: | ||
| MICRUSFRAME, | |||
| DELTAFILL, | |||
| DELTAXSFT, GALAXY | |||
| G3, GALAXY G3 XSFT | |||
| Microcoil Delivery | |||
| Systems | |||
| 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. | Same as Predicate | ||
| Microcoil | |||
| Microcoil Material | Platinum/Tungsten | Same as Predicate | |
| Microcoil Primary | |||
| Wind | Triangular or Cylindrical | Same as Predicate | |
| Microcoil Secondary | |||
| Shape | Complex, Helical, or Spherical | Same as Predicate | |
| Microcoil Stretch- | |||
| Resistant | PGA= Polyglycolic Acid Suture | ||
| PP= Polypropylene Suture | Same as Predicate | ||
| Primary Coil Wind | |||
| Outer Diameter (OD) | 0.009" - 0.015" | Same as Predicate | |
| Secondary Shape OD | |||
| Ranges | 1.5mm - 24mm | Same as Predicate | |
| Microcoil Length | |||
| Ranges | 1cm - 60cm | Same as Predicate | |
| Delivery System Type | Wire Shaft with radiopaque marker | Same as Predicate | |
| Delivery System | |||
| Delivery System | |||
| Introducer Sheath | HDPE Introducer | Same as Predicate | |
| Delivery System | |||
| Resheathing Tool | Nylon 12 | Same as Predicate | |
| Introducer Tip Wall | |||
| Thickness | 0.0103" | Same as Predicate | |
| Introducer Sheath | |||
| Length | 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, GALAXY | |||
| G3 XSFT Microcoil Delivery Systems | |||
| (K150319, K171747) | This Submission: | ||
| MICRUSFRAME, | |||
| DELTAFILL, | |||
| DELTAXSFT, GALAXY | |||
| G3, GALAXY G3 XSFT | |||
| Microcoil Delivery | |||
| Systems | |||
| Delivery System, continued | |||
| Device Positioning | |||
| Unit (DPU) Delivery | |||
| System Length | 190cm ± 5cm | Same as Predicate | |
| Device Positioning | |||
| Unit Diameter | 0.0159" | Same as Predicate | |
| Fluoroscopy Saver | |||
| Markers | Five Markers Located on the Proximal | ||
| Section of the Shaft | Same as Predicate | ||
| Fluoro Saver Marker | |||
| Microcatheter | |||
| Compatibility | 150cm Length | Same as Predicate | |
| Mechanism of | |||
| Detachment | Connection to Microcoil System: Uses | ||
| Connecting Cable or ENPOWER | |||
| Control Cable | |||
| Detachment: Thermo-Mechanical System | |||
| uses the ENPOWER Detachment Control | |||
| Box (DCB) with ENPOWER Control Cable | |||
| or Connecting Cable | Same as Predicate | ||
| Sterilization, Shelf Life, and Packaging | |||
| Sterilization | |||
| Method | Electron Beam Radiation | Same as Predicate | |
| Shelf Life | 3 years | Same as Predicate | |
| Packaging | Packaged in a plastic hoop and enclosed in a | ||
| pouch | Same as Predicate |
7
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 Delivery | |||
| System | |||
| (K171862) | This Submission: | ||
| GALAXY G3 Mini | |||
| Microcoil Delivery System | |||
| Indications for | |||
| Use | 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. | Same as Predicate | ||
| VI. | |||
| Comparison of | |||
| Technological | |||
| Characteristics | |||
| with Predicate | |||
| Device, | |||
| continued | Table 3-2. Technological Characteristics of the Predicate and Subject Device, | ||
| continued | |||
| Description | Predicate Device: | ||
| GALAXY G3 Mini Microcoil Delivery | |||
| System | |||
| (K171862) | This Submission: | ||
| GALAXY G3 Mini | |||
| Microcoil Delivery System | |||
| Microcoil | |||
| Microcoil Material | Platinum/Tungsten | Same as Predicate | |
| Microcoil Primary | |||
| Wind | Cylindrical | Same as Predicate | |
| Microcoil Secondary | |||
| Shape | Complex | Same as Predicate | |
| Microcoil Stretch- | |||
| Resistant | PP= Polypropylene Suture | Same as Predicate | |
| Primary Coil Wind | |||
| Outer Diameter | |||
| (OD) | 0.009" | Same as Predicate | |
| Secondary Shape | |||
| OD Ranges | 1.0mm – 3.0mm | Same as Predicate | |
| Microcoil Length | |||
| Ranges | 1cm – 8cm | Same as Predicate | |
| Delivery System | |||
| Delivery System Type | Wire Shaft with radiopaque marker | Same as Predicate | |
| Delivery System | |||
| Introducer Sheath | HDPE Introducer | Same as Predicate | |
| Delivery System | |||
| Resheathing Tool | Nylon 12 | Same as Predicate | |
| Introducer Tip Wall | |||
| Thickness | 0.0103" | Same as Predicate | |
| Introducer Sheath | |||
| Length | 81cm and 120cm | Same as Predicate | |
| Device Positioning | |||
| Unit (DPU) Delivery | |||
| System Length | 190cm ± 5cm | Same as Predicate | |
| Device Positioning | |||
| Unit Diameter | 0.0159" | Same as Predicate | |
| Fluoroscopy Saver | |||
| Markers | Five Markers Located on the Proximal | ||
| Section of the Shaft | Same as Predicate | ||
| Fluoro Saver Marker | |||
| Microcatheter | |||
| Compatibility | 150cm Length | Same as Predicate | |
| Mechanism of | |||
| Detachment | Connection to Microcoil System: Uses | ||
| Connecting Cable or ENPOWER | |||
| Control Cable | |||
| Detachment: Thermo-Mechanical System | |||
| uses the ENPOWER Detachment Control | |||
| Box (DCB) with ENPOWER Control Cable | |||
| or 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 a | ||
| pouch | 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 evaluate | ||
| the force it takes to deliver the subject device | |||
| through a microcatheter; utilizing the system | |||
| Catheter Performance Simulation System (CPSS). | Pass | ||
| Samples passed the | |||
| established | |||
| acceptance criteria |
| Table 5: Validation Testing | ||
|---|---|---|
| Test | Test Method Summary | Results |
| Simulated Use: | ||
| Tracking Force | ||
| (delivery) | The purpose of the Tracking Force test was to | |
| evaluate the ease of deliverability of the coils | ||
| through the microcatheter in a clinically relevant | ||
| bench top model. | Pass | |
| Samples passed the | ||
| established | ||
| acceptance criteria | ||
| Simulated Use: | ||
| Microcatheter | ||
| Stability | The purpose of the Microcatheter Stability test was | |
| to evaluate the amount of movement of the | ||
| microcatheter tip from its starting position in a | ||
| clinically relevant bench top model. | Pass | |
| Samples passed the | ||
| established | ||
| acceptance 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