(123 days)
No
The device description and performance studies focus on the mechanical and material properties 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 therapeutic interventions.
No
Explanation: This device is an embolization system, meaning it is used for treatment by blocking blood flow, not for diagnosing conditions. Its intended use is for "endovascular embolization of intracranial aneurysms, other neurovascular abnormalities... and for arterial and venous embolizations in the peripheral vasculature."
No
The device description clearly outlines multiple hardware components including microcoils, a connecting cable, and a Detachment Control Box (DCB). The submission also details bench testing and biocompatibility testing on these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are for "endovascular embolization of intracranial aneurysms, other neurovascular abnormalities... and are also intended for arterial and venous embolizations in the peripheral vasculature." This describes a therapeutic procedure performed within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a system for delivering microcoils into blood vessels to block blood flow. This is a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is a therapeutic medical device used for embolization procedures.
N/A
Intended Use / 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.
Product codes
HCG, KRD
Device Description
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. 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. 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
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial, neurovascular, 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)
Verification and validation activities were focused on the Microcoil Systems' proposed Device Positioning Unit (DPU3). 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. All testing was conducted using statistical sampling methods.
Bench Testing included:
- Microcatheter Stability (Tip Deflection Force): Measured deflection/stability of microcatheter by recording force at distal tip as DPU device is advanced. Results: PASS.
- Coil Detachment Durability & Reliability: Evaluated reliability of detachment mechanism after cycling into/out of a clinically relevant anatomical model six times. Results: PASS.
- Coil Durability (Coil to Device Positioning Unit): Evaluated coil's ability to stay attached during simulated use of six insertions and withdrawals cycled into/out of a clinically relevant aneurysm model. Results: PASS.
- Distal Outer Sheath Durability: Evaluated durability of distal outer sheath during simulated use of six insertions and withdrawals into/out of a clinically relevant aneurysm model. Results: PASS.
- Track Force (Delivery): Evaluated force to deliver the device through a microcatheter and into a clinically relevant model, using CPSS. Results: PASS.
- Re-Sheathing Reliability: Evaluated ability to re-insert the device into the split sheath introducer after it has been unzipped after insertion/withdrawal from a clinically relevant model. Results: PASS.
- Fluoro Saver Marker Durability: Evaluated ability of Fluoro Saver Markers to stay affixed and in correct position on the shaft after cycling into/out of a clinically relevant anatomical model six times. Results: PASS.
- Detachment Zone Tensile Strength: Evaluated attachment strength of detachment fiber by measuring force to break the fiber. Results: PASS.
- Dimensional Inspection of the Outer Diameter: Verified OD is within specification to ensure microcatheter compatibility. Results: PASS.
- Dimensional Inspection of Overall Length: Verified appropriate length for compatibility with other required devices. Results: PASS.
- Dimensional Inspection of the Length from the Distal Tip to the Radiopaque Marker Band: Verified proximal radiopaque marker band is appropriately placed for alignment with microcatheter's 3cm marker. Results: PASS.
- Dimensional Inspection of the Distal Fluoro Saver Markers: Verified Fluoro Saver Markers are in correct proximal position for visual indication that microcoil is approaching distal tip of microcatheter. Results: PASS.
- Detachment Zone Microcatheter Surface Temperature Comparison: Compared external surface temperature of microcatheter distal tip during detachment of proposed and predicate device. Results: PASS, equivalent temperatures to predicate, not leading to acute tissue inflammatory response.
Shelf-Life Testing: Will be conducted on finished devices according to FDA Guidance and internal requirements. Final sterile devices will be subjected to environmental conditioning, simulated transportation, and accelerated/real time aging before testing.
Biocompatibility Testing: Conducted in accordance with ISO 10993-1, FDA Blue Book Memorandum #G95-1, and FDA's Draft Guidance Document. Biocompatibility testing was conducted on the Device Positioning Unit (DPU).
- In Vitro Cytotoxicity - ISO MEM Elution with serial dilutions (DPU3 wire cut into smaller segments): PASS
- In Vitro Cytotoxicity - ISO MEM Elution (uncut DPU3): PASS
- Guinea Pig Sensitization - ISO Maximization: PASS
- Intracutaneous/Irritation Reactivity - ISO Skin Irritation Study in Rabbits: PASS
- Acute Systemic Toxicity - ISO Systemic Toxicity in Mice: PASS
- Material Mediated Pyrogenicity – USP Rabbit Pyrogen: PASS
- Endotoxin - USP Limulus Amebocyte Lysate (LAL) Kinetic-Chromogenic Method: PASS
- In Vitro Ames Bacterial Reverse Mutation Assay: PASS
- In Vitro Mouse Lymphoma Mutagenicity Assay: PASS
- In Vivo Mouse Peripheral Blood Micronucleus Assay: PASS
- In Vitro Hemolysis (ASTM Method - Direct Contact and Extract): PASS
- ASTM Partial Thromboplastin Time: PASS
- C3a Complement Activation: PASS
- SC5b-9 Complement Activation: PASS
- In Vivo Thromboresistance in Dogs: PASS
- USP Physicochemical Tests (Aqueous Extracts): PASS
- Determination of Extractable Metals By Inductively Coupled Plasma - Optical Emission Spectroscopy (ICP-OES): PASS
- Physicochemical Tests (Non-aqueous Extracts): PASS
Sterilization: The Microcoil System is electron beam sterilized to assure a Sterility Assurance Level (SAL) 10^-6 according to ISO 11137-1, ISO 11137-2, ISO 11137-3, and ISO 11737-1.
Animal Study: Not required.
Clinical Study: Not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K083646, K033813, K053160, K062036, K072173, K080437, K073442, K120686, K120274, K142429, K093973, K132281, K140080, K123377
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/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
2
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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3
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 Device | |||
| K082739 | 10/17/2008 | Micrus Microcoil Delivery System** | Micrus Endovascular |
| Corporation* | |||
| Reference Devices | |||
| Reference Device | |||
| K083646 | 01/02/2009 | Micrus Microcoil System DELTAPLUSH | Micrus Endovascular |
| Corporation* | |||
| Reference Device | |||
| K033813 | 04/04/2004 | Micrus Modified Microcoil System, Cerecyte | Micrus Endovascular |
| Corporation* | |||
| Reference Device | |||
| K053160 | 12/07/2005 | Micrus Modified Microcoil 18-System, "Cerecyte" | Micrus Endovascular |
| Corporation* | |||
| Reference Device | |||
| K062036 | 08/25/2006 | Micrus Microcoil System "Presidio-18" | Micrus Endovascular |
| Corporation* | |||
| Reference Device | |||
| K072173 | 10/05/2007 | Micrus Microcoil Delivery System | Micrus Endovascular |
| Corporation* | |||
| Reference Device | |||
| K080437 | 05/08/2008 | Micrus Microcoil Delivery System | Micrus Endovascular |
| Corporation* | |||
| Reference Device | |||
| K073442 | 02/26/2008 | Micrus Microcoil Delivery System | Micrus Endovascular |
| Corporation* | |||
| Reference Device | |||
| K120686 | 04/04/2012 | ORBIT GALAXY G2 Microcoil Delivery System | Codman & Shurtleff, Inc |
| Reference Device | |||
| K120274 | 03/02/2012 | DELTAMAXX 18 Microcoil System | Codman & Shurtleff, Inc |
| Reference Device | |||
| K142429 | 12/24/2014 | CODMAN, DELTAMAXX, and ORBIT GALAXY | |
| G2 Microcoil Delivery Systems and Cables | Codman & Shurtleff, Inc | ||
| Reference Device | |||
| K093973 | 05/26/2010 | ORBIT GALAXY Detachable Coil System | Codman & Shurtleff, Inc |
| Reference Device | |||
| K132281 | 08/30/2013 | REVIVE Peripheral Vascular (PV) Thrombectomy | |
| Device | Codman & Shurtleff, Inc | ||
| Reference Device | |||
| K140080 | 04/24/2014 | ENVOY Distal Access (DA) Guiding Catheter | Codman & Shurtleff, Inc |
| Reference Device | |||
| K123377 | 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-owned | |||
| subsidiary of Codman & Shurtleff, Inc within the Johnson & Johnson family of companies. Medos International SARL (Medos) will | |||
| be 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. |
4
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.
5
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 Secondary | ||
| Shape Diameter and | |||
| Length | 510(k) | ||
| Numbers | This Submission: | ||
| Proposed Device Proprietary | |||
| Names | |||
| MICRUSPHERE 10 & | |||
| PRESIDIO 10 CERECYTE Coils | 2mm-10mm x 1cm-30cm | K033813 | MICRUSFRAME S 10 Stretch |
| Resistant Coil | |||
| MICRUSPHERE 18 & | |||
| PRESIDIO 18 CERECYTE Coils | 2mm-20mm x 4cm-50cm | K062036 & | |
| K053160 | MICRUSFRAME S 18 Stretch | ||
| Resistant Coil | |||
| CASHMERE 14 CERECYTE Coil | 2mm-12mm x 2.5cm-30cm | K072173 | MICRUSFRAME C 14 Stretch |
| Resistant Coil | |||
| DELTAPAQ 10 & | |||
| DELTAPLUSH 10 CERECYTE Coils | 1.5mm-10mm x 1cm-25cm | K080437 & | |
| K083646 | DELTAXSFT 10 & | ||
| DELTAFILL 10 Stretch Resistant | |||
| Coil | |||
| DELTAMAXX 18 CERECYTE Coil | 3mm-24mm x 12cm-60cm | K120274 | DELTAFILL 18 Stretch Resistant |
| Coil | |||
| ORBIT GALAXY G2 FILL Stretch Resistant | |||
| Coil | 2mm-20mm x 1.5cm-30cm | K120686 | GALAXY G3 Stretch Resistant |
| Coil | |||
| ORBIT GALAXY G2 XSFT Stretch Resistant | |||
| Coil | 2mm-6mm x 1.5cm-8cm | K120686 | GALAXY G3 XSFT Stretch |
| Resistant 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.
6
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, and | ||
| GALAXY G3 XSFT Microcoil Delivery | ||
| Systems | ||
| Indications for Use | The CODMAN 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 ORBIT GALAXY G2 FILL | ||
| 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. | Same as predicate | |
| 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. | ||
| 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. * | ||
| 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" - 0.016" | 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 Proximal |
| Section of the Shaft ** | ||
| Fluoro Saver Marker | ||
| Microcatheter Compatibility | Not Applicable | 150cm Length** |
| Distal Segment of the Device | ||
| Positioning Unit | Device Positioning Unit 2-3 (DPU2-3) | Device Positioning Unit 3 (DPU3) Design |
| modified to enhance overall performance | ||
| 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 and Shelf Life | ||
| Sterilization Method | E-Beam Radiation | Same as predicate |
| Shelf Life | 5 years | 18 months |
| Packaging | Packaged in a plastic hoop and enclosed | |
| in 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 Fill | ||
| and Xtrasoft Microcoils therefore the same indications for use were utilized. | ||
| ** Same material and similar use as the REVIVE PV Peripheral Vascular Thrombectomy Device K132281. |
7
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 | |
| Microcatheter | |||
| Stability | |||
| (Tip Deflection | |||
| Force) | The purpose of the Microcatheter Stability (Tip Deflection | ||
| Force) test is to measure the deflection and/or stability of the | |||
| microcatheter by recording the force generated at the distal tip | |||
| of the microcatheter as the DPU device is advanced to the tip | |||
| of the microcatheter. | PASS: | ||
| Samples passed the established | |||
| acceptance criterion | |||
| Coil Detachment | |||
| Durability & | |||
| Reliability | The purpose of the Coil Detachment Durability & Reliability | ||
| test was to evaluate the reliability of the detachment | |||
| mechanism of the proposed device after being cycled into and | |||
| then out of a clinically relevant anatomical model six times. | PASS: | ||
| Samples passed the established | |||
| acceptance criterion | |||
| Coil Durability | |||
| (Coil to Device | |||
| Positioning Unit) | The purpose of the Coil Durability test was to evaluate the | ||
| coil's ability to stay attached to the proposed device during | |||
| simulated use of six insertions and withdrawals cycled into and | |||
| out of a clinically relevant aneurysm model. | PASS: | ||
| Samples passed the established | |||
| acceptance criterion | |||
| Distal Outer Sheath | |||
| Durability | The purpose of the Distal Outer Sheath Durability test was to | ||
| evaluate the durability of the distal outer sheath during the | |||
| simulated use of six insertions and withdrawals of the proposed | |||
| device into and then out of a clinically relevant aneurysm | |||
| model. | PASS: | ||
| Samples passed the established | |||
| acceptance criterion | |||
| Track Force | |||
| (Delivery) | The purpose of the Track Force test was to evaluate the force it | ||
| takes to deliver the proposed device through a microcatheter | |||
| and into a clinically relevant model; utilizing the system | |||
| Catheter Performance Simulation System (CPSS). | PASS: | ||
| Samples passed the established | |||
| acceptance criterion | |||
| Re-Sheathing | |||
| Reliability | The purpose of the Re-Sheathing Reliability test was to | ||
| evaluate the ability to re-insert the proposed device into the | |||
| split sheath introducer after it has been unzipped after the | |||
| proposed device has been inserted and withdrawal from a | |||
| clinically relevant model. | PASS: | ||
| Samples passed the established | |||
| acceptance criterion | |||
| Fluoro Saver | |||
| Marker Durability | The purpose of the Fluoro Saver Marker Durability test was to | ||
| evaluate the ability of the Fluoro Saver Markers ability to stay | |||
| affixed and in the correct position on the shaft of the propose | |||
| device after being cycled into and then out of a clinically | |||
| relevant anatomical model six times. | PASS: | ||
| Samples passed the established | |||
| acceptance criterion | |||
| Detachment Zone | |||
| Tensile Strength | The purpose of the Detachment Zone Tensile Strength | ||
| test was to evaluate the attachment strength of the | |||
| detachment fiber that holds the microcoil to the | |||
| proposed device by measuring the force it takes to | |||
| break the fiber. | PASS: | ||
| Samples passed the established | |||
| acceptance criterion | |||
| Dimensional | |||
| Inspection of the | |||
| Outer Diameter | The purpose of the Dimensional Inspection of the | ||
| Outer Diameter of the proposed device is to verify the | |||
| OD is within specification to ensure microcatheter | |||
| compatibility. | PASS: | ||
| Samples passed the established | |||
| acceptance criterion |
8
VII. Performance Data (Cont.)
| Table 6: Verification and Validation Testing, Continued | |||
|---|---|---|---|
| Test | Test Method Summary | Results | |
| Dimensional | |||
| Inspection of | |||
| Overall Length | The purpose of the Dimensional Inspection of the Overall | ||
| (OAL) Length of the proposed device was to verify that the | |||
| proposed device is of appropriate length to be compatible with | |||
| other required device need to complete a procedure. | PASS: | ||
| Samples passed the established | |||
| acceptance criterion | |||
| Dimensional | |||
| Inspection of the | |||
| Length from the | |||
| Distal Tip to the | |||
| Radiopaque Marker | |||
| Band | The purpose of the Dimensional Inspection of the Length from | ||
| the Distal Tip to the Radiopaque Marker Band was to verify | |||
| that the proximal radiopaque marker band is appropriately | |||
| placed to allow the alignment with the microcatheter's 3cm | |||
| marker. | PASS: | ||
| Samples passed the established | |||
| acceptance criterion | |||
| Dimensional | |||
| Inspection of the | |||
| Distal Fluoro Saver | |||
| Markers | The purpose of the Dimensional Inspection of the Distal Fluoro | ||
| Saver Marker was to verify that that the Fluoro Saver Markers | |||
| are in the correct proximal position in order to give the | |||
| physician a visual indication that the microcoil is approaching | |||
| the distal tip of the microcatheter. | PASS: | ||
| Samples passed the established | |||
| acceptance criterion | |||
| Detachment Zone | |||
| Microcatheter | |||
| Surface | |||
| Temperature | |||
| Comparison | The purpose of the Detachment Zone Microcatheter Surface | ||
| Temperature Comparison test was to compare the external | |||
| surface temperature of the microcatheter distal tip during | |||
| detachment of the proposed and predicate device. | PASS: | ||
| The proposed device samples were | |||
| found to have equivalent | |||
| temperatures to the predicate device; | |||
| which has established that the heat | |||
| generated during detachment does | |||
| not lead to an acute tissue | |||
| inflammatory 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.
9
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 wire | ||
| cut into smaller segments) | ISO 10993-5: 2009 | |
| ISO 10993-12: 2012 | PASS | |
| In Vitro Cytotoxicity - | ||
| ISO MEM Elution (uncut DPU3) | ISO 10993-5: 2009 | |
| ISO 10993-12: 2012 | PASS | |
| Guinea Pig Sensitization - | ||
| ISO Maximization | ISO 10993-10: 2010 | |
| ISO 10993-12: 2012 | PASS | |
| Intracutaneous/Irritation Reactivity - ISO Skin | ||
| Irritation Study in Rabbits | ISO 10993-10: 2010 | |
| ISO 10993-12: 2012 | PASS | |
| Acute Systemic Toxicity - | ||
| ISO Systemic Toxicity in Mice | ISO 10993-11: 2006 | |
| ISO 10993-12: 2012 | PASS | |
| Material Mediated Pyrogenicity – USP Rabbit | ||
| Pyrogen | ISO 10993-11: 2006 | |
| ISO 10993-12: 2012 | ||
| USP 37, NF 32, 2014 | ||
| General Chapter , Pyrogen Test | ||
| ISO 10993-12: 2012 | PASS | |
| Endotoxin - | ||
| USP Limulus Amebocyte Lysate (LAL) | ||
| Kinetic-Chromogenic Method | AAMI ST72: 2011 | |
| USP 37, NF 32, 2014 | ||
| General Chapter , Bacterial Endotoxins | ||
| ISO 10993-12: 2012 | PASS | |
| In Vitro Ames Bacterial Reverse Mutation Assay | ISO 10993-3: 2014 | |
| ISO 10993-12: 2012 | ||
| OECD 471: 1997 | PASS | |
| In Vitro Mouse Lymphoma Mutagenicity Assay | ISO 10993-3: 2014 | |
| ISO 10993-12: 2012 | ||
| OECD 476: 1997 | ||
| ASTM E1280: 2008 | PASS | |
| In Vivo Mouse Peripheral Blood Micronucleus Assay | ISO 10993-3: 2014 | |
| ISO 10993-12: 2012 | ||
| OECD 474: 1997 | PASS | |
| In Vitro Hemolysis (ASTM Method - Direct Contact | ||
| and Extract) | ISO 10993-4: 2002/(R)2013 | |
| ISO 10993-12: 2012 | ||
| ASTM F756: 2013 | PASS | |
| ASTM Partial Thromboplastin Time | ISO 10993-4: 2002/(R)2013 | |
| ISO 10993-12: 2012 | ||
| ASTM F2382: 2010 | PASS | |
| C3a Complement Activation | ISO 10993-4: 2002/Amendment 1 2006 | |
| ISO 10993-12: 2012 | PASS | |
| SC5b-9 Complement Activation | ISO 10993-4: 2002/Amendment 1 2006 | |
| ISO 10993-12: 2012 | PASS | |
| In Vivo Thromboresistance in Dogs | ISO 10993-4: 2002/(R)2013 | |
| ISO 10993-12: 2012 | PASS | |
| USP Physicochemical Tests | ||
| (Aqueous Extracts) | USP 37, NF 32, 2014 | |
| General Chapter Heavy Metals | ||
| General Chapter Residue on Ignition | ||
| General Chapter Containers-Plastics | ||
| General Chapter pH | PASS | |
| Determination of Extractable Metals By Inductively | ||
| Coupled Plasma - Optical Emission Spectroscopy | ||
| (ICP-OES) | ISO 10993-18: 2009 | PASS |
| Physicochemical Tests | ||
| (Non-aqueous Extracts) | USP 37, NF 32, 2014 | |
| General Chapter Residue on Ignition | ||
| General Chapter Containers-Plastics | ||
| General Chapter Loss on Drying | ||
| General Chapter 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.
10
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.