(95 days)
No
The device description and performance studies focus on the mechanical and electrical aspects of a microcoil delivery system for embolization. There is no mention of AI or ML in the intended use, device description, or performance testing.
Yes.
The device, a microcoil delivery system, is intended for endovascular embolization of various neurovascular and peripheral vascular abnormalities, which are medical treatments for diseases or conditions.
No
Explanation: The device is a GALAXY G3 Mini Microcoil Delivery System intended for endovascular embolization, which is a therapeutic treatment. It is used to deliver a microcoil to treat conditions, not to diagnose them.
No
The device description clearly outlines multiple hardware components including a Microcoil System (with an implantable microcoil and DPU), a connecting cable, and a Detachment Control Box. Performance studies also include extensive bench testing on physical properties of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for endovascular embolization of intracranial aneurysms and other vascular abnormalities. This is a therapeutic procedure performed in vivo (within the body) to block blood flow.
- Device Description: The device is a system for delivering a microcoil implant into the body. It involves physical components like a microcoil, delivery unit, and detachment system.
- Lack of Diagnostic Purpose: The device is not used to diagnose a condition by examining samples of blood, tissue, or other body fluids in vitro (outside the body).
IVD devices are specifically designed for diagnostic purposes using samples taken from the body. This device is designed for a therapeutic intervention within the body.
N/A
Intended Use / Indications for Use
The GALAXY G3 Mini Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
HCG, KRD
Device Description
The GALAXY G3 Mini Microcoil Delivery Systems consist of three components, a Microcoil System, a connecting cable, and a Detachment Control Box (DCB). Each component is sold separately. As shown in Figure 1, the Microcoil System consists of a microcoil attached to a Device Positioning Unit (DPU). 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 contains a polypropylene suture (SR) and then formed into a secondary shape. The secondary shape is complex.
- o 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial (aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae), arterial and venous in the 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 conducted on the finished sterile device based on current standards and FDA Guidance Document; "Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices". The following performance data were provided in support of the substantial equivalence determination. The bench testing included the following tests: Spring Constant, Complex Shape, Particulate, Atraumatic Bead, DPU 3 System Outer Diameter, Microcatheter Tip Deflection Force, Detachment Zone Tensile Strength, Stretch Resistance Fiber Tensile Strength, Track Force (Delivery), Dimensional Inspection of FDL Diameter and Coil Length, Coil OD Verification on Final Assembly, Dimensional Inspection of the Distal Fluro-saver markers, Coil Durability, Detachment, Coil Durability & Reliability, Resheathing Reliability, Fluro saver Marker Durability, Distal Outer Sheath Durability, Dimensional Inspection of the Introducer, Introducer Bond Strength, Coil Transfer to Microcatheter, Introducer Flushing, Radiopacity, Overall Coil Performance, MRI Testing. All samples passed the established acceptance criterion for all tests.
Shelf-Life Testing: Codman successfully completed accelerated aging testing to support a shelf life of 12 months. Finished sterile devices were subjected to environmental conditioning, simulated transportation and accelerated aging before being tested.
Packaging: The modification to the current packaging consists of a change in pouch material due to the change in sterilization method from e-beam to ethylene oxide. Utilizing previously validated pouch material used in the same sterilization cycle (K021591), the new packaging configuration 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.
Biocompatibility Testing: Conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation of Testing Within a Risk Management Process" (ISO 10993-1:2009/2010AC), and FDA's Guidance Document entitled "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (June 16. 2016). Tests performed: ISO MEM Elution, Hemocompatibility Tests (In Vitro Hemolysis Direct Contact (ASTM F756), In Vitro Hemolysis - Extract, In Vivo Thromboresistance O), Chemical Characterization of Extractables (ISO 10993-18).
Sterilization: Ethylene oxide sterilized and validated to assure a Sterility Assurance Level (SAL) 10-6 according to ISO 11135-1 and ISO 10993-7.
Animal Study: Not required.
Clinical Study: Not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "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, stacked one behind the other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 25, 2017
Codman & Shurtleff, Inc. Yoon Hee Beattv Sr. Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
Re: K171862
Trade/Device Name: GALAXY G3 Mini Microcoil Delivery System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: August 21, 2017 Received: August 23, 2017
Dear Ms. Beatty:
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 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 (DICE) 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 (DICE) 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,
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) K171862
Device Name
GALAXY G3 Mini Microcoil Delivery System
Indications for Use (Describe)
The GALAXY G3 Mini Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
510(k) Summary
Codman & Shurtleff, Inc. I. Submitter 325 Paramount Drive Raynham, MA 02767
Tel: (305) 265-2919 Fax: (305) 265-6889
Contact Person: Yoon Hee Beatty Date Prepared: August 21, 2017
II. Device
| Table 1. Device | |
|---|---|
| Device Proprietary Name | GALAXY G3 Mini 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 |
The corresponding predicate devices that are listed in Table 2 below are applicable III. Predicate Device to the devices in this submission.
| Table 2. Prior 510(k) Clearance | |||
|---|---|---|---|
| 510(k) Number | Date Cleared | Name | Manufacturer |
| Primary Predicate | |||
| K150319 | 06/12/2015 | Micrus Microcoil System DELTAXFT | Codman & Shurtleff, Inc. |
| Reference Predicate | |||
| K083646 | 01/02/2009 | Micrus Microcoil System DELTAPLUSH | Micrus Endovascular |
| Corporation* | |||
| Reference Device | |||
| K093973 | 05/26/2010 | ORBIT GALAXY Detachable Coil System | Codman & Shurtleff, Inc. |
| Reference Device | |||
| K021591 | 05/22/2002 | PROWLER SELECT Infusion Catheters | Cordis Neurovascular, |
| Inc.** | |||
| *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. | |||
| ** This 510(k) was originally owned by Cordis Neurovascular, Inc., a subsidiary of Cordis Corporation. In 2008, Cordis | |||
| Neurovascular, Inc., was merged with Codman and Shurtleff, Inc. This 510(k) is presently owned by Codman & Shurtleff, Inc. |
4
IV. Device The GALAXY G3 Mini Microcoil Delivery Systems consist of three components, a Description Microcoil System, a connecting cable, and a Detachment Control Box (DCB). Each component is sold separately. As shown in Figure 1, the Microcoil System consists of a microcoil attached to a Device Positioning Unit (DPU).
Image /page/4/Figure/4 description: The image is titled "Figure 1. Microcoil System" and shows a diagram of the 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 tip of the system and is a small, coiled wire.
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 contains a polypropylene suture (SR) and then formed into a secondary shape. The secondary shape is complex.
- o 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
V. Indications for Use
The GALAXY G3 Mini Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.
6
VI. Comparison of Technological Characteristics With Predicate Device
Endovascular coil embolization is the technological principle for both the subject and predicate devices. It is based on placing embolic coils in the neurovascular or peripheral vasculature in order to reduce or block blood flow. The subject device and predicate devices are based on the following same technological characteristics:
| Table 3. Technological Characteristics of the Predicate and Proposed Devices | ||
|---|---|---|
| Description | Predicate Device: | |
| DELTAXSFT | ||
| Microcoil Delivery Systems | ||
| (K150319) | This Submission: | |
| GALAXY G3 Mini | ||
| Microcoil Delivery Systems | ||
| Indications for Use | 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. | Same as predicate | |
| GALAXY G3 Mini Microcoil Delivery | ||
| System is intended for endovascular | ||
| embolization of intracranial aneurysms, | ||
| other neurovascular abnormalities such | ||
| as arteriovenous malformations and | ||
| arteriovenous fistulae, and is also | ||
| intended for arterial and venous | ||
| embolizations in the peripheral | ||
| vasculature. | ||
| Microcoil | ||
| Microcoil Material | Platinum/Tungsten | Same as predicate |
| Microcoil Primary Wind | Triangular | Cylindrical* |
| Microcoil Secondary Shape | Helical | Complex* |
| Microcoil Stretch-Resistant | PGA= Polyglycolic Acid Suture | PP= Polypropylene Suture** |
| Primary Coil Wind Outer | ||
| Diameter | 0.0096" | 0.009" |
| Secondary Shape Outer | ||
| Diameter Ranges | 1.5mm-4mm | 1.0mm - 3.0mm |
| Microcoil Length Ranges | 1cm-8cm | Same as predicate |
| Delivery System | ||
| Delivery System Type | Wire Shaft with radiopaque marker | Same as predicate |
| Delivery System Introducer | ||
| Sheath | HDPE Introducer | Same as predicate |
| Delivery System Resheathing | ||
| Tool | Nylon 12 | Same as predicate |
| Flush Ports | None | Flush ports |
| Introducer Sheath Tip Shape | Straight | Tapered |
| Introducer Sheath Length | 120cm | 81cm and 120cm |
| Device Positioning Unit (DPU3) | ||
| Delivery System Length | 190cm ± 5cm | Same as predicate |
| Device Positioning Unit | ||
| Diameter | 0.0159" | Same as predicate |
| Fluoroscopy Saver Markers | Five Markers Located on the | |
| Proximal Section of the Shaft | Same as predicate | |
| Fluoro Saver Marker | ||
| Microcatheter Compatibility | 150cm Length | Same as predicate |
| Distal Segment of the Device | ||
| Positioning Unit | Device Positioning Unit 3 (DPU3) | Same as predicate |
| Mechanism of Detachment | Connection to Microcoil System: | |
| Uses Connecting Cable or | ||
| EnPOWER Control Cable | ||
| Detachment: Thermo-Mechanical | ||
| System uses the EnPOWER | ||
| Detachment Control Box (DCB) | ||
| with EnPOWER Control Cable or | ||
| Connecting Cable | Same as predicate | |
| Sterilization and Shelf Life | ||
| Sterilization Method | E-Beam Radiation | Ethylene Oxide (EtO)* |
| Shelf Life | 3 years | Same as predicate |
| Packaging | Packaged in a plastic hoop and | |
| enclosed in a pouch. | Same as predicate*** | |
| * Same shape and sterilization method as ORBIT GALAXY DCS (K093973) | ||
| ** Same material as DELTAPLUSH Microcoil (K083646) | ||
| *** Same pouch material as PROWLER SELECT Infusion Catheters (K021591) |
7
VII. Performance Data
Verification and Validation Testing
Verification and validation activities were conducted on the finished sterile device based on current standards and FDA Guidance Document; "Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices". The following performance data were provided in support of the substantial equivalence determination. The bench testing included the following tests:
| Table 4. Verification and Validation Testing | |||
|---|---|---|---|
| Test | Test Method Summary | Results | |
| Spring | |||
| Constant | The purpose of the Spring Constant test is to | ||
| measure the softness of the coil by recording the | |||
| spring constant of the primary wind. | PASS: | ||
| Samples passed the | |||
| established acceptance | |||
| criterion | |||
| Complex | |||
| Shape | The purpose of the Complex Shape test is to | ||
| visually inspect the complex shape of the G3 | |||
| Mini Microcoils. | PASS: | ||
| Samples passed the | |||
| established acceptance | |||
| criterion | |||
| Particulate | The purpose of the Particulate test is to measure | ||
| particulate count during simulated use per the | |||
| requirements of USP788. | PASS: | ||
| Samples passed the | |||
| established acceptance | |||
| criterion | |||
| Atraumatic | |||
| Bead | The purpose of the Atraumatic Bead test is to | ||
| visually verify that the bead end of the coil | |||
| meets the final assembly specification. | PASS: | ||
| Samples passed the | |||
| established acceptance | |||
| criterion | |||
| DPU 3 | |||
| System Outer | |||
| Diameter | The purpose of the DPU 3 System Outer | ||
| Diameter test is to verify the OD is within | |||
| specification to ensure microcatheter | |||
| compatibility. | PASS: | ||
| Samples passed the | |||
| established acceptance | |||
| criterion | |||
| Microcatheter | |||
| 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 | |||
| Detachment | |||
| Zone Tensile | |||
| Strength | The purpose of the Detachment Zone Tensile | ||
| Strength test was to evaluate the attachment | |||
| strength of the detachment fiber to prevent | |||
| unintentional coil detachments | PASS: | ||
| Samples passed the | |||
| established acceptance | |||
| criterion | |||
| Stretch | |||
| Resistance | |||
| Fiber Tensile | |||
| Strength | The objective of test is to verify that the coil | ||
| provides sufficient stretch resistance under | |||
| tensile loading to ensure the coil can be retracted | |||
| and repositioned without stretching. | PASS: | ||
| Samples passed the | |||
| established acceptance | |||
| criterion | |||
| VII. | Table 4. Verification and Validation Testing, continued | ||
| Performance | |||
| Data, | |||
| continued | Test | Test Method Summary | Results |
| 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 | |||
| Dimensional | |||
| Inspection of | |||
| FDL | |||
| Diameter and | |||
| Coil Length | The objective of test is to verify the FDL | ||
| diameter and the coil length meets the | |||
| specification. | PASS: | ||
| Samples passed the | |||
| established acceptance | |||
| criterion | |||
| Coil OD | |||
| Verification | |||
| on Final | |||
| Assembly | The purpose of the Dimensional Inspection of | ||
| the Outer Diameter of the proposed device is to | |||
| verify the OD is within specification. | PASS: | ||
| Samples passed the | |||
| established acceptance | |||
| criterion | |||
| Dimensional | |||
| Inspection of | |||
| the Distal | |||
| Fluro-saver | |||
| markers | The purpose of the Dimensional Inspection of | ||
| the Distal Fluoro Saver Marker was to verify | |||
| 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 | |||
| Coil | |||
| Durability | 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 | |||
| Detachment, | |||
| Coil | |||
| 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 | |||
| Resheathing | |||
| 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 | |||
| Fluro saver | |||
| Marker | |||
| Durability | The purpose of the Fluoro Saver Marker | ||
| Durability test was to evaluate the ability of the | |||
| Fluoro Saver Markers to stay affixed and in the | |||
| correct position on the shaft 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 |
8
510(k) Summary, Continued
9
| VII. | |
|---|---|
| Performance | Test |
| Data, (Cont.) | |
| Distal Outer | |
| Sheath | |
| Durability | |
| Table 4. Verification and Validation Testing, continued | ||
|---|---|---|
| Test | Test Method Summary | Results |
| 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 | ||
| Dimensional | ||
| Inspection of | ||
| the | ||
| Introducer | The introducer underwent dimensional | |
| inspection per approved test method. | PASS: | |
| Samples passed the | ||
| established acceptance | ||
| criterion | ||
| Introducer | ||
| Bond | ||
| Strength | The objective of the test is to verify that the | |
| bond strength of the introducer fuse joint. | PASS: | |
| Samples passed the | ||
| established acceptance | ||
| criterion | ||
| Coil Transfer | ||
| to | ||
| Microcatheter | The purpose of the test is to evaluate the | |
| introducer sheath for allowing for insertion of | ||
| the embolic coil into the microcatheter through | ||
| the RHV. | PASS: | |
| Samples passed the | ||
| established acceptance | ||
| criterion | ||
| Introducer | ||
| Flushing | The purpose of the test is to visually inspect to | |
| confirm flushing. | PASS: | |
| Samples passed the | ||
| established acceptance | ||
| criterion | ||
| Radiopacity | The purpose of the test is to verify the ability to | |
| visualize the coil under fluoroscopy for | ||
| physician to determine the location of the coil | ||
| during use. | PASS: | |
| Samples passed the | ||
| established acceptance | ||
| criterion | ||
| Overall Coil | ||
| Performance | The objective of the test is to evaluate | |
| physician's satisfaction rating on performance | ||
| compared to a predicate device. | PASS: | |
| Samples passed the | ||
| established acceptance | ||
| criterion | ||
| MRI Testing | The purpose of the test is to demonstrate that | |
| GALAXY G3 MINI Microcoil to be "MR- | ||
| conditional" according to the specific conditions | ||
| used for the assessment. | PASS: | |
| Samples passed the | ||
| established acceptance | ||
| criterion |
Shelf-Life Testing
Codman successfully completed accelerated aging testing to support a shelf life of 12 months. Finished sterile devices were subjected to environmental conditioning, simulated transportation and accelerated aging before being tested.
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VII. Performance Packaging
Data (Cont.)
The modification to the current packaging consists of a change in pouch material due to the change in sterilization method from e-beam to ethylene oxide. Utilizing previously validated pouch material used in the same sterilization cycle (K021591), the new packaging configuration 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.
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" (ISO 10993-1:2009/2010AC), and FDA's Guidance Document entitled "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (June 16. 2016).
The following tests were performed:
- ISO MEM Elution
- Hemocompatibility Tests ●
- O In Vitro Hemolysis Direct Contact (ASTM F756)
- O In Vitro Hemolysis - Extract
- In Vivo Thromboresistance O
- Chemical Characterization of Extractables (ISO 10993-18)
Sterilization
The GALAXY G3 Mini Microcoil System is ethylene oxide sterilized and was validated to assure a Sterility Assurance Level (SAL) 10-6 according to the requirements of International Standards ISO 11135-1 "Sterilization of Health Care Products Ethylene Oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, and ISO 10993-7 "Biological Evaluation of medical devices - Part 7: Ethylene Oxide sterilization residual" as recognized by FDA.
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VII. Performance Animal Study
Data (Cont.)
An animal study was not required as appropriate verification and validation of the GALAXY G3 Mini Microcoil Delivery System 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 GALAXY G3 Mini Microcoil Delivery System was achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Based upon the design, materials, function, intended use, performance, VIII. Conclusion manufacturing and sterilization process and the non-clinical testing performed by Codman, it is concluded that the GALAXY G3 Mini Microcoil Delivery Systems are substantially equivalent to the currently marketed CODMAN DELTAXSFT Microcoil Delivery Systems (K150319) and therefore, does not raise any new questions of safety or effectiveness.
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