(90 days)
K9993415, K002056
Not Found
No
The device description focuses on the physical characteristics and materials of the microcoil system, and the performance studies are based on non-clinical tests comparing it to predicate devices. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is intended for the endovascular embolization of intracranial aneurysms, which involves treating a medical condition to improve patient health.
No
The device is an embolic coil delivery system intended for the endovascular embolization of intracranial aneurysms, which is a therapeutic procedure, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including a platinum embolic coil, a Device Positioning Unit, a Connecting Cable, and a Detachment Control Box.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the endovascular embolization of intracranial aneurysms. This is a therapeutic procedure performed in vivo (within the body) to treat a medical condition.
- Device Description: The device is a physical implantable coil and its delivery system. It is designed to be placed inside the body to block blood flow to an aneurysm.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, tissue, etc.) or to provide information for diagnosis. Its purpose is purely interventional/therapeutic.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes
HCG
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 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: - 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.)
- 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-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.
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 self-grounded, 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 polyethylene (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 cycle 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
treating neurosurgical team
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
The non-clinical tests performed on the Coil System were based upon the intended use of the device, the performance of the predicate devices (GDC Soft and Ultra Soft Stretch-Resistant).
- Aneurysm Packing Ability & Detachment Reliability:
- Test result: No filling defects evident on angio. No premature detachment / auto-detach caused by exposure to blood, body fluids, body temperatures or repeated manipulation. 100% first detach-cycle detachment achieved.
- Substantially equivalent to Micrus predicate device.
- Coil Stability & Aneurysm Occlusion:
- Test result: Positional stability and aneurysm occlusion maintained through 6 months of implant. No coil compaction present at 6-month angio.
- Substantially equivalent to predicate devices.
- GDC Bench Marking:
- Test result: Showed substantial equivalence in delivery
force, tensile, and stiffness. - Substantially equivalent to GDC Benchmark.
- Test result: Showed substantial equivalence in delivery
- Coil Stiffness/Softness:
- Test result: Finishing Stretch Resistant MicroCoil and Helical Stretch Resistant MicroCoil stiffness is within desired stiffness limit.
- Substantially equivalent to predicate devices.
- Friction in the Microcatheter (Delivery Force):
- Test result: Finishing Stretch Resistant MicroCoil and Helical Stretch Resistant MicroCoil average push force exhibit comparable delivery forces.
- Substantially equivalent to predicate devices.
- MDR Database Review:
- Test result: MSR01 risk assessment includes and addresses all risks encountered in review of predicate device MDR review.
- Substantially equivalent to predicate devices.
- Biocompatibility of Materials:
- Test result: 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.
- Substantially equivalent to GDC predicate device.
- Sterilization Validation:
- Test result: Passed minimum sterility assurance level of 10-6.
- Substantially equivalent to predicate devices.
- Shelf Life Test:
- Test result: Minimum tensile strength after 1 year accelerated aging shows no degradation.
- Substantially equivalent to predicate devices.
- Tensile Strength:
- Test result: Tensile strength meets desired strength criteria.
- Substantially equivalent to predicate devices.
- Durability (Reliability after Fatigue):
- Test result: No knotting, no breakage, no stretching occurred. Durability meets desired durability criteria.
- Substantially equivalent to Micrus predicate device.
- MRI Compatibility of Implant:
- Test result: No change was made which would impact MRI compatibility.
- Substantially equivalent to predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K9993415, K002056
Reference Device(s)
Not Found
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
KOZURO
Page 1 of 12
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 | Clearance
Date |
|----------|-------------------------------------------------------------------------------------------------------------------------------|-------------------|
| K9993415 | GDC-10 and GDC-10 (2D) Stretch Resistant
Detachable 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
1
Page 2 of 12
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.
2
- KÜZZAZO
Pace 3 of 12
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
3
KP22420
Page 4 of 12
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.
4
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 of | |||
| Construction | 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 to | ||
| treat a variety of aneurysm sizes. | Various diameters and lengths | ||
| to treat a variety of aneurysm | |||
| sizes. | 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 Attachment | |||
| to Device Positioning | |||
| Unit | High tensile strength, highly | ||
| oriented polyethylene fiber. | Welded or soldered to wire. | Same as Micrus predicate | |
| Method of | |||
| Detachment from | |||
| DPU | Shear polyethylene fiber with a | ||
| loop of resistively heated coil. | Electrolytic corrosion of | ||
| positioning wire near junction of | |||
| implantable coil. | Same as Micrus predicate | ||
| Provided: | Sterile, single use | Sterile, single use | Same as predicates |
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5
| Uni |
|---|
| Positioning |
| ice |
| Dev |
| Device Positioning Unit
| Characteristic | Micrus MicroCoil Predicate | GDC Stretch Resistant Predicate | Micrus Stretch Resistant |
|---|---|---|---|
| Physical | Variable stiffness. | ||
| Composite introducer. | |||
| Most flexible distally, medium | |||
| flexibility in mid-section and | |||
| stiffest proximally to allow | |||
| pushing of the embolic coil | |||
| through the tortuous cerebral | |||
| vasculature. | Variable stiffness. | ||
| Guide wire introducer. | |||
| Most flexible distally, medium | |||
| flexibility in mid-section and | |||
| stiffest proximally to allow | |||
| pushing of the embolic coil | |||
| through the tortuous cerebral | |||
| vasculature. | Same as predicates | ||
| Construction | Stainless steel hypotube | ||
| (proximal), stainless steel braid | |||
| (mid) and polymer (distal) | |||
| sheathing for 2 conduction wires | |||
| and distal RH coil. | Variably ground stainless steel | ||
| wire, with polymer coverings in | |||
| the distal section to facilitate | |||
| electrochemical corrosion of wire | |||
| to release coil. | Same as Micrus predicate | ||
| Working Length | 175 cm | 175 cm | Same as predicates |
| Package | |||
| Configuration | In plastic packaging hoop. | ||
| Introducer in place (for | |||
| introduction of MicroCoil into the | |||
| microcatheter). | In plastic packaging hoop. | ||
| Introducer in place (for | |||
| introduction of coil into the | |||
| microcatheter). | Same as predicates | ||
| Compatible with: | Microcatheters with minimum | ||
| 0.14" i.d. ("10" sized systems), or | |||
| 0.16" i.d. ("18" sized systems). |
2 radiopaque tip markers 3 cm
apart (examples: Tracker 10,
Tracker 18, Excel 14, Prowler
10, Prowler 14). | Microcatheters with minimum
0.14" i.d. ("10" sized systems), or
0.16" i.d. ("18" sized systems).
2 radiopaque tip markers 3 cm
apart (examples: Tracker 10,
Tracker 18, Excel 14, Prowler
10, Prowler 14). | Same as predicates "10"
sized systems |
10022420 6 of 12 Page
6
| 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) to | |
| achieve 1 mA current through | |||
| device and patient ground | Same as Micrus predicate | ||
| Output Current | 125 mA nominal, 200 mA max. | Variable: Attempts to achieve 1 | |
| mA through device and patient | |||
| ground. | Same as Micrus predicate | ||
| Characteristic | Micrus MicroCoil Predicate | GDC Stretch Resistant Predicate | Micrus Stretch Resistant |
| "Detach" feedback | "Detach Cycle" light goes from | ||
| illuminated to off. Also, a beep | |||
| sounds once a second for 5 | |||
| seconds to provide an audible | |||
| countdown of the 5 second | |||
| detachment time. Clinician | |||
| verifies detachment | |||
| fluoroscopically per device | |||
| labeling. | Tone sounds and "Detach" light | ||
| goes on. Based upon voltages | |||
| seen during detachment cycle, | |||
| clinician may re-initiate | |||
| detachment cycle, or verifies | |||
| detachment fluoroscopically per | |||
| device labeling. | Same as Micrus predicate | ||
| Method to attach | |||
| Connecting Cable to | |||
| Detachment Box | Proprietary connector; fits only | ||
| one-way to assure proper polarity. | Banana plugs, one male, one | ||
| female to assure proper polarity. | Same as Micrus predicate | ||
| Flow of Current | From positive terminal, through | ||
| positive lead in connecting cable, | |||
| through positive conductor of | |||
| DPU, through resistance heating | |||
| coil, through negative conductor | |||
| of DPU, through negative lead in | |||
| connecting cable, back to | |||
| negative terminal of detachment | |||
| control box. | From positive terminal, through | ||
| positive connecting cable lead, | |||
| through stainless steel pusher | |||
| wire, through patient's circulatory | |||
| system to needle placed in | |||
| patient's blood vessel or a | |||
| grounding pad, through negative | |||
| connecting cable lead, back to | |||
| negative terminal of GDC Power | |||
| Supply box. | Same as Micrus predicate |
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റ്റ
7
: ۱۱ Recistant Micro 1 nt Co Detach
K022420
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8
Micrus Corporatio
| Accessories |
|---|
| Characteristic | Micrus MicroCoil Predicate | GDC Stretch Resistant Predicate | Micrus Stretch Resistant Predicate |
|---|---|---|---|
| Accessory Products | |||
| Required to Perform | |||
| Procedure. | 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 part | |||
| of the system, chosen | |||
| upon physician | |||
| experience and | |||
| preference. | Microcatheter (see above)* | Microcatheter (see above)* | Same as predicates |
| Guide wire compatible with | |||
| microcatheter* | Guide wire compatible with | ||
| microcatheter* | Same as predicates | ||
| Continuous saline/heparin saline | |||
| flush* | Continuous saline/heparin saline | ||
| flush* | 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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9
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 Equivalence
of MSR01 |
|--------------------|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| V0284-A | 1. Aneurysm Packing Ability
2. 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-detach
caused by exposure to blood, body fluids, body
temperatures or repeated manipulation. 100% first detach-
cycle detachment achieved. | Substantially equivalent
to Micrus predicate
device. |
| V0284-B
V0284-C | Coil Stability
Aneurysm Occlusion | Characteristic: Positional stability and aneurysm occlusion.
Test data: Positional stability and aneurysm occlusion
maintained through 6 months of implant. No coil compaction
present at 6-month angio. | Substantially equivalent
to predicate devices. |
| V0288 | GDC Bench Marking | Characteristic: Established specifications for delivery force,
tensile strength, and stiffness. The Micrus Stretch Resistant
MicroCoil must be substantially equivalent to predicates.
Test data: Showed substantial equivalence in delivery
force, tensile, and stiffness. | Substantially equivalent
to GDC Benchmark. |
10 of 12
Page
10
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 Stretch
Resistant MicroCoil.
Test data: Finishing Stretch Resistant MicroCoil and Helical
Stretch Resistant MicroCoil stiffness is within desired
stiffness limit. | V0290-A
V0290-B | Characteristic: Average push force must be substantially
equivalent to predicates.
Test data: Finishing Stretch Resistant MicroCoil and Helical
Stretch Resistant MicroCoil average push force exhibit
comparable delivery forces. | V0295 | Characteristic: MDR review for clinical risks.
Test data: MSR01 risk assessment includes and addresses
all risks encountered in review of predicate device MDR
review. | V0298 | Characteristics: Meets the requirements of ISO 10993.
Test data: 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. | V0301 | Characteristic: Minimum Sterility Assurance Level of 10-6.
Test data: Passed minimum sterility assurance level of 10-6. |
| | Substantially equivalent
to predicate devices. | | Substantially equivalent
to predicate devices. | | Substantially equivalent
to predicate devices. | | Substantially equivalent
to GDC predicate device. | | Substantially equivalent
to predicate devices. |
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| V0302 | Shelf Life Test | Characteristic: No performance degradation after 1 year of
shelf life aging.
Test data: Minimum tensile strength after 1 year
accelerated aging shows no degradation. | Substantially equivalent
to predicate devices. |
|-------|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| V0304 | Tensile Strength | Characteristic: Tensile strength of suture ball tip and
MicroCoil to DPU must be substantially equivalent to
predicates.
Test data: Tensile strength meets desired strength criteria. | Substantially equivalent
to predicate devices. |
| V0305 | Durability (Reliability after
Fatigue) | Characteristic: Withstand deployment and retraction 6
times in a tortuous anatomy.
Test data: No knotting, no breakage, no stretching occurred.
Durability meets desired durability criteria. | Substantially equivalent
to Micrus predicate
device. |
| V0026 | MRI Compatibility of
Implant | No change was made which would impact MRI
compatibility. | Substantially equivalent
to 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.
13
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
14
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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