(123 days)
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 MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT 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). 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 catheter. 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). 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. 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 works with the EnPower Control Cable and with the standard connecting cable. The device in this submission includes design changes only to the Device Positioning Unit (DPU) element of the microcoil system. There are no modifications to the microcoil components or to the EnPOWER Detachment Control system.
This document describes the premarket notification (510(k)) for the MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, and GALAXY G3 XSFT Microcoil Delivery Systems. The submission focuses on design changes to the Device Positioning Unit (DPU) element of the microcoil system, emphasizing that there are no modifications to the microcoil components or the detachment control system.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established as "PASS," indicating that the samples met the predetermined criteria for each test. Specific quantitative criteria are not explicitly detailed in this summary.
| Test Category | Acceptance Criteria (Implicit from "PASS") | Reported Device Performance |
|---|---|---|
| Performance Verification | ||
| Microcatheter Stability | Samples passed established criterion | PASS |
| Coil Detachment Durability & Reliability | Samples passed established criterion | PASS |
| Coil Durability (Coil to DPU) | Samples passed established criterion | PASS |
| Distal Outer Sheath Durability | Samples passed established criterion | PASS |
| Track Force (Delivery) | Samples passed established criterion | PASS |
| Re-Sheathing Reliability | Samples passed established criterion | PASS |
| Fluoro Saver Marker Durability | Samples passed established criterion | PASS |
| Detachment Zone Tensile Strength | Samples passed established criterion | PASS |
| Dimensional Inspection of OD | OD within specification for compatibility | PASS |
| Dimensional Inspection of OAL | Appropriate length for compatibility | PASS |
| Dimensional Inspection of Length from Distal Tip to Radiopaque Marker Band | Appropriately placed marker band | PASS |
| Dimensional Inspection of Distal Fluoro Saver Markers | Correct proximal position | PASS |
| Detachment Zone Microcatheter Surface Temperature Comparison | Equivalent temperatures to predicate, no acute tissue inflammatory response | PASS (equivalent, no inflammation) |
| Biocompatibility Testing | ||
| In Vitro Cytotoxicity (Cut DPU3) | PASS | PASS |
| In Vitro Cytotoxicity (Uncut DPU3) | PASS | PASS |
| Guinea Pig Sensitization | PASS | PASS |
| Intracutaneous/Irritation Reactivity | PASS | PASS |
| Acute Systemic Toxicity | PASS | PASS |
| Material Mediated Pyrogenicity | PASS | PASS |
| Endotoxin | PASS | PASS |
| In Vitro Ames Bacterial Reverse Mutation Assay | PASS | PASS |
| In Vitro Mouse Lymphoma Mutagenicity Assay | PASS | PASS |
| In Vivo Mouse Peripheral Blood Micronucleus Assay | PASS | PASS |
| In Vitro Hemolysis | PASS | PASS |
| ASTM Partial Thromboplastin Time | PASS | PASS |
| C3a Complement Activation | PASS | PASS |
| SC5b-9 Complement Activation | PASS | PASS |
| In Vivo Thromboresistance in Dogs | PASS | PASS |
| USP Physicochemical Tests (Aqueous Extracts) | PASS | PASS |
| Determination of Extractable Metals By ICP-OES | PASS | PASS |
| Physicochemical Tests (Non-aqueous Extracts) | PASS | PASS |
| Sterilization Validation | Sterility Assurance Level (SAL) 10⁻⁶ | Achieved SAL 10⁻⁶ |
| Shelf-Life Testing | Will be conducted per FDA guidance | Not yet reported (will be conducted) |
2. Sample Sizes Used for the Test Set and Data Provenance
The document states that testing was conducted using "statistical sampling methods as required by the Codman & Shurtleff, Inc. Design Control procedures." However, specific numerical sample sizes for each test are not provided.
The data provenance is not explicitly stated as retrospective or prospective, nor is a country of origin mentioned. However, being a premarket notification to the U.S. FDA, it can be inferred that the testing was conducted to meet U.S. regulatory standards, likely in a controlled laboratory environment. The testing is bench testing and biocompatibility testing, not human clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the studies described are bench tests and biocompatibility tests, not clinical studies involving human patients or expert interpretation of diagnostic images/data. The "ground truth" for these tests is defined by the technical specifications and performance requirements of the device, assessed through quantitative measurements and established protocols.
4. Adjudication Method for the Test Set
This information is not applicable for the bench and biocompatibility tests described. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "A clinical study was not required as appropriate verification and validation of the modified Device Positioning Unit (DPU) was achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing." Therefore, there is no effect size for human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device described is a physical medical device (microcoil delivery system), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
For the performance verification testing, the ground truth is established by engineering specifications, direct physical measurements, and adherence to established industry standards and regulatory guidance documents (e.g., ISO, FDA Guidance Document: "Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices").
For biocompatibility testing, the ground truth is defined by established international standards (ISO 10993 series) and USP (United States Pharmacopeia) guidelines for biological response within acceptable limits.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above; there is no training set for a physical device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2015
Codman & Shurtleff, Inc. Ms. Hannah Foley Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
Re: K150319
Trade/Device Name: MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, and GALAXY G3 XSFT Microcoil Delivery Systems Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: May 11, 2015 Received: May 13, 2015
Dear Ms. Foley:
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 device
{1}------------------------------------------------
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150319
Device Name
MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, and GALAXY G3 XSFT 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.
| 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
I. Submitter
Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767
Tel: (305) 265-6810 Fax: (305) 265-6889
Contact Person: Hannah Foley Date Prepared: June 9, 2015
II. Device
| Table 2: Device | |
|---|---|
| Device Proprietary Name | MICRUSFRAME Microcoil Delivery System, DELTAFILL Microcoil Delivery System, DELTAXSFT Microcoil Delivery System, GALAXY G3 Microcoil Delivery System, GALAXY G3 XSFT Microcoil Delivery System |
| Common or Usual Name | Device, Neurovascular Embolization & Vascular, For Promoting Embolization |
| Classification Name | Device, Neurovascular Embolization, Class II, 21 CFR 882.5950 & Vascular, For Promoting Embolization, Class II 21 CFR 870.3300 |
| Regulatory Classification | II |
| Product Codes | HCG, KRD |
III. Predicate Device
The corresponding predicate and reference devices that are listed in Table 3 below are applicable to the devices being bundled in this submission.
| Table 3 : Prior 510(k) Clearance | |||
|---|---|---|---|
| 510(k) Number | Date Cleared | Name | Manufacturer |
| Predicate Device | |||
| Predicate DeviceK082739 | 10/17/2008 | Micrus Microcoil Delivery System** | Micrus EndovascularCorporation* |
| Reference Devices | |||
| Reference DeviceK083646 | 01/02/2009 | Micrus Microcoil System DELTAPLUSH | Micrus EndovascularCorporation* |
| Reference DeviceK033813 | 04/04/2004 | Micrus Modified Microcoil System, Cerecyte | Micrus EndovascularCorporation* |
| Reference DeviceK053160 | 12/07/2005 | Micrus Modified Microcoil 18-System, "Cerecyte" | Micrus EndovascularCorporation* |
| Reference DeviceK062036 | 08/25/2006 | Micrus Microcoil System "Presidio-18" | Micrus EndovascularCorporation* |
| Reference DeviceK072173 | 10/05/2007 | Micrus Microcoil Delivery System | Micrus EndovascularCorporation* |
| Reference DeviceK080437 | 05/08/2008 | Micrus Microcoil Delivery System | Micrus EndovascularCorporation* |
| Reference DeviceK073442 | 02/26/2008 | Micrus Microcoil Delivery System | Micrus EndovascularCorporation* |
| Reference DeviceK120686 | 04/04/2012 | ORBIT GALAXY G2 Microcoil Delivery System | Codman & Shurtleff, Inc |
| Reference DeviceK120274 | 03/02/2012 | DELTAMAXX 18 Microcoil System | Codman & Shurtleff, Inc |
| Reference DeviceK142429 | 12/24/2014 | CODMAN, DELTAMAXX, and ORBIT GALAXYG2 Microcoil Delivery Systems and Cables | Codman & Shurtleff, Inc |
| Reference DeviceK093973 | 05/26/2010 | ORBIT GALAXY Detachable Coil System | Codman & Shurtleff, Inc |
| Reference DeviceK132281 | 08/30/2013 | REVIVE Peripheral Vascular (PV) ThrombectomyDevice | Codman & Shurtleff, Inc |
| Reference DeviceK140080 | 04/24/2014 | ENVOY Distal Access (DA) Guiding Catheter | Codman & Shurtleff, Inc |
| Reference DeviceK123377 | 11/30/2012 | Target Detachable Coils | Stryker Neurovascular |
| On 09/27/10, Micrus Endovascular Corporation was acquired by Johnson & Johnson and now operates as a wholly-ownedsubsidiary of Codman & Shurtleff, Inc within the Johnson & Johnson family of companies. Medos International SARL (Medos) willbe the recognized legal manufacturer and Codman & Shurtleff, Inc. will be the subcontractor appointed by Medos.* The predicate Device Positioning Unit 2-3 (DPU2-3) was cleared under this submission. |
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The MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 IV. Device Description XSFT 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/3 description: This image is a diagram of a microcoil system. The diagram labels the different parts of the system, including the hub connector, re-sheathing tool, introducer sheath body, introducer sheath tip, device positioning unit (DPU), and microcoil. The microcoil is located at the end of the system.
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 catheter. 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).
- 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.
- 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 works with the EnPower Control Cable and with the standard connecting cable.
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The device in this submission includes design changes only to the Device Positioning IV. Device Unit (DPU) element of the microcoil system. There are no modifications to the Description (Cont.) microcoil components or to the EnPOWER Detachment Control system. The following is a summarized list of the modifications to the predicate and reference devices:
- . Minor design modifications to the Device Positioning Unit (DPU) to enhance the system's overall performance
- Labeling changes as a result of the minor design modifications and additional ● clarifications.
- . Rebranding Microcoil Systems with new Proprietary Names (Refer to Table 4)
The currently cleared microcoils will be attached to the proposed Device Positioning Unit. The proposed microcoil system will remain compatible with the EnPOWER Control Box and Connecting Cables. These microcoil systems are also being rebranded with new proprietary names. Table 4 provides a cross referenced summary of the currently cleared microcoils, secondary shape diameter and length, the 510(k) it was cleared under and new proprietary name with the proposed DPU.
| Table 4: Microcoil Proprietary Name Conversion | |||
|---|---|---|---|
| Current Device Proprietary Names | Microcoil SecondaryShape Diameter andLength | 510(k)Numbers | This Submission:Proposed Device ProprietaryNames |
| MICRUSPHERE 10 &PRESIDIO 10 CERECYTE Coils | 2mm-10mm x 1cm-30cm | K033813 | MICRUSFRAME S 10 StretchResistant Coil |
| MICRUSPHERE 18 &PRESIDIO 18 CERECYTE Coils | 2mm-20mm x 4cm-50cm | K062036 &K053160 | MICRUSFRAME S 18 StretchResistant Coil |
| CASHMERE 14 CERECYTE Coil | 2mm-12mm x 2.5cm-30cm | K072173 | MICRUSFRAME C 14 StretchResistant Coil |
| DELTAPAQ 10 &DELTAPLUSH 10 CERECYTE Coils | 1.5mm-10mm x 1cm-25cm | K080437 &K083646 | DELTAXSFT 10 &DELTAFILL 10 Stretch ResistantCoil |
| DELTAMAXX 18 CERECYTE Coil | 3mm-24mm x 12cm-60cm | K120274 | DELTAFILL 18 Stretch ResistantCoil |
| ORBIT GALAXY G2 FILL Stretch ResistantCoil | 2mm-20mm x 1.5cm-30cm | K120686 | GALAXY G3 Stretch ResistantCoil |
| ORBIT GALAXY G2 XSFT Stretch ResistantCoil | 2mm-6mm x 1.5cm-8cm | K120686 | GALAXY G3 XSFT StretchResistant Coil |
| S: Represents Spherical which is the Secondary Shape of the Microcoil.C: Represents Complex which is the Secondary Shape of the Microcoil. |
V. Indications MICRUSFRAME, DELTAFILL, and DELTAXSFT Microcoil Delivery Systems are intended for endovascular embolization of intracranial aneurysms, other neurovascular for Use 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.
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VI. Comparison of Technological Characteristics With Predicate Device
Endovascular coil embolization is the technological principle for both the subject and predicate device. It is based on placing embolic coils in the neurovascular or peripheral vasculature in order to reduce or block blood flow. At a high level, the subject device and predicate device are based on the following same technological characteristics:
| Table 5: Technological Characteristics of the Predicate and Proposed Devices | ||
|---|---|---|
| Description | Predicate Device:(K082739) | This Submission:MICRUSFRAME, DELTAFILL,DELTAXSFT, GALAXY G3, andGALAXY G3 XSFT Microcoil DeliverySystems |
| Indications for Use | The CODMAN Microcoil DeliverySystem is intended for endovascularembolization of intracranial aneurysms,other neurovascular abnormalities such asarteriovenous malformations andarteriovenous fistulae, and is also intendedfor arterial and venous embolizations inthe peripheral vasculature.The ORBIT GALAXY G2 FILLMicrocoil Delivery System is intended forendovascular embolization of intracranialaneurysms, other neurovascularabnormalities such as arteriovenousmalformations and arteriovenous fistulae,and is also intended for arterial andvenous embolizations in the peripheralvasculature.The XTRASOFT ORBIT GALAXY G2Microcoil Delivery System is intended forendovascular embolization of intracranialaneurysms. | Same as predicateMICRUSFRAME, DELTAFILL, andDELTAXSFT Microcoil Delivery Systemsare intended for endovascular embolizationof intracranial aneurysms, otherneurovascular abnormalities such asarteriovenous malformations andarteriovenous fistulae, and are alsointended for arterial and venousembolizations in the peripheral vasculature.GALAXY G3 Microcoil Delivery Systemis intended for endovascular embolizationof intracranial aneurysms, otherneurovascular abnormalities such asarteriovenous malformations andarteriovenous fistulae, and is also intendedfor arterial and venous embolizations in theperipheral vasculature. *The GALAXY G3 XSFT MicrocoilDelivery System is intended forendovascular embolization of intracranialaneurysms. * |
| 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 SuturePP= Polypropylene Suture | Same as predicate |
| Primary Coil Wind OuterDiameter (OD) | 0.009" - 0.016" | Same as predicate |
| Secondary Shape OD Ranges | 1.5mm - 24mm | Same as predicate |
| Microcoil Length Ranges | 1cm - 60cm | 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 |
| Device Positioning Unit (DPU)Delivery System Length | 190cm ± 5cm | Same as predicate |
| Device Positioning Unit Diameter | 0.0138" | 0.0159" |
| Fluoroscopy Saver Markers | None | Five Markers Located on the ProximalSection of the Shaft ** |
| Fluoro Saver MarkerMicrocatheter Compatibility | Not Applicable | 150cm Length** |
| Distal Segment of the DevicePositioning Unit | Device Positioning Unit 2-3 (DPU2-3) | Device Positioning Unit 3 (DPU3) Designmodified to enhance overall performance |
| Mechanism of Detachment | Connection to Microcoil System: UsesConnecting Cable or EnPOWER ControlCableDetachment: Thermo-Mechanical Systemuses the EnPOWER Detachment ControlBox (DCB) with EnPOWER ControlCable or Connecting Cable | Same as predicate |
| Sterilization and Shelf Life | ||
| Sterilization Method | E-Beam Radiation | Same as predicate |
| Shelf Life | 5 years | 18 months |
| Packaging | Packaged in a plastic hoop and enclosedin a pouch. | Same as predicate |
| Note: Size ranges provided cover entire microcoil product offering.The GALAXY G3 Microcoils are the same Microcoils cleared under reference device K120686 ORBIT GALAXY G2 Filland Xtrasoft Microcoils therefore the same indications for use were utilized.* Same material and similar use as the REVIVE PV Peripheral Vascular Thrombectomy Device K132281. |
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Data
510(k) Summary, Continued
VII. Performance Verification and Validation Testing
There were no changes made that affect the Microcoils intended use, operational principle, design principle, manufacturing or sterilization processes. The modifications proposed in this submission are for the Device Positioning Unit (DPU) only.
Verification and validation activities were focused on the Microcoil Systems' proposed Device Positioning Unit (DPU3). Appropriate testing was identified based on the modifications and a review of the products' risk analyses and previous use of the predicate Device Positioning Unit 2-3 (DPU2-3) which was cleared under K082739. Testing was conducted as appropriate for the inclusion of the proposed DPU based on current standards and FDA Guidance Document; "Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices"; all testing was performed on final sterile product unless otherwise justified. The following performance data were provided in support of the substantial equivalence determination. All testing was conducted using statistical sampling methods as required by the Codman & Shurtleff, Inc. Design Control procedures. The bench testing included the following tests:
| Table 6: Verification and Validation Testing | |||
|---|---|---|---|
| Test | Test Method Summary | Results | |
| MicrocatheterStability(Tip DeflectionForce) | The purpose of the Microcatheter Stability (Tip DeflectionForce) test is to measure the deflection and/or stability of themicrocatheter by recording the force generated at the distal tipof the microcatheter as the DPU device is advanced to the tipof the microcatheter. | PASS:Samples passed the establishedacceptance criterion | |
| Coil DetachmentDurability &Reliability | The purpose of the Coil Detachment Durability & Reliabilitytest was to evaluate the reliability of the detachmentmechanism of the proposed device after being cycled into andthen out of a clinically relevant anatomical model six times. | PASS:Samples passed the establishedacceptance criterion | |
| Coil Durability(Coil to DevicePositioning Unit) | The purpose of the Coil Durability test was to evaluate thecoil's ability to stay attached to the proposed device duringsimulated use of six insertions and withdrawals cycled into andout of a clinically relevant aneurysm model. | PASS:Samples passed the establishedacceptance criterion | |
| Distal Outer SheathDurability | The purpose of the Distal Outer Sheath Durability test was toevaluate the durability of the distal outer sheath during thesimulated use of six insertions and withdrawals of the proposeddevice into and then out of a clinically relevant aneurysmmodel. | PASS:Samples passed the establishedacceptance criterion | |
| Track Force(Delivery) | The purpose of the Track Force test was to evaluate the force ittakes to deliver the proposed device through a microcatheterand into a clinically relevant model; utilizing the systemCatheter Performance Simulation System (CPSS). | PASS:Samples passed the establishedacceptance criterion | |
| Re-SheathingReliability | The purpose of the Re-Sheathing Reliability test was toevaluate the ability to re-insert the proposed device into thesplit sheath introducer after it has been unzipped after theproposed device has been inserted and withdrawal from aclinically relevant model. | PASS:Samples passed the establishedacceptance criterion | |
| Fluoro SaverMarker Durability | The purpose of the Fluoro Saver Marker Durability test was toevaluate the ability of the Fluoro Saver Markers ability to stayaffixed and in the correct position on the shaft of the proposedevice after being cycled into and then out of a clinicallyrelevant anatomical model six times. | PASS:Samples passed the establishedacceptance criterion | |
| Detachment ZoneTensile Strength | The purpose of the Detachment Zone Tensile Strengthtest was to evaluate the attachment strength of thedetachment fiber that holds the microcoil to theproposed device by measuring the force it takes tobreak the fiber. | PASS:Samples passed the establishedacceptance criterion | |
| DimensionalInspection of theOuter Diameter | The purpose of the Dimensional Inspection of theOuter Diameter of the proposed device is to verify theOD is within specification to ensure microcathetercompatibility. | PASS:Samples passed the establishedacceptance criterion |
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VII. Performance Data (Cont.)
| Table 6: Verification and Validation Testing, Continued | |||
|---|---|---|---|
| Test | Test Method Summary | Results | |
| DimensionalInspection ofOverall Length | The purpose of the Dimensional Inspection of the Overall(OAL) Length of the proposed device was to verify that theproposed device is of appropriate length to be compatible withother required device need to complete a procedure. | PASS:Samples passed the establishedacceptance criterion | |
| DimensionalInspection of theLength from theDistal Tip to theRadiopaque MarkerBand | The purpose of the Dimensional Inspection of the Length fromthe Distal Tip to the Radiopaque Marker Band was to verifythat the proximal radiopaque marker band is appropriatelyplaced to allow the alignment with the microcatheter's 3cmmarker. | PASS:Samples passed the establishedacceptance criterion | |
| DimensionalInspection of theDistal Fluoro SaverMarkers | The purpose of the Dimensional Inspection of the Distal FluoroSaver Marker was to verify that that the Fluoro Saver Markersare in the correct proximal position in order to give thephysician a visual indication that the microcoil is approachingthe distal tip of the microcatheter. | PASS:Samples passed the establishedacceptance criterion | |
| Detachment ZoneMicrocatheterSurfaceTemperatureComparison | The purpose of the Detachment Zone Microcatheter SurfaceTemperature Comparison test was to compare the externalsurface temperature of the microcatheter distal tip duringdetachment of the proposed and predicate device. | PASS:The proposed device samples werefound to have equivalenttemperatures to the predicate device;which has established that the heatgenerated during detachment doesnot lead to an acute tissueinflammatory response. |
Shelf-Life Testing
Shelf-Life Testing will be conducted on finished devices in accordance with FDA Guidance Shelf Life of Medical Devices issued April 1991 and internal requirements. Final sterile devices will be subjected to environmental conditioning, simulated transportation and accelerated and real time aging before being tested.
There were no modifications to the current packaging. The currently cleared packaging was validated in accordance with applicable recommendations in International Standard ISO 11607-1 "Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems, and Packaging Systems" and ISO 11607-2 "Packaging for Terminally Sterilized Medical Devices - Part 2: Validation Requirements for Forming, Sealing, and Assembly Processes" as recognized by FDA.
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VII. Performance Biocompatibility Testing
Data (Cont.)
Biocompatibility Testing
Biocompatibility testing was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation of Testing Within a Risk Management Process", FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing.' May 1, 1995", and FDA's Draft Guidance Document (April 23, 2013) entitled "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The following tests were performed:
| Table 7: Biocompatibility | ||
|---|---|---|
| Test | Test Method | Results |
| In Vitro Cytotoxicity -ISO MEM Elution with serial dilutions (DPU3 wirecut into smaller segments) | ISO 10993-5: 2009ISO 10993-12: 2012 | PASS |
| In Vitro Cytotoxicity -ISO MEM Elution (uncut DPU3) | ISO 10993-5: 2009ISO 10993-12: 2012 | PASS |
| Guinea Pig Sensitization -ISO Maximization | ISO 10993-10: 2010ISO 10993-12: 2012 | PASS |
| Intracutaneous/Irritation Reactivity - ISO SkinIrritation Study in Rabbits | ISO 10993-10: 2010ISO 10993-12: 2012 | PASS |
| Acute Systemic Toxicity -ISO Systemic Toxicity in Mice | ISO 10993-11: 2006ISO 10993-12: 2012 | PASS |
| Material Mediated Pyrogenicity – USP RabbitPyrogen | ISO 10993-11: 2006ISO 10993-12: 2012USP 37, NF 32, 2014General Chapter <151>, Pyrogen TestISO 10993-12: 2012 | PASS |
| Endotoxin -USP Limulus Amebocyte Lysate (LAL)Kinetic-Chromogenic Method | AAMI ST72: 2011USP 37, NF 32, 2014General Chapter <85>, Bacterial EndotoxinsISO 10993-12: 2012 | PASS |
| In Vitro Ames Bacterial Reverse Mutation Assay | ISO 10993-3: 2014ISO 10993-12: 2012OECD 471: 1997 | PASS |
| In Vitro Mouse Lymphoma Mutagenicity Assay | ISO 10993-3: 2014ISO 10993-12: 2012OECD 476: 1997ASTM E1280: 2008 | PASS |
| In Vivo Mouse Peripheral Blood Micronucleus Assay | ISO 10993-3: 2014ISO 10993-12: 2012OECD 474: 1997 | PASS |
| In Vitro Hemolysis (ASTM Method - Direct Contactand Extract) | ISO 10993-4: 2002/(R)2013ISO 10993-12: 2012ASTM F756: 2013 | PASS |
| ASTM Partial Thromboplastin Time | ISO 10993-4: 2002/(R)2013ISO 10993-12: 2012ASTM F2382: 2010 | PASS |
| C3a Complement Activation | ISO 10993-4: 2002/Amendment 1 2006ISO 10993-12: 2012 | PASS |
| SC5b-9 Complement Activation | ISO 10993-4: 2002/Amendment 1 2006ISO 10993-12: 2012 | PASS |
| In Vivo Thromboresistance in Dogs | ISO 10993-4: 2002/(R)2013ISO 10993-12: 2012 | PASS |
| USP Physicochemical Tests(Aqueous Extracts) | USP 37, NF 32, 2014General Chapter <231> Heavy MetalsGeneral Chapter <281> Residue on IgnitionGeneral Chapter <661> Containers-PlasticsGeneral Chapter <791> pH | PASS |
| Determination of Extractable Metals By InductivelyCoupled Plasma - Optical Emission Spectroscopy(ICP-OES) | ISO 10993-18: 2009 | PASS |
| Physicochemical Tests(Non-aqueous Extracts) | USP 37, NF 32, 2014General Chapter <281> Residue on IgnitionGeneral Chapter <661> Containers-PlasticsGeneral Chapter <731> Loss on DryingGeneral Chapter <851> Spectrophotometry and Light-Scattering | PASS |
The Microcoil System is comprised of the microcoil and the Device Positioning Unit (DPU). The DPU is considered blood contacting for duration of less than 24 hours while the Microcoils are considered permanent implants. Because only the design of the Device Positioning Unit was modified, the biocompatibility testing was conducted on the Device Positioning Unit.
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VII. Performance Sterilization
Data (Cont.) The Microcoil System is electron beam sterilized and was validated and audited to assure a Sterility Assurance Level (SAL) 10° according to the requirements of International Standards ISO 11137-1 "Sterilization of Health Care Products -Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices", ISO 11137-2 "Sterilization of Health Care Products - Radiation - Part 2: Establishing the Sterilization Dose", ISO 11137-3 "Sterilization of Health Care Products - Radiation - Part 3: Guidance on dosimetric aspects", and ISO 11737-1 "Sterilization of Medical Devices -Microbiological Methods - Part 1: Determination of a Population of Microorganisms on Products" as recognized by FDA
Animal Study
An animal study was not required as appropriate verification and validation of the modified Device Positioning Unit (DPU) was achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Summary of Clinical Testing
A clinical study was not required as appropriate verification and validation of the modified Device Positioning Unit (DPU) was achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
VIII. Conclusion Based upon the design, materials, function, intended use, performance, manufacturing and sterilization process and the non-clinical testing performed by Codman, it is concluded that the MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3 and GALAXY G3 XSFT Microcoil Systems with the modified Device Positioning Unit are substantially equivalent to the currently marketed CODMAN, DELTAMAXX, and ORBIT GALAXY G2 Microcoil Systems (K082739) and therefore, does not raise any new questions of safety or effectiveness.
§ 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).