(90 days)
The Micrus Stretch-Resistant MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms that – because of their morphology, their location or the patient's general medical condition -- are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques or b) inoperable.
The Micrus Stretch Resistant MicroCoil System consists of a platinum embolic coil ("MicroCoil") attached to a Device Positioning Unit (DPU) (single use, sterile). The Micrus Stretch Resistant MicroCoil System connects to a Micrus Connecting Cable (single use, sterile) which traverses the sterile field to connect to a Micrus Detachment Control Box (DCB) (reusable, non-sterile). The Connecting Cable and Detachment Control Box are sold separately. The Micrus Stretch-Resistant MicroCoils are available in a 10-System size, compatible with 10 and 14 sized microcatheters. They are helically shaped and are available in various diameters/dimensions. Coil lengths range from 1 to 15 centimeters and diameters range from 2 to 10 millimeters. The Stretch Resistant MicroCoils are available in two levels of softness: 1. The Micrus Soft, Stretch-Resistant MicroCoil (catalog # FSR) corresponds to the 10-System GDC Ultra Soft Stretch Resistant Coil, using a primary wind of 0.0015" to create softness. 2. The Standard Micrus Stretch-Resistant MicroCoil (catalog # HSR) corresponds to the 10-System GDC Soft, Stretch Resistant coil, using a primary wind of 0.00175". Micrus Stretch Resistant MicroCoils are fabricated from a platinum alloy wire, which is first wound into a primary coil (containing a non absorbable polypropylene suture inside the wind) and then formed into a secondary helical shape. The Micrus Stretch-Resistant MicroCoil System is identical to the FDAcleared MicroCoil System with the 4 following exceptions: 1. The coil's primary wind wire diameter has been reduced from 0.00175" to 0.0015" to create softness in the Micrus Soft Stretch-Resistant MicroCoil. (The Standard Micrus Stretch-Resistant MicroCoil uses the same 0.00175" diameter primary wind as is used in the Micrus 10-System Helical MicroCoil.) 2. A non absorbable polypropylene suture has been inserted inside the primary wind coil to create stretch-resistance. 3. The polypropylene suture is connected to the distal coil end to make a non-traumatic distal ball tip. 4. A loop of polypropylene suture has been added to the socket/ring connection at the coil to Device Positioning Unit junction to secure the polypropylene suture to the Device Positioning Unit.
The Micrus Stretch-Resistant MicroCoil System (MSR01) underwent several non-clinical tests to demonstrate its safety and effectiveness, and substantial equivalence to predicate devices (GDC Soft and Ultra Soft Stretch-Resistant). The study primarily focuses on bench testing and comparisons to established specifications of predicate devices rather than human clinical trials.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Characteristic) | Reported Device Performance (Test Data) |
|---|---|---|
| Aneurysm Packing Ability | Complete occlusion of aneurysms. | No filling defects evident on angio. |
| Detachment Reliability | No premature detachment / auto-detach caused by exposure to blood, body fluids, body temperatures, or repeated manipulation. 100% first detach-cycle detachment achieved. | 100% first detach-cycle detachment achieved. |
| Coil Stability & Aneurysm Occlusion | Positional stability and aneurysm occlusion maintained through 6 months of implant. No coil compaction. | Positional stability and aneurysm occlusion maintained through 6 months of implant. No coil compaction present at 6-month angio. |
| GDC Bench Marking | Established specifications for delivery force, tensile strength, and stiffness. The Micrus Stretch Resistant MicroCoil must be substantially equivalent to predicates. | Showed substantial equivalence in delivery force, tensile, and stiffness. |
| Coil Stiffness/Softness | Stiffness limit desired for Finishing Stretch Resistant MicroCoil. | Finishing Stretch Resistant MicroCoil and Helical Stretch Resistant MicroCoil stiffness is within desired stiffness limit. |
| Friction in the Microcatheter (Delivery Force) | Average push force must be substantially equivalent to predicates. | Finishing Stretch Resistant MicroCoil and Helical Stretch Resistant MicroCoil average push force exhibit comparable delivery forces. |
| MDR Database Review | MDR review for clinical risks. MSR01 risk assessment includes and addresses all risks encountered in review of predicate device MDR review. | MSR01 risk assessment includes and addresses all risks encountered in review of predicate device MDR review. |
| Biocompatibility of Materials | Meets the requirements of ISO 10993. The new material (polypropylene monofilament # 6523) must be identical to the pre-approved GDC stretch resistant suture. | The only new material in the Micrus Stretch Resistant MicroCoil is polypropylene monofilament # 6523. It is identical to the pre-approved GDC stretch resistant suture. |
| Sterilization Validation | Minimum Sterility Assurance Level of 10^-6^. | Passed minimum sterility assurance level of 10^-6^. |
| Shelf Life Test | No performance degradation after 1 year of shelf life aging. | Minimum tensile strength after 1 year accelerated aging shows no degradation. |
| Tensile Strength | Tensile strength of suture ball tip and MicroCoil to DPU must be substantially equivalent to predicates. | Tensile strength meets desired strength criteria. |
| Durability (Reliability after Fatigue) | Withstand deployment and retraction 6 times in a tortuous anatomy. No knotting, no breakage, no stretching. | No knotting, no breakage, no stretching occurred. Durability meets desired durability criteria. |
| MRI Compatibility of Implant | No change was made which would impact MRI compatibility. (Compared to predicate devices) | No change was made which would impact MRI compatibility (Therefore, assumed to be compatible based on predicate device compatibility, as mentioned in the "Technological Comparison" table under "Implantable Embolic Coil"). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical bench testing.
- Sample Size for Test Set: The exact sample sizes for each specific test (e.g., number of coils tested for detachment, number of "implants" for coil stability) are not explicitly stated in numerical terms (e.g., 100 coils, 20 coils). However, the narrative implies a sufficient quantity of samples were tested to generate the "Test data" against the "Characteristics" (acceptance criteria).
- Data Provenance: The data is from non-clinical bench tests performed on the "Micrus Stretch-Resistant Delivery System (MSR01)". This indicates the data was generated in a lab setting, likely within the manufacturing facility or a contracted testing facility, rather than from human patients. The document does not specify a country of origin beyond "Micrus Corporation" in Mountain View, California, USA. The data is prospective in the sense that the tests were conducted specifically for this submission to prove performance against established criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The concept of "ground truth established by experts" typically applies to clinical studies or image-based diagnostic systems. For these non-clinical, bench-level performance tests:
- Number of Experts: Not applicable in the context of establishing ground truth for these types of engineering and material performance tests.
- Qualifications of Experts: The "ground truth" (acceptance criteria) for these non-clinical tests is established based on engineering specifications, recognized industry standards (e.g., ISO 10993 for biocompatibility, sterility assurance levels), and the established performance characteristics of the predicate devices. These criteria would be developed and validated by engineers, quality control specialists, and regulatory affairs personnel with expertise in medical device design, manufacturing, and testing, rather than clinical experts like radiologists.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are relevant for clinical studies, especially those involving human readers or subjective assessments. For these non-clinical bench tests:
- Adjudication Method: Not applicable. The results are typically quantitative measurements against objective criteria (e.g., "no filling defects," "100% first detach-cycle detachment," "within desired stiffness limit"). The determination of whether a test "passed" or "failed" is based on meeting these pre-defined, measurable criteria, not on expert consensus or adjudication of subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly focuses on non-clinical tests and substantial equivalence to predicate devices based on technological characteristics and bench performance.
- Effect Size of Human Readers with/without AI: This information is not applicable as no MRMC study or AI component is mentioned.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance: No, a standalone algorithm performance study was not done. The device is a physical medical implant (microcoil system), not a software algorithm.
7. Type of Ground Truth Used
For the non-clinical tests described:
- Ground Truth: The "ground truth" is defined by engineering specifications, material science standards (e.g., ISO 10993, sterility standards), and established performance characteristics of the legally marketed predicate devices. For example, "complete occlusion of aneurysms" (as assessed in a simulated environment or animal model for aneurysm packing ability), "10^-6^ Sterility Assurance Level," and "delivery force, tensile strength, and stiffness" that are comparable to predicate devices. This is a form of objective, pre-defined technical and biological performance criteria.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. The device is a physical medical device, not a machine learning model, so there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
- Establishment of Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
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Safety and Effectiveness Summary 11.
A. Contact Information
Marqaret Webber Director, Regulatory and Clinical Affairs Micrus Corporation 495 Clyde Avenue Mountain View, CA 94043
B. Device Name
Micrus Stretch-Resistant MicroCoil System, MSR01
Device, Artificial Embolization
Regulation Number: 882.5950
Product Code: HCG
Device Class: III
C. Predicate Device(s)
| Number | Description | ClearanceDate |
|---|---|---|
| K9993415 | GDC-10 and GDC-10 (2D) Stretch ResistantDetachable Coils and GDC-18 and GDC-18(2D) Stretch Resistant Detachable Coils | 01/21/2000 |
| K002056 | Micrus MicroCoil Delivery System | 01/11/2001 |
D. Device Description
The Micrus Stretch Resistant MicroCoil System consists of a platinum embolic coil ("MicroCoil") attached to a Device Positioning Unit (DPU) (single use, sterile),
The Micrus Stretch Resistant MicroCoil System connects to a Micrus Connecting Cable (single use, sterile) which traverses the sterile field to connect to a Micrus Detachment Control Box (DCB) (reusable, non-sterile). The Connecting Cable and Detachment Control Box are sold separately.
The Micrus Stretch-Resistant MicroCoils are available in a 10-System size, compatible with 10 and 14 sized microcatheters. They are helically shaped and are available in various diameters/dimensions. Coil lengths range from 1 to 15 centimeters and diameters range from 2 to 10 millimeters. The Stretch Resistant MicroCoils are available in two levels of softness:
-
- The Micrus Soft, Stretch-Resistant MicroCoil (catalog # FSR) corresponds to the 10-System GDC Ultra Soft Stretch Resistant Coil, using a primary wind of 0.0015" to create softness.
-
- The Standard Micrus Stretch-Resistant MicroCoil (catalog # HSR) corresponds to the 10-System GDC Soft, Stretch Resistant coil, using a primary wind of 0.00175".
Micrus Stretch Resistant MicroCoils are fabricated from a platinum allov wire. which is first wound into a primary coil (containing a non absorbable polypropylene suture inside the wind) and then formed into a secondary helical
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K022420
shape. The Micrus Stretch-Resistant MicroCoil System is identical to the FDAcleared MicroCoil System with the 4 following exceptions:
- The coil's primary wind wire diameter has been reduced from 0.00175" to 1. 0.0015" to create softness in the Micrus Soft Stretch-Resistant MicroCoil. (The Standard Micrus Stretch-Resistant MicroCoil uses the same 0.00175" diameter primary wind as is used in the Micrus 10-System Helical MicroCoil.)
-
- A non absorbable polypropylene suture has been inserted inside the primary wind coil to create stretch-resistance.
- The polypropylene suture is connected to the distal coil end to make a non-ന് traumatic distal ball tip.
-
- A loop of polypropylene suture has been added to the socket/ring connection at the coil to Device Positioning Unit junction to secure the polypropylene suture to the Device Positioning Unit. A diagram of the socket/ring connection is provided below.
Diagram of Predicate MicroCoil Socket/Ring Connection
Image /page/1/Figure/8 description: The image shows a diagram of two loops, one labeled "Loop from DPU" and the other labeled "Platinum loop from MicroCoil". The "Loop from DPU" is a circular loop, while the "Platinum loop from MicroCoil" is a more complex shape with a rectangular section. Arrows point from the labels to the corresponding loops in the diagram.
Diagram of Micrus Stretch Resistant MicroCoil Socket/Ring Connection
Image /page/1/Figure/10 description: The image shows a diagram of a loop from DPU, a polyethylene suture, and a platinum loop from MicroCoil. The loop from DPU is on the left side of the image, and the polyethylene suture is in the middle. The platinum loop from MicroCoil is on the right side of the image. The diagram is labeled with arrows pointing to each of the components.
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The Stretch-Resistant MicroCoils are provided attached to a Device Positioning Unit (DPU). The Device Positioning Unit is unchanged from the original FDA cleared Micrus product. The Device Positioning Unit is designed with variable stiffness: It is most stiff at the proximal end for pushability, transitions to increased flexibility in the mid-section, and becomes most flexible at the distal end for successfully navigating the tortuosity of the cerebral vasculature. The Device Positioning Unit is fabricated from various materials including stainless steel, nitinol, platinum and polymer sheathing. It contains 2 copper conductor wires down the center, which carry the electrical energy to a platinum resistive heating coil on the distal tip of the device. The Device Positioning Unit is selfarounded, requiring no external grounding through the patient, a grounding pad, etc.
The Stretch-Resistant MicroCoil is detached from the Device Positioning Unit through a heat initiated shearing of a highly oriented, high tensile strength polvethylene (PE) fiber upon the clinician's command, once the coil is deployed into the aneurysm as desired. The Device Positioning Unit is then removed from the microcatheter and discarded. The detachment process and design is identical to the original FDA cleared Micrus products except the detachment time is reduced from 10 seconds to 5 seconds. The 5-second detachment time applies to all Micrus MicroCoil Systems.
The Detachment Control Box (DCB) is a self-contained, battery-operated device, which provides the controlled electrical energy for detachment of the MicroCoil from the Device Positioning Unit. The Detachment Control Box is unchanged from the original FDA cleared device. During aneurysm embolization, the Detachment Control Box remains outside of the sterile field (as is the case with the predicate system). The Detachment Control Box has no user adjustments for output voltage, output current or detachment cvcle time. It has an on/off button, and a detach cycle start button, as well as voltage and current displays and fault and low battery indicators. When the clinician depresses the detach button, the Detachment Control Box outputs a constant voltage of 6.5 VDC at a nominal current of 125mA for 5 seconds. The delivered electrical energy serves to heat a platinum resistive heating coil at the distal end of the DPU, thereby initiating a heat shearing of the PE fiber which holds the MicroCoil to the Device Positioning Unit. Once the fiber shears, the MicroCoil is free from the Device Positioning Unit ("detached"), and the Device Positioning Unit is withdrawn and discarded.
The Connecting Cable (CCB) is used to connect the MicroCoil System to the Detachment Control Box. The Connecting Cable is unchanged from the original FDA cleared Micrus device. It utilizes proprietary connectors to prevent accidental or inappropriate connections to other devices. It traverses from the MicroCoil System (which is within the sterile field) to the Detachment Control Box (which is outside the sterile field). The Connecting Cable is provided sterile, and discarded after a single patient treatment.
E. Intended Use
The Micrus Stretch-Resistant MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms that - because of their morphology, their location or the patient's general medical condition -- are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques or b) inoperable.
4
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Intended Use Predicate Devices F.
The predicate MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms that - because of their morphology, their location or the patient's general medical condition - are considered by the treating neurosurgical team to be
- very high risk for management by traditional operative techniques, or a)
- inoperable. b)
0264 4 and
The predicate Guglielmi Detachable Coil is intended for embolization of those intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition – are considered by the treating neurosurgical team to be
a) very high risk for management by traditional operative techniques, or b) inoperable,
and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature. The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.
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Technological Comparison
MicroCoil System G.
Microsystem
| Characteristic | Micrus MicroCoil Predicate | GDC Stretch Resistant Predicate | Micrus Stretch Resistant |
|---|---|---|---|
| How Supplied | Sterile, Single Use | Sterile, Single Use | Same as predicates |
| MicroCoil attached to DPU. | Coil attached to pusher wire. | Same as Micrus predicate | |
| Polyethylene introducer over coil. | Polyethylene introducer over coil. | Same as predicates | |
| In plastic packaging hoop. | In plastic packaging hoop. | Same as predicates |
mplantable Embolic Coi
| Characteristic | Micrus MicroCoil Predicate | GDC Stretch Resistant Predicate | Micrus Stretch Resistant |
|---|---|---|---|
| Materials ofConstruction | Platinum/Tungsten alloy wire &Au/Sn solder. | Platinum/Tungsten alloy wire &Au/Sn solder. | Same as predicates |
| Polypropylene suture. | Same as GDC predicate | ||
| Shape | 2 mm – 30 mm | 2 mm – 30 mm | 1 mm – 15 mm |
| Dimensions | Various diameters and lengths totreat a variety of aneurysm sizes. | Various diameters and lengthsto treat a variety of aneurysmsizes. | Same as predicates |
| Radiopacity | Radiopaque from Pt alloy wire. | Radiopaque from Pt alloy wire. | Same as predicates |
| MRI Compatibility | Yes | Yes | Same as predicates |
| Method of Attachmentto Device PositioningUnit | High tensile strength, highlyoriented polyethylene fiber. | Welded or soldered to wire. | Same as Micrus predicate |
| Method ofDetachment fromDPU | Shear polyethylene fiber with aloop of resistively heated coil. | Electrolytic corrosion ofpositioning wire near junction ofimplantable coil. | Same as Micrus predicate |
| Provided: | Sterile, single use | Sterile, single use | Same as predicates |
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| Uni |
|---|
| Positioning |
| ice |
| Dev |
| Device Positioning UnitCharacteristic | Micrus MicroCoil Predicate | GDC Stretch Resistant Predicate | Micrus Stretch Resistant |
|---|---|---|---|
| Physical | Variable stiffness.Composite introducer.Most flexible distally, mediumflexibility in mid-section andstiffest proximally to allowpushing of the embolic coilthrough the tortuous cerebralvasculature. | Variable stiffness.Guide wire introducer.Most flexible distally, mediumflexibility in mid-section andstiffest proximally to allowpushing of the embolic coilthrough the tortuous cerebralvasculature. | Same as predicates |
| Construction | Stainless steel hypotube(proximal), stainless steel braid(mid) and polymer (distal)sheathing for 2 conduction wiresand distal RH coil. | Variably ground stainless steelwire, with polymer coverings inthe distal section to facilitateelectrochemical corrosion of wireto release coil. | Same as Micrus predicate |
| Working Length | 175 cm | 175 cm | Same as predicates |
| PackageConfiguration | In plastic packaging hoop.Introducer in place (forintroduction of MicroCoil into themicrocatheter). | In plastic packaging hoop.Introducer in place (forintroduction of coil into themicrocatheter). | Same as predicates |
| Compatible with: | Microcatheters with minimum0.14" i.d. ("10" sized systems), or0.16" i.d. ("18" sized systems).2 radiopaque tip markers 3 cmapart (examples: Tracker 10,Tracker 18, Excel 14, Prowler10, Prowler 14). | Microcatheters with minimum0.14" i.d. ("10" sized systems), or0.16" i.d. ("18" sized systems).2 radiopaque tip markers 3 cmapart (examples: Tracker 10,Tracker 18, Excel 14, Prowler10, Prowler 14). | Same as predicates "10"sized systems |
10022420 6 of 12 Page
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| Characteristic | Micrus MicroCoil Predicate | GDC Stretch Resistant Predicate | Micrus Stretch Resistant |
|---|---|---|---|
| How supplied | Sterile, single use | Sterile, single use | Same as predicates |
| Physical | Single cable with proprietary connectors to fit only the Micrus Detachment Control Box and the Micrus MicroCoil System | Two separate cables with proprietary connectors at one end to fit the GDC Power Supply, "Test Lead Clip" type connector to grasp pusher wire and patient grounding electrode | Same as Micrus predicate |
| Length | 262 cm. | 152 and 274 cm. | Same as Micrus predicate |
Connecting Cables (Unchanged for Micrus Stretch Resistant MicroCol
d for Micrus Stretch Resistant MicroCoil) rol Roy //Incha Date
| Detachment Control Box (Unchanged for Micrus Stretch Resistant MicroCoil) | |||
|---|---|---|---|
| Characteristic | Micrus MicroCoil Predicate | GDC Stretch Resistant Predicate | Micrus Stretch Resistant |
| How supplied | Non-Sterile, reusable. | Non-Sterile, reusable. | Same as predicates |
| Used outside the sterile field. | Used outside the sterile field. | Same as predicates | |
| Power Source | Alkaline batteries. | Alkaline batteries. | Same as predicates |
| Displays | Voltage, Current, Low Battery,Fault, Detach Cycle | Voltage, Current, Low Battery,Fault (Check), Detach Time | Same as Micrus predicate |
| Detachment Cycle Duration | 5 seconds | Variable (could be more than 60 minutes) | Same as Micrus predicate |
| Output Voltage | 6.5 VDC | Variable (up to 7.4 VDC) toachieve 1 mA current throughdevice and patient ground | Same as Micrus predicate |
| Output Current | 125 mA nominal, 200 mA max. | Variable: Attempts to achieve 1mA through device and patientground. | Same as Micrus predicate |
| Characteristic | Micrus MicroCoil Predicate | GDC Stretch Resistant Predicate | Micrus Stretch Resistant |
| "Detach" feedback | "Detach Cycle" light goes fromilluminated to off. Also, a beepsounds once a second for 5seconds to provide an audiblecountdown of the 5 seconddetachment time. Clinicianverifies detachmentfluoroscopically per devicelabeling. | Tone sounds and "Detach" lightgoes on. Based upon voltagesseen during detachment cycle,clinician may re-initiatedetachment cycle, or verifiesdetachment fluoroscopically perdevice labeling. | Same as Micrus predicate |
| Method to attachConnecting Cable toDetachment Box | Proprietary connector; fits onlyone-way to assure proper polarity. | Banana plugs, one male, onefemale to assure proper polarity. | Same as Micrus predicate |
| Flow of Current | From positive terminal, throughpositive lead in connecting cable,through positive conductor ofDPU, through resistance heatingcoil, through negative conductorof DPU, through negative lead inconnecting cable, back tonegative terminal of detachmentcontrol box. | From positive terminal, throughpositive connecting cable lead,through stainless steel pusherwire, through patient's circulatorysystem to needle placed inpatient's blood vessel or agrounding pad, through negativeconnecting cable lead, back tonegative terminal of GDC PowerSupply box. | Same as Micrus predicate |
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Micrus Corporatio
| Accessories |
|---|
| Characteristic | Micrus MicroCoil Predicate | GDC Stretch Resistant Predicate | Micrus Stretch Resistant Predicate |
|---|---|---|---|
| Accessory ProductsRequired to PerformProcedure. | Micrus Sterile Connecting Cable | Sterile Connecting Cables for GDC | Same as Micrus predicate |
| Micrus Detachment Control Box | GDC Power Supply | Same as Micrus predicate | |
| 5-7F Guide Catheter | 5-7F Guide Catheter* | Same as predicates | |
| Not provided as partof the system, chosenupon physicianexperience andpreference. | Microcatheter (see above)* | Microcatheter (see above)* | Same as predicates |
| Guide wire compatible withmicrocatheter* | Guide wire compatible withmicrocatheter* | Same as predicates | |
| Continuous saline/heparin salineflush* | Continuous saline/heparin salineflush* | Same as predicates | |
| Rotating haemostatic valves* | Rotating haemostatic valves* | Same as predicates | |
| 3-Way stopcock* | 3-Way stopcock* | Same as predicates | |
| 1-Way valve* | 1-Way valve* | Same as predicates | |
| IV pole* | IV pole* | Same as predicates | |
| Femoral Sheath* | Femoral Sheath* | Same as predicates | |
| Alkaline Batteries* | Alkaline Batteries* | Same as predicates |
This technological comparison de substanially equivalent technologies used in the Micros Stretch-Resistant MicroCol
Delivery System as compared with the 2 predicate devices:
KU22420
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icrus Corporatio
i :
scussion of Non-Clinical Tests and Conclusion ਮ
2.77
he no-clinical tests performed on the Coil System were based upon the intended use of the device, the perform
ne predicate devices (GDC Soft and Ultra Soft Stretch-Resistant
e following table outlines the important device characteristics and the non-clinical test data generati
| Test | MicroCoil Stretch-Resistant Delivery System (MSR01)Test Result | Substantial Equivalenceof MSR01 | |
|---|---|---|---|
| V0284-A | 1. Aneurysm Packing Ability2. Detachment Reliability | Characteristic: (1) Complete occlusion aneurysms.(2) Detachment Reliability.Test data (1): No filling defects evident on angio.Test data (2): No premature detachment / auto-detachcaused by exposure to blood, body fluids, bodytemperatures or repeated manipulation. 100% first detach-cycle detachment achieved. | Substantially equivalentto Micrus predicatedevice. |
| V0284-BV0284-C | Coil StabilityAneurysm Occlusion | Characteristic: Positional stability and aneurysm occlusion.Test data: Positional stability and aneurysm occlusionmaintained through 6 months of implant. No coil compactionpresent at 6-month angio. | Substantially equivalentto predicate devices. |
| V0288 | GDC Bench Marking | Characteristic: Established specifications for delivery force,tensile strength, and stiffness. The Micrus Stretch ResistantMicroCoil must be substantially equivalent to predicates.Test data: Showed substantial equivalence in deliveryforce, tensile, and stiffness. | Substantially equivalentto GDC Benchmark. |
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Micrus Corporation
| Coil Stiffness/Softness | Friction in the Microcatheter(Delivery Force) | MDR Database Review | Biocompatibility of Materials | Sterilization Validation | |||||
|---|---|---|---|---|---|---|---|---|---|
| V0289 | Characteristic: Stiffness limit desired for Finishing StretchResistant MicroCoil.Test data: Finishing Stretch Resistant MicroCoil and HelicalStretch Resistant MicroCoil stiffness is within desiredstiffness limit. | V0290-AV0290-B | Characteristic: Average push force must be substantiallyequivalent to predicates.Test data: Finishing Stretch Resistant MicroCoil and HelicalStretch Resistant MicroCoil average push force exhibitcomparable delivery forces. | V0295 | Characteristic: MDR review for clinical risks.Test data: MSR01 risk assessment includes and addressesall risks encountered in review of predicate device MDRreview. | V0298 | Characteristics: Meets the requirements of ISO 10993.Test data: The only new material in the Micrus StretchResistant MicroCoil is polypropylene monofilament # 6523.It is identical to the pre-approved GDC stretch resistantsuture. | V0301 | Characteristic: Minimum Sterility Assurance Level of 10-6.Test data: Passed minimum sterility assurance level of 10-6. |
| Substantially equivalentto predicate devices. | Substantially equivalentto predicate devices. | Substantially equivalentto predicate devices. | Substantially equivalentto GDC predicate device. | Substantially equivalentto predicate devices. |
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| V0302 | Shelf Life Test | Characteristic: No performance degradation after 1 year ofshelf life aging.Test data: Minimum tensile strength after 1 yearaccelerated aging shows no degradation. | Substantially equivalentto predicate devices. |
|---|---|---|---|
| V0304 | Tensile Strength | Characteristic: Tensile strength of suture ball tip andMicroCoil to DPU must be substantially equivalent topredicates.Test data: Tensile strength meets desired strength criteria. | Substantially equivalentto predicate devices. |
| V0305 | Durability (Reliability afterFatigue) | Characteristic: Withstand deployment and retraction 6times in a tortuous anatomy.Test data: No knotting, no breakage, no stretching occurred.Durability meets desired durability criteria. | Substantially equivalentto Micrus predicatedevice. |
| V0026 | MRI Compatibility ofImplant | No change was made which would impact MRIcompatibility. | Substantially equivalentto predicate devices. |
(1) (1) (1) (1) (1) (1) (1) (1) (1) (1) Sustantaly equivalent performance of the MicroCoil Streth-Resistant MicroOol
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Image /page/12/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
00 Corporate Boulevard Rockville MD 20850
Ms. Margaret Webber Director, Regulatory & Clinical Affairs Micrus Corporation 495 Clyde Avenue Mountain View. California 94043
OCT 22 2002
Re: K022420
Trade/Device Name: Micrus Stretch-Resistant MicroCoil System Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: Class III Product Code: HCG Dated: July 16, 2002 Received: July 24, 2002
Dear Ms. Weber:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Ms. Margaret Webber
This letter will allow you to begin marketing your device as described in your Section 510(k). premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark M. Millenson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Micrus Corporation
Device Name: Micrus Stretch-Resistant MicroCoil System
510(k) Number (if known):
Indications for Use:
Stretch-Resistant MicroCoil System is intended for Micrus The endovascular embolization of intracranial aneurysms that – because of their morphology, their location or the patient's general medical condition are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques or b) inoperable.
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CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Over the Counter Use: or Prescription Use: \ (Per 21 CFR 801.109)
for Mark N. Milliken
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number K0224
§ 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).