ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
Device Facts
| Record ID | K120686 |
|---|---|
| Device Name | ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM |
| Applicant | Codman & Shurtleff, Inc. |
| Product Code | HCG · Neurology |
| Decision Date | Apr 4, 2012 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 882.5950 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Fill Orbit Galaxy G2 Microdelivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is intended for arterial and venous embolizations in the peripheral vasculature. The Xtrasoft Orbit Galaxy® G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
Device Story
Device is an endovascular embolization system for intracranial aneurysms and peripheral vascular abnormalities. Consists of a microcoil attached to a device positioning unit (DPU), a connecting cable, and an ENPOWER detachment control box (DCB). Physician delivers microcoil via microcatheter into aneurysm lumen; coil mass packs lumen to eliminate blood influx, promoting thrombosis and isolating aneurysm from arterial pressure. Detachment is thermo-mechanical, triggered by energy delivered from DCB through connecting cable to detachment zone. System includes stretch-resistant, fill, and XTRASOFT models in various lengths/diameters. Used in clinical settings by physicians; provides mechanical occlusion to benefit patients by reducing aneurysm rupture risk.
Clinical Evidence
Bench testing only. No clinical data required. Verification and validation testing included delivery force, microcatheter compatibility, secondary shape retention, tensile strength of detachment zones, and durability/detachability. Biocompatibility testing performed per ISO 10993-1.
Technological Characteristics
Platinum-tungsten alloy microcoils with polypropylene internal suture for stretch resistance. Delivery system: wire shaft with radiopaque markers, HDPE introducer, Nylon 12 resheathing tool. Thermo-mechanical detachment via ENPOWER DCB. Sterilization: E-beam radiation. Compatible with 0.0165-0.019 inch ID microcatheters.
Indications for Use
Indicated for endovascular embolization of intracranial aneurysms, neurovascular abnormalities (AVMs, AV fistulae), and peripheral arterial/venous embolizations. Fill models indicated for all listed; XTRASOFT models indicated for intracranial aneurysms only.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
Submission Summary (Full Text)
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Codman & Shurtleff, Inc.
# 1686
Special 510(k) ORBIT GALAXY® G2 Microcoil System
# 510(k) Summary
(As Required By 21 CFR 807.92(a))
APR - 4 2012
# A. Submitter Information
| Submitter's name: | Codman & Shurtleff, Inc. |
|-----------------------|---------------------------------------------|
| Address: | 325 Paramount Drive |
| | Raynham, MA 02767 |
| Telephone: | 408-433-1420 |
| Fax: | 408-433-1585 |
| Contact Person: | Kim Fonda |
| Date of Submission: | March 5, 2012 |
| B. Trade/Device Name: | ORBIT GALAXY ® G2 Microcoil Delivery System |
| Common Name: | Artificial embolization device |
Neurovascular Embolization Device Classification Name:
Class II per 21 CFR 882.5950 Regulation Number:
C, Predicate Devices:
| Device | Company | 510(k)<br>Number/<br>Concurrence<br>Date | Product<br>Code | Predicate For: |
|--------------------------------------------------------------------|----------------------------------------------------------------------|------------------------------------------|-----------------|-----------------------------------------------------------------------|
| Micrus Microcoil<br>System,<br>CASHMERE® SR<br>(Primary predicate) | Codman & Shurtleff, Inc<br>(Previously Micrus<br>Endovascular Corp.) | K072173<br>(10/5/2007) | HCG | Intended Use<br>Design<br>Materials<br>Manufacturing<br>Sterilization |
| ORBIT GALAXY®<br>Detachable Coil<br>System | Codman & Shurtleff, Inc | K093973<br>(5/26/2010) | HCG | Intended Use<br>Design<br>Materials<br>Manufacturing |
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## D. Device Description:
The intent of endovascular treatment using embolic microcoils is to pack the lumen of the aneurysm with the microcoil mass, thereby eliminating the influx of blood into the aneurysm. The aneurysm neck will be covered with loops of coils to help eliminate the influx of blood, a blood flow pathway is then re-established down the lumen of the parent artery, and the weakened wall of the aneurysm is isolated from arterial pressures. The existing blood and soft clot trapped within the lumen of the aneurysm begins to solidify, ultimately becoming hardened clot and scar tissue. The process will re-establish blood flow down the lumen of the parent artery and thromboses the aneurysm.
The ORBIT GALAXY® G2 Microcoil Delivery System consists of a Microcoil System, a Connecting Cable (CC), and an ENPOWER Detachment Control Box (DCB). Each component is sold separately. ORBIT GALAXY® G2 Microcoil Systems are provided as Stretch Resistant, with Fill and XTRASOFT™ microcoil models, and will be offered in lengths ranging from 1.5 cm to 30 cm and diameters ranging from 2 mm to 20 mm. The ORBIT GALAXY® G2 Microcoil System is compatible with commercially available 2-tip marker microcatheters which have internal lumen diameters between 0.0165 inches and v 0.019 inches.
The Microcoil System consists of an embolic microcoil attached to a device positioning unit (DPU) which is covered by an introducer sheath. The Fill ORBIT GALAXY® G2 Microcoils are provided in complex shape, and the XTRASOFT™ ORBIT GALAXY® G2 Microcoils are provided in complex and helical shapes. The DPU is a variable stiffness pushing system and has a radiopaque marker band located three (3) cm from its distal end. The introducer sheath system has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool. The Microcoil System is packaged individually in a protective hoop and sealed in a film pouch. A Microcoil System carton contains one Microcoil System and the associated Instructions for Use, and is provided as a sterile and single-use product.
The Connecting Cable delivers the energy needed to detach the microcoil from the Microcoil System's detachment zone. The connecting cable connects the DPU to the DCB. The DCB provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU.
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The ORBIT GALAXY® G2 Microcoil System is a modification to the currently marketed CASHMERE® SR Microcoil System (K072173), and to the ORBIT GALAXY® Detachable Coil System (K093973). The ORBIT GALAXY® G2 Microcoil System uses the same Device Positioning Unit, Introducer Sheath System, Detachment Control Box, and Connecting Cable components as the CASHMERE® SR Microcoil System (predicate device). The ORBIT GALAXY® G2 System offers a microcoil similar to the CASHMERE® SR and ORBIT GALAXY® Microcoils (predicate devices). The ORBIT GALAXY® G2 microcoil is similar to the CASHMERE® SR predicate device in regards to microcoil size, material, monofilament suture used for stretch resistance, primary wind profile, secondary shape, outer diameter and length. Device modifications include design and manufacturing process changes necessary to expand the product line to include additional microcoil shapes and sizes.
#### E. Intended Use:
The Fill ORBIT GALAXY® G2 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 XTRASOFT™ ORBIT GALAXY® G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
F. Summary of technological characteristics of the proposed to the predicate device:
The ORBIT GALAXY® G2 Microcoil Delivery System is similar to the CASHMERE® SR Microcoil System with regard to intended use, function, design, materials, manufacturing, and sterilization processes.
The ORBIT GALAXY® G2 Microcoil Delivery System is similar to the ORBIT GALAXY® Detachable Coil System with regard to the intended use, function, microcoil material, shape and dimensions, and microcoil manufacturing processes.
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Device modifications include design and manufacturing process changes necessary to expand the product line to include additional microcoil shapes and sizes. No new technological characteristics are being introduced with the proposed device.
A summary table including specifications of the proposed device compared with those of the predicate devices follows.
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Codman & Shurtleff, Inc
ORBIT GALAXY® G2 Microcoil System
| Characteristic | Proposed Device<br>G2 System | Comparative Information<br>Predicate Device<br>CASHMERE SR System | Predicate Device<br>GALAXY System | |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Intended Use | The Fill ORBIT GALAXY G2<br>Microcoil Delivery System is<br>intended for endovascular<br>embolization of intracranial<br>aneurysms, other neurovascular<br>abnormalities such as arteriovenous<br>malformations and arteriovenous<br>fistulae, and is also intended for<br>arterial and venous embolizations in<br>the peripheral vasculature. | The Micrus Microcoil Delivery<br>System is intended for endovascular<br>embolization of intracranial<br>aneurysms, other neurovascular<br>abnormalities such as arteriovenous<br>malformations and arteriovenous<br>fistulae, and are also intended for<br>arterial and venous embolizations in<br>the peripheral vasculature.<br>As modified per premarket notification<br>K073442 (2/26/08) | The Fill ORBIT GALAXY<br>Detachable Coil and the Frame<br>ORBIT GALAXY Detachable Coil<br>are indicated for embolizing<br>intracranial aneurysms and other<br>vascular malformations such as<br>arteriovenous malformations and<br>arteriovenous fistulae of the<br>neurovasculature. | |
| | The XTRASOFT ORBIT GALAXY<br>G2 Microcoil Delivery System is<br>intended for endovascular<br>embolization of intracranial<br>aneurysms | K072173 (10/5/07)<br>The Micrus Microcoil Delivery<br>System is intended for<br>endovascular embolization of<br>intracranial aneurysms. | The Fill ORBIT GALAXY<br>Detachable Coil and the Frame<br>ORBIT GALAXY Detachable Coil<br>are also intended for arterial and<br>venous embolization in the<br>peripheral vasculature.<br><br>The XTRASOFT ORBIT GALAXY<br>Detachable Coil is indicated for<br>embolizing intracranial aneurysms | |
| Characteristic | Proposed Device<br>G2 System | Comparative Information | Predicate Device<br>CASHMERE SR System | Predicate Device<br>GALAXY System |
| Microcoil<br>Characteristics<br>Configurations | XTRASOFT Stretch Resistant<br>and Fill Stretch Resistant<br>Platinum Tungsten Alloy Wire | Complex<br>Stretch resistant<br>Platinum Tungsten Alloy Wire | XTRASOFT Stretch Resistant<br>and Fill Stretch Resistant<br>Platinum Tungsten Alloy Wire | |
| Embolic Microcoil<br>material | Polypropylene | Polypropylene | Polypropylene | |
| Internal suture<br>material | 0.012 inches | 0.0135 inches | 0.012 inches | |
| Primary Coil Wind<br>OD | Cylindrical | Cylindrical | Cylindrical | |
| Profile of Primary<br>Coil Wind | Fills -Complex<br>XTRASOFT -Complex and Helical | Complex | Fills -Complex<br>XTRASOFT -Complex and Helical | |
| Secondary shape | 2-20 mm | 2-12 mm | 2-20 mm | |
| Secondary Shape<br>Coil OD | 1.5-30 cm | 2.5-30cm | 1.5-30 cm | |
| Coil length | | | | |
| System<br>Characteristics<br>Delivery System<br>Type | Wire shaft with radiopaque markers. | Wire shaft with radiopaque markers. | Hypotube welded to support coil with<br>welded in-line marker bands | |
| Delivery System<br>Introducer Sheath | HDPE Introducer | HDPE Introducer | Nylon/HDPE Introducer | |
| Delivery System<br>Resheathing tool | Nylon 12 | Nylon 12 | HDPE | |
| Characteristic | Proposed Device<br>G2 System | Comparative Information<br>Predicate Device<br>CASHMERE SR System | Predicate Device<br>GALAXY System | |
| DPU Delivery System<br>Length | 190 cm (185-195cm) | 190 cm (185-195cm) | 155-210 cm | |
| Microcatheter<br>compatibility | Compatible with 2-tip marker<br>microcatheters of ID from 0.0165 to<br>0.019 inches | Compatible with 2-tip marker<br>microcatheters of ID from 0.0165 to<br>0.019 inches | Compatible with 0.014" or 0.018"<br>guidewire compatible infusion catheter,<br>150 cm long, dual marker band | |
| Detachment<br>Mechanism | Connection to Microcoil System: Uses<br>Connecting Cable | Connection to Microcoil System: Uses<br>Connecting Cable | Hydraulic Detachment System uses<br>TRUFILL DCS Syringe 11 | |
| | Detachment: Thermo-mechanical<br>System uses ENPOWER Detachment<br>Control Box (DCB) with ENPOWER<br>Control Cable | Detachment: Thermo-mechanical<br>System uses ENPOWER Detachment<br>Control Box (DCB) with ENPOWER<br>Control Cable | | |
| Sterilization | E-Beam Radiation | E-Beam Radiation | ETO | |
| Packaging | Packaged in a plastic hoop and enclosed<br>in a sealed LD Polyethylene/Polyester<br>film pouch. | Packaged in a plastic hoop and enclosed<br>in a sealed LD Polyethylene/Polyester<br>pouch. | Packaged in a plastic hoop and enclosed<br>in a sealed Nylon/Tyvek pouch. | |
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Codman & Shurtleff, Inc.
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ORBIT GALAXY® G2 Microcoil System
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Codman & Shurtleff, Inc
ORBIT GALAXY® C2 Microcoil System
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# G. Testing Summary:
Bench testing data demonstrated that the ORBIT GALAXY® G2 Microcoil System performed according to its description and intended use, and established the performance characteristics of this device. The ORBIT GALAXY®G2 Microcoil System passed equivalent bench testing as compared to the CASHMERE® SR System predicate device. Clinical testing was not required to establish substantial equivalence.
Results of verification and validation testing conducted on the ORBIT GALAXY G2 Microcoil System demonstrated that the system performed as designed, is suitable for the intended use, and is substantially equivalent to the predicate devices.
The following tests were conducted to verify the modified design:
- · Delivery Force Test
- · System Delivery Force
- · Microcatheter compatibility
- · Secondary Shape Retention Test
- Coil Secondary Shape OD
- · Detachment Zone Tensile Test
- · Coil Socket Ring Tensile Strength
- · Detachment Suture Tensile Strength
- · Stretch resistance of suture/Tensile Strength
- · Ball Tip Tensile Strength
- Durability and Detachability Test
- Durability-Cyclic advancement and retrieval of the microcoil system .
- Detachment of the microcoil from the delivery system 트
- Coil damage after microcoil system delivery 0
- I Microcatheter compatibility
The materials, packaging, and sterilization used in the ORBIT GALAXY® G2 Microcoil Delivery System are identical to the materials, packaging, and sterilization used in the current CASHMERE SR Microcoil System. Full biocompatibility testing in accordance with ISO 10993-1 was previously successfully conducted on the ORBIT GALAXY® Detachable Coil System (K093973); additional biocompatibility testing was performed on the CASHMERE SR System (K072173).
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Codman & Shurtleff, Inc.
For final confirmation biocompatibility screening testing was successfully performed. Results demonstrated that the ORBIT GALAXY® G2 Microcoil Delivery System meets all the same biocompatibility requirements as the predicate devices and as specified by the ISO 10993 Part I, and the General Program Memorandum # G95-1 on Biological Evaluation of Medical Devices.
Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by Codman & Shurtleff, Inc., it is concluded that the ORBIT GALAXY® G2 Microcoil Delivery System is substantially equivalent to the CASHMERE® Microcoil Delivery System and to the ORBIT GALAXY® Detachable Coil System and, therefore, does not raise any new questions of safety and effectiveness.
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Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Codman & Shurtleff, Inc. % Ms. Kim Fonda 325 Paramount Drive Raynham, MA 02767
APR - 4 2012
Re: K120686
Trade/Device Name: Orbit Galaxy® G2 Microcoil Delivery System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: Class II Product Code: HCG, KRD Dated: March 5, 2012 Received: March 6, 2012
Dear Ms. Fonda:
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 I least oc advised that I Drivedants or vour device complies with other requirements of the Act that I Dr has Intacted and regulations administered by other Federal agencies. You must or any I carated and the registernents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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#### Page 2-Ms. Kim Fonda ·
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Debrah Falls
Malvina B. Eydelman, M.D. Director
Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known): K120686
Device Name: Orbit Galaxy® G2 Microcoil Delivery System
Indications for Use:
The Fill Orbit Galaxy G2 Microdelivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is intended for arterial and venous embolizations in the peripheral vasculature.
The Xtrasoft Orbit Galaxy® G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
JOE HUTTER
Page 1 of
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
K 120686
510(k) Number_
